Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial
Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex patho...Trials 2020 21:808Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)
The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptabi...Trials 2020 21:807Correction to: Using qualitative research to explore intervention mechanisms: findings from the trial of the learning together whole-school health intervention
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:806The original article was published in Trials 2020 21:774Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers
Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as p...Trials 2020 21:805A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial
Almost half of people living with HIV (PLWH) in the USA are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physica...Trials 2020 21:804The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial
Every year, many infants are infected with the respiratory syncytial virus (RSV) or other agents and need hospitalisation due to bronchiolitis. The disease causes much suffering and high costs. Thus, it is imp...Trials 2020 21:803Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial
Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two dis...Trials 2020 21:802Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study
Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation tech...Trials 2020 21:801Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial
Exercise has been shown to significantly improve pain and function in individuals with fibromyalgia. Research into the effectiveness of exercise is often based on standardised exercise programmes that are chos...Trials 2020 21:800Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
Objectives: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and morta...Trials 2020 21:799Patient and healthcare professional experiences of the Salford Lung Studies: qualitative insights for future effectiveness trials
Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved u...Trials 2020 21:798Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY)
Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant propo...Trials 2020 21:797Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current...Trials 2020 21:796Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial
Osteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. Th...Trials 2020 21:795Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial
In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6...Trials 2020 21:794Long-term physical activity on prescription intervention for patients with insufficient physical activity level—a randomized controlled trial
Physical activity (PA) can be used to prevent and treat diseases. In Sweden, licensed healthcare professionals use PA on prescription (PAP) to support patients to increase their PA level. The aim of this rando...Trials 2020 21:793Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial
Cancer survivors experience compromised quality of life due to impaired cognitive function as a result of cancer diagnosis and treatment. Although exercise has proven to be effective in improving cognitive fun...Trials 2020 21:792The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion—study protocol for a randomized controlled trial
Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgica...Trials 2020 21:791Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial
We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients ...Trials 2020 21:790Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement—study protocol for a randomized controlled trial
Engagement in activities meaningful to the individual may support the process of recovery in those with mental illness. Persons with psychiatric disabilities may reduce their engagement in meaningful activitie...Trials 2020 21:789Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial
Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture ...Trials 2020 21:788A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial
To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC.Trials 2020 21:787An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial
Despite the enormous investment governments allocate to fight obesity, its worldwide prevalence is still on the rise. Moreover, the majority of the programs implemented are still targeting adults struggling wi...Trials 2020 21:786A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive p...Trials 2020 21:785
It is unprecedented: trial management during the COVID-19 pandemic and beyond
The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporari...Trials 2020 21:784Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)
Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and o...Trials 2020 21:783VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures
Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing techn...Trials 2020 21:782Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial
This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (...Trials 2020 21:781High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China
The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant a...Trials 2020 21:780Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high resea...Trials 2020 21:779Correction to: Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:778The original article was published in Trials 2020 21:530
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