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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Experimental medicine study with stabilised native-like HIV-1 Env immunogens drives long-term antibody responses, but lacks neutralising breadthResearch in context by Katrina M. Pollock, Hannah M. Cheeseman, Leon R. McFarlane, Suzanne Day, Monica Tolazzi, Hannah L. Turner, Jennifer Joypooranachandran, Katsiaryna Shramko, Stefania Dispinseri, Philipp Mundsperger, Ilja Bontjer, Nana-Marie Lemm, Sofia Coelho, Maniola Tanaka, Tom Cole, Bette Korber, Dietmar Katinger, Quentin J. Sattentau, Andrew B. Ward, Gabriella Scarlatti, Rogier W. Sanders, Robin J. Shattock

“…Participants gave written informed consent to join the study. The study is registered on ClinicalTrials.gov ID NCT03816137. …”
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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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FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial by Laith Alrubaiy, Rachel Cooney, Tariq Iqbal, Mohammed Nabil Quraishi, Susan Manzoor, Christopher Quince, Palak J Trivedi, Andrew D Beggs, Alexandra Vince, Chris Weston, Benjamin Mullish, Sahida Shabir, Nicola Jackson, Anna Rowe, Victoria Homer, Willem van Schaik, Peter Rimmer, Sarah Al-Shakhshir, Arzoo Patel, Derick Gyimah, Miriam Hares, Elena Efstathiou

“…Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registration number The trial was registered at ClinicalTrials.gov on 23 February 2024 (NCT06286709). …”
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Comparison of dark-field chest radiography and CT for the assessment of COVID-19 pneumonia by Florian T. Gassert, Henriette Bast, Henriette Bast, Henriette Bast, Theresa Urban, Theresa Urban, Theresa Urban, Manuela Frank, Manuela Frank, Felix G. Gassert, Konstantin Willer, Konstantin Willer, Rafael C. Schick, Rafael C. Schick, Bernhard Renger, Thomas Koehler, Thomas Koehler, Alexandra Karrer, Andreas P. Sauter, Alexander A. Fingerle, Marcus R. Makowski, Franz Pfeiffer, Franz Pfeiffer, Franz Pfeiffer, Franz Pfeiffer, Daniela Pfeiffer, Daniela Pfeiffer

“…Inclusion criteria were a CO-RADS score ≥4, the ability to consent to the procedure and to stand upright without help. …”
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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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Frailty assessment in adults undergoing allogeneic hematopoietic cell transplantation: insights from a multicenter GETH-TC study to optimize outcomes and care by María Queralt Salas, María Teresa Solano, Mónica Baile González, Marina Acera Gómez, Laura Fox, María del Mar Pérez Artigas, Ana Santamaría, María del Carmen Quintela González, Andrés Sánchez Salinas, Joaquina M. Salmerón Camacho, Verónica Illana Álvaro, Zahra Abdallahi-Lefdil, Javier Cornago Navascues, Laura Pardo, Sara Fernández-Luis, Leddy Patricia Vega Suárez, Sara Villar, Patricia Beorlegui-Murillo, Albert Esquirol, Isabel Izquierdo García, Sonia Rodríguez González, Alberto Mussetti, Esperanza Lavilla, Javier Lopez-Marín, Silvia Filaferro, Ángel Cedillo, Leyre Bento, Leyre Bento, Anna Sureda, Anna Sureda

“…Data was collected prospectively and all patients signed informed consent.ResultsAt first consultation, 102 (26.2%) patients were classified as fit, 248 (61.4%) as pre-frail, and 50 (12.4%) as frail. …”
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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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Experiencia en DAC cardiaca en la Comunidad Valenciana: programa de extracción cardiaca extrahospitalaria by Audelio Guevara-Bonilla, Eduardo Tébar-Botí, Claudia Aguirre-Ramón, Alexandra Merino-Orozco, Carlos Domínguez-Massa, Manuel Pérez-Guillén, Ana Bel-Mínguez, Salvador Torregrosa-Puerta, Tomás Heredia-Cambra, Alejandro Rincón-Almanza, María J. Dalmau-Sorli, Iván Martín González, Francisco J. Valera Martínez, Ana Tur-Alonso, Juan B. Martínez León

“…Materials and method: From November 2022 to April 2024, 21 cardiac assessments have been performed in the context of DCD.Donor inclusion criteria: donor < 55 years old; family donation consent; functional warm ischemia time < 30 min.Donor exclusion criteria, additional to those of a cardiac donation: adrenaline infusion; dobutamine infusion; norepinephrine infusion > 0,3 μg/kg/min.This is a retrospective descriptive study. …”
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Comparative analysis of C-Reactive protein levels among Non-comorbid, Comorbid, and Multimorbid Hospitalized COVID-19 patients by Maria Shoukat, Haseeb Khan, Moona Nazish, Abdur Rehman, Sheharyar Raashid, Saad Ahmed, Wajid Munir, Abdulwahed Fahad Alrefaei, Massab Umair, Muhammad Osama Bin Abid, Nasim Akhtar, Wajid Zaman, Malik Badshah

“…Methods This study involves a retrospective observational framework to monitor CRP levels among hospitalized COVID-19 patients after getting ethical approval and patient consent. The information on underlying health conditions or comorbidities and age was collected from the patient data files. …”
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Nonalcoholic Fatty Liver Disease and Associated Metabolic Risks of Hypertension in Type 2 Diabetes: A Cross-Sectional Community-Based Study by Xiaoying Ding, Ying Xu, Yufan Wang, Xiaohua Li, Chunhua Lu, Jing Su, Yuhang Ma, Yuting Chen, Yanhua Yin, Lijun Zhang, Yong Wu, Yaqiong Jin, Lijun Zheng, Songmei Xu, Xiuli Zhu, Jilin Ma, Lihua Yu, Junyi Jiang, Naisi Zhao, Qingwu Yan, Andrew S. Greenberg, Qianfang Huang, Qian Ren, Haiyan Sun, Mingyu Gu, Li Zhao, Yunhong Huang, Yijie Wu, Chunxian Qian, Yongde Peng

“…The aim of this study is to investigate the prevalence of hypertension in different glycemic statuses and to analyze relationships between NAFLD, metabolic risks, and hypertension within a large community-based population after informed written consent. A total of 9473 subjects aged over 45 years, including 1648 patients with T2DM, were enrolled in this cross-sectional study. …”
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Assessment of the Impact of Community-Based Tourism on the Economic, Social, and Cultural Empowerment of Women (Case Study: Coastal Villages of Bushehr Province) by Ali Shamsoddini, Fatemeh Dehghani

“…Ethical Considerations:All study participants provided informed consent and the researchers assured them of complete confidentiality and anonymity in relation to the study results. …”
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Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht) by Steven J R Meex, Walther N K A van Mook, Iwan C C van der Horst, Jeanette Tas, Coen D A Stehouwer, Rob J J van Gassel, Serge J H Heines, Mark M G Mulder, Nanon F L Heijnen, Melanie J Acampo-de Jong, Julia L M Bels, Frank C Bennis, Marcel Koelmann, Rald V M Groven, Moniek A Donkers, Frank van Rosmalen, Ben J M Hermans, Otto Bekers, Astrid M L Oude Lashof, Fabian H Tijssen, Jan-Willem E M Sels, Chahinda Ghossein-Doha, Rob G H Driessen, Pieter L Kubben, Marcus L F Janssen, Gerry A F Nicolaes, Ulrich Strauch, Zafer Geyik, Thijs S R Delnoij, Kim H M Walraven, Jeanine A M C F Verbunt, Susanne van Santen, Ronny M Schnabel, Marcel J H Aries, Marcel C G van de Poll, Bas C T van Bussel, Joachim E Wildberger, Sander M J van Kuijk, Dennis C J J Bergmans, Paul H M Savelkoul, Alma M A Mingels, Wolfgang F F A Buhre

“…During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. …”
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Connecting The Dots: The Impact Of Subclinical Hypothyroidism On Female Subfertility And Obesity by Naila Ashfaq, Warda Hussain, Mugheera Hussain, Neelam Saba, Asma Muddasir, Jawairiah Liaqat

“…A total of 159 females meeting inclusion criteria were included after taking informed consent. Females were enquired about infertility status and their thyroid status was measured in terms of thyroid stimulating hormone (TSH) and free thyroxine (FT4). …”
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600 meters to VO2max: Predicting Cardiorespiratory Fitness with an Uphill Run by Kübra Stoican, Regina Oeschger

“…All participants provided informed consent before participating in the study and they were given detailed information about the objectives of the study, procedures, and potential risks. …”
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Improving the experience of health services for trans and gender-diverse young people and their families: an exploratory qualitative study by Melissa Stepney, Samantha Martin, Magdalena Mikulak, Sara Ryan, Jay Stewart, Richard Ma, Adam Barnett

“…What young people wanted to see, was less hierarchy in their encounters with health professionals and more equitable, shared decision-making, based around an informed consent model. They wanted to work in partnership with healthcare professionals based upon an equal relationship that recognised their autonomy and expertise over their own bodies. …”
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