Trials

http://www.trialsjournal.com/

List of Papers (Total 4,076)

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial

Background The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. Methods This proposed study is a single-center, ...

PRONTOX – proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial

Background Primary radiochemotherapy with photons is the standard treatment for locally advanced-stage non-small cell lung cancer (NSCLC) patients. Acute radiation-induced side effects such as oesophagitis and radiation pneumonitis limit patients’ quality of life, and the latter can be potentially life-threatening. Due to its distinct physical characteristics, proton therapy ...

Regional Anesthesia for Painful Injuries after Disasters (RAPID): study protocol for a randomized controlled trial

Background Lower extremity trauma during earthquakes accounts for the largest burden of disaster-related injuries. Insufficient pain management is common in resource-limited disaster settings, and regional anesthesia (RA) may reduce pain in injured patients beyond current standards of care. To date, no controlled trials have been conducted to evaluate the use of RA for pain ...

How can we optimise inhaled beta2 agonist dose as ‘reliever’ medicine for wheezy pre-school children? Study protocol for a randomised controlled trial

Background Asthma is a common problem in children and, if inadequately controlled, may seriously diminish their quality of life. Inhaled short-acting beta2 agonists such as salbutamol are usually prescribed as ‘reliever’ medication to help control day-to-day symptoms such as wheeze. As with many medications currently prescribed for younger children (defined as those aged 2 years ...

Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial

Background Since 1990, the lives of 48 million children under the age of 5 years have been saved because of increased investments in reducing child mortality. However, despite these unprecedented gains, 250 million children younger than 5 years in low- and middle-income countries (LMIC) cannot meet their developmental potential due to poverty, poor health and nutrition, and lack of ...

Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial

Background Individuals who are edentulous have a lower intake of fruit, vegetables, fiber, and protein compared with their dentate counterparts because tooth loss is accompanied by a decrease in ability to chew. Whether or not a combination of prosthetic rehabilitation and simple dietary advice produces improvement in dietary intake among edentulous persons is unclear. We aim to ...

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Background Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new ...

Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial

Background Transition-age youth have elevated rates of mental disorders, and they often do not receive services. This is a serious public health concern, as mental health conditions persist into adulthood. Continuing to engage this population has been a pervasive challenge for the mental health care system worldwide. Few mental health interventions have been developed for ...

A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

Background The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. ...

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Background Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course ...

Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial

Background The prevalence of obesity is escalating alarmingly worldwide, and it is now becoming a rapidly growing epidemic in developing countries. Recent studies have reported that zinc has been implicated in altered lipid markers, insulin resistance and some obesity markers. There is a lack of evidence on zinc as a potential therapeutic agent to reduce weight and improve ...

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Background Preliminary clinical studies on the single-implant mandibular overdenture (SIMO) have reported favorable results as an alternative to the conventional complete dentures for rehabilitation of the edentulous mandible. Clinical and patient-reported outcomes were assessed but no evidence is available with respect to the cost-effectiveness of this treatment, which is ...

Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial

Background Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and ...

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial

Background Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and ...

Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial

Background Heart failure (HF) is a common and disabling condition in older people. Randomized clinical trials and meta-analyses have clearly demonstrated that the long-term use of β-Blockers improves the outcome of patients with HF. However, limited data are available on the treatment of older HF patients with preserved ejection fraction (EF). No study has specifically compared the ...

Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial

Background Generalized tonic-clonic seizures (GTCSs) are the main risk factor for sudden unexpected death in epilepsy (SUDEP). Experimental and clinical data strongly suggest that the majority of SUDEP results from a postictal respiratory dysfunction progressing to terminal apnea. Postictal apnea could partly derive from a seizure-induced massive release of endogenous opioids. The ...

The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

Background The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. Methods/design This is a multicenter randomized controlled trial to evaluate the Luminor® ...

Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial

Background Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future ...

High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial

Background About 2–3 % of the population participates in blood donation programmes. Each whole blood donation or ten apheresis donations cause a loss of 200–250 mg of iron. As a result, one of the most common risks of regular blood donors is iron deficiency. Although this has been known for decades, in most countries, iron status is currently not assessed or treated in this ...

Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study

Background Nonpharmacologic interventions, such as cognitive training or physical exercise, are effective in improving cognitive functions for older adults with mild cognitive impairment (MCI). Some researchers have proposed that combining physical exercise with cognitive training may augment the benefits of cognition. However, strong evidence is lacking regarding whether a ...

Factors associated with study attrition in a pilot randomised controlled trial to explore the role of exercise-assisted reduction to stop (EARS) smoking in disadvantaged groups

Background Study attrition has the potential to compromise a trial’s internal and external validity. The aim of the present study was to identify factors associated with participant attrition in a pilot trial of the effectiveness of a novel behavioural support intervention focused on increasing physical activity to reduce smoking, to inform the methods to reduce attrition in a ...

Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial

Background After a lesion to the central nervous system, many patients suffer from reduced walking capability. In the first rehabilitation phase, repeated walking exercises facilitate muscular strength and stimulate brain plasticity and motor relearning. However, marked limping, an unsteady gait, and poor management of obstacle clearance may persist, which increases a patient’s ...

Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial

Background An anti-reflux catheter (ARC) may increase the tumor absorbed dose during radioembolization (RE) by elimination of particle reflux and its effects on hemodynamics. Since the catheter is fixed in a centro-luminal position, it may also increase the predictive accuracy of a scout dose administration before treatment. The purpose of the SIM trial is to compare the effects of ...

Postprandial effect of breakfast glycaemic index on vascular function, glycaemic control and cognitive performance (BGI study): study protocol for a randomised crossover trial

Background Postprandial glycaemic response affects cognitive and vascular function. The acute effect of breakfast glycaemic index on vascular parameters is not sufficiently known. Also, the influence of breakfasts with different glycaemic index on cognitive performance has been mostly studied in children and adolescents with varying results. Therefore, the purpose of this study is ...

Sequential Hybrid CryoMaze Ablation versus Surgical CryoMaze Alone for the Treatment of Atrial Fibrillation (SurHyb): study protocol for a randomized controlled trial

Background Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47–95 %. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high ...