RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC)
Post-acute sequelae of SARS-CoV-2 infection (PASC) symptoms have broad impact, and may affect individuals regardless of COVID-19 severity, socioeconomic status, race, ethnicity, or age. A prominent PASC sympto... (Source: Trials)
Source: Trials - May 17, 2024 Category: General Medicine Authors: David S. Knopman, Daniel T. Laskowitz, Deborah C. Koltai, Leigh E. Charvet, Jacqueline H. Becker, Alex D. Federman, Juan Wisnivesky, Henry Mahncke, Thomas M. Van Vleet, Lucinda Bateman, Dong-Yun Kim, Ashley O ’Steen, Melissa James, Adam Silverstein, Yul Tags: Study protocol Source Type: research

Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery: study protocol for a randomized controlled trial
The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions... (Source: Trials)
Source: Trials - May 17, 2024 Category: General Medicine Authors: Shota Fukai, Yuki Mizusawa, Hiroshi Noda, Shingo Tsujinaka, Yukihisa Maeda, Ryuji Hasebe, Yusuke Eguchi, Rina Kanemitsu, Natsumi Matsuzawa, Iku Abe, Yuhei Endo, Taro Fukui, Yuji Takayama, Kosuke Ichida, Koetsu Inoue, Yuta Muto & hellip; Tags: Study protocol Source Type: research

RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC)
This study is designed to test whether cognitive dysfunction symptoms can be alleviated by the use of pragmatic and established interventions with different mechanisms of action and with prior evidence of improving cognitive function in patients with neurocognitive disorder. If successful, results will provide beneficial treatments for PASC-related cognitive dysfunction.Trial registrationClinicalTrials.gov NCT05965739. Registered on July 25, 2023. (Source: Trials)
Source: Trials - May 17, 2024 Category: Research Source Type: clinical trials

Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery: study protocol for a randomized controlled trial
DiscussionThis trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates.Trial registrationUMIN-CTR UMIN000048442. Registered on 1 August 2022.https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi...
Source: Trials - May 17, 2024 Category: Research Source Type: clinical trials

Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial
Prediabetes is a highly prevalent condition that heralds an increased risk of progression to type 2 diabetes, along with associated microvascular and macrovascular complications. The Diabetes Prevention Progra... (Source: Trials)
Source: Trials - May 16, 2024 Category: General Medicine Authors: Mohammed S. Abusamaan, Jeromie Ballreich, Adrian Dobs, Brian Kane, Nisa Maruthur, John McGready, Kristin Riekert, Amal A. Wanigatunga, Mary Alderfer, Defne Alver, Benjamin Lalani, Benjamin Ringham, Fatmata Vandi, Daniel Zade and Nestoras N. Mathioudakis Tags: Study protocol Source Type: research

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts
The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process th... (Source: Trials)
Source: Trials - May 16, 2024 Category: General Medicine Authors: Jeremy Segrott, Sue Channon, Amy Lloyd, Eleni Glarou, Josie Henley, Jacqueline Hughes, Nina Jacob, Sarah Milosevic, Yvonne Moriarty, Bethan Pell, Mike Robling, Heather Strange, Julia Townson and Lucy Brookes-Howell Tags: Research Source Type: research

Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial
The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicyli... (Source: Trials)
Source: Trials - May 16, 2024 Category: General Medicine Authors: Tomislav Kopjar, Hrvoje Gasparovic, Maja Hrabak Paar, Daniel Lovric, Petra Cerina, Tomislav Tokic and Davor Milicic Tags: Study protocol Source Type: research

Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial
DiscussionAntithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenua...
Source: Trials - May 16, 2024 Category: Research Source Type: clinical trials

Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial
DiscussionPrediabetes is a significant public health issue, necessitating scalable interventions for the millions affected. Our pragmatic clinical trial is unique in directly comparing a fully automated AI-powered approach without direct human coach interaction. If proven effective, it could be a scalable, cost-effective strategy. This trial will offer vital insights into both AI and human coach-based behavioral change strategies in real-world clinical settings.Trial registrationClinicalTrials.gov NCT05056376. Registered on September 24, 2021,https://clinicaltrials.gov/study/NCT05056376 (Source: Trials)
Source: Trials - May 16, 2024 Category: Research Source Type: clinical trials

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts
ConclusionsGiven that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit ’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introd ucing new practices within organisations. (Source: Trials)
Source: Trials - May 16, 2024 Category: Research Source Type: clinical trials

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial
Although the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physi... (Source: Trials)
Source: Trials - May 15, 2024 Category: General Medicine Authors: Johannes Carl, Eva Gr üne, Johanna Popp, Verena Hartung and Klaus Pfeifer Tags: Study protocol Source Type: research

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial
ConclusionThe study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.Trial registrationClinical trials NCT05817396. Registered on April 18, 2023. (Source: Trials)
Source: Trials - May 15, 2024 Category: Research Source Type: clinical trials

Comparing effectiveness of physiotherapy versus drug management on fatigue, physical functioning, and episodic disability for myalgic encephalomyelitis in post-COVID-19 condition: a study protocol of randomized control trial
This study will address the research gap to determine the appropriate approach of physiotherapy or drug management for ME/CFS in PCC cases. The future direction of the study will contribute to developing evidence-based practice in post-COVID-19 condition rehabilitation.Trial registrationThe trial is registered prospectively from a primary Clinical Trial Registry side of WHO CTRI/2024/01/061987. Registered on 29 January 2024. (Source: Trials)
Source: Trials - May 15, 2024 Category: Research Source Type: clinical trials

High-definition transcranial direct current stimulation (HD-tDCS) in major depressive disorder with anxious distress —a study protocol for a double-blinded randomized sham-controlled trial
DiscussionThe HD-tDCS applied in this trial may have treatment effects on MDD with ADS and have minimal side effects.Trial registrationThe trial protocol is registered withwww.chictr.org.cn under protocol registration number ChiCTR2300071726.  Registered 23 May 2023. (Source: Trials)
Source: Trials - May 15, 2024 Category: Research Source Type: clinical trials

High-definition transcranial direct current stimulation (HD-tDCS) in major depressive disorder with anxious distress —a study protocol for a double-blinded randomized sham-controlled trial
Comorbid anxiety disorders and anxious distress are highly prevalent among individuals with major depressive disorder (MDD). The presence of the DSM-5 anxious distress specifier (ADS) has been associated with ... (Source: Trials)
Source: Trials - May 15, 2024 Category: General Medicine Authors: Danwei Zhang, Bei Zhao, Xue Sun, Kaimo Ding, Jingjing Sun and Sheng Tao Tags: Study protocol Source Type: research