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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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 by Alicia J Spittle, Peter J Anderson, Angela T Morgan, Rachel Schembri, Li Huang, Kim Dalziel, Rod W Hunt, Katherine Lee, Anne E Holland, Karli Treyvaud, Abbey L Eeles, Stacey Dusing, Shaaron Brown, Susan M Fehring, Gillian Henty, Elizabeth Kozaris

“…Here we present the protocol outlining a multicentre, pragmatic, parallel-group, randomised controlled trial to determine the efficacy of TEDI-Prem plus usual care, compared with usual care alone.Methods and analysis We will recruit 466 VPT infants from the neonatal units of five hospitals in Victoria, Australia. …”
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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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Effect of porcine collagen matrix versus rotated pedicle palatal connective tissue flap on the soft-tissue closure after the immediate posterior implantation: study protocol for a randomised controlled trial by Wei Zhang, Si Chen, Chenyang Zhang, Shuobo Fang, Zhengjie Dong, Tong Chen, Wanqi Lv, Keyi Hao

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Correction for ‘multicentre, open-label, randomised, controlled trial to compare early intervention with calcimimetics and conventional therapy in preventing coronary artery calcification in patients with secondary hyperparathyroidism (UPCOMING): a study protocol’

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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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Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study by Katia Iglesias, Catherine Busnel, Florian Dufour, Sophie Pautex, Laurence Séchaud

“…A cluster randomised controlled trials with three parallel arms will be conducted with 45 patients with chronic progressive diseases impacting life expectancy in each group: (1) Group A, Go Wish intervention for patients and their relatives; (2) Group A, Go Wish intervention for patients alone and (3) Group B, for patients (with a waiting list), who will receive the standardised information on ADs (usual care). …”
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Trial of alginates in throat symptoms: protocol for a pragmatic, multicentre, placebo controlled, double blind, parallel, randomised controlled trial of liquid alginate (Gaviscon Advance) for the treatment of persistent throat symptoms by David Hamilton, Ruth Wood, Dawn Teare, Miranda Morton, Rebecca Maier, James O’Hara, Tony Fouweather, Julian McGlashan, Julie Thompson, Richard Joyce, Hesther Smith, Lysbeth Evans

“…Trial of alginates in throat symptoms aims to compare symptomatic response of the symptoms of PTS in liquid alginate (Gaviscon Advance) in comparison to a near matched placebo over an 8-week period to provide definitive evidence of the use of alginates in treating PTS.Methods and analysis This is a multicentre, pragmatic, double blind, parallel, randomised controlled trial. 250 adults with PTS will be recruited from NHS secondary care sites and randomised to either liquid alginate (Gaviscon Advance) or near matched placebo in a 1:1 ratio. …”
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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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Advantages and challenges of using arterial spin labelling MRI to monitor cerebral blood flow in multi-centre clinical trials of neurodegenerative disease: Experience from the RADA... by Lina Jarutyte, Jan Petr, Nicholas Turner, Patrick G. Kehoe, Henk-Jan Mutsaerts, David L. Thomas

Subjects: “…Multi-centre randomised controlled trials…”
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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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Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial by Jane Daniels, Lee Middleton, Tina Sara Verghese, Versha Cheed, Lisa Leighton, Pallavi Manish Latthe

“…Objective To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.Design and setting A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015–August 2016).Participants Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.Intervention Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. …”
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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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Preoperative Physical Activity Improvement with the Use of Activity Trackers in Patients Undergoing Radical Cystectomy—A Bicentric, Open-label, Randomised Controlled Trial: A Clinical Study Protocol of the PreAct Trial by Johannes Hermann Kilz, Marie Angela Sidoti Abate, Victoria Luise Simone Wieland, Luisa Egen, Caelan Max Haney, Aleksander Antoniewicz, Alexander Studier-Fischer, Thomas Stefan Worst, Maurice Stephan Michel, Patrick Honeck, Niklas Westhoff, Maximilian Christian Kriegmair, Karl-Friedrich Kowalewski

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Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme by Richard D Neal, David Baldwin, Sarah Lewis, John Britton, Rachael L Murray, Qi Wu, Kate Brain, Samantha L Quaife, Matthew EJ Callister, Philip A J Crosbie, Harriet D Quinn-Scoggins, Grace M McCutchan, Alex Ashurst, Suzanne Rogerson, Rebecca Thorley

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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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