Results 191 to 200 of about 16,336,802 (316)

Study of TOfacitinib for the treatment of chronic PouchITis (STOPit): a multi-centre open label induction with randomised, double blind, placebo-controlled maintenance trial [PDF]

Emi Khoo, Gerald Holtmann, Jakob Begun
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

Author Correction: A randomized trial that compared brain activity, efficacy and plausibility of open-label placebo treatment and cognitive reappraisal for reducing emotional distress. [PDF]

Sci Rep, 2023
Schienle A, Kogler W, Wabnegger A.
europepmc   +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

Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study]. [PDF]

BMC Psychiatry, 2023
Müller A, Konigorski S, Meißner C, Fadai T, Warren CV, Falkenberg I, Kircher T, Nestoriuc Y.   +7 more
europepmc   +1 more source

Reply

Arthritis &Rheumatology, EarlyView.
Joseph F. Merola, Cynthia E. Kartman, Peter Fischer, Luna Sun, Anabela Cardoso, Mark C. Genovese, Alexis Ogdie   +6 more
wiley   +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

Open-label placebo treatment for reducing overeating in children: A study protocol for a randomized clinical trial with an app-assisted approach. [PDF]

Contemp Clin Trials Commun, 2023
Schienle A, Unger I.
europepmc   +1 more source

Available datapackage for study 'Multicenter, Open-label, Randomised, Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor Followed by a Double-blind, Randomised, Parallel-group, Placebo-controlled 4 Weeks Extension Phase in Paediatric Patients With Sickle Cell Disease'

AstraZeneca
openalex   +1 more source

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source