TrialsCorrection to: Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
Following publication of the original article [1], we have been notified that Figure 1 was published with the track changes. In this Correction the incorrect and correct Fig. 1 are shown.Trials 2019 20:617The original article was published in Trials 2019 20:545European survey on national training activities in clinical research
Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs...Trials 2019 20:616Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial
The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is ca...Trials 2019 20:615Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial
Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation...Trials 2019 20:614Reducing research waste by promoting informed responses to invitations to participate in clinical trials
Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be w...Trials 2019 20:613CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial
Wound repair is one of the most complex biological processes of human life. Allogeneic cell-based engineered skin substitutes provide off-the-shelf temporary wound coverage and act as biologically active dress...Trials 2019 20:612Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?
Following publication of the original article [1], we have been notified that one of an error in the Conclusions section of the Abstract.Trials 2019 20:611The original article was published in Trials 2019 20:566Correction to: Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial
Following publication of the original article [1], we have been notified that the final specification of randomisation implemented in the study is slightly different to that stated in the protocol and needs to...Trials 2019 20:610The original article was published in Trials 2018 19:633Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial
Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBR...Trials 2019 20:609A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study
Treatment of bipolar disorder (BD) usually requires drug combinations. Combinations of lithium plus valproic acid (Li/VPA) and lithium plus carbamazepine (Li/CBZ) are used in clinical practice but were not pre...Trials 2019 20:608Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature sugg...Trials 2019 20:607Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Following publication of the original article [1], we have been notified that one of the authors’ names is spelled incorrectly. In this Correction the incorrect and correct author name are shown.Trials 2019 20:606The original article was published in Trials 2019 20:532Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial
Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of...Trials 2019 20:605Multimodal analysis of the effects of dexamethasone on high-altitude cerebral oedema: protocol for a pilot study
Acute mountain sickness (AMS) is a cluster of symptoms that commonly occur in those ascending to high altitudes. Symptoms can include headaches, nausea, insomnia and fatigue. Exposure to high altitude can also...Trials 2019 20:604Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study
Routine application of chlorhexidine oral rinse is recommended to reduce risk of ventilator-associated pneumonia (VAP) in mechanically ventilated patients. Recent reappraisal of the evidence from two meta-anal...Trials 2019 20:603Correction to: Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial – the development of the DELTA2 guidance
Following publication of the original article [1], we have been notified of a few mistakes:Trials 2019 20:602The original article was published in Trials 2018 19:542Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR-HD)
Fibroblast growth factor 23 (FGF23) is associated with left ventricular hypertrophy (LVH) in patients with chronic kidney disease, and calcimimetic therapy reduces plasma concentrations of FGF23. It remains un...Trials 2019 20:601The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial
There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend ...Trials 2019 20:600Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial
With the substantially growing trend of the aging populations in China and the rest of the world, the number of total hip and total knee arthroplasty (THA and TKA) cases are increasing dramatically. It is impo...Trials 2019 20:599- Trials 2019 20(Suppl 1):579This article is part of a Supplement: Volume 20 Supplement 1
Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
The Mesothelioma and Radical Surgery Trial (MARS 2) aims to evaluate a surgical procedure by comparing chemotherapy and surgery against chemotherapy alone. The pilot study for MARS 2 evaluated the viability of...Trials 2019 20:598Load monitoring on Pilates training: a study protocol for a randomized clinical trial
Currently there are campaigns to raise the awareness of the need to practice physical exercise with several objectives, mainly as a preventive measure. The Pilates method is a form of therapeutic exercise for ...Trials 2019 20:597Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial
Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imp...Trials 2019 20:596Correction to: Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial
Following publication of the original article [1], we have been notified of a few mistakes in the “Sample size calculations” section, second paragraph.Trials 2019 20:595The original article was published in Trials 2018 19:688The trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias: study protocol for a cluster randomized controlled trial
Infections are common in nursing home (NH) residents with advanced dementia but are often managed inappropriately. Antimicrobials are extensively prescribed, but frequently with insufficient evidence to suppor...Trials 2019 20:594What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is l...Trials 2019 20:593The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial
Patients with haematological malignancies often develop thrombocytopenia as a consequence of either their disease or its treatment. Platelet transfusions are commonly given to raise a low platelet count and re...Trials 2019 20:592A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol
Older people are frequent emergency department (ED) users who present with complex issues that are linked to poorer health outcomes following the index visit, often have increased ED length of stay, and tend t...Trials 2019 20:591The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial
Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with per...Trials 2019 20:590Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set
Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demo...Trials 2019 20:589Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial
Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide ...Trials 2019 20:588Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial
In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followe...Trials 2019 20:587Effects of neuromuscular training and strengthening of trunk and lower limbs muscles in women with Patellofemoral Pain: A protocol of randomized controlled clinical trial, blinded
Patellofemoral pain (PFP) often affects young women, and the etiology is multifactorial and poorly understood. Conservative intervention has been focused on risk factors or aggravating factors and is composed ...Trials 2019 20:586Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial
Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric inte...Trials 2019 20:585The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial
High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulat...Trials 2019 20:584Contributions of vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial
Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular mo...Trials 2019 20:583The Correction to this article has been published in Trials 2019 20:628The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial
Intraoperative hypotension is associated with increased morbidity and mortality. Current treatment is mostly reactive. The Hypotension Prediction Index (HPI) algorithm is able to predict hypotension minutes be...Trials 2019 20:582Social group and health care provider interventions to increase the demand for malaria rapid diagnostic test among community members in Ebonyi state, Nigeria: study protocol for a cluster randomized controlled trial
The World Health Organization recommended (in 2010) universal testing for suspected malaria, due to some fundamental changes in malaria trends such as the declining incidence of malaria in high-burden countrie...Trials 2019 20:581Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol
Recently factors in the relationship between gut microbiota, obesity, diabetes and the metabolic syndrome have been suggested in the development and progression of nonalcoholic steatohepatitis (NASH). In this ...Trials 2019 20:580Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices
Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients...Trials 2019 20:578Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.Trials 2019 20:577An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial
Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3–10% of the population has an increased risk for colorectal cancer due to family history and warrants more fr...Trials 2019 20:576Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial
Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. Ho...Trials 2019 20:575Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial
Adolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adul...Trials 2019 20:574Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)
Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional e...Trials 2019 20:573Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols
Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populati...Trials 2019 20:572A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known abo...Trials 2019 20:571The effect of Baduanjin exercise on health-related physical fitness of college students: study protocol for a randomized controlled trial
Low health-related physical fitness in college students is a risk factor for future development of cardiovascular diseases at later stages in life, but appropriate exercise is one of the main determinant facto...Trials 2019 20:569The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial
Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going ado...Trials 2019 20:568Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial
Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown...Trials 2019 20:567
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