Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
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 PDFBackground/aims: Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632).
Methods: Participants aged 50-77 years were recruited from eight Cancer Alliance regions in England.
The Effect of Transition From Multiple Daily Injection Therapy to Automated Insulin Delivery in People With Type 1 Diabetes and Limited Diabetes Self-Management.
J Diabetes Sci Technol
January 2025
Department of Endocrinology and Nephrology, Copenhagen University Hospital-North Zealand, Hillerød, Denmark.
Design and early progress of the Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
Int J Stroke
January 2025
Medical University of South Carolina, Charleston, SC, USA.
Background: The usual antithrombotic treatment for symptomatic intracranial atherosclerotic stenosis (ICAS) consists of dual treatment with clopidogrel and aspirin for 90 days followed by aspirin alone but the risk of recurrent stroke remains high up to 12 months. The Comparison of Anticoagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial was designed to determine whether other combinations of dual antithrombotic therapy are superior to clopidogrel and aspirin.
Methods: CAPTIVA is an ongoing, prospective, double-blinded, three-arm clinical trial at over 100 sites in the United States and Canada that will randomize 1683 high-risk subjects with a symptomatic infarct attributed to 70-99% stenosis of a major intracranial artery to 12 months of treatment with (1) ticagrelor (180 mg loading dose, then 90 mg twice daily), (2) low-dose rivaroxaban (2.
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.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!