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Safety studies

Feasibility and safety of in-bed cycling/stepping in critically ill patients: A study protocol for a pilot randomized controlled clinical trial

Soohyun Wi, Hyung-Ik Shin, Sung Eun Hyun, Kwan-Sik Sung, Woo Hyung Lee

published 10 May 2024

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Efficacy and safety of onasemnogene abeparvovec for the treatment of patients with spinal muscular atrophy type 1: A systematic review with meta-analysis

Brígida Dias Fernandes, Bárbara Corrêa Krug, Fernanda D’Athayde Rodrigues, Hérica Núbia Cardoso Cirilo, Stéfani Sousa Borges, Ida Vanessa D. Schwartz, Livia Fernandes Probst, Ivan Zimmermann

published 07 May 2024

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A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data

André Daher, Júlio Castro-Alves, Leandro Amparo, Natalia Pacheco de Moraes, Thaís Regina Araújo dos Santos, Karla Regina Gram dos Santos, Cristiane Siqueira do Valle, Maria Hermoso, Margareth Catoia Varela, Rodrigo Correa Oliveira

published 22 Nov 2023

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Phase 1b study on the repurposing of meclizine hydrochloride for children with achondroplasia

Masaki Matsushita, Hiroshi Kitoh, Kenichi Mishima, Yasunari Kamiya, Daisaku Kato, Genta Takemoto, Kenta Sawamura, Shinji Ueno, Nakai Yasuhiro, Kazuki Nishida, Shiro Imagama

published 10 Jul 2023

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Gender bias in clinical trials of biological agents for migraine: A systematic review

Marta Alonso-Moreno, Lupe Rodríguez-de Francisco, Pablo Ciudad-Gutiérrez

published 02 Jun 2023

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Exploratory clinical trial to evaluate the efficacy and safety of transdermal electrical stimulation in patients with central retinal artery occlusion

Gen Miura, Tadami Fujiwara, Takayuki Iwase, Yoshihito Ozawa, Yuki Shiko, Yohei Kawasaki, Tomohiro Nizawa, Tomoaki Tatsumi, Takayuki Baba, Takuji Kurimoto, Sotaro Mori, Makoto Nakamura, Hideki Hanaoka, Shuichi Yamamoto

published 24 Feb 2023

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A dose-finding safety and feasibility study of oral activated charcoal and its effects on the gut microbiota in healthy volunteers not receiving antibiotics

Armin Rashidi, Sathappan Karuppiah, Maryam Ebadi, Ryan Shanley, Alexander Khoruts, Daniel J. Weisdorf, Christopher Staley

published 14 Jun 2022

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A phase II open label clinical study of the safety, tolerability and efficacy of ILB^® for Amyotrophic Lateral Sclerosis

Ann Logan, Zsuzsanna Nagy, Nicholas M. Barnes, Antonio Belli, Valentina Di Pietro, Barbara Tavazzi, Giuseppe Lazzarino, Giacomo Lazzarino, Lars Bruce, Lennart I. Persson

published 25 May 2022

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Intradermal injection of lidocaine with a microneedle device to provide rapid local anaesthesia for peripheral intravenous cannulation: A randomised open-label placebo-controlled clinical trial

Alexey Rzhevskiy, Andrei Popov, Chavdar Pavlov, Yuri Anissimov, Andrei Zvyagin, Yotam Levin, Efrat Kochba

published 31 Jan 2022

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Real-world assessment and treatment of locally advanced basal cell carcinoma: Findings from the RegiSONIC disease registry

Aleksandar Sekulic, Simon Yoo, Ragini Kudchadkar, Julie Guillen, Gary Rogers, Anne Lynn S. Chang, Scott Guenthner, Bernard Raskin, Keith Dawson, Yong Mun, Laura Chu, Edward McKenna, Mario Lacouture

published 14 Jan 2022

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Oncologists’ reflections on patient rights and access to compassionate use drugs: A qualitative interview study from an academic cancer center

Jeremiah Stout, Cambray Smith, Jan Buckner, Alex A. Adjei, Mark Wentworth, Jon C. Tilburt, Zubin Master

published 17 Dec 2021

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Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

Corey A. Kalbaugh, Julianne M. Kalbaugh, Lisa McManus, Jill A. Fisher

published 07 Sep 2021

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Description of adverse events among adult men following voluntary medical male circumcision: Findings from a circumcision programme in two provinces of South Africa

Evans Muchiri, Salome Charalambous, Sibuse Ginindza, Mpho Maraisane, Tintswalo Maringa, Peter Vranken, Dayanund Loykissoonlal, Vincent Muturi-Kioi, Candice M. Chetty-Makkan

published 17 Aug 2021

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