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Adaptive promising zone design for sequential parallel comparison design with continuous outcomes.
Clin Trials
January 2025
Department of Biostatistics, University of Florida, Gainesville, FL, USA.
Introduction: The sequential parallel comparison design has emerged as a valuable tool in clinical trials with high placebo response rates. To further enhance its efficiency and effectiveness, adaptive strategies, such as sample size adjustment and allocation ratio modification can be employed.
Methods: We compared the performance of Jennison and Turnbull's method and the Promising Zone approach for sample size adjustment in a two-phase sequential parallel comparison design study.
Background/aims: Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632).
Methods: Participants aged 50-77 years were recruited from eight Cancer Alliance regions in England.
Atomized Neutrophil Membrane-coated MOF Nanoparticles for Direct Delivery of Dexamethasone for Severe Pneumonia.
Front Biosci (Landmark Ed)
January 2025
Institute of Translational Medicine, Shanghai University, 200444 Shanghai, China.
Background: Dexamethasone has proven life-saving in severe acute respiratory syndrome (SARS) and COVID-19 cases. However, its systemic administration is accompanied by serious side effects. Inhalation delivery of dexamethasone (Dex) faces challenges such as low lung deposition, brief residence in the respiratory tract, and the pulmonary mucus barrier, limiting its clinical use.
View Article and Find Full Text PDFSERT-Deficient Mice Fed Western Diet Reveal Altered Metabolic and Pro-Inflammatory Responses of the Liver: A Link to Abnormal Behaviors.
Front Biosci (Landmark Ed)
January 2025
Division of Molecular Psychiatry, Center of Mental Health, University of Hospital Würzburg, 97080 Würzburg, Germany.
Background: The inheritance of the short allele, encoding the serotonin transporter (SERT) in humans, increases susceptibility to neuropsychiatric and metabolic disorders, with aging and female sex further exacerbating these conditions. Both central and peripheral mechanisms of the compromised serotonin (5-HT) system play crucial roles in this context. Previous studies on SERT-deficient (Sert) mice, which model human SERT deficiency, have demonstrated emotional and metabolic disturbances, exacerbated by exposure to a high-fat Western diet (WD).
View Article and Find Full Text PDFComparison of Interportal and Periportal Capsulotomies and Axial Distraction Resistance During Hip Arthroscopy: An In Vivo Propensity-Matched Cohort Study.
Am J Sports Med
January 2025
Department of Orthopaedics, University of Utah, Salt Lake City, Utah, USA.
Background: Intraoperative hip capsule management is increasingly recognized as an important component of hip arthroscopy for the prevention of capsular-related instability. The periportal capsulotomy, relative to the interportal capsulotomy, has been proposed as a minimally invasive technique for decreasing postarthroscopy hip instability; however, the biomechanical effects of this technique are not well established.
Purpose/hypothesis: This study aimed to provide a biomechanical characterization of interportal and periportal capsulotomies, helping inform surgeon choice of capsulotomy type and repair, potentially guiding clinical practice in hip arthroscopy.
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