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Safety and efficacy of different rotational speed during rotational atherectomy in coronary heart disease patients (RACE): study protocol for a randomized controlled trial
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Core outcome sets in cancer clinical trials: current status and future opportunities—an EORTC perspective
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What motivates SARS-CoV-2 vaccine trial participants? A pre- and post-participation survey study
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Implementing palliative care in hepatocellular carcinoma ambulatory clinics—study protocol for Accelerated translational research in PRImary liver CAncer (APRICA) randomised controlled palliative care trial
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The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial
Diabetes affects 10.5% of adults globally, with type 2 diabetes accounting for 90–95% of cases. Achieving optimal gl...
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The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulat...
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Effect of nano-curcumin supplementation on cardiometabolic risk factors, physical and psychological quality of life, and depression in patients with coronary slow flow phenomenon: a randomized double-blind clinical trial
Extensive evidence has suggested the cardio-protective properties of the polyphenol curcumin. The aim of this study was to...
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ROBot-assisted physical training of older patients during acUte hospitaliSaTion—study protocol for a randomised controlled trial (ROBUST)
During hospitalisation, older patients spend most of their time passive in bed, which increases the risk of functional dec...
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The clinical trial activation process: a case study of an Italian public hospital
In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the wor...
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Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial
Functional constipation (FC) in children is a common gastrointestinal disorder with a worldwide-pooled prevalence of 9.5%....
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The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT
Accumulated evidence suggests that exercise training exerts beneficial effects on people with congenital heart conditions....
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Reducing sick leave, improving work ability, and quality of life in patients with mild to moderate Long COVID through psychosocial, physiotherapeutic, and nutritive supportive digital intervention (MiLoCoDaS): study protocol for a randomized controlled trial
Following SARS-CoV-2 infection, a relevant proportion of patients suffer from persistent or recurring sequela, eve...
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Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study
The use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of t...
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REVISE: re-evaluating the inhibition of stress erosions in the ICU—statistical analysis plan for a randomized trial
The REVISE (Re-Evaluating the Inhibition of Stress Erosions in the ICU) trial will evaluate the impact of the proton pump ...
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Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression
Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare intervention...
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A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial
The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that...
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Clinical and cost-effectiveness of ‘Live Well with Parkinson’s’ self-management intervention versus treatment as usual for improving quality of life for people with Parkinson’s: study protocol for a randomised controlled trial
The Live Well with Parkinson’s Self-Management Toolkit is designed for use in the NHS to support people with Parkins...
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Multiphase optimization of a multicomponent intervention for informal dementia caregivers: a study protocol
Family caregiver interventions are essential to support dementia caregiving. However, such interventions are typically com...
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A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial
Amyotrophic lateral sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in u...
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Characterization of COVID-19 vaccine clinical trial discussions on the social question-and-answer site Quora
Throughout the COVID-19 pandemic, underserved populations, such as racial and ethnic minorities, were disproportionately i...
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The effect of a helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia: study protocol for a randomized controlled trial
Alopecia is one of the most common adverse effects of chemotherapy. It reduces the patient’s self-esteem and quality...
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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
Antiviral therapy has been reported to be associated with lower recurrence rate of hepatocellular carcinoma (HCC) for pati...
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Effectiveness of m-health-based core strengthening exercise and health education for public safety workers with chronic non-specific low back pain: study protocol for a superiority randomized controlled trial (SAFEBACK)
Low back pain (LBP) is the leading cause of years lived with disability worldwide. Public safety workers are highly expose...
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Different dosages of vonoprazan for gastroesophageal reflux disease: study protocol for a pragmatic, crossover-cluster, randomized controlled trial with patient preference arms
Vonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors....
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Factors influencing the time to ethics and governance approvals for clinical trials: a retrospective cross-sectional survey
The findings from multi-centre trials are central to the practice of evidence-based medicine, enabling the development and...
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Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder—study protocol for a randomized controlled trial
Adjustment problems and disorders are highly prevalent among university students worldwide. These problems can cause signi...
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Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial
Highly effective, short-course, bedaquiline-containing treatment regimens for multidrug-resistant tuberculosis (MDR-TB) an...
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A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial...
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Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate t...
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The effects of Olmesartan/amlodipine administered in the Morning or At Night on nocturnal blood pressure reduction in Chinese patients with mild-moderate essential hypertension (OMAN Trial): study protocol for a prospective, multicenter, randomized, open-label clinical trial {1}
Hypertension increases the risk of cardiovascular disease. Uncontrolled nocturnal blood pressure is prevalent in patients ...
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