Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial
ConclusionsOur application of estimands defined by the ICH E9 (R1) addendum offers a formalized framework for addressing the primary TB treatment trial objective and can promote uniformity in future trials by limiting heterogeneity in trial outcome definitions. We demonstrated the utility of our proposal using data from the REMoxTB randomized trial. We outlined methods for estimating each estimand and found consistent conclusions across estimands. We recommend future late-phase TB treatment trials to implement some or all of our estimands to promote rigorous outcome definitions and reduce variability between trials.Trial r...
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial
DiscussionHigh-quality evidence guiding the management of women with VLP is lacking. Once completed, this will be the first double-blinded RCT to compare systemic treatments in VLP. The results of this study will provide valuable, high-quality data to guide second-line therapy options for VLP that is recalcitrant to potent topical corticosteroids.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12623000682640. Registered on 26 June 2023. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial
This study will examine an intervention designed to determine early on which patients will benefit from parallel or other measures than assessment and treatment in CMHC and whether these will facilitate their recovery. Findings may potentially contribute to the development of the organisation of mental health services.Trial registrationClinicalTrials.gov NCT05087446. Registered on 21 October 2021. (Source: Trials)
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial
Referrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by s... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Camilla Angelsen Kvestad, Ingvild R ønneberg Holte, Solveig Klæbo Reitan, Charlotte S. Chiappa, Gunn Karin Helle, Anne E. Skjervold, Anne Marit A. Rosenlund, Øyvind Watne, Heidi Brattland, Jon Helle, Turid Follestad, Karen Walseth Hara and Katrine Høy Tags: Study protocol Source Type: research
EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ( “EFFECT-BACK”): study protocol for a randomized controlled trial
ConclusionThis study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it s...
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial
DiscussionIf eliPfad leads to fewer readmissions, proves (cost-)effective, and lowers the treatment burden, it should be introduced as a new standard of care in the German healthcare system.Trial registrationThe trial was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) on 08/14/2023 under the IDDRKS00031500. (Source: Trials)
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial
This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) and immunoglobulin G (IgG), in Norwegian male blood donors.MethodsThis randomized controlled trial (RCT) included 120 male blood donors who were randomized into two intervention groups and one control group: high-frequency plasma donors (HFPDs) who donated 650 mL of plasma 3 times every 2 weeks, whereas regular-frequency plasma donors (RFPDs) who donated 650 mL of plasma 1 time every 2 weeks. The control group consisted of whole blood donors. The primary outcomes are the concentrations ...
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
Correction: Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts
(Source: Trials)
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial
The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Morten Haugen, Karin Magnussen, Tonje Eiane Aarsland, Lise Sofie Haug Nissen-Meyer and Tor A. Strand Tags: Study protocol Source Type: research
EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ( “EFFECT-BACK”): study protocol for a randomized controlled trial
Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfac... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witth öft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen and Julia Anna Glombiewski Tags: Study protocol Source Type: research
Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial
Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hosp... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Christoph Heinrich Lindemann, Volker Burst, Linus Alexander V ölker, Sebastian Brähler, Dusan Simic, Ingrid Becker, Martin Hellmich, Clarissa Kurscheid, Nadine Scholten, Ruben Krauspe, Kerstin Leibel, Stephanie Stock and Paul Thomas Brinkkoetter Tags: Study protocol Source Type: research
Correction: Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts
(Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hofmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S Tags: Correction Source Type: research
Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial
This study adds to a very small number of clinical trials seeking to prevent lethal suicide among a very high-risk group by addressing suicidal ideation directly rather than underlying conditions. It is hypothesized that youth receiving CTSP + SAU will show greater reductions in suicidal ideation (primary outcome), substance use, and depressive symptoms (secondary outcomes) over time compared to SAU alone, as well as improved risk and protective factors.Trial registrationNCT05994612. Date of Registration: August 16, 2023. (Source: Trials)
Source: Trials - March 9, 2024 Category: Research Source Type: clinical trials
Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial
Emerging adults (EAs) who are not 4-year college students nor graduates are at elevated risk for lifetime alcohol use disorder, comorbid drug use, and mental health symptoms, compared to college graduates. The... (Source: Trials)
Source: Trials - March 9, 2024 Category: General Medicine Authors: James G. Murphy, Ashley A. Dennhardt, Jacob Tempchin, Hannah E. Colgonis, Meghan E. McDevitt-Murphy, Brian Borsari and Kristoffer S. Berlin Tags: Study protocol Source Type: research
Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial
DiscussionThe results of this study will inform alcohol prevention efforts for high-risk community dwelling emerging adults.Trial registrationClinicalTrials.gov Identifier: NCT04776278. (Source: Trials)
Source: Trials - March 9, 2024 Category: Research Source Type: clinical trials
