Trials

Article	Citations
Intensive smoking cessation treatment as an adjunct to concurrent psychotherapy: study protocol for a randomized controlled trial	106
Rationale and design of a large trial of perioperative ketamine for prevention of chronic post-surgical pain	66
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	62
Effect of different feeding methods on gastrointestinal function in critical patients (DFM-GFC): study protocol for a randomized controlled trial	59
Lisbon Intensive Falls Trampoline Training (LIFTT) Program for people with Parkinson’s for balance, gait, and falls: study protocol for a randomized controlled trial	56
Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial	55
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	54
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer	52
PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy	52
Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial	48
A self-efficacy-enhancing physical activity intervention in women with high-risk factors for gestational diabetes mellitus: study protocol for a randomized clinical trial	47
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	46
High versus low pneumoperitoneum PressUre for parenchymal transection in minimally invasive major liver surgery (PPULS)—a non-inferiority, multicenter, randomized, controlled trial	46
Parent-guided home skin care for infants via a WeChat platform: a study protocol for a cluster randomized controlled trial	41
Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial	40
Evaluating primary suicide prevention in adolescents with risk factors (ESPAIR): study protocol for a cluster-randomized controlled trial	40
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	39
Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?	39
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
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:	34
Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department	34
Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW)	34
Using web-based CBT-I to improve sleep to prevent depression and anxiety in adolescents at high risk: a randomized controlled trial protocol	33

Disgust-reduction evaluative conditioning (DREC) and brain stimulation in patients with contamination-based obsessive-compulsive disorder: a protocol for a randomized control trial	33
Effect of esketamine on postoperative quality of recovery in patients undergoing arthroscopic rotator cuff repair: protocol for a prospective, randomized, double-blind study	33
The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)	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	31
Art-based beauty appreciation intervention in young adults: protocol for a two-arm active control mixed-method randomised controlled trial (ABBA-Vention)	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
Australasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopi	30
Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial	30
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	30
Correction: The clinical evaluation of electroacupuncture combined with mindfulness meditation for overweight and obesity: study protocol for a randomized sham-controlled clinical trial	29
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)	29
Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT)	29
Correction: Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection	28
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	27
Correction: Development of a core outcome set for the assessment of spasticity in adults: a study protocol	27
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	27
Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals	26
Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial	26
“SPHERE” multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial	26
The effect of coaching on health information literacy in patients with chronic kidney disease: a randomized controlled trial	26
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	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	25
Early oral anti-inflammatory diet in patients with mild acute pancreatitis: study protocol for a randomized controlled trial	25
Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial	25
A review of UK publicly funded non-inferiority trials: is the design more inferior than it should be?	25
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	24
The Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty	24
Remote blood pressure monitoring in high risk pregnancy — study protocol for a randomised controlled trial (REMOTE CONTROL trial)	24
A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial	24
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)	23
Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting	23
Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial	22
The effect of low volume sprint interval training on cardiorespiratory fitness: study protocol for a definitive randomized controlled trial	22
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	22
Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol	22
Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis	21
Pericardiectomy with routine cardiopulmonary bypass: a multicenter, randomized controlled trial	21
Comparison of different intervention methods to reduce the incidence of venous thromboembolism: study protocol for a cluster-randomized, crossover trial	21
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	21
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	21
The multiple facets of registry-based randomised controlled trials	21
Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol	21
Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial	21
Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights	21
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	21
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	21
Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial	21
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	20
Including patient and public contributors on clinical trial Independent Data Monitoring Committees (IDMCs)	20
Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial	20

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	20
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	20
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	20
Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study	20
Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia	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
Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit	20
The effect of Tribulus terrestris supplementation on inflammation, oxidative stress, and performance of recreational runners: study protocol for a randomized placebo-controlled trial	20
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	20
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	20
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure	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
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	19
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	19
Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized trial	19
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	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
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	19
Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial	19
Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1)	18
Impact of model-informed precision dosing in adults receiving vancomycin via continuous infusion: a randomized, controlled clinical trial	18
Effect of the telemedicine-supported multicomponent exercise therapy in patients with knee osteoarthritis: study protocol for a randomized controlled trial	18
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	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
BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy	18
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation	18
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	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
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
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
Comparison of efficacy of rifaximin, probiotics and l-ornithine l-aspartate in overt hepatic encephalopathy: a randomized, phase IV, lactulose controlled clinical trial	18
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	18
Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)	18
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	18
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	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
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
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
EaveTubes for control of vector-borne diseases in Côte d’Ivoire: study protocol for a cluster randomized controlled trial	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
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	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
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
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
How to improve the quality of euglycemic glucose clamp tests in long-acting insulin studies	17
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
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	16
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	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
Intra-articular antibiotic infusions versus intravenous antibiotic administration for infected knee arthroplasty: a study protocol for a randomized multicenter clinical trial	16
A multistage double-blind placebo-controlled study to assess the safety and efficacy of transdermal vitamin D phosphate supplementation (TransVitD)	16
Robot-assisted rehabilitation of people with breast cancer developing upper limb lymphedema: protocol of a randomized controlled trial with a 6-month follow‑up	16
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	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
Patient communication and experiences in cancer clinical drug trials: a mixed-method study at a specialist clinical trials unit	16
Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery: study protocol for a multicenter randomized controlled trial	16
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	16
Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled 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
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	16
Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery (PAISI)—protocol for a randomized controlled study	15
Different dosages of vonoprazan for gastroesophageal reflux disease: study protocol for a pragmatic, crossover-cluster, randomized controlled trial with patient preference arms	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
UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicen	15
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	15
i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia—study protocol of a cluster randomized controlled trial	15
Circular stapled end colostomy versus conventional end colostomy creation in patients undergoing a permanent stoma: a randomized controlled trial	15
Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia	15
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	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
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	15
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	15
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	15
The effect of remote treatment on medical provider creative thinking and patient disclosure: protocol for the MED-CREATE trial	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	15

The efficacy of intraoperatie continuous glucose monitoring in patients undergoing liver transplantation: a study protocol for a prospective randomized controlled superiority trial	15
Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications	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
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	15
Thoracic paravertebral block for perioperative lung preservation during VATS pulmonary surgery: study protocol of a randomized clinical 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
Outdoor nature-based activities for mental vitality and cognitive empowerment in older adults: a randomized controlled trial protocol	15
Study protocol for a pragmatic, cluster, randomized controlled trial of a multifaceted fracture prevention model for long-term care: the PREVENT trial	14
Why do patients take part in research? An updated overview of systematic reviews of psychosocial barriers and facilitators	14
Goal-directed therapy based on rScO2 monitoring in elderly patients with one-lung ventilation: a randomized trial on perioperative inflammation and postoperative delirium	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
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	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
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	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
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
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
The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research	14
A randomized control trial to support smoke-free policy compliance in public housing	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
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	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
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	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
Clinical trials with interim analyses: standardizing terminology to increase clarity	14
Adapting and testing of DeprEnd EMDR therapy for major depressive disorder: a study protocol of mixed method randomized controlled trial	14
Effectiveness of structured self-evaluation of video recorded performance on peripheral intravenous catheter insertion: a randomised control trial study protocol	14
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	14
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	14
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	14
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	14
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	14
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	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
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
Optimising a behavioural intervention to support endocrine therapy adherence for women with breast cancer: protocol for the ROSETA optimisation factorial randomised 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	13
Statistical and health economic analysis plan for a secure care hospital evaluation of manualised (interpersonal) art-psychotherapy: the SCHEMA randomized controlled trial	13
Parenting-STAIR Modular: a randomized controlled trial of a trauma-focused parenting intervention for military-connected mothers and their children	13
Correction: The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials	13
Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials	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
Effect of inulin supplementation on clinical symptoms, inflammatory and oxidative stress markers in women with migraine: study protocol for a randomized clinical trial	13
Mixed-methods process evaluation of the “Karl-Heinz” cardiac prehabilitation program in older patients: protocol for the PRECOVERY trial	13
Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within	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
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	13
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	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
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)	13
SAME day amBulatory Appendectomy (SAMBA): a multicenter, prospective, randomized clinical trial protocol	13
Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer—a study protocol for a randomized controlled trial	13
A randomised controlled trial in preterm infants comparing prophylactic with selective “less invasive surfactant administration” (pro.LISA)	13
Implementation and evaluation of a navigation program for people with cancer in old age and their family caregivers: study protocol for the EU NAVIGATE International Pragmatic Randomized Controlled Tr	13
Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial	13
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	13
Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys	13
A randomized, placebo-controlled, double-blinded trial of MRSA throat carriage treatment, with either standard decolonization alone or in combination with oral clindamycin	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
Early lumbar drainage plus intrathecal urokinase in severe aneurysmal subarachnoid hemorrhage: the LD-ITUK randomized controlled trial protocol	13
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	13
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	13
Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study	13
Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial	13
Rating versus ranking in a Delphi survey: a randomized controlled trial	13
The clinical trial activation process: a case study of an Italian public hospital	13
Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized cont	13
Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial	13
A diagnostic randomized controlled trial to validate novel dried blood spot (DBS) based technology for prognosis and screening of leukemia transcripts: study protocol	13
The effect of an adjunct psychosomatic intervention on perceived pain in patients with musculoskeletal disorders: protocol for a randomized controlled trial	13
Effectiveness of individualized counseling on the duration of exclusive breastfeeding: study protocol for a multicenter, randomized, parallel, and open clinical trial	12
Correction: Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomi	12
Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring v	12
Validation of new diagnostic indices to simplify hyponatremia therapy assessment in patients on thiazide diuretics: study protocol of a randomized, controlled, parallel-group trial (THAT-Study)	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 use of 3D ceramic block graft compared with autogenous block graft for rehabilitation of the atrophic maxilla: a randomized controlled clinical trial	12
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
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
Assessing fragility of statistically significant findings from randomized controlled trials assessing pharmacological therapies for opioid use disorders: a systematic review	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
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	12
The impact of a weekly antimicrobial stewardship team intervention on antibiotic prescriptions in Dutch nursing homes: a protocol for a randomised controlled trial	12
Intubation of obese patients in the operating room with or without facemask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT)	12
Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial	12
Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomiz	12
Suture-tape augmentation of anterior cruciate ligament reconstruction: a prospective, randomised controlled trial (STACLR)	12
Continuous or interrupted suture technique for hepaticojejunostomy during pancreatoduodenectomy (HEKTIK trial): study protocol of a randomized controlled multicenter trial	12
Correction: Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial	12
Study protocol: perinatal mood treatment study	12
Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)	12
Safety and efficacy of camrelizumab combined with radiotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma: a prospective single-arm phase II clinical trial protocol	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
Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol	12
IMI2-PainCare-BioPain-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentad	12