Trials

Article	Citations
Intensive smoking cessation treatment as an adjunct to concurrent psychotherapy: study protocol for a randomized controlled trial	111
Rationale and design of a large trial of perioperative ketamine for prevention of chronic post-surgical pain	68
Effect of different feeding methods on gastrointestinal function in critical patients (DFM-GFC): study protocol for a randomized controlled trial	64
Lisbon Intensive Falls Trampoline Training (LIFTT) Program for people with Parkinson’s for balance, gait, and falls: study protocol for a randomized controlled trial	59
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer	56
A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease	56
PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy	53
Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial	52
Can TElemedicine system replace doctor consultations to Achieve non-inferior blood pressure in patients with Controlled Hypertension (TEACH)? Study protocol for a randomised controlled trial	47
High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery (PPULS)—a non-inferiority, multicenter, randomized, controlled trial	47
Parent-guided home skin care for infants via a WeChat platform: a study protocol for a cluster randomized controlled trial	43
The effect of educational intervention based on the mobile application on women’s knowledge, attitude, and practice on microplastics and health: study protocol for a randomized controlled trial	41
Evaluating primary suicide prevention in adolescents with risk factors (ESPAIR): study protocol for a cluster-randomized controlled trial	41
Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?	40
Promoting mental health and wellbeing among post-secondary students with the JoyPop™ app: study protocol for a randomized controlled trial	36
Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery:	35
Using web-based CBT-I to improve sleep to prevent depression and anxiety in adolescents at high risk: a randomized controlled trial protocol	35
Evaluation of a nurse-led program for the prevention of complications of long-term glucocorticoids (COCORTICO): study protocol for a randomized trial	35
The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery:	35
Effect of esketamine on postoperative quality of recovery in patients undergoing arthroscopic rotator cuff repair: protocol for a prospective, randomized, double-blind study	35
Disgust-reduction evaluative conditioning (DREC) and brain stimulation in patients with contamination-based obsessive-compulsive disorder: a protocol for a randomized control trial	34
The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)	32
Art-based beauty appreciation intervention in young adults: protocol for a two-arm active control mixed-method randomised controlled trial (ABBA-Vention)	32
40-Hz sensory stimulation-induced gamma oscillations enhancing brain network connectivity to improve poststroke cognitive impairment: study protocol for a prospective randomized controlled trial in Ch	32
Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT)	31

Early childhood intervention for children at risk of developmental disabilities and their caregivers in Rwanda: study protocol for the PDC/Baby Ubuntu cluster randomised trial	31
Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial	31
Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized c	31
Correction: The clinical evaluation of electroacupuncture combined with mindfulness meditation for overweight and obesity: study protocol for a randomized sham-controlled clinical trial	30
Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study)	30
Effect of ultrasound-guided continuous erector spinae plane block on postoperative pain and inflammatory response in patients undergoing modified radical mastectomy for breast cancer: study protocol f	29
Correction: Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection	29
Correction: Development of a core outcome set for the assessment of spasticity in adults: a study protocol	29
Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals	28
Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial	28
Early endovascular intervention for unfavorable remodeling of the thoracic aorta after open surgery for acute DeBakey type I aortic dissection: study protocol for a multicenter, randomized, controlled	28
A review of UK publicly funded non-inferiority trials: is the design more inferior than it should be?	27
The effect of coaching on health information literacy in patients with chronic kidney disease: a randomized controlled trial	27
Early oral anti-inflammatory diet in patients with mild acute pancreatitis: study protocol for a randomized controlled trial	26
Effect of intubation in the lateral position under general anesthesia induction on the position of double-lumen tube placement in patients undergoing unilateral video-assisted thoracic surgery: study	26
Digital peer-to-peer support programme for informal caregivers of people living with motor neuron disease: study protocol for a multi-centre parallel group, single-blinded (outcome assessor) randomise	25
The effect of low volume sprint interval training on cardiorespiratory fitness: study protocol for a definitive randomized controlled trial	25
The Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty	25
Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial	25
Enhancement of the haemostatic effect of platelets in the presence of high normal concentrations of von Willebrand factor for critically ill patients needing platelet transfusion—a protocol for the wi	25
A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial	25
Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol	25
Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis	24
HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip	24
Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights	23
Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial	22
Comparison of different intervention methods to reduce the incidence of venous thromboembolism: study protocol for a cluster-randomized, crossover trial	22
Pericardiectomy with routine cardiopulmonary bypass: a multicenter, randomized controlled trial	22
The multiple facets of registry-based randomised controlled trials	22
Evaluating the efficacy and safety of acotiamide in patients with esophagogastric junction outflow obstruction: study protocol for an investigator-initiated, multi-center, randomized, double-blind, pl	22
Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol	22
Preoperative blood flow restriction training combined with postoperative continuous passive motion in elderly patients after total knee arthroplasty: study protocol for a randomized controlled trial	22
RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial	22
Effect of esketamine combined with dexmedetomidine on delirium in sedation for mechanically ventilated ICU patients: protocol for a nested substudy within a randomized controlled trial	22
Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial	21
Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia	21
Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit	21
Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study	21
Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized cont	21
A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial	21
ALCOhol use, Norms, Identities and Motivations-based (ALCONIM) prevention program for binge drinking among college students: a study protocol for a parallel-group randomized controlled trial	21
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure	21
Including patient and public contributors on clinical trial Independent Data Monitoring Committees (IDMCs)	21
The effect of Tribulus terrestris supplementation on inflammation, oxidative stress, and performance of recreational runners: study protocol for a randomized placebo-controlled trial	21
Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge cl	20
Effectiveness of self-management intervention program based on Self-Determination Theory and Solution-Focused Approach in adolescents with inflammatory bowel disease: study protocol for a randomized c	20
Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1)	20
Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter r	20
Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem l	20
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation	20

Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial	20
Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa—a multiphase optimization strategy (MOST) approac	20
Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized trial	20
Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)	20
Effect of pelvic floor muscle training on pelvic floor muscle function and symptoms of dysfunction in women post obstetric anal sphincter injury (OASIS): study protocol for a randomized controlled tri	19
Remote blood pressure monitoring in high risk pregnancy — study protocol for a randomised controlled trial (REMOTE CONTROL trial)	19
Effect of the telemedicine-supported multicomponent exercise therapy in patients with knee osteoarthritis: study protocol for a randomized controlled trial	19
Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW)	19
Impact of model-informed precision dosing in adults receiving vancomycin via continuous infusion: a randomized, controlled clinical trial	19
Study protocol for a multi-center RCT testing a group-based parenting intervention tailored to mothers with borderline personality disorder against a waiting control group (ProChild*-SP1)	19
Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial	19
Early parent-child intervention with Dialogic Book-Sharing: effects on child communicative and socio-emotional development and on parenting. Study protocol for a multicentre randomised controlled tria	19
Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial	19
Partially randomized preference trials in carceral health research: a methodology to advance equity and inclusion	19
BORN study: a multicenter randomized trial investigating cord blood red blood cell transfusions to reduce the severity of retinopathy of prematurity in extremely low gestational age neonates	19
Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial	19
Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals w	19
Assessing the effectiveness and the feasibility of a group-based treatment for self-stigma in people with mental disorders in routine mental health services in North-East Italy: study protocol for a p	19
Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled tr	19
Aerobic exercise as a therapeutic intervention for post-traumatic stress disorder in women who have experienced intimate partner violence: study protocol for an open-label randomised controlled trial	19
Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Côte d’Ivoire: a three group, clus	19
BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy	18
Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department	18
“SPHERE” multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial	18
Effects of monitoring dietary biomarkers and providing vegetable juice on metabolic syndrome components in adults with an overweight or obese body mass index in Ulaanbaatar: a randomized controlled tr	18
Comparison of efficacy of rifaximin, probiotics and l-ornithine l-aspartate in overt hepatic encephalopathy: a randomized, phase IV, lactulose controlled clinical trial	18
How to improve the quality of euglycemic glucose clamp tests in long-acting insulin studies	18
Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial	18
Evaluation of negative binomial and zero-inflated negative binomial models for the analysis of zero-inflated count data: application to the telemedicine for children with medical complexity trial	18
Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronar	18
A qualitative study exploring stakeholders’ perceptions of registry-based randomised controlled trials capacity and capability in Australia	18
Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled tri	18
Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting	18
The efficacy of virtual reality technology for the postoperative rehabilitation of patients with cervical spondylotic myelopathy (CSM): a study protocol for a randomized controlled trial	18
Improving access to family planning for women with disabilities in Kaduna city, Nigeria: study protocol for a pragmatic cluster-randomized controlled trial with integrated process evaluation	18
The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff	18
Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss	17
EaveTubes for control of vector-borne diseases in Côte d’Ivoire: study protocol for a cluster randomized controlled trial	17
The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for multicenter randomized blinded controlled trial	17
The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial	17
MyKid’sNutrition mobile application trial: a randomized controlled trial to promote mothers’ nutritional knowledge and nutritional status of preschool children with undernutrition—a study protocol	17
Comparing the effects of Swiss-ball training and virtual reality training on balance, mobility, and cortical activation in individuals with chronic stroke: study protocol for a multi-center randomized	17
Limitation of site-stratified cox regression analysis in survival data: a cautionary tale of the PANAMO phase III randomized, controlled study in critically ill COVID-19 patients	17
PREVENIR-IVF: study protocol for a prospective multicentre randomized open comparative trial, which explores the efficacy of a multidisciplinary platform reducing and preventing reprotoxic environment	17
Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open	17
Exploring the salivary proteome following intraglandular mesenchymal stromal cell therapy for radiation-induced hyposalivation in previous head and neck cancer patients: a secondary study protocol for	17
ENhancinG vAGinal dElivery in Greece through educational and behavioral interventions among maternity care providers regarding labor management: the ENGAGE stepped-wedge randomized prospective trial p	17
Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children	17
Implementation, mechanisms of change and contextual factors of a complex intervention to improve interprofessional collaboration and the quality of medical care for nursing home residents: study proto	17
The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD	17
Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised co	17
Efficacy of personalized repetitive transcranial magnetic stimulation based on functional reserve to enhance ambulatory function in patients with Parkinson’s disease: study protocol for a randomized c	16
Efficacy of mHealth and education-led peer counseling for patients with hypertension and coronary artery disease in Pakistan: study protocol for a double-blinded pragmatic randomized-controlled trial	16
The clinical efficacy of virtual reality technology based on the mirror neuron theory in upper limb rehabilitation of stroke patients: a protocol for a randomized clinical trial	16
Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery: study protocol for a multicenter randomized controlled trial	16
The effect of exogenous ketone monoester supplementation on cerebral blood flow and functional brain characteristics in adults with subjective cognitive decline: study protocol for a randomized crosso	16
Thoracic paravertebral block for perioperative lung preservation during VATS pulmonary surgery: study protocol of a randomized clinical trial	16
Evaluation of femoral neck fracture migration after internal fixation with an angle stable implant compared with gold standard cannulated cancellous screws in young adults: study protocol for a clinic	16
Base curves of bandage contact lenses and their effects on post Trans-PRK vision and pain: the study protocol for a randomized clinical trial	16
Early Detection Of neovascular age-Related mAcular Degeneration in the cOmmunity assessing persistence, adherence and acceptability: study protocol for the DORADO randomized controlled trial	16
Outdoor nature-based activities for mental vitality and cognitive empowerment in older adults: a randomized controlled trial protocol	16
PRIMA: randomized prospective multicenter non-inferiority study for primary diagnosis of clinically significant PRostate cancer by PSA and MR IMAging—study protocol for a randomized diagnostic accurac	16
Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial	16
A multistage double-blind placebo-controlled study to assess the safety and efficacy of transdermal vitamin D phosphate supplementation (TransVitD)	16
Patient communication and experiences in cancer clinical drug trials: a mixed-method study at a specialist clinical trials unit	16
The effect of remote treatment on medical provider creative thinking and patient disclosure: protocol for the MED-CREATE trial	15
CRYSTALLBrain: crystalloid fluid choice and neurological outcome in patients with non-traumatic subarachnoid haemorrhage—a study protocol for a multi-centre randomised double-blind clinical trial	15
Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trial	15
Goal-directed therapy based on rScO2 monitoring in elderly patients with one-lung ventilation: a randomized trial on perioperative inflammation and postoperative delirium	15
A randomized control trial to support smoke-free policy compliance in public housing	15
Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized	15
Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia	15
Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial	15
Effect of positive event recording based on positive psychology on healthy behaviors and readmission rate of patients after PCI: a study protocol for a prospective, randomized controlled trial	15
Different dosages of vonoprazan for gastroesophageal reflux disease: study protocol for a pragmatic, crossover-cluster, randomized controlled trial with patient preference arms	15
Effect of maternal oxygen supplementation for parturient undergoing elective cesarean section by high-flow nasal oxygen compared with room air on fetal acidemia: study protocol for a randomized contro	15
Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial	15
The effectiveness of the serious game “Broodles” for siblings of children with intellectual disabilities and/or visual impairment: study protocol for a randomized controlled trial	15
Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol	15
Psychosocial stress induction in vivo vs. in virtuo and the influence of a health app on the acute stress reaction in youths: a study protocol for a randomized controlled trial	15

The efficacy of intraoperatie continuous glucose monitoring in patients undergoing liver transplantation: a study protocol for a prospective randomized controlled superiority trial	15
Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial	15
Cognitive training and promoting a healthy lifestyle for individuals with isolated REM sleep behavior disorder: study protocol of the delayed-start randomized controlled trial CogTrAiL-RBD	15
The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research	15
Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a	14
Parenting-STAIR Modular: a randomized controlled trial of a trauma-focused parenting intervention for military-connected mothers and their children	14
Correction: Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-impl	14
SAME day amBulatory Appendectomy (SAMBA): a multicenter, prospective, randomized clinical trial protocol	14
Clinical trials with interim analyses: standardizing terminology to increase clarity	14
Research on the evaluation and rehabilitation training system of upper limb motor function for poststroke patients based on artificial intelligence: a study protocol for a randomized controlled trial	14
NEO-HYPORT: does neoadjuvant radiotherapy improve breast cancer outcomes? An open label, randomised, parallel group, superiority trial to compare the disease-free survival following neoadjuvant versus	14
i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia—study protocol of a cluster randomized controlled trial	14
Automated screening for clinically ascertained loss of cerebral functions in patients with severe brain injury—study protocol for a cluster-randomized interventional trial	14
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (G	14
Why do patients take part in research? An updated overview of systematic reviews of psychosocial barriers and facilitators	14
Effectiveness and adherence to closed face shields in the prevention of COVID-19 transmission: a non-inferiority randomized controlled trial in a middle-income setting (COVPROSHIELD)	14
Early lumbar drainage plus intrathecal urokinase in severe aneurysmal subarachnoid hemorrhage: the LD-ITUK randomized controlled trial protocol	14
Statistical and health economic analysis plan for a secure care hospital evaluation of manualised (interpersonal) art-psychotherapy: the SCHEMA randomized controlled trial	14
The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol	14
High-definition transcranial direct current stimulation (HD-tDCS) as augmentation therapy in late-life depression (LLD) with suboptimal response to treatment—a study protocol for a double-blinded rand	14
Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation (OrcHESTRAS): a protocol for a pragmatic, decentralized, longitudinal, multi-phase, withdrawal with randomized re-treatment	14
A diagnostic randomized controlled trial to validate novel dried blood spot (DBS) based technology for prognosis and screening of leukemia transcripts: study protocol	14
High-flow nasal cannula versus continuous positive airway pressure for initial respiratory support in very preterm infants: study protocol for a multicenter randomized controlled trial (SIMPLSAFE3)	14
Transforming healthcare by prioritizing qualitative and quantitative clinical trial evidence: evaluating the Aging, Community and Health Research Unit’s Community Partnership Program for Older Adults	14
Robot-assisted rehabilitation of people with breast cancer developing upper limb lymphedema: protocol of a randomized controlled trial with a 6-month follow‑up	14
Effectiveness of a blended school-based mindfulness program for the prevention of co-rumination and internalizing problems in Dutch secondary school girls: a cluster randomized controlled trial	14
The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery — study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled	14
Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study	14
Correction: Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized contr	14
CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in ol	14
C5–C6 and thoracic spine mobilization with postural correction exercise compared with conventional therapy in patients with adhesive capsulitis: a two-group, parallel-arm, single-blinded, randomized c	14
Adapting and testing of DeprEnd EMDR therapy for major depressive disorder: a study protocol of mixed method randomized controlled trial	14
Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled cl	14
A double-masked, sham-controlled trial of rose bengal photodynamic therapy for the treatment of fungal and acanthamoeba keratitis: Rose Bengal Electromagnetic Activation with Green Light for Infection	14
Efficacy and safety of SarogLItazar as an add-on medication to Metformin and lifestyle intervention in women with PolyCystic Ovary Syndrome (SLIM-PCOS trial): study protocol for a randomized, open-lab	14
The impact of a weekly antimicrobial stewardship team intervention on antibiotic prescriptions in Dutch nursing homes: a protocol for a randomised controlled trial	13
Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials	13
Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial	13
Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany	13
Little All Children in Focus (Little ACF), evaluation of a parental support program for parents of children aged 1–2 years: study protocol for a randomized controlled trial	13
Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual pr	13
Correction: The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials	13
SurfON trial: study protocol for a multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory	13
TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma p	13
Efficacy of manual acupuncture, electro-acupuncture, and warm acupuncture for knee osteoarthritis: study protocol for a randomized controlled trial	13
Whole genome sequencing of M. tuberculosis for disease control in high-burden settings: study protocol for a cluster randomized controlled trial evaluating different community-wide intervention strate	13
Effectiveness of an 8-week overground walking with paretic lower limb loading on spatiotemporal gait parameters and motor function among chronic stroke survivors: a study protocol for a randomised con	13
The efficacy and safety of combination therapy of repeated low-level red light and defocus-incorporated multiple segments spectacle lenses for myopia control in children: the study protocol for a 12-m	13
Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications	13
Effectiveness and brain mechanism of multi-target transcranial alternating current stimulation (tACS) on motor learning in stroke patients: study protocol for a randomized controlled trial	13
Continuous Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT): study protocol for an adaptive randomised crossover trial comparing the benefits and costs of combining two establishe	13
Bictegravir/emtricitabine/tenofovir alafenamide versus dolutegravir plus lamivudine plus tenofovir disoproxil fumarate in people living with HIV experiencing virologic failure in China: a study protoc	13
Minimum important difference is minimally important in sample size calculations	13
Prospective identification of variables as outcomes for treatment (PIVOT): study protocol for a randomised, placebo-controlled trial of hydroxyurea for Ghanaian children and adults with haemoglobin SC	13
Behavioral parent training interventions to improve health outcomes of preschool children with ADHD symptoms from Chinese disadvantaged families: study protocol for a randomized controlled trial	13
Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised control	13
Intra-articular antibiotic infusions versus intravenous antibiotic administration for infected knee arthroplasty: a study protocol for a randomized multicenter clinical trial	13
Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFE	13
Effectiveness of structured self-evaluation of video recorded performance on peripheral intravenous catheter insertion: a randomised control trial study protocol	13
UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicen	13
Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer—a study protocol for a randomized controlled trial	13
Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery (PAISI)—protocol for a randomized controlled study	13
Optimising a behavioural intervention to support endocrine therapy adherence for women with breast cancer: protocol for the ROSETA optimisation factorial randomised controlled trial	13
Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial	13
Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (	12
Effects of programmed flexor–extensor alternating electrical acupoint stimulation on upper limb motor functional reconstruction after stroke: study protocol for a double-blind, randomized controlled t	12
Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study	12
The effects of aerobic exercise on body composition in overweight and obese patients with gout: a randomized, open-labeled, controlled trial	12
Effect of post-extubation high-flow nasal cannula combined with respiratory training versus conventional oxygen therapy on postoperative pulmonary complications in patients after major abdominal surge	12
Surrogate endpoints in trials: a call for better reporting	12
Towards an understanding of the ethics of electronic consent in clinical trials	12
Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a par	12
Estimating quantile treatment effect on the original scale of the outcome variable: a case study of common cold treatments	12
Effects of high-intensity interval inspiratory muscle training on diaphragm function and quality of life among tracheostomized patients: study protocol for a randomized controlled trial	12
The use of 3D ceramic block graft compared with autogenous block graft for rehabilitation of the atrophic maxilla: a randomized controlled clinical trial	12
Assessing fragility of statistically significant findings from randomized controlled trials assessing pharmacological therapies for opioid use disorders: a systematic review	12
Suture-tape augmentation of anterior cruciate ligament reconstruction: a prospective, randomised controlled trial (STACLR)	12
A multi-component family intervention to lower depression and address intimate partner violence (MILAP) among young married women in Nepal: a study protocol for a randomized controlled trial	12
Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and	12
Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial	12
The multifactorial approach and the food allergen-specific substitutive diet as a tool to manage and ameliorate adverse reactions to foodstuffs in adulthood: study protocol for a randomized controlled	12
Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults—the TAKEOVER study	12
Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial	12
Single-session intervention on growth mindset on negative emotions for university student mental health (U-SIGMA): a protocol of two-armed randomized controlled trial	12
Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)	12
Effects of a physical exercise program on HIF-1α in people with Chronic Obstructive Pulmonary Disease living at high altitude: study protocol for a clinical trial	12
Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis: study protocol for a large European multi-centre randomised controlled trial	12
Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial	12
Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR)	12
Evaluation of randomized controlled trial literature in traditional Chinese medicine: a literature quality assessment system	12
Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial	12
Effectiveness of individualized counseling on the duration of exclusive breastfeeding: study protocol for a multicenter, randomized, parallel, and open clinical trial	12
Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth	11
Community-engaged participatory methods for embedding equity in trial design	11
Determining the effects of targeted high-definition transcranial direct current stimulation on reducing post-stroke upper limb motor impairments—a randomized cross-over study	11