Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial by Ben J Marais, Joel Negin, James Johnston, Virginia Wiseman, Greg J Fox, Thu Anh Nguyen, Binh Hoa Nguyen, Viet Nhung Nguyen, Justin Beardsley, Guy Barrington Marks, Kavindhran Velen, Tho Dang, Hoang Anh Nguyen, Dinh Hoa Vu, Thu Thuong Do, Cuong Pham Duc, Huu Lan Nguyen, Huu Thuong Pham, Warwick Britton

“…This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice.Methods and analysis A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. …”
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Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) by Stepan Havranek, Jiri Jarkovsky, Otakar Jiravský, Pavel Osmancik, Veronika Bulková, Jan Chovančík, Tomáš Roubíček, Dalibor Heřman, Zuzana Čarná, Vladimír Tuka, Martin Matoulek, Martin Fiala, Sylvie Stregl-Hruskova, Adam Latiňák, Jiřina Kotryová

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Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R) by Bin Wu, Yi Xiao, Xiao Zhang, Tao Xu, Qian Liu, Wei Fu, Yang An, Yongheng Li, Guole Lin, Huadan Xue, Guoju Wu, Jiaolin Zhou, Hongwei Yao, Zhenjun Wang, Weijie Chen, Junyang Lu, Guannan Zhang, Xiaoyuan Qiu

“…Our previous study has shown that circulating tumour DNA (ctDNA) effectively reflects tumour burden and genetic characteristics and has significant predictive value for tumour recurrence, demonstrating great potential in guiding the choice of neoadjuvant strategies.Methods and analysis The CINTS-R trial is a multicentre, open-label, randomised controlled trial designed to evaluate the efficacy and safety of a ctDNA-guided neoadjuvant treatment strategy compared with conventional neoadjuvant therapy regime in patients with LARC. …”
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Estradiol and progesterone levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer cycle: a randomised controlled trial protocol by Nina Freiesleben Mørch, Mette Petri Lauritsen, Pernille Fog Svendsen

“…We aim to investigate serum estradiol and progesterone levels in women who conceived after natural, estradiol and progesterone, or gonadotrophin stimulated frozen embryo transfer.Methods and analysis The study is an open-label, randomised controlled trial with normo-ovulatory women being randomised to natural cycle or estradiol and progesterone substitution and anovulatory women being randomised to estradiol and progesterone substitution or gonadotrophin stimulation. …”
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Effectiveness of nurse-led volunteer support and technology-driven pain assessment in improving the outcomes of hospitalised older adults: protocol for a cluster randomised controlled trial by Max K Bulsara, Christopher Etherton-Beer, Rosemary Saunders, Kate Crookes, Mustafa Atee, Caroline Bulsara, Beverley Ewens, Olivia Gallagher, Renee M Graham, Karen Gullick, Sue Haydon, Kim-Huong Nguyen, Bev O'Connell, Karla Seaman, Jeff Hughes, Seng Giap Marcus Ang, Debra Scaini

“…Two interventions that have the potential to prevent progression of frailty and improve patient outcomes in hospitalised older adults but have yet to be subject to clinical trials are nurse-led volunteer support and technology-driven assessment of pain.Methods and analysis This single-centre, prospective, non-blinded, cluster randomised controlled trial will compare the efficacy of nurse-led volunteer support, technology-driven pain assessment and the combination of the two interventions to usual care for hospitalised older adults. …”
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Ghanaian women’s experience of intimate partner violence (IPV) during group antenatal care: a brief report from a cluster randomised controlled trial by Samia J. Abdelnabi, Michelle L. Munro-Kramer, Cheryl A. Moyer, John E.O. Williams, Jody R. Lori

“…This study describes an exploratory aim of a cluster randomised controlled trial designed to assess the outcomes of Group Antenatal Care (ANC) in Ghana. …”
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Daily versus three-times-weekly azithromycin in Chinese patients with non-cystic fibrosis bronchiectasis: protocol for a prospective, open-label and randomised controlled trial by Jing Li, Fei Chen, Wei Xiao, Feng Li, Lan Chen, Ting He, Yanxiong Mao, Aiping Zou, Bo Fan, Weihao Ni, Huimin You, Wenjiang Fu

“…This protocol describes a head-to-head clinical trial designed to compare the efficacy of two dosing regimens of azithromycin in Chinese NCFB population.Methods and analysis This prospective, open-label and randomised controlled trial will be conducted in the First People’s Hospital of Jiashan, China. …”
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Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial by Stephanie Book, Elmar Graessel, Julia Schneider, Michael Jeitler, Petra Scheerbaum, Michael Jank, Etienne Hanslian, Melanie DellO’ro, Julia-Sophia Scheuermann, Sophia Bösl, Christian Kessler

“…The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysis Participants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. …”
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Timely short-term specialised palliative home care for older people with frailty and their family: a mixed-methods pilot randomised controlled trial and process evaluation by Lieve Van den Block, Kim de Nooijer, Lara Pivodic, Peter Pype, Nele Van Den Noortgate, Rose Miranda, Kim Eecloo, Stefanie De Buyser, Aurelie Joos, Katlijn Van Mulders

“…Objective The primary study aims were to evaluate the implementation, mechanisms and context of a timely short-term specialised palliative care intervention for older people with frailty (Frailty+ intervention) as well as to assess the feasibility of a randomised controlled trial to evaluate Frailty+. Our secondary aim was to describe any preliminary effects of Frailty+.Design Pilot randomised controlled trial with process evaluation.Setting/Participants We aimed to recruit 50 adults (≥70 years) with Clinical Frailty Scale score 5–7, and complex care needs and their main family carer, if available, from two Belgian hospitals on discharge.Interventions Patients were randomised to the Frailty+ intervention alongside standard care or standard care alone.Outcome measures Implementation and trial feasibility were assessed through interviews, focus groups and quantitative data. …”
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Exercise-based cardiac rehabilitation for patients with atrial fibrillation receiving catheter ablation: protocol for a feasibility randomised controlled trial (RCT) with embedded process evaluation by Gregory Y H Lip, Helen Jones, Mark T Mills, Dhiraj Gupta, Lawrence Foweather, Benjamin JR Buckley, Charlotte Fitzhugh

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The effect of nursing care provided to coronary intensive care patients according to their circadian rhythms on sleep quality, pain, anxiety, and delirium: a randomised controlled trial by Meryem Pelin, Havva Sert

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A digital intervention to reduce home-office workers’ sedentary behaviour: protocol for the evaluation of the Click2Move programme, a cluster randomised controlled trial by Judit Bort-Roig, Iris Parés-Salomón, Bette Loef, Cristina Vaqué-Crusellas, Alan Coffey, Arnau Gustems-Morral, Anna M. Señé-Mir, Izabela Luznik, Maja Pajek, Kieran P. Dowd, Anna Puig-Ribera, Karin I. Proper

“…Methods A two-arm cluster randomised controlled trial will be undertaken among hybrid office employees. …”
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Comparative analysis of LMA Blockbuster® clinical performance: Blind versus Miller laryngoscope-guided insertion in paediatric general anaesthesia – A double-blinded, randomised controlled trial by Pooja Bihani, Shivanand, Rishabh Jaju, Naveen Paliwal, Sarita Janweja, Ankit Vyas

“…Methods: This randomised controlled trial study enroled 100 patients aged 1–4 years undergoing elective surgery. …”
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PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the emergency department (PRONTO): protocol for a multicentre, open-label, randomised controlled trial by David Taylor-Robinson, Steve Goodacre, Neil French, Richard Body, Kerenza Hood, Emma Thomas-Jones, Jane Daniels, Sarah Walker, Ingeborg Welters, Mike Bradburn, Paul Schmidt, Enitan Carrol, Lucy Brookes-Howell, Sarah Milosevic, Andrew Tabner, Philip Pallmann, Stephen Aston, Gavin Barlow, Emma Richards, Emmanuel Nsutebu, Philip Howard, Matthew Inada-Kim, Stacy Todd, Fiona McGill, Martin Llewelyn, Louis Wihelmus Niessen, Joanne Euden, Julie Carman, Stephanie Gilbert, Sam Clarkstone, Jacqui Hughes, Lena Meister, Angela Brain, Matthew Scarborough, Sian O'Shea, Claire James

“…The PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal (PRONTO) study is a randomised controlled trial (RCT) in adults with suspected sepsis presenting to the ED to compare standard clinical management based on NEWS2 scoring plus PCT-guided risk assessment with standard clinical management based on NEWS2 scoring alone and compare if this approach reduces prescriptions of antibiotics without increasing mortality.Methods and analysis PRONTO is a parallel two-arm open-label individually RCT set in up to 20 NHS EDs in the UK with a target sample size of 7676 participants. …”
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Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-Based Context (TrainStim-Home): study protocol for a randomised controlled trial by Ulrike Grittner, Agnes Flöel, Rafal Nowak, Friederike Thams, Daria Antonenko, Merle Rocke, Robert Malinowski

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Neuromuscular and structural tendon adaptations after 6 weeks of either concentric or eccentric exercise in individuals with non-insertional Achilles tendinopathy: protocol for a randomised controlled trial by Deborah Falla, Eduardo Martinez-Valdes, Ignacio Contreras-Hernandez

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Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial by Jung-Yoon Choe, Hwajeong Lee, Yun-Kyoung Song, Seong-Kyu Kim, Ji-Won Kim, Ji-Eun Park, Ju-Eun Lee, Bo-Kyung Moon, Sung-Hoon Park

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Parenting with nutrition education and unconditional cash reduce maternal depressive symptoms and improve quality of life: findings from a cluster randomised controlled trial in urban Bangladesh by Sheikh Jamal Hossain, Fahmida Tofail, Anisur Rahman, Jane Fisher, Jena Derakhshani Hamadani, Syed Moshfiqur Rahman

“…Methods The study was a cluster randomised controlled trial with two arms: i) intervention: parenting with nutrition education and unconditional cash and ii) comparison: unconditional cash in an urban setting in Bangladesh. …”
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Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being by Harald Baumeister, Ann-Marie Küchler, David Ebert, Natalie Bauereiss, Eileen Bendig, Benjamin Erb, Lena Weger, Echo Meißner

“…The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.Methods and analysis Within a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. …”
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Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial by Kenny A Rodriguez-Wallberg, Christina Bergh, Ali Khatibi, Annika Strandell, Mats Brännström, Caroline Stadelmann, Kristbjörg Heiður Olsen, Margareta Kitlinski, Susanne Liffner, Eva Lundborg, Göran Westlander, Gabriella Widlund, Åsa Magnusson

“…To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low.Methods and analysis The ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. …”
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