clinical trials

Protocol for an open-label, single-arm, multicentre clinical study to evaluate the efficacy and safety of rituximab in the first episode of paediatric idiopathic nephrotic syndrome
Jialu Liu, Qian Shen, Li Xie, Jiyang Wang, Yaxuan Li, Jing Chen, Xiaoyan Fang, Xiaoshan Tang, Biyun Qian, Hong Xu

BMJ Open Oct 2022, 12 (10) e064216; DOI: 10.1136/bmjopen-2022-064216
Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial)
Mathias Ebbesen Jensen, Dea Siggaard Stenbæk, Tobias Søgaard Juul, Patrick MacDonald Fisher, Claus Thorn Ekstrøm, Gitte Moos Knudsen, Anders Fink-Jensen

BMJ Open Oct 2022, 12 (10) e066019; DOI: 10.1136/bmjopen-2022-066019
Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial
Behnam Liaghat, Stig Brorson

BMJ Open Oct 2022, 12 (10) e064156; DOI: 10.1136/bmjopen-2022-064156
Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study
Tomohiro Nishina, Tomoko Fujita, Naoto Yoshizuka, Ko Sugibayashi, Kosho Murayama, Yasutoshi Kuboki

BMJ Open Oct 2022, 12 (10) e055718; DOI: 10.1136/bmjopen-2021-055718
RAPID-2 study protocol: a cluster randomised feasibility trial of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety
Kerry Evans, Helen Spiby, Mike Slade, Julie Jomeen, Jacqueline Beckhelling

BMJ Open Oct 2022, 12 (10) e064659; DOI: 10.1136/bmjopen-2022-064659
Calibrating a network meta-analysis of diabetes trials of sodium glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor analogues and dipeptidyl peptidase-4 inhibitors to a representative routine population: a systematic review protocol
Elaine Butterly, Lili Wei, Amanda I Adler, Saleh A M Almazam, Khalid Alsallumi, Luke A K Blackbourn, Sofia Dias, Peter Hanlon, Katherine Hughes, Jim Lewsey, Robert Lindsay, Stuart McGurnaghan, John Petrie, David Phillippo, Naveed Sattar, Laurie A Tomlinson, Nicky Welton, Sarah Wild, David McAllister

BMJ Open Oct 2022, 12 (10) e066491; DOI: 10.1136/bmjopen-2022-066491
Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention
Pamela Kohler, Kawango Agot, Irene N Njuguna, Jessica Dyer, Jacinta Badia, Wenwen Jiang, Kristin Beima-Sofie, Nok Chhun, Irene Inwani, Seema K Shah, Barbra A Richardson, Nahida Chaktoura, Grace John-Stewart

BMJ Open Oct 2022, 12 (10) e062134; DOI: 10.1136/bmjopen-2022-062134
Trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in New Zealand 1999–2017
Andrew Jull, Natalie Walker

BMJ Open Oct 2022, 12 (10) e065050; DOI: 10.1136/bmjopen-2022-065050
What drives cancer clinical trial accrual? An empirical analysis of studies leading to FDA authorisation (2015–2020)
Kristina Jenei, Alyson Haslam, Timothée Olivier, Milos Miljkovíc, Vinay Prasad

BMJ Open Oct 2022, 12 (10) e064458; DOI: 10.1136/bmjopen-2022-064458
Low-dose interleukin 2 for the reduction of vascular inflammation in acute coronary syndromes (IVORY): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase II clinical trial
Rouchelle Sriranjan, Tian Xiao Zhao, Jason Tarkin, Annette Hubsch, Joanna Helmy, Evangelia Vamvaka, Navazh Jalaludeen, Simon Bond, Stephen P Hoole, Philip Knott, Samantha Buckenham, Victoria Warnes, Nick Bird, Heok Cheow, Heike Templin, Paul Cacciottolo, James H F Rudd, Ziad Mallat, Joseph Cheriyan

BMJ Open Oct 2022, 12 (10) e062602; DOI: 10.1136/bmjopen-2022-062602

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