Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial
In this study, patients with confirmed positive COVID-19 tests receive imatinib for a total of 14 days; 400 mg orally daily Days 1-14. Imatinib 400 mg tablets will be encapsulated using size 000 capsules and cellulose microcrystalline filler. For patients on ventilator or ECMO, imatinib will be given as oral suspension (40 mg/mL). To make the oral suspension, imatinib tablets will be crushed and mixed in Ora-sweet solution to yield a concentration of 40 mg/mL suspension by pharmacy. Additionally, in the absence of supportive microbiological testing results, we confirm that the in-use stability period for the prepared imati...
Source: Trials - October 28, 2020 Category: Research Source Type: clinical trials
Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial
DiscussionTo our knowledge, this is the first RCT of its kind to be conducted in France, and so far, there are no studies in the literature on group psychotherapy for the treatment of individuals who have attempted suicide. The outcomes will provide clear guidance for professionals to apply psychological intervention with suicide attempts. The protocol respects ethical principles, and ethical approval was obtained from the local ethics committee. The results will be disseminated through an original research published as original research in peer-reviewed manuscript, through a therapist manual for cognitive therapy, and pre...
Source: Trials - October 27, 2020 Category: Research Source Type: clinical trials
Effectiveness and safety of tenosynovitis of the long head of the biceps brachii with acupuncture: a protocol for a systematic review and meta-analysis
ConclusionThe conclusion of this study will confirm the effectiveness and safety of acupuncture in the treatment of tenosynovitis of LHB brachii, which can provide new evidence to guide appropriate interventions on tenosynovitis of LHB brachii with acupuncture in the future.Ethics and disseminationEthical approval is not required because no individual patient data are collected. This review will be published in a peer-reviewed journal and presented at an international academic conference for dissemination.Trial registrationPROSPERO registration numberCRD42020167434. Registered on April 28, 2020. (Source: Trials)
Source: Trials - October 20, 2020 Category: Research Source Type: clinical trials
Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program
ConclusionsFuture studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a “ramp-up” period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.Trial registrationClinicalsTr...
Source: Trials - October 16, 2020 Category: Research Source Type: clinical trials
Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study
This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180). The results will be disseminated at academic conferences and submitted to peer-reviewed publications. Either positive or negative results will provide guidance for clinical practice.Trial registrationThe Chinese Clinical Trial Registry (http://www.chictr.org.cn) ChiCTR1900022583. Registered on 17 April 2019. (Source: Trials)
Source: Trials - July 13, 2020 Category: Research Source Type: clinical trials
Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength
DiscussionEthical approval has been granted by the Dasman Diabetes Institute ethical review committee (RA/197/2019). Study findings will be disseminated through presentation at scientific conferences and in scientific journals.Trial registrationNCT04136730: Retrospectively registered on 21 October 2019 (Source: Trials)
Source: Trials - June 21, 2020 Category: Research Source Type: clinical trials
Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) when compared to standard care. Furthermore, we hypothesize that early treatment with hydroxychloroquine sulphate is associated with more rapid resolve of clinical symptoms as assessed by the National Early Warning Score 2 (NEWS2), decreased admission rate to intensive care units and mortality, and improvement in pro...
Source: Trials - June 4, 2020 Category: Research Source Type: clinical trials
Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care
This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home.MethodsThis is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing gui deline and providing informati...
Source: Trials - March 19, 2020 Category: Research Source Type: clinical trials
Family Care Conferences Criteria in the Pediatric Intensive Care Unit-Reliability
Condition: Critical Illness Intervention: Sponsors: Ann& Robert H Lurie Children's Hospital of Chicago; Advocate Lutheran General Hospital; Icahn School of Medicine at Mount Sinai Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 6, 2020 Category: Research Source Type: clinical trials
