The impact of different gastrointestinal reconstruction techniques on gut microbiota after gastric cancer surgery by Yu Yang, Yu Yang, Hang-Yu Zhou, Guo-Min Zhou, Guo-Min Zhou, Jin Chen, Rui Ming, Dong Zhang, Huai-Wu Jiang, Huai-Wu Jiang

“…All patients signed written informed consent forms. Standardized perioperative management was conducted for the patients in the study, including preoperative preparation, intraoperative handling, and postoperative treatment. …”
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Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial by Li Wang, Li Jin, Yao Lu, Chen Zhang, He-Feng Huang, Yun Sun, Xian-hua Lin, Meng-xi Guo, Dan-dan Wu, Jian-lin Zhang, Cheng-liang Zhou, Chen-ming Xu, Song-chang Chen, Song-ying Zhang, Xiao-xi Sun, Yan-ting Wu

“…To demonstrate or refute a difference between the two groups, we plan to include 188 participants in each group; taking consideration of 20% of dropout, the total target sample size is 450.Ethics and dissemination Ethical approval was obtained from International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University Medical Science Research Ethics Committee (GKLW2016-16). Informed consent will be obtained from each participant. The findings will be disseminated to the public through conference presentations and publication in peer-reviewed scientific journals.Trial registration number ClinicalTrials.gov, NCT02941965.…”
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Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial by Michael Walsh, Salim Yusuf, Chirag Parikh, Jessica Vincent, P J Devereaux, Francois Lamontagne, Matthew T V Chan, Richard Whitlock, Meaghan Cuerden, Amit X Garg, Andre Lamy, Daniel I Sessler, Kevin Teoh, Ainslie Hildebrand, Yunxia Zuo, Pallav Shah, Seyed Hesameddin Abbasi, Mackenzie Quantz, Jean-Pierre Yared, Nicolas Noiseux, Georgios Tagarakis, Antoine Rochon, Janice Pogue, Abbas Salehiomran

“…In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. …”
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Role of cardiac CT in the diagnostic evaluation and risk stratification of patients with myocardial infarction and non-obstructive coronary arteries (MINOCA): rationale and design... by Konstantinos Tsioufis, Haralambos Karvounis, George Giannakoulas, Theodoros Karamitsos, Ronny R Buechel, Konstantinos Kouskouras, Ioannis Vogiatzis, Konstantinos Toutouzas, Nathaniel R Smilowitz, Georgios P Rampidis, Polydoros Ν Kampaktsis, Athanasios Samaras, Georgios Benetos, Andreas Α Giannopoulos, Alexandros Kallifatidis, Antonios Samaras, Stavros Hadjimiltiades, Antonios Ziakas, Catherine Gebhard, Panagiotis Prassopoulos, Harmony Reynolds

“…All patients will provide written informed consent. Results will be disseminated at national meetings and published in peer-reviewed journals.Trial registration number NCT4186676.…”
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Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain by Fiona Campbell, Jennifer Stinson, Sara E Williams, Christopher D King, Laura Simons, Massieh Moayedi, Robert C Coghill, Martin S Angst, Nima Aghaeepour, Brice Gaudilliere, Marina López-Solà, Marie-Eve Hoeppli, Emma Biggs, Ed Ganio, Kenneth R Goldschneider, Danielle Ruskin, Elliot J Krane, Suellen Walker, Gillian Rush, Marissa Heirich

“…All participants provide signed informed consent. We are committed to open-access publication, so that patients, clinicians and scientists have access to the study data and the signature(s) derived. …”
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L’aqueduc du Gier à Lyon : la complexité de la protection au titre des monuments historiques by Josiane Boulon

“…The following events subsequent to the law of 1905, and the need for management of religious heritage, accelerated the creation of the December 31, 1913 law. To this day, owner consent remains a necessary legal step toward obtaining a classification of a monument. …”
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Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-direct... by Marshall Pitz, Eng-Siew Koh, Elizabeth H Barnes, Lucille Sebastian, Mandy L Ballinger, David M Thomas, Christopher O'Callaghan, John Simes, Hui K Gan, Sonia Yip, Hao-Wen Sim, Desma Spyridopoulos, Richard De Abreu Lourenco, Cynthia Hawkins, Kristen McParland, Benjamin Kong, Subotheni Thavaneswaran, Patrick J Wheeler

“…Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. A report describing the results of the study will be submitted to international meetings and peer-reviewed journals.Trial registration number ACTRN12623000096651.…”
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Determining the incidence, risk factors and biological drivers of irritable bowel syndrome (IBS) as part of the constellation of postacute sequelae of SARS-CoV-2 infection (PASC) o... by Erika Austhof, Kelly M Heslin, Xiaoxiao Sun, Kristen Pogreba Brown, Caitlyn M McFadden, Caroline Scranton, Ivan Vujkovic-Cviji, Dominic Rodriguez, Laura Falk, Gayatri Arani, Victoria Obergh, Kate Bessey, Kerry Cooper

“…Participants gave informed consent to participate in the study before taking part. …”
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Noel Hernández Rodríguez, scalpel in hand plastic surgeon by Tatiana Hernández González, Yaneisy Valdés Gutierrez, Yurisbel Tomás Solenzal Alvarez

“…We will reveal, with the consent of his daughter, a little secret: his real name was Hilario, that is why he could not be found when he was searched for official documents, he never allowed to be called this way, he did not like that name, he had been called Noel since he was a child. …”
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Relationship between vaginal and gut microbiome and pregnancy outcomes in eastern Ethiopia: a protocol for a longitudinal maternal-infant cohort study (the EthiOMICS study) by Piet Cools, Alemseged Abdissa, Abera Kenay Tura, Nega Assefa, Merga Dheresa, Kedir Teji Roba, Tara Wilfong, Tesfaye Assebe Yadeta, Fitsum Weldegebreal, Desalegn Admassu Ayana, Akewok Sime Negesa, Yohannes Mulugeta Demmu, Tewodros Tesfa, Tegbaru Nibrat Alemu, Tadesse Gure Eticha, Abraham Geremew, Abel Abera Negash

“…IHRERC/033/2022) of Haramaya University, Ethiopia has approved this study ethically. Written informed consent regarding the study and sample storage for biobanking will be obtained from all participants. …”
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Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19: a multicentre prospective cohort study among UK healthcare workers – the SIRE... by Nick Andrews, Mary Ramsay, Maria Zambon, Victoria Hall, Sarah Wallace, Susan Hopkins, Jean Timeyin, Tim J G Brooks, Amoolya Vusirikala, Meera Chand, Andre Charlett, Sakib Rokadiya, Colin S Brown, Madhumita Shrotri, Peter D Kirwan, Michele Cole, Natalie Gillson, Ana Atti, Sarah Foulkes, Andrew Taylor-Kerr, Blanche Oguti, Jasmin Islam

“…Participants gave informed consent before taking part in the study.Regular reports to national and international expert advisory groups and peer-reviewed publications ensure timely dissemination of findings to inform decision making.Trial registration number ISRCTN11041050.…”
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Cross-cultural adaptation of the simple Chinese version of the medication adherence reasons scale in patients undergoing adjuvant endocrine therapy for breast cancer by Lei Xu, Ping Li, Yan Hu, Weijie Xing, Jiajia Qiu, Xiaoju Zhang, Lingying Jia, Feng Jing, Ye Liu, Lili Li, Chunyang Lu

“…Inclusion criteria were: (a) female, (b) aged 18 years or older, (c) diagnosed with Stage I to III BrCa, (d) completed primary treatment for hormone receptor-positive BrCa and had been on AET for more than six months but less than five years, (e) proficient in Mandarin, and (f) provided informed consent. Exclusion criteria included psychiatric illness, cognitive impairment, or a diagnosis of another cancer type. …”
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Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes (INSTITUT) study: a protocol for a quasi-experimental study to ass... by Dissou Affolabi, Chelsie Cintron, Madolyn Dauphinais, Attannon Arnauld Fiogbe, Mohammed Fall Dogo, Safiou Ate, Christine Adjonou, Kokou Agossou, Susie Jiaxing Pan, Marius Esse, Benjamin Ade, Komi Séraphin Adjoh, Pranay Sinha, Kobto G Koura

“…The study also received a favourable decision from the Benin Comité d’Ethique de la Recherche and approval from the Comité de Bioéthique pour la Recherche en Santé of Togo. Informed consent will be obtained from all study participants prior to their engagement in the research. …”
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NEUROlogical Prognosis After Cardiac Arrest in Kids (NEUROPACK) study: protocol for a prospective multicentre clinical prediction model derivation and validation study in children... by Elizabeth S Draper, John Pappachan, Kent Thorburn, David Inwald, Richard Feltbower, Buvana Dwarakanathan, Patrick Davies, Kate Penny-Thomas, James Martin, Rum Thomas, Kevin P Morris, Roger Parslow, Timothy Thiruchelvam, Sophie Skellett, Hari Krishnan Kanthimathinathan, Victoria Hiley, Peter Barry, Sian Cooper, Rohit Saxena, Cormac Breatnach, Barnaby Robert Scholefield, Sarah Evans, Mirjam Kool, Alice J Sitch, Fang Smith, Yamuna Thiru, Richard Levin, Rachel Agbecko, James Weitz, Akash Deep, Sandra Gala-Peralta, Milly Lo, Rachael Barber, Stewart Reid, Siva Oruganti, Kalai Sadasivam, Mark Bebbington

“…We aim to identify 370 patients, with successful consent and follow-up of 150 patients. Patient inclusion started 1 January 2018 and inclusion will continue over 18 months.Ethics and dissemination Ethical review of this protocol was completed by 27 September 2017 at the Wales Research Ethics Committee 5, 17/WA/0306. …”
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Epidemiology of chronic and acute pancreatitis in India (EPICAP-India): protocol for a multicentre study by Sanjeev Kumar, Saransh Jain, Vineet Ahuja, Rakesh Kumar, Anand Krishnan, Pankaj Bhardwaj, Shalimar, Nitya Wadhwa, Ashish Agarwal, Deepak Gunjan, Sudipta Dhar Chowdhury, Anoop Saraya, Saurabh Kedia, Govind K Makharia, Pramod Kumar Garg, Ritvik Amarchand, Deepti Dabar, Rajib Sarkar, Gopal Krishna Dhali, Anmol Gupta, Shivendra Singh, Divya Pillai, Vineeta Baloni, Subhra Samujjwal Basu, Bikash Choudhury, Soumi Das, Pradeep Deshmukh, Krishnadas Devadas, Nitika Monga, Sumit Rungta, Brij Sharma, Chintha Sujatha

“…All the participants whose data will be collected will be included after written informed consent. The results may be presented at national or international conferences and will be reported in peer-reviewed publications.…”
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Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III... by Roger Owen, John Jones, David Meads, David A Cairns, Christopher Parrish, Gordon Cook, Neil Rabin, Matthew Jenner, Martin Kaiser, Kevin Boyd, Graham Jackson, Catherine Olivier, Amy Beth Coulson, Kara-Louise Royle, Charlotte Pawlyn, Anna Hockaday, Jennifer Bird, Stella Bowcock, Ruth de Tute, Hayley Gardner, Bryony Dawkins, Rowena Henderson, Phillip Best, Bhuvan Kishore, Mark Drayson

“…Participants are required to provide written informed consent prior to trial registration. Trial results will be disseminated by conference presentations and peer-reviewed publications.Trial registration number ISRCTN17973108, NCT03720041.…”
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Multifaceted Assessment of Chronic Gastritis: A Study of Correlations between Serological, Endoscopic, and Histological Diagnostics by Toshitatsu Takao, Takeshi Ishikawa, Takashi Ando, Madoka Takao, Tsuguhiro Matsumoto, Yutaka Isozaki, Mika Okita, Yasuyuki Nagao, Hirokazu Oyamada, Keiichi Yokoyama, Atsushi Tatebe, Kazuhiko Uchiyama, Osamu Handa, Tomohisa Takagi, Nobuaki Yagi, Satoshi Kokura, Yuji Naito, Toshikazu Yoshikawa

“…Subjects comprised 319 patients who had provided informed consent. Serological assessment of chronic gastritis was based on the pepsinogen test method. …”
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Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct by Dirk Schadendorf, Peter Martus, Stephan Zipfel, Yesim Erim, Alexander Bäuerle, Martin Teufel, Caterina Schug, Johanna Graf, Wolfgang Bethge, Andreas Dinkel, Anja Neumann, Jasmin Steinbach, Jana Heinen, Julia Barbara Krakowczyk, Mirjam Damerau, Sebastian Dries, Anja Mehnert-Theuerkauf, Mitra Tewes, Jörg Wiltink, Alexander Wünsch

“…We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18–65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. …”
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The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung can... by Rachel Hess, Angela Fagerlin, Devin Mann, Tanner Caverly, Yue Zhang, Guilherme Del Fiol, Jorie Butler, Michael Flynn, Kensaku Kawamoto, Douglas Martin, Chelsey R Schlechter, Haojia Li, Polina Kukhareva, Christian Balbin, Elizabeth Stevens, Victoria Tiase, Kim Kaphingst, Chakravarthy Reddy, Phillip Warner, Joshua Choi, Claude Nanjo, Quyen Metzger

“…The patient data collected for this study will not be shared publicly due to the sensitive nature of the patient health information and the fact that we will not be obtaining written informed consent to allow public sharing of their data. Results will be disseminated through peer-reviewed publications.Trial registration number Clinicaltrials.gov, NCT06338592.…”
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Examining the effect of direct-from-blood bacterial testing on antibiotic administration and clinical outcomes: a protocol and statistical analysis plan for a pragmatic randomised... by Li Wang, Wesley H Self, Todd W Rice, Matthew W Semler, Karen F Miller, Cheryl L Gatto, Andrea Fletcher, Romney M Humphries, Joanna L Stollings, Adrienne Baughman, Jakea Johnson, Edward T Qian, Mary Lynn Dear, David C Gaston, Ariel A Lewis, George E Nelson, Benjamin J Ereshefsky, Matthew A Christensen, Ritu Banerjee, Dan Albert, Alison Benton, Laura Bobbitt, Carleigh Burns, Timothy Duff, David C. Gaston, MLS Sharon Glover, Allyson Hobbie, Austin Ing, Gabriel Kemp, Sheryl Mangrum, Geoff Mavrak, Kelly Moser, David Mulherin, Shannon Pugh, Matthew Rodgers, Chrissie Schaeffer, Adam Turner, Sabrina Shipman, Halden Z VanCleave, Hamilton Wen Li Wang, LaKeysha Wiggins

“…Enrolment began on 13 December 2023.Ethics and dissemination The trial involves human participants and was approved by the Vanderbilt University Medical Center institutional review board with a waiver of informed consent (IRB#231229). Results will be submitted in a peer-reviewed journal and presented at scientific conferences.Trial registration number NCT06069206.…”
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