Randomized controlled trial of cognitive behavioral therapy versus health education for sleep disturbance and fatigue following stroke and traumatic brain injury by Lucy Ymer, Adam McKay, Dana Wong, Kate Frencham, Natalie Grima, Monique Roper, Sylvia Nguyen, Jade Murray, Gershon Spitz, Jennie Ponsford

“…Objective: Evaluate efficacy of cognitive behavioural therapy for sleep and fatigue adapted for brain injury relative to health education control in alleviating sleep disturbance and fatigue after acquired brain injury. Design: Parallel groups randomized controlled trial. Subjects: 126 community dwelling adults with stroke or traumatic brain injury. …”
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Evaluation of the skeletal, dental, and soft-tissue changes after the en-masse retraction of upper anterior teeth stimulated by low-intensity electrical current: a randomized contr... by Rashad I. Shaadouh, Mohammad Y. Hajeer, Mohammad Khursheed Alam, Kinda Sultan, Ossama Aljabban

“…However, a greater bodily movement of the upper incisors was noted in the LIES group. Registration This trial was retrospectively registered in the Clinical Trials database (ID: NCT06639204) and it was first posted on 15/10/2024.…”
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The effect of an educational intervention based on a mobile application on women’s knowledge, attitudes, and practices with respect to microplastics and health: a randomized contro... by Zahra Seifi, Fatemeh Zarei, Fazlollah Ahmadi

“…Recruitment is estimated to be completed by 2024-11‒21. Trial registration Iranian Clinical Trial Register (IRCT20240529061941N1). …”
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Pilot study to evaluate the use of remote patient monitoring to guide the timing of valve intervention in patients with severe asymptomatic aortic stenosis (APRAISE-AS): study prot... by James M Cotton, Derek Kyte, Nazish Khan, Winnie Chua, Larissa Fabritz, Richard P Steeds, Yongzhong Sun, Samir Mehta, Katie Kirkham, Philip Collis, Clive Stubbs, Mary Nulty

“…Results will be submitted for publication in peer-reviewed journals and disseminated at local, regional and national meetings where appropriate.Trial registration number ISRCTN19413194 registered on 14.07.2023.…”
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Early Supervised Incremental Resistance Training (ESpIRiT) following cardiac surgery via a median sternotomy: a study protocol of a multicentre randomised controlled trial by Doa El-Ansary, Md Ali Katijjahbe, Mohd Rizal Abdul Manaf, Colin Royse, Alistair Royse, Nur Ayub Md Ali, Mohd Ramzisham Abdul Rahman, Suriah Ahmad, Chong Tze Huat, Mohamad Arif Muhammad Nor, Jeswant Dillon, Hairulfaizi Haron, Muhamad Ishamudin Ismail

“…Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.Trial registration number International Standard Randomised Controlled Trials Number (ISRCTN17842822).…”
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Effects of traditional Chinese medicine massage therapy on pain, functional activity, muscle activation patterns and proprioception in knee osteoarthritis: a randomised controlled... by Xin Zhou, Cheng Tang, Bowen Zhu, Yangyang Fu, Min Fang, Sitong Fang, Qingguang Zhu, Yuen Yee Janice Hiew

“…Additionally, the participants will receive copies of the results.Trial registration number ChiCTR2300077308.…”
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Effect of osteopathic manipulative treatment on comorbid depressive symptoms in patients with chronic low back pain: study protocol for a randomised controlled trial by Meike Shedden-Mora, Robert Schleip, Francesco Cerritelli, Tobias Schmidt, Lucas Bohlen, Michael Eggart, Bruno Müller-Oerlinghausen, Jürgen Lorenz, Torsten Liem, Jorge E Esteves

“…The anonymised dataset will be published in an online repository, and the results will be published in peer-reviewed scientific journals.Trial registration number DRKS00031694.…”
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Effects of supervised exercise training during pregnancy on psychological well-being among overweight and obese women: secondary analyses of the ETIP-trial, a randomised controlled... by Siv Mørkved, Øyvind Salvesen, Trine Moholdt, Signe N Stafne, Kirsti Krohn Garnæs, A S Helvik, Kjell Salvesen

“…Our findings may be hampered by low adherence to the exercise protocol.Trial registration number NCT01243554…”
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Health extension workers led home-based multicomponent intervention improves linkage to hypertension care in northwest Ethiopia: cluster-randomized controlled trial by Destaw Fetene Teshome, Shitaye Alemu Balcha, Tadesse Awoke Ayele, Asmamaw Atnafu, Getnet Mitike, Kassahun Alemu Gelaye

“…This study aimed to evaluate the effects of health extension workers led home-based multicomponent intervention on linkage to hypertension care in patients with hypertension in rural districts of northwest Ethiopia. Methods A parallel group, cluster randomized controlled trial was conducted in 20 rural communities. …”
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Simvastatin as a neuroprotective treatment for Parkinson’s disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study by Susan Ball, Douglas Webb, Camille B Carroll, Kara Nicola Stevens, Jane Vickery, Vicky Eyre, Richard Wyse, Mike Webber, Andy Foggo, John Zajicek, Alan Whone, Siobhan Creanor

“…A summary of the study findings will be posted to participants at the end of the study.Trial Registration ISRCTN16108482 (prospectively registered); EudraCT 2015-000148-40; ClinicalTrials.gov NCT02787590; Pre-results.…”
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Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in People With Hemophilia: Protocol for a Randomized Contro... by Tugce Poyraz Isleyen, Ela Tarakci, Gokce Leblebici, Ipek Yeldan, Bulent Zulfikar

“…MethodsThis study is a 3-arm, parallel-group randomized controlled trial with 63 people with hemophilia aged 13-25 years who meet the inclusion criteria. …”
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Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial by Anni Pulkkinen, Ilkka Helanterä, Aki Uutela, Karl Lemström, Arie Passov, Simo Syrjälä, Fredrik Åberg, Heikki Mäkisalo, Arno Nordin, Marko Lempinen, Minna Bäcklund, Markus Skrifvars, Teemu Luostarinen, Janne Reitala, Maarit Lång, Ilona Leppänen, Jaakko Långsjö, Juha Grönlund, Pekka Loisa, Björn Jäschke

“…The study results will be submitted to an international peer-reviewed scientific journal for publication.Trial registration number NCT03855722.…”
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Effectiveness of Continuous Glucose Monitoring on Short-Term, In-Hospital Mortality Among Frail and Critically Ill Patients With COVID-19: Randomized Controlled Trial by Jiawei Shang, Ziming Yuan, Zuoyan Zhang, Quanhong Zhou, Yan Zou, Wei Wang

“…MethodsThis was an exploratory, prospective, open-label, parallel, single-center, randomized controlled trial. …”
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Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial by Laurie Meade, Andrea Cheville, Matthew A Warner, Phillip J Schulte, Daryl J Kor, Ognjen Gajic, Ronald S Go, William B Beam, Jonathan E Charnin, Kim A Droege, Brenda K Anderson, Matthew L Johnson, Brad Karon

“…The PABST-BR trial will inform the development of a larger multicentre clinical trial.Trial registration number NCT05167734.…”
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Midpalatal suture osteotomy combined with microimplant-assisted rapid palatal expansion for adult maxillary transverse deficiency treatment: a study protocol of a randomised contro... by Lei Zhang, Yifeng Qian, Wenyi Zhang, Miri Chung, Yanfei Zhu, Lingyong Jiang

“…Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.Trial registration number ChiCTR2400081545.…”
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Home-based self-administered transcranial direct current stimulation for women affected by primary dysmenorrhoea in Northeastern Brazil: a protocol study by Thiago Anderson Brito De Araújo, Edson Silva-Filho, Rodrigo Pegado, Tatiana Camila de Lima Alves da Silva, Yvinna Tamiris Rodrigues, Paloma Cristina Alves de Oliveira, Ervinas Bernatavicius, Alexander Anthony Cook, Emilè Radytè, Maria Thereza Micussi

“…All procedures will follow Good Clinical Practice and international ethical standards.Trail registration https://ensaiosclinicos.gov.br/rg/RBR-747k8vb…”
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Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial by Jeanett Friis Rohde, Elisabeth Ginnerup-Nielsen, Sofus Christian Larsen, Camilla Tjott, Robin Christensen, Berit Lilienthal Heitmann, Eva Ejlersen Waehrens, Anne Katrine Pagsberg, Ina Olmer Specht

“…We here describe a trial which aims to compare the effect of using a weighted blanket relative to a non-weighted sham blanket on total sleep time in children with ADHD. Methods A parallel group randomised controlled trial will be conducted. …”
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Effectiveness of a web-based virtual journal club to promote medical education (Web-Ed): protocol of a multicentre pragmatic randomised trial by Mohamed Abdelrahman, Neil Cowan, Meera Ramcharn, Bassel H Al Wattar, William Parry-Smith, Sarah McRobbie, Michael Rimmer, Nagla Elfaki, Cheryl Dunlop, Damien Coleburt, Olivia Raglan, Jhia Jiat Teh, Maria Fisher, Nilaani Murugesu, Yazid Jibrel, Matthew Wood

“…The trial has been approved by the NHS Health Regulation Authority (21/HRA/3361).Trial registration number ISRCTN18036769.…”
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Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial by Michael Skovdal Rathleff, Are Hugo Pripp, Jens Ivar Brox, Britt Elin Øiestad, Marianne Bakke Johnsen, John Bjørneboe, Niels Gunnar Juel, Rikke Munk Killingmo, Kaia B Engebretsen, Thea Morin Melås, Maren Lunder Wefring, Sigrid Skatteboe, Helene Lundgaard Søberg

“…The aim of this study protocol is to describe a randomised controlled trial (RCT) investigating the effectiveness of a self-management programme versus usual care for patients with GTPS.Methods and analysis The study is designed as an observer-blinded, parallel group, superiority RCTcomparing a self-management programme (n=55) with usual care (n=55). …”
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Effects of Using a Smart Bassinet on the Mental Health of Military-Affiliated Pregnant Women: Protocol for a Randomized Controlled Sleep Health and Mood in Newly Expectant Military... by Michele L Okun, Jennifer L Payne, Lauren M Osborne, Leilani Feliciano, Andrew Lac

“…MethodsThis study is a 6-month, parallel-arm, randomized controlled trial. Pregnant women (N=342) in the third trimester will be randomized at 1:1 ratio to use a smart bassinet (SB) or a standard commercially available bassinet (HALO BassiNest Swivel Sleeper 3.0; traditional bassinet [TB]) for up to 6 months after delivery. …”
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