A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol by Rachel Pritchett, Bridie Fitzpatrick, Nicholas Watson, Richard Cotmore, Philip Wilson, Graham Bryce, Julia Donaldson, Kathleen Boyd, Charles Zeanah, John Norrie, Julie Taylor, Julie Larrieu, Martina Messow, Matt Forde, Fiona Turner, Susan Irving, Helen Minnis

“…This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. …”
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Pharyngeal Electrical Stimulation for Treatment of Poststroke Dysphagia: Individual Patient Data Meta-Analysis of Randomised Controlled Trials by Polly Scutt, Han S. Lee, Shaheen Hamdy, Philip M. Bath

“…We searched electronically for randomised controlled trials of PES in dysphagic patients within 3 months of stroke. …”
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Randomised control trial to compare the efficacy of traditional Thai massage and ultrasound therapy for treating plantar heel pain by Supamas Somphai, Wiraphong Sucharit, Punnee Peungsuwan, Neil Roberts, Uraiwan Chatchawan

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Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial by Li Wang, Li Jin, Yao Lu, Chen Zhang, He-Feng Huang, Yun Sun, Xian-hua Lin, Meng-xi Guo, Dan-dan Wu, Jian-lin Zhang, Cheng-liang Zhou, Chen-ming Xu, Song-chang Chen, Song-ying Zhang, Xiao-xi Sun, Yan-ting Wu

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Hypotension prediction index for minimising intraoperative hypotension: A systematic review and meta-analysis of randomised controlled trials by Kamath Sriganesh, Thomas Francis, Rajeeb Kumar Mishra, Nisarga N Prasad, Dhritiman Chakrabarti

“…Therefore, the aim of this systematic review and meta-analysis of randomised controlled trials (RCTs) was to evaluate the overall effect of using HPI on intraoperative hypotension outcomes of time-weighted average (TWA), area under the hypotension threshold (AUHT), incidence and duration of hypotension. …”
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A Randomised Controlled Trial of Efficacy of Cognitive Rehabilitation in Multiple Sclerosis: A Cognitive, Behavioural, and MRI Study by J. Campbell, D. Langdon, M. Cercignani, W. Rashid

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Levobupivacaine versus ropivacaine for brachial plexus block: A systematic review and meta-analysis of randomised controlled trials by Abdullah M. Alharran, Muteb N. Alotaibi, Yaqoub Y. Alenezi, Yousef M. Alharran, Ahmad A. Alahmad, Abdulmuhsen Alqallaf, Mohammad F. Al-Mutairi, Abdulbadih R. Saad, Mohammed H. Alazemi, Duaij S. Saif, Ebraheem Albazee, Ahmad Y. Almohammad

“…Methods: A systematic review and meta-analysis synthesising randomised controlled trials (RCTs), retrieved by systematically searching PubMed, EMBASE, WOS, SCOPUS, Google Scholar, and CENTRAL since inception till June 2024. …”
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Effect of intramuscular midazolam premedication on patient satisfaction in women undergoing general anaesthesia: a randomised control trial by Kwang Ho Lee, Seung Woo Song, Younghyun Jin, Hyunjae Lim, Jonghoon Lee

“…Objective To determine the effect of premedication with intramuscular midazolam on patient satisfaction in women undergoing general anaesthesia.Trial design, setting and participants Double-blind, parallel randomised control trial at a tertiary care medical centre in South Korea. …”
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Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial by Patrick WHE Vriens, Edith M Willigendael, Maarten A Lijkwan, Friedo W Dekker, Chava L Ramspek, Michiel W de Haan, Çaĝdaş Ünlü, Boudewijn DC Heggen, Koen E A van der Bogt, Marc H Hemmelder, Mickaël J C Hiligsmann, Magda M van Loon, Joris I Rotmans, Jan H M Tordoir, Geert Willem H Schurink, Maarten G J Snoeijs, Marijke J Molegraaf, Philippe WM Cuypers, Denise Nio, Cora H Arts, Jacobien C Verhave, Goos D Laverman, Aron S Bode, Marcel C Weijmer, Bas Govaert, Aaltje Y Adema, Gijs MJM Welten, Michel MPJ Reijnen, Marc JH Groeneveld, Hans S Brink, Jeroen B van der Net, Arno Kuijper, Hilde PE Peters, Roos C van Nieuwenhuizen, Rombout R Kruse, Yvonne C Schrama, Karina A de Groot, Karima Farhat

“…Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients.Methods and analysis OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. …”
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Clinical efficacy of a virtual reality tool for the treatment of obesity: study protocol of a randomised controlled trial by Dimitra Anastasiadou, Jose Antonio Ramos-Quiroga, Mel Slater, Bernhard Spanlang, Desiderio Cano Porras, Marta Comas, Andreea Ciudin, Gemma Parramon Puig, Julia Vázquez-De Sebastián, Pilar Lusilla-Palacios

“…The objective of this study is to assess the clinical efficacy of a VR intervention that uses embodiment and body-swapping techniques and has been specifically developed to cover the needs of PLWO.Methods and analysis A randomised control trial will be carried out with an estimated sample of 96 participants with body mass index (BMI)>30. …”
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Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial by Claire Shuiqing Zhang, Bin Li, Lin Zeng, Lu Liu, Luo-peng Zhao, Kelun Wang, Jingxia Zhao, Linpeng Wang, Xianghong Jing

“…This study is designed as a single-blinded, double-dummy randomised controlled trial to evaluate the efficacy and safety of acupuncture compared with topiramate in patients with chronic migraine.Methods and analysis A total of 60 participants will be randomly assigned to two different groups. …”
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Process evaluation of the New Interventions for independence in Dementia Study (NIDUS) Family stream randomised controlled trial: protocol by Julie Barber, Laurie Butler, Claudia Cooper, Sarah Morgan-Trimmer, Danielle Laura Wyman, Peter Bright

“…This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. …”
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Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial by Merel Kimman, Ilse Bekkers, Lynn Hoen, Huib A A M van Vliet, Nicol A C Smeets, Anne Damoiseaux, Martine M L H Wassen

“…The aim of this study is to compare hysterectomy by VANH versus VH for same-day discharge (SDD), complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Methods and analysis The study is a single-blinded, multicentre, randomised controlled trial. Eligible women with benign indication for hysterectomy will be randomly allocated to the VH (control) group or the VANH (intervention) group. …”
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Effectiveness of the ARTHE-e app for exercise adherence in people with knee osteoarthritis: protocol for a randomised controlled trial by Bruno Pereira, Charlotte Lanhers, Emmanuel Coudeyre, Lech Dobija, Mathilde Pelletier-Visa, Alexis Bonhomme

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A randomised controlled trial of fluoxetine versus naltrexone in compulsive sexual behaviour disorder: presentation of the study protocol by Jussi Jokinen, Josephine Savard, Katarina Görts Öberg, Cecilia Dhejne

“…This proposed study will be the largest and the first randomised controlled trial comparing the efficacy and tolerability of two active drugs in compulsive sexual behaviour disorder.Methods and analysis Eighty adult participants with compulsive sexual behaviour disorder according to ICD-11 will be randomised to receive either naltrexone 25–50 mg or fluoxetine 20–40 mg for 8 weeks, followed by 6 weeks without treatment. …”
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Effects of a nurse-led peer support intervention for stroke survivors: protocol for a randomised controlled trial by Ying Wu, Janita Pak Chun Chau, Xiaojuan Wan, Limei Xu, Weijuan Gong

“…This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person–Environment–Occupation–Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysis This is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. …”
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Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial) by Tero Rautio, Pasi Ohtonen, Outi Uimari, Anna Maria Terho, Johanna Mäkelä-Kaikkonen, Terhi Puhto, Sari Koivurova

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Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol by Bruno Pereira, Martine Duclos, Alexandre Mazéas, Aïna Chalabaev, Marine Blond

“…To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.Methods and analysis This trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. …”
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Evaluating agreement between individual nutrition randomised controlled trials and cohort studies - a meta-epidemiological study by Julia Stadelmaier, Gina Bantle, Lea Gorenflo, Eva Kiesswetter, Adriani Nikolakopoulou, Lukas Schwingshackl

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Network Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials Comparing Robotic, Laparoscopic, and Open Pancreatoduodenectomy by Nejo Joseph, MBChB, Chris Varghese, MBChB, James Lucocq, MBChB, Matthew J. McGuinness, MBChB, Samuel Tingle, MBChB, Giovanni Marchegiani, PhD, Kjetil Soreide, PhD, Mohammed Abu-Hilal, Jas Samra, Marc Besselink, PhD, Steve White, Sanjay Pandanaboyana, FRCS

“…With recent randomised controlled trials (RCTs) comparing open pancreatoduodenectomy (OPD) with robotic or laparoscopic pancreatoduodenectomy (RPD or LPD), we undertook a network meta-analysis (NMA) comparing all 3 approaches to evaluate comparative outcomes. …”
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