Adaptation and Feasibility Study of a Digital Health Program to Prevent Diabetes among Low-Income Patients: Results from a Partnership between a Digital Health Company and an Acade... by Valy Fontil, Kelly McDermott, Lina Tieu, Christina Rios, Eliza Gibson, Cynthia Castro Sweet, Mike Payne, Courtney R. Lyles

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Efficacy and safety of Xiongzhitongluo granules in the treatment of acute ischemic stroke: study protocol for a randomized controlled trial by Yunmeng Chen, Jingjing Wei, Xiao Liang, Yue Liu, Lina Miao, Di Zhao, Yunfan Zhang, Hongxi Liu, Yunling Zhang

“…Investigating novel therapeutic strategies is, therefore, crucial. Our team developed Xiongzhitongluo granules specifically for AIS and is conducting a randomized controlled trial (RCT) to validate their effectiveness.Methods and analysisThis multi-center, randomized, double-blind, placebo-controlled clinical trial includes 120 participants randomly allocated to the intervention or placebo group. …”
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The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial by Doan LV, Burr J, Perez R, Martinez H, Cuevas R, Watt K, Wang J

“…When signing the eConsent, however, all potential participants are provided with a concise summary of the informed consent document, an approach not widely used by multicenter studies. eConsent has been noted to be beneficial to research staff when trying to gather informed consent from participants who live far away from the hospital, want to include their family and friends, and for researchers who can approach patients outside of their clinical appointments.Conclusion: The ability to consent patients remotely has allowed for a flexible workflow within sites and a more patient-centric process that focuses on including loved ones in the discussion and scheduling time to speak to a principal investigator. Demand for eConsent will likely continue in the post-COVID era, and use of a concise summary can allow for a more efficient consenting process.Keywords: electronic consent, clinical trials, informed consent, concise summary…”
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The newborn behavioural observations (NBO) system embedded in routine postpartum care in at-risk families in Iceland: a randomised controlled trial by Lisbeth Valla, Kari Slinning, Tore Wentzel-Larsen, Gun-Mette Røsand, Stefanía Birna Arnardóttir

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Experiences of Māori and Pacific women recruited into a pregnancy clinical trial in Aotearoa, New Zealand: a Kaupapa Māori qualitative study by Matire Harwood, Benjamin B Albert, Rachel Roskvist, Jamie-Lee Rahiri, Richard Enright, Tania Mullane, Vidit Vinod Satokar

“…In contrast, the major barriers described were time pressures and the distance to the research facility.Conclusions Sixteen Māori and Pacific women who participated in a double-blinded randomised controlled trial shared that successful recruitment of Māori and Pacific women into clinical trials can be promoted by research flexibility participants’ whānau/family responsibilities, effective and culturally safe communication, and research teams striving to build and maintain relationships with participants throughout the trial.Trial registeration number Australian New Zealand Clinical Trials Registry, ACTRN12617001078347p. …”
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Parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: outcomes from LOCATE-NAFLD by Sanjeewa Kularatna, James O'Beirne, Adrian Barnett, Patricia C Valery, Elizabeth Powell, Ingrid J Hickman, Ruth Tulleners, David Brain, Katherine Stuart, Carolyn McIvor, Elen Witness, Melanie Aikebuse

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Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study by Maria-Jose Santana, Gina Dimitropoulos, Suneeta Monga, Isabelle J Gagnon, Bruce Wright, Jananee Rasiah, Katrina Hurley, Antonia Stang, Amanda Newton, Stephen Freedman, Jennifer Thull-Freedman, Kassi Prisnie, Yazid N Al Hamarneh, Ellen Louise Lipman, Yaron Finkelstein, Robert Porter, Mohamed Eltorki, Lee Macdonald, Gareth Hopkin, Matthew Prebeg, Margaret Steele, Ahmed Mater, Laurence Katz, Brian Greenfield, Laurie Plotnick

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Open-label dose-extending placebos for opioid use disorder: a protocol for a randomised controlled clinical trial with methadone treatment by Annabelle M Belcher, Thomas O Cole, Aaron D Greenblatt, Stephen W Hoag, David H Epstein, Michael Wagner, Amy S Billing, Ebonie Massey, Kristen R Hamilton, Zofia K Kozak, Christopher J Welsh, Eric Weintraub, Emerson M Wickwire, Eric D Wish, Ted J Kaptchuk, Luana Colloca

“…Participants will meet with study team members five times over the course of 3 months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months postbaseline). …”
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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

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Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial by Tania F Salvini, Glauko Dantas, Isabel C N Sacco, Ana F dos Santos, Ricky Watari, Alessandra B Matias, Paula R M S Serrao, Henrique Pott-Junior

“…Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. …”
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Longitudinal impact of preregistration interprofessional education on the attitudes and skills of health professionals during their early careers: a non-randomised trial with 4-yea... by Ben Darlow, Jennifer Roberts, Patrick McHugh, Melanie Brown, Eileen McKinlay, Peter Gallagher, Lesley Gray, Gordon Purdie, Christine Wilson, Sue Pullon, Louise Beckingsale, Kaye Cheetham, Ruth Crawford, Sue Floyd, Janice Handley, Jackie Herkt, Lisa Kuperus, Alison Meldrum, Margot Skinner, Rose Schwass, Julie Weaver, James Windle, Lyndie Foster-Page

“…Objective To assess whether a preregistration interprofessional education (IPE) programme changed attitudes towards teamwork and team skills during health professionals’ final year of training and first 3 years of professional practice.Design Prospective, longitudinal, non-randomised trial.Setting Final year health professional training at three academic institutions in New Zealand.Participants Students from eight disciplines eligible to attend the IPE programme were recruited (617/730) prior to their final year of training. 130 participants attended the IPE programme; 115 intervention and 372 control participants were included in outcome analysis.Intervention The 5-week Tairāwhiti IPE (TIPE) immersion programme during which students experience clinical placements in interdisciplinary teams, complete collaborative tasks and live together in shared accommodation.Main outcome measures Data were collected via five surveys at 12-month intervals, containing Attitudes Towards Healthcare Teams Scale (ATHCTS), Team Skills Scale (TSS) and free-text items. …”
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The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): study protocol for a randomised placebo-controlled mult... by Toby M Maher, A John Simpson, Anthony Cahn, David Thickett, Luke Vale, Allan B Clark, Nazia Chaudhuri, Ian Forrest, Lisa G Spencer, Christopher Ward, Stephen Jones, Ganesh Raghu, Andrew M Wilson, Helen Parfrey, Megan Jones, Matthew Hammond, Jaclyn Ann Smith, Shajahan Wahed

“…Patients are randomised equally to receive two capsules of lansoprazole or two placebo capsules, two times per day for 12 months. The primary outcome for the trial is change in FVC, measured at home, between the first week and last week of the study period. …”
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Antenatal pelvic floor muscle exercise intervention led by midwives in England to reduce postnatal urinary incontinence: APPEAL feasibility and pilot randomised controlled cluster... by Karla Hemming, Jonathan Bishop, Sarah Dean, Jean Hay-Smith, Tim Coleman, Elizabeth Edwards, Christine MacArthur, Debra Bick, Mark Pearson, Rohini Terry, Eivor Oborn, Sara Webb, Eleni Gkini, Victoria Salmon, Ellie Jones, Helena Frawley

“…Midwives (26%) most frequently reported insufficient time as an implementation barrier.Conclusions This pilot trial produced consistent new findings that training and resourcing midwives to teach and support pregnant women to undertake PFME is acceptable and feasible for women and midwives. …”
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Effectiveness of ‘Tackle Your Tics’, a brief, intensive group-based exposure therapy programme for children with tic disorders: study protocol of a randomised controlled trial by Danielle Cath, Annet Heijerman-Holtgrefe, Chaim Huyser, Cara Verdellen, Jolande van de Griendt, Laura Beljaars, Kees-Jan Kan, Ramón Lindauer, Pieter Hoekstra, Lisbeth Utens

“…Identifying the psychosocial predictors/moderators for the effectiveness of this intervention can provide personalised treatment advice in the future.Trial registration number NL8052.…”
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MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of... by Andrew Clegg, James Wason, Miles Witham, Nina Wilson, Claire J Steves, Helen C Hancock, Avan A P Sayer, Leanne Marsay, Claire McDonald, Thomas von Zglinicki, Katherine J Rennie, Penny Bradley, Stephen Connolly, Shaun Hiu, Laura Robertson, Laura Simms, Alison J Steel, Bryony Storey

“…Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.Trial registration number ISRCTN29932357.…”
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Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: seconda... by Helen Macpherson, Robin M Daly, Patricia M Livingston, Declan G Murphy, Patrick J Owen, Timo Rantalainen, Niamh L Mundell, Jeremy L Millar, Steve F Fraser, Jack Dalla Via, Stephen J Foulkes

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Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity... by Vibhu Paudyal, Nicola Greenlaw, Frances S Mair, Kate Stock, Andrew McPherson, Andrea E Williamson, Richard Lowrie, Donogh Maguire, Steven Ross, James Roy Robertson, Alison Boyle, Clare Duncan, Rebecca Blair, Cian Lombard, Fiona Hughes, Jane Moir, Ailsa Scott, Frank Reilly, Laura Sills, Jennifer Hislop, Stephen Wishart, David Brannan, Rebekah Ramage

“…PHOENIx teams develop therapeutic relationships to address health (physical health, mental health and problem drug use) and social care (housing, welfare benefits and social prescribing) in addition to UC. …”
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Cross-agency working when conducting a pragmatic RCT for older victims of crime: our experiences and lessons learned by Marc Serfaty, Jessica Satchell, Gloria K. Laycock, Chris R. Brewin, Marta Buszewicz, Gerard Leavey, Vari M. Drennan, Jonathan Cooke, Anthony Kessel

“…In the VIP trial, three screening methods were used: (1) visits by safer neighbourhood teams (SNTs), (2) police telephone screening and (3) employment of a university researcher embedded within the police service. …”
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Hypercapnic warm-up and re-warm-up-A novel experimental approach in swimming sprint. by Natalia Danek, Stefan Szczepan, Zofia Wróblewska, Kamil Michalik, Marek Zatoń

“…The purpose of this study was to determine the effective warm-up protocol using an added respiratory dead space (ARDS) 1200 ml volume mask to determine hypercapnic conditions, on the swimming velocity of the 50 m time trial front crawl. Eight male members of the university swimming team, aged 19-25, performed three different warm-up protocols: 1) standardized warm-up in water (WUCON); 2) hypercapnic warm-up in water (WUARDS); 3) hypercapnic a 20-minute transition phase on land, between warm-up in water and swimming test (RE-WUARDS). …”
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Task-specific temporal prediction mechanisms revealed by motor and electroencephalographic indicators by Alana Arrouet, José Eduardo Marques-Carneiro, Pierre Marquet, Anne Giersch

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