Results 121 to 130 of about 338,657 (254)

Predictors of placebo response in three large clinical trials of the V1a receptor antagonist balovaptan in autism spectrum disorder. [PDF]

Neuropsychopharmacology, 2023
Tobe R, Zhu Y, Gleissl T, Rossomanno S, Veenstra-VanderWeele J, Smith J, Hollander E.   +6 more
europepmc   +1 more source

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

British Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley   +1 more source

Placebo Response in Phase II-III Symptom Intervention Studies: A Focus on Chemotherapy-Induced Peripheral Neuropathy and Associated Neuropathic Pain. [PDF]

Cancers (Basel)
Zahrieh D, Satele D, Haamankuli H, Wang XS, Le-Rademacher JG, Lee M, Liu H, Diaz-Cobo J, Shen SE, Chow S, Lustberg M, Ruddy KJ, Smith EML.   +12 more
europepmc   +1 more source

Cortical morphology predicts placebo response in multiple sclerosis. [PDF]

Sci Rep, 2022
Cherkasova MV, Fu JF, Jarrett M, Johnson P, Abel S, Tam R, Rauscher A, Sossi V, Kolind S, Li DKB, Sadovnick AD, Machan L, Girard JM, Emond F, Vosoughi R, Traboulsee A, Stoessl AJ.   +16 more
europepmc   +1 more source

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

A Model-Based Meta-Analysis Framework Quantifying Drivers of Placebo Response in Atopic Dermatitis Trials. [PDF]

CPT Pharmacometrics Syst Pharmacol
Serrano JC, Maringwa J, Straetemans R, Willems W, Liva SG, Verhoeven J, Ford JL, Huang KG, Hubbard JJ, French JL, Devineni D, Vermeulen A, Valiathan C.   +12 more
europepmc   +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

Analyzing the Placebo Response and Identifying Influential Factors in Oral Medication Trials for Acute-Phase Schizophrenia. [PDF]

Schizophr Bull
Ren J, Zhang L, Xu L, Lv Y, Huang J, Feng Y, Guo H, Wang Y, Yang J, Zheng Q, Li L.   +10 more
europepmc   +1 more source

The Impact of Baseline Anxiety on Drug Placebo Separation and Drug/Placebo Response in an Acute Schizophrenia Clinical Trial-A Post-hoc Analysis. [PDF]

Schizophr Bull Open, 2023
Kott A, Brannan S, Wang X, Daniel D.
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