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)
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
The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial
Early, rapid, and accurate pathogen diagnosis can help clinicians select targeted treatment options, thus improving prognosis and reducing mortality rates of severe pneumonia. Metagenomic next-generation seque... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Xiao Song, Hui Jiang, Liang Zong, Di Shi and Huadong Zhu Tags: Study protocol Source Type: research
Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial
Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of ... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: B énédicte Dupas, Daniela Castro-Farias, Jean-François Girmens, Ali Eginay, Aude Couturier, Frederic Villeroy, Marie-Noëlle Delyfer, Catherine Creuzot-Garcher, Audrey Giocanti-Auregan, Laurence Béral, Carl Arndt, Charles Mesnard, Eric Vicaut, Philipp 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
This study represents the clinical investigation into the efficacy of therapeutic LIPUS in the treatment of PD for the first time. If LIPUS is determined to be effective, it could offer a practical and innovative means of expanding the accessibility of ultrasound therapy by using a wearable LIPUS device within a home setting.Trial registrationChinese Clinical Trial Registry ChiCTR2100052093. Registered on 17 October 2021. (Source: Trials)
Source: Trials - April 22, 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
This study will provide a first proof-of-concept on the potential of the TSPO ligand etifoxine in the treatment of depressive disorders.Trial registrationClinical Trials Register (EudraCT number:2021-006773-38, registration date: 14 September 2022) and German Register of Clinical Studies (DRKS number:DRKS00031099, registration date: 23 January 2023). (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial
DiscussionThe clinical benefits of mNGS are potentially significant, but its limitations should also be considered.Trial registrationChineseClinicalTrialRegistry.org, ChiCTR2300076853. Registered on 22 October 2023. (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
