Using a theory-based, customized video game as an educational tool to improve physicians ’ trauma triage decisions: study protocol for a randomized cluster trial
DiscussionThe results of the trial will inform future efforts to improve the implementation of clinical practice guidelines in trauma triage and will provide deeper understanding of effective strategies to reduce diagnostic errors during time-sensitive decision making.Trial registrationClinicalTrials.gov;NCT06063434. Registered 26 September 2023. (Source: Trials)
Source: Trials - February 16, 2024 Category: Research Source Type: clinical trials
Obesity Treatments to Improve Type 1 Diabetes (OTID): a randomized controlled trial of the combination of glucagon-like peptide 1 analogues and sodium-glucose cotransporter 2 inhibitors —protocol for Obesity Treatments to Improve Type 1 Diabetes (the OTID trial)
This study addresses the current gap in the evidence base regarding the combination of these two drugs, which is particularly relevant given the American Diabetes Association and European Association for the Study of Diabetes guidelines recommending their combined use for patients with obesity, type 2 diabetes, and chronic kidney disease who do not achieve metabolic control with either drug alone.Trial registrationClinicalTrials.gov Identifier: NCT05390307 Trial registration date - 25th May 2022 (Source: Trials)
Source: Trials - February 16, 2024 Category: Research Source Type: clinical trials
Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals
The objective of this study is to investigate whether the developed recruitment tool has a positive effect on study recruitment within a multi-center environment by increasing the number of participants. Its secondary objective is the measurement of organizational burden and user satisfaction of the provided IT solution.MethodsThe study uses an Interrupted Time Series Design with a duration of 15 months. All trials start in the control phase of randomized length with regular recruitment and change to the intervention phase with additional IT support. The intervention consists of the application of a recruitment-support sys...
Source: Trials - February 16, 2024 Category: Research Source Type: clinical trials
Impact of model-informed precision dosing in adults receiving vancomycin via continuous infusion: a randomized, controlled clinical trial
Discussion This trial will clarify the propagated benefits and provide new insights into how to optimally monitor vancomycin treatment.Trial registrationEudraCT number: 2021-003670-31. Registered June 28, 2021. ClinicalTrials.gov identifier: NCT05535075. Registered September 10, 2022. Protocol version 3, protocol date: April 21, 2023. (Source: Trials)
Source: Trials - February 16, 2024 Category: Research Source Type: clinical trials
Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study): study protocol for a multicenter randomized, double-blind clinical trial
Anorectal fistula, which is a relatively common pathology, is the chronic manifestation of the acute perirectal process that forms an anal abscess. The development of a fistula after incision and drainage of a... (Source: Trials)
Source: Trials - February 15, 2024 Category: General Medicine Authors: Ver ónica Polaino Moreno, Antonio F. Caballero-Bermejo, Mariano Artés Caselles, Javier Serrano González, Xabier Remírez Arriaga, Natalia González Alcolea, Aritz Equisoain Azcona, Eva Iglesias García, José Luis Lucena de la Poza, Arsenio Sánchez Mo Tags: Study protocol Source Type: research
Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!)
Currently, there is no evidence-based hormonal treatment for migraine in women. Several small studies suggest a beneficial effect of combined oral contraceptives, but no large randomized controlled trial has b... (Source: Trials)
Source: Trials - February 15, 2024 Category: General Medicine Authors: Britt W. H. van der Arend, Daphne S. van Casteren, Iris E. Verhagen, Antoinette MaassenVanDenBrink and Gisela M. Terwindt Tags: Study protocol Source Type: research
Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)
Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to hea... (Source: Trials)
Source: Trials - February 15, 2024 Category: General Medicine Authors: David Goodman-Meza, Steven Shoptaw, Brett Hanscom, Laramie R. Smith, Philip Andrew, Irene Kuo, Jordan E. Lake, David Metzger, Ellen A. B. Morrison, Melissa Cummings, Jessica M. Fogel, Paul Richardson, Jayla Harris, Jesse Heitner, Sarah Stansfield and Nabi Tags: Study protocol Source Type: research
Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!)
ConclusionsThe WHAT! trial aims to investigate effectivity and safety of continuous combined oral contraceptive treatment for menstrual migraine. Immediate implementation of results in clinical practice is possible.Trial registrationClinical trials.govNCT04007874. Registered 28 June 2019. (Source: Trials)
Source: Trials - February 15, 2024 Category: Research Source Type: clinical trials
Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)
DiscussionThis trial responds to a need for evidence on using a “whole-person” strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care.Trial registrationClinicalTria...
Source: Trials - February 15, 2024 Category: Research Source Type: clinical trials
Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study): study protocol for a multicenter randomized, double-blind clinical trial
DiscussionThis clinical trial is designed to evaluate the efficacy and safety of amoxicillin/clavulanic in the prevention of perianal fistula. The results of this study are expected to contribute to stablish the potential role of antibiotherapy in the therapeutics for anal abscess.Trial registrationEudraCT Number: 2021 –003376-14. Registered on November 26, 2021. (Source: Trials)
Source: Trials - February 15, 2024 Category: Research Source Type: clinical trials
HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life: study protocol and rationale for the HYDRO-PROTECT randomized controlled trial
Autosomal dominant polycystic kidney disease (ADPKD) leads to progressive renal cyst formation and loss of kidney function in most patients. Vasopressin 2 receptor antagonists (V2RA) like tolvaptan are current... (Source: Trials)
Source: Trials - February 14, 2024 Category: General Medicine Authors: Thomas Bais, Esther Meijer, Bart J. Kramers, Priya Vart, Marc Vervloet, Mahdi Salih, Bert Bammens, Nathalie Demoulin, Polina Todorova, Roman-Ulrich M üller, Jan Halbritter, Alexander Paliege, Emilie Cornec-Le Gall, Bertrand Knebelmann, Roser Torra, Alber Tags: Methodology Source Type: research
Outpatient follow-up of tumour diseases through video-based value-oriented behavioural activation (ViVA): study protocol for a randomised controlled trial
In Germany, approximately half a million people are diagnosed with cancer annually; this can be traumatic and lead to depression, anxiety, and adjustment disorders necessitating psycho-oncological intervention... (Source: Trials)
Source: Trials - February 14, 2024 Category: General Medicine Authors: Maren Reder, Christine Hofheinz, Lena Melzner, Gabriele Prinz and Christoph Kr öger Tags: Study protocol Source Type: research
Outpatient follow-up of tumour diseases through video-based value-oriented behavioural activation (ViVA): study protocol for a randomised controlled trial
This study was registered at the German Clinical Trials Register: DRKS00031900 on Sep 19, 2023. (Source: Trials)
Source: Trials - February 14, 2024 Category: Research Source Type: clinical trials
HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life: study protocol and rationale for the HYDRO-PROTECT randomized controlled trial
ConclusionThe HYDRO-PROTECT study will demonstrate whether co-treatment with HCT can improve the renoprotective efficacy and tolerability of tolvaptan in patients with ADPKD. (Source: Trials)
Source: Trials - February 14, 2024 Category: Research Source Type: clinical trials
Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial
Out-of-hospital cardiac arrest (OHCA) is a significant public health issue worldwide and is associated with low survival rates and poor neurological outcomes. The generation of optimal coronary perfusion press... (Source: Trials)
Source: Trials - February 13, 2024 Category: General Medicine Authors: Hee Eun Kim, Sheng-En Chu, You Hwan Jo, Wen-Chu Chiang, Dong-Hyun Jang, Chin-Hao Chang, So Hee Oh, Hsuan-An Chen, Seung Min Park, Jen-Tang Sun and Dong Keon Lee Tags: Methodology Source Type: research
