North of England Women’s Diet and ActivitY - After Breast Cancer (NEWDAY-ABC) intervention in women diagnosed with early oestrogen-positive, HER2-negative breast cancer: a randomis... by C. Wilson, K. Pickering, S. Wane, J. Cohen, C. Huang, M. Northgraves, H. Crank, A. Anderson, H. Cain, R. Copeland, J. Gray, J. Hargreaves, R. J. Q. McNally, J. M. Saxton

“…Methods This was a two-arm, parallel group, randomised controlled feasibility study. …”
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Effect of Zhan Zhuang Qigong on upper limb static tremor and aerobic exercise capacity in patients with mild-to-moderate Parkinson’s disease: study protocol for a randomised contro... by Hang Su, Xiaoyu Jiang, Limin Wang, Linlin Zhang, Qing Wang, Xihua Liu, Xiaoming Xi, Yuxiao Chen, Xinjie Qu, Haihao Cao, Wenyu Sun, Guoming Chen, Huifen Liu, Jiahui Jiang, Hongyan Bi

“…Study results will be presented as a paper at an international conference or in a journal.Trial registration number ChiCTR2100053529.…”
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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

“…Findings will also be shared at local, regional and international scientific meetings.Trial registration number ClinicalTrials.gov: NCT05614089.…”
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PRIORITY IR: Protocol for implementation research on single-dose postpartum IV iron to treat iron-deficiency anemia among women in India and Pakistan [version 1; peer review: await... by Valerie L. Flax, Umesh Charantimath, Narjis Rizvi, Avinash Kavi, Saleem Jessani, Manjunath Somannavar, Sarah Saleem, Anika Hannan, Shivaprasad S. Goudar, Simal Thind, Elizabeth M. McClure, Richard Derman, Rosemary Frasso

“…Methods The PRIORITY IR study will use a mixed methods convergent parallel design guided by two frameworks: the Consolidated Framework for Implementation Research and Proctor’s implementation outcomes. …”
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Costs and cost-effectiveness of management of possible serious bacterial infections in young infants in outpatient settings when referral to a hospital was not possible: Results fr... by Charu C Garg, Antoinette Tshefu, Adrien Lokangaka Longombe, Jean-Serge Ngaima Kila, Fabian Esamai, Peter Gisore, Adejumoke Idowu Ayede, Adegoke Gbadegesin Falade, Ebunoluwa A Adejuyigbe, Chineme Henry Anyabolu, Robinson D Wammanda, Joshua Daba Hyellashelni, Sachiyo Yoshida, Lu Gram, Yasir Bin Nisar, Shamim Ahmad Qazi, Rajiv Bahl

“…<h4>Clinical trial registration</h4>The trial was registered with Australian New Zealand Clinical Trials Registry under ID ACTRN 12610000286044.…”
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Multimodality local consolidative treatment versus conventional care of advanced lung cancer after first-line systemic anti-cancer treatment: study protocol for the RAMON multicent... by Matthew Evison, Tim Batchelor, Chris A Rogers, Sarah Baos, Elizabeth A Stokes, Rosie Harris, Eric Lim, Chloe Beard, Janette Rawlinson, Nicola Mills, John Conibear, Paulo De Sousa, Thomas Newsom-Davis, Tara Barwick, Leah Fleming

“…Findings will be presented at international meetings, in peer-reviewed publications, through patient organisations and notifications to patients.Trial registration number ISRCTN11613852.…”
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Efficacy and safety of musculoskeletal manipulations in elderly population with musculoskeletal disorders: a systematic review by Alessandro Mauro, Donatella Bagagiolo, Michela Persiani, Luca Cicchitti, Luca Vismara, Irene Bruini, Francesca Buffone

“…However, MM appears to be generally safe and well-tolerated.PROSPERO registration number CRD42023473203.…”
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A randomized comparative feasibility study of neuromodulation and cognitive training for post-COVID fatigue by Silvia Oliver-Mas, Jordi A. Matias-Guiu, Cristina Delgado-Alonso, Lidia Gil-Martínez, Constanza Cuevas, Carmen Polidura, Lucía Fernández-Romero, Andreu Matias-Guiu, Natividad Gómez-Ruiz, María José Gil-Moreno, Miguel Yus-Fuertes, Jorge Matias-Guiu, Maria Diez-Cirarda

“…Abstract Fatigue and cognitive deficits are common and disabling symptoms in patients experiencing post-COVID condition. This randomized parallel study aimed to evaluate the effects of transcranial direct current stimulation (tDCS) over the primary motor cortex combined with cognitive training (M1 + CT), compared to tDCS over the dorsolateral prefrontal cortex with cognitive training (DLPFC + CT), on fatigue, cognition, and other clinical symptoms in post-COVID. …”
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Enhancing Quality of Life in Patients With Hypothyroidism Using a Scientific Yoga Module: Randomized Controlled Trial by Savithri Nilkantham, Amit Singh, Vijaya Majumdar, Harini K N, Snigdha Atmakur

“…MethodsA single-blinded, 2-arm, parallel-group randomized controlled trial was conducted for 6 months (April 1, 2022-September 30, 2022) with 134 clinically diagnosed patients with hypothyroidism recruited from the Arogyadhama Holistic Health Home registry (2013-2021). …”
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Navigator programme for hospitalised adults experiencing homelessness: protocol for a pragmatic randomised controlled trial by Lucie Richard, Rosane Nisenbaum, Vicky Stergiopoulos, Kerry McBrien, Michael Liu, Rebecca Brown, Anita Palepu, Jesse Jenkinson, Gabriel Fabreau, Cheryl Pedersen, Katherine Francombe Pridham, Sareeha Virani, Fred Ellerington, Alyssa Ranieri, Oluwagbenga Dada, Matthew To, Stephen Hwang

“…Results of the main trial and process evaluation will be reported in peer-reviewed journals and shared with hospital leadership, community partners and policy makers.Trial registration number NCT04961762.…”
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Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis... by Susan Veldheer, Jonathan Foulds, Caroline O Cobb, Xi Wang, Sarah Maloney, Matthew Halquist, Le Kang, Shari Hrabovsky, Alexa A Lopez, Sitasnu Dahal, Jessica Yingst, Matthew Carrillo, Rebecca Bascom

“…Future studies of e-cigarettes for smoking cessation would benefit from including these measures to further explore the results found in this study.Trial registration number NCT02342795.…”
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Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Al... by Martin Kraepelien, Michael R Irwin, Eva Kosek, Michael T Smith, Martin F Bjurström, Kristoffer Bothelius, Pernilla Maathz, Susanna Jernelöv, Alexander H C Rosenström, Andrea Niklasson, Richard Olmstead, Patrick H Finan

“…Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.Trial registration number NCT06145516.…”
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REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis. by Robert T Woods, Martin Orrell, Errollyn Bruce, Rhiannon T Edwards, Zoe Hoare, Barry Hounsome, John Keady, Esme Moniz-Cook, Vasiliki Orgeta, Janice Rees, Ian Russell

“…<h4>Methods</h4>This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. …”
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Multicentre randomised double-blind placebo controlled trial of combination vancomycin and cefazolin surgical antibiotic prophylaxis: the Australian surgical antibiotic prophylaxis... by Allen C Cheng, Catherine McDougall, Allen Cheng, An Tran-Duy, Janine Roney, Kirsty Buising, Peter Choong, Michelle Dowsey, Trisha Peel, Sarah Astbury, David Paterson, Richard S de Steiger, Ross Crawford, Richard de Steiger, Philip Clarke, Peter Rehfisch Ben Howden, Robert Molnar, Sam Adie, Glenn Boyce, Jonathon Mulford, Michael Solomon, Tiffany Harris-Brown, Anton Peleg, Jessica Wisniewski, Stephanie Pereira, Zweena Badoordeen

“…Study findings will be disseminated in the printed media, and learnt forums.Trial registration number ACTRN12618000642280…”
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Behavioural activation in nursing homes to treat depression (BAN-Dep): study protocol for a pragmatic randomised controlled trial by Simon Gilbody, Christopher Etherton-Beer, Kathryn A Ellis, Leon Flicker, Diana Velasquez Reyes, Hema Patel, Nicola Lautenschlager, Andrew H Ford, Eleanor Curran, Rachael Kelly, Rhoda Lai, Terence Chong, David Ekers, Dina Lo Giudice, Angelita Martini, Osvaldo P Almeida

“…Only de-identified group data will be presented.Trial registration ACTRN12618000634279.…”
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Comparison of low-pressure and standard-pressure pneumoperitoneum laparoscopic cholecystectomy in patients with cardiopulmonary comorbidities: a double blinded randomized clinical... by Feng Tian, Xiaowei Sun, Yang Yu, Ning Zhang, Tao Hong, Lu Liang, Bihui Yao, Lei Song, Changhong Pei, Yu Wang, Wenlong Lu, Qiang Qu, Junchao Guo, Taiping Zhang, Xiaodong He

“…Methods This was a multicenter, parallel, double-blind, randomized controlled trial. …”
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The Effect of the Mediterranean Diet–Integrated Gamified Home-Based Cognitive-Nutritional (GAHOCON) Training Programme for Older People With Cognitive Frailty: Pilot Randomized Con... by Rick Yiu Cho Kwan, Queenie Pui Sze Law, Jenny Tsun Yee Tsang, Siu Hin Lam, Kam To Wang, Olive Shuk Kan Sin, Daphne Sze Ki Cheung

“…MethodsThis study applied a 2-center, assessor-blinded, 2-parallel-group, noninferiority, randomized controlled trial design. …”
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Effects of hydromorphone-based patient-controlled intravenous analgesia on postoperative hypoxaemia: a randomised controlled non-inferiority clinical trial by Xuan Yang, Ziyu Zheng, Yumei Ma, Zhuomin Deng, Xiangying Feng, Jialin Luo, Yang Meng, Jingjing Lin, Xiaoxiao Mu, Huang Nie, Hailong Dong, Nong Yan, Jiejuan Du

“…Objective This study aimed to compare the effects of patient-controlled intravenous analgesia (PCIA) with and without low-basal infusion on postoperative hypoxaemia.Design A randomised parallel-group non-inferiority trial.Setting The trial was conducted at a grade-A tertiary hospital from December 2021 to August 2022.Participants 160 adults undergoing gastrointestinal tumour surgery and receiving postoperative PCIA.Interventions Participants randomly received a low-basal (0.1 mg/hour of hydromorphone) or no-basal infusion PCIA for postoperative 48 hours.Primary and secondary outcome measures Primary outcome was area under curve (AUC) per hour for hypoxaemia, defined as pulse oxygen saturation (SpO2) &lt;95%. …”
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Autism Transition to Adulthood Groups (ATAG): protocol for a feasibility RCT of a new peer-group intervention to promote successful transition to adulthood for autistic young peopl... by Bryony Beresford, Annabel Burnley, W Mandy, Ailsa Russell, Kate Cooper, Leon Allain, Laura Crane, Maximiliano Vazquez Morales, Lucy Portway, Benjamin Redmayne

“…Results will inform the design of a full RCT and will be disseminated through peer-reviewed journals, conferences, and stakeholder events.Trial registration number ISRCTN10513626.…”
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Virtual Coach–Guided Online Acceptance and Commitment Therapy for Chronic Pain: Pilot Feasibility Randomized Controlled Trial by Erin D Reilly, Megan M Kelly, Hannah L Grigorian, Molly E Waring, Karen S Quigley, Timothy P Hogan, Alicia A Heapy, Charles E Drebing, Matias Volonte, Ummul-Kiram Kathawalla, Hannah E Robins, Katarina Bernice, Timothy Bickmore

“…MethodsVeterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). …”
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