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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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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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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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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Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventiona... by Ursula Panzner, Katharina Kranzer, Tsitsi Bandason, Kuda Mutasa, Sandra Rukobo, Charles Sandy, Bariki Mtafya, Andrea Rachow, Norbert Heinrich, Michael Hoelscher, Judith Bruchfeld, Olena Ivanova, Nyanda Elias Ntinginya, Doreen Pamba, Laura Olbrich, Issa Sabi, Simeon Mwanyonga, Elmar Saathoff, Willyhelmina Olomi, Junior Mutsvangwa, Hazel M Dockrell, Edson Tawanda Marambire, Denise Banze, Alfred Mfinanga, Theodora D Mbunda, Khosa Celso, Gunilla Kallenius, Claire J Calderwood, Christof Geldmacher, Kathrin Held, Tejaswi Appalarowthu, Friedrich Rieß, Anna Shepherd, Christopher Sundling, Mishelle Mugava, Martha Chipinduro, Lwitiho Sudi, Antelmo Haule, Emmanuel Sichone, Paschal Qwaray, Harrieth Mwambola, Lilian Minja, Peter Edwin, Dogo Ngalison, Stella Luswema, Celina Nhamuave, António Machiana, Carla Madeira, Emelva Manhiça, Nádia Sitoe, Jorge Ribeiro

“…Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity.Ethics and dissemination ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants <18 years, is voluntary. …”
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Tadalafil treatment for fetuses with early-onset growth restriction: a protocol for a multicentre, randomised, placebo-controlled, double-blind phase II trial (TADAFER IIb) by Hiroaki Tanaka, Yasuhiro Tanaka, Yoichi Aoki, Masayuki Endo, Tomoaki Ikeda, Shintaro Maki, Masafumi Nii, Kayo Tanaka, Satoshi Tamaru, Toru Ogura, Yuki Nishimura, Tomomi Kotani, Akihiko Sekizawa, Masahiko Nakata, Koji Nakamura, Kenji Nagao, Ichiro Yasuhi, Hiroshi Kawamura, Sho Takakura, Mayumi Kotera, Takafumi Ushida, Norihiko Kikuchi, Tadatsugu Kinjo, Mayumi Takano, Sachie Suga, Michi Kasai, Osamu Yasui, Yuka Maegawa, Shigeru Aoki, Yoshio Yoshida

“…The investigator will evaluate fetal baseline conditions at enrolment and decide the timing of delivery based on this indication.Ethics and dissemination This study has been approved by Mie University Hospital Clinical Research Review Board on 22 July 2019 (S2018-007). Written informed consent will be obtained from all mothers before recruitment. …”
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HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in... by Augustine T Choko, Elizabeth L Corbett, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Cheryl C Johnson, Doreen Sakala, Thokozani Kalua, Moses Kumwenda, Richard Hayes, Katherine Fielding

“…Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women's partners. …”
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Status of cerebrovascular autoregulation relates to outcome in severe paediatric head injury: STARSHIP, a prospective multicentre validation studyResearch in context by Shruti Agrawal, Claudia Smith, Stefan Y. Bogli, Michal M. Placek, Manuel Cabeleira, Deborah White, Esther Daubney, Adam Young, Erta Beqiri, Riaz Kayani, Diarmuid O'Donnell, Nazima Pathan, Suzanna Watson, Anna Maw, Matthew Ganrett, Hari Krishan Kanthimathianathan, Harish Bangalore, Santosh Sundararajan, Gayathri Subramanian, Dusan Raffaj, Avishay Sarfatti, Simona Lampareillo, Anton Mayer, Oliver Ross, Marek Czosnyka, Peter J. Hutchinson, Peter Smielewski, Carly Tooke, Caroline Payne, Holly Belfield, Amisha Mistry, Collette Spencer, Claire Jennings, Lara Bunni, Laura Anderson, Emily Morgan, Melanie James, Rebecca Beckley, Tahnima Khatun, Hafiza Khatun, Olivia Nugent, Richard Aldridge, Ruth Morgan, Julie Morcombe, Martin Quinton, Catherine Postlethwaite, Jenny Pond, Jessica Cutler, Caitlin Oxford

“…Findings: Out of 153 recruited, 135 children (median age 96 months) with consent and adequate data were included. Overall median PRx of the cohort was −0.09 (IQR −0.19 to 0.08). …”
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Infrared illumination for difficult peripheral venous catheterisation in critically ill adult patients: the prospective, randomised, multicentre ICARE trial by Étienne Audureau, Sophie Demeret, Nicolas Mongardon, Damien Contou, Matthieu Schmidt, Muriel Fartoukh, Armand Mekontso Dessap, Daniel Da Silva, Frédérique Schortgen, Rachida Ouedraogo, Aline Alves, Amélie Bruant, Oumar Sy, Cécilia Tabra Osorio, Amélie Chenal, Laurence Krzyzaniak, Marianne Le Joncour, Latifa Ait Benaissa, Meriem Bouguerra, Stéphanie Tanguy Dubois, Eric Starczala, Chirine Petyt, Séverine Dezellus, Jean Francois Georger, Ann-Cécile Pallud, Damien Carras, Fabien Boussely

“…Following the provision of informed consent, patients will be included in the study. The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT03932214.…”
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Trifluridine-tipiracil in previously treated patients with oestrogen receptor-positive, HER2-negative metastatic breast cancer (BOOG 2019-01 TIBET trial): a single-arm, multicentre... by Niels A.D. Guchelaar, Ron H.J. Mathijssen, Maaike de Boer, Marlies L. van Bekkum, Joan B. Heijns, Birgit E.P.J. Vriens, Mandy M. van Rosmalen, Lonneke W. Kessels, Lisanne Hamming, Karin J. Beelen, Peter Nieboer, Susan M. van den Berg, Esther Oomen-de Hoop, Rhodé M. Bijlsma, Monique E.M.M. Bos

“…The participants received trifluridine-tipiracil 35 mg/m2 orally twice a day on days 1–5 and days 8–12 during a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the disease control rate (DCR) at 8 weeks, defined as the percentage of patients that had stable disease, partial response or complete response according to RECIST 1.1, in all patients that received at least one dose of trifluridine-tipiracil and met the key eligibility criteria defined a priori. …”
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Navigating Ethical Dilemmas Of Generative AI In Medical Writing by Qurrat Ulain Hamdan, Waleed Umar, Mahnoor Hasan

“…It may also be worthwhile to consider adding the use of AI generative tools in article writing as part of informed consent at the start of new scientific research. The settings section of the said tools needs to be simplified and easily accessible for researchers so that they can remove their data from the repository if they prefer to do so. …”
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Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, ran... by Keith Barton, Tin Aung, Ling Jin, Ping Lu, Xiulan Zhang, Robert N Weinreb, Yi Zhang, Li Tang, Guangxian Tang, Hengli Zhang, Aiguo Lv, Huiping Yuan, Yunhe Song, Fengbin Lin, DENNIS S C LAM, Lin Xie, Kun Hu, Xiaohong Liang, Yingzhe Zhang, Wulian Song, Xiaomin Zhu, Xinbo Gao, Sujie Fan, Yuying Peng, Mengfei Liao, Xin Nie, Ki-Ho Park

“…All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings.Trial registration number NCT05163951.…”
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