Trials

Article	Citations
Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial	103
Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial	85
Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary byp	70
Design and evaluation of mobile application for adolescents’ self-care: protocol for a randomized controlled field trial	62
Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial	47
Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs	46
An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protoc	46
Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial	44
Comparison of effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of primary dysmenorrhea: a randomized clinical trial	41
Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)	40
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	40
Personalized therapy in rheumatoid arthritis (PETRA): a protocol for a randomized controlled trial to test the effect of a psychological intervention in rheumatoid arthritis	39
Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial	39
Self-guided virtual reality therapy for social anxiety disorder: a study protocol for a randomized controlled trial	37
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)	35
Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial	35
Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial	35
Would high-dose corticosteroid addition to multimodal cocktail periarticular injection contribute to prolonged pain control and better recovery following total knee arthroplasty?: study protocol for a	35
ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial	33
The efficacy and safety of Longmu Tang granule for the treatment of atopic dermatitis: study protocol for a single-centred, double-blinded, randomised, placebo-controlled trial	33
Does interactive ultrasound intervention relieve minor depressive symptoms and increase maternal attachment in pregnancy? A protocol for a randomized controlled trial	33
Statistical analysis of publicly funded cluster randomised controlled trials: a review of the National Institute for Health Research Journals Library	32
Effectiveness of breathing exercises on urinary symptoms, muscle activity, and strength in women with multiple sclerosis and urinary incontinence—a study protocol for a randomized controlled trial stu	32
Twenty-four weeks of combined training in different environments, aquatic and land, in the type 2 diabetes management (Aquatic and Land Exercise for Diabetes -ALED): protocol of a randomized clinical	31
Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial	31

Optimal target blood pressure in elderly with septic shock (OPTPRESS) trial: study protocol for a randomized controlled trial	30
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	29
A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial	29
Study protocol for a randomized controlled trial to improve the quality of life of housewives with musculoskeletal disorders: a health promotion intervention based on a participatory ergonomic approac	27
Efficacy and safety of Tanreqing oral liquid in treatment of acute bronchitis: study protocol for a randomized controlled trial	27
The SME tool supporting employers of small- and medium-sized enterprises during the return to work of employees on long-term sick leave: study protocol for a randomized controlled trial and for a proc	27
The OBS UK Dashboard: an interactive tool for representative trial site selection to facilitate equality and diversity in maternity research	26
Vitamin D combined with whole-body vibration training for the treatment of osteo-sarcopenia: study protocol for a randomized controlled trial	26
Impact of oral azithromycin and intermittent preventive treatment with sulfadoxine-pyrimethamine regimen on child mortality in Sierra Leone: trial protocol for a randomised, two-arm, double-blinded, p	25
Calcium carbonate supplementation for the prevention of preeclampsia in high-risk pregnant women: a randomized clinical trial protocol	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
Improving the continuity and coordination of ambulatory care through feedback and facilitated dialogue—a study protocol for a cluster-randomised trial to evaluate the ACD study (Accountable Care in Ge	24
Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT	24
Nucleos(t)ide analogs to treat patients with positive hepatitis B virus deoxyribonucleic acid and normal alanine transaminase: protocol for an open-label single-center randomized parallel controlled t	24
Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)	24
Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial	23
An intervention to reduce stigma and improve management of depression, risk of suicide/self-harm and other significant emotional or medically unexplained complaints among adolescents living in urban s	23
Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program a	22
Effect of minocycline on the left ventricular function following ST-elevation myocardial infarction treated by primary percutaneous coronary intervention	22
The effect of a parental preparation video (Take5) on child and parent anxiety during anaesthetic induction: a protocol for a randomised controlled trial	22
Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized cli	22
Inclusion of progression criteria in external randomised pilot trials: a cross-sectional study of funding applications submitted to the NIHR Research for Patient Benefit Programme	22
Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava	22
PROPENSIX: pressure garment therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol	22
The INITIATE trial protocol: a randomized controlled trial testing the effectiveness of a “quit card” intervention on long-term abstinence among tobacco smokers presenting to the emergency department	22
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer	21
Effects of small-dose S-ketamine on anesthesia-induced atelectasis in patients undergoing general anesthesia accessed by lung ultrasound: study protocol for a randomized, double-blinded controlled tri	21
Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial	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
Creating a best practice template for participant communication plans in global health clinical studies	21
General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization	21
Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan	21
Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study	21
Effect of traditional Chinese medicine formula Guilu Xian on in vitro fertilization and embryo transfer outcome in older women with low prognosis: study protocol for a prospective, multicenter, random	20
E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized contro	20
Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled	20
Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters	20
A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project	20
Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial	20
Randomized double-blind controlled trial to assess the efficacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol	20
A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment o	20
Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study	19
Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)—efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled cl	19
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	19
An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial	19
Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial	19
Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial	18
Evaluation of the PhunkyFoods intervention on food literacy and cooking skills of children aged 7–9 years: a cluster randomised controlled trial in Yorkshire Primary Schools UK	18
Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or <1000 g birth weight: study protocol	18
Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectivene	18

Effectiveness of promotion and support for physical activity maintenance post total hip arthroplasty—study protocol for a pragmatic, assessor-blinded, randomized controlled trial (the PANORAMA trial)	18
Health Information and Monitoring of Sexually Transmitted Infections (SIM study): a single-center, parallel, three-arm randomized controlled trial protocol for enhancing adherence to syphilis treatmen	18
Comparison of a tube core and Magill forceps for nasotracheal intubation: a randomised controlled trial	18
Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study	17
The ReInvigorate Study—phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial	17
The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis	17
Effects of exercise prehabilitation before anterior cruciate ligament reconstruction on functional outcomes during pre- and postoperative rehabilitation — protocol for a single-blinded randomised cont	17
The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial	17
Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment	17
Effects of a peripherally acting µ-opioid receptor antagonist for the prevention of recurrent acute pancreatitis: study protocol for an investigator-initiated, randomized, placebo-controlled, double-b	17
Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial	17
The AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage	17
Effect of early vs. delayed extubation on functional outcome among patients with acute ischemic stroke treated with endovascular thrombectomy under general anesthesia: the prospective, randomized cont	17
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	16
Anti-infectivity efficacy and pharmacokinetics of WHO recommended single low-dose primaquine in children with acute Plasmodium falciparum in Burkina Faso: study protocol	16
A multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and torque teno virus-guided immunosuppression in kidney transplant recipien	16
Can multisite clinical trial results change clinical practice? Use of long-acting injectable risperidone nationally in the Veterans Health Administration	16
Commentary: an industry perspective on the importance of incorporating participant voice before, during, and after clinical trials	16
N-acetyl-L-leucine for Niemann-Pick type C: a multinational double-blind randomized placebo-controlled crossover study	16
Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE	16
Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia	16
Study on the efficiency of virtual reality in the treatment of alcohol use disorder: study protocol for a randomized controlled trial	16
Acupuncture in diabetic peripheral neuropathy—protocol for the randomized, multicenter ACUDPN trial	15
Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial	15
The impact of different researchers to capture quality of life measures in a dementia randomised controlled trial	15
Effects of robot-assisted upper limb training combined with functional electrical stimulation in stroke patients: study protocol for a randomized controlled trial	15
Comparing conventional treatment, single-target rTMS, or dual-target rTMS for the treatment of post-stroke cognitive impairment — clinical effects and neuroscientific insights: study protocol for a ra	15
The effect of an online acceptance and commitment intervention on the meaning-making process in cancer patients following hematopoietic cell transplantation: study protocol for a randomized controlled	15
Impact of a shared decision-making mHealth tool on caregivers’ team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol o	15
Effectiveness of personalized meal recommendation in improving dietary behaviors of Chinese community-dwelling elders: study protocol for a cluster randomized controlled trial	15
Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery	15
Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool	15
Comparing the effects of smartphone-based and face-to-face pulmonary rehabilitation education on caregiver burden and quality of life among the family caregivers of patients with chronic obstructive p	15
Nutrition-focused group intervention with a strength-based counseling approach for people with clinical depression: a study protocol for the Food for Mind randomized controlled trial	15
DON in pediatric cerebral malaria, a phase I/IIA dose-escalation safety study: study protocol for a clinical trial	15
The effect of an integrated care intervention of multidisciplinary mental health treatment and employment services for trauma-affected refugees: study protocol for a randomised controlled trial	15
Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game	15
Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-cent	15
Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial	15
Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial	15
Effect of ‘hand and foot acupuncture with twelve needles’ on hemiplegia patients with ‘qi deficiency and blood stasis’ syndrome in the convalescent stage of Ischaemic stroke: study protocol for a rand	14
Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial	14
A randomized wait-list controlled trial to investigate the role of cognitive mechanisms in parenting interventions on mothers with substance use disorder	14
Effects of double vs triple injection on block dynamics for ultrasound-guided intertruncal approach to the supraclavicular brachial plexus block in patients undergoing upper limb arteriovenous access	14
Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study)	14
A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease	14
Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences	14
Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy	14
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	14
Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial	14
Overcoming the barriers to better evidence generation from clinical trials	14
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)	14
Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies	14
Brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression during the COVID-19 pandemic: a randomised controlled trial protocol	14
Retention in RCTs of physical rehabilitation for adults with frailty: a systematic review and meta-analysis	14
Telerehabilitation program for older adults on a waiting list for physical therapy after hospital discharge: study protocol for a pragmatic randomized trial protocol	14
PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial	14
Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death	14
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 tr	14
Internet videoconferencing delivered cognitive behavior therapy for generalized anxiety disorder: protocol for a randomized controlled trial	14
Autologous full-thickness skin graft as reinforcement in parastomal hernia repair: a randomised controlled trial	14
Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas—a randomized controlled trial (PRIMA)	14
Effect of denosumab on glucose metabolism in postmenopausal osteoporotic women with prediabetes: a study protocol for a 12-month multicenter, open-label, randomized controlled trial	14
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	14
Impact of a medico-pharmaceutical follow-up and an optimized communication between hospital and community on the readmission to the emergency department for an adverse drug event: URGEIM, study protoc	14
“Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial	14
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 pl	14
Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depressi	13
A randomized, controlled clinical study of low-molecular-weight heparin improving pregnancy outcomes in PCOS women undergoing IVF: study protocol	13
Comparison of different intervention methods to reduce the incidence of venous thromboembolism: study protocol for a cluster-randomized, crossover trial	13
SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial	13
Disgust-reduction evaluative conditioning (DREC) and brain stimulation in patients with contamination-based obsessive-compulsive disorder: a protocol for a randomized control trial	13
COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summa	13
Testing pathways to scale: study protocol for a three-arm randomized controlled trial of a centralized and a decentralized (“Train the Trainers”) dissemination of a mental health program for Kenyan ad	13
The tooth movement efficiency of different orthodontic thermoplastics for clear aligners: study protocol for a randomized controlled clinical trial	13
Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study	13
Nutritional treatment of children 6–59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial	13
Prophylactic use of dural tenting sutures in elective craniotomies in adults—is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-	13
Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol	13
A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study	13

The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial	13
A prospective, single-centre, randomized, double-blind controlled study protocol to study whether long-term oral metronidazole can effectively reduce the incidence of postoperative liver metastasis in	13
Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial)	13
Impact of a recognition package as an incentive to strengthen the motivation, performance, and retention of village health teams in Uganda: a study protocol for a cluster randomized controlled trial	13
Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial	13
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	13
Use of a real-time risk-prediction model to identify pediatric patients at risk for thromboembolic events: study protocol for the Children’s Likelihood Of Thrombosis (CLOT) trial	13
Effects of photobiomodulation on re-epithelialization of burn wound: protocol for a randomized controlled trial	13
Analysis of the relationship between EEG burst suppression and poor prognosis in children under general anaesthesia: study protocol for a prospective, observational, single-centre study	13
Effectiveness and safety of digital rectal stimulation and abdominal massage for neurogenic bowel dysfunction in stroke patients: a randomized controlled trial protocol	13
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	13
Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials	13
Chopstick technique versus cross technique in LESS hysterectomy (CCLEH study): a prospective randomized controlled trial	13
Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial	12
Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance	12
The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial	12
The cost of community research—recruiting community-dwelling participants to a feasibility primary care cluster randomised controlled trial	12
Can we decrease the duration of basal thumb joint distraction for early osteoarthritis from 8 to 6 weeks? Study protocol for a non-inferiority randomized controlled trial	12
SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults—a study protocol for a prospective randomized double-blind multicenter clinical trial	12
Coerced consent in clinical research: study protocol for a randomized controlled trial	12
Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial	12
A framework for handling missing accelerometer outcome data in trials	12
Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial	12
CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry neste	12
Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses	12
The effect of a social network-based cognitive behavioral therapy intervention on the severity of premenstrual syndrome symptoms: a protocol of a randomized clinical trial study	12
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	12
Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial	12
Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?	12
Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK – experience from the ActWELL trial”	12
Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized control	12
Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study	12
Effects of salvianolate on microcirculatory disturbance in patients with stable coronary heart disease: study protocol for a randomized controlled trial	12
Remote blood pressure monitoring in high risk pregnancy — study protocol for a randomised controlled trial (REMOTE CONTROL trial)	12
Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation	12
Hidden blood loss and the influential factors after minimally invasive treatment of posterior pelvic ring injury with sacroiliac screw	12
PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients w	12
Measuring the effectiveness of integrated vector management with targeted outdoor residual spraying and autodissemination devices on the incidence of dengue in urban Malaysia in the iDEM trial (interv	12
Effect of perioperative cognitive behavioural therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: protocol for a double-blinded randomise	12
How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme	12
DMC reports in the 21st century: towards better tools for decision-making	12
When describing harms and benefits to potential trial participants, participant information leaflets are inadequate	12
Effectiveness of referral to a population-level telephone coaching service for improving health risk behaviours in people with a mental health condition: study protocol for a randomised controlled tri	12
The effect of focused lung ultrasonography on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice: study protocol for a pragmatic randomized con	12
Intermittent blood flow restriction with low-load resistance training for older adults with knee osteoarthritis: a randomized, controlled, non-inferiority trial protocol	12
A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolu	12
Dimensional changes of peri-implant tissue following immediate flapless implant placement and provisionalization with or without xenograft in the anterior maxilla: a study protocol for a randomized co	11
A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol	11
Testing the effects of the Shamiri Intervention and its components on anxiety, depression, wellbeing, and academic functioning in Kenyan adolescents: study protocol for a five-arm randomized controlle	11
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	11
The novel effectiveness of Tai Chi on cardiopulmonary fitness among stroke patients in the recovery phase: a study protocol for a randomized controlled trial	11
Mindfulness-based intervention for hypertension patients with depression and/or anxiety in the community: a randomized controlled trial	11
Comparing acute normovolumic hemodilution with autologous platelet-rich plasma for blood preservation during aortic surgery : study protocol for a randomized controlled clinical trial	11
Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial	11
Pulsed electromagnetic fields for post-appendicectomy pain management: a randomized, placebo-controlled trial	11
Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial	11
Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes	11
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	11
The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023	11
Reducing HIV-related stigma among young people attending school in Northern Uganda: study protocol for a participatory arts-based population health intervention and stepped-wedge cluster-randomized tr	11
Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery:	11
Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study	11
Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial	11
Testing an attachment- and trauma-informed intervention approach for parents and young children after interparental violence: protocol for a randomized controlled trial	11
Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities	11
iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol	11
Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional	11
Surgical treatment versus observation in moderate intermittent exotropia (SOMIX): study protocol for a randomized controlled trial	11
Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study proto	11
Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial	11
Comparison of intradialytic neuromuscular electrical stimulation and oral nutritional supplements in hemodialysis patients: study protocol for a multicenter, parallel-group, randomized controlled tria	11
Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial	11
Effectiveness of the holistic primary school-based intervention MindMatters: study protocol for a cluster-randomised controlled trial	11
Securing jugular central venous access devices with dressings fixed to a liquid adhesive in an intensive care unit population: a randomised controlled trial	11
Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol	11
Clinical and healthcare improvement through My Health Record usage and education in general practice (CHIME-GP): a study protocol for a cluster-randomised controlled trial	11
A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depressio	11
Study protocol for a multicenter non-inferiority randomized controlled trial to assess functional outcomes and cost-effectiveness of a primarily non-operative treatment strategy with cast immobilizati	11
Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals	11
Promoting psychological well-being in preschool children: study protocol for a randomized controlled trial of a mindfulness- and yoga-based socio-emotional learning intervention	11
Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST): protocol for a 24-week hybrid type 1 randomised controlled trial of a fully online psycho-educational programme for adults wi	11
Effect of different feeding methods on gastrointestinal function in critical patients (DFM-GFC): study protocol for a randomized controlled trial	11
SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol	11
Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights	11
The effect of switch therapy to tenofovir versus entecavir maintenance on recurrence of hepatocellular carcinoma after surgery (SWITE): study protocol for a randomized controlled trial	11
The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD—study protocol for a randomized controlled non-inferiority trial	11
Trauma-focused treatments for refugee children: study protocol for a randomized controlled trial of the effectiveness of KIDNET versus EMDR therapy versus a waitlist control group (KIEM)	10
General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-	10
Covariate-constrained randomization in cluster randomized 2 × 2 factorial trials: application to a diabetes prevention study	10
An adaptive design to screen, treat, and retain people with opioid use disorders who use methamphetamine in methadone clinics (STAR-OM): study protocol of a clinical trial	10
Immediate effect of manual therapy techniques on the limitation of ankle dorsiflexion: a randomized, controlled, blind clinical trial protocol	10
Effects of a remotely supervised physical training program combined with cognitive training for older individuals at increased risk of clinical-functional vulnerability: study protocol for a randomize	10
Move-PCD—a multi-center longitudinal randomized controlled superiority trial on the effect of a 6-month individualized supported physical activity (PA) program on quality of life (QoL) in children, ad	10
Assessing the effectiveness of a community health advisor plus screen to save educational intervention on stool-based testing adherence in an African American safety net clinic population: study proto	10
Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine	10