FAIRsharing.m3g9n9; Last edited: Jan. 8, 2019, 1:35 p.m.; Last accessed: Jan 03 2022 7:13 p.m.

Other names: SPIRIT

This source may no longer be available. No known URL could be resolved successfully.

The protocol of a clinical trial is essential for study conduct, review, reporting, and interpretation. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.

Webpage:

http://www.spirit-statement.org/

Licence:

Name: Creative Commons Attribution-NonCommercial-NoDerivs 3.0 United States (CC BY-NC-ND 3.0 US)
URL: https://creativecommons.org/licenses/by-nc-nd/3.0/us/

Publications:

Publications
More detailed information about this field from each metasource.

SPIRIT 2013 statement: defining standard protocol items for clinical trials
PMID: 23295957
metasource: Fairsharing.org
version: FAIRsharing.org: SPIRIT; Standard Protocol Items: Recommendations for Interventional Trials; DOI: https://doi.org/10.25504/FAIRsharing.m3g9n9; Last edited: Jan. 8, 2019, 1:35 p.m.; Last accessed: Jan 03 2022 7:13 p.m.

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
PMID: 23303884
metasource: Fairsharing.org
version: FAIRsharing.org: SPIRIT; Standard Protocol Items: Recommendations for Interventional Trials; DOI: https://doi.org/10.25504/FAIRsharing.m3g9n9; Last edited: Jan. 8, 2019, 1:35 p.m.; Last accessed: Jan 03 2022 7:13 p.m.

SPIRIT 2013 statement: defining standard protocol items for clinical trials PubMed citations: 2112.

2112 articles citing: SPIRIT 2013 statement: defining standard protocol items for clinical trials

Effects of high frequency rTMS of contralesional dorsal premotor cortex in severe subcortical chronic stroke: protocol of a randomized controlled trial with multimodal neuroimaging assessments. PMID:35365121
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT): Study Protocol for a Multicenter, Two-Arm Parallel-Group Randomized Controlled Superiority Trial. PMID:35359909
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)-protocol for a multicenter, randomized, clinical, proof-of-concept trial. PMID:35351214
The UK stand together trial: protocol for a multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of KiVa to reduce bullying in primary schools. PMID:35351054
A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial. PMID:35351035
The Efficacy and Safety of Phase I Cardiac Rehabilitation in Patients Hospitalized in Cardiac Intensive Care Unit With Acute Decompensated Heart Failure: A Study Protocol for a Randomized, Controlled, Clinical Trial. PMID:35350537
The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial. PMID:35346380
Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression-study protocol for a multi-site, cluster randomised controlled trial [TACK]. PMID:35346348
Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial. PMID:35337389
The NILS Study Protocol: A Retrospective Validation Study of an Artificial Neural Network Based Preoperative Decision-Making Tool for Noninvasive Lymph Node Staging in Women with Primary Breast Cancer (ISRCTN14341750). PMID:35328135
An evidence-based tailored eHealth patient education tool for patients with knee osteoarthritis: protocol for a randomized controlled trial. PMID:35317764
Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. PMID:35313988
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). PMID:35305587
Implementation of a strategy to facilitate effective medical follow-up for Australian First Nations children hospitalised with lower respiratory tract infections: study protocol. PMID:35300670
The effect of motor relearning on balance, mobility and performance of activities of daily living among post-stroke patients: Study protocol for a randomised controlled trial. PMID:35300258
Effect of targeted nutrient supplementation on physical activity and health-related quality of life in COPD: study protocol for the randomised controlled NUTRECOVER trial. PMID:35296491
Remote ischemic conditioning in necrotizing enterocolitis: study protocol of a multi-center phase II feasibility randomized controlled trial. PMID:35294595
Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol. PMID:35292085
EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation. PMID:35284389
The Effects of Comprehensive Home-Based Cardiac Rehabilitation versus Usual Care in Patients with Ischemic Heart Disease in Iran: Study Protocol for a Multicenter Randomized Controlled Trial. PMID:35281981
Integrating a web-based intervention into routine care of binge-eating disorder: Study protocol for a randomized controlled trial. PMID:35281702
Tolerance induction through early feeding to prevent food allergy in infants with eczema (TEFFA): rationale, study design, and methods of a randomized controlled trial. PMID:35279213
Pilot study to investigate the feasibility of conducting a randomised controlled trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute Anterior cruciate ligament injury: IODA pilot trial. PMID:35277406
Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP). PMID:35273049
Early mobilisation using a mobile patient lift in the intensive care unit: protocol for a randomised controlled trial. PMID:35264368
Hypnotherapy for procedural pain, itch, and state anxiety in children with acute burns: a feasibility and acceptability study protocol. PMID:35264248
Neuroimmune responses following joint mobilisation and manipulation in people with persistent neck pain: a protocol for a randomised placebo-controlled trial. PMID:35260459
Protocol summary and statistical analysis plan for Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults (INTENT): a phase II randomised controlled trial. PMID:35260448
The Physical Activity and Fitness in Childhood Cancer Survivors (PACCS) Study: Protocol for an International Mixed Methods Study. PMID:35258456
Randomized Study on the Efficacy of Standard Versus Low Roxadustat Dose for Anemia in Patients on Peritoneal Dialysis. PMID:35257058
Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial. PMID:35251938
ROBOCOP (ROBOtic Care of Poststroke Pain): Study Protocol for a Randomized Trial to Assess Robot-Assisted Functional and Motor Recovery and Impact on Poststroke Pain Development. PMID:35250820
Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial. PMID:35248012
Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol. PMID:35247960
Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial. PMID:35246425
The incremental value of the contribution of a biostatistician to the reporting quality in health research-A retrospective, single center, observational cohort study. PMID:35245326
Evaluation of short-term effects of three passive aquatic interventions on chronic non-specific low back pain: Study protocol for a randomized cross-over clinical trial. PMID:35243125
Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the treatment of panic disorder in adolescents (PANDA). PMID:35241182
Implementation of an ED surge management platform: a study protocol. PMID:35236510
Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students. PMID:35236397
Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a prospective, multicentre, single-blind, randomised controlled trial (TOP-IDDVT). PMID:35228291
Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial. PMID:35211010
Reporting Quality of Studies Developing and Validating Melanoma Prediction Models: An Assessment Based on the TRIPOD Statement. PMID:35206853
ICOnnecta't: Development and Initial Results of a Stepped Psychosocial eHealth Ecosystem to Facilitate Risk Assessment and Prevention of Early Emotional Distress in Breast Cancer Survivors' Journey. PMID:35205722
An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial. PMID:35200576
Effects of Transcranial Direct Current Stimulation on Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance in Healthy and Fibromyalgia Women: A Study Protocol. PMID:35200288
Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study. PMID:35200153
Designing industrial work to be 'just right' to promote health - a study protocol for a goldilocks work intervention. PMID:35197018
Efficacy of probucol on cognitive function in Alzheimer's disease: study protocol for a double-blind, placebo-controlled, randomised phase II trial (PIA study). PMID:35190446
Comparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: a protocol for a randomised controlled trial. PMID:35190407
Comparison of time-matched aerobic, resistance or combined exercise training in women living with obesity: a protocol for a pilot randomised controlled trial-the EXOFFIT (Exercise for Obesity in Females to increase Fitness) study. PMID:35189970
A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol. PMID:35189848
Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. PMID:35188478
Home Physical Exercise Protocol for Older Adults, Applied Remotely During the COVID-19 Pandemic: Protocol for Randomized and Controlled Trial. PMID:35185739
Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial. PMID:35183261
Effects of clown visits on stress and mood in children and adolescents in psychiatric care-Protocol for a pilot study. PMID:35180260
Effectiveness of Faith-Based Interventions on the Rate of Discharged Against Medical Advice in Tertiary Newborn Units in Nigeria: A Protocol for an Open Label Randomized Control Trial. PMID:35178371
Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. PMID:35177042
Prediction of Communication Impairment in Children With Bilateral Cerebral Palsy Using Multivariate Lesion- and Connectome-Based Approaches: Protocol for a Multicenter Prospective Cohort Study. PMID:35173593
Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial. PMID:35172875
Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. PMID:35172871
Effectiveness of a multifaceted intervention to improve interpersonal skills of physicians in medical consultations (EPECREM): protocol for a randomised controlled trial. PMID:35168969
Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: a randomised controlled trial. PMID:35168963
Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial. PMID:35164853
Randomised controlled trial of Interpersonal and Social Rhythm Therapy and group-based Cognitive Remediation versus Interpersonal and Social Rhythm Therapy alone for mood disorders: study protocol. PMID:35164720
A multifactorial interdisciplinary intervention to prevent functional and mobility decline for more participation in (pre-)frail community-dwelling older adults (PromeTheus): study protocol for a multicenter randomized controlled trial. PMID:35164686
'Physio-EndEA' Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis. PMID:35162761
Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials. PMID:35162416
Effects of Celecoxib Adjunct to Selective Serotonin Reuptake Inhibitors on Obsessive-Compulsive Disorder. PMID:35154589
A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients. PMID:35154365
Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol. PMID:35144958
Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial. PMID:35144662
Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2). PMID:35141317
Combined online interactive mindfulness and exercise programme (MOVE-Online) compared with a self-management guide for adults with chronic pain: protocol for a randomised controlled feasibility trial. PMID:35140163
Person-centred care provided by a multidisciplinary primary care team to improve therapeutic adequacy in polymedicated elderly patients (PCMR): randomised controlled trial protocol. PMID:35140146
Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial. PMID:35135619
The effect of combined action observation therapy and eccentric exercises in the treatment of mid-portion Achilles tendinopathy: study protocol for a feasibility pilot randomised controlled trial. PMID:35130966
The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. PMID:35130935
The Shishu Pushti Trial-Extended Peer Counseling for Improving Feeding Practices and Reducing Undernutrition in Children Aged 0-48 Months in Urban Bangladesh: Protocol for a Cluster-Randomized Controlled Trial. PMID:35129457
Registration and primary outcome reporting in behavioral health trials. PMID:35125101
Towards optimal treatment selection for borderline personality disorder patients (BOOTS): a study protocol for a multicenter randomized clinical trial comparing schema therapy and dialectical behavior therapy. PMID:35123450
Improving management of needle distress during the journey to dialysis through psychological education and training-the INJECT study feasibility pilot protocol. PMID:35120560
Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. PMID:35120559
The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial. PMID:35120457
Neural management plus advice to stay active on clinical measures and sciatic neurodynamic for patients with chronic sciatica: Study protocol for a controlled randomised clinical trial. PMID:35120149
Safety of intravenous tranexamic acid in patients undergoing supratentorial meningiomas resection: protocol for a randomised, parallel-group, placebo control, non-inferiority trial. PMID:35110315
Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT). PMID:35110309
Efficacy and safety of traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial. PMID:35109889
Protocol for a single-centre mixed-method pre-post single-arm feasibility trial of a culturally appropriate 6-week pulmonary rehabilitation programme among adults with functionally limiting chronic respiratory diseases in Malawi. PMID:35105655
Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly. PMID:35105643
Mobile health-based gamification intervention to increase physical activity participation among patients with coronary heart disease: study protocol of a randomised controlled trial. PMID:35105640
Investigating the effect of an online self-compassion for weight management (SC4WM) intervention on self-compassion, eating behaviour, physical activity and body weight in adults seeking to manage weight: protocol for a randomised controlled trial. PMID:35105594
Interdisciplinary, internet-based trans health care (i²TransHealth): study protocol for a randomised controlled trial. PMID:35105559
Moving on trial: protocol for a pilot randomised controlled trial of models of housing and support to reduce risks of COVID-19 infection and homelessness. PMID:35105383
MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial. PMID:35101085
Efficacy of acupuncture on cognitive function in poststroke depression: study protocol for a randomized, placebo-controlled trial. PMID:35090538
Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger. PMID:35090531
Effectiveness of a web-based behavioural activation intervention for individuals with depression based on the Health Action Process Approach: protocol for a randomised controlled trial with a 6-month follow-up. PMID:35074820
Chinese herbal medicine treatment based on subgroup differentiation as adjunct therapy for Parkinson's disease: study protocol of a pilot add-on, randomised, controlled, pragmatic clinical trial. PMID:35073963
The physical activity experience of prostate cancer patients: a multicentre peer motivation monitoring feasibility study. The Acti-Pair study. PMID:35063040
Evaluating 'Power 4 a Healthy Pregnancy' (P4HP) - protocol for a cluster randomized controlled trial and process evaluation to empower pregnant women towards improved diet quality. PMID:35062921
Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial. PMID:35058263
The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30-33 weeks gestational age). PMID:35057837
Mental imagery interventions to promote face covering use among UK university students and employees during the COVID-19 pandemic: study protocol for a randomized controlled trial. PMID:35042564
Effect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial. PMID:35039313
Camu Camu effects on microbial translocation and systemic immune activation in ART-treated people living with HIV: protocol of the single-arm non-randomised Camu Camu prebiotic pilot study (CIHR/CTN PT032). PMID:35039291
Study design and rationale for a cluster randomized trial of a safe child feces management intervention in rural Odisha, India. PMID:35033048
Human assumed central sensitisation (HACS) in patients with chronic low back pain radiating to the leg (CLaSSICO study). PMID:35027419
Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. PMID:35019846
Feasibility of delivering and evaluating stratified care integrated with telehealth ('Rapid Stratified Telehealth') for patients with low back pain: protocol for a feasibility and pilot randomised controlled trial. PMID:35017255
Effect of Early Supraglottic Airway Device Insertion on Chest Compression Fraction during Simulated Out-of-Hospital Cardiac Arrest: Randomised Controlled Trial. PMID:35011958
Compliance of Clinical Trial Protocols for Foods with Function Claims (FFC) in Japan: Consistency between Clinical Trial Registrations and Published Reports. PMID:35010956
China Registry Study on Cognitive Impairment in the Elderly: Protocol of a Prospective Cohort Study. PMID:35002683
Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain. PMID:34996786
Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost-utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study). PMID:34992118
DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial. PMID:34991688
Nurse-led self-management support after organ transplantation-protocol of a multicentre, stepped-wedge randomized controlled trial. PMID:34991680
Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Chemotherapy With and Without Sequential Cytoreductive Interventions for Patients with Oligometastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Levels. PMID:34988836
Vascular and neurosensory evaluation in relation to lingual canal anatomy after mandibular midline implant installation in edentulous patients. PMID:34985576
Value of ultra-high field MRI in patients with suspected focal epilepsy and negative 3 T MRI (EpiUltraStudy): protocol for a prospective, longitudinal therapeutic study. PMID:34984522
Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol. PMID:34983760
The combination of transcatheter arterial chemoembolisation (TACE) and thermal ablation versus TACE alone for hepatocellular carcinoma. PMID:34981511
A physiotherapy-led transition to home intervention for older adults following emergency department discharge: protocol for a pilot feasibility randomised controlled trial. PMID:34980285
Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial. PMID:34980237
Effect of different conditioning methods of traditional Chinese health exercise on lung function in healthy middle-aged and elderly people: study protocol for a randomized controlled trial. PMID:34980233
Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial). PMID:34980232
Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial. PMID:34980197
Serious game to promote socioemotional learning and mental health (emoTIC): a study protocol for randomised controlled trial. PMID:34972764
SPECT-CT metabolic and morphological study of 2 types of cemented hip stem prostheses in primary total hip arthroplasty patients: A protocol for a randomized controlled clinical trial (SPECT-PROTMA). PMID:34967362
Efficacy of Acupuncture in Post-partum With Diastasis Recti Abdominis: A Randomized Controlled Clinical Trial Study Protocol. PMID:34966711
A new strategy of enteral nutrition intervention for ICU patients targeting intestinal flora. PMID:34964735
Evaluation of efficacy and safety of Qiangzhu-qinggan formula as an adjunctive therapy in adult patients with severe influenza: study protocol for a randomized parallel placebo-controlled double-blind multicenter trial. PMID:34961550
Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial. PMID:34952881
Hemodynamic evaluation by serial right heart catheterizations after cardiac arrest; protocol of a sub-study from the Blood Pressure and Oxygenation Targets after Out-of-Hospital Cardiac Arrest-trial (BOX). PMID:34950913
Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial. PMID:34949603
Combined Korean medicine therapies in children with allergic rhinitis: A multi-center, observational explanatory registry trial: A study protocol. PMID:34941074
Reward During Arm Training Improves Impairment and Activity After Stroke: A Randomized Controlled Trial. PMID:34937456
A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial. PMID:34931994
Assessing Causal Pathways and Targets of Implementation Variability for EBP use (Project ACTIVE): a study protocol. PMID:34930483
Comparison of intradialytic neuromuscular electrical stimulation and oral nutritional supplements in hemodialysis patients: study protocol for a multicenter, parallel-group, randomized controlled trial in Korea. PMID:34930408
Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial. PMID:34930222
Omega-3 mechanism of action in inflammation and endoplasmic reticulum stress in mononuclear cells from overweight non-alcoholic fatty liver disease participants: study protocol for the "Brazilian Omega Study" (BROS)-a randomized controlled trial. PMID:34922604
Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial. PMID:34922588
Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial. PMID:34921084
Are orthodontic randomised controlled trials justified with a citation of an appropriate systematic review? PMID:34918200
Two-step versus 1-step subretinal injection to compare subretinal drug delivery: a randomised study protocol. PMID:34911710
Emotional Regulation in Teens and Improvement of Constructive Skills (EmoTIConS): study protocol for a randomized controlled trial. PMID:34906222
Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. PMID:34899612
Correlates of interpersonal emotion regulation problems in Loss of Control eating (LOC) in youth: study protocol of the combined online and App based questionnaire, laboratory and randomized controlled online intervention i-BEAT trial. PMID:34895337
Evaluation of the Intensive Treatment and Rehabilitation Program for Residential Treatment and Rehabilitation Centers (INTREPRET) in the Philippines: a study protocol for a randomized controlled trial. PMID:34895317
TIMELAPSE study-efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial. PMID:34895308
The Moo'D Study: protocol for a randomised controlled trial of A2 beta-casein only versus conventional dairy products in women with low mood. PMID:34895297
A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE). PMID:34877471
Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial. PMID:34872597
Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial. PMID:34863239
Protocol for #iBeatCRC: a community-based intervention to increase early-onset colorectal cancer awareness using a sequential explanatory mixed-methods approach. PMID:34862279
Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation. PMID:34857585
A Mobile App for Wound and Symptom Surveillance After Colorectal Surgery: Protocol for a Feasibility Randomized Controlled Trial. PMID:34854816
High Adherence to Mediterranean Diet Is Not Associated with an Improved Sodium and Potassium Intake. PMID:34836406
Multimodal brain imaging effect of "Adjust Zang-fu and Arouse Spirit" electroacupuncture on diabetic cognitive impairment: study protocol of a randomized, sham-controlled pilot trial. PMID:34823569
Effects of prismatic adaptation on balance and postural disorders in patients with chronic right stroke: protocol for a multicentre double-blind randomised sham-controlled trial. PMID:34819284
Efficacy of manual acupuncture versus placebo acupuncture for generalized anxiety disorder (GAD) in perimenopause women: study protocol for a randomized controlled trial. PMID:34819129
Feasibility and safety of an immersive virtual reality-based vestibular rehabilitation programme in people with multiple sclerosis experiencing vestibular impairment: a protocol for a pilot randomised controlled trial. PMID:34810187
Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial. PMID:34806998
Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation. PMID:34801063
A protocol for developing a core outcome set for ectopic pregnancy. PMID:34789295
Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial. PMID:34785545
Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. PMID:34781991
The effects of supervision on three different exercises modalities (supervised vs. home vs. supervised+home) in older adults: Randomized controlled trial protocol. PMID:34780532
Multimodal cerebral imaging study on the effects of "Adjust Zang Dredge Meridian" electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial. PMID:34774110
Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. PMID:34774099
Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer. PMID:34772747
Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial. PMID:34765229
Improving peer review of systematic reviews by involving librarians and information specialists: protocol for a randomized controlled trial. PMID:34763714
High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial. PMID:34758808
Protocol for a quasi-experimental study examining the effect of a ball skills intervention on four domains of preschooler development. PMID:34753530
The Manual Therapy and Strengthening for the Hip (MASH) Trial: Protocol for a Multisite Randomized Trial of a Subgroup of Older Adults With Chronic Back and Hip Pain. PMID:34751784
Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. PMID:34749822
A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial. PMID:34749762
SaeboGlove therapy for upper limb disability and severe hand impairment after stroke (SUSHI): Study protocol for a randomised controlled trial. PMID:34746427
Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial. PMID:34743745
Efficacy of abdomen-rubbing qigong exercise for chronic insomnia: study protocol for a randomized controlled trial. PMID:34742345
Beta-blockers in patients without heart failure after myocardial infarction. PMID:34739733
The Effect of Music Therapy on Perceived Pain, Mental Health, Vital Signs, and Medication Usage of Burn Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Feasibility Study Protocol. PMID:34733185
Observation of the curative effect of Guizhi-Shaoyao-Zhimu decoction combined with methotrexate in the treatment of early rheumatoid arthritis based on ultrasonic evaluation: study protocol of a randomized, double-blind, controlled clinical trial. PMID:34732237
Effectiveness of a Walking Football Program for Middle-Aged and Older Men With Type 2 Diabetes: Protocol for a Randomized Controlled Trial. PMID:34730549
Comparison of binocular game and patching in treating mild to moderate anisometropic amblyopia: a study protocol for a randomized controlled trial. PMID:34717748
Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE): study protocol for a randomized controlled trial of a bridge clinic compared with usual care for patients with opioid use disorder. PMID:34717736
Ergothioneine supplementation in people with metabolic syndrome (ErgMS): protocol for a randomised, double-blind, placebo-controlled pilot study. PMID:34715934
The Second Heart Program-A multidisciplinary team supporting people who inject drugs with infective endocarditis: Protocol of a feasibility study. PMID:34710094
Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial. PMID:34707516
Inconsistent and incomplete retraction of published research: A cross-sectional study on Covid-19 retractions and recommendations to mitigate risks for research, policy and practice. PMID:34705841
Clinical efficacy of 0.75% ropivacaine vs. 2% lignocaine hydrochloride with adrenaline (1:80,000) in patients undergoing removal of bilateral maxillary third molars: a randomized controlled trial. PMID:34703894
Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. PMID:34702336
Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. PMID:34693999
Effects of Dog-Assisted Therapy in Adolescents with Eating Disorders: A Study Protocol for a Pilot Controlled Trial. PMID:34679805
Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial. PMID:34674738
The effect of a multidisciplinary lifestyle program for patients with rheumatoid arthritis, an increased risk for rheumatoid arthritis or with metabolic syndrome-associated osteoarthritis: the "Plants for Joints" randomized controlled trial protocol. PMID:34663431
GoodReports: developing a website to help health researchers find and use reporting guidelines. PMID:34657590
Strategies for Empowering activities in Everyday life (SEE 1.0): study protocol for a feasibility study of an Internet-based occupational therapy intervention for people with stroke. PMID:34656173
Supported online cognitive behavioural therapy for bulimia nervosa: a study protocol of a randomised controlled trial. PMID:34649625
Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial. PMID:34649590
Effects of a nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) for adult burn survivors: protocol for a randomised controlled trial. PMID:34645512
Supporting participation in paid work of cancer survivors and their partners in the Netherlands: protocol of the SusTained Employability in cancer Patients and their partnerS (STEPS) multi-centre randomized controlled trial and cohort study. PMID:34641839
FullFix: a randomised controlled trial of a telephone delivered transdiagnostic intervention for comorbid substance and mental health problems in young people. PMID:34635511
Estimands in published protocols of randomised trials: urgent improvement needed. PMID:34627347
Comparative Efficacy of Jaungo, A Traditional Herbal Ointment, and the Water-in-Oil Type Non-Steroidal Moisturizer for Radiation-Induced Dermatitis in Patients With Breast Cancer: A Study Protocol for a Prospective, Randomized, Single-Blinded, Pilot Study. PMID:34621177
INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial. PMID:34620213
Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. PMID:34593497
Deep brain stimulation for locomotion in incomplete human spinal cord injury (DBS-SCI): protocol of a prospective one-armed multi-centre study. PMID:34593490
Feasibility, experiences and outcomes of using DIALOG+ in primary care to improve quality of life and mental distress of patients with chronic conditions: an exploratory non-controlled trial in Bosnia and Herzegovina, Colombia and Uganda. PMID:34593055
Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service. PMID:34593044
Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM). PMID:34588245
The effect of caregiver key opinion leaders on increasing caregiver demand for evidence-based practices to treat youth anxiety: protocol for a randomized control trial. PMID:34556182
Surgery for Obesity and Weight-Related Diseases Changes the Inflammatory Profile in Women with Severe Obesity: a Randomized Controlled Clinical Trial. PMID:34554379
Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial. PMID:34552549
Cognitive-bias modification intervention to improve physical activity in patients following a rehabilitation programme: protocol for the randomised controlled IMPACT trial. PMID:34548372
Effectiveness of a brief positive skills intervention to improve psychological adjustment in patients with end-stage kidney disease newly initiated on haemodialysis: protocol for a randomised controlled trial (HED-Start). PMID:34548369
Dancing Against falls iN Community-dwElling older adults (DANCE): a study protocol of a stratified, block-randomised trial. PMID:34544808
A Text Messaging Intervention (StayWell at Home) to Counteract Depression and Anxiety During COVID-19 Social Distancing: Pre-Post Study. PMID:34543230
Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial. PMID:34530800
Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial. PMID:34526073
Compound glycyrrhizin injection for improving liver function in children with acute icteric hepatitis: A systematic review and meta-analysis. PMID:34522606
SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial. PMID:34518276
Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. PMID:34518253
Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. PMID:34518248
Efficacy and Safety of Different Aerobic Exercise Intensities in Patients With Heart Failure With Reduced Ejection Fraction: Design of a Multicenter Randomized Controlled Trial (HF-EI Trial). PMID:34513951
Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study. PMID:34512012
The Acute Effects of Aerobic Exercise on Nocturnal and Pre-Sleep Arousal in Patients with Unipolar Depression: Preplanned Secondary Analysis of a Randomized Controlled Trial. PMID:34501476
Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. PMID:34496924
Tocolysis in the management of preterm prelabor rupture of membranes at 22-33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM). PMID:34496799
Protocol for a pilot trial to assess the feasibility of the Move More @ Work intervention to encourage employees to take the opportunity to move (be physically active) after every 30 min of sitting. PMID:34493322
Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial. PMID:34489276
Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial. PMID:34488856
Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial. PMID:34479930
Expectation-induced enhancement of pain, itch and quality of life in psoriasis patients: study protocol of a randomised controlled trial. PMID:34475155
Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial. PMID:34460414
Evaluation of Technology-Enabled Monitoring of Patient-Reported Outcomes to Detect and Treat Toxic Effects Linked to Immune Checkpoint Inhibitors. PMID:34459906
Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the COVID-19 Pandemic: CONSERVE 2021. PMID:34456331
Randomised Controlled Trials in Diabetes Research: A Pathway to Interpreting Published Results. PMID:34455574
Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics. PMID:34454637
Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain: study protocol of a pragmatic, parallel-group, randomized, controlled trial. PMID:34454582
Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial. PMID:34454580
The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. PMID:34454458
Phase 3 randomised trial of eltrombopag versus standard first-line pharmacological management for newly diagnosed immune thrombocytopaenia (ITP) in children: study protocol. PMID:34452956
Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial. PMID:34446499
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): protocol of a prospective, randomised, adaptive, multicentre clinical trial. PMID:34446497
Effects of a waiting list control design on alcohol consumption among online help-seekers: protocol for a randomised controlled trial. PMID:34446493
Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study. PMID:34435968
Exergaming Using Postural Feedback From Wearable Sensors and Exercise Therapy to Improve Postural Balance in People With Nonspecific Low Back Pain: Protocol for a Factorial Pilot Randomized Controlled Trial. PMID:34435954
Comparison of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament with posterior quadratus lumborum block for perioperative analgesia in laparoscopic nephrectomy: a protocol for a randomised, prospective, parallel group, non-inferior trial. PMID:34429312
Protocol for an interventional study to reduce postpartum weight retention in obese mothers using the internet of things and a mobile application: a randomized controlled trial (SpringMom). PMID:34425784
Evaluating implementation of LEAPS, a youth-led early childhood care and education intervention in rural Pakistan: protocol for a stepped wedge cluster-randomized trial. PMID:34404454
The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER. PMID:34401394
Anonymous online cognitive behavioral therapy for sleep disorders in shift workers-a study protocol for a randomized controlled trial. PMID:34399824
National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol. PMID:34397699
Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery. PMID:34389577
Preventive effects of tamsulosin for postoperative urinary retention after lower limb arthroplasty: A randomized controlled study. PMID:34387038
Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial. PMID:34384461
Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. PMID:34384459
Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation ('My Therapy'): protocol for a stepped-wedge cluster randomised trial. PMID:34384427
Efficacy of therapeutic fasting and plant-based diet in patients with rheumatoid arthritis (NutriFast): study protocol for a randomised controlled clinical trial. PMID:34380725
Primary Periphyseal Stress Injuries in Young Athletes: A Systematic Review. PMID:34370212
Multicentre, randomised, open-label, phase IV-III study to evaluate the efficacy of cloxacillin plus fosfomycin versus cloxacillin alone in adult patients with methicillin-susceptible Staphylococcus aureus bacteraemia: study protocol for the SAFO trial. PMID:34353808
Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial. PMID:34348775
Feasibility, tolerance and effects of adding impact loading exercise to pulmonary rehabilitation in people with chronic obstructive pulmonary disease: study protocol for a pilot randomised controlled trial. PMID:34344482
Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial. PMID:34344428
The iSTOPP study: Protocol for a proof-of-concept randomised clinical trial of sensory discrimination training in people with persistent neck pain. PMID:34337189
Effects of Baduanjin Exercise on Antihypertensive Medication Reduction in Older Patients with Hypertension: A Study Protocol for a Randomized Controlled Trial. PMID:34335840
The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial. PMID:34335460
REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial. PMID:34332617
A phase I/II clinical trial on the efficacy and safety of NKT cells combined with gefitinib for advanced EGFR-mutated non-small-cell lung cancer. PMID:34332557
Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. PMID:34330855
Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol. PMID:34330334
Nursing research on intimate partner violence in China: A scoping review. PMID:34327373
Treatment of tungiasis using a tea tree oil-based gel formulation: protocol for a randomised controlled proof-of-principle trial. PMID:34326048
A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. PMID:34321880
Efficacy of a strategy-based intervention on text-level reading comprehension in persons with aphasia: a study protocol for a repeated measures study. PMID:34321303
Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review. PMID:34320934
Physical rehabilitation versus no physical rehabilitation after total hip and knee arthroplasties: Protocol for a pragmatic, randomized, controlled, superiority trial (The DRAW1 trial). PMID:34316356
The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial. PMID:34313599
A prospective, phase II, single-centre, cross-sectional, randomised study investigating Dehydroepiandrosterone supplementation and its Profile in Trauma: ADaPT. PMID:34312190
The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial. PMID:34311755
Handling oxygenation targets in ICU patients with COVID-19-Protocol and statistical analysis plan in the HOT-COVID trial. PMID:34310694
Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial. PMID:34301652
Non-invasive, vagus nerve stimulation to reduce ileus after colorectal surgery: protocol for a feasibility trial with nested mechanistic studies. PMID:34290065
Smartphone-Based Interventions for Physical Activity Promotion: Scoping Review of the Evidence Over the Last 10 Years. PMID:34287209
Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis. PMID:34285004
Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis. PMID:34280304
Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study. PMID:34278044
Efficacy and Safety of Leflunomide for Refractory COVID-19: A Pilot Study. PMID:34276351
Can Task Specificity Impact tDCS-Linked to Dual Task Training Gains in Parkinson's Disease? A Protocol for a Randomized Controlled Trial. PMID:34276344
Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress-a randomized controlled trial protocol. PMID:34271952
mHealth intervention for multiple lifestyle behaviour change among high school students in Sweden (LIFE4YOUth): protocol for a randomised controlled trial. PMID:34271882
Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial. PMID:34268680
Effectiveness of the ABCDEF bundle on delirium, functional outcomes and quality of life in intensive care patients: a study protocol for a randomised controlled trial with embedded process evaluation. PMID:34266839
Differences in the individual curative effect of acupuncture for obese women with polycystic ovary syndrome based on metagenomic analysis: study protocol for a randomized controlled trial. PMID:34266458
The safety and efficacy of fecal microbiota transplantation in a population with bipolar disorder during depressive episodes: study protocol for a pilot randomized controlled trial. PMID:34261526
The effect of propolis supplementation on inflammatory factors and oxidative status in women with rheumatoid arthritis: Design and research protocol of a double-blind, randomized controlled. PMID:34258468
Telerehabilitation program for older adults on a waiting list for physical therapy after hospital discharge: study protocol for a pragmatic randomized trial protocol. PMID:34256830
The Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER) as an eHealth Approach to Presurgical Hip Replacement Education: Protocol for a Randomized Controlled Trial. PMID:34255722
The acute effects of aerobic exercise on sleep in patients with unipolar depression: a randomized controlled trial. PMID:34255075
Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: A Trial Protocol for a Multicenter Randomized Controlled Trial. PMID:34254233
Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking. PMID:34253678
Optimising Treatment Outcomes for Children and Adults Through Rapid Genome Sequencing of Sepsis Pathogens. A Study Protocol for a Prospective, Multi-Centre Trial (DIRECT). PMID:34249774
Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial. PMID:34243746
Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial. PMID:34230018
Replication studies in the clinical decision support literature-frequency, fidelity, and impact. PMID:34226931
Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial. PMID:34226226
Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial. PMID:34223388
Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. PMID:34223347
Prognostic factor analysis in patients with temporomandibular disorders after reversible treatment: study protocol for a prospective cohort study in China. PMID:34215608
Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): protocol of a feasibility and pilot study. PMID:34215323
DECRYPT trial: study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors. PMID:34210731
The DANTE trial protocol: a randomised phase III trial to evaluate the Duration of ANti-PD-1 monoclonal antibody Treatment in patients with metastatic mElanoma. PMID:34210290
Primary care implementation study to scale up early identification and brief intervention and reduce alcohol-related negative outcomes at the community level (PINO): study protocol for a quasi-experimental 3-arm study. PMID:34210261
Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study). PMID:34206058
The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. PMID:34205457
Effects of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Controlled Trial Study Protocol. PMID:34204415
Blinding in Clinical Trials: Seeing the Big Picture. PMID:34202486
Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial. PMID:34200805
Feasibility of a socio-spiritual intervention to improve quality of life of adult Nigerians with cancer and their family caregivers: Protocol for a randomised controlled trial. PMID:34195469
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. PMID:34193486
Sleep Apnea and Fetal Growth Restriction (SAFER) study: protocol for a pragmatic randomised clinical trial of positive airway pressure as an antenatal therapy for fetal growth restriction in maternal obstructive sleep apnoea. PMID:34187829
Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. PMID:34187541
Effects of combining manual therapy, neck muscle exercises, and therapeutic pain neuroscience education in patients with migraine: a study protocol for a randomized clinical trial. PMID:34187384
Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. PMID:34185020
Study protocol for SKIPMDD: subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder (phase II pilot feasibility study). PMID:34183351
Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial. PMID:34183350
High-intensity strength training in patients with idiopathic inflammatory myopathies: a randomised controlled trial protocol. PMID:34172544
Contextual interference in children with brain lesions: a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame. PMID:34172085
Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention. PMID:34172030
Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial. PMID:34167594
Video decision support tool promoting values conversations in advanced care planning in cancer: protocol of a randomised controlled trial. PMID:34167538
Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA): protocol for a prospective observational study. PMID:34162435
The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women's response to integrative breast cancer treatment. PMID:34162339
Ultrasound-guided platelet-rich plasma injections for post-traumatic greater occipital neuralgia: study protocol for a pilot randomized controlled trial. PMID:34158124
Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial. PMID:34155075
TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil. PMID:34155070
Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial. PMID:34147107
Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN). PMID:34134744
Effects of an Avocado-based Mediterranean Diet on Serum Lipids for Secondary Prevention after Ischemic Stroke Trial (ADD-SPISE): Study protocol. PMID:34128908
Effects of seated lumbar rotation manipulation in treating degenerative lumbar instability: a protocol for a randomized controlled trial. PMID:34127039
Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis. PMID:34114650
Assessing the impact of a combined nutrition counselling and cash transfer intervention on women's empowerment in rural Bangladesh: a randomised control trial protocol. PMID:34108160
Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): study protocol of a dual-centre, two-armed phase I randomised controlled trial. PMID:34099463
The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review. PMID:34098998
Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. PMID:34095161
Moving from bytes to bedside: a systematic review on the use of artificial intelligence in the intensive care unit. PMID:34089064
Current clinical trials and patent update on lung cancer: a retrospective review. PMID:34084211
Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS). PMID:34078374
Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial. PMID:34078324
Physical Activity Together for People With Multiple Sclerosis and Their Care Partners: Protocol for a Feasibility Randomized Controlled Trial of a Dyadic Intervention. PMID:34061040
Scalable modEls of Community rehAbilitation for Individuals Recovering From COVID:19 reLated illnEss: A Longitudinal Service Evaluation Protocol-"SeaCole Cohort Evaluation". PMID:34055711
Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders. PMID:34054617
Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial). PMID:34049908
Cluster-randomised controlled trial of Stroke 1-2-0 education programme to reduce stroke prehospital delay in China: a study protocol. PMID:34035108
A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol. PMID:34034365
Preconsultation compassion intervention to reduce anxiety among patients referred to a cancer center: protocol for a randomised control trial. PMID:34031118
Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. PMID:34022863
Effectiveness of a digital alcohol moderation intervention as an add-on to depression treatment for young adults: study protocol of a multicentre pragmatic randomized controlled trial. PMID:34022840
Exercise and education for community-dwelling older participants with knee osteoarthritis: a video-linked programme protocol based on a randomised controlled trial. PMID:34022825
STOP leg clots-Swedish multicentre trial of outpatient prevention of leg clots: study protocol for a randomised controlled trial on the efficacy of intermittent pneumatic compression on venous thromboembolism in lower leg immobilised patients. PMID:34016662
Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project). PMID:34016658
Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial. PMID:34013139
Specialized post-inpatient psychotherapy for sustained recovery in anorexia nervosa via videoconference - study protocol of the randomized controlled SUSTAIN trial. PMID:34011399
Protocol for a four parallel-arm, single-blind, cluster-randomised trial to assess the effectiveness of three types of dual active ingredient treated nets compared to pyrethroid-only long-lasting insecticidal nets to prevent malaria transmitted by pyrethroid insecticide-resistant vector mosquitoes in Tanzania. PMID:34006037
Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study. PMID:33985574
Combination of gemcitabine, nab-paclitaxel, and S-1(GAS) as the first-line treatment for patients with locally advanced or advanced pancreatic ductal adenocarcinoma: study protocol for an open-label, single-arm phase I study. PMID:33985455
Brief interventions for older adults (BIO) delivered by non-specialist community health workers to reduce at-risk drinking in primary care: a study protocol for a randomised controlled trial. PMID:33980519
Parenting, child development and primary care-'Crescer em Grande!' intervention (CeG!) based on the Touchpoints approach: a cluster-randomised controlled trial protocol. PMID:33980514
Effectiveness and cost-effectiveness of integrating the management of depression into routine HIV Care in Uganda (the HIV + D trial): A protocol for a cluster-randomised trial. PMID:33980299
Factors contributing to cognitive improvement effects of acupuncture in patients with mild cognitive impairment: a pilot randomized controlled trial. PMID:33980288
Success of Masking 5% Povidone-Iodine Treatment: The Reducing Adenoviral Patient Infected Days Study. PMID:33973917
Pulmonary hypertension and home-based (PHAHB) exercise intervention: protocol for a feasibility study. PMID:33972341
Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial. PMID:33971940
Efficacy and Safety of Panax Notoginseng Saponins (Xueshuantong) in Patients With Acute Ischemic Stroke (EXPECT) Trial: Rationale and Design. PMID:33967788
Active elderly and health-can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial. PMID:33962664
Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials. PMID:33957978
Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol. PMID:33952552
Self-management for patients on ventricular assist device support: a national, multicentre study: protocol for a 3-phase study. PMID:33952544
Effects of different ischemic preconditioning occlusion pressures on muscle damage induced by eccentric exercise: a study protocol for a randomized controlled placebo clinical trial. PMID:33952329
A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial. PMID:33948191
The effect of automated audit and feedback on data completeness in the electronic health record of the general physician: protocol for a cluster randomized controlled trial. PMID:33947448
Acute effects of physical exercise with different levels of blood flow restriction on vascular reactivity and biomarkers of muscle hypertrophy, endothelial function and oxidative stress in young and elderly subjects - A randomized controlled protocol. PMID:33937579
The Advancing Understanding of Transportation Options (AUTO) study: design and methods of a multi-center study of decision aid for older drivers. PMID:33934709
Optimising psychological treatment for Anxiety DisordErs in Pregnancy (ADEPT): study protocol for a feasibility trial of time-intensive CBT versus weekly CBT. PMID:33931111
Impact of Face-to-Face Teaching in Addition to Electronic Learning on Personal Protective Equipment Doffing Proficiency in Student Paramedics: Protocol for a Randomized Controlled Trial. PMID:33929334
Implementing eScreening for suicide prevention in VA post-9/11 transition programs using a stepped-wedge, mixed-method, hybrid type-II implementation trial: a study protocol. PMID:33926577
Age-based targeting of biannual azithromycin distribution for child survival in Niger: an adaptive cluster-randomized trial protocol (AVENIR). PMID:33926403
Efficacy and Safety of Multi-Session Transcranial Direct Current Stimulation on Social Cognition in Schizophrenia: A Study Protocol for an Open-Label, Single-Arm Trial. PMID:33921706
The Effectiveness of an Acceptance and Commitment Therapy and Mindfulness Group Intervention for Enhancing the Psychological and Physical Well-Being of Adults with Overweight or Obesity Seeking Treatment: The Mind&Life Randomized Control Trial Study Protocol. PMID:33919059
The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. PMID:33892682
Protocol for a feasibility study incorporating a randomised pilot trial with an embedded process evaluation and feasibility economic analysis of ThinkCancer!: a primary care intervention to expedite cancer diagnosis in Wales. PMID:33883033
The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial. PMID:33883001
Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study. PMID:33868140
Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study. PMID:33861209
Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial. PMID:33858486
Sulfur amino acid restriction, energy metabolism and obesity: a study protocol of an 8-week randomized controlled dietary intervention with whole foods and amino acid supplements. PMID:33858441
Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19. PMID:33853806
Treatment for bleeding oesophageal varices in people with decompensated liver cirrhosis: a network meta-analysis. PMID:33837526
CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial. PMID:33837106
Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial. PMID:33837098
Effects of improved information and volunteer support on segregation of solid waste at the household level in urban settings in Madhya Pradesh, India (I-MISS): protocol of a cluster randomized controlled trial. PMID:33836723
Adapting and adopting highly specialized pediatric eating disorder treatment to virtual care: a protocol for an implementation study in the COVID-19 context. PMID:33832543
Diagnostic accuracy of deep learning in medical imaging: a systematic review and meta-analysis. PMID:33828217
From hospitalisation to primary care: integrative model of clinical pharmacy with patients implanted with a PICC line-research protocol for a prospective before-after study. PMID:33827827
Koshu GRoup Activity, Active Play and Exercise (GRAPE) Study: A Cluster Randomised Controlled Trial Protocol of a School-Based Intervention among Japanese Children. PMID:33805025
Pragmatic Quasi-Experimental Controlled Trial Evaluating the Outcomes of Blended CBT Compared to Face-to-Face CBT and Treatment as Usual for Adolescents with Depressive Disorders. PMID:33802913
The EPICURE study: a pilot prospective cohort study of heterogeneous and massive data integration in metastatic breast cancer patients. PMID:33789635
Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. PMID:33785064
Secondary prevention of variceal bleeding in adults with previous oesophageal variceal bleeding due to decompensated liver cirrhosis: a network meta-analysis. PMID:33784794
Dapagliflozin effect on endothelial dysfunction in diabetic patients with atherosclerotic disease: a randomized active-controlled trial. PMID:33771149
Rationale and protocol for randomized study of transrectal and transperineal prostate biopsy efficacy and complications (ProBE-PC study). PMID:33767354
A preconception intervention targeted at women with modifiable risk factors before pregnancy to improve outcomes; protocol for the Get Ready! feasibility trial. PMID:33766149
Repetitive transcranial magnetic stimulation alone and in combination with motor control exercise for the treatment of individuals with chronic non-specific low back pain (ExTraStim trial): study protocol for a randomised controlled trial. PMID:33762244
Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial. PMID:33757568
Development, implementation, evaluation and scaling-up of physical activity referral schemes in Germany: protocol for a study using a co-production approach. PMID:33753444
Brief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial. PMID:33750351
Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns. PMID:33748529
Protocol for an open-label feasibility study for a randomised controlled trial of vitamin D supplementation in Crohn's Disease patients with vitamin D deficiency: D-CODE Feasiblity study. PMID:33743801
A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. PMID:33741077
An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol. PMID:33741071
Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial. PMID:33739297
Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS). PMID:33739292
Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial. PMID:33737443
Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children's type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial. PMID:33736674
Implementation and preliminary testing of a theory-guided nursing discharge teaching intervention for adult inpatients aged 50 and over with multimorbidity: a pragmatic feasibility study protocol. PMID:33731212
A single-arm, open-label, intervention study to investigate the improvement of glucose tolerance after administration of the 5-aminolevulinic acid (5-ALA) in the patients with mitochondrial diabetes mellitus. PMID:33725905
Randomized controlled clinical study on Yiqi Liangxue Shengji prescription for intervention cardiac function of acute myocardial infarction with ischemia-reperfusion injury. PMID:33725857
Executive Function Training in Childhood Obesity: Food Choice, Quality of Life, and Brain Connectivity (TOuCH): A Randomized Control Trial Protocol. PMID:33718294
Mindfulness Training Improves Quality of Life and Reduces Depression and Anxiety Symptoms Among Police Officers: Results From the POLICE Study-A Multicenter Randomized Controlled Trial. PMID:33716824
A comparison between the effects of school-based education programs provided by peer group versus health practitioners on premenstrual syndrome in adolescents: A protocol for a non-masked clinical trial. PMID:33715300
Protocol of the study: the effectiveness of pleuran in the treatment of acute gastroenteritis in children-a randomised, placebo-controlled, double-blind trial (EPTAGE). PMID:33707267
Closed-Loop Acoustic Stimulation During Sedation with Dexmedetomidine (CLASS-D): Protocol for a Within-Subject, Crossover, Controlled, Interventional Trial with Healthy Volunteers. PMID:33692642
Mobile App-Based Intervention for Pregnant Women With Stress Urinary Incontinence: Protocol for a Hybrid Effectiveness-Implementation Trial. PMID:33688842
Identifying options for oncology therapy regimen codification to improve standardization-combined results of an expert panel and a review. PMID:33687085
Effectiveness and cost effectiveness of a stress management training for leaders of small and medium sized enterprises - study protocol for a randomized controlled-trial. PMID:33685418
Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial. PMID:33679447
BLEND-A: blending internet treatment into conventional face-to-face treatment for alcohol use disorder - a study protocol. PMID:33676429
Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial. PMID:33675247
Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). PMID:33673868
Promoting Mental Health and Well-Being among Adolescent Young Carers in Europe: A Randomized Controlled Trial Protocol. PMID:33669796
A Family-Based Lifestyle Intervention Focusing on Fathers and Their Children Using Co-Creation: Study Protocol of the Run Daddy Run Intervention. PMID:33668562
Impact of Intersecting Systems of Oppression on Diabetic Retinopathy Screening Among Those Who Identify as Women of Low Socioeconomic Status: Protocol for a Convergent Mixed Methods Study. PMID:33666559
"Body & Brain": effects of a multicomponent exercise intervention on physical and cognitive function of adults with dementia - study protocol for a quasi-experimental controlled trial. PMID:33663414
Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial. PMID:33657998
Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial. PMID:33653766
Preschool HABIT-ILE: study protocol for a randomised controlled trial to determine efficacy of intensive rehabilitation compared with usual care to improve motor skills of children, aged 2-5 years, with bilateral cerebral palsy. PMID:33653745
A community-based nurse-led medication self-management intervention in the improvement of medication adherence in older patients with multimorbidity: protocol for a randomised controlled trial. PMID:33653300
Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial. PMID:33648572
Prevention of AcuTe admIssioN algorithm (PATINA): study protocol of a stepped wedge randomized controlled trial. PMID:33639833
Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial. PMID:33637548
Internet-based acceptance and commitment therapy programme 'Happiness Mom' for well-being: a protocol for a randomised controlled trial. PMID:33637541
Serious Game Platform as a Possibility for Home-Based Telerehabilitation for Individuals With Cerebral Palsy During COVID-19 Quarantine - A Cross-Sectional Pilot Study. PMID:33633648
Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial. PMID:33628323
Observational study on wearable biosensors and machine learning-based remote monitoring of COVID-19 patients. PMID:33623096
Effects of a gratitude intervention program on work engagement among Japanese workers: a protocol for a cluster randomized controlled trial. PMID:33622408
Microinvasive pars plana vitrectomy versus panretinal photocoagulation in the treatment of severe non-proliferative diabetic retinopathy (the VIP study): study protocol for a randomised controlled trial. PMID:33619191
Assessing the efficacy of two dual-active ingredients long-lasting insecticidal nets for the control of malaria transmitted by pyrethroid-resistant vectors in Benin: study protocol for a three-arm, single-blinded, parallel, cluster-randomized controlled trial. PMID:33607958
Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions. PMID:33602338
A comparison of standard occupational therapy versus early enhanced occupation-based therapy in a medical/surgical intensive care unit: study protocol for a single site feasibility trial (EFFORT-ICU). PMID:33602337
A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies. PMID:33596904
Impact of BCG revaccination on the response to unrelated vaccines in a Ugandan adolescent birth cohort: randomised controlled trial protocol C for the 'POPulation differences in VACcine responses' (POPVAC) programme. PMID:33593770
Effect of intermittent preventive treatment for malaria with dihydroartemisinin-piperaquine on immune responses to vaccines among rural Ugandan adolescents: randomised controlled trial protocol B for the 'POPulation differences in VACcine responses' (POPVAC) programme. PMID:33593769
Effect of intensive treatment for schistosomiasis on immune responses to vaccines among rural Ugandan island adolescents: randomised controlled trial protocol A for the 'POPulation differences in VACcine responses' (POPVAC) programme. PMID:33593768
Population differences in vaccine responses (POPVAC): scientific rationale and cross-cutting analyses for three linked, randomised controlled trials assessing the role, reversibility and mediators of immunomodulation by chronic infections in the tropics. PMID:33593767
A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma. PMID:33593311
Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial. PMID:33593307
Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial. PMID:33588938
Effects of neuromuscular electrical stimulation therapy on physical function in patients with COVID-19 associated pneumonia: Study protocol of a randomized controlled trial. PMID:33585723
Anesthetic efficacy of single buccal infiltration of 4% articaine compared to routine inferior alveolar nerve block with 2% lidocaine during bilateral extraction of mandibular primary molars: a randomized controlled trial. PMID:33585685
Higher vs lower doses of dexamethasone in patients with COVID-19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan. PMID:33583034
Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis. PMID:33583027
Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study. PMID:33579762
One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol. PMID:33579256
Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial. PMID:33574155
Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study. PMID:33574145
Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial. PMID:33574141
Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study. PMID:33568368
A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania. PMID:33568230
Comparing two interdisciplinary occupational rehabilitation programs for employees on sick leave: a mixed-method design study protocol. PMID:33563250
Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial. PMID:33561055
Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial. PMID:33559842
Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial. PMID:33558354
Evaluation of eight-style Tai chi on cognitive function in patients with cognitive impairment of cerebral small vessel disease: study protocol for a randomised controlled trial. PMID:33558352
Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being. PMID:33558351
Effects of different wavelengths of invasive laser acupuncture on chronic non-specific low back pain: a study protocol for a pilot randomized controlled trial. PMID:33546748
Study for the Design of a Protocol to Assess the Impact of Stress in the Quality of Life of Workers. PMID:33546392
The Template for Intervention Description and Replication as a Measure of Intervention Reporting Quality: Rasch Analysis. PMID:33543082
Postprandial effects of macronutrient composition meals on the metabolic responses and arterial stiffness indices of lean and obese male adults: a protocol of a pilot study. PMID:33536071
Variable- versus constant-frequency sacral neuromodulation in black-zone overactive bladder patients: a study protocol for a multicenter, prospective, randomized, blind, self-controlled trial. PMID:33532338
Effects of Baduanjin on patients with chronic nonspecific low back pain: A randomized controlled trial. PMID:33530252
A randomized, controlled, multicenter clinical study of the "improved sitting Wuqinxi" intervention for mechanically ventilated patients in the intensive care unit. PMID:33530186
Link workers providing social prescribing and health and social care coordination for people with multimorbidity in socially deprived areas (the LinkMM trial): protocol for a pragmatic randomised controlled trial. PMID:33526499
Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. PMID:33522977
Effects of Guanxinshutong Capsules as Complementary Treatment in Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial. PMID:33519434
Study Protocol on the Validation of the Quality of Sleep Data from Xiaomi Domestic Wristbands. PMID:33513712
Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial). PMID:33509845
Efficacy of transcutaneous perineal electrostimulation versus intracavitary anal electrostimulation in the treatment of urinary incontinence after a radical prostatectomy: randomized controlled trial study protocol. PMID:33509164
Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. PMID:33494795
Effects of whole-body electromyostimulation on function, muscle mass, strength, social participation, and falls-efficacy in older people: A randomized trial protocol. PMID:33493160
A Fully-Immersive and Automated Virtual Reality System to Assess the Six Domains of Cognition: Protocol for a Feasibility Study. PMID:33488382
Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol. PMID:33483444
Is the Thoughts and Health programme feasible in the context of Swedish schools? A quasi-experimental controlled trial study protocol. PMID:33483440
Effectiveness of a pathway-driven eHealth-based integrated care model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial. PMID:33482896
Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke). PMID:33482893
The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial. PMID:33482878
Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial. PMID:33482853
Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial. PMID:33478562
Timely short-term specialised palliative care service intervention for frail older people and their family carers in primary care: study protocol for a pilot randomised controlled trial. PMID:33472789
Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care. PMID:33472773
A study protocol for a feasibility trial of telephone-delivered Adherence Therapy for adults with type 2 diabetes. PMID:33471963
A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. PMID:33470990
Optimal intervention time and risk of the activating blood and removing stasis method in acute cerebral hemorrhage patients: A randomized placebo-controlled trial. PMID:33466200
Evaluating the Impact of Stopping Chronic Therapies after Modulator Drug Therapy in Cystic Fibrosis: The SIMPLIFY Clinical Trial Study Design. PMID:33465316
Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial. PMID:33461579
Registry versus publication: discrepancy of primary outcomes and possible outcome reporting bias in child and adolescent mental health. PMID:33459886
Randomised, cross-over trial on the effect of isotonic and isometric exercise on pain and strength in proximal hamstring tendinopathy: trial protocol. PMID:33456785
Participatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: protocol of the PATHway trial. PMID:33455931
Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial. PMID:33452200
Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE). PMID:33444199
Specialised orthotic care to improve functioning in adults with neuromuscular disorders: protocol of a prospective randomised open-label blinded end-point study. PMID:33444196
Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. PMID:33444192
Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial. PMID:33441157
Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES). PMID:33436475
KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol. PMID:33436465
Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial. PMID:33431040
Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. PMID:33431018
Nocebo-Hypothesis Cognitive Behavioral Therapy (NH-CBT) for Persons With Functional Neurological Symptoms (Motor Type): Design and Implementation of a Randomized Active-Controlled Trial. PMID:33424742
Evaluation of robotic versus open partial pancreatoduodenectomy-study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407). PMID:33419452
Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study). PMID:33413664
Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study. PMID:33407727
Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial. PMID:33407195
EHealth to empower patients with musculoskeletal pain in rural Australia (EMPoweR) a randomised clinical trial: study protocol. PMID:33402161
Motor-enriched learning for improving pre-reading and word recognition skills in preschool children aged 5-6 years - study protocol for the PLAYMORE randomized controlled trial. PMID:33397297
Effects of a single bout of walking on postprandial triglycerides in men of Chinese, European and Japanese descent: a multisite randomised crossover trial. PMID:33376598
Clinical outcomes and cost-utility of rotator cuff repair surgery by open and arthroscopic techniques: study protocol for a randomised clinical trial. PMID:33372080
TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea-a MASTERMIND study protocol. PMID:33371044
Multimodal prehabilitation as strategy for reduction of postoperative complications after cardiac surgery: a randomised controlled trial protocol. PMID:33371022
A Text Messaging Intervention for Coping With Social Distancing During COVID-19 (StayWell at Home): Protocol for a Randomized Controlled Trial. PMID:33370721
Effects of neuromuscular training compared to classic strength-resistance training in patients with acute coronary syndrome: A study protocol for a randomized controlled trial. PMID:33362223
Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial. PMID:33361164
Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. PMID:33361162
A mobile delivered self-exercise program for female farmers. PMID:33350739
Cultural adaptation of the Smiling is Fun program for the treatment of depression in the Ecuadorian public health care system: A study protocol for a randomized controlled trial. PMID:33335847
ED to EPI: protocol for a pragmatic randomised controlled trial of an SMS (text) messaging intervention to improve the transition from the emergency department to early psychosis intervention for young people with psychosis. PMID:33334839
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. PMID:33328049
Peony and licorice decoction fumigation treatment for strephenopodia after stroke: Study protocol for a randomized controlled pilot trial. PMID:33327326
An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease: Study protocol for an investigator-initiated, multicenter, open-label trial (SPIRIT compliant). PMID:33327255
Single-arm, open-label pilot intervention study to investigate an effect of oral 5-aminolevulinic acid plus sodium ferrous citrate on glucocorticoid reduction in patients with adult-onset Still disease: Study protocol for clinical trial (SPIRIT compliant). PMID:33327226
Protocol for a Case-Control Study to Investigate the Association of Pellagra With Isoniazid Exposure During Tuberculosis Preventive Treatment Scale-Up in Malawi. PMID:33324593
Effect of a tailored multidimensional intervention on the care burden among family caregivers of stroke survivors: study protocol for a randomised controlled trial. PMID:33323445
Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: study protocol. PMID:33323442
Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial. PMID:33318119
Scientometric measures of prospectively registered clinical trials over time: A comparison of IRCT and ClinicalTrials.gov. PMID:33315992
Investigation of opposition to diagnostic or therapeutic procedures in older people hospitalized in acute geriatric services: the OPTAH pilot study protocol. PMID:33308277
Transparency in reporting of phase 3 cancer clinical trial results. PMID:33307924
Effectiveness of a web-based decision aid for patients with generalised anxiety disorder: a protocol for a randomised controlled trial. PMID:33303445
Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial. PMID:33302926
Factors affecting the use of neurally adjusted ventilatory assist in the adult critical care unit: a clinician survey. PMID:33293357
Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol. PMID:33292854
Pediatric tuina for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in preschool children: study protocol for a pilot randomized controlled trial. PMID:33292826
The feasibility of a Comprehensive Resilience-building psychosocial Intervention (CREST) for people with dementia in the community: protocol for a non-randomised feasibility study. PMID:33292667
Effect of acupuncture for methadone maintenance treatment patients: study protocol of a randomized clinical trial. PMID:33287868
Effects of Danlou tablet for the treatment of stable angina pectoris: A study protocol of a randomized, double-blind, and placebo-controlled clinical trial. PMID:33285733
The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial. PMID:33272311
Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice. PMID:33268429
Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo. PMID:33268424
Impact of a Pharmacist-included Mobile Geriatrics team intervention on potentially inappropriate drug prescribing: protocol for a prospective feasibility study (PharMoG study). PMID:33268421
Randomised controlled trial for high-dose intravenous zinc as adjunctive therapy in SARS-CoV-2 (COVID-19) positive critically ill patients: trial protocol. PMID:33268419
Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol. PMID:33268416
A critical analysis of CTRI registered AYUSH studies for COVID- 19. PMID:33262559
Randomised controlled trial of tailored support to increase physical activity and reduce smoking in smokers not immediately ready to quit: protocol for the Trial of physical Activity-assisted Reduction of Smoking (TARS) Study. PMID:33262194
Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial. PMID:33262189
A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study. PMID:33261635
Interface management concepts in healthcare for rare diseases in Germany: a study protocol for a mixed-methods study to develop best practice recommendations. PMID:33257484
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials. PMID:33254286
Developing a core outcome set for future infertility research: an international consensus development study† ‡. PMID:33252685
Effect of barberry (Berberis vulgaris) consumption on blood pressure, plasma lipids, and inflammation in patients with hypertension and other cardiovascular risk factors: study protocol for a randomized clinical trial. PMID:33246500
Protocol for the cultural adaptation of pulmonary rehabilitation and subsequent testing in a randomised controlled feasibility trial for adults with chronic obstructive pulmonary disease in Sri Lanka. PMID:33243812
StudiCare mindfulness-study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and "on demand" guidance. PMID:33243300
Integrating nutrition into the mathematics curriculum in Australian primary schools: protocol for a randomised controlled trial. PMID:33243231
Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method. PMID:33243149
Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial. PMID:33243016
The Effect of Question Order on Outcomes in the Core Outcome Set for Brief Alcohol Interventions Among Online Help-Seekers: Protocol for a Factorial Randomized Trial. PMID:33242024
Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocol. PMID:33240121
The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study. PMID:33239101
Integrating implementation science in clinical research to maximize public health impact: a call for the reporting and alignment of implementation strategy use with implementation outcomes in clinical research. PMID:33239097
A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial. PMID:33237877
Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial. PMID:33234648
Design and development of the Pediatric Urology Recovery After Surgery Endeavor (PURSUE) multicentre pilot and exploratory study. PMID:33234633
Assessing the Effect of Training on the Cognition and Brain of Older Adults: Protocol for a Three-Arm Randomized Double-Blind Controlled Trial (ACTOP). PMID:33231556
MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. PMID:33228572
Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial). PMID:33225983
An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial. PMID:33225982
One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}. PMID:33225972
Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design. PMID:33218310
A protocol of randomized controlled trial for Modified Xiaoyao Powder in the treatment of chronic obstructive pulmonary disease combined mild to moderate depression. PMID:33217836
WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial. PMID:33213446
Development and evaluation of an eHealth self-management intervention for patients with chronic kidney disease in China: protocol for a mixed-method hybrid type 2 trial. PMID:33213398
Machine learning in cardiovascular radiology: ESCR position statement on design requirements, quality assessment, current applications, opportunities, and challenges. PMID:33211147
Publication of study protocols in the CJRT. PMID:33209974
Evaluating the diagnostic accuracy of a ctDNA methylation classifier for incidental lung nodules: protocol for a prospective, observational, and multicenter clinical trial of 10,560 cases. PMID:33209621
Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. PMID:33208330
Laparoscopic bowel resection combined with infliximab treatment (LaRIC) versus infliximab for terminal ileitis in Crohn's disease: a randomised, controlled, open-label trial. PMID:33199421
Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial. PMID:33199419
NTNU intranasal naloxone trial (NINA-1) study protocol for a double-blind, double-dummy, non-inferiority randomised controlled trial comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use. PMID:33184084
Food Outlets Dietary Risk (FODR) assessment tool: study protocol for assessing the public health nutrition risks of community food environments. PMID:33183279
The effect of comprehensive assessment and multi-disciplinary management for the geriatric and frail patient: A multi-center, randomized, parallel controlled trial. PMID:33181655
Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial. PMID:33178309
Effects of Creative Expressive Arts-based Storytelling (CrEAS) programme on older adults with mild cognitive impairment: protocol for a randomised, controlled three-arm trial. PMID:33177133
Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol. PMID:33177129
Pilot Randomized Controlled Trial of a Standard Versus a Modified Low-Phosphorus Diet in Hemodialysis Patients. PMID:33163715
Cognitive training and brain stimulation in prodromal Alzheimer's disease (AD-Stim)-study protocol for a double-blind randomized controlled phase IIb (monocenter) trial. PMID:33160420
Pharmaceutical management of elderly high-risk patients in perioperative settings (PHAROS): protocol of a pilot sequential intervention study. PMID:33158825
Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol. PMID:33157937
Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial. PMID:33154058
Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review. PMID:33153462
Assessing the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy for treating locally advanced prostate cancer: protocol for an open-label, dose-escalation, single-centre, phase I clinical trial. PMID:33148738
IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG. PMID:33141398
An Algorithm for Comprehensive Medication Management in Nursing Homes: Results of the AMBER Project. PMID:33128697
The feasibility and effectiveness of internet-based rehabilitation for patients with knee osteoarthritis: A study protocol of randomized controlled trial in the community setting. PMID:33126366
Study on the preventive effect of ramelteon on the onset of sleep disorder after general anesthesia in patients with autism spectrum disorder: A study protocol. PMID:33120808
An Evaluation of the Video Narrative Technique on the Self-Efficacy of Medication Understanding and Use Among Post-Stroke Patients: A Randomized-Controlled Trial. PMID:33116441
Bridging research integrity and global health epidemiology (BRIDGE) guidelines: explanation and elaboration. PMID:33115860
Bridging research integrity and global health epidemiology (BRIDGE) statement: guidelines for good epidemiological practice. PMID:33115859
Prospective reporting of statistical analysis plans for randomised controlled trials. PMID:33115516
Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study. PMID:33109515
A contemporary neuroscience approach compared to biomedically focused education combined with symptom-contingent exercise therapy in people with chronic whiplash associated disorders: a randomized controlled trial protocol. PMID:33109480
'Be on the TEAM' Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents. PMID:33093030
The efficacy of specialised rehabilitation using the Op-reha Guide for cancer patients in palliative care units: protocol of a multicentre, randomised controlled trial (JORTC-RHB02). PMID:33092573
A community feasibility study of a cooking behavior intervention in African-American adults at risk for cardiovascular disease: DC COOKS (DC Community Organizing for Optimal culinary Knowledge Study) with Heart. PMID:33088581
Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi Study. PMID:33084592
The MIPAM trial: a 12-week intervention with motivational interviewing and physical activity monitoring to enhance the daily amount of physical activity in community-dwelling older adults - a study protocol for a randomized controlled trial. PMID:33081715
Effectiveness of negative pressure wound therapy in the prevention of surgical wound complications in the cesarean section at-risk population: a parallel group randomised multicentre trial-the CYGNUS protocol. PMID:33077559
Contextual interference in children with brain lesions: protocol of a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame. PMID:33072397
Effect of wheelchair-modified rowing exercise on cardiometabolic risk factors in spinal cord injured wheelchair users: protocol for a randomised controlled trial. PMID:33067301
Internet-based patient- primary care physician-cardiologist integrated management model of hypertension in China: study protocol for a multicentre randomised controlled trial. PMID:33067295
Collaborative model of care between Orthopaedics and allied healthcare professionals in knee osteoarthritis (CONNACT): study protocol for an effectiveness-implementation hybrid randomized control trial. PMID:33066746
Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol. PMID:33060092
Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial. PMID:33060088
Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention. PMID:33060086
IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol. PMID:33059647
Impact of the implementation of best practice guidelines on nurse's evidence-based practice and on nurses' work environment: Research protocol. PMID:33058281
Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial. PMID:33054811
COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial. PMID:33053024
Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol. PMID:33052400
Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial. PMID:33050952
Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial. PMID:33050917
Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care. PMID:33050179
The outcome of COVID-19 among the geriatric age group in African countries: protocol for a systematic review and meta-analysis. PMID:33047071
Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial. PMID:33046478
Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. PMID:33039992
Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial. PMID:33036591
Yoga-based exercise to prevent falls in community-dwelling people aged 60 years and over: study protocol for the Successful AGEing (SAGE) yoga randomised controlled trial. PMID:33033622
Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity. PMID:33033101
Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial. PMID:33033088
Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery. PMID:33033035
Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa. PMID:33033021
Do measures of physical function enhance the prediction of persistent pain and disability following a whiplash injury? Protocol for a prospective observational study in Spain. PMID:33033010
The effect of an online exercise programme on bone health in paediatric cancer survivors (iBoneFIT): study protocol of a multi-centre randomized controlled trial. PMID:33032564
Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD). PMID:33028560
SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis. PMID:33028548
PartnerCARE-a psycho-oncological online intervention for partners of patients with cancer: study protocol for a randomised controlled feasibility trial. PMID:33020078
Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. PMID:33005816
Pancreatic resection with perioperative drug repurposing of propranolol and etodolac: trial protocol of the phase-II randomised placebo controlled PROSPER trial. PMID:32998931
Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate. PMID:32998926
Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol. PMID:32998761
Implementing nudges for suicide prevention in real-world environments: project INSPIRE study protocol. PMID:32995040
Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients. PMID:32994242
Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial. PMID:32993779
Cognitive-behavioral family therapy as psychoeducation for adolescents with high-functioning autism spectrum disorders: Aware and Care for my Autistic Traits (ACAT) program study protocol for a pragmatic multisite randomized controlled trial. PMID:32993775
Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study. PMID:32988951
A Phase II Multi-Center, Non-Randomized, Parallel Group, Non-Inferiority Study to Compare the Efficacy of No Radioactive Iodine Remnant Ablation to Remnant Ablation Treatment in Low- to Intermediate-Risk of Papillary Thyroid Cancer: The MOREthyroid Trial Protocol. PMID:32981299
Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study. PMID:32978200
Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educational trial. PMID:32978193
Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings. PMID:32973581
Quality Assessment of the Chinese Clinical Trial Protocols Regarding Treatments for Coronavirus Disease 2019. PMID:32973535
Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort. PMID:32972373
Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol. PMID:32967883
The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial. PMID:32965223
The efficacy and safety of hachimijiogan for mild Alzheimer disease in an exploratory, open standard treatment controlled, randomized allocation, multicenter trial: A study protocol. PMID:32957414
Heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: A protocol for a multi-center, pragmatic, non-randomized trial. PMID:32957364
An interactive retrieval system for clinical trial studies with context-dependent protocol elements. PMID:32946464
Therapeutic play to teach children with type 1 diabetes insulin self-injection: A pilot trial in a developing country. PMID:32945620
Chinese Herbal Formula Xuefu Zhuyu for Stable Angina (CheruSA): Study Protocol for a Multicenter Randomized Controlled Trial. PMID:32934661
Protocol for a systematic review on tertiary prevention interventions for patients with stroke in African countries. PMID:32928859
Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement-study protocol for a randomized controlled trial. PMID:32928298
Influence of Baduanjin on lung function, exercise capacity, and quality of life in patients with mild chronic obstructive pulmonary disease. PMID:32925765
Effects of a multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme on improving vaccine acceptance and uptake among female adolescents: A cluster randomized controlled trial. PMID:32925744
Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme. PMID:32912948
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. PMID:32908284
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension. PMID:32907797
Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial. PMID:32905158
How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework. PMID:32892743
IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors. PMID:32887564
Contextual influences on the impact of a peer worker-led self-stigma program for people with mental health issues: protocol for an interventional implementation science study. PMID:32885185
Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial. PMID:32883322
Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP) among hypertensive patients in Nepal: study protocol for a feasibility randomised controlled trial. PMID:32873686
Effects of coenzyme Q10 on endothelial and cardiac function in patients undergoing haemodialysis: study protocol for a pilot randomised controlled trial. PMID:32873669
Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study). PMID:32868360
Feasibility and acceptability of a dietary intervention study to reduce salt intake and increase high-nitrate vegetable consumption among middle-aged and older Malaysian adults with elevated blood pressure: a study protocol. PMID:32859661
Rationale and protocol of the StayFitLonger study: a multicentre trial to measure efficacy and adherence of a home-based computerised multidomain intervention in healthy older adults. PMID:32859156
MECHANISMS Study: Using Game Theory to Assess the Effects of Social Norms and Social Networks on Adolescent Smoking in Schools-Study Protocol. PMID:32850598
Study protocol for a pragmatic randomised controlled trial comparing the effectiveness and cost-effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of standard and new antiepileptic drugs (SANAD-II). PMID:32847927
Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease. PMID:32847918
Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised controlled trial. PMID:32847900
Effectiveness of an online education intervention on stress and coping of family members after placing a relative with dementia into a residential care facility: protocol of a randomised controlled trial. PMID:32847494
Efficacy of nasal high flow therapy on the coordination between breathing and swallowing of saliva during daytime nap in chronic obstructive pulmonary disease patients: A single center, randomized crossover controlled study. PMID:32846806
Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. PMID:32843084
mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study. PMID:32819981
Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial. PMID:32812886
The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial. PMID:32807208
Acute neurological care in north-east Germany with telemedicine support (ANNOTeM): protocol of a multi-center, controlled, open-label, two-arm intervention study. PMID:32807159
Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial. PMID:32799933
Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation. PMID:32795381
Effects of intravenous and inhalation anesthesia on blood glucose and complications in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial. PMID:32793670
Effects of Whole Body Electromyostimulation on Physical Fitness and Health in Postmenopausal Women: A Study Protocol for a Randomized Controlled Trial. PMID:32793536
Criteria to Qualify Microorganisms as "Probiotic" in Foods and Dietary Supplements. PMID:32793153
The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a 68 Ga -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of lan reotide on t umour size. PMID:32792446
Maternal bacteria to correct abnormal gut microbiota in babies born by C-section. PMID:32791721
Ear mold for congenital ear malformation: A randomized controlled trial. PMID:32791720
Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound, and biomarker assessments. PMID:32791688
Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease: Study protocol for clinical trial. PMID:32791665
Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan. PMID:32779728
Using electroacupuncture to recover muscle strength in patients with knee osteoarthritis after total knee arthroplasty: a study protocol for a double-blinded, randomized, and placebo-controlled trial. PMID:32778158
Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer - DIA-PANC study: study protocol for an international, multicenter, diagnostic trial. PMID:32778061
Protocol of the VICTORIA study: personalized vitamin D supplementation for reducing or preventing fatigue and enhancing quality of life of patients with colorectal tumor - randomized intervention trial. PMID:32770972
Effect of butylphthalide on new cerebral microbleeds in patients with acute ischemic stroke. PMID:32769914
Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX-SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments. PMID:32769882
Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study. PMID:32767992
Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled trial. PMID:32767989
A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. PMID:32767988
Evaluating the Effectiveness of an Intervention Integrating Technology and In-Person Sexual Health Education for Adolescents (In the Know): Protocol for a Cluster Randomized Controlled Trial. PMID:32763885
Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention. PMID:32763086
Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial. PMID:32759239
Who knew? The misleading specificity of "double-blind" and what to do about it. PMID:32758278
A study on respiratory management in acute postoperative period by nasal high flow for patients undergoing surgery under general anesthesia. PMID:32756204
A randomized controlled clinical trial study protocol of Liuwei Dihuang pills in the adjuvant treatment of diabetic kidney disease. PMID:32756091
FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care. PMID:32753452
Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial. PMID:32746941
Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study. PMID:32737091
Effectiveness of a Theory- and Web-Based Adaptive Implementation Intervention on Nurses' and Nursing Students' Intentions to Provide Brief Counseling: Protocol for a Randomized Controlled Trial. PMID:32734932
A Web-Based Program for Cannabis Use and Psychotic Experiences in Young People (Keep It Real): Protocol for a Randomized Controlled Trial. PMID:32723727
Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study. PMID:32723318
Brain-Responsive Neurostimulation for Loss of Control Eating: Early Feasibility Study. PMID:32717033
Assessing the impact of Social Networking Site use on older people's loneliness and social isolation. A randomized controlled trial: The Aging in a Networked Society-Social Experiment Study (ANS-SE). PMID:32715151
Neurofeedback self-regulating training in patients with Post traumatic stress disorder: A randomized controlled trial study protocol. PMID:32714831
Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial. PMID:32711555
Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study). PMID:32709656
Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors-Results from the NUTRI-HAB Randomized Controlled Trial. PMID:32708864
Extended Support Within a Person-Centered Practice After Surgery for Patients With Pituitary Tumors: Protocol for a Quasiexperimental Study. PMID:32706741
Effects of Fusu mixture (Wen-Shen-Qian-Yang Method) on sepsis-induced acute respiratory distress syndrome. PMID:32702849
Artificial intelligence mobile health platform for early detection of COVID-19 in quarantine subjects using a wearable biosensor: protocol for a randomised controlled trial. PMID:32699167
Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial. PMID:32698830
Psychological interventions to foster resilience in healthcare students. PMID:32691879
Study protocol for a 9-month randomised controlled trial assessing the effects of almonds versus carbohydrate-rich snack foods on weight loss and weight maintenance. PMID:32690523
Efficacy of different load intensity and time-under-tension calf loading protocols for Achilles tendinopathy (the LOADIT trial): protocol for a randomised pilot study. PMID:32685183
A phase II trial of the FGFR inhibitor pemigatinib in patients with metastatic esophageal-gastric junction/gastric cancer trastuzumab resistant: the FiGhTeR trial. PMID:32684989
Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project). PMID:32682408
A prospective multicenter phase II study on the efficacy and safety of dasatinib in the treatment of metastatic gastrointestinal stromal tumors failed by imatinib and sunitinib and analysis of NGS in peripheral blood. PMID:32677196
Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. PMID:32665394
Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial. PMID:32664149
A randomized double-blind placebo-controlled multicenter trial of Bushen Yisui and Ziyin Jiangzhuo formula for constipation in Parkinson disease. PMID:32664145
Targeting the Intestinal Microbiota to Prevent Type 2 Diabetes and Enhance the Effect of Metformin on Glycaemia: A Randomised Controlled Pilot Study. PMID:32660025
Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial. PMID:32650732
Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. PMID:32641343
Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis. PMID:32641101
Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial. PMID:32641081
Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. PMID:32637558
Early clinical management of severe burn patients using telemedicine: a pilot study protocol. PMID:32637150
Cognitive Enhancement via Neuromodulation and Video Games: Synergistic Effects? PMID:32636739
High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. PMID:32636290
Exploratory study on the safety and effectiveness of Yizhi Qingxin Decoction (capsules) in the treatment of hypertension in the elderly with mild cognitive impairment (deficiency of kidney essence syndrome). PMID:32629662
Psychological interventions to foster resilience in healthcare professionals. PMID:32627860
Skill Acquisition Methods Fostering Physical Literacy in Early-Physical Education (SAMPLE-PE): Rationale and Study Protocol for a Cluster Randomized Controlled Trial in 5-6-Year-Old Children From Deprived Areas of North West England. PMID:32625143
Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial. PMID:32625091
Effect of melatonin on heart failure: design for a double-blinded randomized clinical trial. PMID:32618134
The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial. PMID:32617173
Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn's disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course. PMID:32611737
The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial. PMID:32611377
Active Women over 50 online information and support to promote physical activity behaviour change: study protocol for a pilot trial. PMID:32607250
A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol. PMID:32605614
The study protocol for a pseudo-randomised pre-post designed controlled intervention trial to study the effects of a 7-week cooking program on self-efficacy and biomarkers of health: the ECU lifestyle and biomarkers get connected study (ECULABJMOF) including the Jamie's Ministry of Food WA participant experience. PMID:32605552
Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol. PMID:32595142
The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response. PMID:32593293
Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation. PMID:32590959
Determining the Impact of a School-Based Health Education Package for Prevention of Intestinal Worm Infections in the Philippines: Protocol for a Cluster Randomized Intervention Trial. PMID:32584263
Prevention of Early Alzheimer's Disease by Erinacine A-Enriched Hericium erinaceus Mycelia Pilot Double-Blind Placebo-Controlled Study. PMID:32581767
Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol. PMID:32580984
ENG-releasing subdermal implants in postpartum teenagers - an open-label trial study protocol. PMID:32576199
The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease. PMID:32571859
The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France. PMID:32571432
A critical evaluation of systematic reviews assessing the effect of chronic physical activity on academic achievement, cognition and the brain in children and adolescents: a systematic review. PMID:32571336
Evaluation of clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of acute respiratory distress syndrome. PMID:32569164
Interventions for treating intrahepatic cholestasis in people with sickle cell disease. PMID:32567054
Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study). PMID:32565458
Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol. PMID:32546493
Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial. PMID:32546217
Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial. PMID:32539850
Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial. PMID:32539740
Immediate versus delayed loading of strategic mini-implants under existing removable partial dentures: patient satisfaction in a multi-center randomized clinical trial. PMID:32533264
Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study. PMID:32532781
Study protocol for an exploratory interventional study investigating the feasibility of video-based non-contact physiological monitoring in healthy volunteers by Mapping Of Lower Limb skIn pErfusion (MOLLIE). PMID:32532774
Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon). PMID:32528650
Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial. PMID:32518518
Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study. PMID:32515748
Interventions for oropharyngeal dysphagia in acute and critical care: a systematic review and meta-analysis. PMID:32514597
Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study. PMID:32513307
Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease. PMID:32512291
A guided participation nursing intervention to theraupeutic positioning and care (GP_Posit) for mothers of preterm infants: protocol of a pilot randomized controlled trial. PMID:32509322
Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation. PMID:32503866
Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial. PMID:32503654
Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults. PMID:32499262
The KOMPACT-P study: Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy-Pilot study protocol. PMID:32499254
Changes to aspects of ongoing randomised controlled trials with fixed designs. PMID:32493444
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. PMID:32493442
Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19. PMID:32492354
Effect of Aspirin vs Placebo on the Prevention of Depression in Older People: A Randomized Clinical Trial. PMID:32492080
Photobiomodulation therapy associated with supervised therapeutic exercises for people with knee osteoarthritis: a randomised controlled trial protocol. PMID:32482669
Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial. PMID:32482668
Standardization of rehabilitation program for post-apoplectic limb spasm treated by Tongjing Tiaoxing tuina and scalp acupuncture with physical therapy. PMID:32481332
Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial. PMID:32474427
Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial. PMID:32471478
Probiotics for the prevention of antibiotic-associated adverse events in children-A scoping review to inform development of a core outcome set. PMID:32469907
An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT. PMID:32468989
Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials. PMID:32466758
A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design. PMID:32462131
Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. PMID:32461289
A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial. PMID:32460885
A typology of useful evidence: approaches to increase the practical value of intervention research. PMID:32460833
Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial. PMID:32460818
Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial. PMID:32457078
The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. PMID:32449505
Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial. PMID:32448335
The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial. PMID:32448331
Assessing the reporting quality of physical activity programs in randomized controlled trials for the management of juvenile idiopathic arthritis using three standardized assessment tools. PMID:32448277
Research "recover from illness defense complex" helper T cell immune mechanisms based on the "Fuxie" theory clearing away heat evil thoroughly nourishing kidney treatment of recurrent blood-heat syndrome Psoriasis. PMID:32443332
Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study. PMID:32442144
Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial. PMID:32442139
Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial. PMID:32430454
A study protocol to assess the feasibility of conducting an evaluation trial of the ADVANCE integrated intervention to address both substance use and intimate partner abuse perpetration to men in substance use treatment. PMID:32426156
Effect of Remote Ischemic Conditioning in Patients With Takotsubo Syndrome After Acute Stroke: Study Protocol for a Randomized Controlled Trial. PMID:32425872
Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial. PMID:32423936
Innovative equipment to monitor and control salt usage when cooking at home: iMC SALT research protocol for a randomised controlled trial. PMID:32423935
Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE). PMID:32423462
Neck-specific strengthening exercise compared with sham ultrasound when added to home-stretching exercise in patients with migraine: study protocol of a two-armed, parallel-groups randomized controlled trial. PMID:32423454
Mindful Eating and Active Living: Development and Implementation of a Multidisciplinary Pediatric Weight Management Intervention. PMID:32423162
Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial. PMID:32414414
The Exercise, Arterial Modulation and Nutrition in Youth South Africa Study (ExAMIN Youth SA). PMID:32411640
Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial. PMID:32410697
Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial. PMID:32410641
Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation. PMID:32408883
Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial. PMID:32404390
Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I'M FINE): study protocol of a randomized controlled trial. PMID:32404133
A randomised controlled crossover trial investigating the short-term effects of different types of vegetables on vascular and metabolic function in middle-aged and older adults with mildly elevated blood pressure: the VEgetableS for vaScular hEaLth (VESSEL) study protocol. PMID:32398091
Retaining participants in community-based health research: a case example on standardized planning and reporting. PMID:32393334
Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. PMID:32385063
Comparison of high tone therapy and transcutaneous electrical nerve stimulation therapy in chemotherapy-induced polyneuropathy. PMID:32384502
Study on prevention of hypercapnia by Nasal High Flow in patients with endoscopic submucosal dissection during intravenous anesthesia. PMID:32384465
Study on prevention of hypercapnia by nasal high flow in patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia. PMID:32384464
Randomized cross-over trial of demand oxygen delivery system. PMID:32384457
Feasibility of the Internet Attachment-Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial. PMID:32384051
Improving rheumatoid arthritis comparative effectiveness research through causal inference principles: systematic review using a target trial emulation framework. PMID:32381560
Translation of two healthy eating and active living support programs for parents of 2-6 year old children: a parallel partially randomised preference trial protocol (the 'time for healthy habits' trial). PMID:32381052
Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). PMID:32371520
Traditional Chinese medicine may reduce the dosage of systemic glucocorticoids in required patients with acute exacerbation of chronic obstructive pulmonary disease: Study protocol for a randomized placebo-controlled trial. PMID:32358383
To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. PMID:32358359
Design of a randomized controlled trial of a partnership-based, needs-tailored self-management support intervention for post-treatment breast cancer survivors. PMID:32357926
Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial. PMID:32357913
Electronic Monitoring Of Mom's Schedule (eMOMS™): Protocol for a feasibility randomized controlled trial to improve postpartum weight, blood sugars, and breastfeeding among high BMI women. PMID:32346648
Acupuncture or auricular electro-acupuncture as adjuncts to lifestyle interventions for weight management in PCOS: protocol for a randomised controlled feasibility study. PMID:32346487
Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial. PMID:32345358
The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial. PMID:32345344
Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial. PMID:32331323
[18F]DCFPyL PET-MRI/CT for unveiling a molecularly defined oligorecurrent prostate cancer state amenable for curative-intent ablative therapy: study protocol for a phase II trial. PMID:32327479
Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial. PMID:32326980
A protocol for a pilot cluster randomized control trial of e-vouchers and mobile phone application to enhance access to maternal health services in Cameroon. PMID:32313683
A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol. PMID:32302791
Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial. PMID:32299515
Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital. PMID:32295774
Family-based habit intervention to promote parent support for child physical activity in Canada: protocol for a randomised trial. PMID:32295773
Footwear for osteoarthritis of the lateral knee: protocol for the FOLK randomised controlled trial. PMID:32295645
A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial. PMID:32293533
COVID-19 randomised trial protocols: rapid publication without barriers. PMID:32293511
Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol. PMID:32290859
Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS). PMID:32284387
Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses: protocol for a cluster randomised controlled trial. PMID:32276953
Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan. PMID:32270496
Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation. PMID:32264945
Impact of alcohol marketing on drinkers with Alcohol use disorders seeking treatment: a mixed-method study protocol. PMID:32264848
Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. PMID:32259266
The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial. PMID:32245480
Effect of acupuncture on hormone level in patients with gastrointestinal dysfunction after general anesthesia: A study protocol for a randomized controlled trial. PMID:32243385
Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. PMID:32238172
A survey of 434 clinical trials about coronavirus disease 2019 in China. PMID:32220077
Group problem management plus (gPM+) in the treatment of common mental disorders in Syrian refugees in a Jordanian camp: study protocol for a randomized controlled trial. PMID:32216762
Nasogastric versus nasojejunal tube feeding for severe acute pancreatitis. PMID:32216139
Design and conduct of facility-based surveillance for severe childhood pneumonia in the Household Air Pollution Intervention Network (HAPIN) trial. PMID:32211438
Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial. PMID:32209621
Protocol for a feasibility study of OnTrack: a digital system for upper limb rehabilitation after stroke. PMID:32205375
Neuromuscular exercise and pain neuroscience education compared with pain neuroscience education alone in patients with chronic pain after primary total knee arthroplasty: study protocol for the NEPNEP randomized controlled trial. PMID:32197629
Physical Exercise following bariatric surgery in women with Morbid obesity: Study protocol clinical trial (SPIRIT compliant). PMID:32195937
Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial. PMID:32184315
Phase II double-blind randomised controlled trial of exogenous administration of melatonin in chronic pain (DREAM-CP): a study protocol. PMID:32184313
Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): study protocol for a cluster randomised controlled trial. PMID:32183897
Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial). PMID:32183835
Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial. PMID:32179562
Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing. PMID:32179560
A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. PMID:32178655
Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial. PMID:32171318
Neurosurgical Randomized Trials in Low- and Middle-Income Countries. PMID:32171011
Transcranial direct current stimulation (tDCS) as an intervention to improve empathic abilities and reduce violent behavior in forensic offenders: study protocol for a randomized controlled trial. PMID:32169111
Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial. PMID:32164723
Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial. PMID:32164719
Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial. PMID:32164604
Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial. PMID:32164535
Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. PMID:32163181
Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial. PMID:32152174
A randomized controlled trial for prevention of acute exacerbation of stable chronic obstructive pulmonary disease with acupoint application of traditional Chinese medicine: Study protocol clinical trial (SPIRIT Compliant). PMID:32150085
Peer support for discharge from inpatient to community mental health services: Study protocol clinical trial (SPIRIT Compliant). PMID:32150057
Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication. PMID:32143725
A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome. PMID:32131886
Effectiveness of an Educational Intervention in Reducing New International Postgraduates' Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial. PMID:32130180
Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden. PMID:32111264
MinT-trial: Mindfulness versus cognitive behavioural therapy in Tinnitus patients: protocol for a randomised controlled, non-inferiority trial. PMID:32102813
Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial. PMID:32102679
Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial. PMID:32093778
CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial. PMID:32093769
Dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults: A protocol for a randomized controlled trial : Variable- and fixed-priority dual-task for older adults. PMID:32087694
Comparison of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder drainage in acute suppurative cholecystitis: Study Protocol Clinical Trial (SPIRIT Compliant). PMID:32080085
Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study). PMID:32075845
Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial. PMID:32075832
Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640). PMID:32075823
Protocol for the feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL). PMID:32066605
Can childcare work be designed to promote moderate and vigorous physical activity, cardiorespiratory fitness and health? Study protocol for the Goldilocks-childcare randomised controlled trial. PMID:32066404
Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial. PMID:32060156
The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT). PMID:32059695
Loneliness and social isolation interventions for older adults: a scoping review of reviews. PMID:32054474
Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. PMID:32051002
Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial. PMID:32047015
Identification and evaluation of risk of generalizability biases in pilot versus efficacy/effectiveness trials: a systematic review and meta-analysis. PMID:32046735
Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating. PMID:32041861
How the EMERGE guideline on medication adherence can improve the quality of clinical trials. PMID:32034923
To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis: HAMLETT, a pragmatic multicenter single-blind randomized controlled trial. PMID:32033579
Computerised cognitive training to improve cognition including delirium following coronary artery bypass grafting surgery: protocol for a blinded randomised controlled trial. PMID:32029497
Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol. PMID:32028926
Comprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols. PMID:32024788
Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial). PMID:32024533
Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial. PMID:32022904
Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand. PMID:32019609
Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. PMID:32019596
A behavioural change intervention study for the prevention of childhood obesity in South Africa: protocol for a randomized controlled trial. PMID:32019551
Group cognitive behavioural therapy (GCBT) versus treatment as usual (TAU) in the treatment of irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial. PMID:32019509
Percutaneous ethanol injection for liver metastases. PMID:32017845
Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. PMID:32014057
Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease. PMID:32012103
Effect of 5-Minute Movies Shown via a Mobile Phone App on Risk Factors and Mortality After Stroke in a Low- to Middle-Income Country: Randomized Controlled Trial for the Stroke Caregiver Dyad Education Intervention (Movies4Stroke). PMID:32012080
Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial. PMID:32005780
A randomized controlled trial study protocol for Xiao-Qing-Long decoction in the treatment of refractory asthma: Study protocol clinical trial (spirit compliant). PMID:32000396
Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial. PMID:31997819
An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study. PMID:31996250
Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. PMID:31996235
Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study. PMID:31988225
Treatment for ascites in adults with decompensated liver cirrhosis: a network meta-analysis. PMID:31978257
Antibiotic prophylaxis to prevent spontaneous bacterial peritonitis in people with liver cirrhosis: a network meta-analysis. PMID:31978256
Induction immunosuppression in adults undergoing liver transplantation: a network meta-analysis. PMID:31978255
Effectiveness of supervised early exercise program in patients with arthroscopic rotator cuff repair: Study protocol clinical trial. PMID:31977882
Effectiveness of a multicomponent treatment versus conventional treatment in patients with fibromyalgia: Study protocol. PMID:31977878
A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study. PMID:31975288
Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial. PMID:31963773
Study Protocol for the Evaluation of "SuperFIT", a Multicomponent Nutrition and Physical Activity Intervention Approach for Preschools and Families. PMID:31963506
Embedded Motivational Interviewing combined with a smartphone app to increase physical activity in people with sub-acute low back pain: Study protocol of a cluster randomised control trial. PMID:31956722
The cost-effectiveness of specialized nursing interventions for people with Parkinson's disease: the NICE-PD study protocol for a randomized controlled clinical trial. PMID:31941538
Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial. PMID:31941483
Feasibility of alcohol screening and brief intervention in primary health care in Kazakhstan: study protocol of a pilot cluster randomised trial. PMID:31938551
Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial. PMID:31937355
Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study. PMID:31937347
Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). PMID:31937322
Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement. PMID:31932393
Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. PMID:31931855
REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol. PMID:31931767
A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial. PMID:31918760
Monitoring in practice - How are UK academic clinical trials monitored? A survey. PMID:31918743
Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial. PMID:31914959
Cognitive behavioural therapy for tinnitus. PMID:31912887
LIFEStyle, Prevention and Risk of Acute PaNcreatitis (LIFESPAN): protocol of a multicentre and multinational observational case-control study. PMID:31911510
Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis. PMID:31910857
Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomised controlled study. PMID:31907080
Effects of tai chi on postural control during dual-task stair negotiation in knee osteoarthritis: a randomised controlled trial protocol. PMID:31900273
An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance: Study protocol for investigator-initiated, multicenter, open-label trial. PMID:31895769
Finding/identifying primaries with neck disease (FIND) clinical trial protocol: a study integrating transoral robotic surgery, histopathological localisation and tailored deintensification of radiotherapy for unknown primary and small oropharyngeal head and neck squamous cell carcinoma. PMID:31892671
Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. PMID:31892650
Health promotion and cardiovascular risk reduction in people with spinal cord injury: physical activity, healthy diet and maintenance after discharge- protocol for a prospective national cohort study and a preintervention- postintervention study. PMID:31892644
Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol. PMID:31888947
Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study. PMID:31888941
Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol. PMID:31888938
Safety of switching from vitamin K antagonist to non-vitamin K antagonist oral anticoagulant in frail elderly with atrial fibrillation: rationale and design of the FRAIL-AF randomised controlled trial. PMID:31888928
C1 inhibitor in canine intravascular hemolysis (C1INCH): study protocol for a randomized controlled trial. PMID:31888626
Virtual reality as an adjunct to anesthesia in the operating room. PMID:31882015
Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial. PMID:31881911
Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials. PMID:31881910
Cluster randomised controlled trial to determine the effect of peer delivery HIV self-testing to support linkage to HIV prevention among young women in rural KwaZulu-Natal, South Africa: a study protocol. PMID:31874891
Effects of dietary nitrate and folate supplementation on blood pressure in hypertensive Tanzanians: Design and baseline characteristics of a feasibility trial. PMID:31872153
Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study. PMID:31871257
Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial. PMID:31870458
A double masked randomised 4-week, placebo-controlled study in the USA, Thailand and Taiwan to compare the efficacy of oral valganciclovir and topical 2% ganciclovir in the treatment of cytomegalovirus anterior uveitis: study protocol. PMID:31862739
Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol. PMID:31856900
Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial. PMID:31855189
Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care 'test-and-treat' strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol. PMID:31852699
Short- versus long-term complementary nutritional support via needle catheter jejunostomy after pancreaticoduodenectomy: Study protocol of a randomized controlled trial. PMID:31851756
Prospective mixed-methods study of patients undergoing relaparotomy (ReLap study; DRKS00013001). PMID:31851738
Nutritional risk in major abdominal surgery: NURIMAS Liver (DRKS00010923) - protocol of a prospective observational trial to evaluate the prognostic value of different nutritional scores in hepatic surgery. PMID:31851731
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). PMID:31847914
Cluster-randomised trial evaluating a complex intervention to improve mental health and well-being of employees working in hospital - a protocol for the SEEGEN trial. PMID:31847898
Beta-blockers for suspected or diagnosed acute myocardial infarction. PMID:31845756
Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial. PMID:31843833
DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care. PMID:31843821
Breastfeeding success with the use of the inverted syringe technique for management of inverted nipples in lactating women: a study protocol for a randomized controlled trial. PMID:31842992
Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine. PMID:31842977
Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. PMID:31842969
Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial): study protocol for a randomized controlled trial. PMID:31842966
Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol. PMID:31826899
A survey exploring biomedical editors' perceptions of editorial interventions to improve adherence to reporting guidelines. PMID:31824668
GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. PMID:31823812
The effect of canola oil compared with sesame and sesame-canola oil on cardio-metabolic biomarkers in patients with type 2 diabetes: Design and research protocol of a randomized, triple-blind, three-way, crossover clinical trial. PMID:31819750
Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin: protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial. PMID:31818845
Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol. PMID:31818831
Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial. PMID:31818310
Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. PMID:31815655
Efficacy and safety of Sijunzi Decoction for chronic fatigue syndrome with spleen deficiency pattern: study protocol for a randomized, double-blind, placebo-controlled trial. PMID:31807568
Effects of combining functional exercises with exercise training on daily physical activities and functionality in patients with COPD: a protocol for a randomized clinical trial. PMID:31805981
Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol. PMID:31798650
Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial. PMID:31791396
Analysis of reporting completeness in exercise cancer trials: a systematic review. PMID:31791246
Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial. PMID:31783900
ENACT: a protocol for a randomised placebo-controlled trial investigating the efficacy and mechanisms of action of adjunctive N-acetylcysteine for first-episode psychosis. PMID:31779696
Protocols-more structure, less 'Wuthering Heights'. PMID:31779685
A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial. PMID:31779683
The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial. PMID:31779675
A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial. PMID:31775831
Effectiveness of the Labour Inspection Authority's regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers. PMID:31772092
Efficacy of sofosbuvir as treatment for yellow fever: protocol for a randomised controlled trial in Brazil (SOFFA study). PMID:31772079
Psychological interventions for co-occurring depression and substance use disorders. PMID:31769015
Effects of a chattering teeth training oral appliance for working memory improvement in healthy volunteers: a cross-over randomized trial. PMID:31768310
Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol. PMID:31767581
Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group. PMID:31766999
Rationale and design of the Lowlands Saves Lives trial: a randomised trial to compare CPR quality and long-term attitude towards CPR performance between face-to-face and virtual reality training with the Lifesaver VR app. PMID:31753903
The Incentives to Quit tobacco in Pregnancy (IQuiP) protocol: piloting a financial incentive-based smoking treatment for women attending substance use in pregnancy antenatal services. PMID:31753890
Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol. PMID:31753880
Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE). PMID:31753004
Interventions to improve human papillomavirus vaccination among Chinese female college students: study protocol for a randomized controlled trial. PMID:31752785
Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT). PMID:31748296
Sleeping sound with autism spectrum disorder (ASD): study protocol for an efficacy randomised controlled trial of a tailored brief behavioural sleep intervention for ASD. PMID:31748288
Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis. PMID:31747971
The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building: a program protocol for building implementation science and mental health research and policymaking capacity in Malawi and Tanzania. PMID:31728158
PRISM protocol: a randomised phase II trial of nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma. PMID:31727024
Effects of Chaihu-Shugan-San capsule for psychogenic erectile dysfunction: Study protocol of a randomized placebo-controlled trial. PMID:31725644
Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial. PMID:31722937
10-Year Update on Study Results Submitted to ClinicalTrials.gov. PMID:31722160
A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol. PMID:31719999
Evaluation of the efficacy of 3D total-body photography with sequential digital dermoscopy in a high-risk melanoma cohort: protocol for a randomised controlled trial. PMID:31712348
Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols. PMID:31712328
Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial. PMID:31700924
MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery. PMID:31699720
Xiao Chai Hu Tang, a herbal medicine, for chronic hepatitis B. PMID:31697415
Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol. PMID:31696127
The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia. PMID:31694851
Comparison of drug safety data obtained from the monitoring system, literature, and social media: An empirical proof from a Chinese patent medicine. PMID:31693665
Endotype-driven prediction of acute exacerbations in chronic obstructive pulmonary disease (EndAECOPD): protocol for a prospective cohort study. PMID:31690612
Heart rate variability in middle-aged adults: Use of Sasang typology to distinguish individuals susceptible to stress. PMID:31689836
Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial. PMID:31689771
A randomised controlled feasibility trial and qualitative evaluation of an early years language development intervention: study protocol of the 'outcomes of Talking Together evaluation and results' (oTTer) project. PMID:31687175
Multicentre randomised double-blind placebo controlled trial of combination vancomycin and cefazolin surgical antibiotic prophylaxis: the Australian surgical antibiotic prophylaxis (ASAP) trial. PMID:31685516
Pain neuroscience education and physical exercise for patients with chronic spinal pain in primary healthcare: a randomised trial protocol. PMID:31679512
A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study). PMID:31678935
Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. PMID:31676642
Protocol for a two-arm feasibility RCT to support postnatal maternal weight management and positive lifestyle behaviour in women from an ethnically diverse inner city population: the SWAN feasibility trial. PMID:31666983
Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America. PMID:31662385
Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol. PMID:31662381
Group antenatal care versus standard antenatal care and effect on mean gestational age at birth in Rwanda: protocol for a cluster randomized controlled trial. PMID:31656954
Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. PMID:31642928
Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial. PMID:31638593
Study Protocol: Does an Acute Intervention of High-Intensity Physical Exercise Followed by a Brain Training Video Game Have Immediate Effects on Brain Activity of Older People During Stroop Task in fMRI?-A Randomized Controlled Trial With Crossover Design. PMID:31619984
Process-evaluation and outcome-evaluation of a training programme for healthcare professionals in oncology to enhance their competencies in caring for patients with minor children: a study protocol for a randomised controlled pilot study. PMID:31615803
Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes. PMID:31615456
Can Between-Session Homework Be Delivered Digitally? A Pilot Randomized Clinical Trial of CBT for Adjustment Disorders. PMID:31614596
Guidelines for reporting non-randomised pilot and feasibility studies. PMID:31608150
A Digital Intervention for Australian Adolescents Above a Healthy Weight (Health Online for Teens): Protocol for an Implementation and User Experience Study. PMID:31603435
Protocol for a quasiexperimental study testing the effectiveness of strengthening growth monitoring and promotion in community clinics for improving the nutritional status of under-two children in rural Bangladesh. PMID:31601604
Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol. PMID:31601229
Attachment-based compassion therapy and adapted mindfulness-based stress reduction for the treatment of depressive, anxious and adjustment disorders in mental health settings: a randomised controlled clinical trial protocol. PMID:31597650
Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study. PMID:31594904
Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial. PMID:31594892
Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial. PMID:31594889
Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study. PMID:31594876
Effectiveness and Cost-Effectiveness of Blended Cognitive Behavioral Therapy in Clinically Depressed Adolescents: Protocol for a Pragmatic Quasi-Experimental Controlled Trial. PMID:31593538
Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial. PMID:31590692
Outcomes of nurse practitioner-led care in patients with cardiovascular disease: A systematic review and meta-analysis. PMID:31588598
Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial. PMID:31588356
Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial. PMID:31575574
The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults. PMID:31575569
Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): Study protocol for a randomized controlled trial. PMID:31574878
Effectiveness, safety, and economic evaluation of adjuvant moxibustion therapy for aromatase inhibitor-induced arthralgia of postmenopausal breast cancer stage I to III patients: Study protocol for a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial. PMID:31568000
Efficacy and safety of electroacupuncture on metabolic syndrome due to olanzapine and risperidone: Study protocol for a randomized controlled pilot trial. PMID:31567988
Treatment response prediction of rehabilitation program in children with cerebral palsy using radiomics strategy: protocol for a multicenter prospective cohort study in west China. PMID:31559169
Effectiveness of a Self-Monitoring Quality of Life Intervention For Patients with Cancer Receiving Palliative Care: A Randomized Controlled Clinical Trial. PMID:31554379
Counselling for physical activity, life-space mobility and falls prevention in old age (COSMOS): protocol of a randomised controlled trial. PMID:31551378
ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design. PMID:31542738
A cluster-randomised controlled trial comparing school and community-based deworming for soil transmitted helminth control in school-age children: the CoDe-STH trial protocol. PMID:31533666
Antibiotics for treating acute chest syndrome in people with sickle cell disease. PMID:31531967
Acceptability of escitalopram versus duloxetine in outpatients with depression who did not respond to initial second-generation antidepressants: Study protocol for a randomized, parallel-group, non-inferiority trial. PMID:31531962
Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. PMID:31530611
Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial. PMID:31530607
Effectiveness of a multifactorial context-enhancing functional therapy to promote functional arm use and recovery of stroke survivors: study protocol for a clinical trial. PMID:31530586
Antibiotic treatment for spontaneous bacterial peritonitis in people with decompensated liver cirrhosis: a network meta-analysis. PMID:31524949
Treatment for hepatorenal syndrome in people with decompensated liver cirrhosis: a network meta-analysis. PMID:31513287
Protocol for a multisite randomised trial of Hand-Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia. PMID:31501133
A single-centre investigator-blinded randomised parallel group clinical trial to investigate the effect of probiotic strains Streptococcus salivarius M18 and Lactobacillus acidophilus on gingival health of paediatric patients undergoing treatment with fixed orthodontic appliances: study protocol. PMID:31501124
Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial. PMID:31500602
Prospective multicentre cohort trial on acute appendicitis and microbiota, aetiology and effects of antimicrobial treatment: study protocol for the MAPPAC (Microbiology APPendicitis ACuta) trial. PMID:31494621
The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study. PMID:31494615
A minimum evaluation protocol and stepped-wedge cluster randomized trial of ACCESS Open Minds, a large Canadian youth mental health services transformation project. PMID:31488144
Active women over 50: study protocol for RCT of a low-dose information and support program to promote physical activity behaviour change. PMID:31484565
Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial. PMID:31484559
Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial. PMID:31484523
'Optimising PharmacoTherapy In the multimorbid elderly in primary CAre' (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial. PMID:31481568
Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan. PMID:31477178
Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol. PMID:31477140
Next generation sequencing based assessment of the alloreactive T cell receptor repertoire in kidney transplant patients during rejection: a prospective cohort study. PMID:31477052
Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. PMID:31474848
A study protocol of a single-center investigator-blinded randomized parallel group study to investigate the effect of an acclimatization visit on children's behavior during inhalational sedation in a United Arab Emirates pediatric dentistry postgraduate setting as measured by the levels of salivary Alpha Amylase and Cortisol. PMID:31464945
Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial. PMID:31462466
The malnutrition in polytrauma patients (MaPP) study: Research protocol. PMID:31456469
Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial. PMID:31455710
Acupressure to Reduce Treatment-Related Symptoms for Children With Cancer and Recipients of Hematopoietic Stem Cell Transplant: Protocol for a Randomized Controlled Trial. PMID:31453017
Clinical and cost-effectiveness of teen online problem-solving for adolescents who have survived an acquired brain injury in the UK: protocol for a randomised, controlled feasibility study (TOPS-UK). PMID:31444185
Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial. PMID:31439599
Acupuncture for chronic hepatitis B. PMID:31436846
Study protocol for a randomised controlled trial with clinical, neurophysiological, laboratory and radiological outcome for surgical versus non-surgical treatment for lumbar spinal stenosis: the Uppsala Spinal Stenosis Trial (UppSten). PMID:31434781
Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. PMID:31434770
Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial. PMID:31429792
RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial. PMID:31427344
Effect of aerobic exercise prior to modified constraint-induced movement therapy outcomes in individuals with chronic hemiparesis: a study protocol for a randomized clinical trial. PMID:31416436
Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial. PMID:31412937
Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial. PMID:31409383
Sensitivity of point-of-care testing C reactive protein and procalcitonin to diagnose urinary tract infections in Dutch nursing homes: PROGRESS study protocol. PMID:31401614
Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial. PMID:31400107
Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial. PMID:31399446
The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial. PMID:31399147
Radical prostatectomy and simultaneous penile prosthesis implantation: a narrative review. PMID:31395986
Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial. PMID:31391104
Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III-IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial. PMID:31391092
Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on improving depressive symptoms and work-related outcomes among nurses in Japan: a protocol for a randomized controlled trial. PMID:31391029
Efficacy and mechanisms underlying a gamified attention bias modification training in anxious youth: protocol for a randomized controlled trial. PMID:31391027
Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial. PMID:31387574
Evaluation of the Music Engagement Program for people with Alzheimer's disease and dementia: Study protocol for a pilot trial. PMID:31384692
HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults-study protocol for a double blind, placebo-controlled randomised feasibility trial. PMID:31384480
Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. PMID:31382998
The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial. PMID:31382981
Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial. PMID:31382934
Tablet-based sensorimotor home-training system for amnestic mild cognitive impairments in the elderly: design of a randomised clinical trial. PMID:31377702
Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia. PMID:31375620
Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial. PMID:31375148
The use of text messaging for improving adherence to anti-diabetic regimen and glycaemic control in low-resource settings of South Africa: A study protocol for a randomised controlled trial. PMID:31372574
A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions. PMID:31370871
Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT). PMID:31366659
The redox-dependent regulation of satellite cells following aseptic muscle trauma (SpEED): study protocol for a randomized controlled trial. PMID:31366396
Evaluation of the clinical effectiveness of a work-based mentoring programme to develop clinical reasoning on patient outcome: A stepped wedge cluster randomised controlled trial. PMID:31365565
Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. PMID:31349833
Rationale and methods of a randomized clinical trial to compare specific exercise programs versus home exercises in patients with subacromial impingement syndrome. PMID:31348227
Guideline implementation in the Canadian chiropractic setting: a pilot cluster randomized controlled trial and parallel study. PMID:31346409
Study protocol for developing #CuttingCRC: a barbershop-based trial on masculinity barriers to care and colorectal cancer screening uptake among African-American men using an exploratory sequential mixed-methods design. PMID:31345981
Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study. PMID:31345964
Erythrocyte Encapsulated Thymidine Phosphorylase for the Treatment of Patients with Mitochondrial Neurogastrointestinal Encephalomyopathy: Study Protocol for a Multi-Centre, Multiple Dose, Open Label Trial. PMID:31344955
Quality of Systematic Reviews of the Foods with Function Claims in Japan: Comparative Before- and After-Evaluation of Verification Reports by the Consumer Affairs Agency. PMID:31336978
Implementation of a training program to increase knowledge, improve attitudes and reduce nursing care omissions towards patients with dementia in hospital settings: a mixed-method study protocol. PMID:31326938
Protocol for a non-randomised pilot and feasibility study evaluating a multicomponent intervention to simplify medication regimens for people receiving community-based home care services. PMID:31326924
Protocol for a randomized clinical trial exploring the effect of antimicrobial agents on the penile microbiota, immunology and HIV susceptibility of Ugandan men. PMID:31324206
Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. PMID:31324199
A protocol for a randomised controlled, double-blind feasibility trial investigating fluoxetine treatment in improving memory and learning impairments in patients with mesial temporal lobe epilepsy: Fluoxetine, Learning and Memory in Epilepsy (FLAME trial). PMID:31321071
Protocol for phase I study of pembrolizumab in combination with Bacillus Calmette-Guérin for patients with high-risk non-muscle invasive bladder cancer. PMID:31320352
Implementing an allied health team intervention to improve the care of older adults in the emergency department: protocol for a process evaluation. PMID:31315881
A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project. PMID:31307412
Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality. PMID:31291974
Cryotherapy for liver metastases. PMID:31291464
Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized Controlled Trial. PMID:31290402
Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial. PMID:31289058
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial. PMID:31288829
A classroom-based intervention targeting working memory, attention and language skills in 4-5 year olds (RECALL): study protocol for a cluster randomised feasibility trial. PMID:31285835
Effects of β-hydroxy-β-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. PMID:31277595
HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. PMID:31272495
Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial. PMID:31272494
Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial. PMID:31270121
DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial. PMID:31243035
Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data. PMID:31243034
Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial. PMID:31242936
Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial. PMID:31239304
The Post Ischaemic Stroke Cardiovascular Exercise Study: Protocol for a randomised controlled trial of fitness training for brain health. PMID:31236486
Radix Sophorae flavescentis versus other drugs or herbs for chronic hepatitis B. PMID:31232459
Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT. PMID:31227528
Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years. PMID:31222721
Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial. PMID:31221870
STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. PMID:31218013
Comparison of weight bearing functional exercise and non-weight bearing quadriceps strengthening exercise on pain and function for people with knee osteoarthritis and obesity: protocol for the TARGET randomised controlled trial. PMID:31208435
Investigating the potential clinical benefit of Selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy (SEL-I-METRY): protocol for a multicentre UK single arm phase II trial. PMID:31200667
Impact of endurance exercise and probiotic supplementation on the intestinal microbiota: a cross-over pilot study. PMID:31198580
The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial. PMID:31196147
Effectiveness evaluation of the school-based drug prevention program #Tamojunto2.0: protocol of a cluster randomized controlled trial. PMID:31196037
Efficacy of the bile leak test using contrast-enhanced intraoperative ultrasonic cholangiography in liver resection: a study protocol for a non-randomised, prospective, off-label, single-arm trial. PMID:31182455
Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial. PMID:31182440
A factorial randomised controlled trial to identify efficacious self-regulation techniques in an e- and m-health intervention to target an active lifestyle: study protocol. PMID:31182147
Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial. PMID:31182140
Randomized controlled trial on Pringle Maneuver to reduce blood loss during stapler hepatectomy - PriMal StHep. PMID:31182077
Evaluation of a structured skills training group for adolescents with attention deficit/hyperactivity disorder (ADHD) - study protocol of a randomised controlled trial. PMID:31182047
Internet- and App-Based Stress Intervention for Distance-Learning Students With Depressive Symptoms: Protocol of a Randomized Controlled Trial. PMID:31178770
Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2). PMID:31174586
Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial. PMID:31174583
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study). PMID:31171031
Pomegranate juice to reduce fecal calprotectin levels in inflammatory bowel disease patients with a high risk of clinical relapse: Study protocol for a randomized controlled trial. PMID:31171016
Improving care for elderly patients living with polypharmacy: protocol for a pragmatic cluster randomized trial in community-based primary care practices in Canada. PMID:31171011
Efficacy of Mentalization-based group therapy for adolescents: the results of a pilot randomised controlled trial. PMID:31170947
Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia. PMID:31167867
Supporting Harm Reduction through Peer Support (SHARPS): testing the feasibility and acceptability of a peer-delivered, relational intervention for people with problem substance use who are homeless, to improve health outcomes, quality of life and social functioning and reduce harms: study protocol. PMID:31164989
Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial. PMID:31164366
Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham-controlled pilot trial. PMID:31164178
Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma. PMID:31159849
Electronic Alerts for Acute Kidney Injury Amelioration (ELAIA-1): a completely electronic, multicentre, randomised controlled trial: design and rationale. PMID:31154298
Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge). PMID:31147363
Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study. PMID:31147361
A double-blinded randomised dietary supplement crossover trial design to investigate the short-term influence of medium chain fatty acid (MCT) supplement on canine idiopathic epilepsy: study protocol. PMID:31146740
Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185]. PMID:31142350
This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols. PMID:31138317
Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial. PMID:31138315
Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease. PMID:31133061
Effect of a community health worker delivered health, nutrition and responsive stimulation package and conditional cash transfers on child development and growth in rural Tanzania: protocol for a cluster-randomized trial. PMID:31132997
Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol. PMID:31129600
Feasibility and effectiveness assessment of a mobile application for subhealth management: Study protocol for a randomized controlled trial. PMID:31124947
Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia: a protocol for a randomIsed controlled Trial (CAP-IT). PMID:31123008
Proactive healthcare for frail elderly persons: study protocol for a prospective controlled primary care intervention in Sweden. PMID:31122995
Effects of brain training on brain blood flow (The Cognition and Flow Study-CogFlowS): protocol for a feasibility randomised controlled trial of cognitive training in dementia. PMID:31122994
Early recognition and treatment of neuropsychiatric symptoms to improve quality of life in early Alzheimer's disease: protocol of the BEAT-IT study. PMID:31122267
The impact of short message services and personal consultation by pharmacy students on medication adherence and blood pressure control: study protocol for a cluster randomized trial. PMID:31118586
Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial. PMID:31110776
Improving bereavement outcomes in Zimbabwe: protocol for a feasibility cluster trial of the 9-cell bereavement tool. PMID:31110775
Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. PMID:31110092
Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. PMID:31110087
Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial. PMID:31109343
Implementing Systematic Screening and Structured Care for Distressed Callers Using Cancer Council's Telephone Services: Protocol for a Randomized Stepped-Wedge Trial. PMID:31099341
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients' treatment adherence via electronic monitors and an app versus usual care in Tibet. PMID:31097023
PREhabilitation for improving QUality of recovery after ELective cardiac surgery (PREQUEL) study: protocol of a randomised controlled trial. PMID:31092666
MyBackPain-evaluation of an innovative consumer-focused website for low back pain: study protocol for a randomised controlled trial. PMID:31092664
A blended face-to-face and smartphone intervention for suicide prevention in the construction industry: protocol for a randomized controlled trial with MATES in Construction. PMID:31088405
New requirements for clinical trial transparency provide new opportunities for informatics research. PMID:31087069
The effects of intradialytic resistance training on muscle strength, psychological well-being, clinical outcomes and circulatory micro-ribonucleic acid profiles in haemodialysis patients: Protocol for a quasi-experimental study. PMID:31083229
Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial. PMID:31083195
Effectiveness of an internet-based intervention for procrastination in college students (StudiCare Procrastination): Study protocol of a randomized controlled trial. PMID:31080750
Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial. PMID:31079083
Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol. PMID:31079082
Multifaceted intervention to enhance cognition in older people at risk of cognitive decline: study protocol for the Protein Omega-3 and Vitamin D Exercise Research (PONDER) study. PMID:31072850
Efficacy of a personalised pelvic floor muscle training programme on urinary incontinence after radical prostatectomy (MaTchUP): protocol for a randomised controlled trial. PMID:31061057
A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial. PMID:31057807
Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies. PMID:31053067
Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial. PMID:31046819
Multifactorial intervention for hip and pelvic fracture patients with mild to moderate cognitive impairment: study protocol of a dual-centre randomised controlled trial (OF-CARE). PMID:31039754
Family in Rehabilitation, Empowering Carers for Improved Malnutrition Outcomes: Protocol for the FREER Pilot Study. PMID:31038466
Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the Treatment of Anxiety Disorders in Adolescents (TAD-A). PMID:31023352
Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6). PMID:31023318
Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal. PMID:31015275
Effects of different modalities of inspiratory muscle training as an add-on to conventional treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a randomized controlled trial. PMID:31014365
Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain. PMID:31011944
Effect of metformin on the size of the HIV reservoir in non-diabetic ART-treated individuals: single-arm non-randomised Lilac pilot study protocol. PMID:31005944
Protocol for the Gut Bugs Trial: a randomised double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents. PMID:31005929
Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression. PMID:31005923
The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis. PMID:31005917
Dementia Stigma Reduction (DESeRvE): Study protocol for a randomized controlled trial of an online intervention program to reduce dementia-related public stigma. PMID:30997434
A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study. PMID:30997142
Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia. PMID:30992081
Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer (GREEN study): Study protocol for a randomized controlled trial. PMID:30985703
Efficacy of laser acupuncture for patients with chronic Bell's palsy: A study protocol for a randomized, double-blind, sham-controlled pilot trial. PMID:30985671
A web-based psycho-educational intervention (Fex-Can) targeting sexual dysfunction and fertility-related distress in young adults with cancer: study protocol of a randomized controlled trial. PMID:30975116
Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial. PMID:30971301
Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials. PMID:30959516
Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial. PMID:30958279
The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial. PMID:30953543
Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial. PMID:30953536
Rationale and design of the randomized, multicenter, open-label, controlled POLBOS 3 trial aimed to compare regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM C stent. PMID:30946377
Sleep Apnea Multilevel Surgery (SAMS) trial protocol: a multicenter randomized clinical trial of upper airway surgery for patients with obstructive sleep apnea who have failed continuous positive airway pressure. PMID:30945740
Radix Sophorae flavescentis versus no intervention or placebo for chronic hepatitis B. PMID:30941748
Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study). PMID:30940171
Five good reasons to be disappointed with randomized trials. PMID:30935322
Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial. PMID:30928927
Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial. PMID:30928924
Improving continuity of patient care across sectors: study protocol of a quasi-experimental multi-centre study regarding an admission and discharge model in Germany (VESPEERA). PMID:30925879
Study reporting guidelines: How valid are they? PMID:30923775
Protocol for the prospective observational clinical study: estimation of fetal weight by MRI to PREdict neonatal MACROsomia (PREMACRO study) and small-for-gestational age neonates. PMID:30918039
Short-Term Effects of a Multidimensional Stress Prevention Program on Quality of Life, Well-Being and Psychological Resources. A Randomized Controlled Trial. PMID:30914974
A couples-focused intervention for smoking cessation during pregnancy: The study protocol of the Quit Together pilot randomized controlled trial. PMID:30906906
Protocol and Rationale: A 24-week Double-blind, Randomized, Placebo Controlled Trial of the Efficacy of Adjunctive Garcinia mangostanaLinn. (Mangosteen) Pericarp for Schizophrenia. PMID:30905130
INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol. PMID:30904880
Haemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with non-coeliac, non-IBD subjects (HERMES): a case-control study protocol. PMID:30904871
Dose escalation of preoperative short-course radiotherapy followed by neoadjuvant chemotherapy in locally advanced rectal cancer: protocol for an open-label, single-centre, phase I clinical trial. PMID:30904869
A Self-Regulation-Based eHealth and mHealth Intervention for an Active Lifestyle in Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial. PMID:30901002
Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol. PMID:30898822
Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial. PMID:30898098
Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol. PMID:30894146
A multicomponent prehabilitation pathway to reduce the incidence of delirium in elderly patients in need of major abdominal surgery: study protocol for a before-and-after study. PMID:30894131
Feasibility and preliminary effects of an integrated hospital-to-home transitional care intervention for older adults with stroke and multimorbidity: A study protocol. PMID:30891429
Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial. PMID:30885259
Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial. PMID:30885242
Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial. PMID:30885157
Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial. PMID:30876438
Lateral episiotomy versus no episiotomy to reduce obstetric anal sphincter injury in vacuum-assisted delivery in nulliparous women: study protocol on a randomised controlled trial. PMID:30872546
The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial. PMID:30867017
Effectiveness and safety of electroacupuncture for poststroke patients with shoulder pain: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial. PMID:30866914
A multicentre randomized controlled trial of food supplement intervention for wasting children in Indonesia-study protocol. PMID:30866888
Improving cancer symptom awareness and help-seeking among adults living in socioeconomically deprived communities in the UK using a facilitated health check: A protocol for the Awareness and Beliefs About Cancer (ABACus) Randomised Control Trial. PMID:30866887
Laparoscopic uncut Roux-en-Y for radical distal gastrectomy: the study protocol for a multirandomized controlled trial. PMID:30863178
A guide to the reporting of protocols of pilot and feasibility trials. PMID:30858987
eHealth-based intervention to increase physical activity levels in people with cancer: protocol of a feasibility trial in an Irish acute hospital setting. PMID:30852540
App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial. PMID:30845949
Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial. PMID:30837256
Reporting guidelines for health research: protocol for a cross-sectional analysis of the EQUATOR Network Library. PMID:30837245
Effects of camera-based mirror visual feedback therapy for patients who had a stroke and the neural mechanisms involved: protocol of a multicentre randomised control study. PMID:30833310
The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial. PMID:30832739
DTEXT - text messaging intervention to improve outcomes of people with type 2 diabetes: protocol for randomised controlled trial and cost-effectiveness analysis. PMID:30832638
The Impact of a Web-Based Course Concerning Patient Education for Mental Health Care Professionals: Quasi-Experimental Study. PMID:30821697
A Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial. PMID:30821695
Home-based aerobic exercise in patients with lacunar stroke: Design of the HITPALS randomized controlled trial. PMID:30815618
Protocol for a mixed-methods exploratory investigation of care following intensive care discharge: the REFLECT study. PMID:30813113
Randomized clinical trials with run-in periods: frequency, characteristics and reporting. PMID:30809104
Preventive skin analgesia with lidocaine patch for management of post-thoracotomy pain: Results of a randomized, double blind, placebo controlled study. PMID:30806017
Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial. PMID:30804818
Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). PMID:30804032
Protocol for a randomised trial evaluating the effect of applying gamification to simulation-based endoscopy training. PMID:30804029
Protocol for developing a mental imagery intervention: a randomised controlled trial testing a novel implementation imagery e-health intervention to change driver behaviour during floods. PMID:30782937
Does care in a specialised stroke prevention clinic improve poststroke blood pressure control: a protocol for a randomised comparative effectiveness study. PMID:30782915
HORYZONS trial: protocol for a randomised controlled trial of a moderated online social therapy to maintain treatment effects from first-episode psychosis services. PMID:30782893
Prevention of child mental health problems in Southeastern Europe: a multicentre sequential study to adapt, optimise and test the parenting programme 'Parenting for Lifelong Health for Young Children', protocol for stage 1, the feasibility study. PMID:30782760
Evaluating a custom-designed aid to improve communication of genetic results in families with hypertrophic cardiomyopathy: study protocol for a randomised controlled trial. PMID:30782759
Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. PMID:30782716
A prospective cohort for the investigation of alteration in temporal transcriptional and microbiome trajectories preceding preterm birth: a study protocol. PMID:30782707
Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): protocol for a single-centre, pilot, randomised controlled trial. PMID:30782696
The (cost-) effectiveness of exergaming in people living with dementia and their informal caregivers: protocol for a randomized controlled trial. PMID:30782127
Effects of blood flow restriction exercise with very low load and low volume in patients with knee osteoarthritis: protocol for a randomized trial. PMID:30777115
An Internet based intervention for improving resilience and coping strategies in university students: Study protocol for a randomized controlled trial. PMID:30775264
Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell's palsy: A protocol for a patient-assessor blinded, randomized, controlled, parallel clinical trial. PMID:30762782
How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the 'CLASSIC' trial). PMID:30760305
Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial. PMID:30755274
Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. PMID:30747964
Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement. PMID:30744706
Effect of an interactive voice response system on self-management in kidney transplant recipients: Protocol for a randomized controlled trial. PMID:30732143
Study protocol for a peer-led web-based intervention to promote safe usage of dating applications among young adults: a cluster randomized controlled trial. PMID:30728064
Feasibility of Integrating Residential Care Pharmacists into Aged Care Homes to Improve Quality Use of Medicines: Study Protocol for a Non-Randomised Controlled Pilot Trial. PMID:30720779
Activation therapy for the treatment of inpatients with depression - protocol for a randomised control trial compared to treatment as usual. PMID:30709391
The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease. PMID:30706520
Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial. PMID:30696686
Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB). PMID:30693094
Protocol for pilot cluster RCT of project respect: a school-based intervention to prevent dating and relationship violence and address health inequalities among young people. PMID:30693093
Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial). PMID:30691442
A novel cognitive behavioural intervention with Theory of Mind (ToM) training for children with epilepsy: protocol for a case series feasibility study. PMID:30680226
Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. PMID:30680225
Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study). PMID:30674284
Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. PMID:30671005
Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial. PMID:30664480
PreImplantation Trial of Histopathology In renal Allografts (PITHIA): a stepped-wedge cluster randomised controlled trial protocol. PMID:30659043
Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028-study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation. PMID:30659041
Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients. PMID:30659035
Introducing the new CONSORT extension for stepped-wedge cluster randomised trials. PMID:30658677
Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial. PMID:30658669
A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patients' reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol. PMID:30658657
Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery. PMID:30647034
Effects of three home-based exercise programmes regarding falls, quality of life and exercise-adherence in older adults at risk of falling: protocol for a randomized controlled trial. PMID:30642252
Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective? PMID:30637541
Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial. PMID:30635261
Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation. PMID:30633776
Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies. PMID:30626413
Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. PMID:30622590
Sciatic nerve block or not for outpatient total knee arthroplasty? Study protocol for a randomized controlled trial. PMID:30621742
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease-1: Study Protocol for a Multicenter Clinical Trial. PMID:30619615
Single dose of intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of postoperative anaemia in colorectal cancer patients: study protocol for a randomised controlled trial. PMID:30616657
Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial. PMID:30616613
Evidence-based sizing of non-inferiority trials using decision models. PMID:30612554
Acetyl-L-carnitine for patients with hepatic encephalopathy. PMID:30610762
Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study). PMID:30606246
Preventing PTSD, depression and associated health problems in student paramedics: protocol for PREVENT-PTSD, a randomised controlled trial of supported online cognitive training for resilience versus alternative online training and standard practice. PMID:30598484
Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial. PMID:30594222
Randomization procedures for multicomponent behavioral intervention factorial trials in the multiphase optimization strategy framework: challenges and recommendations. PMID:30590759
Chemoprevention in BRCA1 mutation carriers (CIBRAC): protocol for an open allocation crossover feasibility trial assessing mechanisms of chemoprevention with goserelin and anastrozole versus tamoxifen and acceptability of treatment. PMID:30580266
A Customized Intervention Program Aiming to Improve Healthy Eating and Physical Activity Among Preschool Children: Protocol for a Randomized Controlled Trial (Iran Healthy Start Study). PMID:30578226
Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. PMID:30577848
Efficacy of erbium-doped yttrium aluminium garnet for achieving pre-emptive dental laser analgesia in children: A study protocol for a randomized clinical trial. PMID:30572467
Structured diet and exercise guidance in pregnancy to improve health in women and their offspring: study protocol for the Be Healthy in Pregnancy (BHIP) randomized controlled trial. PMID:30567604
Optimising the antibiotic treatment of uncomplicated acute appendicitis: a protocol for a multicentre randomised clinical trial (APPAC II trial). PMID:30558607
Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial. PMID:30558079
Consent and recruitment: the reporting of paediatric trials published in 2012. PMID:30555937
Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children. PMID:30552264
Rationale and design of a single-blind, randomised controlled trial of exercise training for managing learning and memory impairment in persons with multiple sclerosis. PMID:30552263
VA Telederm study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process. PMID:30552249
Study protocol for a double-blind randomised controlled trial investigating the impact of 12 weeks supplementation with a Fucus vesiculosus extract on cholesterol levels in adults with elevated fasting LDL cholesterol who are overweight or have obesity. PMID:30552248
Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme. PMID:30552239
Applying for regulatory approval of a clinical trial of a medical device in the UK - A practical guide. PMID:30547908
Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG (CONNECT-ME): Protocol for a Longitudinal Prospective Study and a Tertiary Clinical Care Service. PMID:30542319
Effect of a home-based exercise program on functional mobility and quality of life in elderly people: protocol of a single-blind, randomized controlled trial. PMID:30541592
Body, Brain, Life for Cognitive Decline (BBL-CD): protocol for a multidomain dementia risk reduction randomized controlled trial for subjective cognitive decline and mild cognitive impairment. PMID:30538436
Prevention of Early Postoperative Decline (PEaPoD): protocol for a randomized, controlled feasibility trial. PMID:30537982
PRedicting Outcomes For Crohn's dIsease using a moLecular biomarkEr (PROFILE): protocol for a multicentre, randomised, biomarker-stratified trial. PMID:30523133
Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial. PMID:30522504
Pharmacological interventions for acute hepatitis C infection. PMID:30521693
Establishment of trauma treatment teams within a regional severe trauma treatment system in China: study protocol for a national cluster-randomised trial. PMID:30518584
Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design. PMID:30514378
Point-of-care ultrasound-guided cannulation versus standard cannulation in haemodialysis vascular access: protocol for a controlled random order crossover pilot and feasibility study. PMID:30505458
The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial. PMID:30501629
Acceptance and commitment therapy (ACT) for adult type 1 diabetes management: study protocol for a randomised controlled trial. PMID:30498037
Influence of a periodized circuit training protocol on intermuscular adipose tissue of patients with knee osteoarthritis: protocol for a randomized controlled trial. PMID:30497420
Wearable Activity Technology And Action-Planning (WATAAP) to promote physical activity in cancer survivors: Randomised controlled trial protocol. PMID:30487917
Effects of a Self-Monitoring Quality of Life Intervention for Patients with Cancer Receiving Palliative Care in Japan: Study Protocol for a Randomized Controlled Trial. PMID:30484987
Positive end-expiratory pressure (PEEP) level to prevent expiratory flow limitation during cardiac surgery: study protocol for a randomized clinical trial (EFLcore study). PMID:30477541
A randomized controlled feasibility study to evaluate the effects of a goal-setting coaching intervention using feedback from an accelerometer on sedentary time in older people at risk of falls (SMART-MOVE): a study protocol. PMID:30473871
The importance of patient-reported outcomes in clinical trials and strategies for future optimization. PMID:30464666
Research protocol: general practice organ donation intervention-a feasibility study (GPOD). PMID:30459960
Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial. PMID:30454075
Comorbidity and diagnosis distribution in transdiagnostic treatments for emotional disorders: A systematic review of randomized controlled trials. PMID:30440020
Goal-directed fluid therapy in urgent GAstrointestinal Surgery-study protocol for A Randomised multicentre Trial: The GAS-ART trial. PMID:30429144
Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. PMID:30428863
Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial. PMID:30424738
Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial. PMID:30419961
Meditation-based clinical study to determine the correlation of quantitative electroencephalogram (qEEG) and 24-hour EEG activity. PMID:30412061
Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial. PMID:30409170
Low-dose aspirin in the prevention of pre-eclampsia in China (APPEC study): protocol for a multicentre randomized controlled trial. PMID:30400937
Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial. PMID:30400832
A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol. PMID:30391919
School-based behavioral intervention to reduce the habit of smokeless tobacco and betel quid use in high-risk youth in Karachi: A randomized controlled trial. PMID:30388182
Atrial Fibrillation Screen, Management And Guideline Recommended Therapy (AF SMART II) in the rural primary care setting: an implementation study protocol. PMID:30385444
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. PMID:30376893
Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial. PMID:30368450
The extent and nature of supermarket own brand foods in Australia: study protocol for describing the contribution of selected products to the healthfulness of food environments. PMID:30359258
Collaborative mental health care program versus a general practitioner program and usual care for treatment of patients with mental or neurological disorders in Germany: protocol of a multiperspective evaluation study. PMID:30359248
Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain: a study protocol for a randomised controlled trial. PMID:30349585
Video clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: study protocol for a pragmatic randomised evaluation of myVideoClinic. PMID:30340637
PRO*BPD: effectiveness of outpatient treatment programs for borderline personality disorder: a comparison of Schema therapy and dialectical behavior therapy: study protocol for a randomized trial. PMID:30340474
Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial. PMID:30337316
Protocol for a gender-sensitised weight loss and healthy living programme for overweight and obese men delivered in Australian football league settings (Aussie-FIT): A feasibility and pilot randomised controlled trial. PMID:30337315
Efficacy of adjunctive Garcinia mangostana Linn (mangosteen) pericarp for bipolar depression: study protocol for a proof-of-concept trial. PMID:30328970
Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial. PMID:30326932
iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial. PMID:30326883
Smartphone app in self-management of chronic low back pain: a randomized controlled trial. PMID:30324496
Is care based on comprehensive geriatric assessment with mobile teams better than usual care? A study protocol of a randomised controlled trial (The GerMoT study). PMID:30309994
Occupational therapy delivered by specialists versus non-specialists for people with schizophrenia. PMID:30293234
Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial. PMID:30290615
Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial. PMID:30287612
Optimizing huddle engagement through leadership and problem-solving within primary care: A study protocol for a cluster randomized trial. PMID:30286798
Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial. PMID:30282686
A fixed nitrous oxide/oxygen mixture as an analgesic for trauma patients in emergency department: study protocol for a randomized, controlled trial. PMID:30268163
Antenatal sildenafil administration to prevent pulmonary hypertension in congenital diaphragmatic hernia (SToP-PH): study protocol for a phase I/IIb placenta transfer and safety study. PMID:30261903
Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial. PMID:30249293
Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study. PMID:30249204
Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial. PMID:30244214
Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial. PMID:30236151
Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The 'HIGH-FLOW ACRF' study. PMID:30232113
[Physical training as core component of multimodal treatment of older frail people-study protocol of a randomized controlled pilot study]. PMID:30206744
Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial. PMID:30206549
Study protocol for a randomised controlled trial of consenting processes and their effects on patient decision-making when undergoing spinal injections: the Risks In Spinal Consenting for Surgery (RISCS) trial. PMID:30206091
Study protocol for the MEXiletine hydrochloride administration trial: a placebo-controlled, randomised, double-blind, multicentre, crossover study of its efficacy and safety in spinal and bulbar muscular atrophy (MEXPRESS). PMID:30206090
Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study). PMID:30201040
Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial. PMID:30201029
Adverse effects of psychotherapy: protocol for a systematic review and meta-analysis. PMID:30193585
The INCLUDE study: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community; identifying multimorbidity: Protocol for a pilot randomized controlled trial. PMID:30191145
Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. PMID:30191144
The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial. PMID:30176923
Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study. PMID:30157920
A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial. PMID:30157880
WELCOME: improving WEight controL and CO-Morbidities in children with obesity via Executive function training: study protocol for a randomized controlled trial. PMID:30157826
DREAMeR: Drug use Reconsidered in the Elderly using goal Attainment scales during Medication Review; study protocol of a randomised controlled trial. PMID:30143003
Treating anxiety after stroke (TASK): the feasibility phase of a novel web-enabled randomised controlled trial. PMID:30128164
A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial. PMID:30119663
Topiramate versus naltrexone for alcohol use disorder: study protocol for a genotype-stratified, double-blind randomised controlled trial (TOP study). PMID:30115121
Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT). PMID:30115112
Translational Sepsis Research: Spanning the Divide. PMID:30113370
Effect and Safety of Huannao Yicong Formula () in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized, Double-Blinded, Donepezil-Controlled Trial. PMID:30109588
Passive exercise to improve quality of life, activities of daily living, care burden and cognitive functioning in institutionalized older adults with dementia - a randomized controlled trial study protocol. PMID:30107789
Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial. PMID:30103785
Protocol for the avatar acceptability study: a multiperspective cross-sectional study evaluating the acceptability of using patient-derived xenografts to guide personalised cancer care in Australia and New Zealand. PMID:30093523
Integration of musculoskeletal physical therapy care in the patient-centred medical home (IMPaC): protocol for a single-site randomised clinical trial. PMID:30093522
0Phobia - towards a virtual cure for acrophobia: study protocol for a randomized controlled trial. PMID:30092844
Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol. PMID:30089523
Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial. PMID:30081933
Randomised controlled feasibility trial of the Active Communication Education programme plus hearing aid provision versus hearing aid provision alone (ACE to HEAR): a study protocol. PMID:30068614
Improving work for the body - a participatory ergonomic intervention aiming at reducing physical exertion and musculoskeletal pain among childcare workers (the TOY-project): study protocol for a wait-list cluster-randomized controlled trial. PMID:30064464
"EspaiJove.net"- a school-based intervention programme to promote mental health and eradicate stigma in the adolescent population: study protocol for a cluster randomised controlled trial. PMID:30064404
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. PMID:30060763
Using primary care-based paper and telephone interventions to increase uptake of bowel scope screening in Yorkshire: a protocol of a randomised controlled trial. PMID:30056395
JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives. PMID:30056390
Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol. PMID:30055602
The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial. PMID:30045764
Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial. PMID:30041626
Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis. PMID:30038794
Footwear for self-managing knee osteoarthritis symptoms: protocol for the Footstep randomised controlled trial. PMID:30021584
De-escalation techniques for managing non-psychosis induced aggression in adults. PMID:30019748
Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial. PMID:30012180
SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial. PMID:30012178
Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial. PMID:30012122
The Smart City Active Mobile Phone Intervention (SCAMPI) study to promote physical activity through active transportation in healthy adults: a study protocol for a randomised controlled trial. PMID:30012116
Smartphone application for preventing depression: study protocol for a workplace randomised controlled trial. PMID:30007927
Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol. PMID:30001704
Ethics reporting practices in randomized controlled trials of physical therapy interventions after stroke. PMID:29992047
Breastfeeding self-efficacy and breastmilk feeding for moderate and late preterm infants in the Family Integrated Care trial: a mixed methods protocol. PMID:29989087
ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery. PMID:29988707
Testing a strength and conditioning program to prevent common manipulative technique training injuries in chiropractic students: a study protocol for a randomised controlled trial. PMID:29988310
Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial. PMID:29976227
Towards a health-enabling working environment - developing and testing interventions to decrease HIV and TB stigma among healthcare workers in the Free State, South Africa: study protocol for a randomised controlled trial. PMID:29973259
Healthy Campus Trial: a multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: study protocol for a randomized controlled trial. PMID:29973252
Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. PMID:29970156
Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial. PMID:29970155
Can a Traditional Korean Manual Therapy Be a Complementary and Alternative Strategy for Cervicogenic Dizziness? A Study Protocol for a Randomized Controlled Trial. PMID:29967645
The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial: A study of crenezumab versus placebo in preclinical PSEN1 E280A mutation carriers to evaluate efficacy and safety in the treatment of autosomal-dominant Alzheimer's disease, including a placebo-treated noncarrier cohort. PMID:29955659
The cardiac care bridge program: design of a randomized trial of nurse-coordinated transitional care in older hospitalized cardiac patients at high risk of readmission and mortality. PMID:29954403
Research methodology for orthopaedic surgeons, with a focus on outcome. PMID:29951252
PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. PMID:29934394
Cardiovascular disease risk marker responses to breaking up prolonged sedentary time in individuals with paraplegia: the Spinal Cord Injury Move More (SCIMM) randomised crossover laboratory trial protocol. PMID:29934392
A protocol for a three-arm cluster randomized controlled superiority trial investigating the effects of two pedagogical methodologies in Swedish preschool settings on language and communication, executive functions, auditive selective attention, socioemotional skills and early maths skills. PMID:29914566
Comparative impact of two continuing education activities targeted at COPD educators on educational outcomes: protocol for a non-randomized controlled study using mixed methods. PMID:29914484
Study protocol for a feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer. PMID:29903802
Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study. PMID:29886446
'Allocation concealment': the evolution and adoption of a methodological term. PMID:29877772
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2). PMID:29873315
Safety and Efficacy of High Versus Standard Starting Doses of Insulin Glargine in Overweight and Obese Chinese Individuals with Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Medications (Beyond VII): Study Protocol for a Randomized Controlled Trial. PMID:29873004
A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement. PMID:29872509
Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol. PMID:29867602
Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN). PMID:29866736
An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial. PMID:29855281
Efficacy and Safety of Zhenyuan Capsule for Coronary Heart Disease with Abnormal Glucose and Lipid Metabolism: Study Protocol for a Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial. PMID:29853944
The effectiveness of culturally tailored video narratives on medication understanding and use self-efficacy among stroke patients: A randomized controlled trial study protocol. PMID:29851804
Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study. PMID:29801444
Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain: A study protocol for a randomized, controlled, assessor-blinded, multicenter clinical trial. PMID:29794761
Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial. PMID:29794738
Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial. PMID:29788996
Evaluation of an intervention programme addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a feasibility trial (ABLE). PMID:29780029
ESCAlate - Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial. PMID:29776383
Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol. PMID:29776349
TIDieR-PHP: a reporting guideline for population health and policy interventions. PMID:29769210
The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial. PMID:29766257
Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial. PMID:29766087
Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. PMID:29764892
Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial. PMID:29764447
Glucocorticosteroids for infants with biliary atresia following Kasai portoenterostomy. PMID:29761473
Effect of combined vitamin D receptor activator and lanthanum carbonate on serum fibroblast growth factor 23 level in predialysis patients (CVD-LAF study): design and method. PMID:29748907
Effectiveness of the "Elderly Activity Performance Intervention" on elderly patients' discharge from a short-stay unit at the emergency department: a quasi-experimental trial. PMID:29731615
A randomized controlled trial testing the effectiveness of a paramedic-delivered care transitions intervention to reduce emergency department revisits. PMID:29724172
Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT). PMID:29720244
Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention. PMID:29719517
A blended psychosocial support program for partners of patients with amyotrophic lateral sclerosis and progressive muscular atrophy: protocol of a randomized controlled trial. PMID:29716660
Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial. PMID:29707034
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial. PMID:29703266
Physical activity and nutrition intervention for Singaporean women aged 50 years and above: study protocol for a randomised controlled trial. PMID:29703218
Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial. PMID:29696173
Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada. PMID:29680811
Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial. PMID:29678995
Development and evaluation of an algorithm-based tool for Medication Management in nursing homes: the AMBER study protocol. PMID:29678967
Does sensorimotor upper limb therapy post stroke alter behavior and brain connectivity differently compared to motor therapy? Protocol of a phase II randomized controlled trial. PMID:29678195
Implementation of an evidence-based model of care for low back pain in emergency departments: protocol for the Sydney Health Partners Emergency Department (SHaPED) trial. PMID:29674362
The effect and biomechanical mechanisms of intradermal needle for post-stroke hemiplegia recovery: Study protocol for a randomized controlled pilot trial. PMID:29668611
'Re-engage' pilot study protocol: a nurse-led eHealth intervention to re-engage, educate and empower childhood cancer survivors. PMID:29654052
Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study). PMID:29654049
Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial. PMID:29653555
A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial. PMID:29653523
Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol. PMID:29643169
Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial. PMID:29637088
Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa. PMID:29631553
Glucocorticosteroid-free versus glucocorticosteroid-containing immunosuppression for liver transplanted patients. PMID:29630730
Admission rates in a general practitioner-based versus a hospital specialist based, hospital-at-home model: ACCESS, an open-labelled randomised clinical trial of effectiveness. PMID:29622029
Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol). PMID:29619634
A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study. PMID:29618329
SPIRE - combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial. PMID:29615077
Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial. PMID:29606109
The STAR Data Reporting Guidelines for Clinical High Altitude Research. PMID:29596018
Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial. PMID:29593022
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial. PMID:29587808
Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial. PMID:29587801
Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. PMID:29580249
Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation. PMID:29574443
A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial. PMID:29566766
Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial. PMID:29566744
Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial. PMID:29566656
Protocol for a pragmatic randomised controlled trial of Body Brain Life-General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting. PMID:29550779
Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. PMID:29546560
Improving sudden cardiac death risk stratification by evaluating electrocardiographic measures of global electrical heterogeneity and clinical outcomes among patients with implantable cardioverter-defibrillators: rationale and design for a retrospective, multicenter, cohort study. PMID:29541969
Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial. PMID:29540410
Promoting self-management, health literacy and social capital to reduce health inequalities in older adults living in urban disadvantaged areas: protocol of the randomised controlled trial AEQUALIS. PMID:29534699
Standards for design and measurement would make clinical research reproducible and usable. PMID:29531086
Digoxin for atrial fibrillation and atrial flutter: A systematic review with meta-analysis and trial sequential analysis of randomised clinical trials. PMID:29518134
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial. PMID:29506580
Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations. PMID:29506563
Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial. PMID:29501740
The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial. PMID:29499710
Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial. PMID:29499675
Systemic Inflammation in Severe Obese Patients Undergoing Surgery for Obesity and Weight-Related Diseases. PMID:29497960
Effect of an exercise-based cardiac rehabilitation program "Baduanjin Eight-Silken-Movements with self-efficacy building" for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial. PMID:29490680
Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial. PMID:29487073
Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial. PMID:29486765
The VOICE Study: Valuing Opinions, Individual Communication and Experience: building the evidence base for undertaking Patient-Centred Family Meetings in palliative care - a mixed methods study. PMID:29479471
Reporting guidelines for oncology research: helping to maximise the impact of your research. PMID:29471308
Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial. PMID:29467019
Antibiotics for treating gonorrhoea in pregnancy. PMID:29465747
A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV. PMID:29458404
The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial. PMID:29458399
Promoting public access to clinical trial protocols: challenges and recommendations. PMID:29454390
Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial). PMID:29452599
Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations. PMID:29444787
Efficacy and safety of the Shexiang Baoxin Pill for the treatment of coronary artery disease not amenable to revascularisation: study protocol for a randomised, placebo-controlled, double-blinded trial. PMID:29444778
The knitting community-based trial for older women with osteoarthritis of the hands: design and rationale of a randomized controlled trial. PMID:29444664
Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial. PMID:29439711
Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol. PMID:29431123
The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial. PMID:29430253
Pulmonary artery perfusion versus no perfusion during cardiopulmonary bypass for open heart surgery in adults. PMID:29419895
Guanxinning tablet for patients who switch from dual antiplatelet therapy to aspirin alone after percutaneous coronary intervention: study protocol for a cluster randomized controlled trial. PMID:29415754
Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial. PMID:29402319
Exercise-based cardiac rehabilitation for adults with stable angina. PMID:29394453
Bench-to-Bedside: A Translational Perspective on Murine Models of Sepsis. PMID:29394153
Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol. PMID:29391366
Immediate relief of herniated lumbar disc-related sciatica by ankle acupuncture: A study protocol for a randomized controlled clinical trial. PMID:29390461
Evaluating the effectiveness of intensive versus non-intensive image interpretation education for radiographers: a randomised control trial study protocol. PMID:29388344
A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness. PMID:29387128
Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial. PMID:29382391
The effects of an 8-week computerized cognitive training program in older adults: a study protocol for a randomized controlled trial. PMID:29378515
Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial. PMID:29375891
Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial. PMID:29370829
Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial. PMID:29362276
Evaluating the effectiveness of home exercise programmes using an online exercise prescription tool in children with cerebral palsy: protocol for a randomised controlled trial. PMID:29362255
The effect of a ketogenic diet versus a high-carbohydrate, low-fat diet on sleep, cognition, thyroid function, and cardiovascular health independent of weight loss: study protocol for a randomized controlled trial. PMID:29361967
MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial. PMID:29357943
Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). PMID:29343998
Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals - a feasibility study for a randomised controlled trial. PMID:29343280
Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial. PMID:29325595
Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol. PMID:29317414
Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial. PMID:29316946
Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial. PMID:29310679
Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial. PMID:29301544
The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol. PMID:29284402
Parenteral nutrition during neoadjuvant chemotherapy for patients with non-metastatic gastric or esophago-gastric cancer to reduce postoperative morbidity (PERCOG): study protocol for a randomized controlled trial. PMID:29282145
Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. PMID:29282143
The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention. PMID:29273070
Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013. PMID:29272315
Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry. PMID:29268758
The effect of Danshen extract on lipoprotein-associated phospholipase A2 levels in patients with stable angina pectoris: study protocol for a randomized controlled trial - the DOLPHIN study. PMID:29262859
Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial. PMID:29254495
Effects of Acute Phase Intensive Electrical Muscle Stimulation in Frail Elderly Patients With Acute Heart Failure (ACTIVE-EMS): Rationale and protocol for a multicenter randomized controlled trial. PMID:29247531
Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial. PMID:29237487
Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME). PMID:29234923
Testing the effectiveness of a transdiagnostic treatment approach in reducing violence and alcohol abuse among families in Zambia: study protocol of the Violence and Alcohol Treatment (VATU) trial. PMID:29230314
The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial. PMID:29229589
Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review. PMID:29229588
Comparison of primary endpoints between publications, registries, and protocols of phase III cancer clinical trials. PMID:29228640
Thrombolysis for acute upper extremity deep vein thrombosis. PMID:29226949
A partially supervised physical activity program for adult and adolescent survivors of childhood cancer (SURfit): study design of a randomized controlled trial [NCT02730767]. PMID:29207962
Coping with Unusual ExperienceS for 12-18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial. PMID:29202862
Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study. PMID:29202079
Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. PMID:29197414
Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial. PMID:29197412
Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. PMID:29197404
Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial. PMID:29191232
Randomized controlled trials in children's heart surgery in the 21st century: a systematic review. PMID:29186478
Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial. PMID:29178955
Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial. PMID:29149914
Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial. PMID:29149909
The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial. PMID:29149905
Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). PMID:29146647
COPD online-rehabilitation versus conventional COPD rehabilitation - rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). PMID:29145831
The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov. PMID:29138646
Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. PMID:29138201
Efficacy of Banha-sasim-tang on functional dyspepsia classified as excess pattern: study protocol for a randomized controlled trial. PMID:29121988
Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial. PMID:29121884
Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway (radioX): study protocol for a randomised control trial. PMID:29110698
Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial. PMID:29110690
Study protocol for a randomised controlled trial of ultrasound-guided pulsed radiofrequency of the genicular nerves in the treatment of patients with osteoarthritis knee pain. PMID:29102985
Oral Chinese herbal medicine for psoriasis vulgaris: protocol for a randomised, double-blind, double-dummy, multicentre clinical trial. PMID:29101128
Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial. PMID:29100550
SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial. PMID:29096681
"Active Team" a social and gamified app-based physical activity intervention: randomised controlled trial study protocol. PMID:29096614
Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial. PMID:29090162
Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity. PMID:29074513
The effects of rhythm control strategies versus rate control strategies for atrial fibrillation and atrial flutter: A systematic review with meta-analysis and Trial Sequential Analysis. PMID:29073191
Does the behavioural type-specific approach for type 2 diabetes promote changes in lifestyle? Protocol of a cluster randomised trial in Japan. PMID:29070640
Effects of a multicomponent workplace intervention programme with environmental changes on physical activity among Japanese white collar employees: a protocol for a cluster randomised controlled trial. PMID:29070639
A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. PMID:29067347
The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression. PMID:29061185
POWERS forID: Personalized Online Weight and Exercise Response System for Individuals with Intellectual Disability: study protocol for a randomized controlled trial. PMID:29058620
Community-based intervention to promote physical activity in rheumatoid arthritis (CIPPA-RA): a study protocol for a pilot randomised control trial. PMID:29043493
Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol. PMID:29042386
[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study]. PMID:29026932
Protocol for a pilot, randomised, double-blinded, placebo-controlled trial of prophylactic use of tranexamic acid for preventing postpartum haemorrhage (TAPPH-1). PMID:29025850
Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial. PMID:29020995
A series of N-of-1 trials to assess the therapeutic interchangeability of two enalapril formulations in the treatment of hypertension in Addis Ababa, Ethiopia: study protocol for a randomized controlled trial. PMID:29017595
Sensing interstitial glucose to nudge active lifestyles (SIGNAL): feasibility of combining novel self-monitoring technologies for persuasive behaviour change. PMID:28993396
The Team to Address Bariatric Care in Canadian Children (Team ABC3): Team Grant Research Proposal. PMID:28992812
Neurological outcome after minimal invasive coronary artery surgery (NOMICS): protocol for an observational prospective cohort study. PMID:28988183
Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance. PMID:28982811
Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial. PMID:28969715
A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13-14 years. PMID:28963278
Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial. PMID:28962662
Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial. PMID:28962661
Knowledge translation tools for parents on child health topics: a scoping review. PMID:28962637
Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial. PMID:28962608
Topiramate's effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial. PMID:28931411
REACH: study protocol of a randomised trial of rehabilitation very early in congenital hemiplegia. PMID:28928195
Direct-acting antivirals for chronic hepatitis C. PMID:28922704
A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials. PMID:28918414
Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial. PMID:28918408
TIGA-CUB - manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5-11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial. PMID:28915904
Gaps in Current Knowledge and Priorities for Future Research in Dry Eye. PMID:28914633
Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. PMID:28913966
High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial): protocol of a multicentre randomised double-blind clinical trial. PMID:28912191
Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications. PMID:28892118
Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial. PMID:28874181
Intraoperative wound irrigation to prevent surgical site infection after laparotomy (IOWISI): study protocol for a randomized controlled trial. PMID:28870242
Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial. PMID:28870177
A telehealth intervention to promote healthy lifestyles after stroke: The Stroke Coach protocol. PMID:28869405
A protocol for a randomised controlled trial of the bone response to impact loading or resistance training in young women with lower than average bone mass: the OPTIMA-Ex trial. PMID:28864705
Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study. PMID:28852318
Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial. PMID:28835268
Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board. PMID:28835231
Drug-eluting stents versus bare-metal stents for acute coronary syndrome. PMID:28832903
Are Routine Radiographs Needed the Day After Open Reduction and Internal Fixation Surgery for Distal Radius and Ankle Fractures: Study Protocol for a Prospective, Open Label, Randomized Controlled Trial. PMID:28814379
Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics. PMID:28808771
Computer-assisted instruction before colonoscopy is as effective as nurse counselling, a clinical pilot trial. PMID:28791330
Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial. PMID:28778174
Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial. PMID:28768538
Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. PMID:28765136
Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study. PMID:28765131
Interventions for treating intrahepatic cholestasis in people with sickle cell disease. PMID:28759700
Advancing the evidence to improve the nutrition of populations: a refreshed vision and scope for Nutrition Journal. PMID:28747181
Optimising decision making on illness absenteeism due to fever and common infections within childcare centres: development of a multicomponent intervention and study protocol of a cluster randomised controlled trial. PMID:28747169
Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial. PMID:28743315
ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials. PMID:28738794
A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials. PMID:28733301
Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial. PMID:28728604
Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial. PMID:28728602
Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial. PMID:28728560
Protocol for an online randomised controlled trial to evaluate the clinical and cost-effectiveness of a peer-supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT). PMID:28720617
The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients' adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial. PMID:28720121
A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol. PMID:28716797
Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set. PMID:28709445
The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: A systematic review with network meta-analyses of randomised trials. PMID:28700715
Randomised controlled trials and changing public health practice. PMID:28699541
Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial. PMID:28697773
A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study). PMID:28694991
Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study. PMID:28694989
Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial. PMID:28693599
The efficacy of traditional acupuncture on patients with chronic neck pain: study protocol of a randomized controlled trial. PMID:28693563
Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial. PMID:28689056
Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial. PMID:28683833
Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines. PMID:28679407
Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set. PMID:28669969
PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. PMID:28667228
Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. PMID:28667201
A pragmatic randomised controlled trial comparing the efficacy of a femoral nerve block and periarticular infiltration for early pain relief following total knee arthroplasty. PMID:28663395
Study protocol for a randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression (the LQD study). PMID:28651526
Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial. PMID:28646887
A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE)-a study protocol. PMID:28645976
Protocol for the residents in action pilot cluster randomised controlled trial (RiAT): evaluating a behaviour change intervention to promote walking, reduce sitting and improve mental health in physically inactive older adults in retirement villages. PMID:28645969
Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate). PMID:28637740
Effectiveness of an online SUpport PRogramme (SUPR) for older hearing aid users: study protocol for a cluster randomised controlled trial. PMID:28634259
Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial. PMID:28630086
The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. PMID:28623944
Improving transitions in acute stroke patients discharged to home: the Michigan stroke transitions trial (MISTT) protocol. PMID:28623892
Three-Trocar Sleeve Gastrectomy vs Standard Five-Trocar Technique: a Randomized Controlled Trial. PMID:28620894
Interventions for treating patients with chikungunya virus infection-related rheumatic and musculoskeletal disorders: A systematic review. PMID:28609439
Targeted simplification versus antipseudomonal broad-spectrum beta-lactams in patients with bloodstream infections due to Enterobacteriaceae (SIMPLIFY): a study protocol for a multicentre, open-label, phase III randomised, controlled, non-inferiority clinical trial. PMID:28601833
Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. PMID:28587609
Direct-acting antivirals for chronic hepatitis C. PMID:28585310
Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. PMID:28583162
Effect of low-level laser therapy (LLLT) and light-emitting diodes (LEDT) applied during combined training on performance and post-exercise recovery: protocol for a randomized placebo-controlled trial. PMID:28579190
Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial. PMID:28578679
Evidence of selective reporting bias in hematology journals: A systematic review. PMID:28570573
Development and evaluation of an "emergency access button" in Danish out-of-hours primary care: a study protocol of a randomized controlled trial. PMID:28566087
The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination. PMID:28550023
Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial. PMID:28550021
Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial. PMID:28533916
Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial. PMID:28532439
A multimodal day treatment program for multi-problem young adults: study protocol for a randomized controlled trial. PMID:28526087
How to design a randomised controlled trial. PMID:28496211
Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial. PMID:28494802
The effect of empagliflozin on oxidative nucleic acid modifications in patients with type 2 diabetes: protocol for a randomised, double-blinded, placebo-controlled trial. PMID:28490557
Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial. PMID:28476136
Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients. PMID:28464887
A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol. PMID:28450898
Evaluation of a Web-Based Tailored Nursing Intervention (TAVIE en m@rche) Aimed at Increasing Walking After an Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial Protocol. PMID:28450272
A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. PMID:28446141
The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581). PMID:28441971
Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial. PMID:28441966
Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial. PMID:28438182
Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. PMID:28431551
Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial. PMID:28427442
Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. PMID:28424068
Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project). PMID:28420661
Pharmacological interventions for primary sclerosing cholangitis: an attempted network meta-analysis. PMID:28417463
Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial. PMID:28408545
Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. PMID:28399933
Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes. PMID:28391237
Study on the utility of a statewide counselling programme for improving mortality outcomes of patients with Staphylococcus aureus bacteraemia in Thuringia (SUPPORT): a study protocol of a cluster-randomised crossover trial. PMID:28391236
Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial. PMID:28390417
Farm Fresh Foods for Healthy Kids (F3HK): An innovative community supported agriculture intervention to prevent childhood obesity in low-income families and strengthen local agricultural economies. PMID:28390403
Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial. PMID:28389421
Pharmacological interventions for alcoholic liver disease (alcohol-related liver disease): an attempted network meta-analysis. PMID:28368093
Maintenance immunosuppression for adults undergoing liver transplantation: a network meta-analysis. PMID:28362060
Pharmacological interventions for non-alcohol related fatty liver disease (NAFLD): an attempted network meta-analysis. PMID:28358980
Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial). PMID:28356136
Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial. PMID:28356125
Management of people with early- or very early-stage hepatocellular carcinoma: an attempted network meta-analysis. PMID:28351116
Pharmacological interventions for primary biliary cholangitis: an attempted network meta-analysis. PMID:28350426
Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. PMID:28348183
Time to publication for publicly funded clinical trials in Australia: an observational study. PMID:28336734
Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness. PMID:28327086
Pharmacological interventions for acute hepatitis B infection: an attempted network meta-analysis. PMID:28321877
Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial. PMID:28315479
The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients: study protocol for a randomized controlled trial. PMID:28292331
A protocol for a cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls. PMID:28286668
Pharmacological interventions for acute hepatitis C infection: an attempted network meta-analysis. PMID:28285495
Management of people with intermediate-stage hepatocellular carcinoma: an attempted network meta-analysis. PMID:28281295
Interventions for hereditary haemochromatosis: an attempted network meta-analysis. PMID:28273330
Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial. PMID:28270180
Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial. PMID:28264717
Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial. PMID:28258048
A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial. PMID:28253904
The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial. PMID:28245835
Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial. PMID:28237958
GAMBLINGLESS: FOR LIFE study protocol: a pragmatic randomised trial of an online cognitive-behavioural programme for disordered gambling. PMID:28235970
Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial. PMID:28231811
Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. PMID:28193189
Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress. PMID:28186934
Exercise-based cardiac rehabilitation for adults with atrial fibrillation. PMID:28181684
Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis. PMID:28178949
Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy. PMID:28173780
Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC). PMID:28166743
Family caregiving for persons with heart failure at the intersection of heart failure and palliative care: a state-of-the-science review. PMID:28160116
Reducing falls after hospital discharge: a protocol for a randomised controlled trial evaluating an individualised multimodal falls education programme for older adults. PMID:28153933
Efficacy of paracetamol, diclofenac and advice for acute low back pain in general practice: design of a randomized controlled trial (PACE Plus). PMID:28143496
Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial. PMID:28129780
Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. PMID:28122609
Update on Trial Registration 11 Years after the ICMJE Policy Was Established. PMID:28121511
NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. PMID:28118856
Review and publication of protocol submissions to Trials - what have we learned in 10 years? PMID:28114958
The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial. PMID:28103950
The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial. PMID:28103948
Moderated online social therapy for carers of young people recovering from first-episode psychosis: study protocol for a randomised controlled trial. PMID:28095883
Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial. PMID:28088218
A fixed inhaled nitrous oxide/oxygen mixture as an analgesic for adult cancer patients with breakthrough pain: study protocol for a randomized controlled trial. PMID:28077162
PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial. PMID:28069072
The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial. PMID:28069054
Publishing protocols for trials of complex interventions before trial completion - potential pitfalls, solutions and the need for public debate. PMID:28069042
Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: a strategy to reduce the incidence of postoperative delirium in elderly patients. PMID:28068834
Protocol for intraoperative assessment of the human cerebrovascular glycocalyx. PMID:28057660
Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial. PMID:28057058
Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose. PMID:28056894
Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial. PMID:28042304
Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial. PMID:28031038
Protocol for developing, disseminating and implementing a core outcome set for endometriosis. PMID:28003300
Participatory organizational intervention for improved use of assistive devices for patient transfer: study protocol for a single-blinded cluster randomized controlled trial. PMID:27998265
Assessment Fidelity in Aphasia Research. PMID:27997953
Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy. PMID:27994627
Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial. PMID:27993163
Investigating the differential impact of school and community-based integrated control programmes for soil-transmitted helminths in Timor-Leste: the (S)WASH-D for Worms pilot study protocol. PMID:27965884
EXercise to prevent AnthrCycline-based Cardio-Toxicity (EXACT) in individuals with breast or hematological cancers: a feasibility study protocol. PMID:27965861
Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol. PMID:27965808
Evaluating an online support package delivered within a disability unemployment service: study protocol for a randomised controlled feasibility study. PMID:27965793
Combining Exergame Training with Omega-3 Fatty Acid Supplementation: Protocol for a Randomized Controlled Study Assessing the Effect on Neuronal Structure/Function in the Elderly Brain. PMID:27965570
Topical interventions to prevent acute radiation dermatitis in head and neck cancer patients: a systematic review. PMID:27957620
Physical activity as intervention for age-related loss of muscle mass and function: protocol for a randomised controlled trial (the LISA study). PMID:27913559
Completeness of Outcomes Description Reported in Low Back Pain Rehabilitation Interventions: A Survey of 185 Randomized Trials. PMID:27909376
The TIDieR Checklist Will Benefit the Physiotherapy Profession. PMID:27904230
Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness. PMID:27899400
ACCESS HD pilot: A randomised feasibility trial Comparing Catheters with fistulas in Elderly patientS Starting haemodialysis. PMID:27884849
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial. PMID:27884165
Effects of osteopathic treatment on pulmonary function and chronic thoracic pain after coronary artery bypass graft surgery (OstinCaRe): study protocol for a randomised controlled trial. PMID:27884147
A randomised controlled demonstration trial of multifaceted nutritional intervention and or probiotics: the healthy mums and babies (HUMBA) trial. PMID:27884128
Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial. PMID:27876082
Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial. PMID:27864607
Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: human papillomavirus self-sampling versus Papanicolaou cytology. PMID:27855089
High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation. PMID:27852718
The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. PMID:27852230
Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial. PMID:27842579
Cognitive remediation therapy (CRT) as a treatment enhancer of eating disorders and obsessive compulsive disorders: study protocol for a randomized controlled trial. PMID:27832747
Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. PMID:27829464
Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial. PMID:27821142
Rehabilitation Enablement in Chronic Heart Failure-a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial. PMID:27798024
Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial. PMID:27793181
Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial. PMID:27788679
Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial. PMID:27782851
CINGLE-trial: cochlear implantation for siNGLE-sided deafness, a randomised controlled trial and economic evaluation. PMID:27777509
A Systematic Review of Outcome Measures Use, Analytical Approaches, Reporting Methods, and Publication Volume by Year in Low Back Pain Trials Published between 1980 and 2012: Respice, adspice, et prospice. PMID:27776141
COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial. PMID:27737685
Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial. PMID:27724972
The NSPCC UK Minding the Baby® (MTB) home-visiting programme, supporting young mothers (aged 14-25) in the first 2 years of their baby's life: study protocol for a randomised controlled trial. PMID:27717374
Effect of day-case unilateral cochlear implantation in adults on general and disease-specific quality of life, postoperative complications and hearing results, tinnitus, vertigo and cost-effectiveness: protocol for a randomised controlled trial. PMID:27697874
STEPWISE - STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial. PMID:27681572
Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial. PMID:27671748
Effects of added involvement from concerned significant others in internet-delivered CBT treatments for problem gambling: study protocol for a randomised controlled trial. PMID:27670519
Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol. PMID:27655263
Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). PMID:27646142
A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health Care: A Protocol of the Motivation 2 Quit (M2Q) Study. PMID:27637517
Cancer@Work - a nurse-led, stepped-care, e-health intervention to enhance the return to work of patients with cancer: study protocol for a randomized controlled trial. PMID:27634549
N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms. PMID:27629871
Qing-Xin-Jie-Yu Granules in addition to conventional treatment for patients with stable coronary artery disease (QUEST Trial): study protocol for a randomized controlled trial. PMID:27628038
Implementation of a Transfer Intervention Procedure (TIP) to improve handovers from hospital to home: interrupted time series analysis. PMID:27604974
SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol. PMID:27596569
Improving completeness and transparency of reporting in clinical trials using the template for intervention description and replication (TIDieR) checklist will benefit the physiotherapy profession. PMID:27582616
Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial. PMID:27561822
The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. PMID:27555884
An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial. PMID:27544428
Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial. PMID:27530758
Personalized prescription feedback to reduce antibiotic overuse in primary care: rationale and design of a nationwide pragmatic randomized trial. PMID:27530528
The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial. PMID:27515515
Prevention of selective outcome reporting: let us start from the beginning. PMID:27484242
Reporting quality of stepped wedge design randomized trials: a systematic review protocol. PMID:27468249
Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial. PMID:27457560
Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial. PMID:27456976
Study protocol of the CAREST-trial: a randomised controlled trial on the (cost-) effectiveness of a CBT-based online self-help training for fear of cancer recurrence in women with curatively treated breast cancer. PMID:27455846
Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial. PMID:27449500
Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial. PMID:27448663
The TIDieR checklist will benefit the physical therapy profession. PMID:27437709
Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial. PMID:27405522
Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial. PMID:27389248
Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). PMID:27388352
Pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy. PMID:27388039
Guidelines for Reporting Medical Research: A Critical Appraisal. PMID:27382637
Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness. PMID:27358088
A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study. PMID:27354070
Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study. PMID:27334885
Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention. PMID:27334883
Efficacy and safety of Yirui capsule in patients with hyperlipidemia: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. PMID:27316679
Does menopausal hormone therapy (MHT), exercise or a combination of both, improve pain and function in post-menopausal women with greater trochanteric pain syndrome (GTPS)? A randomised controlled trial. PMID:27312538
Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial. PMID:27311914
Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. PMID:27295978
The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols. PMID:27294435
Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial. PMID:27266776
Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. PMID:27262594
Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a methodological systematic review. PMID:27259528
Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial. PMID:27255280
Concise Review: Stem Cell Interventions for People With Cerebral Palsy: Systematic Review With Meta-Analysis. PMID:27245364
TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain-study rationale and protocol. PMID:27217287
Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial. PMID:27189087
Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial. PMID:27165652
Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. PMID:27150916
Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial. PMID:27129580
A high-selenium lentil dietary intervention in Bangladesh to counteract arsenic toxicity: study protocol for a randomized controlled trial. PMID:27121115
Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ. PMID:27105712
Protocol for evaluating the effects of a therapeutic foot exercise program on injury incidence, foot functionality and biomechanics in long-distance runners: a randomized controlled trial. PMID:27075480
Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial. PMID:27067894
Protocol for a prospective randomized controlled trial of recipient remote ischaemic preconditioning in orthotopic liver transplantation (RIPCOLT trial). PMID:27054029
A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults. PMID:27044360
Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial. PMID:27039300
Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial. PMID:27038611
Laparoscopic versus open gastrectomy for gastric cancer. PMID:27030300
Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. PMID:27029775
Non-surgical versus surgical treatment for oesophageal cancer. PMID:27021481
Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy-health psychology intervention feasibility study. PMID:27009145
Systematic collection of patient reported outcome research data: A checklist for clinical research professionals. PMID:27002223
Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial. PMID:26975720
Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial. PMID:26948468
Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol. PMID:26940112
Randomised controlled trial of referral to a telephone-based weight management and healthy lifestyle programme for patients with knee osteoarthritis who are overweight or obese: a study protocol. PMID:26940110
Day-case stapes surgery: Day-case versus inpatient stapes surgery for otosclerosis: a randomized controlled trial. PMID:26924941
Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study). PMID:26921267
Efficacy and safety of Qi-Wei-Qing-Yan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): study protocol for a randomized controlled trial. PMID:26896352
Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial. PMID:26887958
Effect of aqua-cycling on pain and physical functioning compared with usual care in patients with knee osteoarthritis: study protocol of a randomised controlled trial. PMID:26887576
Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial. PMID:26842871
Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. PMID:26833396
Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. PMID:26831727
The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. PMID:26831332
Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial. PMID:26822418
The quality of reporting methods and results of cost-effectiveness analyses in Spain: a methodological systematic review. PMID:26822374
Integrating Mobile health and Physical Activity to reduce the burden of Chronic low back pain Trial (IMPACT): a pilot trial protocol. PMID:26787469
Internet-based treatment for Romanian adults with panic disorder: protocol of a randomized controlled trial comparing a Skype-guided with an unguided self-help intervention (the PAXPD study). PMID:26769021
Systemic therapy for vulval Erosive Lichen Planus (the 'hELP' trial): study protocol for a randomised controlled trial. PMID:26729245
Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial. PMID:26729193
The Karnataka Anemia Project 2--design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial. PMID:26718897
Remote ischemic preconditioning in the prevention of ischemic brain damage during intracranial aneurysm treatment (RIPAT): study protocol for a randomized controlled trial. PMID:26714784
Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial. PMID:26700291
Protocol for a single-centre randomised controlled trial of multimodal periarticular anaesthetic infiltration versus single-agent femoral nerve blockade as analgesia for total knee arthroplasty: Perioperative Analgesia for Knee Arthroplasty (PAKA). PMID:26692559
Internet-delivered cognitive behaviour therapy for depression in people with diabetes: study protocol for a randomised controlled trial. PMID:26688735
Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial. PMID:26685032
How should individual participant data (IPD) from publicly funded clinical trials be shared? PMID:26675031
Early versus delayed erythropoietin for the anaemia of end-stage kidney disease. PMID:26671531
Effects of postural specific sensorimotor training in patients with chronic low back pain: study protocol for randomised controlled trial. PMID:26666457
The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma. PMID:26651333
Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial. PMID:26634828
Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial. PMID:26631224
Improving the organisation of maternal health service delivery and optimising childbirth by increasing vaginal birth after caesarean section through enhanced women-centred care (OptiBIRTH trial): study protocol for a randomised controlled trial (ISRCTN10612254). PMID:26620402
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). PMID:26599576
Nutritional Risk in Major Abdominal Surgery: Protocol of a Prospective Observational Trial to Evaluate the Prognostic Value of Different Nutritional Scores in Pancreatic Surgery. PMID:26573991
Co-design and implementation research: challenges and solutions for ethics committees. PMID:26573410
Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial. PMID:26527536
Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials. PMID:26490367
Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. PMID:26474867
Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial. PMID:26458964
Evaluation of a Web-based tailored intervention (TAVIE en santé) to support people living with HIV in the adoption of health promoting behaviours: an online randomized controlled trial protocol. PMID:26458508
Activities to support the implementation of complex interventions as part of routine care: a review of the quality of reporting in cluster randomised controlled trials. PMID:26453590
The iTreAD project: a study protocol for a randomised controlled clinical trial of online treatment and social networking for binge drinking and depression in young people. PMID:26444863
Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial. PMID:26420269
COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial. PMID:26399603
Using an internet intervention to support self-management of low back pain in primary care: protocol for a randomised controlled feasibility trial (SupportBack). PMID:26399575
Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial. PMID:26399571
Methodology and reporting quality of reporting guidelines: systematic review. PMID:26395179
Keeping Up with the Standards. PMID:26388959
Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. PMID:26385379
Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial. PMID:26353829
The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial. PMID:26314740
Development of a universal approach to increase physical activity among adolescents: the GoActive intervention. PMID:26307618
From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology. PMID:26304898
The long-term effect of minimalist shoes on running performance and injury: design of a randomised controlled trial. PMID:26297368
Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial. PMID:26286147
The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. PMID:26265452
Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial. PMID:26264735
The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency. PMID:26242226
Reporting of pre-enrolment screening with randomized clinical trials: A small item that could impact a big difference. PMID:26229749
UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. PMID:26169841
Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. PMID:26163031
Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial. PMID:26159834
Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study. PMID:26152325
Dementia Prevention: optimizing the use of observational data for personal, clinical, and public health decision-making. PMID:26146610
Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial. PMID:26116444
The effects of high perioperative inspiratory oxygen fraction for adult surgical patients. PMID:26110757
Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study. PMID:26107924
The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial. PMID:26077459
Managing the incidence of selective reporting bias: a survey of Cochrane review groups. PMID:26071043
Antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. PMID:26058965
Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases. PMID:26058964
Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial. PMID:26041365
Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial. PMID:26037907
Endogenous opioid antagonism in physiological experimental pain models: a systematic review. PMID:26029906
Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial. PMID:26016697
MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial. PMID:25997633
Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial. PMID:25986648
Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy. PMID:25979230
Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol. PMID:25967990
What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial. PMID:25956926
Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial. PMID:25947578
Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers. PMID:25928502
Non-surgical treatment of dentin caries in preschool children--systematic review. PMID:25888484
A person-centred approach to health promotion for persons 70+ who have migrated to Sweden: promoting aging migrants' capabilities implementation and RCT study protocol. PMID:25887506
Reducing suicidal thoughts in the Australian general population through web-based self-help: study protocol for a randomized controlled trial. PMID:25886941
A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial. PMID:25886009
Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study). PMID:25885818
Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial. PMID:25873050
Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial. PMID:25872780
Research design and statistical methods in Indian medical journals: a retrospective survey. PMID:25856194
Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. PMID:25829373
Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. PMID:25753362
Antibiotics for treating acute chest syndrome in people with sickle cell disease. PMID:25749695
The natural history of conducting and reporting clinical trials: interviews with trialists. PMID:25619208
Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. PMID:25604352
Use of auricular acupressure to improve the quality of life in diabetic patients with chronic kidney diseases: a prospective randomized controlled trial. PMID:25574180
Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. PMID:25554246
The Fifth German Oral Health Study (Fünfte Deutsche Mundgesundheitsstudie, DMS V) - rationale, design, and methods. PMID:25547464
Effects of levosimendan for low cardiac output syndrome in critically ill patients: systematic review with meta-analysis and trial sequential analysis. PMID:25518953
Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial. PMID:25476698
The remote exercise monitoring trial for exercise-based cardiac rehabilitation (REMOTE-CR): a randomised controlled trial protocol. PMID:25432467
Protocol for the Femoroacetabular Impingement Trial (FAIT): a multi-centre randomised controlled trial comparing surgical and non-surgical management of femoroacetabular impingement. PMID:25431439
Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial. PMID:25410607
Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial. PMID:25359307
The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial. PMID:25344736
Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers. PMID:25333995
Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PMID:25333349
Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer's disease: study protocol of a randomized controlled trial (The FIT-AD trial). PMID:25304364
Study protocol for a randomised controlled trial of a cognitive-behavioural prevention programme for the children of parents with depression: the PRODO trial. PMID:25269863
Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson's disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014). PMID:25257518
Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol. PMID:25209897
Collaborative treatment of late-life depression in primary care (GermanIMPACT): study protocol of a cluster-randomized controlled trial. PMID:25195020
Buyang huanwu decoction for healthcare: evidence-based theoretical interpretations of treating different diseases with the same method and target of vascularity. PMID:25126100
METRIC (MREnterography or ulTRasound in Crohn's disease): a study protocol for a multicentre, non-randomised, single-arm, prospective comparison study of magnetic resonance enterography and small bowel ultrasound compared to a reference standard in those aged 16 and over. PMID:25110044
A design to investigate the feasibility and effects of partnered ballroom dancing on people with Parkinson disease: randomized controlled trial protocol. PMID:25051989
Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. PMID:25030633
Corticosteroid treatment for community-acquired pneumonia--the STEP trial: study protocol for a randomized controlled trial. PMID:24974155
Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PMID:24959719
The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial. PMID:24939812
Current research and future directions in pattern identification: Results of an international symposium. PMID:24938445
Antibody induction versus placebo, no induction, or another type of antibody induction for liver transplant recipients. PMID:24901467
Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial. PMID:24885548
Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial. PMID:24767719
Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE). PMID:24767671
Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. PMID:24708773
Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial. PMID:24629063
Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol. PMID:24588893
Formal education of patients about to undergo laparoscopic cholecystectomy. PMID:24585482
Physical fitness training in Subacute Stroke (PHYS-STROKE)--study protocol for a randomised controlled trial. PMID:24491065
Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised trial protocol. PMID:24423411
Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial. PMID:24422876
Increasing value and reducing waste: addressing inaccessible research. PMID:24411650
Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. PMID:24383441
Surgical versus endoscopic treatment of bile duct stones. PMID:24338858
The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov. PMID:24315119
Triclosan/copolymer containing toothpastes for oral health. PMID:24310847
Antiviral interventions for liver transplant patients with recurrent graft infection due to hepatitis C virus. PMID:24307460
Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial. PMID:24304745
The Ontology of Clinical Research (OCRe): an informatics foundation for the science of clinical research. PMID:24239612
Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003). PMID:24236154
Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. PMID:24180235
Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists. PMID:24124580
Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial. PMID:24028201
Interventions for the management of dry mouth: non-pharmacological interventions. PMID:24006231
Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial. PMID:24004961
Free for service: the inadequate incentives for quality peer review. PMID:23925527
Clonidine versus captopril for treatment of postpartum very high blood pressure: study protocol for a randomized controlled trial (CLONCAP). PMID:23899372
Rationale and methodology of the impact of continuous positive airway pressure on patients with ACS and nonsleepy OSA: the ISAACC Trial. PMID:23843147
Restoring invisible and abandoned trials: a call for people to publish the findings. PMID:23766480
Education in health research methodology: use of a wiki for knowledge translation. PMID:23741424
Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial. PMID:23702006
Do external stimuli impact the gait of children with idiopathic toe walking? A study protocol for a within-subject randomised control trial. PMID:23454667
Centre selection for clinical trials and the generalisability of results: a mixed methods study. PMID:23451055
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. PMID:23303884
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials PubMed citations: 1570.

1570 articles citing: SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)-protocol for a multicenter, randomized, clinical, proof-of-concept trial. PMID:35351214
An app with brief behavioural support to promote physical activity after a cancer diagnosis (APPROACH): study protocol for a pilot randomised controlled trial. PMID:35351187
Social network-based group intervention to promote HIV prevention in Uganda: study protocol for a cluster randomized controlled trial of Game Changers. PMID:35346329
Facilitating stress prevention in micro and small-sized enterprises: protocol for a mixed method study to evaluate the effectiveness and implementation process of targeted web-based interventions. PMID:35346127
Effect of Two Different Rehabilitation Approaches on Pulmonary Functional Tests, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A Randomized Controlled Trial Study. PMID:35334548
Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial. PMID:35313949
Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized, multiple-blind, placebo-controlled trial. PMID:35313933
Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP)-a single center, open-label, three-arm, randomized, controlled intervention trial. PMID:35303938
The effects of exercise training on autonomic and hemodynamic responses to muscle metaboreflex in people living with HIV/AIDS: A randomized clinical trial protocol. PMID:35303017
Effect of Supervised Resistance Training on Arm Volume, Quality of Life and Physical Perfomance Among Women at High Risk for Breast Cancer-Related Lymphedema: A Study Protocol for a Randomized Controlled Trial (STRONG-B). PMID:35299753
Efficacy of the integrative Body-Mind-Spirit group intervention for improving quality of life in parent-child dyads adjusting to atopic dermatitis: protocol for a randomised controlled trial. PMID:35296490
Fast-track referral for health interventions during pregnancy: study protocol of a randomised pragmatic experimental study to reduce low birth weight in Portugal (STOP LBW). PMID:35292492
Feasibility and safety of physical exercise in men with prostate cancer receiving androgen deprivation therapy and radiotherapy: a study protocol. PMID:35292485
Electro-acupuncture for protracted amphetamine abstinence syndrome: study protocol for a pragmatic randomized controlled trial. PMID:35292088
Effectiveness of herb-partitioned moxibustion on the navel for pregnancy outcomes in patients with recurrent implantation failure undergoing in vitro fertilization and embryo transfer: a study protocol for a randomized controlled trial. PMID:35292074
An innovative case management intervention for people at high risk of permanent work disability to improve rehabilitation coverage and coordination of health services: a randomized controlled trial (AktiFAME, DRKS00024648). PMID:35292005
Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial. PMID:35279220
Reducing readmission rates for individuals discharged from acute psychiatric care in Alberta using peer and text message support: Protocol for an innovative supportive program. PMID:35279142
Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP). PMID:35273049
Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD). PMID:35273045
Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH). PMID:35264227
Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial. PMID:35264216
A prospective, single-arm trial of fluorescent ureteroscopy-assisted thulium-holmium:YAG dual laser ablation for upper urinary tract cancer: Study protocol of the FLUAM trial. PMID:35257033
Clinical- and Cost Effectiveness of a Guided Internet-Based Intervention for Children (12-18 Years) of Parents With Mental Disorders (iCHIMPS): Study Protocol of a Multicentered Cluster-Randomized Controlled Trial. PMID:35252960
Efficacy and safety of Qinghua Zhixie Decoction against diarrhea-predominate irritable bowel syndrome: A protocol for a randomized controlled trial. PMID:35244043
Evaluation of short-term effects of three passive aquatic interventions on chronic non-specific low back pain: Study protocol for a randomized cross-over clinical trial. PMID:35243125
Reduction on Proinflammatory Cytokines after Application of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients with a Breast Cancer: A Nonrandomized, Open, and Single-Arm Study Protocol with Paired Analysis. PMID:35241969
Functional standing frame programme early after severe sub-acute stroke (SPIRES): a randomised controlled feasibility trial. PMID:35241176
Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students. PMID:35236397
Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal. PMID:35232469
Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries. PMID:35232454
Short- and long-term effects of whole-body photobiomodulation on pain, functionality, tissue quality, central sensitisation and psychological factors in a population suffering from fibromyalgia: protocol for a triple-blinded randomised clinical trial. PMID:35222905
Let's Agree to Disagree on Operative versus Nonoperative (LADON) treatment for proximal humerus fractures: Study protocol for an international multicenter prospective cohort study. PMID:35213647
Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial. PMID:35210352
Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study. PMID:35209934
Evaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial. PMID:35209877
A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes. PMID:35197106
CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial. PMID:35197082
Effect and neural mechanisms of the transcutaneous vagus nerve stimulation for relapse prevention in patients with remitted major depressive disorder: protocol for a longitudinal study. PMID:35193903
Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial. PMID:35193666
Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial. PMID:35193619
Comparison of the procedure time differences between hybrid endoscopic submucosal dissection and conventional endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for a multi-center randomized controlled trial (Hybrid-G trial). PMID:35189939
Efficacy and Safety of Shenqu Xiaoshi Oral Liquid Compared With Domperidone Syrup in Children With Functional Dyspepsia. PMID:35185585
Efficacy and Mechanism of the Jiangtang Tiaozhi Recipe in the Management of Type 2 Diabetes and Dyslipidaemia: A Clinical Trial Protocol. PMID:35185579
Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants. PMID:35183238
Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial. PMID:35177467
Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): report of a feasibility randomized controlled trial. PMID:35177019
Protocol for the Lovisenberg Open Acute Door Study (LOADS): a pragmatic randomised controlled trial to compare safety and coercion between open-door policy and usual-care services in acute psychiatric inpatients. PMID:35173011
Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: a protocol for a single center randomized controlled trial. PMID:35172872
Minimising young children's anxiety through schools (MY-CATS): protocol for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders. PMID:35168635
Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial. PMID:35164853
Evaluating the effectiveness of the Play Active policy intervention and implementation support in early childhood education and care: a pragmatic cluster randomised trial protocol. PMID:35164729
'Physio-EndEA' Study: A Randomized, Parallel-Group Controlled Trial to Evaluate the Effect of a Supervised and Adapted Therapeutic Exercise Program to Improve Quality of Life in Symptomatic Women Diagnosed with Endometriosis. PMID:35162761
Multicomponent Aquatic Training (MAT) Program for People with Parkinson's Disease: A Protocol for a Controlled Study. PMID:35162750
Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials. PMID:35162416
Evaluating a Psychological First Aid Training Intervention (Preparing Me) to Support the Mental Health and Wellbeing of Chinese Healthcare Workers During Healthcare Emergencies: Protocol for a Randomized Controlled Feasibility Trial. PMID:35153867
Cost-effectiveness and cost-utility evaluation of individual vs. group transdiagnostic psychological treatment for emotional disorders in primary care (PsicAP-Costs): a multicentre randomized controlled trial protocol. PMID:35139809
Study protocol ROTATE-trial: anterior cruciate ligament rupture, the influence of a treatment algorithm and shared decision making on clinical outcome- a cluster randomized controlled trial. PMID:35123469
Three-dimensional corrective exercise therapy for idiopathic scoliosis: study protocol for a prospective non-randomized trial. PMID:35123460
Protocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys' intentions to seek help. PMID:35115023
Effects of combined training on metabolic profile, lung function, stress and quality of life in sedentary adults: A study protocol for a randomized controlled trial. PMID:35113957
Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial. PMID:35110313
Evaluation of gender differences in postoperative sore throat and hoarseness following the use of Ambu AuraGain laryngeal mask: the randomised controlled LadyLAMA trial study protocol. PMID:35105650
Mobile health-based gamification intervention to increase physical activity participation among patients with coronary heart disease: study protocol of a randomised controlled trial. PMID:35105640
Celecoxib versus placebo as an adjunct to treatment-as-usual in children and youth with obsessive-compulsive disorder: protocol for a single-site randomised quadruple-blind phase II study. PMID:35105633
Diaphragm ultrasound to evaluate the antagonistic effect of sugammadex on rocuronium after liver surgery in patients with different liver Child-Pugh grades: study protocol for a prospective, double-blind, non-randomised controlled trial. PMID:35105573
β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial). PMID:35101139
Intertruncal versus classical approach to the ultrasound-guided supraclavicular brachial plexus block for upper extremity surgery: study protocol for a randomized non-inferiority trial. PMID:35093129
Gamified Web-Delivered Attentional Bias Modification Training for Adults With Chronic Pain: Protocol for a Randomized, Double-blind, Placebo-Controlled Trial. PMID:35084344
Communication, Coordination, and Security for People with Multiple Sclerosis (COCOS-MS): a randomised phase II clinical trial protocol. PMID:35078833
Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial. PMID:35078446
A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial. PMID:35073989
Evaluating 'Power 4 a Healthy Pregnancy' (P4HP) - protocol for a cluster randomized controlled trial and process evaluation to empower pregnant women towards improved diet quality. PMID:35062921
Feasibility and therapeutic efficacy of a two-week low-level laser acupuncture therapy for shoulder and neck pain in office workers: Protocol for a pilot, single-blind, double-armed, randomised controlled trial. PMID:35061682
The screening of diagnostic biomarker microRNA in first-trimester maternal plasma for Down syndrome: A study protocol. PMID:35060501
Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126). PMID:35057840
Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study). PMID:35056316
A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. PMID:35055641
Non-invasive ventilation versus oxygen therapy after extubation in patients with obesity in intensive care units: the multicentre randomised EXTUB-OBESE study protocol. PMID:35045999
Mental imagery interventions to promote face covering use among UK university students and employees during the COVID-19 pandemic: study protocol for a randomized controlled trial. PMID:35042564
Prolonged dual hypothermic oxygenated machine preservation (DHOPE-PRO) in liver transplantation: study protocol for a stage 2, prospective, dual-arm, safety and feasibility clinical trial. PMID:35039326
Effect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial. PMID:35039313
Efficacy of ultrasound therapy for the treatment of lateral elbow tendinopathy (the UCICLET Trial): study protocol for a three-arm, prospective, multicentre, randomised controlled trial. PMID:35039305
Camu Camu effects on microbial translocation and systemic immune activation in ART-treated people living with HIV: protocol of the single-arm non-randomised Camu Camu prebiotic pilot study (CIHR/CTN PT032). PMID:35039291
A first remotely-delivered guided brief intervention to reduce intrusive memories of psychological trauma for healthcare staff working during the ongoing COVID-19 pandemic: Study protocol for a randomised controlled trial. PMID:35036626
Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial. PMID:35033182
Pneumococcal conjugate vaccination schedules in infants-acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study. PMID:35033180
Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial. PMID:35033169
Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial. PMID:35033168
Effect of a cervical collar on head and neck acceleration profiles during emergency spinal immobilisation and extrication procedures in elite football (soccer) players: protocol for a randomised, controlled cross-over trial. PMID:35028158
Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial. PMID:35027415
Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. PMID:35022169
Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial. PMID:35022086
Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. PMID:35019846
PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial. PMID:35012628
Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study). PMID:35007306
The effect of obstructive jaundice on the sensitivity of intravenous anesthetic of remimazolam: study protocol for a controlled multicenter trial. PMID:34998423
Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be). PMID:34996794
Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial. PMID:34991694
Recurrent acute pancreatitis prevention by the elimination of alcohol and cigarette smoking (REAPPEAR): protocol of a randomised controlled trial and a cohort study. PMID:34983758
SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial. PMID:34983749
Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial. PMID:34983620
Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings. PMID:34980208
New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia. PMID:34972765
Study protocol of a randomized controlled clinical trial investigating the effects of omega-3 supplementation on endothelial function, vascular structure, and metabolic parameters in adolescents with type 1 diabetes. PMID:34961564
Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial. PMID:34937712
Wearables in rugby union: A protocol for multimodal digital sports-related concussion assessment. PMID:34936689
Rehabilitation care planning on a digital communication platform for patients with a work disability: protocol for the RehaPro-SERVE feasibility study. PMID:34933685
Evaluation of the insertion parameters and complications of the i-gel Plus airway device for maintaining patent airway during planned procedures under general anaesthesia: a protocol for a prospective multicentre cohort study. PMID:34930740
Promoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial. PMID:34930422
The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial. PMID:34930194
SmartFeeding4Kids, an online self-guided parenting intervention to promote positive feeding practices and healthy diet in young children: study protocol for a randomized controlled trial. PMID:34922616
Evaluation of new or repurposed treatments for COVID-19: protocol for the phase Ib/IIa DEFINE trial platform. PMID:34911721
PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial. PMID:34907065
Protocol for thiamine and folic acid in the treatment of cognitive impairment in maintenance haemodialysis patients: a prospective, randomised, placebo-controlled, double-blind, multicentre study. PMID:34907051
Effect of RUSI-based core stability exercise on chronic non-specific low back pain patients: study protocol for a randomised controlled trial. PMID:34907039
Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia. PMID:34903265
Topical corticosteroid for treatment of hand osteoarthritis: study protocol for a randomised controlled trial. PMID:34903211
Online supervised versus workplace corrective exercises for upper crossed syndrome: a protocol for a randomized controlled trial. PMID:34895301
The ELSA trial: single versus combinatory effects of non-prohibited beta-2 agonists on skeletal muscle metabolism, cardio-pulmonary function and endurance performance-study protocol for a randomized 4-way balanced cross-over trial. PMID:34895300
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology. PMID:34895296
HAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study. PMID:34893092
Community promotion and application of Wuqinxi combined with brief behavioral therapy for insomnia: A study protocol. PMID:34889248
Efficacy of Perioperative Continuous Intravenous Lidocaine Infusion for 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: Study Protocol for a Prospective Randomized Controlled Trial. PMID:34880671
Determining the effectiveness of cognitive behavioural therapy in improving quality of life in patients undergoing endometriosis surgery: a study protocol for a randomised controlled trial. PMID:34880026
Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden. PMID:34880010
A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE). PMID:34877471
Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. PMID:34876420
The COPE-Trial-Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants. PMID:34872601
Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial. PMID:34872597
Dual-Task Performance in Hearing-Impaired Older Adults-Study Protocol for a Cross-Sectional Mobile Brain/Body Imaging Study. PMID:34867299
Neurophysiological and transcriptomic predictors of chronic low back pain: Study protocol for a longitudinal inception cohort study. PMID:34866207
Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial. PMID:34863270
Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI): study protocol for a randomized, placebo-controlled, multi-center trial. PMID:34863258
Performance feedback on the quality of care in hospitals performing thrombectomy for ischemic stroke (PERFEQTOS): protocol of a stepped wedge cluster randomized trial. PMID:34863254
A gamified mobile health intervention for children in day surgery care: Protocol for a randomized controlled trial. PMID:34859602
A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol. PMID:34857010
Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy. PMID:34848516
Association of Innate and Acquired Aerobic Capacity With Resilience in Healthy Adults: Protocol for a Randomized Controlled Trial of an 8-Week Web-Based Physical Exercise Intervention. PMID:34847062
Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial. PMID:34846635
Pylorus resection versus pylorus preservation in pancreatoduodenectomy (PyloResPres): study protocol and statistical analysis plan for a German multicentre, single-blind, surgical, registry-based randomised controlled trial. PMID:34845079
The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial. PMID:34838105
The effect of twice-weekly versus once-weekly sessions of either imagery rescripting or eye movement desensitization and reprocessing for adults with PTSD from childhood trauma (IREM-Freq): a study protocol for an international randomized clinical trial. PMID:34838102
The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial. PMID:34838101
Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees - study protocol for a pragmatic, randomized, non-inferiority trial. PMID:34837999
FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese sUbjects aged 50 years and older with Insomnia Disorder. PMID:34836909
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial. PMID:34836904
Evaluating a complex intervention addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a randomised controlled trial (ABLE). PMID:34836902
Online computer or therapist-guided cognitive behavioral therapy in university students with anxiety and/or depression: study protocol of a randomised controlled trial. PMID:34836897
Comparison of (Cost-)Effectiveness of Magnetic Resonance Image-Guided High-Intensity-Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE). PMID:34821569
Deep Neuromuscular Blockade Combined with Low Pneumoperitoneum Pressure for Nociceptive Recovery After Major Laparoscopic Gastrointestinal Surgery: Study Protocol for a Randomized Controlled Trial. PMID:34815710
Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. PMID:34805194
Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial. PMID:34801059
Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial. PMID:34801006
Effects of free range-of-motion upper limb exercise based on mirror therapy on shoulder function in patients after breast cancer surgery: study protocol for a randomized controlled trial. PMID:34789309
The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care. PMID:34784953
Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial). PMID:34784941
Effect of acupuncture at Zusanli (ST36) point on antral contraction function under ultrasound guidance: study protocol of a randomized controlled trial. PMID:34781992
Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial. PMID:34781988
Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study. PMID:34779787
A Counseling Application as an Alternative Tool in Increasing Coping Self-Efficacy Among University Students With Academic Distress During Coronavirus Disease 2019 Pandemic in Indonesia: A Study Protocol for a Randomized Controlled Non-Inferiority Trial. PMID:34777093
Acupuncture for retinitis pigmentosa: study protocol for a randomised, sham-controlled trial. PMID:34772749
Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer. PMID:34772747
Single-centre, double-blind, randomised, parallel-group, superiority study to evaluate the effectiveness of general anaesthesia and ultrasound-guided transversus thoracis muscle plane block combination in adult cardiac surgery for reducing the surgical stress response: clinical trial protocol. PMID:34764171
Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol. PMID:34752494
Measuring the effects of nurse practitioner (NP)-led care on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial. PMID:34749784
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy. PMID:34749782
Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial. PMID:34736504
The design of a Bayesian adaptive clinical trial of tranexamic acid in severely injured children. PMID:34736498
REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain-a study protocol for a randomized controlled trial. PMID:34736497
The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. PMID:34733883
BuqiTongluo Granule for Ischemic Stroke, Stable Angina Pectoris, Diabetic Peripheral Neuropathy with Qi Deficiency and Blood Stasis Syndrome: Rationale and Novel Basket Design. PMID:34733163
Protocol for pragmatic randomised trial: integrating electronic health record-based behavioural economic 'nudges' into the electronic health record to reduce preoperative testing for patients undergoing cataract surgery. PMID:34732478
Observation of the curative effect of Guizhi-Shaoyao-Zhimu decoction combined with methotrexate in the treatment of early rheumatoid arthritis based on ultrasonic evaluation: study protocol of a randomized, double-blind, controlled clinical trial. PMID:34732237
Efficacy of Acupuncture Combined with Rehabilitation Training for Intensive Care Unit-Acquired Muscle Weakness: A Protocol for a Randomized, Sham-Procedure-Controlled Clinical Trial. PMID:34721629
Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial. PMID:34717722
The Central Response of Electroacupuncture on Trigeminal Neuralgia Based on Resting-State Functional Magnetic Resonance Imaging: A Protocol for a Pre-Experimental, Single-Centre, Randomized, Controlled Trial. PMID:34707400
Immediate versus postponed single blastocyst transfer in modified natural cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre randomised controlled trial. PMID:34706963
Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation. PMID:34697125
Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. PMID:34693999
Clinical trial recruiters' experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK. PMID:34689802
Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial. PMID:34686555
Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. PMID:34682453
Effects of Shenfu injection on inflammatory factors and immune function in children with Mycoplasma pneumoniae: A protocol for a double-blind, randomized controlled trial. PMID:34678908
Video game therapy on mobility and dual tasking in multiple sclerosis: study protocol for a randomised controlled trial. PMID:34675018
The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial. PMID:34674741
Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial. PMID:34674737
Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: a study protocol for a multicenter randomized controlled trial. PMID:34666815
Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study. PMID:34663243
Strategies for Empowering activities in Everyday life (SEE 1.0): study protocol for a feasibility study of an Internet-based occupational therapy intervention for people with stroke. PMID:34656173
Efficacy of a Low-threshold, Culturally-Sensitive Group Psychoeducation Programme for Asylum Seekers (LoPe): study protocol for a multicentre randomised controlled trial. PMID:34649846
YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multi-center randomized controlled trial. PMID:34649610
Effects of immersive virtual reality for preventing and managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: A study protocol for an exploratory trial. PMID:34648568
Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial. PMID:34646753
Efficacy of metamizole versus ibuprofen and a short educational intervention versus standard care in acute and subacute low back pain: a study protocol of a randomised, multicentre, factorial trial (EMISI trial). PMID:34645660
Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial. PMID:34643541
Technology-Supported Guidance Model to Support the Development of Critical Thinking Among Undergraduate Nursing Students in Clinical Practice: Protocol of an Exploratory, Flexible Mixed Methods Feasibility Study. PMID:34643536
Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors: study protocol of a randomized controlled trial (MATCH-study). PMID:34641961
An Animation- Versus Text-Based Computer-Tailored Game Intervention to Prevent Alcohol Consumption and Binge Drinking in Adolescents: Study Protocol. PMID:34639280
Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial. PMID:34635066
Efficacy and safety of polysaccharide iron complex capsules compared with iron sucrose in hemodialysis patients: study protocol for a randomized, open-label, positive control, multicenter trial (IHOPE). PMID:34629085
Estimands in published protocols of randomised trials: urgent improvement needed. PMID:34627347
Clinical interventions for adults with comorbid alcohol use and depressive disorders: A systematic review and network meta-analysis. PMID:34624018
Multifaceted antibiotic stewardship intervention using a participatory-action-research approach to improve antibiotic prescribing for urinary tract infections in frail elderly (ImpresU): study protocol for a European qualitative study followed by a pragmatic cluster randomised controlled trial. PMID:34620666
Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial. PMID:34620193
Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol. PMID:34615684
Anaesthetic protocol for paediatric glaucoma examinations: the prospective EyeBIS Study protocol. PMID:34610927
Assessing the effectiveness and implementation of a chronic disease self-management programme in faith-based organisations in Barbados: protocol for a cluster randomised parallel trial. PMID:34607863
Effectiveness of expiratory technique and induced sputum in obtaining good quality sputum from patients acutely hospitalized with suspected lower respiratory tract infection: a statistical analysis plan for a randomized controlled trial. PMID:34600559
A randomised controlled feasibility trial of music-assisted language telehealth intervention for minimally verbal autistic children-the MAP study protocol. PMID:34598714
Introducing the Needs in Recovery Assessment (NiRA) into clinical practice: protocol for a pilot study investigating the formal and systematic assessment of clinical and social needs experienced by service users at a tertiary, metropolitan mental health service. PMID:34593044
Effects of modified-Paleo and moderate-carbohydrate diets on body composition, serum levels of hepatokines and adipocytokines, and flow cytometric analysis of endothelial microparticles in adults with metabolic syndrome: a study protocol for a randomized clinical trial. PMID:34593030
Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial. PMID:34593022
Observational study investigating Tolerance Of Anticancer Systemic Therapy In the Elderly (TOASTIE): a protocol. PMID:34588257
Healing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury. PMID:34588230
A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial. PMID:34586075
Effect of low-dose amitriptyline on reducing pain in clinical knee osteoarthritis compared to benztropine: study protocol of a randomised, double blind, placebo-controlled trial. PMID:34579675
Blended Care in In-Patient Acute Psychiatric Care. The Example of a Group Training for Social Competences in Adults-A Pretest-Posttest Feasibility Study. PMID:34574357
Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial. PMID:34564307
Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial. PMID:34563246
Bladder cancer and exeRcise trAining during intraVesical thErapy-the BRAVE trial: a study protocol for a prospective, single-centre, phase II randomised controlled trial. PMID:34561265
Interventions for treating leg ulcers in people with sickle cell disease. PMID:34559425
Efficacy and safety of Zhen Wu Decoction against chronic heart failure: A protocol of randomized, double-blinded, and controlled trial. PMID:34559129
Filipino Multicomponent Intervention to Maintain Cognitive Performance in High-Risk Population (FINOMAIN): Study Protocol for a Cluster Randomized Controlled Trial. PMID:34557142
Impact of using spirometry on clinical decision making and quality of life in children: protocol for a single centre randomised controlled trial. PMID:34548360
Altering Dynamics of Autonomic Processing Therapy (ADAPT) trial: a novel, targeted treatment for reducing anxiety in joint hypermobility. PMID:34548065
ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair. PMID:34538275
Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial. PMID:34535474
DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population. PMID:34535162
Compound glycyrrhizin injection for improving liver function in children with acute icteric hepatitis: A systematic review and meta-analysis. PMID:34522606
Effect of Lycium barbarum polysaccharide supplementation in non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial. PMID:34521466
SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial. PMID:34518276
Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. PMID:34518253
An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial. PMID:34511058
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial. PMID:34503548
Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial. PMID:34496941
The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age. PMID:34488846
IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. PMID:34488691
The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial. PMID:34479619
Optimizing the Periconception Lifestyle of Women With Overweight Using a Blended Personalized Care Intervention Combining eHealth and Face-to-face Counseling (eFUSE): Protocol for a Randomized Controlled Trial. PMID:34477561
Advance care planning for adolescents with cancer and their parents: study protocol of the BOOST pACP multi-centre randomised controlled trial and process evaluation. PMID:34470598
Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2). PMID:34466711
Teriparatide and stress fracture healing in young adults (RETURN - Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial. PMID:34461961
Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial. PMID:34456565
Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics. PMID:34454637
The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial. PMID:34454594
Immediate Effects of Myofascial Release on the Thoracolumbar Fascia and Osteopathic Treatment for Acute Low Back Pain on Spine Shape Parameters: A Randomized, Placebo-Controlled Trial. PMID:34440589
Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study. PMID:34435968
Exergaming Using Postural Feedback From Wearable Sensors and Exercise Therapy to Improve Postural Balance in People With Nonspecific Low Back Pain: Protocol for a Factorial Pilot Randomized Controlled Trial. PMID:34435954
Review of study reporting guidelines for clinical studies using artificial intelligence in healthcare. PMID:34426417
Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial. PMID:34419114
Cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis: study protocol for a preliminary non-randomized, open-label, multi-center feasibility and safety study. PMID:34416898
Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners. PMID:34414154
Pentoxifylline in diabetic kidney disease (VA PTXRx): protocol for a pragmatic randomised controlled trial. PMID:34400461
Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial. PMID:34400453
Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial. PMID:34399856
National systemic lupus erythematosus prospective cohort in Saudi Arabia: A study protocol. PMID:34397699
Study protocol on advance care planning in multiple sclerosis (ConCure-SM): intervention construction and multicentre feasibility trial. PMID:34389580
Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery. PMID:34389577
Study protocol for the evaluation of long-term effects of the school-based obesity prevention program Lekker Fit! ('enjoy being fit'): a retrospective, controlled design. PMID:34389567
Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial. PMID:34384461
Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation ('My Therapy'): protocol for a mixed-methods process evaluation. PMID:34384420
Effectiveness of endolymphatic duct blockage versus endolymphatic sac decompression in patients with intractable Ménière's disease: study protocol for a double-blinded, randomised controlled trial. PMID:34376454
Clearinghouse Standards of Evidence on the Transparency, Openness, and Reproducibility of Intervention Evaluations. PMID:34357509
Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial. PMID:34353802
The PATCH trial: efficacy and safety of 5% lidocaine-medicated plaster for the treatment of patients with trigeminal neuralgia: a study protocol for a multicentric, double-blind, enriched enrolment randomised withdrawal, vehicle-controlled study. PMID:34341037
'Relearning how to think': A brief online intervention to modify biased interpretations in emotional disorders-study protocol for a randomised controlled trial. PMID:34332616
MYNd&CO (Mindfulness, Yoga, Nutrition, development & Coaching, and Osteopathy) randomized controlled trial for a positive psychophysical experience in pregnancy and after birth: a study protocol. PMID:34328141
COVEPIC (Cognitive and spOrt Virtual EPIC training) investigating the effects of home-based physical exercise and cognitive training on cognitive and physical functions in community-dwelling older adults: study protocol of a randomized single-blinded clinical trial. PMID:34325710
A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. PMID:34321880
Microbial Interventions to Control and Reduce Blood Pressure in Australia (MICRoBIA): rationale and design of a double-blinded randomised cross-over placebo controlled trial. PMID:34315522
Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial. PMID:34311783
Impact of removing prescription charges on health outcomes: protocol for a randomised controlled trial. PMID:34301661
Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis. PMID:34285004
Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial. PMID:34281590
Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study. PMID:34278044
Evaluation of immediate and short-term efficacy of DualStim therapy with and without intracavernosal umbilical cord-derived Wharton's jelly in patients with erectile dysfunction: Study protocol for a randomized controlled trial. PMID:34278040
Heart failure and promotion of physical activity before and after cardiac rehabilitation (HF-aPProACH): a study protocol. PMID:34268900
Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial. PMID:34262619
Individualized mobile health interventions for cardiovascular event prevention in patients with coronary heart disease: study protocol for the iCARE randomized controlled trial. PMID:34256698
Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: A Trial Protocol for a Multicenter Randomized Controlled Trial. PMID:34254233
WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section. PMID:34250266
Impact of duration of antibiotic prophylaxis on rates of surgical site infection (SSI) in patients undergoing mastectomy without immediate reconstruction, comparing a single prophylactic dose versus continued antibiotic prophylaxis postoperatively: a multicentre, double-blinded randomised control trial protocol. PMID:34244280
Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants. PMID:34233983
Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial. PMID:34230018
Subsidy programme for gestational diabetes mellitus screening and lifestyle management in rural areas of western China: a study protocol for a multicentre randomised controlled trial. PMID:34230016
Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19. PMID:34226219
Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial. PMID:34226218
SAVER: sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia-a phase II randomised control trial study protocol. PMID:34225765
Vasopressin and methylprednisolone for in-hospital cardiac arrest - Protocol for a randomized, double-blind, placebo-controlled trial. PMID:34223347
COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study - study protocol for a randomized controlled trial. PMID:34217259
PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19. PMID:34193503
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. PMID:34193486
Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial. PMID:34187835
Relationship between trajectories of post-stroke disability and self-rated health (NeuroAdapt): protocol for a prospective observational study. PMID:34187831
Decreasing ICU-associated Clostridioides difficile infection through fluoroquinolone restriction, the FIRST trial: a study protocol. PMID:34187821
Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial. PMID:34183341
The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial. PMID:34172071
Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention. PMID:34172030
In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility: study protocol for the randomised, controlled, multicentre trial INVICSI. PMID:34168037
Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial. PMID:34168032
The Efficacy and Safety of Chinese Medicine Fufang Zhenzhu Tiaozhi Capsule (FTZ) in the Treatment of Diabetic Coronary Heart Disease: Study Protocol for Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. PMID:34163193
Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely preterm infants. PMID:34162644
Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial. PMID:34162198
Identification of biomarkers that predict response to subthalamic nucleus deep brain stimulation in resistant obsessive-compulsive disorder: protocol for an open-label follow-up study. PMID:34158304
The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation. PMID:34154636
Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). PMID:34146143
Compliance with evidence-based clinical guidelines in the management of acute biliary pancreatitis: the MANCTRA-1 study protocol. PMID:34142315
Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study. PMID:34135038
Brief early adolescent multi-family therapy (BEAM) trial for anorexia nervosa: a feasibility randomized controlled trial protocol. PMID:34134769
Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2. PMID:34130959
The cerebral mechanism underlying the acupoints with specific effect for gallbladder stone disease: protocol for a randomized controlled task-fMRI trial. PMID:34127059
Using Surface Electromyography to Evaluate the Efficacy of Governor Vessel Electroacupuncture in Poststroke Lower Limb Spasticity: Study Protocol for a Randomized Controlled Parallel Trial. PMID:34122592
Harnessing Life's Slings and Arrows: The Science and Opportunities for Mindfulness Meditation During a Global Pandemic and Beyond. PMID:34117158
Acupoint injection combined with pelvic floor rehabilitation in the treatment of postpartum pelvic floor disorders: A protocol of randomized controlled trial. PMID:34114980
Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial. PMID:34112154
Pre-operative/Neoadjuvant Therapy and Vascular Debranching Followed by Resection for Locally Advanced Pancreatic Cancer (PREVADER): Clinical Feasibility Trial. PMID:34109185
Assessing the impact of a combined nutrition counselling and cash transfer intervention on women's empowerment in rural Bangladesh: a randomised control trial protocol. PMID:34108160
Postoperative delirium after long-term general anesthesia in elderly patients, how to reduce it?: Protocol of a double-blinded, randomized, placebo-controlled trial. PMID:34087831
Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial. PMID:34068534
Influence of low-level laser therapy on implant stability in implants placed in healed sites: a randomized controlled trial. PMID:34059974
Safety and efficacy of umbilical cord-derived Wharton's jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial. PMID:34059080
Efficacy of calcium dobesilate in treating Chinese patients with mild-to-moderate non-proliferative diabetic retinopathy (CALM-DR): protocol for a single-blind, multicentre, 24-armed cluster-randomised, controlled trial. PMID:34049911
Effects of combined training performed two or four times per week on 24-h blood pressure, glycosylated hemoglobin and other health-related outcomes in aging individuals with hypertension: Rationale and study protocol of a randomized clinical trial. PMID:34038410
Cluster-randomised controlled trial of Stroke 1-2-0 education programme to reduce stroke prehospital delay in China: a study protocol. PMID:34035108
BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial. PMID:34035106
Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a prospective, observational cohort study. PMID:34035097
Clinical efficacy and safety of nazartinib for epidermal growth factor receptor mutated non-small cell lung cancer: Study protocol for a prospective, multicenter, open-label. PMID:34032715
Efficacy and safety of two different adjuvant chemotherapy regimens in combination with concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma: A protocol for randomized controlled trial. PMID:34032710
Preconsultation compassion intervention to reduce anxiety among patients referred to a cancer center: protocol for a randomised control trial. PMID:34031118
The effects of combined motor control and isolated extensor strengthening versus general exercise on paraspinal muscle morphology and function in patients with chronic low back pain: a randomised controlled trial protocol. PMID:34022854
Evaluating OzHarvest's primary-school Food Education and Sustainability Training (FEAST) program in 10-12-year-old children in Australia: protocol for a pragmatic cluster non-randomized controlled trial. PMID:34022839
Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project). PMID:34016658
Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation. PMID:34014922
Cochlear implantation for tinnitus in adults with bilateral hearing loss: protocol of a randomised controlled trial. PMID:34006544
Mindfulness-based online intervention on mental health and quality of life among COVID-19 patients in China: an intervention design. PMID:34001277
Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial. PMID:33986070
Use of carnosine in the prevention of cardiometabolic risk factors in overweight and obese individuals: study protocol for a randomised, double-blind placebo-controlled trial. PMID:33986049
Efficacy of high-intensity interval training compared with moderate-intensity continuous training on maximal aerobic potency in dogs: Trial protocol for a randomised controlled clinical study. PMID:33981438
Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial. PMID:33971940
The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study. PMID:33960949
Mixed-method research protocol: Development and evaluation of a nursing intervention in patients discharged from the intensive care unit. PMID:33955196
Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial). PMID:33952313
Perspectives of scientists on disseminating research findings to non-research audiences. PMID:33948281
Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial. PMID:33948127
Work-related medical rehabilitation in patients with mental disorders: the protocol of a randomized controlled trial (WMR-P, DRKS00023175). PMID:33941123
An Internet-based treatment for Flying Phobia using 360° images: Study protocol for a feasibility pilot study. PMID:33936953
Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial. PMID:33926539
Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial. PMID:33902546
Feasibility of Simplification From a Basal-Bolus Insulin Regimen to a Fixed-Ratio Formulation of Basal Insulin Plus a GLP-1RA or to Basal Insulin Plus an SGLT2 Inhibitor: BEYOND, a Randomized, Pragmatic Trial. PMID:33883195
Effect of acupotomy in knee osteoarthritis patients: study protocol for a randomized controlled trial. PMID:33879221
The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults. PMID:33879131
Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study. PMID:33874993
A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial. PMID:33874974
Randomized Controlled Trials 1: Design. PMID:33871845
Development and Evaluation of a Digital Health Intervention for Substance Use Reduction in Young Refugees With Problematic Use of Alcohol and/or Cannabis-Study Protocol for a Single-Armed Feasibility Trial. PMID:33869122
Withholding vs. Continuing Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers Before Non-cardiac Surgery in Older Patients: Study Protocol for a Multicenter Randomized Controlled Trial. PMID:33859991
Feasibility of a ballet-inspired low-impact at-home workout programme for adults with stroke: a mixed-methods exploratory study protocol. PMID:33849853
Impact of a shared decision-making mHealth tool on caregivers' team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial. PMID:33849611
The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement. PMID:33845856
[Effect of delayed cord clamping and umbilical cord milking on cerebral hemodynamics in preterm infants: a randomized double-blind controlled trial]. PMID:33840403
Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial. PMID:33834863
Effects of virtual reality in post-stroke aphasia: a systematic review and meta-analysis. PMID:33834356
Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2). PMID:33827851
Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): a protocol for a participant and assessor-blinded randomised controlled trial. PMID:33827828
Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial. PMID:33827631
Validation of Cognitive Rehabilitation as a Balance Rehabilitation Strategy in Patients with Parkinson's Disease: Study Protocol for a Randomized Controlled Trial. PMID:33810477
Bone Pain in Multiple Myeloma (BPMM)-A Protocol for a Prospective, Longitudinal, Observational Study. PMID:33808348
Effect on Chest Compression Fraction of Continuous Manual Compressions with Asynchronous Ventilations Using an i-gel® versus 30:2 Approach during Simulated Out-of-Hospital Cardiac Arrest: Protocol for a Manikin Multicenter Randomized Controlled Trial. PMID:33804664
New Methodologies for Conducting Maternal, Infant, and Child Nutrition Research in the Era of COVID-19. PMID:33803970
Study protocol for the Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI): a multicentre, cluster-randomised, parallel-group, superiority trial of a multifaceted community-family-mother-child intervention to prevent childhood overweight and obesity. PMID:33795307
Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA-Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomised controlled trial. PMID:33794971
Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial. PMID:33785016
Study protocol of a phase 1 clinical trial establishing the safety of intrapleural administration of liposomal curcumin: curcumin as a palliative treatment for malignant pleural effusion (IPAL-MPE). PMID:33782024
Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study. PMID:33781339
Comparison Between Pioglitazone/Metformin Combination Therapy and Sitagliptin/Metformin Combination Therapy on the Efficacy in Chinese Type 2 Diabetic Adults Insufficiently Controlled with Metformin: Study Protocol of an Open-Label, Multicenter, Non-Inferiority Parallel-Group Randomized Controlled Trial. PMID:33776461
Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. PMID:33774775
System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies. PMID:33769299
A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers. PMID:33743804
Systematic review of outcome domains and instruments used in designs of clinical trials for interventions that seek to restore bilateral and binaural hearing in adults with unilateral severe to profound sensorineural hearing loss ('single-sided deafness'). PMID:33743802
Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol. PMID:33722864
Comparison Between Conventional Intervention and Non-immersive Virtual Reality in the Rehabilitation of Individuals in an Inpatient Unit for the Treatment of COVID-19: A Study Protocol for a Randomized Controlled Crossover Trial. PMID:33716889
Effect of Reading Rehabilitation for Age-Related Macular Degeneration on Cognitive Functioning: Protocol for a Nonrandomized Pre-Post Intervention Study. PMID:33704074
Closed-Loop Acoustic Stimulation During Sedation with Dexmedetomidine (CLASS-D): Protocol for a Within-Subject, Crossover, Controlled, Interventional Trial with Healthy Volunteers. PMID:33692642
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. PMID:33688276
A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults. PMID:33663229
Effect of vibration therapy on physical function in critically ill adults (VTICIA trial): protocol for a single-blinded randomised controlled trial. PMID:33653754
An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme. PMID:33653406
Feasibility and Acceptability of a Digital Intervention to Support Shared Decision-making in Children's and Young People's Mental Health: Mixed Methods Pilot Randomized Controlled Trial. PMID:33650973
Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial. PMID:33644082
Recovery of early postoperative muscle strength after deep neuromuscular block by means of ultrasonography with comparison of neostigmine versus sugammadex as reversal drugs: study protocol for a randomised controlled trial. PMID:33637547
A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records. PMID:33632282
Observational study on wearable biosensors and machine learning-based remote monitoring of COVID-19 patients. PMID:33623096
Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia. PMID:33622390
Microinvasive pars plana vitrectomy versus panretinal photocoagulation in the treatment of severe non-proliferative diabetic retinopathy (the VIP study): study protocol for a randomised controlled trial. PMID:33619191
The efficacy and safety of auricular acupuncture versus electroacupuncture in ameliorating chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based regimens. PMID:33607790
Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions. PMID:33602338
Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial. PMID:33602286
Study into the reversal of septic shock with landiolol (beta blockade): STRESS-L Study protocol for a randomised trial. PMID:33593781
Efficacy and safety of an innovatively modified cutting seton technique for the treatment of high anal fistula: A protocol for a randomized controlled trial. PMID:33592892
Effects of foreign language learning on executive functions in healthy older adults: study protocol for a randomised controlled trial. PMID:33588784
A Multicomponent Intervention to Reduce Screen Time Among Children Aged 2-5 Years in Chandigarh, North India: Protocol for a Randomized Controlled Trial. PMID:33570499
Achieving optimal adherence to medical therapy by telehealth: Findings from the ORBITA medication adherence sub-study. PMID:33570248
New Approaches Based on Non-Invasive Brain Stimulation and Mental Representation Techniques Targeting Pain in Parkinson's Disease Patients: Two Study Protocols for Two Randomized Controlled Trials. PMID:33561080
Effectiveness of Dry Needling versus Placebo on Gait Performance, Spasticity, Electromyographic Activity, Pain, Range-of-Movement and Quality of Life in Patients with Multiple Sclerosis: A Randomized Controlled Trial Protocol. PMID:33561042
Feasibility and acceptability of a multi-domain intervention to increase Mediterranean diet adherence and physical activity in older UK adults at risk of dementia: protocol for the MedEx-UK randomised controlled trial. PMID:33550254
Reliability and validity of an adapted hip abductor strength measure as a potential new fall risk assessment for older persons: a study protocol. PMID:33546611
Efficacy of minimally invasive surgery for the treatment of hypertensive intracerebral hemorrhage: A protocol of randomized controlled trial. PMID:33546039
Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study. PMID:33531062
mHealth-Supported Delivery of an Evidence-Based Family Home-Visiting Intervention in Sierra Leone: Protocol for a Pilot Randomized Controlled Trial. PMID:33528371
Virtual reality intervention to improve apathy in residential aged care: protocol for a multisite non-randomised controlled trial. PMID:33526504
Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. PMID:33522977
Band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis. PMID:33522602
Designing deep learning studies in cancer diagnostics. PMID:33514930
The effect of a multicomponent exercise protocol (VIVIFRAIL©) on inflammatory profile and physical performance of older adults with different frailty status: study protocol for a randomized controlled trial. PMID:33514329
The FitSpirit approach for increasing physical activity in canadian teenage girls: protocol of a longitudinal, quasi-experimental study. PMID:33509155
Comparison of Effects and Brain-Gut Regulatory Mechanisms of Acupuncture and Flunarizine for Migraine: Study Protocol for a Randomized Controlled Trial. PMID:33505495
Improving nursing documentation for surgical patients in a referral hospital in Freetown, Sierra Leone: protocol for assessing feasibility of a pilot multifaceted quality improvement hybrid type project. PMID:33504369
Beta-blockers versus placebo or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. PMID:33498095
Neuromodulatory Effect of Sensorimotor Network Functional Connectivity of Temporal Three-Needle Therapy for Ischemic Stroke Patients with Motor Dysfunction: Study Protocol for a Randomized, Patient-Assessor Blind, Controlled, Neuroimaging Trial. PMID:33488759
Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial. PMID:33482853
Text messaging as a tool to improve cancer screening programs (M-TICS Study): A randomized controlled trial protocol. PMID:33481914
Which Exercise for Low Back Pain? (WELBack) trial predicting response to exercise treatments for patients with low back pain: a validation randomised controlled trial protocol. PMID:33472786
What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. PMID:33472621
Program for Healthier School Cafeterias in Rio Grande do Sul, Brazil: Protocol for a Community-Based Randomized Trial. PMID:33464219
Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial. PMID:33461579
Kentucky Women's Justice Community Opioid Innovation Network (JCOIN): A type 1 effectiveness-implementation hybrid trial to increase utilization of medications for opioid use disorder among justice-involved women. PMID:33455828
Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial. PMID:33444192
Effect of spironolactone on cardiovascular morbidity and mortality in patients with hypertension and glucose metabolism disorders (ESCAM): a study protocol for a pragmatic randomised controlled trial. PMID:33444188
KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol. PMID:33436465
Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. PMID:33431018
Efficacy and safety of radiofrequency ablation versus laparoscopic hepatectomy for small hepatocellular carcinoma: A protocol for a randomized controlled trial. PMID:33429736
Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial. PMID:33413569
The effectiveness and safety of Tai Chi for patients with essential hypertension: study protocol for an open-label single-center randomized controlled trial. PMID:33413354
Exercise therapy and patient education versus intra-articular saline injections in the treatment of knee osteoarthritis: an evidence-based protocol for an open-label randomised controlled trial (the DISCO trial). PMID:33407791
Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China. PMID:33407788
Reporting guidelines for clinical trials of artificial intelligence interventions: the SPIRIT-AI and CONSORT-AI guidelines. PMID:33407780
Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial. PMID:33407753
Effect of recreational beach tennis on ambulatory blood pressure and physical fitness in hypertensive individuals (BAH study): rationale and study protocol. PMID:33407276
Effect of a low-FODMAP diet for the management of functional abdominal pain disorders in children: a study protocol for a randomized controlled trial. PMID:33388067
Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. PMID:33387056
Effects of ACT Out! Social Issue Theater on Social-Emotional Competence and Bullying in Youth and Adolescents: Cluster Randomized Controlled Trial. PMID:33338986
Cultural adaptation of the Smiling is Fun program for the treatment of depression in the Ecuadorian public health care system: A study protocol for a randomized controlled trial. PMID:33335847
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. PMID:33328049
Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study. PMID:33324894
An Intervention With Dance and Yoga for Girls With Functional Abdominal Pain Disorders (Just in TIME): Protocol for a Randomized Controlled Trial. PMID:33320103
Management of acromioclavicular joint disease by manual therapy versus corticosteroid injections: the protocol of a non-inferiority study. PMID:33303428
Exercise and Nutrition for Healthy AgeiNg (ENHANce) project - effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial. PMID:33302879
An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial. PMID:33298162
A pilot randomised controlled trial of a web-based implementation intervention to increase child intake of fruit and vegetables within childcare centres. PMID:33292720
Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations. PMID:33289919
Effect of arthroscopic acromioplasty on reducing critical shoulder angle: a protocol for a prospective randomized clinical trial. PMID:33287773
The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial. PMID:33268431
Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol. PMID:33268416
Research Objectives, Statistical Analyses and Interpretation of Health-Related Quality of Life Data in Glioma Research: A Systematic Review. PMID:33255505
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials. PMID:33254286
Individualised physical exercise training and enhanced protein intake in older citizens during municipality-based rehabilitation: protocol for a randomised controlled trial. PMID:33243811
DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF): study protocol for a randomized controlled trial. PMID:33243277
Internal Fixation Construct and Defect Size Affect Healing of a Translational Porcine Diaphyseal Tibial Segmental Bone Defect. PMID:33242094
Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study Protocol. PMID:33240121
A phase Ib/IIa, randomised, double-blind, multicentre trial to assess the safety and efficacy of expanded Cx611 allogeneic adipose-derived stem cells (eASCs) for the treatment of patients with community-acquired bacterial pneumonia admitted to the intensive care unit. PMID:33238991
Shonjibon cash and counselling: a community-based cluster randomised controlled trial to measure the effectiveness of unconditional cash transfers and mobile behaviour change communications to reduce child undernutrition in rural Bangladesh. PMID:33238946
Community psychosocial music intervention (CHIME) to reduce antenatal common mental disorder symptoms in The Gambia: a feasibility trial. PMID:33234641
Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial). PMID:33225983
WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial. PMID:33213446
Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol. PMID:33177134
Subcutaneous Sarilumab in Patients With Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open-Label Extension of a Randomized Clinical Trial. PMID:33164349
Band ligation versus sclerotherapy for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. PMID:33164205
Cognitive training and brain stimulation in prodromal Alzheimer's disease (AD-Stim)-study protocol for a double-blind randomized controlled phase IIb (monocenter) trial. PMID:33160420
Acupuncture for chronic stable angina pectoris based on the theory of Meridian-Viscera Association: study protocol for a multicenter randomized controlled trial. PMID:33158451
Tissue selecting technique mega-window stapler combined with anal canal epithelial preservation operation for the treatment of severe prolapsed hemorrhoids: A study protocol for a randomized controlled trial. PMID:33157990
Assessing the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy for treating locally advanced prostate cancer: protocol for an open-label, dose-escalation, single-centre, phase I clinical trial. PMID:33148738
Effects of exergames training on postural balance in patients who had a chronic stroke: study protocol for a randomised controlled trial. PMID:33148737
A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project. PMID:33129261
A randomized controlled trial of resistance and balance exercise for sarcopenic patients aged 80-99 years. PMID:33127948
A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections: Study protocol for the optimal early intervention for cryptococcal antigenemia in HIV-infected patients. PMID:33126335
The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China. PMID:33116533
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects. PMID:33115541
Redundant trials can be prevented, if the EU clinical trial regulation is applied duly. PMID:33115456
The Effects of Physical Exercise on Cognition: How Heart Rate Variability Can Predict Cognitive Performances. PMID:33110405
A randomized controlled trial of a home-based exercise program on prognostic biomarkers in men with prostate cancer: A study protocol. PMID:33083630
Internet-based patient- primary care physician-cardiologist integrated management model of hypertension in China: study protocol for a multicentre randomised controlled trial. PMID:33067295
Rationale and design of the expanded combination of evolocumab plus empagliflozin in diabetes: EXCEED-BHS3 trial. PMID:33062236
Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol. PMID:33060092
IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol. PMID:33059647
The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial. PMID:33059610
Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol. PMID:33052400
Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson's disease H&Y 1-3: study protocol for a randomised controlled trial (PARK-BAND Study). PMID:33046475
Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial. PMID:33046465
Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial. PMID:33040011
Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial. PMID:33036605
Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia for patients with critical limb ischaemia: a study protocol for a randomised controlled trial. PMID:33033091
Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE). PMID:33033025
Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol. PMID:33033014
Contrast-enhanced ultrasound for determining muscular perfusion after oral intake of L-citrulline, L-arginine, and galloylated epicatechines: A study protocol. PMID:33031270
Physical activity and health promotion for nursing staff in elderly care: a study protocol for a randomised controlled trial. PMID:33028557
A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study. PMID:33019888
Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial. PMID:33019480
Intraoperative visualisation and treatment of salivary glands in Sjögren's syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study. PMID:32998913
Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study). PMID:32994236
Long-term effects of a food pattern on cardiovascular risk factors and age-related changes of muscular and cognitive function. PMID:32991458
Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial. PMID:32990629
Early Weight-Based Aggressive vs. Non-Aggressive Goal-Directed Fluid Resuscitation in the Early Phase of Acute Pancreatitis: An Open-Label Multicenter Randomized Controlled Trial (The WATERFALL Trial), Design, and Rationale. PMID:32984361
Effect of Combined Therapy of Virtual Reality and Transcranial Direct Current Stimulation in Children and Adolescents With Cerebral Palsy: A Study Protocol for a Triple-Blinded Randomized Controlled Crossover Trial. PMID:32982950
Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. PMID:32978204
Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study. PMID:32978200
Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial. PMID:32978194
Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial. PMID:32978188
Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes. PMID:32978185
Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial. PMID:32978183
Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial. PMID:32967874
Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches. PMID:32957959
Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol. PMID:32957420
Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial. PMID:32948554
An iPad application-based intervention for improving post-stroke depression symptoms in a convalescent rehabilitation ward: A pilot randomized controlled clinical trial protocol. PMID:32944505
The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion-study protocol for a randomized controlled trial. PMID:32933571
Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement-study protocol for a randomized controlled trial. PMID:32928298
The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial). PMID:32912199
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. PMID:32908284
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension. PMID:32907797
Feasibility and Efficacy of a Psychological Therapy for Patients With a Schizophrenic Psychosis in an Inpatient Setting: Study Protocol of a Randomized Switch Controlled Trial. PMID:32903368
Internet-based support program on parenting outcomes for Chinese primiparous women: Study protocol for a randomized controlled trial. PMID:32901984
Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK): A study protocol for a randomized controlled trial. PMID:32899022
How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework. PMID:32892743
Protocol for the measurement of changes in knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND)). PMID:32887655
IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors. PMID:32887564
Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial. PMID:32883322
Progressive active mobilization with dose control and training load in critically ill patients (PROMOB): Protocol for a randomized controlled trial. PMID:32881921
Ten simple rules for open human health research. PMID:32881878
Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE). PMID:32873675
Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: A multi-center, randomized, double-blind, controlled trial. PMID:32871923
Scapular movement training versus standardized exercises for individuals with chronic shoulder pain: protocol for a randomized controlled trial. PMID:32855073
Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial. PMID:32854756
Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study. PMID:32847919
Efficacy and safety of high-dose Xueshuantong injection (lyophilised) in reducing the incidence of major adverse cardiovascular events in patients with unstable angina: a protocol of a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial based on dual antiplatelet therapy. PMID:32847917
Determining the optimal dose of reactive balance training after stroke: study protocol for a pilot randomised controlled trial. PMID:32847916
Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. PMID:32847912
Care of family caregivers of persons with dementia (CaFCa) through a tailor-made mobile app: study protocol of a complex intervention study. PMID:32847495
Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial. PMID:32819331
Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial. PMID:32811539
Developing and testing a nurse-led intervention to support bereavement in relatives in the intensive care (BRIC study): a protocol of a pre-post intervention study. PMID:32811499
Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. PMID:32796016
Effects of intravenous and inhalation anesthesia on blood glucose and complications in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial. PMID:32793670
The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a 68 Ga -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of lan reotide on t umour size. PMID:32792446
Ear mold for congenital ear malformation: A randomized controlled trial. PMID:32791720
Study protocol: pragmatic randomized control trial of my tools 4 care- in care (MT4C-in care) a web-based tool for family Carers of persons with dementia residing in long term care. PMID:32778059
A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. PMID:32767988
Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial. PMID:32763878
Amyotrophic lateral sclerosis and the innate immune system: protocol for establishing a biobank and statistical analysis plan. PMID:32759248
The effect of Sancai powder on glycemic variability of type 2 diabetes in the elderly: A randomized controlled trial. PMID:32756078
HRV-Guided Training for Professional Endurance Athletes: A Protocol for a Cluster-Randomized Controlled Trial. PMID:32751204
Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study). PMID:32746899
HAPPi Kneecaps! Protocol for a participant- and assessor-blinded, randomised, parallel group feasibility trial of foot orthoses for adolescents with patellofemoral pain. PMID:32741375
Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project. PMID:32737088
Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors-Results from the NUTRI-HAB Randomized Controlled Trial. PMID:32708864
Efficacy of brief dynamic interpersonal therapy in patients with major depressive disorder: a prospective, multicenter randomized controlled trial protocol. PMID:32703316
Improving shared decision-making in vascular surgery by implementing decision support tools: study protocol for the stepped-wedge cluster-randomised OVIDIUS trial. PMID:32703205
A randomized controlled trial to evaluate the effectiveness and safety of electro acupuncture and transcranial direct current stimulation with computerized cognitive rehabilitation in patients with vascular cognitive impairment. PMID:32702911
Effects of Sihogayonggolmoryeo-tang (Saikokaryukotsuboreito or Chai-Hu-Jia-Long-Gu-Mu-Li-Tang) for insomnia disorder with prehypertension or stage 1 hypertension: A study protocol for a randomized controlled trial. PMID:32702837
Artificial intelligence mobile health platform for early detection of COVID-19 in quarantine subjects using a wearable biosensor: protocol for a randomised controlled trial. PMID:32699167
Psychological interventions to foster resilience in healthcare students. PMID:32691879
Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial. PMID:32690519
Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project). PMID:32682408
WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration. PMID:32680474
Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in Mutual Support Groups Coordinated by SMART Recovery Australia: Protocol for a Pilot Study. PMID:32673272
Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial. PMID:32673255
Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study. PMID:32665034
HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation. PMID:32641332
Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. PMID:32641085
High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. PMID:32636290
Systematic review of the registered clinical trials for coronavirus disease 2019 (COVID-19). PMID:32631442
Psychological interventions to foster resilience in healthcare professionals. PMID:32627860
Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial. PMID:32625091
Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial). PMID:32616489
Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study. PMID:32616003
Dynamic contrast-enhanced MRI analysis for prognosis of intracranial dissecting aneurysm with intramural haematoma after endovascular treatment: an observational registry study. PMID:32611729
The study protocol for a pseudo-randomised pre-post designed controlled intervention trial to study the effects of a 7-week cooking program on self-efficacy and biomarkers of health: the ECU lifestyle and biomarkers get connected study (ECULABJMOF) including the Jamie's Ministry of Food WA participant experience. PMID:32605552
The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial. PMID:32600386
A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research. PMID:32591018
INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial. PMID:32591007
Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2). PMID:32586400
Activity and Health During the SARS-CoV2 Pandemic (ASAP): Study Protocol for a Multi-National Network Trial. PMID:32582744
OASIS-a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol. PMID:32580990
Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial. PMID:32576237
The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease. PMID:32571859
The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France. PMID:32571432
Timing of antiretroviral therapy for HIV-infected patients with moderate to severe Pneumocystis pneumonia: study protocol for a multi-centre prospective randomised controlled trial. PMID:32571429
Interventions for treating intrahepatic cholestasis in people with sickle cell disease. PMID:32567054
Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial. PMID:32565480
Is virtual reality effective to teach prevention of surgical site infections in the operating room? study protocol for a randomised controlled multicentre trial entitled VIP Room study. PMID:32565477
Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT). PMID:32565465
Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol. PMID:32554724
The cirrhosis care Alberta (CCAB) protocol: implementing an evidence-based best practice order set for the management of liver cirrhosis - a hybrid type I effectiveness-implementation trial. PMID:32552833
Study protocol for daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial. PMID:32546262
Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals. PMID:32540886
Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial. PMID:32539740
Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial. PMID:32532283
Safety and Efficacy of 630-nm Red Light on Cognitive Function in Older Adults With Mild to Moderate Alzheimer's Disease: Protocol for a Randomized Controlled Study. PMID:32528273
Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients. PMID:32521358
Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial. PMID:32513881
A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial ("MoVo-App"). PMID:32513291
Morbidity Prevalence Estimate at 6 Months Following a Stroke: Protocol for a Cohort Study. PMID:32512539
Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial. PMID:32499263
The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial. PMID:32493500
MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial. PMID:32493383
Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study). PMID:32487210
Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT. PMID:32484432
High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial. PMID:32471494
Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials. PMID:32466758
Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study. PMID:32461297
A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections. PMID:32443329
Impact of Co-Designed Game Learning on Cultural Safety in Colombian Medical Education: Protocol for a Randomized Controlled Trial. PMID:32442146
Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial. PMID:32442139
Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) for chronic insomnia disorder ('CANSLEEP' trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial. PMID:32430450
Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial. PMID:32429969
Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization. PMID:32426409
Internet-based cognitive-behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial. PMID:32423941
Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial. PMID:32423936
Men living through multiple miscarriages: protocol for a qualitative exploration of experiences and support requirements. PMID:32414830
Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial. PMID:32410715
A comparison of different antibiotic regimens for the treatment of infective endocarditis. PMID:32407558
A controlled pilot trial of a nurse-led intervention (Mini-AFTERc) to manage fear of cancer recurrence in patients affected by breast cancer. PMID:32399254
A randomised controlled crossover trial investigating the short-term effects of different types of vegetables on vascular and metabolic function in middle-aged and older adults with mildly elevated blood pressure: the VEgetableS for vaScular hEaLth (VESSEL) study protocol. PMID:32398091
Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. PMID:32385063
Foot exercise plus education versus wait and see for the treatment of plantar heel pain (FEET trial): a protocol for a feasibility study. PMID:32384905
Clinical study of XiangShaLiuJunZi decoction combined with S-1 as maintenance therapy for stage III or IV gastric carcinoma and colorectal carcinoma. PMID:32384478
Interventions for improving medication-taking ability and adherence in older adults prescribed multiple medications. PMID:32383493
Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial. PMID:32381630
Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial. PMID:32381031
Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease. PMID:32376754
Is natural (6S)-5-methyltetrahydrofolic acid as effective as synthetic folic acid in increasing serum and red blood cell folate concentrations during pregnancy? A proof-of-concept pilot study. PMID:32370802
Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial. PMID:32370780
Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial. PMID:32370774
Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT). PMID:32357903
A cognitive remediation training for young adults with psychotic disorders to support their participation in education - study protocol for a pilot randomized controlled trial. PMID:32355565
Electronic Monitoring Of Mom's Schedule (eMOMS™): Protocol for a feasibility randomized controlled trial to improve postpartum weight, blood sugars, and breastfeeding among high BMI women. PMID:32346648
The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial. PMID:32345344
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention in At-Risk Elderly People: Protocol of a Multicenter, Randomized Controlled Feasibility Trial. PMID:32319247
Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial. PMID:32305061
Efficacy and safety of herbal medicine (Dangguijagyag-san) for primary dysmenorrhea: study protocol for a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. PMID:32300524
STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol. PMID:32295779
The ResidentialCare Transition Module: a single-blinded randomized controlled evaluation of a telehealth support intervention for family caregivers of persons with dementia living in residential long-term care. PMID:32293314
Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial. PMID:32290852
Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial. PMID:32281541
Australian Indigenous model of mental healthcare based on transdiagnostic cognitive-behavioural therapy co-designed with the Indigenous community: protocol for a randomised controlled trial. PMID:32249727
The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial. PMID:32248825
Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial. PMID:32242518
Traumatic brain injury-needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention. PMID:32216840
Design and conduct of facility-based surveillance for severe childhood pneumonia in the Household Air Pollution Intervention Network (HAPIN) trial. PMID:32211438
Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial. PMID:32198306
Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant). PMID:32195955
Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial. PMID:32194251
Optimizing the design of invasive placebo interventions in randomized controlled trials. PMID:32187680
Effect and Neuroimaging Mechanism of Electroacupuncture for Vascular Cognitive Impairment No Dementia: Study Protocol for a Randomized, Assessor-Blind, Controlled Clinical Trial. PMID:32184898
Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial. PMID:32184315
Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial). PMID:32183835
Effectiveness of prescribing physical activity in parks to improve health and wellbeing - the park prescription randomized controlled trial. PMID:32183815
The effect of dialectical behaviour therapy in autism spectrum patients with suicidality and/ or self-destructive behaviour (DIASS): study protocol for a multicentre randomised controlled trial. PMID:32183793
Study protocol: a randomized controlled trial comparing the efficacy of therapist guided internet-delivered cognitive therapy (TG-iConquerFear) with augmented treatment as usual in reducing fear of cancer recurrence in Danish colorectal cancer survivors. PMID:32178640
Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial. PMID:32164535
Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. PMID:32163181
Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized controlled trial. PMID:32149773
Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol. PMID:32145739
Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC). PMID:32143737
Sclerotherapy versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. PMID:32133620
Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey. PMID:32131880
iCOPE, a multi-level, cluster randomized, 36-month, parallel-group study to assess the efficacy of HIV disclosure intervention in HIV parental disclosure among parents living with HIV in China. PMID:32128208
Study protocol for a cluster-randomized split-plot design trial to assess the effectiveness of targeted active malaria case detection among high-risk populations in Southern Lao PDR (the AcME-Lao study). PMID:32118199
Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden. PMID:32111264
Promoting sport participation during early parenthood: a randomized controlled trial protocol. PMID:32103772
Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial. PMID:32099661
Dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults: A protocol for a randomized controlled trial : Variable- and fixed-priority dual-task for older adults. PMID:32087694
Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial. PMID:32086350
Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands: study protocol for the retrospective ODYSSEUS study. PMID:32075831
The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial. PMID:32075674
The Quebec Low Back Pain Study: a protocol for an innovative 2-tier provincial cohort. PMID:32072095
Effect of availability of HIV self-testing on HIV testing frequency among men who have sex with men attending university in China (UniTest): protocol of a stepped-wedge randomized controlled trial. PMID:32070297
Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study. PMID:32066599
Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach. PMID:32059693
The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial. PMID:32059684
Effectiveness of An Educational Intervention of Breast Cancer Screening Practices Uptake, Knowledge, and Beliefs among Yemeni Female School Teachers in Klang Valley, Malaysia: A Study Protocol for a Cluster-Randomized Controlled Trial. PMID:32059587
Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial. PMID:32054509
Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction. PMID:32054508
A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU. PMID:32046760
Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial. PMID:32046750
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral? PMID:32041661
How the EMERGE guideline on medication adherence can improve the quality of clinical trials. PMID:32034923
Spinal cord publishes its first protocol paper. PMID:32034298
Effects of a Humanoid Socially Assistive Robot Versus Tablet Training on Psychosocial and Physical Outcomes of Persons With Dementia: Protocol for a Mixed Methods Study. PMID:32022697
Percutaneous ethanol injection for liver metastases. PMID:32017845
Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. PMID:32014057
The efficacy and safety of Chinese herbal medicine Shen-Qi Hua-Yu formula in patients with diabetic lower extremity artery disease: Study protocol of a multi-center, randomized, double-blind, placebo-controlled trial. PMID:32011447
A community-based parent-support programme to prevent child maltreatment: Protocol for a randomised controlled trial. PMID:32002506
Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial. PMID:31997819
Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol. PMID:31992367
Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial). PMID:31992358
Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol. PMID:31992344
Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant). PMID:31977910
Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial. PMID:31974091
A prospective cohort study of self-reported computerised medical history taking for acute chest pain: protocol of the CLEOS-Chest Pain Danderyd Study (CLEOS-CPDS). PMID:31969363
French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial. PMID:31969168
Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials. PMID:31959235
Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial. PMID:31937342
Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial. PMID:31937335
Teledentistry as a novel pathway to improve dental health in school children: a research protocol for a randomised controlled trial. PMID:31937284
Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial. PMID:31924256
Sclerotherapy versus beta-blockers for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis. PMID:31922266
Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial-the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study. PMID:31915052
Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial. PMID:31915044
Implementing the theory-based advance care planning ACP+ programme for nursing homes: study protocol for a cluster randomised controlled trial and process evaluation. PMID:31915000
Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial. PMID:31911526
Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial. PMID:31910819
Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial. PMID:31907076
Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial. PMID:31907074
The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. PMID:31899499
Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial). PMID:31898517
Protocol for a multicentre randomised controlled trial to investigate the effect on asthma-related quality of life from breathing retraining in patients with incomplete asthma control attending specialist care in Denmark. PMID:31892661
Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial. PMID:31888766
Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. PMID:31888764
A clinical trial of group-based body psychotherapy to improve bodily disturbances in post-treatment cancer patients in combination with randomized controlled smartphone-triggered bodily interventions (KPTK): study protocol. PMID:31888741
C1 inhibitor in canine intravascular hemolysis (C1INCH): study protocol for a randomized controlled trial. PMID:31888626
Virtual reality as an adjunct to anesthesia in the operating room. PMID:31882015
Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. PMID:31882012
A multicomponent exercise intervention to improve physical functioning, cognition and psychosocial well-being in elderly nursing home residents: a study protocol of a randomized controlled trial in the PROCARE (prevention and occupational health in long-term care) project. PMID:31870314
Effectiveness of a School-Based 'Tobacco Free' Intervention on Adolescents' Knowledge and Exposure to Second Hand Tobacco Smoke - A Multiphase Study. PMID:31870091
Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial. PMID:31864393
Q fever-the superstition of avoiding the word "quiet" as a coping mechanism: randomised controlled non-inferiority trial. PMID:31852676
Learning from the surgeon's real perspective - First-person view versus laparoscopic view in e-learning for training of surgical skills? Study protocol for a randomized controlled trial. PMID:31851752
Chemotherapy in conjunction with traditional Chinese medicine for survival of patients with early female breast cancer: protocol for a non-randomized, single center prospective cohort study. PMID:31847861
Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial. PMID:31843024
Protocol for a partially nested randomized controlled trial to evaluate the effectiveness of the Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program. PMID:31831073
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial. PMID:31829232
Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol. PMID:31826899
DEBATE-statistical analysis plans for observational studies. PMID:31818263
Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03). PMID:31811480
Efficacy and safety of Sijunzi Decoction for chronic fatigue syndrome with spleen deficiency pattern: study protocol for a randomized, double-blind, placebo-controlled trial. PMID:31807568
Papass clinical trial protocol: a multi-component school-based intervention study to increase acceptance and adherence to school feeding. PMID:31805902
An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. PMID:31793897
We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland-study protocol for a pilot cluster randomised controlled trial. PMID:31788324
Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: the CATAPuLT trial. PMID:31783742
Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study. PMID:31767591
En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial. PMID:31752815
Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands. PMID:31748290
A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial. PMID:31747951
Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden. PMID:31744523
Effects of Chaihu-Shugan-San capsule for psychogenic erectile dysfunction: Study protocol of a randomized placebo-controlled trial. PMID:31725644
The Effect of Advance Care Planning on Heart Failure: a Systematic Review and Meta-analysis. PMID:31720968
Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study). PMID:31718683
Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols. PMID:31712328
Comparative effectiveness of Biobrane®, RECELL® Autologous skin Cell suspension and Silver dressings in partial thickness paediatric burns: BRACS randomised trial protocol. PMID:31696127
Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial. PMID:31690647
The effect of contact needle therapy on fatigue in patients with cancer in palliative care: A study protocol for a randomized controlled trial. PMID:31689865
Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study. PMID:31678945
A school-based, multi-faceted health promotion programme to prevent obesity among children: protocol of a cluster-randomised controlled trial (the DECIDE-Children study). PMID:31678935
Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial. PMID:31664441
Improving Mood with Physical ACTivity (IMPACT) trial: a cluster randomised controlled trial to determine the effectiveness of a brief physical activity behaviour change intervention on depressive symptoms in young people, compared with psychoeducation, in addition to routine clinical care within youth mental health services-a protocol study. PMID:31662409
The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis. PMID:31640992
High-flow oxygen for children's airway surgery: randomised controlled trial protocol (HAMSTER). PMID:31615801
Can Between-Session Homework Be Delivered Digitally? A Pilot Randomized Clinical Trial of CBT for Adjustment Disorders. PMID:31614596
A Digital Intervention for Australian Adolescents Above a Healthy Weight (Health Online for Teens): Protocol for an Implementation and User Experience Study. PMID:31603435
Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis. PMID:31603076
Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial. PMID:31601585
The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. PMID:31601239
Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial. PMID:31594892
Web-based support for self-management strategies versus usual care for people with COPD in primary healthcare: a protocol for a randomised, 12-month, parallel-group pragmatic trial. PMID:31594889
Outcomes of nurse practitioner-led care in patients with cardiovascular disease: A systematic review and meta-analysis. PMID:31588598
Protocol for the electroencephalography guidance of anesthesia to alleviate geriatric syndromes (ENGAGES-Canada) study: A pragmatic, randomized clinical trial. PMID:31588356
Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol. PMID:31575571
Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. PMID:31573942
Development and Evaluation of the Implementation of Guidelines for Healthier Canteens in Dutch Secondary Schools: Study Protocol of a Quasi-Experimental Trial. PMID:31555634
Band ligation versus beta-blockers for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. PMID:31550050
Salt Reduction Intervention in Families Investigating Metabolic, Behavioral and Health Effects of Targeted Intake Reductions: Study Protocol for a Four Months Three-Armed, Randomized, Controlled "Real-Life" Trial. PMID:31546576
Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial. PMID:31542737
The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial. PMID:31533783
Antibiotics for treating acute chest syndrome in people with sickle cell disease. PMID:31531967
Comparing docosahexaenoic acid (DHA) concomitant with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in the treatment of breast cancer (DHA WIN): protocol of a double-blind, phase II, randomised controlled trial. PMID:31530611
Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol. PMID:31519668
A protocol for developing, disseminating, and implementing a core outcome set for stress urinary incontinence. PMID:31517813
Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial. PMID:31511036
Testing the feasibility of a guided imagery tobacco cessation intervention delivered by a telephone quitline: Study protocol for a randomized controlled feasibility trial. PMID:31508532
The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion. PMID:31501123
Intensive and standard group-based treatment for persons with social communication difficulties after an acquired brain injury: study protocol for a randomised controlled trial. PMID:31501112
Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial. PMID:31500602
Mental health specialist video consultations for patients with depression or anxiety disorders in primary care: protocol for a randomised controlled feasibility trial. PMID:31488484
A minimum evaluation protocol and stepped-wedge cluster randomized trial of ACCESS Open Minds, a large Canadian youth mental health services transformation project. PMID:31488144
An Enhanced Self-Care Protocol for People Affected by Moderate to Severe Lymphedema. PMID:31487887
Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial. PMID:31481555
Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. PMID:31474848
Development and evaluation of a tailored e-self-management intervention (dr. Bart app) for knee and/or hip osteoarthritis: study protocol. PMID:31472687
Effect of multidose drug dispensing on the time in therapeutic range in patients using vitamin-K antagonists: A randomized controlled trial. PMID:31469508
Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial. PMID:31467049
Multicenter study of lumbar discectomy with Barricaid annular closure device for prevention of lumbar disc reherniation in US patients: A historically controlled post-market study protocol. PMID:31464935
Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial. PMID:31455312
Increasing awareness of food-choking and nutrition in children through education of caregivers: the CHOP community intervention trial study protocol. PMID:31438901
Relaxation and exercise in lymphoma survivors (REIL study): a randomised clinical trial protocol. PMID:31428434
Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial. PMID:31420057
Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial. PMID:31420050
Effects of prophylactic swallowing exercises on dysphagia and quality of life in patients with head and neck cancer receiving (chemo) radiotherapy: the Redyor study, a protocol for a randomized clinical trial. PMID:31412947
Comparative study of the inhibitory effect on bone erosion progression with denosumab treatment and conventional treatment in rheumatoid arthritis patients: study protocol for an open-label randomized controlled trial by HR-pQCT. PMID:31409388
Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial. PMID:31409383
A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial. PMID:31409380
Beyond Research Reporting Guidelines: How can the Quality of Published Research be Enhanced? PMID:31391660
Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III-IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial. PMID:31391092
A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol. PMID:31383027
Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial. PMID:31377713
Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial. PMID:31370873
Effectiveness of a tailored rehabilitation versus standard strengthening programme for patients with shoulder pain: a protocol for a feasibility randomised controlled trial (the Otago MASTER trial). PMID:31366649
A Core Outcome Set for Critical Care Ventilation Trials. PMID:31356474
Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study. PMID:31345964
Is radial extracorporeal shock wave therapy combined with a specific rehabilitation program (rESWT + RP) more effective than sham-rESWT + RP for acute hamstring muscle complex injury type 3b in athletes? Study protocol for a prospective, randomized, double-blind, sham-controlled single centre trial. PMID:31337441
Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. PMID:31324213
Home-based intervention to test and start (HITS) protocol: a cluster-randomized controlled trial to reduce HIV-related mortality in men and HIV incidence in women through increased coverage of HIV treatment. PMID:31324175
Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial. PMID:31320345
Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial. PMID:31307505
A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project. PMID:31307412
Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality. PMID:31291974
Cryotherapy for liver metastases. PMID:31291464
The 'Pleasure&Pregnancy' web-based interactive educational programme versus expectant management in the treatment of unexplained subfertility: protocol for a randomised controlled trial. PMID:31289062
Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial. PMID:31288859
PEARL: A Non-interventional Study of Real-World Alirocumab Use in German Clinical Practice. PMID:31280466
Effects of β-hydroxy-β-methylbutyrate (HMB) supplementation in addition to multicomponent exercise in adults older than 70 years living in nursing homes, a cluster randomized placebo-controlled trial: the HEAL study protocol. PMID:31277595
Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams - study protocol of a cluster randomized controlled trial. PMID:31253188
Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data. PMID:31243034
Self-administered acupressure for allergic rhinitis: study protocol for a randomized, single-blind, non-specific controlled, parallel trial. PMID:31238972
A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study protocol. PMID:31236285
Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial. PMID:31234864
Protect-me: a parallel-group, triple blinded, placebo-controlled randomised clinical trial protocol assessing antenatal maternal melatonin supplementation for fetal neuroprotection in early-onset fetal growth restriction. PMID:31230020
CADDIE2-evaluation of a clinical decision-support system for early detection of systemic inflammatory response syndrome in paediatric intensive care: study protocol for a diagnostic study. PMID:31221891
Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol. PMID:31221211
Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. PMID:31215440
The Alzheimer's Prevention Initiative Generation Program: Study design of two randomized controlled trials for individuals at risk for clinical onset of Alzheimer's disease. PMID:31211217
iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy. PMID:31208472
Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. PMID:31208471
Is Pelvic Floor Dysfunction Associated With Development of Transient Low Back Pain During Prolonged Standing? A Protocol. PMID:31205437
Older People With Type 2 Diabetes-Individualizing Management With a Specialized (OPTIMISE) Community Team: Protocol for a Safety and Feasibility Mixed Methods Study. PMID:31199316
Impact of endurance exercise and probiotic supplementation on the intestinal microbiota: a cross-over pilot study. PMID:31198580
Protocol for a feasibility study of a cohort embedded randomised controlled trial comparing NEphron Sparing Treatment (NEST) for small renal masses. PMID:31189686
NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study. PMID:31189680
Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial. PMID:31186656
Efficacy of Cognition Support Formula® on cognitive function in older adults with subjective cognitive impairment: a protocol for a 26-week, randomised, double-blind, placebo-controlled trial. PMID:31182153
The effect of implementing an aseptic practice bundle for anaesthetists to reduce postoperative infections, the Anaesthetists Be Cleaner (ABC) study: protocol for a stepped wedge, cluster randomised, multi-site trial. PMID:31182142
Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial. PMID:31182134
Effects of exercise on symptoms of anxiety, cognitive ability and sick leave in patients with anxiety disorders in primary care: study protocol for PHYSBI, a randomized controlled trial. PMID:31182054
Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2). PMID:31174586
"Teaching: Individual" to increase adherence to therapeutic regimen in people with hypertension and type-2 diabetes: protocol of the controlled clinical trial ENURSIN. PMID:31171916
A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy - the PACeR trial protocol. PMID:31153362
Rationale for and Design of the Study of Early Enteral Dextrose in Sepsis: A Pilot Placebo-Controlled Randomized Clinical Trial. PMID:31148210
Protocol of a clinical trial study involving educational intervention in patients treated with warfarin. PMID:31145324
Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185]. PMID:31142350
The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol. PMID:31142294
3D vs. 4K Display System - Influence of "State-of-the-art"-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial. PMID:31138290
Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial. PMID:31132996
Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial. PMID:31132111
A systematic review of quality of reporting in registered intimate partner violence studies: where can we improve? PMID:31129675
Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial. PMID:31126315
Evaluating a Web-Based Mental Health Service for Secondary School Students in Australia: Protocol for a Cluster Randomized Controlled Trial. PMID:31102370
Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial. PMID:31101694
OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose CT (OPTIMACT)-a randomised controlled trial chest X-ray or ultra-low-dose CT at the ED: design and rationale. PMID:31093568
Efficacy of the In2Care® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines. PMID:31088515
A blended face-to-face and smartphone intervention for suicide prevention in the construction industry: protocol for a randomized controlled trial with MATES in Construction. PMID:31088405
The effects of intradialytic resistance training on muscle strength, psychological well-being, clinical outcomes and circulatory micro-ribonucleic acid profiles in haemodialysis patients: Protocol for a quasi-experimental study. PMID:31083229
Investigating the effectiveness of an online acceptance and commitment therapy (ACT) intervention versus a waiting list control condition on pain interference and quality of life in adults with chronic pain and multimorbidity: protocol for a randomised controlled trial. PMID:31076466
Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies. PMID:31053067
HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany - a study protocol of a randomized controlled trial. PMID:31039786
Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. PMID:31039753
HOspitalised Pneumonia Extended (HOPE) Study to reduce the long-term effects of childhood pneumonia: protocol for a multicentre, double-blind, parallel, superiority randomised controlled trial. PMID:31023759
Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial. PMID:31023380
Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial. PMID:31014386
Effect of metformin on the size of the HIV reservoir in non-diabetic ART-treated individuals: single-arm non-randomised Lilac pilot study protocol. PMID:31005944
Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression. PMID:31005923
The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis. PMID:31005917
Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia. PMID:30992081
Protocol for LINKS (linking individual needs to community and clinical services): a prospective matched observational study of a community health worker community clinical linkage intervention on the U.S.-Mexico border. PMID:30975126
Promotion of physical activity-related health competence in physical education: study protocol for the GEKOS cluster randomized controlled trial. PMID:30975111
Process Evaluation of a Medical Student-Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial. PMID:30973348
Effects of two types of smartphone-based stress management programmes on depressive and anxiety symptoms among hospital nurses in Vietnam: a protocol for three-arm randomised controlled trial. PMID:30962230
Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials. PMID:30959516
Person-Centered Interactive Self-Management Support in Primary Health Care for People with Type 2 Diabetes: Protocol for a Randomized Controlled Trial. PMID:30958279
Evaluation of the efficacy of transcranial direct current stimulation in the treatment of cognitive symptomatology in the early stages of psychosis: study protocol for a double-blind randomized controlled trial. PMID:30953544
Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial. PMID:30949243
Electroacupuncture versus manual acupuncture in the treatment of plantar heel pain syndrome: study protocol for an upcoming randomised controlled trial. PMID:30948595
An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study. PMID:30944044
Comparison of combined lumbar and sacral plexus block with sedation versus general anaesthesia on postoperative outcomes in elderly patients undergoing hip fracture surgery (CLSB-HIPELD): study protocol for a prospective, multicentre, randomised controlled trial. PMID:30928924
Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. PMID:30918037
A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial. PMID:30918032
A couples-focused intervention for smoking cessation during pregnancy: The study protocol of the Quit Together pilot randomized controlled trial. PMID:30906906
App to support Recovery in Early Intervention Services (ARIES) study: protocol of a feasibility randomised controlled trial of a self-management Smartphone application for psychosis. PMID:30898825
Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial. PMID:30898098
The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial. PMID:30876432
A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. PMID:30871561
A guide to the reporting of protocols of pilot and feasibility trials. PMID:30858987
Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions. PMID:30855655
App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial. PMID:30845949
Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT). PMID:30841935
Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial. PMID:30837256
Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial). PMID:30836981
Tissue Adhesive for Wound Closure Reduces Immediate Postoperative Wound Dressing Changes After Primary TKA: A Randomized Controlled Study in Simultaneous Bilateral TKA. PMID:30811354
Randomized clinical trials with run-in periods: frequency, characteristics and reporting. PMID:30809104
Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial. PMID:30808379
Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial. PMID:30804818
Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). PMID:30804032
An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. PMID:30797238
Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial. PMID:30786930
Protocol for developing a mental imagery intervention: a randomised controlled trial testing a novel implementation imagery e-health intervention to change driver behaviour during floods. PMID:30782937
Guidance for reporting outcomes in clinical trials: scoping review protocol. PMID:30782872
External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol. PMID:30782698
Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. PMID:30782680
Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial. PMID:30782208
The (cost-) effectiveness of exergaming in people living with dementia and their informal caregivers: protocol for a randomized controlled trial. PMID:30782127
Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer. PMID:30772862
Identifying priorities for cancer caregiver interventions: protocol for a three-round modified Delphi study. PMID:30765405
How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the 'CLASSIC' trial). PMID:30760305
Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE). PMID:30755164
CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial. PMID:30732624
Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial. PMID:30728055
Using physical education to promote out-of school physical activity in lower secondary school students - a randomized controlled trial protocol. PMID:30727989
The Safety, Tolerability, and Effects on the Systemic Inflammatory Response and Renal Function of the Human Chorionic Gonadotropin Hormone-Derivative EA-230 Following On-Pump Cardiac Surgery (The EASI Study): Protocol for a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. PMID:30724734
Prescribing Physical Activity in Parks to Improve Health and Wellbeing: Protocol of the Park Prescription Randomized Controlled Trial. PMID:30720784
EMPOWER-PD - A physical therapy intervention to empower the individuals with Parkinson's disease: a study protocol for a feasibility randomized controlled trial. PMID:30705760
Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial. PMID:30696677
Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial. PMID:30696491
Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB). PMID:30693094
Protocol for pilot cluster RCT of project respect: a school-based intervention to prevent dating and relationship violence and address health inequalities among young people. PMID:30693093
The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial. PMID:30687208
Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial. PMID:30683147
Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1): study protocol of a phase II trial. PMID:30679288
Study protocol of a multi-center RCT testing a social-cognitive intervention to promote volunteering in older adults against an active control. PMID:30678635
Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. PMID:30671005
Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults-study protocol for a stepped-wedge cluster randomized trial (PAWEL Study). PMID:30665435
Cerebral mechanism of celecoxib for treating knee pain: study protocol for a randomized controlled parallel trial. PMID:30651138
Disulfiram repurposing combined with nutritional copper supplement as add-on to chemotherapy in recurrent glioblastoma (DIRECT): Study protocol for a randomized controlled trial. PMID:30647912
Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective? PMID:30637541
Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. PMID:30635064
Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation. PMID:30633776
Sciatic nerve block or not for outpatient total knee arthroplasty? Study protocol for a randomized controlled trial. PMID:30621742
Evidence-based sizing of non-inferiority trials using decision models. PMID:30612554
Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]. PMID:30612110
Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial. PMID:30606240
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program. PMID:30606239
Study protocol for a randomised pilot study of a computer-based, non-pharmacological cognitive intervention for motor slowing and motor fatigue in Parkinson's disease. PMID:30603099
Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double-blind, placebo-controlled trial. PMID:30594227
Randomization procedures for multicomponent behavioral intervention factorial trials in the multiphase optimization strategy framework: challenges and recommendations. PMID:30590759
Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia. PMID:30582172
Intensive Balance Training for Adults With Incomplete Spinal Cord Injuries: Protocol for an Assessor-Blinded Randomized Clinical Trial. PMID:30576475
Structured diet and exercise guidance in pregnancy to improve health in women and their offspring: study protocol for the Be Healthy in Pregnancy (BHIP) randomized controlled trial. PMID:30567604
Prevention of post-operative complications by using a HMG-CoA reductase inhibitor in patients undergoing one-lung ventilation for non-cardiac surgery: study protocol for a randomised controlled trial. PMID:30563555
VA Telederm study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process. PMID:30552249
Ambient air pollution in gastrointestinal endoscopy unit; rationale and design of a prospective study. PMID:30544484
The efficacy of interprofessional simulation in improving collaborative attitude between nursing students and residents in medicine. A study protocol for a randomised controlled trial. PMID:30539929
Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design. PMID:30514378
Influence of a periodized circuit training protocol on intermuscular adipose tissue of patients with knee osteoarthritis: protocol for a randomized controlled trial. PMID:30497420
Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). PMID:30484022
The importance of patient-reported outcomes in clinical trials and strategies for future optimization. PMID:30464666
Neurostimulation Combined With Cognitive Intervention in Alzheimer's Disease (NeuroAD): Study Protocol of Double-Blind, Randomized, Factorial Clinical Trial. PMID:30450044
Effect of a high-protein diet with β-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial. PMID:30445988
Comorbidity and diagnosis distribution in transdiagnostic treatments for emotional disorders: A systematic review of randomized controlled trials. PMID:30440020
Modified quadruple therapy versus bismuth-containing quadruple therapy in first-line treatment of Helicobacter pylori infection in Korea; rationale and design of an open-label, multicenter, randomized controlled trial. PMID:30431605
Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial. PMID:30429118
The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial. PMID:30425027
Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial. PMID:30424738
Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. PMID:30419096
Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial. PMID:30413519
Effects of Shuganjianpihuatanxingqi decoction on mild subclinical hypothyroidism: A SPIRIT compliant randomized controlled trial study protocol. PMID:30407354
Protocol for the "Chemobrain in Motion - study" (CIM - study): a randomized placebo-controlled trial of the impact of a high-intensity interval endurance training on cancer related cognitive impairments in women with breast cancer receiving first-line chemotherapy. PMID:30400840
Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study. PMID:30398039
Drug use in street sex workers (DUSSK) study protocol: a feasibility and acceptability study of a complex intervention to reduce illicit drug use in drug-dependent female street sex workers. PMID:30391916
Surgical portosystemic shunts versus transjugular intrahepatic portosystemic shunt for variceal haemorrhage in people with cirrhosis. PMID:30378107
A systematic review of spatial decision support systems in public health informatics supporting the identification of high risk areas for zoonotic disease outbreaks. PMID:30376842
Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) - study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study). PMID:30373596
Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial. PMID:30368450
Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop. PMID:30360959
Improving cooperation between general practitioners and dermatologists via telemedicine: study protocol of the cluster-randomized controlled TeleDerm study. PMID:30355358
Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study'). PMID:30348142
The 'Better Conversations with Primary Progressive Aphasia (BCPPA)' program for people with PPA (Primary Progressive Aphasia): protocol for a randomised controlled pilot study. PMID:30345067
Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study. PMID:30344179
Comparison of 3 assessment modes of acupuncture effect on patients with chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial. PMID:30335011
B-positive: a randomized controlled trial of a multicomponent positive psychology intervention for euthymic patients with bipolar disorder - study protocol and intervention development. PMID:30333004
Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial. PMID:30326932
Effect of Gabapentin vs Pregabalin on Pain Intensity in Adults With Chronic Sciatica: A Randomized Clinical Trial. PMID:30326006
Protocol for the REVISIT-BPD Trial, a Randomized Controlled Trial Testing the Effectiveness of an Internet-Based Self-Management Intervention in the Treatment of Borderline Personality Disorder (BPD). PMID:30298024
Vitamin D supplementation to prevent vitamin D deficiency for children with epilepsy: Randomized pragmatic trial protocol. PMID:30290685
A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol. PMID:30285672
Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment. PMID:30253809
Development, acceptability and feasibility of a communication skills training package for therapeutic radiographers to reduce fear of recurrence development in breast cancer patients (FORECAST2). PMID:30237899
Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial - Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial. PMID:30236151
Tele-transitions of care. A 12-month, parallel-group, superiority randomized controlled trial protocol, evaluating the use of telehealth versus standard transitions of care in the prevention of avoidable hospital readmissions. PMID:30211339
Study protocol for the MEXiletine hydrochloride administration trial: a placebo-controlled, randomised, double-blind, multicentre, crossover study of its efficacy and safety in spinal and bulbar muscular atrophy (MEXPRESS). PMID:30206090
Effect of a combined brief narrative exposure therapy with case management versus treatment as usual in primary care for patients with traumatic stress sequelae following intensive care medicine: study protocol for a multicenter randomized controlled trial (PICTURE). PMID:30201053
Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study). PMID:30201040
Prolonged exposure therapy and supportive counselling for posttraumatic stress disorder in adolescents in a community-based sample, including experiences of stakeholders: study protocol for a comparative randomized controlled trial using task-shifting. PMID:30189857
The effect of remote ischemic preconditioning on serum creatinine in patients undergoing partial nephrectomy: a study protocol for a randomized controlled trial. PMID:30180887
Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial. PMID:30180874
Voice Disorder Detection via an m-Health System: Design and Results of a Clinical Study to Evaluate Vox4Health. PMID:30175144
A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial. PMID:30139723
Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial. PMID:30134944
A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol. PMID:30123525
A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial. PMID:30119663
Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT). PMID:30115112
Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial. PMID:30111378
Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: randomised controlled trial protocol. PMID:30104317
Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial. PMID:30103785
Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial. PMID:30103692
Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial). PMID:30099402
Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. PMID:30099400
Early intervention program for very low birth weight preterm infants and their parents: a study protocol. PMID:30092772
m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial. PMID:30086778
Effects of ultrasound-guided stellate ganglion block on cervical vascular blood flow: study protocol for a randomized controlled trial. PMID:30086776
Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial. PMID:30081933
Design of non-inferiority randomized trials using the difference in restricted mean survival times. PMID:30074407
Surgical portosystemic shunts versus devascularisation procedures for prevention of variceal rebleeding in people with hepatosplenic schistosomiasis. PMID:30073663
Effectiveness of an intervention for managing victimization risks related to societal participation for persons with severe mental illness: a cluster RCT study protocol. PMID:30071821
A psychoeducational group intervention for family and friends of youth with borderline personality disorder features: protocol for a randomised controlled trial. PMID:30065842
Study protocol for a single-centre, prospective, non-blinded, randomised, 12-month, parallel-group superiority study to compare the efficacy of pharmacist intervention versus usual care for elderly patients hospitalised in orthopaedic wards. PMID:30061440
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. PMID:30060754
Using primary care-based paper and telephone interventions to increase uptake of bowel scope screening in Yorkshire: a protocol of a randomised controlled trial. PMID:30056395
JACK trial protocol: a phase III multicentre cluster randomised controlled trial of a school-based relationship and sexuality education intervention focusing on young male perspectives. PMID:30056390
Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity-The TEMPO Diet Trial. PMID:30036996
Efficacy of oral administration of cystine and theanine in patients with colorectal cancer undergoing capecitabine-based adjuvant chemotherapy after surgery: study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled, phase II trial. PMID:30030317
Facilitating physical activity and reducing symptoms in patients with knee osteoarthritis: study protocol of a randomized controlled trial to test a theory-based PrevOP-psychological adherence program (PrevOP-PAP). PMID:30021578
The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam. PMID:30021551
Clinical Trial Protocol: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)]. PMID:30014184
Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST): a prospective multicentre feasibility study protocol in patients and their caregivers. PMID:30012788
The Smart City Active Mobile Phone Intervention (SCAMPI) study to promote physical activity through active transportation in healthy adults: a study protocol for a randomised controlled trial. PMID:30012116
Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial. PMID:30005705
The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial. PMID:30001732
ACTIVE - a randomised feasibility trial study protocol of a behavioural intervention to reduce fatigue in women undergoing radiotherapy for early breast cancer: study protocol. PMID:29992037
Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol. PMID:29983992
The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial. PMID:29973256
Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. PMID:29970156
Effects of a 6-week, whole-body vibration strength-training on depression symptoms, endocrinological and neurobiological parameters in adolescent inpatients experiencing a major depressive episode (the "Balancing Vibrations Study"): study protocol for a randomized placebo-controlled trial. PMID:29970142
An Observational Study for Knowing the Compliance of Patients Scheduled for Major Abdominal and Thoracic Cancer Surgeries in a Single Specialty Center. PMID:29962633
SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol. PMID:29961032
Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study). PMID:29961023
The Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial: A study of crenezumab versus placebo in preclinical PSEN1 E280A mutation carriers to evaluate efficacy and safety in the treatment of autosomal-dominant Alzheimer's disease, including a placebo-treated noncarrier cohort. PMID:29955659
Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial. PMID:29950464
Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogotá, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial. PMID:29941024
Treatment after traumatic shoulder dislocation: a systematic review with a network meta-analysis. PMID:29936432
Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial. PMID:29929533
Comparative impact of two continuing education activities targeted at COPD educators on educational outcomes: protocol for a non-randomized controlled study using mixed methods. PMID:29914484
Augmentation effect of acupuncture on Bi'nao for hypophasis in patients with Bell's palsy: study protocol for a randomized controlled trial. PMID:29891003
Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE). PMID:29879117
'Allocation concealment': the evolution and adoption of a methodological term. PMID:29877772
Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2). PMID:29873315
A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement. PMID:29872509
Cognitive and Neurophysiological Recovery Following Electroconvulsive Therapy: A Study Protocol. PMID:29867602
Study protocol of the randomised placebo-controlled GLOBE trial: GLP-1 for bridging of hyperglycaemia during cardiac surgery. PMID:29866735
Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. PMID:29855317
An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial. PMID:29855281
Efficacy and safety of acupuncture at a single BL1 acupoint in the treatment of moderate to severe dry eye disease: Protocol for a randomized, controlled trial. PMID:29851826
The Efficacy of a Web-Based Screening and Brief Intervention for Reducing Alcohol Consumption Among Japanese Problem Drinkers: Protocol for a Single-Blind Randomized Controlled Trial. PMID:29848471
Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. PMID:29848335
Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial. PMID:29843766
Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set. PMID:29801508
Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial. PMID:29794738
Evaluation of an intervention programme addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a feasibility trial (ABLE). PMID:29780029
ESCAlate - Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial. PMID:29776383
Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital. PMID:29766134
Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. PMID:29764869
Glucocorticosteroids for infants with biliary atresia following Kasai portoenterostomy. PMID:29761473
Resistance training in addition to multidisciplinary rehabilitation for patients with chronic pain in the low back: Study protocol. PMID:29740641
A randomized controlled trial testing the effectiveness of a paramedic-delivered care transitions intervention to reduce emergency department revisits. PMID:29724172
Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study. PMID:29720248
The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial. PMID:29720225
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial. PMID:29703266
Comparative efficacy of combination of 1 L polyethylene glycol, castor oil and ascorbic acid versus 2 L polyethylene glycol plus castor oil versus 3 L polyethylene glycol for colon cleansing before colonoscopy: Study protocol of a randomized, double-blind, single-center study. PMID:29703007
Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial. PMID:29696209
Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial. PMID:29695262
Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial. PMID:29691246
Implementation of evidence-based weekend service recommendations for allied health managers: a cluster randomised controlled trial protocol. PMID:29690882
Development and evaluation of an algorithm-based tool for Medication Management in nursing homes: the AMBER study protocol. PMID:29678967
Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial. PMID:29678193
Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial. PMID:29673408
Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial. PMID:29665830
Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial. PMID:29654027
Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial. PMID:29653545
The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial. PMID:29643802
Diabetes-Specific Formulae Versus Standard Formulae as Enteral Nutrition to Treat Hyperglycemia in Critically Ill Patients: Protocol for a Randomized Controlled Feasibility Trial. PMID:29631990
Glucocorticosteroid-free versus glucocorticosteroid-containing immunosuppression for liver transplanted patients. PMID:29630730
A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial. PMID:29625599
Implementation of a multidisciplinary psychoeducational intervention for Parkinson's disease patients and carers in the community: study protocol. PMID:29621985
A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol. PMID:29609568
Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial. PMID:29606135
Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial. PMID:29606109
Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial. PMID:29588861
Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial. PMID:29587863
Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER). PMID:29574439
Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial. PMID:29566739
Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial. PMID:29566730
Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2). PMID:29566729
Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial. PMID:29566656
Enhancing primary reports of randomized controlled trials: Three most common challenges and suggested solutions. PMID:29531032
The Physiological Bases of Hidden Noise-Induced Hearing Loss: Protocol for a Functional Neuroimaging Study. PMID:29523503
Cardiac output Optimisation following Liver Transplant (COLT) trial: study protocol for a feasibility randomised controlled trial. PMID:29514697
Reducing distress and improving social functioning in daily life in people with auditory verbal hallucinations: study protocol for the 'Temstem' randomised controlled trial. PMID:29511020
Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial. PMID:29510971
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial. PMID:29506580
Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial. PMID:29501740
Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial. PMID:29486765
Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial). PMID:29484196
Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial. PMID:29482662
EEPIC - Enhancing Employability through Positive Interventions for improving Career potential: the impact of a high support career guidance intervention on the wellbeing, hopefulness, self-efficacy and employability of the long-term unemployed - a study protocol for a randomised controlled trial. PMID:29482648
Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET). PMID:29482601
Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial. PMID:29471861
Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial. PMID:29467024
Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial. PMID:29467019
Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial. PMID:29458406
Promoting public access to clinical trial protocols: challenges and recommendations. PMID:29454390
Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial). PMID:29452599
Exploring computerised cognitive training as a therapeutic intervention for people with Huntington's disease (CogTrainHD): protocol for a randomised feasibility study. PMID:29445514
The knitting community-based trial for older women with osteoarthritis of the hands: design and rationale of a randomized controlled trial. PMID:29444664
Effects of exercise on secretion transport, inflammation, and quality of life in patients with noncystic fibrosis bronchiectasis: Protocol for a randomized controlled trial. PMID:29443739
Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. PMID:29436756
Fluid resuscitation with lactated Ringer's solution vs normal saline in acute pancreatitis: A triple-blind, randomized, controlled trial. PMID:29435315
Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese. PMID:29431125
Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol. PMID:29431123
Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial. PMID:29426359
Encouragement-Induced Real-World Upper Limb Use after Stroke by a Tracking and Feedback Device: A Study Protocol for a Multi-Center, Assessor-Blinded, Randomized Controlled Trial. PMID:29422881
The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design. PMID:29419665
Feasibility of using risk prompts to prevent falls, dehydration and pulmonary aspiration in nursing homes: a clinical study protocol. PMID:29416872
Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances. PMID:29415697
The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial. PMID:29402313
Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction: the NARES trial. A study protocol for a pilot, factorial randomised controlled trial. PMID:29391372
Efficacy of acupuncture on menstrual frequency in women with polycystic ovary syndrome: Protocol for a randomized, controlled trial. PMID:29381988
Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia. PMID:29374672
HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial. PMID:29368658
Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA). PMID:29362263
Two alternatives versus the standard Grading of Recommendations Assessment, Development and Evaluation (GRADE) summary of findings (SoF) tables to improve understanding in the presentation of systematic review results: a three-arm, randomised, controlled, non-inferiority trial. PMID:29362242
Antipruritic Effect of Acupuncture in Patients with Atopic Dermatitis: Feasibility Study Protocol for a Randomised, Sham-Controlled Trial. PMID:29358961
An individually randomized controlled trial to determine the effectiveness of the Women for Women International Programme in reducing intimate partner violence and strengthening livelihoods amongst women in Afghanistan: trial design, methods and baseline findings. PMID:29357843
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. PMID:29347991
Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial). PMID:29347947
Getting messier with TIDieR: embracing context and complexity in intervention reporting. PMID:29347910
Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial. PMID:29331975
Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial. PMID:29325595
A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. PMID:29325533
Pregabalin versus gabapentin in the treatment of sciatica: study protocol for a randomised, double-blind, cross-over trial (PAGPROS). PMID:29316960
Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial. PMID:29310679
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial. PMID:29301545
Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial. PMID:29298706
Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): study protocol for a randomised controlled pilot study. PMID:29284534
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial. PMID:29273095
United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial. PMID:29273079
Lymphocyte opioid receptors as innovative biomarkers of osteoarthritic pain, for the assessment and risk management of opioid tailored therapy, before hip surgery, to prevent chronic pain and opioid tolerance/addiction development: OpMarkArt (Opioids-Markers-Arthroprosthesis) study protocol for a randomized controlled trial. PMID:29258584
The effects of low-intensity blood flow restricted exercise compared with conventional resistance training on the clinical outcomes of active UK military personnel following a 3-week in-patient rehabilitation programme: protocol for a randomized controlled feasibility study. PMID:29234504
Coping with Unusual ExperienceS for 12-18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial. PMID:29202862
PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial. PMID:29202786
Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study. PMID:29202079
Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial. PMID:29187413
The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial. PMID:29183347
Effect of Transcranial Direct Current Stimulation on Functional Capacity in Schizophrenia: A Study Protocol for a Randomized Controlled Trial. PMID:29180969
A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. PMID:29163981
Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial. PMID:29158206
Interpretation of health news items reported with or without spin: protocol for a prospective meta-analysis of 16 randomised controlled trials. PMID:29151047
Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial. PMID:29149914
Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial. PMID:29149909
Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial. PMID:29137655
Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial. PMID:29121884
Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial. PMID:29110687
An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial. PMID:29101094
Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial. PMID:29095305
Enhancing research quality and reporting: why the Journal of Comorbidity is now publishing study protocols. PMID:29090154
SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial. PMID:29084595
Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. PMID:29074518
Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity. PMID:29074513
Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill. PMID:29061618
Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial. PMID:29061616
Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial. PMID:29061612
Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. PMID:29061194
Pregnant Women's Perceptions of the Risks and Benefits of Disclosure During Web-Based Mental Health E-Screening Versus Paper-Based Screening: Randomized Controlled Trial. PMID:29054833
Nature-based care opportunities and barriers in oncology contexts: a modified international e-Delphi survey. PMID:29042387
The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial. PMID:29021000
The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial. PMID:29020976
COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial. PMID:29017605
Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance. PMID:28982811
pRotective vEntilation with veno-venouS lung assisT in respiratory failure: A protocol for a multicentre randomised controlled trial of extracorporeal carbon dioxide removal in patients with acute hypoxaemic respiratory failure. PMID:28979565
Effectiveness of two web-based cognitive bias modification interventions targeting approach and attentional bias in gambling problems: study protocol for a pilot randomised controlled trial. PMID:28974265
Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. PMID:28969702
A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13-14 years. PMID:28963278
TAILOR - tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder in remission of psychotic symptoms: study protocol for a randomized clinical trial. PMID:28962668
Knowledge translation tools for parents on child health topics: a scoping review. PMID:28962637
Effects of a workplace prevention programme for problem gambling: study protocol for a cluster randomised controlled trial. PMID:28951403
Guidelines for standardizing and increasing the transparency in the reporting of biomedical research. PMID:28932578
Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis. PMID:28928174
Effectiveness, cost-utility and implementation of a decision aid for patients with localised prostate cancer and their partners: study protocol of a stepped-wedge cluster randomised controlled trial. PMID:28918408
Informed decision-making with and for people with dementia - efficacy of the PRODECIDE education program for legal representatives: protocol of a randomized controlled trial (PRODECIDE-RCT). PMID:28915861
A randomised controlled trial of an online menu planning intervention to improve childcare service adherence to dietary guidelines: a study protocol. PMID:28893755
The HAT TRICK programme for improving physical activity, healthy eating and connectedness among overweight, inactive men: study protocol of a pragmatic feasibility trial. PMID:28882920
Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial. PMID:28877729
Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. PMID:28864708
Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score. PMID:28864695
Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial. PMID:28830541
The preventive effect of the bounding exercise programme on hamstring injuries in amateur soccer players: the design of a randomized controlled trial. PMID:28830536
Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults. PMID:28827270
Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol. PMID:28827261
A prospective non-randomized controlled, multicenter trial comparing Appendectomy and Conservative Treatment for Patients with Uncomplicated Acute Appendicitis (the ACTUAA study). PMID:28812175
DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial. PMID:28808581
Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers. PMID:28806917
A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT). PMID:28793916
Implementing a multi-modal support service model for the family caregivers of persons with age-related macular degeneration: a study protocol for a randomised controlled trial. PMID:28780563
A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial Protocol. PMID:28778848
Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial. PMID:28770099
Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare. PMID:28765136
Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study. PMID:28765131
Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) trial. PMID:28760205
Interventions for treating intrahepatic cholestasis in people with sickle cell disease. PMID:28759700
ReaDySpeech for people with dysarthria after stroke: protocol for a feasibility randomised controlled trial. PMID:28748108
Study protocol: a mixed methods feasibility study for a loaded self-managed exercise programme for patellofemoral pain. PMID:28748107
Advancing the evidence to improve the nutrition of populations: a refreshed vision and scope for Nutrition Journal. PMID:28747181
Optimising decision making on illness absenteeism due to fever and common infections within childcare centres: development of a multicomponent intervention and study protocol of a cluster randomised controlled trial. PMID:28747169
Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial. PMID:28743315
ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials. PMID:28738794
A 3D navigation template for guiding a unilateral lumbar pedicle screw with contralateral translaminar facet screw fixation: a study protocol for multicentre randomised controlled trials. PMID:28733301
Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial. PMID:28732521
Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol. PMID:28729911
A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial. PMID:28729311
Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. PMID:28727663
A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol. PMID:28716797
STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. PMID:28716147
Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial. PMID:28716146
Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study. PMID:28716047
Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality. PMID:28715491
The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial. PMID:28709470
Rehabilitation access and effectiveness for persons with back pain: the protocol of a cohort study (REHAB-BP, DRKS00011554). PMID:28709405
A pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy. PMID:28694995
The COMET Handbook: version 1.0. PMID:28681707
Evaluation of the Gold Coast Integrated Care for patients with chronic disease or high risk of hospitalisation through a non-randomised controlled clinical trial: a pilot study protocol. PMID:28674147
Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials. PMID:28673328
PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. PMID:28667228
A Hybrid Web-Based and In-Person Self-Management Intervention to Prevent Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): Protocol for a Pilot Single-Blind Randomized Controlled Trial. PMID:28652226
Feasibility study of a randomised controlled trial to investigate the effectiveness of using a humanoid robot to improve the social skills of children with autism spectrum disorder (Kaspar RCT): a study protocol. PMID:28645986
A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE)-a study protocol. PMID:28645976
Effect of e-cigarette advertisements and antismoking messages on explicit and implicit attitudes towards tobacco and e-cigarette smoking in 18-65-year-olds: a randomised controlled study protocol. PMID:28645957
The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) - standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial. PMID:28645301
Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate). PMID:28637740
Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. PMID:28629447
Interventions for treating patients with chikungunya virus infection-related rheumatic and musculoskeletal disorders: A systematic review. PMID:28609439
Targeted simplification versus antipseudomonal broad-spectrum beta-lactams in patients with bloodstream infections due to Enterobacteriaceae (SIMPLIFY): a study protocol for a multicentre, open-label, phase III randomised, controlled, non-inferiority clinical trial. PMID:28601833
A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised controlled trial. PMID:28595614
Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. PMID:28587609
The Taking Charge After Stroke (TaCAS) study protocol: a multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-Māori, non-Pacific adult New Zealanders discharged to community living. PMID:28576903
AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery. PMID:28576901
Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial. PMID:28558825
The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial). PMID:28558734
Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol. PMID:28554928
The SUPER study: protocol for a randomised controlled trial comparing follicle-stimulating hormone and clomiphene citrate for ovarian stimulation in intrauterine insemination. PMID:28550023
A coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's community hypertension care: study protocol for a randomized controlled trial. PMID:28545514
Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial. PMID:28545498
Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial. PMID:28532439
The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial. PMID:28521831
Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial. PMID:28521796
IMPROVING THE REPORTING OF THERAPEUTIC EXERCISE INTERVENTIONS IN REHABILITATION RESEARCH. PMID:28515984
A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis. PMID:28515234
Integrating culturally informed approaches into the physiotherapy assessment and treatment of chronic pain: protocol for a pilot randomised controlled trial. PMID:28501812
Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol. PMID:28495811
The effect of empagliflozin on oxidative nucleic acid modifications in patients with type 2 diabetes: protocol for a randomised, double-blinded, placebo-controlled trial. PMID:28490557
Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough. PMID:28490554
Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol. PMID:28487349
The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice. PMID:28482829
Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients. PMID:28464887
Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial. PMID:28461284
Lymphoma InterVEntion (LIVE) - patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial. PMID:28454583
A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol. PMID:28450898
Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial. PMID:28449709
Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial. PMID:28449699
The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial. PMID:28446223
A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. PMID:28446141
Maintenance tegafur-uracil versus observation following an adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection: study protocol for a randomized controlled trial. PMID:28441966
A behavioral medicine intervention for community-dwelling older adults with chronic musculoskeletal pain: protocol for a randomized controlled trial. PMID:28435321
Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial. PMID:28431551
Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. PMID:28424068
Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression. PMID:28420367
Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial. PMID:28395659
Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial. PMID:28390417
Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial. PMID:28389489
Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial. PMID:28389421
Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial. PMID:28388963
The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial. PMID:28388932
The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial. PMID:28376921
Smokers making a quit attempt using e-cigarettes with or without nicotine or prescription nicotine replacement therapy: Impact on cardiovascular function (ISME-NRT) - a study protocol. PMID:28376818
Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services. PMID:28372555
Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study. PMID:28348190
Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial. PMID:28327195
A Wellness Mobile Application for Smart Health: Pilot Study Design and Results. PMID:28304332
Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial. PMID:28302179
Worldwide trends in volume and quality of published protocols of randomized controlled trials. PMID:28296925
The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients: study protocol for a randomized controlled trial. PMID:28292331
Identifying opportunities for nature engagement in cancer care practice and design: protocol for four-round modified electronic Delphi. PMID:28274965
Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial. PMID:28274268
Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. PMID:28267469
Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial. PMID:28258048
Telerehabilitation Versus Traditional Care Following Total Hip Replacement: A Randomized Controlled Trial Protocol. PMID:28254734
A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). PMID:28245853
The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. PMID:28241776
Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial. PMID:28237959
Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial. PMID:28231811
Research waste in diagnostic trials: a methods review evaluating the reporting of test-treatment interventions. PMID:28231757
App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial. PMID:28166840
The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. PMID:28166816
The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial. PMID:28166806
The Foot Orthoses versus Hip eXercises (FOHX) trial for patellofemoral pain: a protocol for a randomized clinical trial to determine if foot mobility is associated with better outcomes from foot orthoses. PMID:28138341
Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial. PMID:28132011
Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial. PMID:28129780
Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting. PMID:28122560
NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. PMID:28118856
The impact of torasemide on haemodynamic and neurohormonal stress, and cardiac remodelling in heart failure - TORNADO: a study protocol for a randomized controlled trial. PMID:28114980
Review and publication of protocol submissions to Trials - what have we learned in 10 years? PMID:28114958
Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol. PMID:28100441
Improving Nursing Home Care through Feedback On PerfoRMance Data (INFORM): Protocol for a cluster-randomized trial. PMID:28069045
The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults. PMID:28056906
Evaluation of the effectiveness of an online transition planning program for adolescents on the autism spectrum: trial protocol. PMID:28035240
Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial. PMID:28031039
Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis. PMID:28003294
Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial. PMID:28003177
A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial. PMID:27998295
The PULSAR primary care protocol: a stepped-wedge cluster randomized controlled trial to test a training intervention for general practitioners in recovery-oriented practice to optimize personal recovery in adult patients. PMID:27998277
Participatory organizational intervention for improved use of assistive devices for patient transfer: study protocol for a single-blinded cluster randomized controlled trial. PMID:27998265
The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial. PMID:27993169
Revie ⊕: the influence of a life review intervention including a positive, patient-centered approach towards enhancing the personal dignity of patients with advanced cancer-a study protocol for a feasibility study using a mixed method investigation. PMID:27965878
Survivors of intensive care with type 2 diabetes and the effect of shared care follow-up clinics: study protocol for the SWEET-AS randomised controlled feasibility study. PMID:27965877
Using Specialist Screening Practitioners (SSPs) to increase uptake of the Bowel Scope (Flexible Sigmoidoscopy) Screening Programme: a study protocol for a feasibility single-stage phase II trial. PMID:27965871
Behavioural activation written self-help to improve mood, wellbeing and quality of life in people with dementia supported by informal carers (PROMOTE): a study protocol for a single-arm feasibility study. PMID:27965860
Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. PMID:27965844
Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial. PMID:27965818
A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol. PMID:27965817
Effectiveness of enhanced cognitive behavioral therapy (CBT-E) for eating disorders: study protocol for a randomized controlled trial. PMID:27914473
Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial. PMID:27906034
Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence. PMID:27905916
Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness. PMID:27899400
Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial. PMID:27884165
Fitness and mobility training in patients with Intensive Care Unit-acquired muscle weakness (FITonICU): study protocol for a randomised controlled trial. PMID:27881152
A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial. PMID:27876084
Computed tomography versus invasive coronary angiography: design and methods of the pragmatic randomised multicentre DISCHARGE trial. PMID:27864607
An illness-focused interactive booklet to optimise management and medication for childhood fever and infections in out-of-hours primary care: study protocol for a cluster randomised trial. PMID:27855719
Non-inferiority trials: are they inferior? A systematic review of reporting in major medical journals. PMID:27855102
Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: human papillomavirus self-sampling versus Papanicolaou cytology. PMID:27855089
Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial. PMID:27852717
Evaluating the Efficacy of the "Support for Life" Program for People with Dementia and Their Families and Carers' to Enable Them to Live Well: A Protocol for a Cluster Stepped Wedge Randomized Controlled Trial. PMID:27843893
Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. PMID:27843743
Using reporting guidelines to publish paediatric research. PMID:27831910
The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol. PMID:27821384
Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial. PMID:27821109
Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study. PMID:27782861
Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes. PMID:27716063
Current practices in patient-reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management. PMID:27697875
Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). PMID:27678541
Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial. PMID:27671748
Short time effect of a self-referral to inpatient treatment for patients with severe mental disorders: a randomized controlled trial. PMID:27659102
Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol. PMID:27655263
Guided Act and Feel Indonesia (GAF-ID) - Internet-based behavioral activation intervention for depression in Indonesia: study protocol for a randomized controlled trial. PMID:27639557
Cancer@Work - a nurse-led, stepped-care, e-health intervention to enhance the return to work of patients with cancer: study protocol for a randomized controlled trial. PMID:27634549
Effect of exercise-based management on multidirectional instability of the glenohumeral joint: a pilot randomised controlled trial protocol. PMID:27619831
Self-management interventions to improve skin care for pressure ulcer prevention in people with spinal cord injuries: a systematic review protocol. PMID:27600153
SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol. PMID:27596569
EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial. PMID:27596486
The effects of being habitually barefoot on foot mechanics and motor performance in children and adolescents aged 6-18 years: study protocol for a multicenter cross-sectional study (Barefoot LIFE project). PMID:27594919
The paradox of sham therapy and placebo effect in osteopathy: A systematic review. PMID:27583913
Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial. PMID:27561822
OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain. Trial protocol. PMID:27558901
An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial. PMID:27544428
Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial. PMID:27534856
A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial. PMID:27534747
Work-related medical rehabilitation in patients with musculoskeletal disorders: the protocol of a propensity score matched effectiveness study (EVA-WMR, DRKS00009780). PMID:27534527
One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial. PMID:27527342
New method of preoxygenation for orotracheal intubation in patients with hypoxaemic acute respiratory failure in the intensive care unit, non-invasive ventilation combined with apnoeic oxygenation by high flow nasal oxygen: the randomised OPTINIV study protocol. PMID:27519921
Prediction of cardiovascular outcomes by imaging coronary atherosclerosis. PMID:27500091
European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. PMID:27488181
The beneficial effects of cognitive training with simple calculation and reading aloud in an elderly postsurgical population: study protocol for a randomized controlled trial. PMID:27484173
Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial. PMID:27473256
Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials. PMID:27462835
Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial. PMID:27456976
Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial. PMID:27456342
The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial. PMID:27455960
Study protocol of the CAREST-trial: a randomised controlled trial on the (cost-) effectiveness of a CBT-based online self-help training for fear of cancer recurrence in women with curatively treated breast cancer. PMID:27455846
SPIRIT 2013 Statement: defining standard protocol items for clinical trials. PMID:27440100
A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol. PMID:27422639
Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting. PMID:27412105
Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial. PMID:27405522
Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial. PMID:27389248
Pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy. PMID:27388039
Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PMID:27352244
Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial. PMID:27350131
High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial. PMID:27342073
How Well Do Randomized Controlled Trials Reflect Standard Care: A Comparison between Scientific Research Data and Standard Care Data in Patients with Intermittent Claudication undergoing Supervised Exercise Therapy. PMID:27336741
Study protocol for a pilot, randomised, double-blinded, placebo controlled trial of perineural local anaesthetics and steroids for chronic post-traumatic neuropathic pain in the ankle and foot: the PREPLANS study. PMID:27334885
Efficacy and safety of Yirui capsule in patients with hyperlipidemia: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. PMID:27316679
Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial. PMID:27311914
The effect of fines on nonattendance in public hospital outpatient clinics: study protocol for a randomized controlled trial. PMID:27296439
The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols. PMID:27294435
Reporting behaviour change interventions: do the behaviour change technique taxonomy v1, and training in its use, improve the quality of intervention descriptions? PMID:27268131
Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a methodological systematic review. PMID:27259528
Efficacy of live feedback to improve objectively monitored compliance to prescribed, home-based, exercise therapy-dosage in 15 to 19 year old adolescents with patellofemoral pain- a study protocol of a randomized controlled superiority trial (The XRCISE-AS-INSTRUcted-1 trial). PMID:27250984
BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial. PMID:27250730
Protocol for a pragmatic cluster randomised controlled trial for reducing irrational antibiotic prescribing among children with upper respiratory infections in rural China. PMID:27235297
Qualitative study investigating the commissioning process for older people's services provided by third sector organisations: SOPRANO study protocol. PMID:27194316
The evaluation of three treatments for plantar callus: a three-armed randomised, comparative trial using biophysical outcome measures. PMID:27189190
Using the TIDieR Checklist to Standardize the Description of a Functional Strength Training Intervention for the Upper Limb After Stroke. PMID:27187925
Dealing with daily challenges in dementia (deal-id study): effectiveness of the experience sampling method intervention 'Partner in Sight' for spousal caregivers of people with dementia: design of a randomized controlled trial. PMID:27169811
Standing up in multiple sclerosis (SUMS): protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis. PMID:27149954
Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial. PMID:27142588
Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. PMID:27075841
Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial. PMID:27068582
Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial. PMID:27068478
A comparison of methods to adjust for continuous covariates in the analysis of randomised trials. PMID:27068456
How Well Is Quality Improvement Described in the Perioperative Care Literature? A Systematic Review. PMID:27066922
The efficacy of continuous-flow cryo and cyclic compression therapy after hip fracture surgery on postoperative pain: design of a prospective, open-label, parallel, multicenter, randomized controlled, clinical trial. PMID:27059990
CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. PMID:27059469
NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in children aged 2-4 years. PMID:27053273
Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. PMID:27044576
Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial). PMID:27039381
Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial. PMID:27038786
Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. PMID:27029775
Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol. PMID:27012938
Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial. PMID:27006007
Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial. PMID:27005901
The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial. PMID:27004517
Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial. PMID:26965165
Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial. PMID:26944938
Improving the relevance and consistency of outcomes in comparative effectiveness research. PMID:26930385
Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial. PMID:26927298
Evidence regarding patient compliance with incentive spirometry interventions after cardiac, thoracic and abdominal surgeries: A systematic literature review. PMID:26909010
Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial. PMID:26887958
Better plans and more powerful evidence are needed in the research and treatment of chronic hepatitis B in China. PMID:26885177
Physical therapy aimed at self-management versus usual care physical therapy after hip arthroscopy for femoroacetabular impingement: study protocol for a randomized controlled trial. PMID:26883504
Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial. PMID:26869015
Efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule on primary insomnia: study protocol for a randomised controlled trial. PMID:26839010
Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. PMID:26811365
Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS). PMID:26801470
Sequential learning of psychomotor and visuospatial skills for laparoscopic suturing and knot tying - study protocol for a randomized controlled trial "The shoebox study". PMID:26739331
Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guide. PMID:26719310
Remote ischemic preconditioning in the prevention of ischemic brain damage during intracranial aneurysm treatment (RIPAT): study protocol for a randomized controlled trial. PMID:26714784
McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. PMID:26700287
Early versus delayed erythropoietin for the anaemia of end-stage kidney disease. PMID:26671531
The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma. PMID:26651333
A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial. PMID:26643072
Mitigating aflatoxin exposure to improve child growth in Eastern Kenya: study protocol for a randomized controlled trial. PMID:26634701
Leukoreduction for the prevention of adverse reactions from allogeneic blood transfusion. PMID:26633306
Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial. PMID:26628268
Methodology guideline for clinical studies investigating traditional Chinese medicine and integrative medicine: executive summary. PMID:26615617
Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology. PMID:26581079
Using an eHealth Intervention to Stimulate Health Behavior for the Prevention of Cognitive Decline in Dutch Adults: A Study Protocol for the Brain Aging Monitor. PMID:26554496
Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial. PMID:26542104
Tecla: a telephone- and text-message based telemedical concept for patients with severe mental health disorders--study protocol for a controlled, randomized, study. PMID:26537570
Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial. PMID:26525422
Growth factors for treating diabetic foot ulcers. PMID:26509249
Comparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): study protocol for a randomised controlled trial. PMID:26489661
Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. PMID:26474867
Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial. PMID:26458896
Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. PMID:26408831
Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial. PMID:26399571
Four Proposals to Help Improve the Medical Research Literature. PMID:26393914
Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. PMID:26374430
Study protocol for a multicenter investigation of reablement in Norway. PMID:26374305
The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection. PMID:26373406
Risk of selection bias in randomised trials. PMID:26357929
Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial. PMID:26350480
Interventions in randomised controlled trials in surgery: issues to consider during trial design. PMID:26337522
Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke)-study protocol for a randomized, controlled trial. PMID:26311325
Development of a universal approach to increase physical activity among adolescents: the GoActive intervention. PMID:26307618
Prophylactic lidocaine for myocardial infarction. PMID:26295202
Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study. PMID:26289560
Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration. PMID:26287998
Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial. PMID:26286147
The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency. PMID:26242226
The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. PMID:26215666
Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial. PMID:26169781
Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial. PMID:26159834
A youth-led social marketing intervention to encourage healthy lifestyles, the EYTO (European Youth Tackling Obesity) project: a cluster randomised controlled0 trial in Catalonia, Spain. PMID:26137843
Treatment for disseminated intravascular coagulation in patients with acute and chronic leukemia. PMID:26107113
Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial. PMID:26093636
Intraoperative blood loss, postoperative drainage, and recovery in patients undergoing lumbar spinal surgery. PMID:26091671
Antifibrinolytic amino acids for upper gastrointestinal bleeding in people with acute or chronic liver disease. PMID:26058965
Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases. PMID:26058964
Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial. PMID:26040644
Minimum reporting standards for clinical research on groin pain in athletes. PMID:26031644
Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial. PMID:26016697
Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. PMID:26001844
Outcome discrepancies and selective reporting: impacting the leading journals? PMID:25996928
Core outcome sets and trial registries. PMID:25971905
Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). PMID:25935741
Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making. PMID:25910987
The acute effect of beta-guanidinopropionic acid versus creatine or placebo in healthy men (ABC Trial): study protocol for a randomized controlled trial. PMID:25888414
A person-centred approach to health promotion for persons 70+ who have migrated to Sweden: promoting aging migrants' capabilities implementation and RCT study protocol. PMID:25887506
An informed shared decision making programme on the prevention of myocardial infarction for patients with type 2 diabetes in primary care: protocol of a cluster randomised, controlled trial. PMID:25887378
Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. PMID:25887302
Reducing suicidal thoughts in the Australian general population through web-based self-help: study protocol for a randomized controlled trial. PMID:25886941
A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial. PMID:25886009
The "Happy Heart" educational program for changes in health habits in children and their families: protocol for a randomized clinical trial. PMID:25885095
Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. PMID:25882712
Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial. PMID:25873338
A living document: reincarnating the research article. PMID:25873052
Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial. PMID:25873050
Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial. PMID:25872666
Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial. PMID:25872529
Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. PMID:25829373
The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting. PMID:25805530
Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial. PMID:25768800
Antibiotics for treating acute chest syndrome in people with sickle cell disease. PMID:25749695
Quality assurance of drugs used in clinical trials: proposal for adapting guidelines. PMID:25716700
NEWTON: Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage. PMID:25678453
The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial. PMID:25623388
A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial. PMID:25622524
The natural history of conducting and reporting clinical trials: interviews with trialists. PMID:25619208
Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. PMID:25554246
Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial). PMID:25543688
Reablement in community-dwelling adults: study protocol for a randomised controlled trial. PMID:25519828
The remote exercise monitoring trial for exercise-based cardiac rehabilitation (REMOTE-CR): a randomised controlled trial protocol. PMID:25432467
Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials. PMID:25416527
The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial). PMID:25399048
Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial. PMID:25359307
Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers. PMID:25333995
Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PMID:25333349
Protocol for a randomized controlled clinical trial investigating the effectiveness of Fast muscle Activation and Stepping Training (FAST) for improving balance and mobility in sub-acute stroke. PMID:25300433
Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study. PMID:25270861
Linked publications from a single trial: a thread of evidence. PMID:25248292
'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial. PMID:25240737
Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol. PMID:25209897
Describing methods and interventions: a protocol for the systematic analysis of the perioperative quality improvement literature. PMID:25193066
A pilot double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART): study protocol. PMID:25180056
ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial. PMID:25141850
Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial. PMID:25073881
The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial. PMID:25047001
Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. PMID:25030633
Five questions that need answering when considering the design of clinical trials. PMID:25027292
The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial. PMID:24943277
Choosing important health outcomes for comparative effectiveness research: a systematic review. PMID:24932522
Antibody induction versus placebo, no induction, or another type of antibody induction for liver transplant recipients. PMID:24901467
Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. PMID:24886555
Supported cognitive-behavioural self-help versus treatment-as-usual for depressed informal carers of stroke survivors (CEDArS): study protocol for a feasibility randomized controlled trial. PMID:24886151
A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc). PMID:24886116
Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial. PMID:24885779
IMPOSE (IMProving Outcomes after Sepsis)-the effect of a multidisciplinary follow-up service on health-related quality of life in patients postsepsis syndromes-a double-blinded randomised controlled trial: protocol. PMID:24861549
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. PMID:24755011
Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study. PMID:24712304
Formal education of patients about to undergo laparoscopic cholecystectomy. PMID:24585482
The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability. PMID:24533890
DO IT Trial: vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial. PMID:24506910
Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care. PMID:24491134
The quality of registration of clinical trials: still a problem. PMID:24427293
Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. PMID:24383441
Antiviral interventions for liver transplant patients with recurrent graft infection due to hepatitis C virus. PMID:24307460
Bladder pain syndrome: validation of simple tests for diagnosis in women with chronic pelvic pain: BRaVADO study protocol. PMID:24304546
Evidence for compliance with long-term medication: a systematic review of randomised controlled trials. PMID:24293307
Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]. PMID:24274589
Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia. PMID:24267010
Ethical and scientific aspects of research publications. PMID:24250138
The Ontology of Clinical Research (OCRe): an informatics foundation for the science of clinical research. PMID:24239612
Automated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF)--an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial. PMID:24220602
Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). PMID:24195916
Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial. PMID:24180235
Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial. PMID:24171941
Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. PMID:24152537
An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial. PMID:24138325
Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists. PMID:24124580
Inverse probability weighting for covariate adjustment in randomized studies. PMID:24038458
Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. PMID:24021722
Protocol for CONSORT-SPI: an extension for social and psychological interventions. PMID:24004579
Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial). PMID:23978275
Author's reply to Shrier: "Publication bias, with a focus on psychiatry: causes and solutions". PMID:23907702
'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial. PMID:23870501
Practices and impact of primary outcome adjustment in randomized controlled trials: meta-epidemiologic study. PMID:23851720
PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial. PMID:23845078
Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial. PMID:23837630
The effects of a multisite aerobic exercise intervention on asthma morbidity in sedentary adults with asthma: the Ex-asthma study randomised controlled trial protocol. PMID:23794569
RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial. PMID:23786716
Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial. PMID:23782520
Restoring invisible and abandoned trials: a call for people to publish the findings. PMID:23766480
Publication bias, with a focus on psychiatry: causes and solutions. PMID:23696308
Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review. PMID:23560103
Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. PMID:23474796
SPIRIT 2013 statement: defining standard protocol items for clinical trials. PMID:23295957

More to explore:

1/20

Previous Next

Need help integrating and/or managing biomedical data?

Webpage:

Licence:

More to explore:

1/20

CLIPS

Novartis Clinical Trial Results Database

Epoch Clinical Trial Ontology

Protocol Registration Data Element Definitions

REporting recommendations for tumour MARKer prognostic studies

Chinese Clinical Trial Registry

EU Clinical Trial Register

Reporting guidElines For randomized controLled trials for livEstoCk and food safeTy

Preferred Reporting Items for Systematic reviews and Meta-Analyses

BACPAC Biobehavioral Research Psychosocial Questionnaires and QST Recommendations

Template for Intervention Description and Replication

CDISC Protocol Representation Model

Zentrum für Klinische Studien der Universität zu Köln

Deutsches Register Klinischer Studien

CONSOlidated standards of Reporting Trials

International Clinical Trials Registry Platform

EORTC clinical trials

Cardamon Clinical Trial Samples

Clinical Trials Ontology

CONSOlidated Standards of Reporting Trials - Official Extensions