Study protocol of a pilot randomised controlled trial assessing the feasibility and acceptability of RecoverEsupport: a digital health intervention to enhance recovery in women undergoing surgery for breast cancer by Christopher Oldmeadow, Mitch J Duncan, Penny Reeves, Priscilla Viana da Silva, Rebecca Wyse, Helen Moore, Alison Zucca, Sancha Robinson, Stephen Ridley Smith, Emma Sansalone, Owen Morris, Rebecca Chenery, Lara Riley, Anna Palazzi-Parsons

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Efficacy and safety of a generic remifentanil formulation versus fentanyl and Ultiva during general anaesthesia: A phase III, prospective, multi-centric, observer-blind, randomised controlled trial by Indrani Hemantkumar, Ashok Kumar Swain, Manjaree Mishra, Swati Singh, Challakere Lakshminarain Gurudatt, Janampet Bekkam Giridhar

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Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial by Jie Qiao, Yan Wang, Rong Li, Ping Liu, Liang Hu, Lin Zeng, Guimin Hao, Jin Huang, Bing Yao, Junzhao Zhao, Juanzi Shi, Liyi Cai, Xiu-Xia Wang, Yanwen Xu, Yuanqing Yao, Yichun Guan, Weiping Qian, Sijia Lu

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Comparison of efficacy and safety between palonosetron and ondansetron to prevent postoperative nausea and vomiting in patients undergoing non-laparoscopic surgery: A systematic review and meta-analysis of randomised controlled trials by Babu Lal, Ragavi Alagarsamy, Jitendra Kumar, Anshul J. Rai, Vineeta Yadav, Rajnish Joshi, Md. Yunus

“…Results: Nineteen randomised controlled trials were included. Pooled risk ratio (RR) revealed that patients receiving palonosetron were significantly less likely to develop nausea [0–2 h, RR = 0.82 (95% confidence interval (CI): 0.50, 1.34), P = 0.317, I2 = 15.3%], [0–6 h, RR = 0.76 (95% CI: 0.44, 1.29), P = 0.137, I2 = 45.7%], [12–24 h, RR = 0.39 (95%CI: 0.16, 0.96), P = 0.088, I2 = 54.2%], [24–48 h, RR = 0.44 (95% CI: 0.20, 0.96), P = 0.598, I2 = 0%], [24–72 h, RR 0.22 (95% CI: 0.08, 0.57), P = 0.119, I2 = 53.0%] and vomiting [0–2 h, RR = 0.59 (95% CI: 0.29, 1.23), P = 0.868, I2 = 0%], [0–6 h, RR = 1.42 (95% CI: 0.74, 2.72), P = 0.790, I2 = 0%], [12–24 h, RR = 0.14 (95% CI: 0.04, 0.51), P = 0.749, I2 = 0.0%], [24–48 h, RR = 0.24 (95%CI: 0.09, 0.62), P = 0.561, I2 = 0%], [24–72 h, RR = 0.11 (95% CI: 0.02, 0.58), P = 0.859, I2 = 0%]. …”
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Effect of transcranial direct current stimulation on postoperative sleep disturbance in older patients undergoing lower limb major arthroplasty: a prospective, double-blind, pilot, randomised controlled trial by Chunyan Li, Jie Yang, He Liu, Wen Tan, Song Zhang, Hongxing Zhang, Yuan Han, Mingshu Tao, Rongguang Liu, Jiaxing Fang, Dexian Chen, Qi Wei, Xingyu Xiong, Wenxin Zhao, Junli Cao

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mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO) in a primary care setting: protocol for a randomised controlled trial in people with low SES and/or migration background by Edo Richard, Esther Van den Berg, Ron Handels, Henrike Galenkamp, Eric P Moll van Charante, Marieke P Hoevenaar-blom, Anne Roos van der Endt, Martien J H Kas

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Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school classrooms: protocol for a cluster randomised controlled trial by Wendy Lou, Michael Farkouh, JoAnne Arcand, Jacqueline Marie Brown, Saman Tahir, Beatriz Franco-Arellano, Ann LeSage, Janette Hughes, Bill Kapralos, Ellen Vogel, Claire Tugault-Lafleur

“…Pilot data have demonstrated that Foodbot Factory can significantly improve children’s nutrition knowledge, but it has not yet been evaluated in classrooms.Methods and analysis A single-blinded cluster randomised controlled trial was designed in 2022 by a research team based at Ontario Tech University to determine the efficacy of the Foodbot Factory intervention in improving children’s nutrition knowledge, attitudes and behaviours. 32 grade 4 and 4/5 classrooms in Ontario will be randomised to receive (1) the Foodbot Factory intervention or (2) a control nutrition education intervention using conventional materials (eg, activity sheets). …”
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Rectal versus vaginal progesterone administration for luteal phase support in the hormone replacement therapy frozen embryo transfer (HRT-FET) cycle: protocol for a non-inferiority randomised controlled trial by Peter Humaidan, Birgit Alsbjerg

“…The reason for comparing the two routes of administration is that rectal administration has been suggested to be more patient friendly.Methods and analysis This study is a randomised controlled trial comparing the ongoing pregnancy rate (OPR) at week 12 in HRT-FET cycles after rectal administered progesterone as the only administered progesterone compared with a vaginal luteal phase support regimen. …”
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Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour by Jianrong Zhang, Yu Huang, Hengrui Liang, Wenhua Liang, Jianxing He, Yiyin Zhang, Jiaxi He, Jieyu Wu, Long Jiang, Shiyan Tang, Qihua He, Lindsey Tristine Hamblin, Zhiheng Xu, Yaoqi Chen, Difei Chen, Xinyu Wang, Kexin Deng, Shuhan Jiang, Jiaqing Zhou, Jiaxuan Xu, Xuanzuo Chen

“…Objective Unbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. …”
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Multicentre, prospective, randomised controlled trial to evaluate hexaminolevulinate photodynamic therapy (Cevira) as a novel treatment in patients with high-grade squamous intraepithelial lesion: APRICITY phase 3 study protocol by Fei Chen, Jinghe Lang, Peter Hillemanns, Youzhong Zhang, Zoltán Novák, Long Sui, Ling Han, Christian Dannecker, Ctirad Mokráš, Zhixue You

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Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study) by Keith Barton, Tin Aung, Ling Jin, Ping Lu, Xiulan Zhang, Robert N Weinreb, Yi Zhang, Li Tang, Guangxian Tang, Hengli Zhang, Aiguo Lv, Huiping Yuan, Yunhe Song, Fengbin Lin, DENNIS S C LAM, Lin Xie, Kun Hu, Xiaohong Liang, Yingzhe Zhang, Wulian Song, Xiaomin Zhu, Xinbo Gao, Sujie Fan, Yuying Peng, Mengfei Liao, Xin Nie, Ki-Ho Park

“…Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interno goniotomy in advanced PACG with no or mild cataracts.Methods and analysis This non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. …”
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Transauricular vagus nerve stimulation in preventing post-traumatic stress disorder in emergency trauma surgery patients in China: a study protocol for a multicenter, double-blind, randomised, controlled trial by Jun Zhang, Xin Yu, Gang Chen, Yu Li, Qi-Hong Shen, Xinru Lin, Tieshuai Liu, Yunyun Yu, Jingwen Liang

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An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial by Ana Paula Taboada Sobral, Elaine Marcilio Santos, Marcela Leticia Leal Gonçalves, Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Elza Padilha Ferri, Juliana Maria Altavista Sagretti Gallo, Thais Gimenez, José Carlos Pettorossi Imparato

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Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol by David Williamson, Francis Bernard, Stefanie Blain-Moraes, Caroline Arbour, Virginie Williams, Louis de Beaumont, Catherine Duclos, Béatrice P De Koninck, Daphnee Brazeau, Amelie A Deshaies, Marie-Michele Briand, Charlotte Maschke

“…This study aims to validate the feasibility and assess the effect of a multi-session transcranial alternating current stimulation (tACS) intervention in subacute brain-injured patients on recovery of consciousness, related brain oscillations and brain network dynamics.Methods and analyses The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. …”
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Study protocol of the PRINCESS trial—PReoperative INtermittent fasting versus CarbohydratE loading to reduce inSulin resiStance versus standard of care in orthopaedic patients: a randomised controlled trial by Markus W Hollmann, Abraham H Hulst, Benedikt Preckel, Jeroen Hermanides, Ayla Y Stobbe, Eline S de Klerk, Robert van Wilpe, Arthur J Kievit, Kee Fong Choi, Mireille F M van Stijn

“…We hypothesise that TRF, as well as CHL, improve postoperative IR.Methods and analysis This open-label, single-centre, randomised controlled trial will compare the effect of short-term preoperative TRF, CHL and standard preoperative fasting on perioperative IR. …”
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Correction for ‘Protocol for a multisite randomised controlled trial assessing the effect of the Telehealth for early developmental Intervention in babies born very preterm (TEDI-Prem) programme on neurodevelopmental outcomes and parent well-being’

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Relative perioperative analgesic efficacy of single-shot serratus anterior plane block versus thoracic paravertebral block in breast and thoracic surgeries – A systematic review and meta-analysis of randomised controlled trials by Jeetinder K. Makkar, Narinder P. Singh, Bisman Jeet Kaur Khurana, Preet M. Singh

“…Methods: A systematic search for randomised controlled trials (RCTs) was conducted in PubMed, EMBASE and Scopus databases, covering studies from their inception to September 2023. …”
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Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 2 approved, 2 approved with reservations] by Pauline Frizelle, Darren Dahly, Aoife O'Shea, Aileen Murphy, Cristina McKean

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Feasibility and therapeutic efficacy of a two-week low-level laser acupuncture therapy for shoulder and neck pain in office workers: Protocol for a pilot, single-blind, double-armed, randomised controlled trial. by Carol Chunfeng Wang, Lisa Whitehead, Travis Cruickshank, Johnny Lo, Jianhong Cecilia Xia, Jun Wen

“…<h4>Methods</h4>This is a pilot, single-blind, double-armed, randomised controlled trial on the feasibility and therapeutic efficacy of a two-week LLLA therapy for office workers with SNP, aged 18 to 65 years. …”
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Economic evaluation of encorafenib with cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer in France: a cost-effectiveness analysis using data from the BEACON CRC randomised controlled trial by David Malka, Philippe Laramée, Mondher Toumi, Jean-Baptiste Trouiller, Bérengère Macabeo, Andrew Poll, Dan Howard, Andy Buckland, Marine Sivignon, Emilie Clay, Emmanuelle Samalin

“…Objective The BEACON CRC randomised controlled trial (NCT02928224) in BRAF-mutant metastatic colorectal cancer (mCRC) patients showed improved overall survival for the combination treatment of encorafenib (BRAF inhibitor) with cetuximab (EGFR inhibitor) compared with cetuximab with chemotherapy (FOLFIRI (folinic acid, fluorouracil and irinotecan) or irinotecan). …”
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