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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.
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 PDFAssociation of Geriatric Nutritional Risk Index Scores with Outcomes in Patients Undergoing Maintenance Hemodialysis.
Br J Hosp Med (Lond)
January 2025
Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.
The Geriatric Nutritional Risk Index (GNRI) is an effective tool for identifying malnutrition, and helps monitor the prognosis of patients undergoing maintenance hemodialysis. However, the association between the GNRI and cardiovascular or all-cause mortality in hemodialysis patients remains unclear. Therefore, this study investigated the correlation of the GNRI with all-cause and cardiovascular mortality in patients undergoing maintenance hemodialysis.
View Article and Find Full Text PDFApplication of the Omaha System-Based Continuous Care Model in Diabetes Health Management for Outpatients within the Framework of "Internet +".
Br J Hosp Med (Lond)
January 2025
Nursing Department, Zhang Ye People's Hospital Affiliated to Hexi University, Zhangye, Gansu, China.
Diabetes is a chronic lifelong condition that requires consistent self-care and daily lifestyle adjustments. Effective disease management involves regular blood glucose monitoring and ongoing nursing support. Inadequate education and poor self-management are key factors contributing to increased mortality among diabetic individuals.
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