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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
Integration of symptom and palliative care for people with advanced cancer is established in many tumour types, but its ro...
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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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