Results 221 to 230 of about 18,552,898 (302)

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source

Longitudinal Analysis of Amyloid PET and Brain MRI for Predicting Conversion from Mild Cognitive Impairment to Alzheimer's Disease: Findings from the ADNI Cohort. [PDF]

Tomography
Kim DH.
europepmc   +1 more source

Urogenital Infection Risk Associated With SGLT2 Inhibitors Versus DPP‐4 Inhibitors in Type 2 Diabetes and Chronic Kidney Disease: A Nationwide Target Trial Emulation

Clinical Pharmacology &Therapeutics, EarlyView.
Although sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) are recommended for patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD), concerns regarding urogenital infections persist. Therefore, we evaluated the risk of urinary tract infection (UTI) and genital tract infection (GTI) after SGLT2i initiation in this population ...
Young‐Mi Ah, Junsung Nam, Jung Wook Youn, Yun Mi Yu, Soyoung Kang   +4 more
wiley   +1 more source

A Prospective Study of Individuals at Risk of Multiple Sclerosis Informs the Design of Primary Prevention Studies. [PDF]

Ann Clin Transl Neurol
Laitinen AW, Tozlu C, Roostaei T, Diallo F, Onomichi K, Son J, Xia Z, De Jager PL.   +7 more
europepmc   +1 more source

Antiviral Activity and Safety of Molnupiravir in Healthy Participants Inoculated With Influenza Virus: A Phase 2a, Randomized, Human Challenge Trial

Clinical Pharmacology &Therapeutics, EarlyView.
Influenza viruses cause substantial global morbidity and mortality. Molnupiravir, an orally administered prodrug of β‐D‐N4‐hydroxycytidine, has broad activity against RNA viruses, including influenza. A phase 2a, randomized, two‐part human challenge trial in healthy adults (NCT05818124) was conducted to evaluate molnupiravir for influenza infection. In
Jesse Nussbaum, Alex J. Mann, Laura E. Liao, Tian Zhao, Melissa Bevan, Gillian Gillespie, Vanessa Levine Weissler, Brian M. Maas, Diane Longo, Andrew Catchpole, David W. Hilbert, Carisa De Anda   +11 more
wiley   +1 more source

Group-level versus individualized approaches for capturing tau PET changes and clinical progression in Alzheimer's disease. [PDF]

Alzheimers Dement
de Bruin H, Groot C, Zhu Z, van de Giessen E, Shcherbinin S, Kotari V, Svaldi DO, Pijnenburg YAL, Coomans EM, Ossenkoppele R, Franzmeier N, Alzheimer's Disease Neuroimaging Initiative (ADNI).   +11 more
europepmc   +1 more source

Differential sensitivity to SHH signaling and neural crest‐mediated Gas1 expression regulate jaw size during development and evolution

Developmental Dynamics, EarlyView.
Abstract Background Developmental control of jaw size is crucial to prevent birth defects and facilitate evolutionary adaptation. We have shown that jaw size is established by neural crest mesenchyme (NCM), which are progenitor cells that migrate into the mandibular primordia and produce the jaws.
Zuzana Vavrušová, Daniel B. Chu, An Nguyen, Yeniko Ta, Jennifer L. Fish, Richard A. Schneider   +5 more
wiley   +1 more source

Nasal Septal Perforation: A Potential Pitfall in Cotton Testing for Suspected Empty Nose Syndrome-A Case Series and Staged Algorithm. [PDF]

Int Forum Allergy Rhinol
Hosokawa Y, Kawamoto T, Sawada M, Harano M, Sato M, Kobayashi R, Ikezono T.   +6 more
europepmc   +1 more source

Empirically Defining “Recurrent” Inappropriate Compensatory Behaviors: Differentiating Binge Eating Disorder From Bulimia Nervosa‐Spectrum Disorders

International Journal of Eating Disorders, EarlyView.
ABSTRACT Objective For multiple disorders, DSM‐5‐TR criteria include “recurrent” engagement in behaviors—for example, in the criteria for binge‐eating disorder (BED), “binge eating is not associated with the recurrent use of inappropriate compensatory behavior.”—without operationalizing how frequently a behavior needs to occur to be considered ...
Sophie R. Abber, Dan V. Blalock, Renee D. Rienecke, Philip S. Mehler, Alan Duffy, Jamie Manwaring, Maryrose Bauschka, Kimberly Anderson, Harry A. Brandt, Craig Johnson, Timothy Brewerton, Thomas E. Joiner, Lauren N. Forrest   +12 more
wiley   +1 more source