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Št. zadetkov: 4
Differences between the 2016 and 2022 food and drug administration guidance
Jurij Hanžel, Christopher Ma, Laurent Peyrin-Biroulet, Silvio Danese, Bruce E Sands, Vipul Jairath
Izvirni znanstveni članek
Oznake: food guidance;drug guidence;differences;
Background: In 2022, the Food and Drug Administration (FDA) updated its draft guidance for drug development in ulcerative colitis, replacing the version from 2016. Several changes from the 2016 version merit further discussion as they impact clinical trial design and the interpretation of trial resu ...
Leto: 2024 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Placebo rates in randomised clinical trials of ulcerative colitis
Virginia Solitano, Malcolm Hogan, Siddharth Singh, Silvio Danese, Laurent Peyrin-Biroulet, Sudheer Kumar Vuyyuru, John K MacDonald, Guangyong Zou, Jurij Hanžel
Pregledni znanstveni članek
Oznake: inflammatory bowel disease;placebo effect;clinical trials;ulcerative colitis;
Background and aims: We assessed placebo rates and associated factors using individual patient data (IDP) from randomised clinical trials (RCTs) in ulcerative colitis (UC). Methods: We conducted an IPD meta-analysis using Vivli and Yale University Open Data Access data-sharing platforms. Phase 2 and ...
Leto: 2025 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Definitions of histological abnormalities in inflammatory bowel disease
Roger Feakins, Roger Feakins, Paulo Borralho-Nunes, Ann Driessen, Ilyssa O. Gordon, Nina Zidar, Pamela Baldin, Britt Christensen, Silvio Danese, Naoimh Herlihy, Marietta Lacucci
Pregledni znanstveni članek
Oznake: inflammatory bowel disease;histology;definition;ulcerative colitis;Crohn's disease;
Histological assessment of endoscopic biopsies in inflammatory bowel disease [IBD] plays an important role in clinical management, investigative studies, and clinical trials. Scoring schemes consisting of multiple histological items and offering considerable precision are widely available. However, ...
Leto: 2023 Vir: Medicinska fakulteta (UL MF)
Recommendations to standardize the conduct of clinical trials evaluating novel therapies for perianal fistulizing Crohn’s disease
Sudheer Kumar Vuyyuru, Jurij Hanžel, Mantaj S. Brar, Silvio Danese, Geert R. D'Haens, William A. Faubion, Brian G. Feagan, Ailsa L. Hart
Izvirni znanstveni članek
Oznake: inflammatory bowel disease;perianal fistula;Crohn's disease;
Background and Aims: Perianal fistulizing Crohn’s disease (PFCD) is a potentially debilitating condition with few systematically evaluated treatment options. We aimed to develop expert recommendations to standardize study design and conduct of randomized controlled trials (RCTs) of medical therapy f ...
Leto: 2026 Vir: Digitalni repozitorij raziskovalnih organizacij Slovenije
Št. zadetkov: 4
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