RANDOMIZED CONTROLLED TRIAL

Preconceptual administration of doxycycline in women with recurrent miscarriage and chronic endometritis: protocol for the Chronic Endometritis and Recurrent Miscarriage (CERM) trial, a multicentre, double-blind, placebo-controlled, adaptive randomised trial with an embedded translational substudy
Joshua Odendaal, Naomi Black, Georgios Bouliotis, Jonathan Guck, Martin Underwood, Joanne Fisher, Siobhan Quenby

BMJ Open Dec 2023, 13 (12) e081470; DOI: 10.1136/bmjopen-2023-081470
Add-on pramipexole for anhedonic depression: study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden
Jesper Lindahl, Marie Asp, Darya Ståhl, Johanna Tjernberg, Moa Eklund, Johannes Björkstrand, Danielle van Westen, Jimmy Jensen, Kristoffer Månsson, Åsa Tornberg, Martina Svensson, Tomas Deierborg, Filip Ventorp, Daniel Lindqvist

BMJ Open Nov 2023, 13 (11) e076900; DOI: 10.1136/bmjopen-2023-076900
REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1)
Sainath Raman, Sarfaraz Rahiman, Melanie Kennedy, Adrian Mattke, Prem Venugopal, Craig McBride, Quyen Tu, Florian Zapf, Eva Kuhlwein, Jemma Woodgate, Puneet Singh, Luregn J Schlapbach, Kristen S Gibbons

BMJ Open Nov 2023, 13 (11) e076460; DOI: 10.1136/bmjopen-2023-076460
Evaluation of ALBA device for upper extremity motor function in adults with subacute and chronic acquired brain injury: a randomised controlled trial protocol in a tertiary clinic of the metropolitan region of Chile
Pamela Salazar-Cifuentes, Thomas Contreras, Emilio Hernández, Evelyn Leiva-Abarca, Paola Castro-Flores, Daniela San Juan, Rodrigo Araneda, Daniela Ebner-Karestinos

BMJ Open Nov 2023, 13 (11) e076774; DOI: 10.1136/bmjopen-2023-076774
Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta
Jannie D Hald, Catriona Keerie, Christopher J Weir, Muhammad K Javaid, Wayne Lam, Patricia Osborne, Jennifer Walsh, Bente L Langdahl, Stuart H Ralston

BMJ Open Nov 2023, 13 (11) e078164; DOI: 10.1136/bmjopen-2023-078164
Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial
Xiangming Hu, Haiyan Xu, Can Wang, Yang Wang, Yan Wang, Daxin Zhou, Qifeng Zhu, Kai Xu, Jian Yang, Haibo Zhang, Nan Jiang, Junjie Zhang, Zhenfei Fang, Guosheng Fu, Yingqiang Guo, Yi Li, Moyang Wang, Dejing Feng, Guannan Niu, Erli Zhang, Yang Chen, Yunqing Ye, Yongjian Wu

BMJ Open Nov 2023, 13 (11) e076781; DOI: 10.1136/bmjopen-2023-076781
Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes
Stacy C Bailey, Allison P Pack, Guisselle Wismer, Norma Calderon, Evelyn Velazquez, Stephanie Batio, Abbey Ekong, Alice Eggleston, Amisha Wallia, Michael S Wolf, Jacob M Schauer, Sandi Tenfelde, David M Liebovitz, William A Grobman

BMJ Open Nov 2023, 13 (11) e078282; DOI: 10.1136/bmjopen-2023-078282
Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial
Saúl Eduardo Contreras Sánchez, Svetlana V Doubova, Rocío Grajales Álvarez, Abdel Krim Dip Borunda, Wendy Jazmín Martínez Pineda, Jose Gustavo Nuñez Cerrillo, Fernando Silva Bravo, Rita Zalapa Velázquez, Marcos Gutiérrez De la Barrera, Hannah H Leslie

BMJ Open Nov 2023, 13 (11) e077322; DOI: 10.1136/bmjopen-2023-077322
Phase II randomised placebo-controlled trial of sodium selenate as a disease-modifying treatment in chronic drug-resistant temporal lobe epilepsy: the SeLECT study protocol
Lucy Vivash, Hannah Johns, Leonid Churilov, Sara MacPhail, Pablo Casillas-Espinosa, Charles Malpas, Sandy R Shultz, Chris Tailby, Manori Wijayath, David Reutens, Lisa Gillinder, Piero Perucca, Patrick Carney, John-Paul Nicolo, Nicholas Lawn, Patrick Kwan, Dennis Velakoulis, Christopher M Hovens, Terence J O’Brien

BMJ Open Oct 2023, 13 (10) e075888; DOI: 10.1136/bmjopen-2023-075888
Scale-up of the Australian Fans in Training (Aussie-FIT) men’s health behaviour change program: a protocol for a randomised controlled hybrid effectiveness–implementation trial
Matthew David McDonald, Bryce Brickley, Toby Pavey, James A Smith, Andrew Maiorana, Tracy McCaffrey, Graham Hillis, Jason Bonson, Hui Jun Chih, Himanshu Gupta, Scarlett Holmes, Kate Hunt, Deborah A Kerr, Dominika Kwaśnicka, Marshall Makate, Joanne McVeigh, Joanna C Moullin, Brendan J Smith, Lee Wharton, Neil Wharton, Eleanor Quested

BMJ Open Oct 2023, 13 (10) e078302; DOI: 10.1136/bmjopen-2023-078302

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