Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial
DiscussionChurch-placed CHWs are trusted influential connectors between communities and health systems. Studies have shown that these CHWs can successfully implement health prevention protocols in churches, including those related to cancer control, making them potentially important community mediators of CRC screening uptake and CRC/CVD risk reduction.Trial registrationNCT05174286; clinicaltrials.gov; August 31st, 2023 (Source: Trials)
Source: Trials - April 26, 2024 Category: Research Source Type: clinical trials
Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study
ConclusionOur findings support perspectives drawn from the Ford Framework regarding the need to consider all barriers, not just up to the point of enrolment into trials but also beyond the point of inclusion in clinical trials. We support calls for the introduction of legislation on including disabled people in clinical trials, implementation of industry/community-wide participatory approaches and the development of guidelines, a combined public –private approach. (Source: Trials)
Source: Trials - April 26, 2024 Category: Research Source Type: clinical trials
Adjustment of positive end-expiratory pressure to body mass index during mechanical ventilation in general anesthesia: BodyVent, a randomized controlled trial
DiscussionThe study results will show whether an intraoperative ventilation strategy with PEEP adjustment based on BMI has the potential of reducing the risk for postoperative pulmonary complications as an easy-to-implement intervention that does not require lengthy ventilator maneuvers nor additional equipment.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00031336. Registered 21st February 2023.Trial statusThe study protocol was approved by the ethics committee of the Christian-Albrechts-Universit ät Kiel, Germany, on 1st February 2023. Recruitment began in March 2023 and is expected to end in September 2...
Source: Trials - April 26, 2024 Category: Research Source Type: clinical trials
Gamma oscillations induced by 40-Hz visual-auditory stimulation for the treatment of acute-phase limb motor rehabilitation after stroke: study protocol for a prospective randomized controlled trial
This study aims to conduct a prospective clinical trial to validate the safety and effectiveness of gamma oscillations induced by 40-Hz visual-auditory stimulation in treating post-stroke upper limb dysfunction and to explore the relevant mechanisms.MethodsThis trial is a prospective, randomized controlled, double-blind study. All enrolled patients were randomly assigned to two groups. The experimental group received intervention through 40-Hz visual-auditory stimulation, while the control group underwent intervention with randomly matched visual-auditory stimulation frequencies. The primary efficacy endpoint is the change...
Source: Trials - April 26, 2024 Category: Research Source Type: clinical trials
Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study
It is crucial to include a wide range of the population in clinical trials for the outcome to be applicable in real-world settings. Existing literature indicates that under-served groups, including disabled pe... (Source: Trials)
Source: Trials - April 26, 2024 Category: General Medicine Authors: Yoshiko Sakuma, Marie L. E. Miller, Daphne S. Babalis, Alex Baker, Meena Reddi, Aisha Anjum, Jane Bruton, Kathryn N Jones, Umm Zeinab Mulla and Henock Taddese Tags: Research Source Type: research
Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2)
DiscussionThis update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial.Trial registrationRegistry of India: CTRI/2019/05/019296. Registered on 23 May 2019.https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2 (Source: Trials)
Source: Trials - April 25, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2)
Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Pr... (Source: Trials)
Source: Trials - April 25, 2024 Category: General Medicine Authors: Nicholas Magill, Siddharudha Shivalli, Ila Fazzio, Diana Elbourne, Suzanne Keddie, Padmanabh Reddy, Rakhi Nair, Madan Gopal, Sridevi Karnati, Harshavardhan Reddy, Peter Boone and Chris Frost Tags: Update Source Type: research
Coordination of COVID-19 platform trials in Europe
To ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investi... (Source: Trials)
Source: Trials - April 25, 2024 Category: General Medicine Authors: Jacques Demotes, Victoria Charlotte Simensen, Keiko Ueda, Sareema Javaid, Paula Garcia, Bur ç Aydin and John-Arne Røttingen Tags: Commentary Source Type: research
The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)
Allergic rhinitis is a chronic respiratory disorder that significantly impacts patients ’ quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient educ... (Source: Trials)
Source: Trials - April 25, 2024 Category: General Medicine Authors: Chii-Chii Chew, Xin-Jie Lim, Pathma Letchumanan, Doris George, Philip Rajan and Chee Ping Chong Tags: Study protocol Source Type: research
The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)
This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm.MethodThis is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 r...
Source: Trials - April 25, 2024 Category: Research Source Type: clinical trials
Coordination of COVID-19 platform trials in Europe
AbstractTo ensure optimal coordination of the EU-funded COVID-19 platform trials, a double coordination mechanism was established. It included the Trial Coordination Board (TCB) to promote the dialogue between investigators and relevant public health stakeholders and the Joint Access Advisory Mechanism (JAAM) to streamline access of new intervention arms to the platform trials. Both the TCB and the JAAM emerged as efficient instruments to promote cooperation and optimise the use of resources within EU-funded adaptive platform trials. In addition, an adaptive platform trial toolbox was developed to collect information and l...
Source: Trials - April 25, 2024 Category: Research Source Type: clinical trials
Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention
Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortali... (Source: Trials)
Source: Trials - April 23, 2024 Category: General Medicine Authors: Anne S øjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau and Kaj Sparle Christensen Tags: Study protocol Source Type: research
Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention
This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being.MethodsA stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offere...
Source: Trials - April 23, 2024 Category: Research Source Type: clinical trials
The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders —a double-blind, randomized, placebo-controlled proof-of-concept study
Recent developments suggest that neurosteroids may achieve rapid antidepressant effects. As such, neurosteroidogenesis mediated by the translocator protein 18 kDa (TSPO) might constitute a promising option for... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Lisa-Marie Brunner, Marco Riebel, Simon Wein, Michael Koller, Florian Zeman, Gunnar Huppertz, Tanja Emmer, Yvonne Eberhardt, Jens Schwarzbach, Rainer Rupprecht and Caroline Nothdurfter Tags: Study protocol Source Type: research
Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson ’s disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial
Parkinson ’s disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treat... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao, Li Cao and Yuanyi Zheng Tags: Study protocol Source Type: research
