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Characterization of medical device randomized controlled trials with adaptive designs.
J Comp Eff Res
January 2025
Department of Clinical Research & Medical Science, Medtronic China, 19th Floor, Building B, The New Bund World Trade Center Phase I, No. 5 Lane 255 Dongyu Road, Pudong New District, Shanghai, 200126, China.
Adaptive designs are frequently used in drug randomized controlled trials (RCTs). However, their use in medical device RCTs remains unclear. We aimed to characterize medical device RCTs with adaptive designs.
View Article and Find Full Text PDFDoravirine/islatravir for the treatment of HIV.
Expert Opin Pharmacother
January 2025
Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, TN, USA.
Introduction: HIV is a global disease affecting millions of people. While treatments have improved over the past decades, treatment failure remains a significant issue for treatment experienced patients. Doravirine/islatravir is a new dual-therapy regimen with a promising resistance profile and reductions in central nervous system effects.
View Article and Find Full Text PDFBooster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial.
BMJ Open
November 2024
Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Introduction: Anti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk for harmful drug-drug interactions (DDI). In this trial, we aim to assess the efficacy of the combination doravirine, dolutegravir and lamivudine (DOR/DTG/3TC) among people with a history of virological failure who receive boosted ART.
View Article and Find Full Text PDFLength of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials.
Crit Care
November 2024
Division of Infectious Diseases, Department of Internal Medicine, and Department of Medical Microbiology and Immunology, University of California Davis Medical Center, Sacramento, CA, USA.
Background: Invasive candidiasis/candidemia (IC/C) is associated with a substantial health economic burden driven primarily by prolonged hospital stay. The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C. This paper reports a post hoc pooled exploratory analysis of length of stay (LoS) for hospital and intensive care unit (ICU) stays in two previously published clinical trials (ReSTORE [NCT03667690] and STRIVE [NCT02734862], that compared rezafungin with daily IV caspofungin (stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more).
View Article and Find Full Text PDFStudy protocol for a multicenter non-inferiority randomized controlled trial to assess functional outcomes and cost-effectiveness of a primarily non-operative treatment strategy with cast immobilization versus immediate operative treatment followed by cast immobilization for patients with complete ulnar collateral ligament ruptures, including Stener lesions: MUSCAT study.
Trials
October 2024
Department of Trauma Surgery, Diakonessenhuis, Utrecht, The Netherlands.
Article Synopsis
- Guidelines recommend surgery followed by casting for UCL ruptures, but high-quality studies comparing surgical and non-surgical treatments are scarce.
- This study aims to investigate if non-operative treatment with cast immobilization is just as effective and less costly than immediate surgery for these injuries.
- The trial includes patients over 18, comparing outcomes between two groups over six months, with a focus on hand function and the potential need for follow-up surgery.
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