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Safety studies

Understanding and predicting COVID-19 clinical trial completion vs. cessation

Magdalyn E. Elkin, Xingquan Zhu

published 12 Jul 2021

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The impact of COVID-19 on the clinical trial

Zhimin Chen, Liran Chen, Huafang Chen

published 11 May 2021

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Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study

Atul T. Patel, Mark F. Lew, Khashayar Dashtipour, Stuart Isaacson, Robert A. Hauser, William Ondo, Pascal Maisonobe, Stefan Wietek, Bruce Rubin, Allison Brashear

published 01 Feb 2021

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On the coherence of model-based dose-finding designs for drug combination trials

Yeonhee Park, Suyu Liu

published 30 Nov 2020

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Efficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial

Mathieu Mogenot, Laurence Hein-Halbgewachs, Christophe Goetz, Nadia Ouamara, Dominique Droz-Desprez, Catherine Strazielle, Sylvie Albecker, Brigitte Mengus, Marion Strub, Marie-Cécile Manière, Pascal Richardin, Stéphane Wang, Giuseppa Piga, Amélie Dalstein, Daniel Anastasio

published 28 Sep 2020

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Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands

Jacqueline C. F. van Oijen, Iris Wallenburg, Roland Bal, Kor J. Grit

published 31 Jul 2020

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Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon

Akiko Ogata, Masayuki Kaneko, Mamoru Narukawa

published 14 Jun 2019

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Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older

Graham R. Foster, Tarik Asselah, Sarah Kopecky-Bromberg, Yang Lei, Armen Asatryan, Roger Trinh, Neddie Zadeikis, Federico J. Mensa

published 02 Jan 2019

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Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

Peter J. Godolphin, Alan A. Montgomery, Lisa J. Woodhouse, Daniel Bereczki, Eivind Berge, Rónán Collins, Exuperio Díez-Tejedor, John Gommans, Kennedy R. Lees, Serefnur Ozturk, Stephen Phillips, Stuart Pocock, Kameshwar Prasad, Szabolcs Szatmari, Yongjun Wang, Philip M. Bath, Nikola Sprigg, on behalf of the ENOS Investigators

published 26 Nov 2018

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The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961–1990)

Rainer Erices, Andreas Frewer, Antje Gumz

published 02 Apr 2018

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The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

Guillermo Izquierdo, Fátima Damas, Maria Dolores Páramo, Juan Luis Ruiz-Peña, Guillermo Navarro

published 28 Apr 2017

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Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

Jonathan West, Simon Ogston, John Foerster

published 11 May 2016

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Epoch Analysis of On-Treatment Disability Progression Events over Time in the Tysabri Observational Program (TOP)

Heinz Wiendl, Helmut Butzkueven, Ludwig Kappos, Maria Trojano, Fabio Pellegrini, Dominic Paes, Annie Zhang, Shibeshih Belachew, Tysabri ® Observational Program (TOP) Investigators

published 15 Jan 2016

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