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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.
Self-regulation in eHealth: definition, contributing factors, and experiences from blended rehabilitation care.
Disabil Rehabil
January 2025
Biomedical Signals and Systems, Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, Netherlands.
Purpose: eHealth might contribute to changes in roles and responsibilities of patients and healthcare professionals (HCPs), including the patient's potential to enhance self-regulation. The aim of this study was to identify important aspects and experiences of self-regulation and factors that may support self-regulation in blended rehabilitation care.
Materials And Methods: Semi-structured interviews were conducted among HCPs and patients regarding perceptions and experiences with self-regulation in relation to a telerehabilitation portal.
Application 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.
View Article and Find Full Text PDFA Comprehensive Weightbearing Computed Tomography Study on Patients With Hallux Valgus: Exploring Multiplanar Deformity Interrelationships.
Foot Ankle Int
January 2025
Division of Foot and Ankle, Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.
Background: Hallux valgus (HV) is a complex, multiplanar deformity. In this study, we examined the interrelationships between various components of this deformity using weightbearing computed tomography (WBCT). We hypothesized that the severity of traditional axial plane deformities would correlate with malpositioning of the metatarsosesamoid complex, first-ray coronal rotational deformity, and malalignment of the hindfoot and midfoot.
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