Results 221 to 230 of about 648,282 (342)

Placebo Response to Oral Administration in Osteoarthritis Clinical Trials and Its Associated Factors: A Model-Based Meta-analysis.

JAMA Netw Open, 2022
Wen X, Luo J, Mai Y, Li Y, Cao Y, Li Z, Han S, Fu Q, Zheng Q, Ding C, Zhu Z, Li L.   +11 more
europepmc   +1 more source

Safety, tolerability and pharmacokinetics of DNDI‐6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim The benzoxaborole derivative DNDI‐6148 is an antiparasitic agent with activity against multiple Leishmania protozoan species, including L. infantum and L. donovani, which cause visceral leishmaniasis. We investigated the safety, tolerability and pharmacokinetics of single oral doses of DNDI‐6148 in a randomized, parallel‐group, placebo‐controlled ...
Jean‐Yves Gillon, Sophie Delhomme, Delphine Launay, Séverine Blesson, Stéphanie Braillard, Pegah Maghdooni, Frauke Assmus, Richard Hoglund, Joel Tarning, Sabrina Loyau, Byron Arana, Mathilde Latreille‐Barbier, Yves Donazzolo   +12 more
wiley   +1 more source

Placebo Response and Its Predictors in Attention Deficit Hyperactivity Disorder: A Meta-Analysis and Comparison of Meta-Regression and MetaForest. [PDF]

Int J Neuropsychopharmacol, 2022
Castells X, Saez M, Barcheni M, Cunill R, Serrano D, López B, van Lissa CJ.   +6 more
europepmc   +1 more source

Lack of QT Prolongation for 2′-O-Methoxyethyl-Modified Antisense Oligonucleotides Based on Retrospective Exposure/Response Analysis of Ten Phase 1 Dose-Escalation Placebo-Controlled Studies in Healthy Subjects [PDF]

, 2017
Rosie Z. Yu, Rudy Gunawan, Richard S. Geary, Steven G. Hughes, Scott P. Henry, Yanfeng Wang   +5 more
openalex   +1 more source

Pentoxifylline dose finding trial in preterm neonates with suspected late onset sepsis (PTX‐trial)

British Journal of Clinical Pharmacology, EarlyView.
Aim The aim of this study (PTX‐trial) is to determine the optimal dose of pentoxifylline (PTX) in preterm neonates (gestational age < 30 weeks) with (suspected) late onset sepsis (LONS). Methods The PTX‐trial is a prospective multicentre open‐label sequential dose‐optimization study with an adapted continual reassessment method.
Serife Kurul, H. Rob Taal, Jan Mazela, Ryszard Lauterbach, Irwin K. M. Reiss, Karel Allegaert, Robert B. Flint, Sinno H. P. Simons   +7 more
wiley   +1 more source

Dosing Biologic Drugs for Patients with Obesity: One Size Does NOT Fit All

Arthritis &Rheumatology, Accepted Article.
Stephen J. Balevic, Daniel Gonzalez, Bernd Meibohm   +2 more
wiley   +1 more source

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

British Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner, Daniela Krepper, Micha Johannes Pilz, Lisa Marie Storz, Maike Thumfart, Johannes Maria Giesinger   +5 more
wiley   +1 more source

Neural correlates of citalopram and placebo response in acute bipolar depression: A randomized trial. [PDF]

J Psychiatr Res, 2021
Sretavan Wong K, Migó M, Dougherty DD, Ghaemi SN.   +3 more
europepmc   +1 more source

532: EFFICACY AND SAFETY OF SELADELPAR IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND COMPENSATED CIRRHOSIS IN THE PHASE 3 PLACEBO-CONTROLLED RESPONSE TRIAL [PDF]

Alejandra Villamil, Ziad Younes, Christopher L. Bowlus, John M. Vierling, Adam Vašura, Andrea Galli, Mordechai Rabinovitz, Frederik Nevens, Susheela Carroll, Kehu Yang, Daria B. Crittenden, Charles A. McWherter, Eric Lawitz   +12 more
openalex   +1 more source

Blood pressure effects of SGLT2 inhibitors and GLP‐1 receptor agonists: Mechanisms, trial evidence and Real‐world data

British Journal of Clinical Pharmacology, EarlyView.
SGLT2 inhibitors and GLP‐1 receptor agonists modestly lower blood pressure across diverse patient populations, including those without diabetes. These effects appear largely independent of glycaemic control and offer additive value in high‐risk patients with overlapping comorbidities.
Andrej Belančić, Yusuf Ziya Sener, Marijana Vučković, Joseph Edgar Blais, Almir Fajkić, Emina Sher, Mislav Radić, Josipa Radić   +7 more
wiley   +1 more source