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Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFDifferences in Brain Volume and Thickness between Shammah (Smokeless Tobacco) Users and Non-Users: A Cross-Sectional Study.
Br J Hosp Med (Lond)
January 2025
Aberdeen Biomedical Imaging Centre, University of Aberdeen, Aberdeen, UK.
Previous research has shown that smoking tobacco is associated with changes or differences in brain volume and cortical thickness, resulting in a smaller brain volume and decreased cortical thickness in smokers compared with non-smokers. However, the effects of smokeless tobacco on brain volume and cortical thickness remain unclear. This study aimed to investigate whether the use of shammah, a nicotine-containing smokeless tobacco popular in Middle Eastern countries, is associated with differences in brain volume and thickness compared with non-users and to assess the influence of shammah quantity and type on these effects.
View Article and Find Full Text PDFMechanism evaluation of a digitally enabled rehabilitation intervention for people in aged care and neurological rehabilitation: mediation analysis of the AMOUNT trial.
Disabil Rehabil
January 2025
Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.
Purpose: To investigate potential mechanisms of a digital rehabilitation intervention associated with improved mobility among adults undertaking rehabilitation.
Materials And Methods: Causal mediation analysis of the AMOUNT trial (ACTRN12614000936628). Participants were randomised to digitally-enabled rehabilitation (virtual reality video games, activity monitors, and handheld computer devices prescribed by a physiotherapist) and usual care or usual care alone.
An evaluation of mepolizumab as an add-on maintenance treatment for severe eosinophilic asthma.
Expert Opin Biol Ther
January 2025
State Key Laboratory of Respiratory Disease, Joint International Research Laboratory of Respiratory Health, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Allergy and Clinical Immunology, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, P.R. China.
Introduction: Clinical experience with anti-interleukin (IL)-5 biologic therapies for severe asthma has been increasing, alongside deeper and broader research focusing on the role of IL-5 and the IL-5 targeted mepolizumab. This review aims to provide an update of the evidence on the role of IL-5 and mepolizumab, with discussions of the benefits of mepolizumab and its future potential, to promote the comprehension of the pathophysiology and therapeutic approaches to asthma.
Areas Covered: For this narrative review, we conducted a database search in PubMed and Embase using the keywords 'IL-5' and 'mepolizumab,' focusing on randomized controlled trials and real-world studies up to September 2024.
Two pathogen-inducible UDP-glycosyltransferases, UGT73C3 and UGT73C4, catalyze the glycosylation of pinoresinol to promote plant immunity in Arabidopsis.
Plant Commun
January 2025
The Key Laboratory of Plant Development and Environmental Adaptation Biology, Ministry of Education; Shandong Key Laboratory of Precision Molecular Crop Design and Breeding; School of Life Sciences, Shandong University, Qingdao 266237, China. Electronic address:
UDP-glycosyltransferases (UGTs) constitute the largest glycosyltransferase family in the plant kingdom. They are responsible for transferring sugar moieties onto various small molecules to control many metabolic processes. However, their physiological significance in plants is largely unknown.
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