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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 PDFSelf-reported health status of patients with acute retinal ischemia and stroke related hemianopia.
Eur Stroke J
January 2025
Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Background: We aimed to assess impairments on health-related quality of life, and mental health resulting from Retinal artery occlusion (RAO) with monocular visual field loss and posterior circulation ischemic stroke (PCIS) with full or partial hemianopia using patient-reported outcome measures (PROMs).
Methods: In a prospective study, consecutive patients with acute RAO on fundoscopy and PCIS on imaging were recruited during their surveillance on a stroke unit over a period of 15 months. Baseline characteristics were determined from medical records and interviews.
Comparison 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.
Diagnostic Value of Neutrophil-to-Lymphocyte Ratio (NLR) in Intrahepatic Cholestasis of Pregnancy.
Br J Hosp Med (Lond)
January 2025
Department of Obstetrics, Beilun District People's Hospital, Ningbo, Zhejiang, China.
Intrahepatic cholestasis of pregnancy (ICP) is associated with adverse perinatal outcomes, yet the correlation between ICP and the neutrophil-to-lymphocyte ratio (NLR) remains unclear. This study aims to investigate the diagnostic value of NLR in ICP. In this retrospective case-control study, 113 patients with ICP treated in Beilun District People's Hospital from January 2020 to December 2022 were recruited and categorized as the ICP group, and 209 healthy pregnant women treated during the same period were selected as the control group.
View Article and Find Full Text PDFProfiling Exosomal Metabolomics as a Means for Diagnosis and Researching Early-Stage Hypertensive Nephropathy.
Br J Hosp Med (Lond)
January 2025
Department of Cardiology, The Second Affiliated Hospital of Chengdu Medical College, Nuclear Industry 416 Hospital, Chengdu, Sichuan, China.
Hypertension (HT) is a prevalent medical condition showing an increasing incidence rate in various populations over recent years. Long-term hypertension increases the risk of the occurrence of hypertensive nephropathy (HTN), which is also a health-threatening disorder. Given that very little is known about the pathogenesis of HTN, this study was designed to identify disease biomarkers, which enable early diagnosis of the disease, through the utilization of high-throughput untargeted metabolomics strategies.
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