Cardiometabolic, functional, and psychosocial effects of a remotely supervised home-based exercise program in individuals with type 2 diabetes (RED study): study protocol for a randomized clinical trial
DiscussionExpected results of the proposed study will provide the knowledge base of health professionals and deliver more evidence for a growing area, i.e., home-based exercise and T2D. Additionally, this protocol aims to verify and demonstrate whether this program can be accessible and effective for different health outcomes in patients with T2D.Trial registrationThe RED study protocol was prospectively registered at ClinicalTrials.gov (NCT05362071). Date registered April 6, 2022.https://clinicaltrials.gov/ct2/show/NCT05362071. (Source: Trials)
Source: Trials - October 19, 2023 Category: Research Source Type: clinical trials
Effectiveness of the Unified Protocol for the transdiagnostic treatment of emotional disorders in online and group format in Argentina: study protocol for a randomized controlled trial
DiscussionThe purpose of this trial is to evaluate the efficacy of the online and group application of the UP in the Argentine population, as well as to evaluate the patient ’s experience and satisfaction with the treatment. It is expected that the findings of this study will be useful in reducing anxious and depressive symptomatology, will allow us to adapt the UP to our culture, and will improve accessibility to treatment.Trial registrationClinicalTrials.gov NCT05275322. Registered on 11 March 2022. (Source: Trials)
Source: Trials - October 19, 2023 Category: Research Source Type: clinical trials
Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic
Conditions: COVID-19 Sponsors: University Hospital, Strasbourg, France Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 16, 2023 Category: Research Source Type: clinical trials
A randomised controlled trial of clinical and cost-effectiveness of the PASS Plus intervention for young children with autism spectrum disorder in New Delhi, India: study protocol for the COMPASS trial
DiscussionIf clinically and cost-effective, this programme will fill an important gap of scalable interventions delivered by non-specialist health workers within the current care pathways for autistic children and their families in low-resource contexts. The programme has been implemented through the COVID-19 pandemic when restrictions were in place; intervention delivery and evaluation processes have been adapted to address these conditions.Trial registrationISRCTN;ISRCTN21454676; Registered 22 June 2018. (Source: Trials)
Source: Trials - October 12, 2023 Category: Research Source Type: clinical trials
Effect of music breathing, a program based on mindful breathing and music listening therapy for promoting sense of coherence in young people: study protocol for a randomized controlled trial
DiscussionThe results will inform practice in coping with stress through promoting sense of coherence. Individuals will benefit from the long-term effect of this intervention to enhance their sense of coherence to cope with stressful events and promote better mental well-being.Trial registrationClinicalTrials.gov Identifier: NCT05655234. Registered on December 8, 2022. (Source: Trials)
Source: Trials - October 12, 2023 Category: Research Source Type: clinical trials
The Impact of nCoV-2019 on Children With Migraine
Conditions: Migraine Disorders; COVID-19 Pandemic Interventions: Other: questionnaires Only Sponsors: Bnai Zion Medical Center Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 11, 2023 Category: Research Source Type: clinical trials
e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence
Conclusione-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent. (Source: Trials)
Source: Trials - October 10, 2023 Category: Research Source Type: clinical trials
Advanced Modeling of the Evolution of the Epidemiological Outbreak of SARS-CoV-2 Pandemic
Conditions: COVID-19 Sponsors: Hospital Galdakao-Usansolo; Basque Government Department of Public Health; University of the Basque Country (UPV/EHU); BCAM (Basque Center for Applied Mathematics); Osakidetza Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 6, 2023 Category: Research Source Type: clinical trials
Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities
ConclusionCompleting a COVID-19 trial in outpatients during the height of the pandemic required multiple innovations in nearly every aspect of clinical trial management, a high commitment level from study staff and patients, and support from study sponsors. Our experience has generated a more robust clinical research infrastructure, building in efficiencies to clinical trial management beyond the pandemic. (Source: Trials)
Source: Trials - October 4, 2023 Category: Research Source Type: clinical trials
Frequency of screening and SBT Technique Trial —North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan
AbstractBackgroundThis update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial —North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidat es to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 ...
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials
H7HLAII DNA Influenza Vaccine
Conditions: Influenza A; Pandemic Influenza Intervention: Biological: H7HLAII Sponsor: Oslo University Hospital Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 21, 2023 Category: Research Source Type: clinical trials
