Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): protocol for a feasibility cluster-randomised controlled trial
Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high preva...Trials 2020 21:269Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1)
Physical Activity 4 Everyone (PA4E1) is a physical activity program for secondary schools located in low-socioeconomic areas. Over a 24-month period, schools in the program arm of a cluster randomised controll...Trials 2020 21:268Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol
Coronary heart disease (CHD) is a clinical syndrome caused by coronary atherosclerosis (AS) or functional changes in coronary arteries. We have previously reported that astragaloside IV (in astragalus) and tan...Trials 2020 21:267Efficacy and safety of Shu-gan-qing-re formula for generalized anxiety disorder: study protocol for a multi-center, prospective, double-blind, double-dummy, randomized controlled trial
Generalized anxiety disorder (GAD) is a persistent and common mental disorder that entails significant impairments in role functioning and quality of life. Currently available effective interventions include p...Trials 2020 21:266Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment–Autism (PAT-A©) pilot randomised controlled feasibility trial
Anxiety is common in autistic adults and significantly limits everyday opportunities and quality of life. Evidence-based psychological therapies offered by mental health services often fail to meet the needs o...Trials 2020 21:265Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial
Knee osteoarthritis (KOA) is a chronic disease with symptoms of persistent pain or resting pain, joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and eff...Trials 2020 21:264Transcranial direct current stimulation (tDCS) as an intervention to improve empathic abilities and reduce violent behavior in forensic offenders: study protocol for a randomized controlled trial
Recent studies show that changes in one of the brain areas related to empathic abilities (i.e. the ventromedial prefrontal cortex (vmPFC)) plays an important role in violent behavior in abusers of alcohol and ...Trials 2020 21:263Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review
Neonatal withdrawal secondary to in utero opioid exposure is a growing global concern stressing the psychosocial well-being of affected families and scarce hospital resources. In the ongoing search for the mos...Trials 2020 21:262Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial
Insomnia is a global disease with a high incidence and acupuncture therapy is a well appropriate method to treat insomnia. Shenmen (HT 7) and Sanyinjiao (SP 6) are the acupoints most commonly used to treat ins...Trials 2020 21:261A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)
In preclinical models, recombinant human relaxin-2 (serelaxin) had anti-fibrotic effects and ameliorated portal hypertension (PH). A small exploratory study in patients with cirrhosis also suggested that serel...Trials 2020 21:260Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators
Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants o...Trials 2020 21:259CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa
South Africa is home to the world’s largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Populati...Trials 2020 21:258Correction to: 3D vs. 4 K Display System - Influence of “State-of-the-art”-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial
After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.Trials 2020 21:257The original article was published in Trials 2019 20:299Improved recording of work relatedness during patient consultations in occupational primary health care: a cluster randomized controlled trial using routine data
Prolonging working careers is a key policy goal in ageing populations in Europe, but reaching this goal is complex. Occupational health services are in the best position to contribute towards prolonging workin...Trials 2020 21:256The effectiveness of a comprehensive corrective exercises program and subsequent detraining on alignment, muscle activation, and movement pattern in men with upper crossed syndrome: protocol for a parallel-group randomized controlled trial
Upper crossed syndrome (UCS) refers to specific altered muscle activation and changed movement patterns along with some postural deviations in the upper quarter of the body. This syndrome might contribute to t...Trials 2020 21:255Effectiveness of LiuZiJue Qigong versus traditional core stability training for poststroke patients complicated with abnormal trunk postural control: study protocol for a single-center randomized controlled trial
Trunk function in stroke patients with hemiplegia is associated with respiration and core stability and is also found to be associated with balance and postural control and activities of daily living. LiuZiJue...Trials 2020 21:254Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial
Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be o...Trials 2020 21:253How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis
Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite ...Trials 2020 21:252Designs for adding a treatment arm to an ongoing clinical trial
For many disease areas, there are often treatments in different stages of the development process. We consider the design of a two-arm parallel group trial where it is planned to add a new experimental treatme...Trials 2020 21:251Correction to: Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial
After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.Trials 2020 21:250The original article was published in Trials 2020 21:193A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer
The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16–18 wee...Trials 2020 21:249The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain
Shoulder impingement syndrome is one of the most common causes of shoulder pain, accounting for approximately 30% of all shoulder pain. Approximately 35% of patients with shoulder impingement syndrome are refr...Trials 2020 21:248Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC)
Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as contin...Trials 2020 21:247Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial
We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents...Trials 2020 21:246Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication
Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol...Trials 2020 21:245Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial
There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to...Trials 2020 21:244A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients—protocol for a randomized controlled trial
Atopic dermatitis (AD) is a common, chronic skin disorder often beginning in infancy. Skin barrier dysfunction early in life serves as a central event in the pathogenesis of AD. In infants at high risk of deve...Trials 2020 21:243Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study
Acute respiratory distress syndrome (ARDS) is caused by rapid-onset (within hours) acute inflammatory processes in lung tissue, and it is a life-threatening condition with high mortality. The treatment of ARDS...Trials 2020 21:242Verifying participant-reported clinical outcomes: challenges and implications
Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, ...Trials 2020 21:241A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial
Hospital to home transition care is a most stressful period for stroke survivors and their caregivers to learn self-management of stroke-related health conditions and to engage in rehabilitation. Health coachi...Trials 2020 21:240A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome
Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clini...Trials 2020 21:239Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey
Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, p...Trials 2020 21:238Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)
Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-...Trials 2020 21:237Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial
Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress diso...Trials 2020 21:236Effect and safety of 4% albumin in the treatment of cardiac surgery patients: study protocol for the randomized, double-blind, clinical ALBICS (ALBumin In Cardiac Surgery) trial
In cardiac surgery with cardiopulmonary bypass (CPB), large amounts of fluids are administered. CPB priming with crystalloid solution causes marked hemodilution and fluid extravasation. Colloid solutions may r...Trials 2020 21:235Scaling up Quality Improvement for Surgical Teams (QIST) – avoiding surgical site infection and anaemia at the time of surgery: protocol for a cluster randomised controlled trial
Measures shown to improve outcomes for patients often fail to be adopted into routine practice in the NHS. The Institute for Health Improvement Breakthrough Series Collaborative (BSC) model is designed to supp...Trials 2020 21:234Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden
Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke) reac...Trials 2020 21:233The original article was published in Trials 2015 16:369
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