Results 191 to 200 of about 643,840 (294)

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

Novel multi-modal methodology to investigate placebo response in major depressive disorder. [PDF]

J Affect Disord
Cusin C, Dillon DG, Belleau E, Normandin MD, Petibon Y, El-Fakri G, Dhaynaut M, Hooker J, Kaptchuk T, McKee M, Hayden E, Meyer A, Jahan A, Origlio J, Ang YS, Brunner D, Kang M, Long Y, Fava M, Pizzagalli DA.   +19 more
europepmc   +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

Factors associated with placebo response rate in randomized controlled trials of antiseizure medications for focal epilepsy. [PDF]

Epilepsia
Kerr WT, Suprun M, Kok N, Reddy AS, McFarlane KN, Kwan P, Somerville E, Bagiella E, French JA.   +8 more
europepmc   +1 more source

Model‐informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Population pharmacokinetic (popPK) and pharmacokinetic‐pharmacodynamic (PK/PD) models were developed to support clinical development of nemolizumab, a humanized monoclonal antibody targeting the IL‐31 receptor α, in adolescents and adults with moderate‐to‐severe atopic dermatitis (AD).
Floris Fauchet, Anna Largajolli, Petra M. Jauslin, Emilie Schindler, Mourad Hamimed, Wannee Kantasiripitak, Antonio Gonçalves, Eline Van Maanen, Khaled Benkali, Tomohisa Saito, Jonathan I. Silverberg, Andreas Wollenberg, Michael Graeber, Liliana Ulianov, Christophe Piketty, Luca Loprete, Vincent Duval, Nathalie Wagner   +17 more
wiley   +1 more source

Herbal placebo response in clinical trials on irritable bowel syndrome: a systematic review and meta-analysis. [PDF]

Front Pharmacol
Huang K, Lv M, Zheng T, Wang F, Tang X, Lv L.   +5 more
europepmc   +1 more source

Pharmacokinetics, safety, tolerability and fluorescence imaging of nizaracianine triflutate administered in three divided doses to healthy volunteers

British Journal of Clinical Pharmacology, EarlyView.
Aim Fluorescence‐guided surgery enhances intraoperative visualization of anatomical structures. Nizaracianine is a near‐infrared fluorescent agent that is exclusively renally cleared in animal models. It enables real‐time ureteral imaging and identification, potentially reduces risk of injury and facilitates assessment before surgical closure.
Lisanne K. A. Neijenhuis, Cedric M. W. Pesch, John V. Frangioni, Alexander L. Vahrmeijer, Jacobus Burggraaf, Naomi B. Klarenbeek   +5 more
wiley   +1 more source

Main factors associated with variability in the assessment of the objective response rate. A re‐analysis of the PHEREXA phase 3 clinical trial

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Local investigators (LIs) overestimate the objective response rate (ORR) in comparison to Blinded Independent Central Reviewers (BICR) in oncology. In this study, we re‐analysed data obtained in the PHEREXA trial (NCT01026142) with the following aims: i) to confirm at the single‐patient level the discrepancy observed by analysing ...
Gennaro Daniele, Tommaso Giovagnoli, Pierluigi Navarra, Cinzia Dello Russo   +3 more
wiley   +1 more source

Inpatient's, therapist's and staff's expectations regarding treatment and their effects on placebo response in the psychiatric ward - results from an add-on oxytocin RCT. [PDF]

Psychopharmacology (Berl)
Nitzan U, Grossman-Girron A, Sedoff O, Maoz H, Arad O, Tilbor E, Dror C, Bitan DT.   +7 more
europepmc   +1 more source

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