Results 211 to 220 of about 229,517 (308)

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative

Clinical Pharmacology &Therapeutics, EarlyView.
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld, Geetha S. Iyer, Suna C. Seo, Andrew Giffin, Andrew L. Simon, Sheryl A. Kluberg, Emma R. Hoffman, Jamal T. Jones, Sarah K. Dutcher, Joyce A. Korvick   +9 more
wiley   +1 more source

Optimal Dose and Safety of Intravenous Favipiravir in Hospitalized Patients With COVID‐19: A Dose‐Escalating, Randomized Controlled Phase Ib Study

Clinical Pharmacology &Therapeutics, EarlyView.
AGILE (NCT04746183) is a Phase Ib/IIa platform, evaluating candidates to treat COVID‐19. Candidate Specific Trial 6 evaluated the safety and optimal dose of a novel intravenous formulation of favipiravir in a dose‐escalating, open‐label, randomized, controlled, Bayesian adaptive Phase Ib trial.
Tim Rowland, Richard FitzGerald, Elizabeth Challenger, Laura Dickinson, Laura J. Else, Lauren Walker, Colin Hale, Victoria Shaw, Callum Kelly, Rebecca Lyon, Jennifer Gibney, Karim Dhamani, Margaret Irwin, Yvanne Enever, Michelle Tetlow, William Wood, Helen Reynolds, Justin Chiong, Orod Osanlou, Henry Pertinez, Katie Bullock, William Greenhalf, Andrew Owen, David G. Lalloo, Michael Jacobs, Julian A. Hiscox, Thomas Jaki, Pavel Mozgunov, Geoffrey Saunders, Gareth Griffiths, Saye H. Khoo, Thomas E. Fletcher, on behalf of the AGILE CST‐6 Study Group, Shazaad Ahmad, Christopher J. Edwards, Lesley Dry, Georgie McKenzie, Aleksandra Ros, Michael Stackpoole, Laura Bradley, Karen Jennings‐Wilding, Nicholas Paton, Fred Hayden, Janet Darbyshire, Amy Lucas, Ulrika Lorch, Andrew Freedman, Richard Knight, Steven Julious   +48 more
wiley   +1 more source

Health economic considerations for pharmacogenomic services in the United Kingdom: The Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics

British Journal of Clinical Pharmacology, EarlyView.
Dyfrig A. Hughes, Henry Fong, Grace Hampson, Catrin O. Plumpton, Chris Sampson   +4 more
wiley   +1 more source

The Squalene Oil‐in‐Water Nanoemulsion Vaccine Carrier AddaVax Potentiates TLR‐Induced B‐Cell Responses

Cytometry Part A, EarlyView.
ABSTRACT For vaccination, the mechanisms of action of antigens and of immunostimulatory pathogen‐associated molecular pattern (PAMP) adjuvants are better understood than the roles of the depot, carrier, and other formulation‐related influences. Here, we carried out cytometric studies of vaccine formulations and the effect of adjuvant formulations on B ...
Egest J. Pone, Jiin Felgner, Jenny Hernandez‐Davies, D. Huw Davies   +3 more
wiley   +1 more source

Immunometabolic and Spatiotemporal Control of Tissue‐Resident Memory T Cell Biology

Barrier Immunity, EarlyView.
Tissue‐resident memory T (TRM) cells in barrier tissues provide a frontline defense against invading pathogens. Immune (Signals 1–3) and nutrient (Signal 4) cues play an integral role in directing TRM formation and heterogeneity. The spatial and temporal organization of these signals establishes durable TRM cells across tissues, enabling diverse ...
Jana L. Raynor, Hongbo Chi
wiley   +1 more source

[Influenza vaccine and influenza vaccination].

Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 1993
L, Flugsrud, H, Nøkleby
openaire   +1 more source

Impacts of delayed influenza vaccination on clinical outcomes in ICU-admitted patients with influenza: A retrospective cohort study. [PDF]

Virus Res
Luo X, Liu H, Kuang H, Xie Y, Zhang R, Zhu Y, Ning B.   +6 more
europepmc   +1 more source

Dried biofluid droplet morphologies for automated and scalable disease classification

Droplet, EarlyView.
For the first time, disease‐specific fingerprints of diabetes and influenza are revealed from dried biofluid droplet morphologies. Using automated droplet detection, texture analysis, and interpretable machine learning, this scalable workflow transforms endpoint droplet patterns into diagnostic biomarkers for point‐of‐care healthcare applications ...
Anusuya Pal, Piyush Thakur, Amalesh Gope, Ryuta Uraki, Kawaoka Yoshihiro, Miho Yanagisawa   +5 more
wiley   +1 more source

Impact of Influenza Vaccination during Pregnancy on Maternal Influenza Disease Severity in Rural Nepal. [PDF]

Am J Trop Med Hyg
Frivold C, Katz J, Lama TP, Tielsch JM, Khatry SK, LeClerq SC, Carone M, John-Stewart G, Khosropour CM, Englund JA, Chu HY.   +10 more
europepmc   +1 more source

Forecasting heart failure: Seasonal alignment of heart failure outcomes in New York

ESC Heart Failure, Volume 12, Issue 2, Page 819-831, April 2025.
Abstract Background Seasonal variations have been observed in heart failure (HF) hospitalization. Numerous explanatory mechanisms have been proposed, but no prior studies have examined potential contributors directly. Our objective was to identify specific factors that could contribute to seasonal variability using a large longitudinal dataset of HF ...
Prerna Gupta, Ellen Brinza, Prateeti Khazanie, Pamela N. Peterson, P Michael Ho, David P. Kao   +5 more
wiley   +1 more source