Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE) by Ingibjörg H Jonsdottir, Hanna Gyllensten, Lilas Ali, Andreas Fors, Karl Swedberg, Inger Ekman, Matilda Cederberg, Kristina Glise

“…A process and health economic evaluation will also be conducted.Ethics and dissemination This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. …”
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CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context by Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap

“…The international consensus-based CONSORT-DEFINE (Consolidated Standards for Reporting Trials Dose-finding Extension) statement, an extension of the CONSORT statement for randomised trials, was developed to improve the reporting of EPDF trials. …”
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Early childhood constraint therapy for sensory/motor impairment in cerebral palsy: a randomised clinical trial protocol by Garey Noritz, Olena Chorna, Jill Heathcock, Alexandra Key, Helen Carey, Ellyn Hamm, Mary Ann Nelin, Micah Murray, Amy Needham, James C Slaughter, Nathalie L Maitre

“…All children with CP, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study. …”
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Current Status and Future Directions of Artificial Intelligence in Post-Traumatic Stress Disorder: A Literature Measurement Analysis by Ruoyu Wan, Ruohong Wan, Qing Xie, Anshu Hu, Wei Xie, Junjie Chen, Yuhan Liu

“…However, there are numerous challenges, and fully realizing AI’s potential will require overcoming hurdles in algorithm design, data integration, and societal ethics. To promote more extensive and in-depth future research, it is crucial to prioritize the development of standardized protocols for AI implementation, foster interdisciplinary collaboration—especially between AI and neuroscience—and address public concerns about AI’s role in healthcare to enhance its acceptance and effectiveness.…”
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Validation of the detection of elder abuse through emergency care technicians (DETECT) screening tool: a study protocol by Melvin D Livingston, Brad Cannell, Julie Weitlauf, Jason Burnett, Megin Parayil, Jennifer Reingle Gonzalez

“…The data from 25% (n=648) of these follow-up interviews will be presented to a longitudinal, experts and all data panel for a final determination of EM exposure status, representing the closest proxy to a ‘gold standard’ measure available.Ethics and dissemination This study has been reviewed and approved by the Committee for the Protection of Human Subjects at the University of Texas School of Public Health. …”
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ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm by M E Schoeny, Sarah A Keim, Michelle M Greene, Julia Berteletti, Mary Lauren Neel, Kousiki Patra, Shea Smoske, Susan Breitenstein

“…While behavioural parent training (BPT), also referred to as behaviour therapy is a gold standard for prevention and treatment of childhood problem behaviours, there are limited accessible and effective BPT interventions for families with children born VPT. …”
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EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial by Alexander Egeberg, Ditte Georgina Zhang, Christian Vestergaard, Simon Francis Thomsen, Jennifer Astrup Sørensen, Misbah Noshela Ghazanfar, Zarqa Ali, Jacob Thyssen

“…Blood samples, Weekly Urticaria Activity Score, Chronic Urticaria Quality of Life Questionnaire, Dermatology Life Quality Index and records of side effects and flares will be obtained throughout the study at weeks 0, 12, 24 and 36.Ethics and dissemination The study has been approved by the Scientific Ethical Committee of the Capital Region in Denmark, the local Data Protection Agency and the Danish Medicines Agency. …”
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Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta by Jennifer Walsh, Catriona Keerie, Stuart H Ralston, Christopher J Weir, Muhammad K Javaid, WAYNE LAM, Bente L Langdahl, Jannie D Hald, Patricia Osborne

“…Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results will inform clinical practice by determining if TPTD/ZA can reduce the risk of fractures in OI compared with standard care.Trial registration number ISRCTN15313991.…”
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PropAngio study protocol: a neoadjuvant trial on the efficacy of propranolol monotherapy in cutaneous angiosarcoma—a proof of principle study by Neeltje Steeghs, Jos H Beijnen, Kimberley M Heinhuis, Nikki S IJzerman, Anne Miek Koenen, Winette T A van der Graaf, Rick L Haas, Alwin D R Huitema, Winan J van Houdt

“…The study will be considered positive when at least three patients have a response to propranolol.Ethics and dissemination Ethical approval was obtained from the Medical Ethical Committee of the Netherlands Cancer Institute. …”
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Clinical validation of an artificial intelligence-based decision support system for diagnosis and risk stratification of heart failure (STRATIFYHF): a protocol for a prospective, m... by Prithwish Banerjee, Guy A MacGowan, Frans H Rutten, Iacopo Olivotto, Petar M Seferović, Jonathan Mant, Djordje G Jakovljevic, Oscar Fernandez, Josep Darbà, Nduka C Okwose, Jose Zamorano, Duncan Edwards, David Sinclair, Lazar Velicki, Amy Groenewegen, Lars S Maier, Dimitris Fotiadis, Sarah Jane Charman, Annamaria Del Franco, Maria Tafelmeier, Andrej Preveden, Cristina Garcia Sebastian, Amy S Fuller, Anne Pauline Nelissen, Petros Malitas, Aikaterini Zisaki, Zoran Bosnic, Petar Vracar, Fausto Barlocco, Marta Jiménez-Blanco Bravo, Nenad Filipovic, Bano Fatima, Williams Kate, Fornaro Alessandra, Milovancev Aleksandra, Ascanio Meritxell, Aguera Ainoa, Pičulin Matej, Flis Borut, Boucharas Dimitrios, Manousos Dimitris, Tsiknakis Manolis, Kassiotis Thomas, Sustersic Tijana, Milicevic Bogdan, Hobbs FD Richard, Kaagman Onno

“…Focus groups and semistructured interviews will be conducted with up to 15 healthcare professionals and up to 20 study participants (10 at risk of HF and 10 diagnosed with HF) to explore the needs of patients and healthcare professionals prior to the development of the STRATIFYHF DSS and to evaluate the acceptability of this mobile application.Ethics and dissemination Ethical approval has been granted by the East Midlands - Leicester Central Research Ethics Committee (24/EM/0101). …”
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Job satisfaction and animal welfare at slaughter: A survey of Official Veterinarians in the United Kingdom and Republic of Ireland by Imogen O’Connor, Kelly Gouveia

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Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial by Liv Mathiesen, Jeanette Schultz Johansen, Kjerstin Havnes, Kjell H. Halvorsen, Stine Haustreis, Lillann Wilsgård Skaue, Elena Kamycheva, Kirsten K. Viktil, Anne Gerd Granås, Beate H. Garcia

“…Patient inclusion started in September 2016.Ethics and dissemination The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority. …”
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Effectiveness of Fewer Falls, an online group-based self-management fall prevention programme for people with multiple sclerosis: protocol of a randomised controlled trial by Maria Flink, Charlotte Ytterberg, Kristina Gottberg, Marie Kierkegaard, Susanna Tuvemo Johnson, Elizabeth Walker Peterson, Ulrika Meijer, Johanna Bylinder

“…Secondary outcomes include injurious falls, falls control, fear of falling, falls self-efficacy, activity curtailment, perceived effect of MS, self-rated health and cost-effectiveness.Ethics and dissemination Ethical approval has been obtained from the Swedish Ethical Review Authority (registration numbers 2022-06667-01 and 2023-07723-02). …”
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Honest Computing: achieving demonstrable data lineage and provenance for driving data and process-sensitive policies by Florian Guitton, Axel Oehmichen, Étienne Bossé, Yike Guo

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Protecting the Autonomy of Patients with Severe Mental Illness Through Psychiatric Advance Directive Peer-Facilitation by Nicholas Karasik

“…Brown, "Psychiatric Advance Directives as an Ethical Communication Tool: An Analysis of Definitions," The Journal of Clinical Ethics 31, no. 3 (2020): [353-363] [5] Heather Murray and Hal S. …”
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Effect of non-pharmacological interventions for overweight/obese women with polycystic ovary syndrome on ovulation and pregnancy outcomes: a protocol for a systematic review and ne... by Juan Li, Jie Yang, Fan-rong Liang, Jun Zhou, Gui-Xing Xu, Han Yang, Yan-qun Xiao, Jia-jia Liu, Zhi-yong Xiao, Xiao-yan Zheng, Li-ying Liu, Zheng Yu

“…The Grading of Recommendations Assessment, Development and Evaluation system will be adopted to evaluate the certainty of evidence.Ethics and dissemination Ethical approval will not be required because the study will not include the original information of participants. …”
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Assessing the impact of different donor milk treatments on infant health and growth: a systematic review protocol by Daniel Klotz, Carolyn Smith, Agnieszka Bzikowska-Jura, Marzia Giribaldi, Tanya Cassidy, Laura Cavallarin, Serena Gandino, Karolina Karcz, Chiara Peila, Bartłomiej Walczak, Aleksandra Wesolowska

“…Much DHM research has focused on its nutritional, immunological and biochemical composition in response to various maternal variables, standard human milk banking procedures and storage protocols. …”
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Factors associated with cancer treatment delay: a protocol for a systematic review and meta-analysis by Timothy P Hanna, Elizabeth T Jacobs, Kristin E Morrill, Rogelio Robles-Morales, Melissa Lopez-Pentecost, Raigam J Martínez Portilla, Ahlam A Saleh, Meghan B Skiba, Taylor S Riall, Jessica D Austin, Rachel Hirschey, Lena Spotleson

“…Risk of bias will be assessed independently by two authors using validated tools according to the article’s study design.Ethics and dissemination Formal ethical approval is not required because the work is being carried out on publicly accessible studies. …”
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The effect of an additional pre-extubational loading dose of caffeine citrate on mechanically ventilated preterm infants (NEOKOFF trial): Study protocol for a multicenter randomize... by Kinga Kovács, Rita Nagy, Lilla Andréka, Brigitta Teutsch, Miklós Szabó, Péter Varga, Péter Hegyi, Péter Hársfalvi, Nándor Ács, Ágnes Harmath, Csaba Nádor, Ákos Gasparics

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Detection of Elder Abuse Through Emergency Care Technicians Screening Tool Revision for Home-Based Primary Care (DETECT-RPC): a cluster randomised controlled trial study protocol by Melvin D Livingston, Brad Cannell, Jason Burnett, Nicholas Sevey, Kristin Lees Haggerty, Carolyn Pickering

“…The results of this study will be disseminated through a peer-reviewed journal as well as through presentations at professional conferences, invited talks and other standard channels.Trial registration number NCT05958654 (ClinicalTrials.gov).…”
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