Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India
DiscussionStepped wedge designs are increasingly used a design to evaluate the real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a low- and middle-income country evaluating the impact of the implementation of a community mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in low- and middle-income countries.Trial registrationThe trial is registered prospectively with the Clinical Trial Registry in India and the Clinical Trial Reg...
Source: Trials - February 21, 2020 Category: Research Source Type: clinical trials

Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial
This study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4  days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as ...
Source: Trials - February 21, 2020 Category: Research Source Type: clinical trials

Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?
ConclusionsAttending a measurement visit or returning a questionnaire is a behaviour and trialists should be mindful of this when designing retention interventions. Our work in this area provides some of the first evidence of the impact of implicit use of BCTs in retention interventions and highlights their potential promise for future trials. (Source: Trials)
Source: Trials - February 21, 2020 Category: Research Source Type: clinical trials

Mesenteric excision surgery or conservative limited resection in Crohn ’s disease: study protocol for an international, multicenter, randomized controlled trial
AbstractBackgroundThe structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn ’s disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studi es suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlle...
Source: Trials - February 21, 2020 Category: Research Source Type: clinical trials

Examining the benefits and harms of Alzheimer ’s disease screening for family members of older adults: study protocol for a randomized controlled trial
Multiple national expert panels have identified early detection of Alzheimer ’s disease and related dementias (ADRD) as a national priority. However, the United States Preventive Services Task Force (USPSTF) do... (Source: Trials)
Source: Trials - February 19, 2020 Category: General Medicine Authors: Nicole R. Fowler, Katharine J. Head, Anthony J. Perkins, Sujuan Gao, Christopher M. Callahan, Tamilyn Bakas, Shelley D. Suarez and Malaz A. Boustani Tags: Study protocol Source Type: research

The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial
The innervation of the shoulder-upper-extremity area is complicated and unclear. Regional anesthesia with a brachial plexus and cervical plexus block is probably inadequate for the proximal humeral surgery. Mi... (Source: Trials)
Source: Trials - February 19, 2020 Category: General Medicine Authors: Xiaofeng Wang, Hui Zhang, Zhenwei Xie, Qingfu Zhang, Wei Jiang and Junfeng Zhang Tags: Study protocol Source Type: research

Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial
Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or secondary open-wound healing after removal of the exter... (Source: Trials)
Source: Trials - February 19, 2020 Category: General Medicine Authors: Franz Roth, Flavio Cagienard, Bj örn C. Link, Sandro Hodel, Dirk Lehnick, Reto Babst and Frank J. P. Beeres Tags: Study protocol Source Type: research

Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial
Thrice-weekly haemodialysis is the usual dose when starting renal replacement therapy; however, this schedule is no longer appropriate since it does not consider residual renal function. Several reports have s... (Source: Trials)
Source: Trials - February 19, 2020 Category: General Medicine Authors: M. Fern ández Lucas, G. Ruíz-Roso, J. L. Merino, R. Sánchez, H. Bouarich, J. A. Herrero, A. Muriel, J. Zamora and A. Collado Tags: Study protocol Source Type: research

Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial
Patients ’ pre-operative health and physical function is known to influence their post-operative outcomes. In patients with knee osteoarthritis, pharmacological and non-pharmacological options are often not opt... (Source: Trials)
Source: Trials - February 19, 2020 Category: General Medicine Authors: A. Hamish R. W. Simpson, Anna Bell-Higgs, Philip G. Conaghan, Peter Craig, David F. Hamilton, Catherine Hankey, Catriona Keerie, Sarah R. Kingsbury, Elaine Kinsella, Anthony R. Leeds, John Norrie, Hemant G. Pandit, Hazel M. Ross, Sharon Anne Simpson and C Tags: Study protocol Source Type: research

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial
The objective of this study is to evaluate the effect of multicomponent training associated with active or sham tDCS on the performance of functional capacity in the elderly before treatment, after treatment and 30 days after the end of treatment. The secondary objective will be to correlate the performance of the primary outcome (functional capacity assessed by the Glittre Daily Life Activity Test) with walking capacity (by 6-min walk test), balance (with the mini-Balance Evaluation Systems Test), functional independence (by the Functional Independence Measure) and quality of life (with the World Health Organization Quali...
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Can learning about trials be child ’s play? A qualitative exploration of the ‘Schools Teaching Awareness of Randomised Trials’ (START) initiative
ConclusionsIncreasing public awareness and understanding of randomised trials can help increase public engagement in trials. By educating children about the importance of trials and supporting them to ‘learn by doing’ by carrying out their own trial, the START initiative can contribute substantially to children’s awareness and understanding of trial processes. Given that children are the public, the patients and the researchers of the future, initiatives such as START deserve attention. (Source: Trials)
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Examining the benefits and harms of Alzheimer ’s disease screening for family members of older adults: study protocol for a randomized controlled trial
DiscussionWe hypothesize that caregivers in the screening arms will express higher levels of health-related quality of life, lower depressive and anxiety symptoms, and better preparation for caregiving with higher self-efficacy at 24  months. Results from this study will directly inform the National Plan to Address Alzheimer’s Disease, the USPSTF and other organizations regarding ADRD screening and early detection policies.Trial registrationClinicalTrials.gov,NCT03300180. Registered on 3 October. (Source: Trials)
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial
This study forms the important first step in developing and assessing whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the design of the effectiveness trial.Trial registrationISRCTN registry, ID:ISRCTN96684272. Registered on 18 April 2018. (Source: Trials)
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial
DiscussionThis RCT aims to confirm whether an additional T2 TPVB can provide better anesthetic effects of regional anesthesia with brachial and cervical plexus block in elderly patients undergoing proximal humeral surgery.Trial registrationClinicalTrials.gov, ID:NCT03919422. Registered on 19 April 2019. (Source: Trials)
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial
This report describes the study protocol of a randomized prospective multi-centre open-label clinical trial to evaluate whether starting renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than the standard thrice-weekly regimen. We also explore other clinical parameters, such as concentrations of uremic toxins, dialysis doses, control of anaemia, removal of medium-weight uremic toxins, nutritional status, quality of life, hospital admissions and mortality. Only incident haemodialysis patients who can maintain a urea clearance rate KrU ≥ 2.5 mL/min/1.73&thin...
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial
This study compares primary wound closure with secondary wound healing for the pin site. The primary aim is to compare pin-site infection rates. The secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing.Methods and designThis is a prospective, randomized controlled, blinded, monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin-entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound ...
Source: Trials - February 19, 2020 Category: Research Source Type: clinical trials

A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty
Total knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy ... (Source: Trials)
Source: Trials - February 18, 2020 Category: General Medicine Authors: Babar Kayani, Sujith Konan, Jenni Tahmassebi, Sam Oussedik, Peter D. Moriarty and Fares S. Haddad Tags: Study protocol Source Type: research

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned. (Source: Trials)
Source: Trials - February 18, 2020 Category: General Medicine Authors: Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr, Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel and Jeanette A. Waxmonsky Tags: Correction Source Type: research

Correction to: Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study
After publication of our article [1] the authors have notified us of missing to include one name to the authorship list: (Source: Trials)
Source: Trials - February 18, 2020 Category: General Medicine Authors: Benjamin Carrot, Jeanne Duclos, Caroline Barry, Leslie Radon, Anne-Sol ène Maria, Irène Kaganski, Zorica Jeremic, Vesper Barton-Clegg, Maurice Corcos, Malaïka Lasfar, Priscille Gerardin, Aurélie Harf, Marie-Rose Moro, Corinne Blanchet, Stéphane Bahra Tags: Correction Source Type: research

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial
Intraoperative driving pressure ( ΔP) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (VT) is kept constant, ΔP may change according to positive end-expiratory pres... (Source: Trials)
Source: Trials - February 18, 2020 Category: General Medicine Tags: Study protocol Source Type: research

Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan
AbstractBackgroundRecurrent bleeding from an intracranial aneurysm after subarachnoid hemorrhage (SAH) is associated with unfavorable outcome. Recurrent bleeding before aneurysm occlusion can be performed occurs in up to one in five patients and most often happens within the first 6 h after the primary hemorrhage. Reducing the rate of recurrent bleeding could be a major factor in improving clinical outcome after SAH. Tranexamic acid (TXA) reduces the risk of recurrent bleeding but has thus far not been shown to improve functional outcome, probably because of a higher risk of delayed cerebral ischemia (DCI). To reduce the r...
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan
This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow-up, while the outcome of the trial is still unknown.Design and methodsTARVA is a randomised, un-blinded, parallel group trial of total ankle replacement versus ankle arthrodesis. The primary outcome is the Manchester-Oxford Foot Questionnaire walking/standing domain score at 52  weeks post-surgery. Secondary outcomes include measures of pain, social interaction, physical function, quality of life, and range of motion. We describe in detail the statistical aspect...
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial
This study tests the hypothesis that individualized high PE EP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery.MethodsThe “Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial” (DESIGNATION) is an international, multicenter, two-group, double-blind randomized clinical superiority trial. A total of 1468 patients will be randomly assigned to one of the two intraoperative ventilation strategies. Investigators screen patients aged ≥ 18 years and with a body mass index ≤ 40 kg/m2, scheduled for open abdomina...
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

Evaluating the re-identification risk of a clinical study report anonymized under EMA Policy 0070 and Health Canada Regulations
ConclusionsThese results suggest that the anonymization guidance from these agencies can provide adequate privacy protection for patients, and the modes of attack can inform further refinements of the methodologies they recommend in their guidance for manufacturers. (Source: Trials)
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty
The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.Methods and analysisThis prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the contr...
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

Correction to: Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study
After publication of our article [1] the authors have notified us of missing to include one name to the authorship list: (Source: Trials)
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

A randomized controlled trial investigating the effect of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols on the intestinal microbiome and inflammation in patients with ulcerative colitis: study protocol for a randomized controlled trial
This study is a randomized clinical trial. Thirty patients with mild to moderate ulcerative colitis will be randomly allocated to receive a low FODMAP diet (n = 15) or to continue their usual diet as control (n = 15), for 4 weeks. The quantity of intestinal microbiota including Clostridium cluster IV,Faecalibacterium prausnitzii, Rosburia spp., Lactobacillus spp., Bifidobacteria spp.,Akkermansia muciniphila,Bacteroides fragilis, and Ruminococcus spp., and theFirmicutes toBacteroidetes ratio and calprotectin and lactoferrin levels will be explored in fecal samples from patients. In additio...
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
After publication of our article [1] the authors have notified us that the title for Figure  1 was incorrectly captioned. (Source: Trials)
Source: Trials - February 18, 2020 Category: Research Source Type: clinical trials

Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial
Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in t... (Source: Trials)
Source: Trials - February 17, 2020 Category: General Medicine Authors: Soobin Jang, Hyung Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go and Jeeyoun Jung Tags: Study protocol Source Type: research

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial
DiscussionIf outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women.Trial registrationAustralia New Zealand Clinical Trials Registry (ANZCTR), ACTRN:12616000739415. Registered on 6 June 2016. (Source: Trials)
Source: Trials - February 17, 2020 Category: Research Source Type: clinical trials

Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial
DiscussionThe aim of this trial is to close the evidence gap on the efficacy of smartphone-based secondary prevention interventions. If proven effective, smartphone-based interventions have the potential to reach a large portion of the population, completing what is available on the Internet.Trial registrationISRCTN,10007691. Registered on 2 December 2019. Recruitment will start in April 2020. (Source: Trials)
Source: Trials - February 17, 2020 Category: Research Source Type: clinical trials

Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial
This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.Methods/designThis study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The imme...
Source: Trials - February 17, 2020 Category: Research Source Type: clinical trials

Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S): a randomized pilot clinical trial
This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation fo llowing repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart.DiscussionTicagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes.Trial registrationEudraCT No.2016 &ndash...
Source: Trials - February 17, 2020 Category: Research Source Type: clinical trials

Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
Dengue is increasing in its global presence with an estimated 4 billion people at-risk of infection in at least 128 countries. Despite the promising results of EcoHealth and community mobilization approaches to A... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Kate Zinszer, Andrea Caprara, Antonio Lima, St éphanie Degroote, Monica Zahreddine, Kellyanne Abreu, Mabel Carabali, Katia Charland, Mayana Azevedo Dantas, José Wellington, Beatriz Parra, Florence Fournet, Emmanuel Bonnet, Denis Pérez, Emilie Robert, C Tags: Study protocol Source Type: research

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)
Germany hosts a large number of refugees from war-affected countries. The integration of refugees, in particular young refugees from the Middle East, is one of the major current social challenges in Germany. M... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Sarah Wilker, Claudia Catani, Jasmin Wittmann, Melissa Preusse, Telja Schmidt, Theodor May, Verena Ertl, Bettina Doering, Rita Rosner, Areej Zindler and Frank Neuner Tags: Study protocol Source Type: research

Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial
Mexico has one of the highest prevalence rates of obesity worldwide. New pharmacological strategies that focus on people with class III obesity are required. Metformin and dapagliflozin are two drugs approved ... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Aldo Ferreira-Hermosillo, Mario Antonio Molina-Ayala, Diana Molina-Guerrero, Ana Pamela Garrido-Mendoza, Claudia Ram írez-Rentería, Victoria Mendoza-Zubieta, Etual Espinosa and Moisés Mercado Tags: Study protocol Source Type: research

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial
Earlier, we designed and evaluated an educational mass media intervention for improving people ’s ability to think more critically and to assess the trustworthiness of claims (assertions) about the benefits and... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Daniel Semakula, Allen Nsangi, Andrew D. Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Christopher J. Rose and Nelson K. Sew Tags: Research Source Type: research

Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial
Informal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decre... (Source: Trials)
Source: Trials - February 14, 2020 Category: General Medicine Authors: Megan Shepherd-Banigan, Valerie A. Smith, Jennifer H. Lindquist, Michael Paul Cary Jr., Katherine E. M. Miller, Jennifer G. Chapman and Courtney H. Van Houtven Tags: Research Source Type: research

Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial
DiscussionThe association of PNF with CRT may be a viable and accessible alternative to increase cardiorespiratory function in patients with stroke.Trial registrationClinicalTrials.gov,NCT03171012. Registered on 6 June 2017. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial
DiscussionThe study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.Trial registrationAustralian New Zealand Clinical Trials Registry,ACTRN12619000474156. Registered on 21 March 2019 (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial
AbstractBackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smo...
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial
DiscussionForty-six percent of the patients in our Obesity Clinic have been diagnosed with prediabetes (32%) or diabetes (14%). The use of dapagliflozin in this population could improve weight loss and other cardiovascular factors. This effect could be translated into less time before undergoing bariatric surgery and better control of associated comorbidities.Trial registrationClinicaltrials.gov, ID:NCT03968224. Retrospectively registered on May 29, 2019. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)
DiscussionThe results of this study should provide evidence regarding effective treatment options for young refugees in Germany, a population that has been understudied and received only limited access to mental health care so far. Next to the effects of treatment on mental health outcomes, integration parameters will be investigated. Therefore, this study should provide broad insights into treatment options for young refugees and their potential implications on successful integration.Trial registrationGerman Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS), ID:DRKS00017222. Registered on 15 May 2019. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
DiscussionThe results of our study will provide evidence on community mobilization as an intervention for dengue control. We anticipate that if community mobilization is effective in Fortaleza, the results of this study will help develop evidence-based vector control programs in Brazil, and also in other countries struggling withAedes-transmitted diseases.Trial registrationISRCTN66131315, registration date: 1 October 2018. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial
AbstractBackgroundInformal caregivers report substantial burden and depressive symptoms which predict higher rates of patient institutionalization. While caregiver education interventions may reduce caregiver distress and decrease the use of long-term institutional care, evidence is mixed. Inconsistent findings across studies may be the result of reporting average treatment effects which do not account for how effects differ by participant characteristics. We apply a machine-learning approach to randomized clinical trial (RCT) data of theHelping Invested Family Members Improve Veteran ’s Experiences Study (HI-FIVES) ...
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial
ConclusionsAlthough listening to the Informed Health Choices podcast initially led to a large improvement in the ability of parents to assess claims about the effects of treatments, our findings show that these skills decreased substantially over 1 year. More active practice could address the substantial skills decay observed over 1 year.Trial registrationPan African Clinical Trial Registry (www.pactr.org),PACTR201606001676150. Registered on 12 June 2016. (Source: Trials)
Source: Trials - February 14, 2020 Category: Research Source Type: clinical trials

Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial
Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with l... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Sang-Hyun Lee, Byung-Jun Kim, In-Hwa Park, Eui-Hyoung Hwang, Eun Ju Park, Insoo Jang and Man-Suk Hwang Tags: Study protocol Source Type: research

Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial
The population of adult patients with early-treated phenylketonuria (PKU) following newborn screening is growing substantially. The ideal target range of blood phenylalanine (Phe) levels in adults outside preg... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis and Regula Everts Tags: Study protocol Source Type: research

Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasti... (Source: Trials)
Source: Trials - February 13, 2020 Category: General Medicine Authors: Katherine J. Rennie, James O ’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abo Tags: Study protocol Source Type: research