Zobrazeno 1 - 10
of 3 321
pro vyhledávání: '"dose-finding"'
Publikováno v:
Journal of Immunotherapy and Precision Oncology, Vol 7, Iss 3, Pp 159-167 (2024)
Introduction: In targeted therapies and immunotherapies, the occurrence of low-grade (e.g., grade 1–2) toxicities (LGT) is common, while dose-limiting toxicities (DLT) are relatively rare. As a result, conventional phase I trial designs, solely bas
Externí odkaz:
https://doaj.org/article/a95808ca83c7417cbe37e7c86e72bee8
Autor:
Jianing Guo, Fangsheng Xu, Luoyun Li, Zeru Zhang, Baichun Xing, Qin Fan, Zehua Wang, Chunyu Li
Publikováno v:
Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Abstract Background Tracheal intubation may cause significant hemodynamic responses. Many drugs have been shown to be effective in modifying these cardiovascular responses, including remifentanil, fentanyl, sufentanil, and alfentanil. However, the 90
Externí odkaz:
https://doaj.org/article/c739fcbfd3c9479f88850d2da0cb4502
Autor:
Emily Alger, Mary Van Zyl, Olalekan Lee Aiyegbusi, Dave Chuter, Lizzie Dean, Anna Minchom, Christina Yap
Publikováno v:
Research Involvement and Engagement, Vol 10, Iss 1, Pp 1-9 (2024)
Abstract Background In light of the FDA’s Project Optimus initiative, there is fresh interest in leveraging Patient-reported Outcome (PRO) data to enhance the assessment of tolerability for investigational therapies within early phase dose-finding
Externí odkaz:
https://doaj.org/article/a5cb45ec14b9497e9b1481114ed722e1
Autor:
Christina Yap, Olalekan Lee Aiyegbusi, Emily Alger, Ethan Basch, Jill Bell, Vishal Bhatnagar, David Cella, Philip Collis, Amylou C. Dueck, Alexandra Gilbert, Ari Gnanasakthy, Alastair Greystoke, Aaron R. Hansen, Paul Kamudoni, Olga Kholmanskikh, Bellinda L. King-Kallimanis, Harlan Krumholz, Anna Minchom, Daniel O'Connor, Joan Petrie, Claire Piccinin, Khadija Rerhou Rantell, Saaeha Rauz, Ameeta Retzer, Steven Rizk, Lynne Wagner, Maxime Sasseville, Lesley K. Seymour, Harald A. Weber, Roger Wilson, Melanie Calvert, John Devin Peipert
Publikováno v:
EClinicalMedicine, Vol 76, Iss , Pp 102838- (2024)
Summary: Early phase clinical trials provide an initial evaluation of therapies’ risks and benefits to patients, including safety and tolerability, which typically relies on reporting outcomes by investigator and laboratory assessments. Use of pati
Externí odkaz:
https://doaj.org/article/67c77703c1de4dd99159ee45db094c8f
Publikováno v:
Contemporary Clinical Trials Communications, Vol 40, Iss , Pp 101329- (2024)
Background: Traditional dose selection for oncology registration trials typically employs a one- or two-step single maximum tolerated dose (MTD) approach. However, this approach may not be appropriate for molecularly targeted therapy, which tends to
Externí odkaz:
https://doaj.org/article/cf6b9d3798e44c5bb59d9d76b7beb11d
Publikováno v:
Indian Journal of Anaesthesia, Vol 68, Iss 5, Pp 480-485 (2024)
Background and Aim: Sevoflurane, a preferred anaesthetic for children, exhibits a dose-dependent reduction in intraocular pressure (IOP). However, consensus is lacking regarding optimal end-tidal sevoflurane concentration for safe IOP measurement. Th
Externí odkaz:
https://doaj.org/article/d1d85fed94204a848fbe307c03a16bfa
Autor:
Amit Patel, Kristian Brock, Daniel Slade, Claire Gaunt, Anthony Kong, Hisham Mehanna, Lucinda Billingham, Piers Gaunt
Publikováno v:
BMC Medical Research Methodology, Vol 24, Iss 1, Pp 1-12 (2024)
Abstract Background In this article we describe the methodology of the time-to-event continual reassessment method in the presence of partial orders (PO-TITE-CRM) and the process of implementing this trial design into a phase I trial in head and neck
Externí odkaz:
https://doaj.org/article/482169edd81b4cb08d5b3a47c93c2213
Autor:
A. David Burden, Robert Bissonnette, Alexander A. Navarini, Masamoto Murakami, Akimichi Morita, Thomas Haeufel, Binqi Ye, Frank Baehner, Tadashi Terui
Publikováno v:
Dermatology and Therapy, Vol 13, Iss 10, Pp 2279-2297 (2023)
Abstract Introduction We evaluated the anti-interleukin-36 receptor antibody spesolimab in patients with moderate-to-severe palmoplantar pustulosis (PPP). Methods This phase IIb trial comprised a loading dose period to week (W) 4, then maintenance do
Externí odkaz:
https://doaj.org/article/6d6cb5a5aa4948e883bc5a0968cd7992
Autor:
Dan‐Dan Tan, Jin Gu, Juan Li, Wan‐Qiu Yu, De‐Xing Liu, Li‐Jin Zhao, Guo‐Hua Zhu, Xin‐Xin Yang, Jin Tian, Qi Tian, Zhao‐Qiong Zhu
Publikováno v:
Ibrain, Vol 9, Iss 3, Pp 290-297 (2023)
Abstract This study aimed to determine the values of the half‐effective dose (ED50) and 95% effective dose (ED95) of remimazolam besylate used in the procedural sedation of endoscopic retrograde cholangiopancreatography (ERCP). Sixty patients who f
Externí odkaz:
https://doaj.org/article/1ca9f906d18d42be91a582b8ac35a1da
Autor:
Mark J. Butler, Anne-Marie N. Romain, Rumisha Augustin, Patrick Robles, Ciaran P. Friel, Thevaa Chandereng, Jerry M. Suls, Elizabeth A. Vrany, Frank Vicari, Ying Kuen Cheung, Karina W. Davidson
Publikováno v:
Trials, Vol 24, Iss 1, Pp 1-13 (2023)
Abstract Background In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. Howe
Externí odkaz:
https://doaj.org/article/9f9a6a3c8d684d0fbaa951b00451fa70