Protocol for a double-blinded randomised controlled trial and process evaluation of a digital psychotherapeutic app in Singapore to improve symptom burden in patients with dermatol... by Nick Sevdalis, Jose M Valderas, Valencia Long, Mark Jean-Aan Koh, Liang Shen, Phillip Phan, Ellie Choi, Nisha Suyien Chandran, Mayank Dalakoti, Ziying Vanessa Lim, Jia Yi Chua, Cyrus S Ho, Kean J Hsu

“…Statistical analysis will be carried out on an intention-to-treat basis, and missing data will be analysed using last observation carried forward.All participants will receive both verbal and written study information that aligns with Good Clinical Practice guidelines. Ethical approval has been obtained from the National Healthcare Group’s Domain Specific Review Board (reference number: 2022/00751). …”
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The observational EURACAN prospective clinical registry dedicated to epithelioid hemangioendothelioma: The protocol of an international and collaborative effort on an ultra-rare en... by Anna Maria Frezza, Hugh Leonard, Ninna Aggerholm-Pedersen, Giuseppe Badalamenti, Paolo Baili, Giacomo G Baldi, Sebastian Bauer, Serena Bazzurri, Irene Benzonelli, Alexia Bertuzzi, Jean-Yves Blay, Giuseppe Bianchi, Simone Bonfarnuzzo, Christophe Bouvier, Kyetil Boye, Javier Martin Broto, Antonella Brunello, Domenico Campanacci, Paolo G Casali, Carlo Cicala, Elisa Crotti, Lorenzo D'Ambrosio, Angelo Paolo Dei Tos, Nils Dieckmann, Armelle Dufresne, Stephanie Elston, Virginia Ferraresi, Stefano Gabellini, Claudia Giani, Vincenzo Giannusa, Melissa Gil Sanjines, Teresa Grassani, Alessandro Gronchi, Paolo Lasalvia, Stefan Lindskog, Nadia Hindi, Matilde Ingrosso, Andrei Ivanescu, Robin Jones, Iwona Lugowska, Julia Ketzer, Anna Mariuk-Jarema, Alessandro Mazzocca, Laura Monteleone, Carlo Morosi, Andrea Napolitano, Francesca Nardozza, Elisabetta Neri, Maria Nilsson, Andri Papakonstantinou, Sandro Pasquali, Marta Sbaraglia, Federico Scolari, Joanna Szkandera, Claudia Valverde, Bruno Vincenzi, Salvatore Vizzaccaro, Federica Zuccheri, Silvia Stacchiotti, Annalisa Trama

“…VariablesFull details on patients and disease features, treatment and outcome will be collected, according to common clinical practice guidelines developed and shared with all the contributing centers. …”
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Diagnostic value of multiparametric ultrasound and the EU-TIRADS system for differentiation of focal thyroid lesions by A. V. Pomortsev, O. S. Tokarenko

“…In 2020, the EU-TIRADS system (2017) was included in Russian Clinical Practice Guidelines. Shear wave elastography (SWE) increases the diagnostic efficacy of ultrasonic B-mode examination of thyroid nodules and can be recommended to be included in the current classification system. …”
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Association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer: a systematic review and meta-analysis by Rui Zhang, Jing Yang, Min Zhang, Qianqian Liu, Min Huang, Yuping Bai, Tingting He, Ziru Zhao, Mengyuan Jiang, Haitong Zhao

“…Objective Clinical practice guidelines recommend retrieving at least 12 lymph nodes for correct staging in colorectal cancer. …”
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Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial... by Jeffrey J Swigris, Toby M Maher, Tamera J Corte, Aryeh Fischer, Hong Xiao, Lisa Lancaster, Takafumi Suda, Xiaojiang Zhan, Jonathan G Goldin, Scott M Palmer, Hideaki Watanabe, Takashi Ogura, Anne Minnich, Giridhar S Tirucherai, Brandon Elpers, R Adam Smith, Edgar D Charles

“…The primary endpoint is rate of change in per cent predicted forced vital capacity from baseline to week 26 in the IPF cohort.Ethics and dissemination This study will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and local ethical and legal requirements. …”
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The Effectiveness of Virtual Reality–Based Mindfulness Interventions for Managing Stress, Anxiety, and Depression: Protocol for a Systematic Review and Meta-Analysis of Randomized... by Ravi Shankar, Anjali Bundele, Amartya Mukhopadhyay

“…The findings will inform clinical practice guidelines for integrating VR-based mindfulness, guide technology development specifications, and establish evidence-based recommendations for health care policy regarding therapeutic VR reimbursement and regulatory frameworks. …”
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Combined 25-hydroxyvitamin D concentrations and physical activity on mortality in US stroke survivors: findings from the NHANES by Junqi Liao, Jingyi Chen, Huimin Wu, Qing Zhu, Xiaogang Tang, Li Li, Aimei Zhang, Peiyi Mo, Yan Liu, Xinyi Yang, Yang Han, Zhaoyao Chen, Wenlei Li, Yuan Zhu, Minghua Wu

“…These findings provide new ideas and possibilities for the prevention and treatment of cardiovascular and cerebrovascular diseases, offering a reference for development of clinical practice guidelines in the future.…”
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Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial by Christian Gluud, Jane Lindschou, Thordis Thomsen, Janus C Jakobsen, Vibeke Zoffmann, Anne Sophie Mathiesen, Tine Bruhn Skytte, Bodil Rasmussen, Emilie Marqvorsen, Mette Rothmann

“…Data will be collected using REDCap and analysed using Stata V.16.Ethics and dissemination The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). …”
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Race as a prognostic factor of breast mucinous carcinoma by Dingyuan Wang, Yang Wang, Songlin Gao, Rongshou Zheng, Guijian Wu, Jianping Wang, Can Lu, Kena Bu, Chun Zhang, Wanqing Chen, Bailin Zhang

“…The goal was to help formulate more personalized clinical practice guidelines for the management of this rare malignancy. …”
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Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics: protocol for a non-randomised clinical trial by Dagmar F Hernandez-Suarez, Kyle Melin, Frances Marin-Maldonado, Hector J Nunez, Ariel F Gonzalez, Lorena Gonzalez-Sepulveda, Sona Rivas-Tumanyan, Hetanshi Naik, Gualberto Ruaño, Stuart A Scott, Jorge Duconge

“…The study will be carried out in compliance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guidelines. Findings will be published in a peer-reviewed journal and controlled access to experimental data will be available.Trial registration number NCT03419325; Pre-results.…”
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Vegetarian dietary patterns and cardiovascular risk factors and disease prevention: An umbrella review of systematic reviews by Matthew J. Landry, Katelyn E. Senkus, A Reed Mangels, Nanci S. Guest, Roman Pawlak, Sudha Raj, Deepa Handu, Mary Rozga

“…As vegetarian dietary patterns are increasingly being included within clinical practice guidelines, there is a need to review the most recent evidence regarding if and how these dietary patterns mitigate CVD risk. …”
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Investigating the nutritional status, outcomes and needs of adolescents and young adults (AYA) following a cancer diagnosis: protocol for a mixed-methods study by Andrew Murnane, Erin Laing, Belinda Steer, Jeremy Lewin, Heather Gilbertson, Elizabeth Mount, Mary-Anne Silvers, Jenelle Loeliger, Jodie Bartle, Kristin Mellett, June Savva, Pasquale L. Fedele, Lisa M. Orme, Leanne Super, Karla Gough, Kate Thompson

“…Results will inform future clinical practice guidelines and interventional nutrition research targeting patients identified at greater risk of nutritional complications.…”
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Association of serum 25-hydroxyvitamin D concentrations with risk of dementia among individuals with type 2 diabetes: A cohort study in the UK Biobank. by Tingting Geng, Qi Lu, Zhenzhen Wan, Jingyu Guo, Liegang Liu, An Pan, Gang Liu

“…Serum 25(OH)D ≥ 75 nmol/L was considered sufficient, according to the Endocrine Society Clinical Practice Guidelines. Incidence of all-cause dementia, AD, and VD cases was ascertained using electronic health records (EHRs). …”
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Assessing TDApp: An AI-based clinical decision support system for ADHD treatment recommendations by Evgenia Baykova, Òscar Raya, Cristina Lombardía, Begoña Gonzalvo, Inés Andreu, David Losada, Tania Falkenhain, Ruth Cunill, Domènec Serrano, David Rigau, David Ramírez-Saco, Beatriz López, Xavier Castells

“…IntroductionClinical practice guidelines (CPGs) have several limitations, namely: obsolescence, lack of personalization, and insufficient patient participation. …”
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Utilization and dose optimization of beta-blockers in chronic heart failure therapy: a mixed-methods study by Sisay Sitotaw Anberbr, Tilaye Arega Moges, Abebech Tewabe Gelaye, Aragaw Dagnew Lakew, Samuel Berihun Dagnew, Gebremariam Wulie Geremew, Getachew Yitayew Tarekegn, Fisseha Nigussie Dagnew

“…Qualitative findings illuminated persistent barriers, including inadequate medication availability, suboptimal adherence to clinical practice guidelines, and patient compliance challenges. …”
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Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – su... by Najib Rahman, Babu Naidu, Eihab O Bedawi, Zaigham Saghir, Uffe Bodtger, Bo Martin Bibby, Christian B Laursen, Thomas Decker Christensen, Morten Bendixen, Søren Helbo Skaarup, Jens-Ulrik Jensen, Rene Horsleben Petersen, Merete Christensen, Peter Licht, Kirsten Neckelmann, Lars B Møller, Morten Hornemann Borg, Sten Langfeldt, Stefan M W Harders

“…The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. …”
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Recomendaciones de manejo de la dispepsia funcional del Grupo de Trabajo de Motilidad y Trastornos Gastrointestinales Funcionales de la SEGHNP by Miguel Ángel Carro Rodríguez, Inmaculada Hidalgo Montes, Carmen Jovani Casano, Aránzazu Recio Linares, Etna Masip Simó, Gloria Rodrigo Garcia, Andrés Bodas Pinedo

“…As a result, there is evidence of substantial heterogeneity in the management of these patients due, in part, to the absence of clinical practice guidelines on this disease. Material and methods: A group was formed that consisted of 19 members of the working group on motility and functional gastrointestinal disorders (FGIDS) of the SEGHNP. …”
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Economic evaluations of maternal health interventions: a scoping review [version 2; peer review: 2 approved] by Sher Ting Chim, Steve McDonald, Rana Islamiah Zahroh, Katherine E. Eddy, Alexander Eggleston, Joshua P. Vogel, Doris Chou, Olufemi T. Oladapo, Caroline S. E. Homer, Nick Scott, Elizabeth Sebastian, Chloe Bykersma

“…Background Evidence on the affordability and cost-effectiveness of interventions is critical to decision-making for clinical practice guidelines and development of national health policies. …”
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A Proposed Diagnostic and Treatment Algorithm for the Management of Lumbar Discogenic Pain by Lorio MP, Beall DP, Myers TJ, Naidu RK, McRoberts WP, Davis TT, Gage EG, Calodney AK, Verrills P, De Palma MJ, Amirdelfan K, Block JE

“…Corresponding treatment options were designated based on published degenerative disc disease (DDD)-specific clinical practice guidelines and/or meta-analyses.Results: This algorithm recommends a systematic rule set for discogenic pain diagnostic and treatment options. …”
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Protocol for the Tallaght University Hospital Institute for Memory and Cognition-Biobank for Research in Ageing and Neurodegeneration by Eimear Connolly, Shane Lyons, Cliona O’Farrelly, Graham Knight, Antoinette O’Connor, Adam H Dyer, Sean P Kennelly, Emily Killeen, Christine Gaffney, Helena Dolphin, Laura Morrison, Gavin Sedgwick, Aoife McFeely, Conal Gallagher, Naomi Davey, Conor Young, Ruth Ennis, Cathy McHale, Jasmine Joseph, Emmet Kelly, Nollaig M Bourke, Aoife Fallon, Sean O’Dowd

“…James’s Hospital/Tallaght University Hospital Joint Research Ethics Committee (Project ID: 2159), which operates in compliance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 and ICH Good Clinical Practice Guidelines. Findings using TIMC-BRAiN will be published in a timely and open-access fashion.…”
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