Pharmacy Integrated Transitions (PIT) trial: a protocol for a pragmatic cluster-randomised crossover trial by Elizabeth Austin, Catherine Kim, Elizabeth J Austin, Giana H Davidson, Bryan A Comstock, Sarah E Monsell, Bryan Comstock, Mariam N Hantouli, Jocelyn Chaing, Arzu Ahmed Dervish, Nick J Gionet, Shalynn Howard, Nathalia Jimenez, Miriam Liberman, Edwin G Lindo, Zachary A Marcum, Thuan D Ong, Elina Serrano, Katherine Simons, Lydia S Sun, Oleg Zaslavsky

“…Results may also be presented at international conferences.Trial registration number NCT05241951.…”
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Statistical analysis plan for the 24-week randomised trial of hypoglycaemia prevention, awareness of symptoms, and treatment: HypoPAST by Sharmala Thuraisingam, Jennifer A. Halliday, Uffe Søholm, Elizabeth Holmes-Truscott, Christel Hendrieckx, Timothy C. Skinner, Vincent L. Versace, Jane Speight

“…Methods: HypoPAST is a 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial. …”
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Efficacy of a Mobile Health–Based Behavioral Treatment for Lifestyle Modification in Type 2 Diabetes Self-Management: Greenhabit Randomized Controlled Trial by Ana Maria Ruiz-Leon, Rosa Casas, Sara Castro-Barquero, Sofia Alfaro-González, Petia Radeva, Emilio Sacanella, Francesc Casanovas-Garriga, Ainhoa Pérez-Gesalí, Ramon Estruch

“…ObjectiveThis study evaluates whether the Greenhabit (mobile health [mHealth]) behavioral treatment enhances T2D outcomes compared with standard care. MethodsA 12-week, parallel, single-blind randomized controlled trial was conducted with 123 participants (62/123, 50%, female; mean age 58.25 years, SD 9.46 years) recently diagnosed with T2D. …”
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Application of point-of-care ultrasound-guided tip navigation combined with visualised directional high-frequency linear array probe compression to improve the success rate of umbi... by Fa Chen, Xianping Liu, Yunfeng Lin, Yanfang Fan, Shaoru Huang, Wen Ling, Jiajia Lin, Xia Ouyang

“…On completion of the trial, the results will be submitted for peer-reviewed publication in an international scientific journal.Trial registration number ChiCTR2400090737.…”
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Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) by Marjolein A Heuvelmans, Kathleen Jahn, Jouke T Annema, Venerino Poletti, Christina Bal, Daniela Gompelmann, Daniël A Korevaar, Juergen Hetzel, Claudia Ravaglia, Grigoris Stratakos, Peter I Bonta, Tess Kramer, Evangelia Koukaki, Saskia van Heumen, Ali Sadoughi, Katerina Bakiri, Nektarios Anagnostopoulos, Jiří Votruba, Zuzana Šestáková, Johannes M.A. Daniels, Daniel M de Bruin

“…Dissemination involves publication in a peer-reviewed journal.Support Financial and material support from Mauna Kea Technologies.Trial registration number NCT06079970.…”
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Impact of real-time glucose monitoring using FreeStyle Libre 3 on glycaemia in type 2 diabetes managed with basal insulin plus SGLT2 inhibitor and/or GLP-1 agonist: the FreeDM2 ran... by Gerry Rayman, Thomas Yates, Ramzi A Ajjan, Patrick Moore, Pratik Choudhary, Thozhukat Sathyapalan, Parth Narendran, Ahmed Iqbal, Rachel Ann Elliott, Sankalpa Neupane, Mark Evans, Hood Thabit, Lalantha Leelarathna, Emma G Wilmot, Katharine Barnard-Kelly, Iain Cranston, Thinzar Min, Yee S Cheah, Shafie Kamaruddin, Alistair Lumb

“…Study results will be disseminated in peer-reviewed journals.Trial registration number NCT05944432.Secondary identifying number Identifier assigned by the sponsor: ADC-UK-PMS-22057.Protocol version Revision D. …”
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Little Journey: a phase III randomised controlled trial of a psychological preparation and education smartphone application for management of paediatric perioperative anxiety compa... by Gareth Ambler, Daisy Fancourt, Chris Brew-Graves, Norman R Williams, Monty Mythen, Matthew Wilson, Mark Emberton, Mohini Samani, Matthew Fenton, Suneetha Ramani Moonesinghe, Christopher Evans, Georgia Bercades, Cinzia Baldini, Nazma Begum-Ali

“…Results will be presented in academic manuscripts and presentations and summarised for diverse audiences (including clinicians and patients/public) in podcasts, infographics and other multimedia formats.Trial registration number NCT03797716.…”
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Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial by Ada Sevinc, Alexandra Papaioannou, Suzanne N. Morin, Jennifer A. Watt, Raheem B. Kherani, Sheila Brien, Larry Funnell, Lehana Thabane, Lauren A. Beaupre, Jenna C. Gibbs, Heather Keller, Caitlin McArthur, Matteo Ponzano, Sonia Singh, Sharon Straus, Jenny Thain, Zachary J. Weston, Timothy H. Wideman, Christopher D. Witiw, Lora Giangregorio

“…The design is a multicentre randomized controlled trial with two parallel groups randomized in a 1:1 ratio, stratified by centre to immediate or delayed (10 weeks after randomization) receipt of the Virtual Intervention for Vertebral frActures (VIVA). …”
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Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial. by Richard A Bryant, Aiysha Malik, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Katie S Dawson, Sarah Watts, Mark J D Jordans, Felicity L Brown, Mark van Ommeren, Aemal Akhtar

“…<h4>Methods and findings</h4>In this single-blind, parallel, controlled trial, Syrian refugees aged 10 to 14 years in Jordan were identified through screening of psychological distress as defined by scores ≥15 on the Paediatric Symptom Scale. …”
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Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled tr... by Gerry Rayman, Christopher Sutton, M Burns, Rachel Ann Elliott, Sankalpa Neupane, Mark Evans, S Lumley, A Krishan, Emma G Wilmot, P Narendran, Katharine Barnard-Kelly, Iain Cranston, G Gkountouras, N Kanumilli, C Kotonya, V P Taxiarchi, H Thabit, L Leelarathna

“…Informed consent will be sought from all participants.Trial registration number NCT03815006.Protocol version 4.0 dated 29 June 2020.…”
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Accounting for stillbirths in maternal health metrics: a cross-country analysisResearch in context by Ursula Gazeley, Hallie Eilerts-Spinelli, Joshua Wilde, Hannah Blencowe, Li Liu, Wendy Graham, Veronique Filippi

“…Progress in the availability of global stillbirth estimates means using total births as the denominator in maternal metrics is increasingly feasible in some countries and, in turn, could further strengthen momentum to institutionalise stillbirth reporting in civil registration systems. As the end of the SDG era approaches, the use of a more conceptually accurate maternal denominator based on total births should be explored in parallel with existing measures. …”
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Function focused care in hospital among nurses and patients from geriatric and neurology wards: A mixed method process evaluation by Selma Kok, Elke G.E. Mathijssen, Lisette Schoonhoven, Carolien Verstraten, Silke F. Metzelthin, Nienke Bleijenberg, Janneke M. de Man-van Ginkel

“…Objective: to gain insight into the experiences of nurses and patients, and to give insight into implementation fidelity, mechanisms of impact, and contextual factors while implementing Function Focused Care in Hospital on geriatric and neurologic hospital wards. Design: convergent parallel mixed-methods study, alongside a stepped wedge clinical trial. …”
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Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mecha... by Joanne R Chalmers, Sanja Kezic, Zarif K Jabbar-Lopez, Nikeeta Gurung, Danielle Greenblatt, Annette Briley, Kim Suzanne Thomas, Tony Frost, John E A Common, Heidi H Kong, Julie A Segre, Simon Danby, Michael J Cork, Janet L Peacock, Carsten Flohr

“…A further aim is to explore the pathophysiological mechanisms for this in an embedded mechanistic study.Methods and analysis Multicentre parallel group assessor-blinded randomised controlled pilot trial. …”
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A Rent Subsidy and Identity Capital Intervention for Youth Exiting Homelessness: Protocol for the Transitioning Youth Out of Homelessness 2.0 Pilot Randomized Controlled Trial by Naomi S Thulien, Rowen K Stark, Alexandra Amiri, Alex Abramovich, Alex Akdikmen, Alexandra Carasco, Mardi Daley, Bernice Downey, Oluwapelumi (Pukky) Fambegbe, Tyler Frederick, Stephen W Hwang, Nicole Kozloff, Amanda Noble, Cheryl Pedersen, Marsha Rampersaud, Ruth Rodney, Tadios Tibebu, Rosane Nisenbaum

“…MethodsThis study is a convergent mixed methods, 2-arm parallel RCT, open-label design with 1:1 allocation. …”
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Impact of mobile health-based nutritional education on hemoglobin levels in anemic adolescent girls in rural Bangladesh: a randomized controlled trial by Md Jiaur Rahman, Md Moshiur Rahman, Mohammad Habibur Rahman Sarker, Ryota Matsuyama, Masayuki Kakehashi, Miwako Tsunematsu, Mohammad Ali, Ashir Ahmed, Mohammad Delwer Hossain Hawlader, Hiromi Kawasaki, Yoko Shimpuku

“…Methods This open-label, parallel-group, randomized controlled trial was conducted at two schools in Chandpur district, Bangladesh from late May 2022 to January 2023. …”
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Early Start Denver Model effectiveness in young autistic children: a large multicentric randomised controlled trial in two European countries by Marie-Maude Geoffray, Sandrine Sonié, Mario Speranza, Bruno Falissard, Sandrine Touzet, Angelique Denis, Lucie Jurek, Marie-Joelle Oreve, Carmen Schroder, Amélie Zelmar, Sabine Manificat, Stephane Bahrami, Flavia Mengarelli, Véronique Delvenne, Sophie Carlier, Mikail Nourredine, Jay Agathe, Gallifet Natacha, Nicolas Petit, Laetitia Bouveret, Sara Linda Dochez, Pauline Auphan, Olivia Febvey-Combes

“…Further research is required to evaluate the long-term effectiveness of ESDM and identify subgroups that may benefit more, thereby guiding optimal implementation strategies.Trial registration number NCT02608333.…”
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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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Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection (STI) Self-Sampling Websites (Wrapped): Feasibility Randomized Controlled Trial by Katie Newby, Kayleigh Kwah, Lauren Schumacher, Rik Crutzen, Louise L Jackson, Stephen Bremner, Julia V Bailey, Katherine E Brown

“…MethodsUsers of web-based STI testing aged 16 years to 24 years were randomized to an online, double-blind, 2-arm, parallel-group feasibility RCT in which Wrapped plus usual care (basic information on STIs and condom use) was tested against usual care alone. …”
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Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness by John Norrie, Graeme Maclennan, Luke Vale, Alison McDonald, Craig Ramsay, Zafer Tandogdu, Rebecca Lewis, Anne Duncan, Steven Penegar, Jing Shen, John D Kelly, Robert Pickard, James N Dow, Hugh Mostafid, Paramananthan Mariappan, Ghulam Nabi, Joanne Creswell, Henry Lazarowicz, John McGrath, Ernest Taylor, Emma Clark, Rakesh Heer

“…Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration numberISRCTN84013636.…”
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Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWE... by Karice K Hyun, Christine Mitchell, Julie Redfern, Nashid Hafiz, Rebecca Raeside, Brooke Nickel, Carolyn Ee, Jennifer McIntosh, Elisabeth Elder, Raymond J Chan, David Mizrahi, Stephanie R Partridge, Anna C Singleton, Allyson Ruth Todd, Kirsty E Stuart

“…Trial results will be disseminated in peer-reviewed publications, presentations, lay summaries, videos and audio for scientific, government and public audiences.Trial registration number Australia and New Zealand Clinical Trial Registry (ACTRN12624000591550, 09/05/2024; U1111-1307-3454).…”
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