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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 PDFMeasurement properties of the Trunk Impairment Scale-modified Norwegian version among people with mild to moderate multiple sclerosis.
Disabil Rehabil
January 2025
Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway.
Purpose: The Trunk Impairment Scale-modified Norwegian version (TIS-modNV) measures trunk control for clinical and research purposes. This study examined the validity and reliability of the TIS-modNV in people with multiple sclerosis (pwMS).
Materials And Methods: Sixty-eight pwMS (mild to moderate) participated.
Equine temporomandibular joint diseases: A systematic review.
Equine Vet J
January 2025
Department of Large Animal Diseases and Clinic, Institute of Veterinary Medicine, Warsaw University of Life Sciences (WULS - SGGW), Warsaw, Poland.
Background: The temporomandibular joint (TMJ) is a unique joint that enables mandibular movement. Temporomandibular diseases (TMDs) impair joint function, leading to more or less specific clinical signs.
Objectives: To compile and disseminate clinical data and research findings from existing publications on equine TMD.
Clinical Features of Human Parvovirus B19-Associated Encephalitis Identified in the Dakar Region, Senegal, and Viral Genome Characterization.
Viruses
January 2025
Virology Department, Institut Pasteur de Dakar, 36 Avenue Pasteur, Dakar 200, Senegal.
Neurological manifestations associated with human parvovirus B19 (B19V) infections are rare and varied. Acute encephalitis and encephalopathy are the most common, accounting for 38.8% of all neurological manifestations associated with human B19V.
View Article and Find Full Text PDFDifference in Optical Coherence Tomography Angiography Parameters After SARS-CoV-2 Infection During the Alpha and Delta Variant Dominance Periods.
Viruses
December 2024
Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Białystok, Poland.
The SARS-CoV-2 infection manifests with diverse clinical manifestations, with severity potentially influenced by the viral variant. COVID-19 has also been shown to impact ocular microcirculation in some patients, but whether this effect varies by viral lineage remains unclear. This prospective study compared clinical features and ocular parameters assessed via optical coherence tomography angiography (OCTA) in patients recovering from SARS-CoV-2 infections during the dominance of two distinctive viral lineages, Alpha (B.
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