The HAVEN study —hydroxychloroquine in ANCA vasculitis evaluation—a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan
DiscussionThis trial aims to explore Hydroxychloroquine as a treatment for patients with AAV. If effective, the need for immunosuppressive treatments such as prednisolone could be reduced. Hydroxychloroquine is safer, cheaper and has fewer adverse effects than conventional immunosuppressive treatments. This could improve patient outcomes while saving money for the NHS.Trial registrationISRCTN: ISRCTN79334891. Registered 07 June 2021.EudraCT: 2018-001268-40. Registered 13 September 2019.Clinicaltrials.gov: NCT04316494. Registered 20 March 2020. (Source: Trials)
Source: Trials - April 6, 2023 Category: Research Source Type: clinical trials
Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
AbstractThe COVID-19 pandemic has had an unprecedented and disruptive impact on people ’s health and lives worldwide. In addition to burdening people’s health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials experienced challenges in ensuring patient safety and enrolling new patient s throughout the pandemic. Here, we investigate and quantify the negative impact that the COVID-19 pandemic has industry-sponsored clinical trials, both in the USA and worldwide. We find a negative correlation between the severity of the COVI...
Source: Trials - April 4, 2023 Category: Research Source Type: clinical trials
Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial
This study will test if adjunctive use of OptiMAT improve MOUD outcomes. Study findings could lead to expansion of OptiMAT into rural clinical settings, and the identification of OptiMAT features which best predict positive clinical outcome could lead to refinement of this and similar smartphone app-based interventions.Trial registration
ClinicalTrials.gov
identifier:NCT05336188, registered March 21, 2022. (Source: Trials)
Source: Trials - April 4, 2023 Category: Research Source Type: clinical trials
Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
DiscussionThis statistical analysis plan will be published prior to enrolment completion and before any data are available and is sought to increase the validity of the DANish Atrial Fibrillation trial.Trial registrationClinicaltrials.gov NCT04542785. Registered on Sept 09, 2020. (Source: Trials)
Source: Trials - April 1, 2023 Category: Research Source Type: clinical trials
Constipation and Changes in the Gut Flora in Parkinson's Disease: a Pilot Study
Condition: Parkinson Disease Intervention: Sponsors: University of Aberdeen; Biomathematics & Statistics Scotland (BioSS); NHS Grampian Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 28, 2023 Category: Research Source Type: clinical trials
