Challenges and Opportunities for Data Sharing Related to Artificial Intelligence Tools in Health Care in Low- and Middle-Income Countries: Systematic Review and Case Study From Tha... by Aprajita Kaushik, Capucine Barcellona, Nikita Kanumoory Mandyam, Si Ying Tan, Jasper Tromp

“…Key solutions included building a conducive digital ecosystem—having shared data input platforms for health facilities to ensure data uniformity and to develop easy-to-understand consent forms, having standardized guidelines for data sharing, and having compensation policies for data breach victims. …”
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Uptake and 4-week outcomes of an ‘opt-out’ smoking cessation referral strategy in a London-based lung cancer screening setting by Anthony Edey, Neal Navani, Kitty Chan, Graham Robinson, Janine Zylstra, Paul Robinson, Laura Green, Anand Devaraj, Jane Rowlands, Allan Hackshaw, Carolyn Horst, Arjun Nair, Sam M Janes, Kate Davies, Jeannie Eng, Mamta Ruparel, Samantha L Quaife, Jennifer L Dickson, Magali Taylor, Angshu Bhowmik, Hasti Robbie, Joseph Jacob, Laura Farrelly, Sophie Tisi, Tanya Patrick, Andrew Creamer, Helen Hall, Samanjit Hare, Jon Teague, Samuel M Janes, Esther Arthur-Darkwa, Thea Buchan, Stephen Ellis, Thomas Callender, Rachael Sarpong, John McCabe, Zaheer Mangera, Ethaar El-Emir, Terry O'Shaughnessy, Geoff Bellingan, Nick Screaton, Priyam Verghese, William M Ricketts, Vicky Bowyer, Kylie Gyertson, Fanta Bojang, Claire Levermore, Tania Anastasiadis, Ruth Prendecki, Amyn Bhamani, Malavika Suresh, Judy Airebamen, Alice Cotton, Kaylene Phua, Elodie Murali, Simranjit Mehta, Karen Parry-Billings, Columbus Ife, April Neville, Zahra Hanif, Helen Kiconco, Ricardo McEwen, Dominique Arancon, Nicholas Beech, Derya Ovayolu, Christine Hosein, Sylvia Patricia Enes, Qin April Neville, Aashna Samson, Urja Patel, Fahmida Hoque, Hina Pervez, Sofia Nnorom, Moksud Miah, Julian McKee, Mark Clark, Anant Patel, Sara Lock, Rajesh Banka, Ugo Ekeowa, Charlotte Cash, Tunku Aziz, Alberto Villanueva, Elena Stefan, Charlie Sayer, Navinah Nundlall, Andrew Crossingham, Tanita Limani, Kate Gowers, Andrew Perugia, James Rusius, Anne-Marie Hacker, Monica L Mullin, Evangelos Katsampouris, Chuen R Khaw, Chuen Khaw, Sheetal Karavadra, Alan Shaw, Chris Valerio, Ali Mohammed, Lynsey Gallagher, Mehran Azimbagirad, Burcu Ozaltin, Maureen Browne, Eleanor Hellier, Catherine Nestor

“…Aggregate data on referral outcomes were obtained from each SSS individually.Results 33.7% (n=2090/6203) of individuals currently smoking tobacco consented to a practitioner-made ‘opt-out’ smoking cessation referral. 42.7% (n=893/2090) of these individuals resided in boroughs where SSS were not present or required self-referral. …”
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Preliminary effectiveness of social prescription and virtual patient information in increasing tertiary prevention among cancer patients (ESPRIT): protocol for a single-centre, ran... by Karen Steindorf, Michael Koller, Michael Leitzmann, Wolfgang Herr, Daniel Heudobler, Lisa Boyer, Anne Herrmann, Tobias Pukrop, Christine Bernardi, Sabine Einhell

“…Signed written informed consent is required from all study participants. The results of the study will be used to inform the power calculation for future confirmatory trials and will be submitted for publication.Trial registration number DRKS00033771.…”
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Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinica... by Jens Juul Holst, Tina Vilsbøll, Claus Thorn Ekstrøm, Helene Benveniste, Nora D Volkow, Anders Fink-Jensen, Gitte M Knudsen, Mette Kruse Klausen, Tugba Kuzey, Julie Niemann Pedersen, Signe Keller Justesen, Line Rasmussen, Ulla B Knorr, Graeme Mason, George Koob

“…All patients will sign the written consent form before being included in the trial. Results will be disseminated through peer-reviewed publications and conference presentations. …”
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Knowledge, Attitude, and Practice Towards Responsible Self-Medication Among Pharmacy Students: A Web-Based Cross-Sectional Survey in Uganda by Brian B, Goruntla N, Bommireddy BR, Mopuri BM, Easwaran V, Mantargi MJS, Thammisetty DP, Bukke SPN, Yadesa TM, Ayogu EE

“…The study included students enrolled in diploma, bachelor, and master of pharmacy programs in Uganda. Informed consent was obtained online by asking a question regarding willingness to participate. …”
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Asymptomatic Malaria Infection and Hidden Parasitic Burden in Gabonese Schoolchildren: Unveiling Silent Co-Infections in Rural and Urban Settings by Patrice Makouloutou-Nzassi, Lady Charlene Kouna, Chérone Nancy Mbani Mpega Ntigui, Neil Michel Longo-Pendy, Judy Armel Bourobou Bourobou, Felicien Bangueboussa, Nick Chenis Atiga, Jean Bernard Lekana-Douki, Larson Boundenga, Sandrine Lydie Oyegue-Liabagui

“…Blood and stool samples were collected from participants whose parents or legal guardians provided informed consent to participate in the study. Hemoglobin concentration (Hb) was measured using a HemoCue photometer (HemoCue 201, HemoCue, Angelholm, Sweden). …”
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Translation and assessment of encultured meaning of the Multi-Dimensional Scale of Perceived Social Support in Diné bizaad (Navajo) using community-based participatory actio... by Tapati Dutta, Jon Agley, Camille Keith, Gregory Zimet

“…All participants provided consent and received gratitude gifts for completion. …”
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Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial by Yu Wang, Xiao Wang, Ying Lin, Chao-Qun Yan, Guang-Xia Shi, Cun-Zhi Liu, Jing-Wen Yang, Jian-Feng Tu, Shi-Yan Yan, Xin-Tong Su, Li-Qiong Wang, Si-Bo Kang, Bao-Hong Mi, He-Wen Li, Xue-Zhou Wang

“…Safety outcomes will be any serious adverse events and clinical events.Ethics and dissemination This study has been approved by ethics committee of Beijing University of Chinese Medicine (No. 2020BZHYLL0104). Written informed consent will be obtained from all patients before randomisation. …”
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Prospective study of factors associated with asthma attack recurrence (ATTACK) in children from three Ecuadorian cities during COVID-19: a study protocol by Cristina Ardura-Garcia, Max Bachmann, Alejandro Rodriguez, Philip Cooper, Michael Richard Perkin, Irina Chis Ster, Natalia Cristina Romero, Martha E Chico, Alvaro Cruz, Diana Morillo, Santiago Mena-Bucheli, Angélica Ochoa, Claudia Rodas, Augusto Maldonado, Karen Arteaga, Jessica Alchundia, Karla Solorzano, Camila Figueiredo

“…Participants gave informed consent to participate in the study before taking part.…”
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Evaluation of the implementation in primary care of genetic testing for the screening of MODY2 (iMOgene): protocol for an implementation pilot study by Marie-Ève Poitras, Luigi Bouchard, Samuel Legeay, Vanessa Tremblay-Vaillancourt, Amélie Fournier, Josianne Leblanc, Philippe Caron, Catherine Savard, Nathalie Bettez, Karine Tremblay

“…This study will document the implementation process of genetic testing in primary care by identifying facilitating and limiting factors to establish specifications for scaling up.Ethics and dissemination The present protocol has been approved by the research ethic committee of the ‘Centre intégré universitaire de santé et de services sociaux of Saguenay-Lac-Saint-Jean’ (CIUSSS-SLSJ) on 9 January 2024 and by the ‘Comité central d’éthique de la recherche’ (CCER) of the ‘Ministère de la Santé et des Services Sociaux’ of Quebec (Canada) on 30 January 2024. The informed consent of participants will be obtained orally. Dissemination of the study results will involve peer-review publications, presentations at major national and international scientific conferences.…”
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Prevalence of psychoactive substance use among acutely hospitalised patients in Oslo and Moscow: a cross-sectional, observational study by Stig Tore Bogstrand, Thomas Berg, Anners Lerdal, Danil Gamboa, Benedicte Jørgenrud, Evgeny A Bryun, Vigdis Vindenes, Evgenya A Koshkina, Aleksei V Nadezhdin, Saranda Kabashi, Elena J Tetenova, Anna Armika Tussilago Nyman, Alexey J Kolgashkin, Aleksei E Petukhov, Sergey N Perekhodov, Elena N Davydova, Gudmund Nordby

“…Patients unable to give informed consent were excluded. The study sites did not admit patients with surgical conditions and/or injuries.Primary and secondary outcomes The presence of psychoactive substances was determined through blood analysis using liquid chromatography-mass spectrometry. …”
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Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects by Massimo Mammucari, Enrica Maggiori, Domenico Russo, Chiara Giorgio, Gianpaolo Ronconi, Paola E Ferrara, Flora Canzona, Luciano Antonaci, Bartolomeo Violo, Renato Vellucci, Domenico Rocco Mediati, Alberto Migliore, Umberto Massafra, Barbara Bifarini, Fabio Gori, Massimo di Carlo, Stefano Brauneis, Teresa Paolucci, Piergiovanni Rocchi, Anna Cuguttu, Raffaele Di Marzo, Alessandro Bomprezzi, Stefania Santini, Manuela Giardini, Anna Rosa Catizzone, Fiammetta Troili, Dario Dorato, Alessandra Gallo, Costanza Guglielmo, Silvia Natoli

“…Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.…”
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Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) by Khalida Ismail, Boon How Chew, Iliatha Papachristou Nadal, Angus Forbes, Nurul Iftida Basri, Rozita Zakaria, Pamela Phui Har Yap, Veronika Rysinova, Intan Nureslyna Samsudin, Nurain Mohd Noor, Ziti Akthar Supian, Haslinda Hassan, Fuziah Paimin, Siti Rohani Mohamed Alias, Norizzati Bukhary Ismail Bukhary, Madeleine Benton

“…All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported.Ethics and dissemination This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.…”
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Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre... by Benjamin Planquette, Christophe Perrin, Thierry Boulain, Mai-Anh Nay, Louis Bernard, Laurent Plantier, Léa Colombain, Jérémy Clément, Aymeric Sève, Sylvie Druelle, Marine Morrier, Jean-Baptiste Lainé, Grégory Corvaisier, Nicolas Bizien, Xavier Pouget-Abadie, Adrien Bigot, Elsa Nyamankolly, Guillaume Fossat

“…Patients are randomised to receive either awake prone position plus usual care or usual care alone with stratification on centres, body mass index and severity of hypoxaemia.The study objective is to compare the rate of treatment failure defined as a composite endpoint comprising the need for non-invasive ventilation (at two pressure levels) or for intubation or death, between the intervention group (awake prone position plus usual care) and the usual care (usual care alone) group at 28 days.Ethics and dissemination The protocol and amendments have been approved by the ethics committees (Comité de protection des personnes Ouest VI, France, no 1279 HPS2 and Comité Consultatif d’Ethique en matière de Recherche Biomédicale, Monaco, no 2020.8894 AP/jv), and patients are included after written informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04363463.…”
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The Use of L-Menthol in Endoscopic Transpapillary Interventions. Prospective Randomized Dual-Center Study by M. A. Anishchenko, M. A. Nazmeev, S. G. Shapovalyants, S. A. Budzinsky, A. V. Rogov, R. R. Zaynutdinov, A. S. Melnikova, E. D. Fedorov, E. N. Platonova

“…The inclusion criteria were age 18–75 years, indications for ERTI, absence of previous endoscopic papillotomy, absence of allergy to menthol, consent to participate in the study. After randomization, the main group (“L”) included 70 patients, the control group — 56. …”
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Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: protocol for a randomised controlled trial (OxyKids study) by Jolita Bekhof, Eleni-Rosalina Andrinopoulou, J Bosmans, Gerard Koppelman, Karlijn J van Stralen, Anja Vaessen-Verberne, Sam Louman, Caroline Brackel, Arvid W A Kamps, Ismé de Kleer, Walter Balemans, Mirjam Scheffer, Marianne Brouwer, Marije van den Beukel, Mariëlle W H Pijnenburg, Annemie L M Boehmer

“…Patients are followed up by digital questionnaires up to 90 days postdischarge.Ethics and dissemination This study has received approval from the research ethics committee (REC) of Leiden, Den Haag and Delft (EU CT number 2023-504817-56). Written informed consent will be obtained from parents or guardians. …”
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Factors influencing changes in the quality of life of the Hainan migratory population with hypertension: a survey of the Chengmai mangrove bay community by Qiaochun Chen, Jing Zhou, Na Li, Luming Liu, Yixuan Li, Wenfang Long, Ziyue Luo, Yunru Liu, Sha Xiao

“…After obtaining informed consent, we investigated the demographic characteristics of the participants and evaluated their QoL with the SF-36 twice; one round of the SF-36 was about their hometown, and the other round was about living in Hainan for 1 month. …”
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Application of SPORT medical care model and nursing practice of hematopoietic stem cells collection for related donors of allogeneic hematopoietic stem cell transplantation (SPORT医... by FU Xiaofeng (傅小凤), ZHU Liying (朱丽影)

“…Nursing interventions were provided during the blood cell collection process, including assessment, informed consent, preoperative preparation, operative cooperation, vascular access care, psychological nursing, observation of adverse reactions during the operation, and postoperative guidance, according to the SPORT(Screen-Preparation-Operation-rehabilitation-Transitional Care) medical care model. …”
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Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period: study protocol for a randomised controlled trial (SOS BPD s... by Anton H van Kaam, Wes Onland, Irwin K M Reiss, Peter H Dijk, Arend F Bos, Eleni-Rosalina Andrinopoulou, E Villamor, LGM van Rooij, M de Jong, JS von Lindern, Lucas Goossens, Stephanie Balink, Elianne J L E Vrijlandt, Anthon R Hulsmann, Debbie H Nuytemans, Arwen J Sprij, André A Kroon, Marielle Pijnenburg, MGA Baartmans, GJ Blok, WP de Boode, HD Buiter, CE Counsilman, CA Dalen Meurs, ACM Dassel, AM de Grauw, MEN van den Heuvel, JLAM van Hillegersberg, JCR van Hoften, JHL van Hoorn, CH ten Hove, A Kamerbeek, AAMW van Kempen, LH van der Meer, RMJ Moonen, EEM Mulder, HJ Niemarkt, MAG van Scherpenzeel-de Vries, IAM Schiering, RNGB Tan

“…Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants.Trial registration number NL7149/NTR7347.…”
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MET-PREVENT: metformin to improve physical performance in older people with sarcopenia and physical prefrailty/frailty – protocol for a double-blind, randomised controlled proof-of... by Andrew Clegg, James Wason, Miles Witham, Nina Wilson, Claire J Steves, Helen C Hancock, Avan A P Sayer, Leanne Marsay, Claire McDonald, Thomas von Zglinicki, Katherine J Rennie, Penny Bradley, Stephen Connolly, Shaun Hiu, Laura Robertson, Laura Simms, Alison J Steel, Bryony Storey

“…Trial participants can participate from their own homes, including completing informed consent and screening assessments. Eligible participants with low grip strength or prolonged sit-to-stand time together with slow walk speed will be randomised to either oral metformin hydrochloride 500 mg tablets or matched placebo, taken three times a day for 4 months. …”
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