Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)
Chronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remai... (Source: Trials)
Source: Trials - March 22, 2024 Category: General Medicine Authors: Lillian Streichart, Marie Felldin, Jana Ekberg, Lars Mj örnstedt, Per Lindnér, Annette Lennerling, Verena Bröcker, Johan Mölne, Jan Holgersson, Kristien Daenen, Lars Wennberg, Tomas Lorant and Seema Baid-Agrawal Tags: Study protocol Source Type: research
Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)
DiscussionNo effective treatment exists for caAMR at present. Based on the hypothesis that inhibition of IL-6 receptor by tocilizumab will reduce antibody production and reduce antibody-mediated damage, our randomized trial has a potential to provide evidence for a novel treatment strategy for caAMR, therewith slowing the decline in graft function in the long-term.Trial registrationClinicalTrials.gov NCT04561986. Registered on September 24, 2020 (Source: Trials)
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspiration and Preservation of Swallowing (PREHAPS): study protocol of a monocentric prospective randomized interventional outcome-blinded trial
DiscussionPrehabilitation measures have already proven successful in other patient groups, e.g., transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually, only subgroups, e.g., patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life.Trial registrationGerman Clinical Trials RegisterDRKS00029676. International Clinical Trials Registry Pl...
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
Sacral neuromodulation for constipation and fecal incontinence in children and adolescents – study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique
DiscussionThis is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM).Trial registrationThe study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021). (Source: Trials)
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV
DiscussionThe efficacy trial of PATH will help to fill gaps in our scientific understanding of how a combined peer navigation and mHealth approach may produce effects on HIV care outcomes while addressing potential implementation challenges of peer navigation in Ryan White-funded clinics.Trial registrationThe PATH trial is registered at the United States National Institutes of Health National Library of Medicine (ClinicalTrials.gov) under ID #NCT05427318. Registered on 22 June 2022. (Source: Trials)
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial
DiscussionOxidative stress is recognized as a key contributor to migraine pathogenesis. Selenium is an essential trace element with antioxidant properties, capable of crossing the blood –brain barrier (BBB), holding promise to alleviate the oxidative stress and neurotoxicity. Thus, selenium may beneficially affect clinical symptoms and oxidative stress as well as the quality of life in migraine patients.Trial registrationThis trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) on 27 May 2023 with the code number IRCT20121216011763N60. (Source: Trials)
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies
Proteinuria is a modifiable risk factor for chronic kidney disease (CKD) progression in children. Finerenone, a selective, non-steroidal, mineralocorticoid receptor antagonist (MRA) has been approved to treat ... (Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Franz Schaefer, Giovanni Montini, Hee Gyung Kang, Johan Vande Walle, Joshua Zaritsky, Michiel F. Schreuder, Mieczyslaw Litwin, Andrea Scalise, Helen Scott, James Potts, Pablo Iveli, Stefanie Breitenstein and Bradley A. Warady Tags: Methodology Source Type: research
Developing generic templates to shape the future for conducting integrated research platform trials
Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Pr... (Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Madhavi Gidh-Jain, Tom Parke, Franz K önig, Cecile Spiertz and Peter Mesenbrink Tags: Methodology Source Type: research
Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation
There is little evidence on how to support ultra-poor people with disabilities to adopt sustainable livelihoods. The Disability-Inclusive Graduation (DIG) programme targets ultra-poor people with disabilities ... (Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Elijah Kipchumba, Calum Davey, Sarah Marks, Anthony Mugeere, Shanquan Chen, Lena Morgon Banks, Kazi Eliza Islam, Tom Shakespeare, Hannah Kuper and Munshi Sulaiman Tags: Study protocol Source Type: research
Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial
This study examines an intervention that targets DD through enhanced cross-sectoral coll... (Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders L. S ønderlund and Jens Søndergaard Tags: Study protocol Source Type: research
Correction: Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda
(Source: Trials)
Source: Trials - March 21, 2024 Category: General Medicine Authors: Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts and Daniela C. Fuhr Tags: Correction Source Type: research
Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial
This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population.Trial registrationClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation
DiscussionDIG is a promising intervention to evaluate for people with disabilities, adapted to be disability inclusive across programme components through extensive consultations and collaboration, and has proven efficacy at reducing poverty in other marginalised groups. However, evaluating a well-evidenced intervention among a new target group poses ethical considerations.Trial registrationRegistry for International Development Impact Evaluations, RIDIE-STUDY-ID-626008898983a (20/04/22). ISRCTN registry,ISRCTN78592382. Retrospectively registered on 17/08/2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies
ConclusionFIONA is evaluating the use of finerenone in children with CKD and proteinuria. Should safety, tolerability, and efficacy be demonstrated, finerenone could become a useful additional therapeutic agent in managing proteinuria and improving kidney outcomes in children with CKD.Trial registrationClinicalTrials.gov NCT05196035. Registered on 19 January 2022. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Developing generic templates to shape the future for conducting integrated research platform trials
ConclusionsThis publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website (http://www.eu-pearl) should facilitate the designing of IRP trials. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
