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http://dx.doi.org/10.1046/j.1537-2995.2000.40060752.x | DOI Listing |
Circ Cardiovasc Interv
January 2025
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.).
Background: Food and Drug Administration-mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with () codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial.
View Article and Find Full Text PDFAJNR Am J Neuroradiol
January 2025
From the Department of Department of Radiology, Brain Health Imaging Institute (A.R-F, J.I, S.P, M.d, G.C.C) Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA; the Department of Neurology (A.R-F), Pontificia Universidad Javeriana, Bogota, Colombia; the Department of Radiology, Division of Molecular Imaging and Therapeutics (A.R-F, J.I) Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA; the Department of Neurology (D.Z, MM, L.R, A.S.N) Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA.
Amyloid-targeting therapy has recently become widely available in the U.S. for the treatment of patients with symptomatic mild Alzheimer's disease (AD).
View Article and Find Full Text PDFHealth Commun
January 2025
Department of Psychological Sciences, University of California Merced.
The current study tested contextual features (product design, imagery, and use) of e-cigarette advertisements on responses to the mandated U.S. FDA addiction text warning.
View Article and Find Full Text PDFActa Biomater
January 2025
Institute of Smart Biomedical Materials, School of Materials Science and Engineering, Zhejiang Sci-Tech University, Hangzhou 310018, PR China. Electronic address:
The U.S. Food and Drug Administration (FDA) has issued a boxed warning and mandated additional safety measures for all gadolinium-based contrast agents (GBCAs) used in clinical magnetic resonance imaging (MRI) due to their prolonged retention in the body and associated adverse health effects.
View Article and Find Full Text PDFPLoS One
January 2025
Worldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, United States of America.
Background: Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).
Methods: Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.
Results: During the study period (June 15, 2011-June 14, 2016), 94.
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