How do serum cytokine levels change in myocarditis and inflammatory dilated cardiomyopathy relative to healthy individuals? A protocol for a systematic review and meta-analysis by Romuald Wojnicz, Piotr Lewandowski, Maciej Baron, Marcin A Rojek, Marcin Goławski, Karol Krystek, Magdalena Żegleń, Pascal Zytkiewicz, Jakub Kancerek, Klaudia Gabriela Lis, Jakub Warecki, Jakub Kufel, Kamila Kuśpiel

“…Subgroup analysis will be stratified by age, sex, sample size, New York Heart Association scale, cardiac Troponin T, N-terminal prohormone of brain natriuretic peptide, C reactive protein, number of lymphocytes per mm2 in the endomyocardial biopsy.Ethics approval and dissemination This study does not require ethics approval. …”
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Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the ‘EEG in Genera... by Luzius A Steiner, Salome Dell-Kuster, Bettina U Gruber, Valerie Girsberger, Lukas Kusstatscher, Simon Funk, Anita Luethy, Lien Jakus, Julien Maillard, Christoph S Burkhart

“…A total of 200 anaesthesia practitioners (and 200 patients) are required to have an 80% chance of detecting the minimum relevant difference for the QoR-15 as significant at the 5% level assuming a SD of 20.Ethics and dissemination Ethical approval has been obtained from all responsible ethics committees (lead committee: Ethikkommission Nordwest- und Zentralschweiz, 16 January 2021). …”
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Exploring the key anthropological drivers of and barriers to zoonotic malaria preventative behaviour in a community exposed to Plasmodium knowlesi infection in Malaysia: protocol f... by Rozita Hod, Nurul Athirah Naserrudin, Richard Culleton, Mohammad Saffree Jeffree, Kamruddin Ahmed, Mohd Rohaizat Hassan

“…We will use a study framework as a theoretical lens to guide the exploration of the beliefs, social contexts, barriers and drivers surrounding zoonotic malaria preventive behaviour.Ethics and dissemination This study has been approved by the Medical Research and Ethics Committee Ministry of Health Malaysia (NMRR ID-21-01980-JEH) and the Research and Innovation Secretariat, Faculty of Medicine, Universiti Kebangsaan Malaysia (FF-2021-462). …”
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It’s safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people’s confidence becoming more active despite back pain... by Ian A Harris, Adrian C Traeger, James H McAuley, Siobhan M Schabrun, Benedict Martin Wand, Aidan Cashin, Christopher Michael Williams, Edel O'Hagan, Sean O'Neill

“…We obtained ethical approval from our institutions Human Research Ethics Committee before data collection. …”
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The Efficacy and Brain Network Mechanism of Acupuncture for Knee Osteoarthritis: A Study Protocol for Randomized Controlled Neuroimaging Trial by Sun YY, Wang ML, Zhao RH, Hao MY, Song S, Zhou Y, Zhang N

“…The primary efficacy indicator will be the change in NRS score after four weeks of treatment, with secondary outcomes including WOMAC, STAI, and safety assessments. fMRI observations will employ independent component analysis, brain network construction, and functional connectivity, complemented by Pearson correlation analysis to explore the relationship between brain responses and clinical improvements.Conclusion: This study will initially uncover how acupuncture intervention for chronic KOA pain centrally regulates and exerts therapeutic effects through the modulation of abnormal brain network functional connectivity patterns, with a demonstrated long-term effect.Ethics and Dissemination: This study has been approved by the ethics committee of Shandong University of Traditional Chinese Medicine Affiliated Hospital ((2024) Lunshen No. (028) - KY).Clinical Trial Registration: This study has been approved by registered in the Chinese Clinical Trial Registry (ChiCTR2400083695).Keywords: acupuncture, knee osteoarthritis, neuroimaging, RCT, protocol…”
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Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial by Philip G Conaghan, Kim L Bennell, Mark Conner, Rana S Hinman, Sarah R Kingsbury, Elizabeth M A Hensor, Gretl A McHugh, Christine Comer, Dawn Groves-Williams, Rachel K Nelligan

“…If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). …”
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Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster rand... by Reinhold Kilian, Harald Baumeister, Yannik Terhorst, Johannes Knauer, Paula Philippi, Selina Kallinger, Sandro Eiler, Tamara Waldmann, Morten Moshagen, Martina Bader

“…The Ethics Committee of Ulm University, has approved the study (on 24 February 2021 ref. 509/20). …”
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Virtual reality and speech analysis for the assessment of impulsivity and decision-making: protocol for a comparison with neuropsychological tasks and self-administered questionnai... by Marta Ruiz, Maria Luisa Barrigon, Antonio Artes, Philippe Courtet, Enrique Baca-Garcia, Jorge Lopez-Castroman, Santiago de Leon-Martinez, Elena Parra-Vargas, Irene Chicchi-Giglioli, Alejandro Albán Porras-Segovia

“…We will also explore the association between VR-assessed impulsivity and history of suicidal thoughts and/or behaviour, and the association between speech and impulsivity and decision-making.Ethics and dissemination This study was approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz (PIC128-21_FJD). …”
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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

“…Assessments are performed at similar time points for both groups: at baseline, after 4 weeks, and at 3 and 6 months of follow-up, on tic severity, quality of life and other psychosocial variables.Ethics and dissemination Ethics approval has been obtained from the medical ethical committee of the Amsterdam Medical Centre (METC nr NL66340.018.18, v3 June 2020). …”
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Co-designing action-oriented mental health conversations between care providers and ageing Canadians in the community: a participatory mixed-methods study protocol by Carrie McAiney, Paul Holyoke, Heather McNeil, Justine L Giosa, Elizabeth Kalles, Nelly D Oelke, Katie Aubrecht, Olinda Habib Perez

“…Phase 3 involves pilot and feasibility testing the co-designed conversations with older adult clients of providers from Phase 2 (n=180).Ethics and dissemination Phases 1 and 2 of this study have received ethics clearance at the University of Waterloo (ORE #44187), University of British Columbia (#H22-02306) and St. …”
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Effects of a social participation-focused virtual reality intervention for community-dwelling stroke survivors with physical disabilities: a randomised controlled trial protocol by Janita Pak Chun Chau, Suzanne Hoi Shan Lo, Vivian Wing Yan Lee, Kai Chow Choi, Alexander Yuk Lun Lau, David R Thompson, Eddie Chi Fai Kwok

“…Data will be collected in person at baseline, immediately after, and 3 months postintervention.Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Research Ethics Committee (Ref. …”
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Working experiences of remote interpreters in health care settings—insights from Austria and Germany by Sophie Klomfar, Sophie Klomfar, Anna Teufel, Gernot Gerger, Maria Kletečka-Pulker, Maria Kletečka-Pulker, Klara Doppler, Klara Doppler, Magdalena Eitenberger, Magdalena Eitenberger, Sabine Völkl-Kernstock, Sabine Völkl-Kernstock

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The LIFTMOR-M (Lifting Intervention For Training Muscle and Osteoporosis Rehabilitation for Men) trial: protocol for a semirandomised controlled trial of supervised targeted exerci... by Benjamin K Weeks, Belinda R Beck, Amy T Harding, Steven L Watson

“…The study has been granted ethical approval from the Griffith University Human Research Ethics Committee (Protocol number AHS/07/14/HREC).Trial registration number Australian New Zealand Clinical Trials Registry (www.anzctr.org.au)ANZCTR12616000344493; Pre-results.…”
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2-Brain Regulation for Improved Neuroprotection during Early Development (2-BRAINED): a translational hyperscanning research project by Lucia Billeci, Valentina Riva, Elena Capelli, Serena Grumi, Miriam Paola Pili, Maddalena Cassa, Eleonora Siri, Elisa Roberti, Renato Borgatti, Renato Borgatti, Livio Provenzi, Livio Provenzi

“…At 9 months CA, all dyads will participate in a lab-based EEG-hyperscanning paradigm to assess brain-to-brain co-regulation through phase-locking value (PLV) and other explorative indices.Ethics and disseminationThis study was funded by the Italian Ministry of Health and received approval by the Ethics Committee of Pavia (Italy) and participating hospitals. …”
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TROPION-Breast04: a randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients... by Heather L. McArthur, Sara M. Tolaney, Rebecca Dent, Peter Schmid, Jamil Asselah, Qiang Liu, Jane Lowe Meisel, Naoki Niikura, Yeon Hee Park, Gustavo Werutsky, Giampaolo Bianchini, Jay C. Andersen, Robert Kozarski, Nana Rokutanda, Barbara Pistilli, Sibylle Loibl

“…Secondary endpoints include overall survival (key), distant disease-free survival, patient-reported outcomes, and safety. Ethics: The study is approved by independent ethics committees and/or institutional review boards at each study site. …”
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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... by Gregory Y H Lip, Helen Jones, Mark T Mills, Dhiraj Gupta, Lawrence Foweather, Benjamin JR Buckley, Charlotte Fitzhugh

“…Secondary outcome measures will be taken at baseline (pre-intervention), post-intervention and at 6-month follow-up and will consist of AF burden, AF recurrence, quality of life, exercise capacity measured by peak oxygen consumption and echocardiographic parameters.Ethics and dissemination The trial was approved in the UK by the Northwest-Preston Research Ethics Committee (24/NW/0061; IRAS project ID: 330155). …”
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Use of virtual reality in port implantation to reduce perioperative anxiety and pain: protocol for a randomised controlled pilot trial at a single German university hospital (VIP-t... by Christoph W Michalski, Felix J Hüttner, Colette Dörr-Harim, Sandra Graf, Hannah Feldmann, Lisa S Hunold, Kira C Steinkraus, Nadir Nasir

“…Further outcomes include patient satisfaction and tolerability, perioperative analgesia and sedation, occurrence of postoperative nausea, vomiting and VR sickness symptoms, surgeon’s satisfaction, procedure duration, postoperative complications until postoperative day 30 and patient willingness to hypothetically undergo port implantation again under the same conditions.Ethics and dissemination The VIP trial has been approved by the Ethics Committee of the Medical Faculty of Ulm University (reference number 03/22). …”
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Protocol for faecal microbiota transplantation in irritable bowel syndrome: the MISCEAT study – a randomised, double-blind cross-over study using mixed microbiota from healthy dono... by Lenka Kramna, Ondrej Cinek, Jakub Hurych, Jiri Vejmelka, Lucie Hlinakova, Vladyslav Larionov, Michal Kulich, Pavel Kohout

“…Secondary outcomes are IBS-SSS at 2 weeks after the intervention and 32 weeks compared with placebo and changes in the number of loose stools, Bristol stool scale, abdominal pain and bloating, anthropometric parameters, psychological evaluation and the gut microbiome composition.Ethics and dissemination The study was approved by the Ethics Committee of Thomayer University Hospital, Czechia (G-18-26); study results will be published in peer-reviewed journals and presented at international conferences and patient group meetings.Trial registration number NCT04899869.…”
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Whole-of-community interventions that address alcohol-related harms: protocol for a scoping review by Asha S George, Tanya Doherty, Mark Tomlinson, Nandi Siegfried, Ida Okeyo, Ulla Walmisley, Michelle De Jong, Carmen Späth, Nadine Harker

“…Findings will be analysed qualitatively and presented using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Review.Ethics and dissemination This review makes use of published and publicly available data and no ethics approval is required. …”
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Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparo... by Miranda Davies-Tuck, Emily Callander, Mary Sharp, Scott W White, Dorota A Doherty, Jane Warland, Zoe Bradfield, Lesley Kuliukas, Monique Rose, Amber Pettitt, Kylie Ekin, JA Keelan

“…All data will be analysed by intention to treat.Ethics and dissemination The study is approved by the Western Australia Health Central Human Research Ethics Committee (RGS0000006283). …”
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