clinical trials

Assessing the impact of a combined nutrition counselling and cash transfer intervention on women’s empowerment in rural Bangladesh: a randomised control trial protocol
Elizabeth K Kirkwood, Michael John Dibley, John Frederick Hoddinott, Tanvir Huda, Tracey Lea Laba, Tazeen Tahsina, Mohammad Mehedi Hasan, Afrin Iqbal, Jasmin Khan, Nazia Binte Ali, Saad Ullah, Nicholas Goodwin, Sumithra Muthayya, M Munirul Islam, Gulshan Ara, Kingsley Emwinyore Agho, Shams E Arifeen, Ashraful Alam

BMJ Open Jun 2021, 11 (6) e044263; DOI: 10.1136/bmjopen-2020-044263
Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial
Anna Price, Susan Ball, Shelley Rhodes, Robert Wickins, Elizabeth Gordon, Alex Aylward, Emma Cockcroft, Sarah Morgan-Trimmer, Roy Powell, John Timperley, John Charity

BMJ Open Jun 2021, 11 (6) e045652; DOI: 10.1136/bmjopen-2020-045652
Platform study of genotyping-guided precision medicine for rare solid tumours: a study protocol for a phase II, non-randomised, 18-month, open-label, multiarm, single-centre clinical trial testing the safety and efficacy of multiple Chinese-approved targeted drugs and PD-1 inhibitors in the treatment of metastatic rare tumours
Shuhang Wang, Hui-Yao Huang, Dawei Wu, Hong Fang, Jianming Ying, Ying Bai, Yue Yu, Yuan Fang, Ning Jiang, Chao Sun, Anqi Yu, Qi Fan, Shujun Xing, Yufen Ni, Wei Zhang, Chenhua Wu, Xinqian Ji, Hui Wang, Yaqian Guo, Qiyu Tang, Yuan Wang, Yu Tang, Ning Li

BMJ Open Jun 2021, 11 (6) e044543; DOI: 10.1136/bmjopen-2020-044543
RELATE—a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol
Tania M Lincoln, Matthias Pillny, Björn Schlier, Mark Hayward

BMJ Open Jun 2021, 11 (6) e046390; DOI: 10.1136/bmjopen-2020-046390
Efficacy of calcium dobesilate in treating Chinese patients with mild-to-moderate non-proliferative diabetic retinopathy (CALM-DR): protocol for a single-blind, multicentre, 24-armed cluster-randomised, controlled trial
Hao Hu, Jiang Liu, Duolao Wang, Shanhu Qiu, Yang Yuan, Fenghua Wang, Liang Wen, Qi Song, Zi-lin Sun

BMJ Open May 2021, 11 (5) e045256; DOI: 10.1136/bmjopen-2020-045256
COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus—protocol for a cluster randomised controlled trial
David A Richards, Holly VR Sugg, Emma Cockcroft, Joanne Cooper, Susanne Cruickshank, Faye Doris, Claire Hulme, Phillipa Logan, Heather Iles-Smith, G.J Melendez-Torres, Anne Marie Rafferty, Nigel Reed, Anne-Marie Russell, Maggie Shepherd, Sally J Singh, Jo Thompson Coon, Susannah Tooze, Stephen Wootton, Rebecca Abbott, Alison Bethel, Siobhan Creanor, Lynne Quinn, Harry Tripp, Fiona C Warren, Rebecca Whear, Jessica Bollen, Harriet A Hunt, Merryn Kent, Leila Morgan, Naomi Morley, Lidia Romanczuk

BMJ Open May 2021, 11 (5) e046436; DOI: 10.1136/bmjopen-2020-046436
Comparison of delivery catheter-based and stylet-based right ventricular lead placement at the right ventricular septum under fluoroscopic guidance judged by cardiac CT (Mt. FUJI): a study protocol for the Mt. FUJI randomised controlled trial
Yoshihisa Naruse, Keisuke Miyajima, Ryo Sugiura, Masahiro Muto, Michio Ogano, Nobutake Kurebayashi, Tomoyuki Shiozawa, Yumi Kiyama, Eiko Nagata, Keiichi Odagiri, Yuichiro Maekawa

BMJ Open May 2021, 11 (5) e046782; DOI: 10.1136/bmjopen-2020-046782
Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19
Jessica Campbell, Matthew Hobbs, Lily O’Hara, Angela Ballantyne, Anita Heywood, Lesley Gray

BMJ Open May 2021, 11 (5) e050114; DOI: 10.1136/bmjopen-2021-050114
TeleNeurological evaluation and Support for the Emergency Department (TeleNS-ED): protocol for an open-label clinical trial
Jessica Mandrioli, Mario Santangelo, Antonio Luciani, Stefano Toscani, Elisabetta Zucchi, Giada Giovannini, Ilaria Martinelli, Sonia Cecoli, Guido Bigliardi, Sara Scanavini, Stefano Meletti

BMJ Open May 2021, 11 (5) e048293; DOI: 10.1136/bmjopen-2020-048293
Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study
Nadine Ezard, Brendan Clifford, Adrian Dunlop, Raimondo Bruno, Andrew Carr, Zhixin Liu, Krista J Siefried, Nicholas Lintzeris

BMJ Open May 2021, 11 (5) e044696; DOI: 10.1136/bmjopen-2020-044696

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