Effect of intensive treatment for schistosomiasis on immune responses to vaccines among rural Ugandan island adolescents: randomised controlled trial protocol A for the ‘POPulation... by Pontiano Kaleebu, Emily Webb, Moses Muwanga, Gyaviira Nkurunungi, Ludoviko Zirimenya, Agnes Natukunda, Jacent Nassuuna, Gloria Oduru, Caroline Ninsiima, Christopher Zziwa, Florence Akello, Robert Kizindo, Mirriam Akello, Anne Wajja, Henry Luzze, Stephen Cose, Alison M Elliott, Alison Elliott, Rebecca Amongin, Beatrice Nassanga, Irene Nambuya, Prossy Kabuubi, Emmanuel Niwagaba, Grace Kabami, Helen Akurut, Alex Mutebe, Milly Namutebi, Caroline Onen, Esther Nakazibwe, Josephine Tumusiime, Susan Amongi, Moses Sewankambo, Denis Nsubuga, Samuel Kiwanuka, Fred Kiwudhu, David Abiriga, Moses Kizza, Samsi Nansukusa, Hermelijn Smits, Maria Yazdanbakhsh, Govert van Dam, Paul Corstjens, Sarah Staedke, James Kaweesa, Edridah Tukahebwa, Elly Tumushabe, Prossy N Kabuubi, Joel Serubanja

“…Further dissemination will be done through conference proceedings and publications.Trial registration number ISRCTN60517191.…”
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Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol by Christopher R Sudfeld, Karim Manji, Rodrick Kisenge, Tisungane Mvalo, Melda Phiri, Christopher Duggan, Lauren Spigel, Anne CC Lee, Bethany A Caruso, Laura Subramanian, Megan Marx Delaney, Shivaprasad S Goudar, Linda Vesel, Katherine EA Semrau, Irving F Hoffman, Melissa Young, Friday Saidi, Jnanindra Nath Behera, Roopa M Bellad, Leena Das, Sangappa Dhaded, Gowdar Guruprasad, Sujata Misra, Sanghamitra Panda, Latha G Shamanur, Sunil S Vernekar, Sarah Somji, Linda Adair, Kiersten Israel-Ballard, Stephanie L Martin, Kimberly L Mansen, Krysten North, Emily Benotti, Eliza Fishman, Katelyn Fleming, Natalie Henrich, Kate Miller, Danielle E Tuller

“…The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.Trial registration numbers NCT04002908 and CTRI/2019/02/017475.…”
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Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multi... by Jie Liu, Jie Zhang, Wen Zhang, Ying Wang, Lu Zhang, Bing Zhang, Kun Wang, Weili Yan, Yan Bi, Zhou Zhang, Xiang Xu, Wenhui Zhu, Fangyi Li, Xiaoya Zhang, Xiaowei Zhu, Congcong Yu, Huijie Yang, Shihua Chen, Sijue Yang, Beibei Zhai, Tianyu Wu, Shengyi Zhao, Xuewei Tong, Yanjie Duan, Yining Chao, Jindan Wu, Xinhua Ye, Haiyan Cheng

“…Findings from this trial are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.Trial registration number NCT05313529.…”
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Protocol and Statistical Analysis Plan for a Multicenter Randomized Trial of Ketamine vs Etomidate for Emergency Tracheal IntubationTake-Home Points by Stephanie C. DeMasi, MD, Brant Imhoff, MS, Ariel A. Lewis, BSN, RN, MPH, Kevin P. Seitz, MD, Brian E. Driver, MD, Kevin W. Gibbs, MD, Adit A. Ginde, MD, MPH, Stacy A. Trent, MD, MPH, Derek W. Russell, MD, Amelia L. Muhs, MD, Matthew E. Prekker, MD, MPH, John P. Gaillard, MD, Daniel Resnick-Ault, MD, L. Jane Stewart, MD, JD, MPH, Micah R. Whitson, MD, Graham W.W. Van Schaik, MD, MBA, Aaron E. Robinson, MD, MPH, Jessica A. Palakshappa, MD, Neil R. Aggarwal, MD, MHSc, Jason C. Brainard, MD, David J. Douin, MD, Carolynn Lyle, PA-C, MPH, Sheetal Gandotra, MD, Aaron J. Lacy, MD, Kristen C. Sherlin, PharmD, Greta K. Carlson, MD, J. Maycee Cain, BS, Brianne Redman, MD, Carrie Higgins, BSN, Cori Withers, BS, Logan L. Beach, MD, Barbara Gould, Jasmine McIntosh, Bradley D. Lloyd, RRT-ACCS, Tiffany L. Israel, MSSW, Li Wang, MS, Todd W. Rice, MD, Wesley H. Self, MD MPH, Jin H. Han, MD, Jonathan D. Casey, MD, Matthew W. Semler, MD

“…Study Design and Methods: The Randomized Trial of Sedative Choice for Intubation (RSI) is a pragmatic, multicenter, unmasked, parallel-group randomized trial being conducted at 14 sites (6 emergency departments and 8 ICUs) in the United States. …”
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Effectiveness of Chlorthalidone Plus Amiloride for the Prevention of Hypertension: The PREVER‐Prevention Randomized Clinical Trial by Sandra Costa Fuchs, Carlos E. Poli‐de‐Figueiredo, José A. Figueiredo Neto, Luiz César N. Scala, Paul K. Whelton, Francisca Mosele, Renato Bandeira de Mello, José F. Vilela‐Martin, Leila B. Moreira, Hilton Chaves, Marco Mota Gomes, Marcos R. de Sousa, Ricardo Pereira e Silva, Iran Castro, Evandro José Cesarino, Paulo Cesar Jardim, João Guilherme Alves, André Avelino Steffens, Andréa Araujo Brandão, Fernanda M. Consolim‐Colombo, Paulo Ricardo de Alencastro, Abrahão Afiune Neto, Antônio C. Nóbrega, Roberto Silva Franco, Dario C. Sobral Filho, Alexandro Bordignon, Fernando Nobre, Rosane Schlatter, Miguel Gus, Felipe C. Fuchs, Otávio Berwanger, Flávio D. Fuchs

“…Methods and Results This randomized, parallel, double‐blind, placebo‐controlled trial was conducted in 21 Brazilian academic medical centers. …”
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A mixed methods study protocol for CONFIVAC, an intervention to enhance paediatric nurses' and paediatricians' skills to promote vaccination and vaccine confidence by Elisabet Henderson, Sara Valmayor, Victoria Porthé, Alba Asensio, Xavier Bruna, Usue Elizondo-Alzola, Anna Ramirez-Morros, Gemma Ricós, Josep Vidal-Alaball, M. Isabel Pasarín, Cristina Rius, Elena Roel, Elia Díez

“…Methods: We will conduct a two-arm parallel cluster randomised controlled trial including PHCWs from 74 paediatric primary healthcare teams from Catalonia, Spain. …”
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Early detection to improve outcome in people with undiagnosed psoriatic arthritis: the PROMPT research programme including RCT by Neil McHugh, Laura Bojke, Mel Brooke Turfrey, Rachel Charlton, Myka Ransom, Laura C Coates, Howard Collier, Claire Davies, Emma Dures, Philip Helliwell, Jana James, Anya Lissina, Vishnu B Madhok, Alison L Nightingale, Jonathan Packham, Catherine Smith, Eldon Spackman, Cerys Tassinari, William Tillett, Sarah T Brown

“…The primary objective of TUDOR was to determine whether the early detection of undiagnosed PsA in people with psoriasis by ES compared to SC improves outcome in physical function at 24 months post registration. Secondary objectives were to compare disease and impact of disease between people diagnosed with PsA in the ES and SC arms at 24 months post registration. …”
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Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention inte... by Carrington CJ. Shepherd, Melissa A. Dunham, Lina Gubhaju, Karen E. Lamb, Digsu N. Koye, Phoebe Fitzpatrick, Emily Banks, Kaarin J. Anstey, Melinda Carrington, Daniel McAullay, Ofra Kalter-Leibovici, Grace Joshy, Lesley Nelson, Jason Agostino, Ellie Paige, Kathleen Abu-Saad, Elise Alexander, Rona MacNiven, Kelsey Griffen, Fiona Collins, Salena Linforth-Milham, Dolores Gilbert, Cindy Prior, Sadia Rind, Richelle Douglas, Sandra Eades

“…Methods: Kaat Koort is a pragmatic two-arm parallel-group randomized controlled trial which will recruit a sample of 354 participants from two Aboriginal community-controlled health services in the south-west of Western Australia. …”
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Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experie... by Brett D. Thombs, Claire Adams, Elsa-Lynn Nassar, Marie-Eve Carrier, Meira Golberg, Kanika Bharthi, Amanda Wurz, Annabelle South, Linda Kwakkenbos, Sabrina Hoa, Danielle B. Rice, Geneviève Guillot, Amanda Lawrie-Jones, Maureen Sauvé, Susan J. Bartlett, Catherine Fortune, Amy Gietzen, Karen Gottesman, Marie Hudson, Laura K. Hummers, Vanessa L. Malcarne, Maureen D. Mayes, Michelle Richard, James Stempel, Robyn K. Wojeck, Kathleen Blagrave, Jill T. Boruff, Vanessa Cook, Nicole Culos-Reed, Ole Fröbert, Katie Gillies, Vera Granikov, Lars G. Hemkens, Elizabeth Yakes Jimenez, Agnes Kocher, Catarina Leite, Mathew A. W. T. Lim, Nancy Maltez, John Michalski, Tracy Mieszczak, Mwidimi Ndosi, Janet Pope, François Rannou, Ken Rozee, Sharon E. Straus, Matthew R. Sydes, Lehana Thabane, John Varga, Tami Yap, Merrick Zwarenstein, Luc Mouthon, Andrea Benedetti, SPIN Investigators

“…Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience. Trial registration ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).…”
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MRI Compatibility Research of Ultrasonic Motor and Material for DBS Surgical Robot by PENG Renyuan, ZHANG Juzhong, WANG Zhisen, CHU Yuyi, WU Yuwen, PENG Haoran, LIN Jun, YANG Hongbo

“…In contrast, the 60 motors, whether parallel or perpendicular, minimally affected MRI imaging with acceptable <italic>S</italic>_NR reductions. …”
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Novel active-feedback device improves sleep quality in insomnia disorder: a randomized placebo-controlled trial by Antonia Ypsilanti, Maan van de Werken, Anna Robson, Petra Examilioti, Lambros Lazuras, Lambros Lazuras

“…This study examined the effectiveness of SleepCogni, an active-feedback device, in reducing insomnia symptom severity and improving perceived sleep quality in individuals with insomnia disorder.MethodA two-arm, parallel-group trial design was used, with 80 participants randomized to either the experimental group or the placebo control group. …”
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Adjunctive ketamine vs. buprenorphine in co-occurring major depressive disorder and opioid use disorder: a randomized, double-blind clinical trial assessing anxiety symptom severit... by Arash Mansoori, Amir Bazrafshan, Jamshid Ahmadi, Seyed Hamdollah Mosavat

“…In contrast, buprenorphine was associated with a more gradual but sustained improvement in anxiety symptoms over several days, paralleled by a modest initial reduction in opioid craving, followed by persistent attenuation. …”
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Supporting self-management with an internet intervention for low back pain in primary care: a RCT (SupportBack 2) by Adam W A Geraghty, Taeko Becque, Lisa C Roberts, Jonathan Hill, Nadine E Foster, Lucy Yardley, Beth Stuart, David A Turner, Gareth Griffiths, Frances Webley, Lorraine Durcan, Alannah Morgan, Stephanie Hughes, Sarah Bathers, Stephanie Butler-Walley, Simon Wathall, Gemma Mansell, Malcolm White, Firoza Davies, Paul Little

“…Design A multicentre, pragmatic, three parallel-arm randomised controlled trial with parallel economic evaluation. …”
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Self-navigating the “Island of Reil”: a systematic review of real-time fMRI neurofeedback training of insula activity by Yuan Zhang, Benjamin Becker, Keith M. Kendrick, Qiong Zhang, Shuxia Yao

“…However, training success of insula regulation was not consistently paralleled by behavioral/symptom-related changes, suggesting a need for optimizing the NF training protocol enabling more robust training effects. …”
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NapBiome trial: Targeting gut microbiota to improve sleep rhythm and developmental and behavioural outcomes in early childhood in a birth cohort in Switzerland – a study protocol by Petra Zimmermann, Salome Kurth, Martin Stocker, Stamatios Giannoukos, Nicholas A Bokulich

“…The first year of life is a critical period for the development of the gut microbiome, which parallels important milestones in establishing sleep rhythm and brain development. …”
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Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (t... by Tim Batchelor, Babu Naidu, Chris A Rogers, Jane Blazeby, Alan Kirk, Paula Rogers, Stacey Stewart, Syed Qadri, Fiona Strachan, Sarah Wordsworth, Susan J Dutton, Arjun Nair, Amy Kerr, Rajesh Shah, Lisa Jones, Elizabeth A Stokes, Mark Ainsworth, Kathryn Saunders, Daisy Elliott, Rosie Harris, Sangeetha Paramasivan, Tom Treasure, Martyn Cain, Eric Lim, Michael Shackcloth, Joel Dunning, Niall McGonigle, Tim Brush, Lucy Dabner, Holly E Mckeon, Dawn Phillips, Holly Mckeon, Chloe Beard, Alba Realpe Rojas, Elizabeth Stokes, Andrew G Nicholson, Sofina Begum, Simon Jordan, Paulo De Sousa, Monica Tavares Barbosa, Eveline Internullo, Rakesh Krishnadas, Gianluca Casali, Doug West, Karen Bobruk, Catherine O’Donovan, Louise Flintoff, Amelia Lowe, Joanna Nicklin, Emma Heron, Jo Chambers, Becky Houlihan, Laura Beacham, Heather Hudson, Katy Tucker, Toni Farmery, Danielle Davis, Mike Shackcloth, Julius Asante-Siaw, Susannah Love, Sarah Feeney, Lindsey Murphy, Almudena Duran Rosas, Andrea Young, Ian Paul, Hyder Latif, Charlotte Jacobs, Alison Chilvers, Edward Stephenson, Nazalie Iqbal, Vladimir Anikin, Claire Prendergast, Hazem Fallouh, Maninder Kalkat, Richard Steyn, Nicola Oswald, Charlotte Ferris, Jo Webb, Joanne Taylor, Hollie Bancroft, Salma Kadiri, Zara Jalal Senior, Elizabeth Belcher, Dionisios Stavroulias, Francesco Di Chiara, May Havinden-Williams, Mahmoud Loubani, Karen Dobbs, Paul Atkin, Dominic Fellowes, Leanne Cox, Vipin Zamvar, Ruth Langley, Joy Adamson, Ian Hunt, Peter B Licht, Chris Hall, Mike Cowen, Keith Kerr, Nagmi Qureshi

“…The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.Trial registration number ISRCTN13472721…”
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Musculoskeletal and body composition response to high-dose testosterone with finasteride after chronic incomplete spinal cord injury—a randomized, double-blind, and placebo-control... by Dana M. Otzel, Dana M. Otzel, Larissa Nichols, Christine F. Conover, Stephen A. Marangi, Jayachandra R. Kura, Dominic K. Iannaccone, David J. Clark, David J. Clark, Chris M. Gregory, Christopher F. Sonntag, Anita Wokhlu, Anita Wokhlu, Hans K. Ghayee, Michael J. McPhaul, Charles E. Levy, Charles A. Plumlee, Charles A. Plumlee, Robert B. Sammel, Robert B. Sammel, Kevin T. White, Joshua F. Yarrow, Joshua F. Yarrow, Joshua F. Yarrow, Joshua F. Yarrow

“…However, sparse evidence supports TRT efficacy after SCI.MethodsThis parallel-group, double-blind, placebo-controlled, and randomized clinical trial (RCT) is a pilot study that enrolled men (N = 12) with low to low–normal testosterone and gait impairments after chronic motor-incomplete SCI. …”
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Multiparametric MRI for assessment of early response to neoadjuvant sunitinib in renal cell carcinoma. by Stephan Ursprung, Andrew N Priest, Fulvio Zaccagna, Wendi Qian, Andrea Machin, Grant D Stewart, Anne Y Warren, Timothy Eisen, Sarah J Welsh, Ferdia A Gallagher, Tristan Barrett

“…An increase in R2* from 19 to 28s-1 (p = 0.001) was observed, paralleled by a decrease in Ktrans from 0.415 to 0.305min-1 (p = 0.01) and a decrease in perfusion fraction from 0.34 to 0.19 (p<0.001).…”
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Prevalence of metabolic dysfunction‐associated steatotic liver disease in people living with HIV and on antiretroviral treatment: A systematic review and meta‐analysis protocol by Amogelang Sedibe, Khanyisa Maswanganyi, Nomusa C. Mzimela, Mlindeli Gamede

“…The prevalence of MASLD continues to increase, paralleling the consistent rising rates of risk factors such as obesity and type 2 diabetes. …”
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Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial by Nan Lin, Shu Li, Juan Wang, Dexiang Wang, Min Zeng, Jia Dong, Yuming Peng, Xiaoyuan Liu, Ruowen Li

“…The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.Trial registration number NCT04674241.…”
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