High-dose glucocorticoid treatment vs. glucocorticoid replacement in immune checkpoint inhibitor associated hypophysitis (CORTICI): an open, randomised controlled trial by Verena Theiler-Schwetz, Christian Trummer, Lisa Schmitt, Angelika Terbuch, Barbara Obermayer-Pietsch, Erika Richtig, Stefan Pilz

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Therapeutic alliance in a stepped digital psychosocial intervention for breast cancer patients: findings from a multicentre randomised controlled trial by Aida Flix-Valle, Joan Carles Medina, Arnau Souto-Sampera, Alejandra Arizu-Onassis, Eva Juan-Linares, Maria Serra-Blasco, Laura Ciria-Suárez, Guillem Feixas, Cristian Ochoa-Arnedo

“…Method A multicentre randomised controlled trial with 184 newly diagnosed breast cancer women was conducted. …”
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Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial by Javier Ripollés-Melchor, Ane Abad-motos, Juan Victor Lorente, Ignacio Jimenez, Alejandra Becerra, Wilbert Wesselink, Francesca Reguant, Irene Mojarro, Maria de los Angeles Fuentes, Elizabeth Agudelo, Francisco Herrero-Machancoses, Paula Callejo, Joan Bosch, Manuel Ignacio Monge

“…This study aims to determine whether a treatment protocol based on the prevention of arterial hypotension using the HPI algorithm reduces the duration and severity of intraoperative hypotension compared with the recommended goal-directed fluid therapy strategy and may improve tissue oxygenation and organ perfusion.Methods and analysis We will conduct a multicentre, randomised, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. …”
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Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial by Yan Yan, Zhishun Liu, Huan Chen, Xiaoxu Liu, Hangyu Shi

“…Therefore, this study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy and safety of electroacupuncture on relieving symptoms of a POP stage II and III among women.Methods and analysis A two-arm, multicentre, patient-blind RCT will be conducted to compare EA with sham electroacupuncture (SEA) for treating symptoms of POP stage II and III among women in six tertiary hospitals in China. …”
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Improving community-based first response to out of hospital cardiac arrest (FirstCPR): protocol for a cluster randomised controlled trial by Sandra Ware, Blake Angell, Julie Redfern, Clara Chow, Cate Ferry, Lee Taylor, Christopher Semsarian, Adrian Bauman, Janet E Bray, Simone Marschner, Michael Nelson, Saurabh Kumar, Matthew Vukasovic, Kevin Lai, Paul M Middleton, Pramesh Kovoor, Garry Jennings, Sonali Munot, Andrew Coggins, Alan Robert Denniss, Sarah Khanlari, Ian Opperman

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The effect of blue-blocking intraocular lenses on circadian biological rhythm: protocol for a randomised controlled trial (CLOCK-IOL colour study) by Taiji Hasegawa, Kenji Obayashi, Kimie Miyata, Tetsuo Ueda, Norio Kurumatani, Keigo Saeki, Nahoko Ogata, Hiroki Tsujinaka, Mariko Yamashita, Tomo Nishi, Nobuhiro Tone, Naonori Masuda, Yutarou Mizusawa, Masahiro Okamoto, Shinji Maruoka, Masashi Kojima, Toyoaki Matsuura

“…At present, clear intraocular lenses (IOLs) and blue-blocking IOLs are both widely used for cataract surgery; there is currently a lack of randomised controlled trials to determine whether clear or blue-blocking IOLs should be used.Methods and analysis This randomised controlled trial will recruit 1000 cataract patients and randomly allocate them to receive clear IOLs or blue-blocking IOLs in a ratio of 1:1. …”
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Effect of enhanced recovery after surgery on older patients undergoing transvaginal pelvic floor reconstruction surgery: a randomised controlled trial by Xuezhu Huang, Sisi Deng, Xiaofeng Lei, Shentao Lu, Ling Dai, Chunyan She

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Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial by Bo Chen, Xu Wang, Hong He, Xiaojie Huang, Qian Du, Shaoyong Xu, Xiaomin Qin, Tongting Kang

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Examining anti-inflammatory therapies in the prevention of cardiovascular events: protocol for a systematic review and network meta-analysis of randomised controlled trials by George A Wells, Kevin Emery Boczar, Sheojung Shin, Kathryn A Bezzina, Aishwarya Geejo, Alexander Liam Pearson, Saba Shahab, Christophe A Fehlmann, Sarah Visintini, Rob Beanlands

“…However, comparative evidence regarding efficacy of these anti-inflammatory treatment options is currently lacking.Methods and analysis This systematic review will include randomised controlled trials evaluating the effect of anti-inflammatory agents on cardiovascular outcomes in patients with known cardiovascular disease. …”
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Transcranial direct current stimulation combined with physical exercise in rotator cuff tendinopathy: a protocol for a blinded randomised controlled trial by César Augusto Medeiros Silva, Clécio Gabriel de Souza, Vinicius Batista Lima, Hannely Beatriz Menezes Cosme, Romário Nóbrega Santos Fonseca, Fuad Ahmad Hazime, Rodrigo Scattone da Silva, Rodrigo Pegado de Abreu Freitas

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Effects of biophilic virtual reality on cognitive function of patients undergoing laparoscopic surgery: study protocol for a sham randomised controlled trial by Bin Gao, Yanling Zhou, Jianhua Wang, Binbin Zhu, Qiuyan Weng, Wenjun Luo, Xiuchao He, Lufei Jin, Qinwen Wang, Ahmad Khaled Ahmad Harb

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Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia by Bei Wu, Gary Yu, Brenda L Plassman, Patricia Poole, Shahrzad Siamdoust, Melanie Bunn, Bobbi Burwell, Yaolin Pei, Christine Downey, Danni Gomes, Angela Kamer, A Leak Bryant, Ruth A Anderson

“…By providing support to perform these tasks successfully, we aim to delay oral health decline among this vulnerable population.Methods and analysis This multisite study is a three-arm randomised controlled trial. The primary objective is to evaluate the efficacy of an intervention to improve oral hygiene outcomes by promoting positive oral hygiene behaviours and skills among individuals with mild dementia. …”
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Efficacy of soft palatal augmentation prosthesis for oral functional rehabilitation in patients with dysarthria and dysphagia: a protocol for a randomised controlled trial by Naoki Kodama, Tomonori Yokoyama, Takao Mukai, Kana Takao, Takashi Hiraoka, Nobuyuki Arai, Jitsuro Yano, Hiroaki Nagatsuka, Yousuke Manda, Kozo Hanayama, Shogo Minagi

“…The aim of this study is to investigate whether soft PAP can improve dysarthria and dysphagia occurring as cerebrovascular disease sequelae.Methods and analysis This prospective, randomised, controlled trial will compare the immediate and training effects of rehabilitation using soft PAP with those of rehabilitation without using it. …”
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Four Weeks of Inspiratory Muscle Training Improves Self-Paced Walking Performance in Overweight and Obese Adults: A Randomised Controlled Trial by A. M. Edwards, G. P. Maguire, D. Graham, V. Boland, G. Richardson

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Efficacy of virtual reality techniques in cardiopulmonary resuscitation training: protocol for a meta-analysis of randomised controlled trials and trial sequential analysis by Jia Wang, Lu Zhang, Guo Chen, Li Du, Jianqiao Zheng, Xiaoqian Deng

“…Thus, we will perform a protocol for a systematic review and meta-analysis to identify the efficacy of the VR technique on CPR quality.Methods and analysis We will search PubMed, Web of Science, Cochrane Library, Ovid Medline, Embase, China National Knowledge Infrastructure, Chinese BioMedical Literature, Wanfang and VIP databases from inception to November 2021, to identify randomised controlled trials and the first period in randomised cross-over trials assessing the efficacy of VR techniques versus non-VR techniques for adult participants accepting adult CPR training. …”
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Evaluation of Randomised Controlled Trials Published in Indian Specialty Dental Journals for Statistical Testing of Baseline Differences: A Meta-Epidemiological Study by Mahesh R. Khairnar, PG Naveen Kumar, Ananta Kusumakar, Zainab Akram, Harloveen Sabharwal, Sachin Jadhav

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A health-education intervention to improve outcomes for children with emotional and behavioural difficulties: protocol for a pilot cluster randomised controlled trial by Rachel Schembri, Harriet Hiscock, Frank Oberklaid, William Garvey

“…However, educators have limited training or access to clinical support in this area.Methods and analysis This study is a pilot cluster randomised controlled trial of a co-designed health and education model aiming to improve educator identification and support of children with emotional and behavioural difficulties. …”
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Simvastatin Does Not Affect Vitamin D Status, but Low Vitamin D Levels Are Associated with Dyslipidemia: Results from a Randomised, Controlled Trial by Lars Rejnmark, Peter Vestergaard, Lene Heickendorff, Leif Mosekilde

“…We now report the results from a randomised controlled trial on effects of simvastatin on plasma 25OHD levels. …”
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Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study by Mike Murphy, Nicholas Parsons, James Mason, Juul Achten, Duncan Appelbe, Edward Dickenson, Damian Griffin, Katy Mironov, Matthew Wyse, Amrita Athwal, Xavier Luke Griffin, Heather O'Connor

“…The objective of this study is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared with standard care, in improving health related quality-of-life of patients undergoing hip fracture surgery.Methods and analysis Multicentre, parallel group, two-arm, randomised controlled trial. Patients aged 60 years and older with a hip fracture treated with surgery are eligible. …”
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Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial by Éimhín Ansbro, Jing Luo, Chung-Chou H Chang, Kaushik Ramaiya, Bruce L Rollman, Sylvia Kehlenbrink, Sae-Rom Chae, Abigail Foulds, Claire Josey, Christina Lalama, Margaret L Prust, Bedowra Zabeen, Graham Ogle

“…To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.Methods and analysis This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). …”
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