GMP‐Compliant Process for the Manufacturing of an Extracellular Vesicles‐Enriched Secretome Product Derived From Cardiovascular Progenitor Cells Suitable for a Phase I Clinical Tri... by Camille Humbert, Chloé Cordier, Iouri Drut, Michele Hamrick, Jacquelyn Wong, Valérie Bellamy, Justine Flaire, Kiranmayee Bakshy, Florent Dingli, Damarys Loew, Jérôme Larghero, Jean‐Roch Fabreguettes, Philippe Menasché, Nisa K. Renault, Guillaume Churlaud

“…QC strategies for in‐process and release testing of an investigational medicinal product (IMP) were developed to guarantee quantity, safety, purity and identity. …”
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Improving outcomes for people with autism spectrum disorders by reducing mental health problems: the IAMHealth research programme including one RCT by Emily Simonoff, Gillian Baird, Bryony Beresford, Tony Charman, Martin Knapp, Andrew Pickles, Carol Povey, Tom Purser, Paramala Santosh, Vicky Slonims, Stephen Scott

“…Objective(s) We aim to improve identification of mental health problems by developing a tool for clinical use, which can also be used to monitor treatment response. …”
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Facilitators and barriers in Academic-Practice Partnerships (APPs) between Approved Educational Institutions (AEIs) and Residential Aged Care Facilities (RACFs) during pre-registra... by Ashley Chivaura, Iseult Wilson, Deborah Rainey, Wai Yee Amy Wong

“…The review will also provide both clinical and academic educators with a deeper understanding of what facilitates and hinders collaboration, which will empower them to facilitate effective collaboration and develop their shared capacity in supporting students. …”
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Development and evaluation of a patient decision aid for patients considering ongoing medical or surgical treatment options for ulcerative colitis using a mixed-methods approach: p... by Shaji Sebastian, Alan J Lobo, Steven R Brown, Sue Blackwell, Kerry Robinson, Matthew James Lee, Daniel Mark Baker, Anne-Mairead Folan, Rebecca Wootton, Georgina Louise Jones

“…This study is in three stages. In stage 1 we will develop the PtDA and its content via systematic reviews and a patient questionnaire. …”
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Development, implementation and evaluation of a smartphone application aimed to reduce sedentary time and increase physical activity among Indian sedentary office workers – finding... by Baskaran Chandrasekaran, Ashokan Arumugam, Arto J. Pesola, Poornima Panduranga Kundapur, Chythra R. Rao

“…This study aimed to explore the development, implementation and acceptability of a SmPh application among Indian desk-based office workers. …”
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Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitu... by Frances Clements, Hima Vedam, Yewon Chung, John Smoleniec, Colin Sullivan, Renuka Shanmugalingam, Annemarie Hennessy, Angela Makris

“…Secondary outcomes include the development of hypertensive disorders of pregnancy (HDP), maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers, and neonatal birthweight complications. …”
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Developing and evaluating a culturally-appropriate food kit for increased access to fruits and vegetables and DASH eating plan alignment in immigrant Hispanic/Latine individuals wi... by Ambria Crusan, Kerrie L. Roozen, Clara Godoy-Henderson, Angela Evans, Katie Reeves

“…This project aims to determine the outcomes associated with improved access to a culturally-appropriate, medically-tailored foods for Hispanic/Latine individuals with HTN via an iterative process: 1) conceptualization of culturally-appropriate F/V for a DASH box using a patient/provider survey, 2) formative DASH box development utilizing individual interviews for food preference feedback, and 3) free-living pilot trial of DASH box intervention to determine impacts on cardiometabolic markers. …”
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Relationship between reticulospinal system sensitization and proprioceptive pathways in the development of dynamic spasticity (ReProDS) post-spinal cord injury: protocol for a pros... by Jingrong Wang, Lianghua Fan, Jing Sun, Jibao Chen, Ying Wang, ZengQiang OuYang, Zhihong Yuan, Changqin Sun, Lingjing Jin, Yue Wang

“…With the growing application of spinal cord stimulation (SCS) for spasticity control, the role of proprioception in DS development has garnered attention. Additionally, advances in diffusion tensor imaging (DTI) allow for the analysis of the reticulospinal tract’s (RST) role in postural control among SCI patients. …”
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A Novel Presurgical Risk Prediction Model for Chronic Post-Surgical Pain in Adults Undergoing Surgical Procedures: Development and Internal Validation of the P4-Prevoque Questionna... by Wildemeersch D, Wauters E, Roelant E, Verhaegen I, De Clerck GR, Dankerlui R, Saldien V, Hans GH

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Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study p... by Christine Kersting, Johannes Just, Alexandra Piotrowski, Alexandra Schmidt, Neele Kufeld, Rebecca Bisplinghoff, Michaela Maas, Veronika Bencheva, Jordan Preuß, Birgitt Wiese, Klaus Weckbecker, Achim Mortsiefer, Petra Thürmann, on behalf of the GESCO study group

“…Methods The development process is designed in accordance with the first two phases of the UK Medical Research Council. …”
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Impact of Educational Activity Formats, Online or In-Person, on the Intention of Medical Specialists to Adopt a Clinical Behaviour: A Comparative Study by Gloria Ayivi-Vinz, Martin Tremblay, Souleymane Gadio, Suélène Georgina Dofara, Sam J Daniel, Denis Talbot, France Légaré

“…COVID-19 accelerated continuing professional development (CPD) delivered online. We aimed to compare the impact of in-person versus online CPD courses on medical specialists’ behavioural intentions and subsequent behaviour. …”
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Core outcome sets in symptomatic peripheral artery disease, COS-PAD: Study protocol for developing core outcome sets in symptomatic PAD utilising systematic reviews, interviews, an... by Akam Shwan, Maria Gonzalez-Aguado, Rob D Sayers, John S M Houghton

“…PAD research suffers from wide heterogeneity and non-comparability of outcome measures. The solution is to develop a core outcome set (COS) - a minimum standard of outcomes developed and agreed by key stakeholders (patients, healthcare professionals, and researchers). …”
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Development and validation of a novel risk assessment model for accurate prediction of intraoperative hypothermia in adult patients undergoing different types of surgery: insights... by Bingbing Cao, Yongxing Li, Xiangnan Chen, Yong Liu, Yao Li, Haihua Shu, Qiang Wu, Fengtao Ji

“…Previous risk assessment models have demonstrated limitations in accurately predicting intraoperative hypothermia, particularly in diverse surgical populations. This study aims to develop and validate a model in adult surgical patients to improve outcomes.Methods This retrospective cohort study utilized data extracted from electronic medical records and anaesthesia information management systems between June 2022 and August 2023. …”
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Patient-Reported Experience Measures in Vascular Surgery Enhancement (PREMIERE) study: protocol for a mixed-methods study to develop and validate a vascular surgery-specific patien... by David C Bosanquet, James Coulson, Robert Palmer, Kathleen Withers, Maram Darwish

“…The qualitative phase will develop a draft PREM; the quantitative phase will validate it. …”
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Effectiveness of an online intervention for parents/guardians of children aged 4–7 years who are concerned about their child’s emotional and behavioural development: protocol for a... by Daniel Frings, Paula Reavey, Michael Leahy, Claudiu Herteliu, Jowinn Chew, Clare Allabyrne

“…Introduction The demand for resources to support emotional and behavioural development in early childhood is ever increasing. However, conventional interventions are lacking in resources and have significant barriers. …”
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IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol f... by Angelita Martini, Lakkhina Troeung, Colin MacLeod, Georgina Mann, Janet Wagland, Thilaga L Sarunga Raja

“…Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. …”
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Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candid... by Joleen T. White, Jonne Terstappen, Micha Levi, Andrijana Radivojevic, Robert Noble, Aparna B. Anderson, Gwendolyn Wise-Blackman, Michael W. Dunne

“…Currently in Phase 1 development, RSM01 is primarily being developed to potentially provide an effective and affordable RSV prevention strategy in low- and middle-income countries. …”
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Developing and assessing the “MultiLife” intervention: a mobile health-based lifestyle toolkit for cardiometabolic multimorbidity in diabetes and hypertension management – a type 1... by Sanghamitra Pati, Jaideep Menon, Tanveer Rehman, Ritik Agrawal, Jayasingh Kshatri, Subrata Kumar Palo, Chandrashekar Janakiram, Srijeeta Mitra, Aswathy Sreedevi, Tanu Anand

“…Mobile health (mHealth) interventions offer a scalable approach for managing CMM by promoting behaviour change and medication adherence. We will develop and evaluate the MultiLife intervention, a mHealth-based lifestyle toolkit aimed at improving CMM management among individuals receiving primary care in Eastern India in the year 2025. …”
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Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutr... by Alemayehu Worku, Yemane Berhane, Parul Christian, Estifanos Baye, Krysten North, Mulatu Melese Derebe, Nebiyou Fasil, Kalkidan Yibeltal, Fred Van Dyk, Firehiwot Workneh, Sarah K G Jensen, Unmesha Roy Paladhi, Sophie Driker, Theresa I Chin, Anne C Lee

“…Introduction Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days.Methods and analysis The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. …”
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dVP_FAM—development and evaluation of a transsectoral digital care platform for individuals with familial cancer risks: study protocol for a multi-centre, cluster-randomised, mixed... by K. Klein, F. Kendel, S. Schüürhuis, K. Neumann, C. Kowalski, P. Thomas, T. Reinhold, U. Felbor, S. Stegen, C. Schmid, N. Mehrhof, S. Asmussen, F. Diel, M.A. Feufel, D. Speiser

“…Abstract Background Individuals with a family history of cancer face an increased risk of developing breast and ovarian cancer. Up to 30% of the 70,000 annual breast cancer cases in Germany are associated with a familial cancer burden. …”
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