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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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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Prevalence and factors associated with potential clinically significant drug-drug interactions in patients with cardiovascular diseases at hospital admission by Marović Iva, Udovičić Mario, Rudan Diana, Manola Šime, Samardžić Ivana, Vrca Vesna Bačić, Hadžiabdić Maja Ortner, Marinović Ivana

“…The research was approved by the Hospital’s Ethics Committee and each patient involved in the study signed an informed consent. Lexicomp® Lexi-InteractTM Online (Lexi-Comp, Inc., USA) was used for DDI analysis. …”
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Genetic characterization of a rare case of pheochromocytoma in a pulmonary transplant patient by Stéfanie Parisien-La Salle, Florence Perreault, Gilles Corbeil, Julie Morisset, Charles Poirier, Catherine Beauregard, Agnès Räkel, Marjorie Labrecque, Martine Tétreault, Martine Tétreault, Christian Cohade, Pasquale Ferraro, Isabelle Bourdeau

“…Consequently, the patient underwent laparoscopic right adrenalectomy, confirming the PCC diagnosis.Genetic studies1) Germline PPGL multigene panel: After consent, the patient underwent a panel of 14 susceptibility genes for PPGLs that revealed no pathogenic variants. 2) Somatic genetic analysis for EPAS1 gene found no variants. …”
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Evaluating the Benefit of Home Support Provider Services for Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for an Ambispective International R... by Sarah Alami, Manuella Schaller, Sylvie Blais, Henry Taupin, Marta Hernández González, Frédéric Gagnadoux, Paula Pinto, Irene Cano-Pumarega, Lieven Bedert, Ben Braithwaite, Hervé Servy, Stéphane Ouary, Céline Fabre, Fabienne Bazin, Joëlle Texereau

“…A secure electronic solution will be used to manage patient information and consent, as well as to administer a web-based questionnaire. …”
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Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar by John Norrie, Julie Woodfield, David J Lowe, Paul M Brennan, Catriona Keerie, Julia Lawton, Matthew J Reed, Andrew Stoddart, Julia Boyd, Helen Eborall, Gina Cranswick, James Tomlinson, Polly L Black, Sadaquate Khan, Patrick Statham, Ellie Edlmann, Phillip Correia Copley, Angela Niven, Susan Deborah Shenkin

“…Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality.Ethics and dissemination Informed consent for participation will be sought from those able to provide it. …”
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SHoes for Adolescent PatEllofemoral pain: study protocol for the SHAPE Australian community-based, randomised clinical trial by Kim L Bennell, Kade L Paterson, Rana S Hinman, Jo-Anne Manski-Nankervis, Adam Bryant, Karen Elaine Lamb, Peixuan Li, Sam Shearer, Anurika P De Silva

“…Other measures include cointervention use, adherence, adverse events, shoe comfort, descriptive characteristics, physical activity levels, footwear characteristics and objective foot measures.Ethics and dissemination This study has been approved by the University of Melbourne Greater than Low Risk Human Research Ethics Committee (reference: 2022-25470-35344-4). Written informed consent is obtained from each participant prior to enrolment. …”
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Can invasive interventions be avoided with a holistic swallowing therapy program in older patients in intensive care units: percutaneous endoscopic gastrostomy tubes or oral intake... by Çağla Eliküçük, Fatma Esen Aydinli, Nazan Has Selmi, Cansu Uzunoğlu, Murathan Köksal, Volkan Öter, Belgin Akan, Erdal Birol Bostanci, Güldeniz Argun

“…The 12 weeks (14−16 sessions) of swallowing therapy were administered to patients with dysphagia who signed the (voluntary) consent form. The bedside water swallowing test (BWSS), Functional Oral Intake Scale (FOIS) Score, Clinical Swallowing Evaluation, Mini Nutritional Assessment Test (MNAT), Eating Assessment Tool (EAT-10), the Turkish version of the World Health Organisation Quality of Life Scale Elderly Module, and the Swallowing Therapy Programme Protocol were applied. …”
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Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients by Xiaowen Guo, Yang Qiao, Sijie Yin, Fengqin Luo, Lingmei Yi, Jiajia Chen, Man Lu

“…All study subjects provided written informed consent.…”
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Protocol for the enhanced management of multimorbid patients with COPD and severe asthma: role of indoor air quality by Emili Vela, Isaac Cano, Josep Roca, Antoni Sisó-Almirall, Carme Hernandez, Ebymar Arismendi, Ramon Farré, Alba Gómez-López, María Figols, Antonio Montilla-Ibarra, Núria Sánchez-Ruano, Benigno Sánchez, Marta Sorribes, Jordi Piera-Jiménez, Jaume Benavent, Jose Fermoso, Rubèn González-Colom

“…Before any procedure, all patients in the study must sign an informed consent form.Trial registration number NCT06421402.…”
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Role of C5aR2 in prognosis of patients with acute respiratory distress syndrome through negative modulation of C5a: A prospective observational study by Muhammed Rashid, Sreedharan Nair, Pooja Gopal Poojari, Vijetha Shenoy Belle, Vijayanarayana Kunhikatta, Daniel A. Vaz, Vishal Shanbhag, Viji Pulikkel Chandran, Shravya Chitrapady, Girish Thunga

“…Methods: A total of 64 adult patients diagnosed with ARDS were prospectively recruited to the study over a period of one year after obtaining the informed consent. The serum C5a and C5aR2were determined using ELISA Kit sandwich method. …”
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Exploring the Impact of the Multimodal CAPABLE eHealth Intervention on Health-Related Quality of Life in Patients With Melanoma Undergoing Immune-Checkpoint Inhibition: Prospective... by Itske Fraterman, Lucia Sacchi, Henk Mallo, Valentina Tibollo, Savannah Lucia Catherina Glaser, Stephanie Medlock, Ronald Cornet, Matteo Gabetta, Vitali Hisko, Vadzim Khadakou, Ella Barkan, Laura Del Campo, David Glasspool, Alexandra Kogan, Giordano Lanzola, Roy Leizer, Manuel Ottaviano, Mor Peleg, Konrad Śniatała, Aneta Lisowska, Szymon Wilk, Enea Parimbelli, Silvana Quaglini, Mimma Rizzo, Laura Deborah Locati, Annelies Boekhout, Lonneke V van de Poll-Franse, Sofie Wilgenhof

“…ResultsFrom the 59 eligible patients for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. …”
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Stigma and fear during the COVID-19 pandemic: a qualitative study on the perceptions of healthcare workers in Canada and Singapore by Christine Fahim, Christine Fahim, Chou Chuen Yu, Jeanette Cooper, Suvabna Theivendrampillai, Taehoon (Tom) Lee, Michelle Wai-Ki Lau, Christine Marquez, Bernard Tang, Mathews Mathew, Malika Sharma, Malika Sharma, Eric Wong, Eric Wong, Tracey O'Sullivan, James Alvin Low, James Alvin Low, Sharon E. Straus, Sharon E. Straus

“…Following participant consent, data were recorded, transcribed verbatim, and coded using a framework approach. …”
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Microbiota, parasitic infections and their relationship with nutritional status and neurocognitive functioning in children from Ecuador—Proyecto Guagua: research protocol for a cro... by Sandra Victoria Abril-Ulloa, Tannia Valeria Carpio-Arias, Renata Alejandra Alvarado-Barba, Cristina Gabriela Ríos-Romero, Pamela Vinueza-Veloz, Sueny Paloma Lima-dos-Santos, Sueny Paloma Lima-dos-Santos, Igor Eduardo Astudillo-Skliarova, Igor Eduardo Astudillo-Skliarova, Ruth Irene Arias-Gutiérrez, Manuel Pérez-Quintana, Henk-Jan Boele, Henk-Jan Boele, Henk-Jan Boele, María Fernanda Vinueza-Veloz

“…Following the pilot phase, an addendum and minor changes to the study design were approved in October 2022. Written consent was obtained from parents before enrolling their children in the study. …”
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Assessing the feasibility of measuring residents’ quality of life in English care homes and the construct validity and internal consistency of measures completed by staff proxy: a... by Claire Goodman, Julienne Meyer, Karen Spilsbury, Barbara Hanratty, Rachael Carroll, Adam L Gordon, Gizdem Akdur, Anne Killett, Jennifer Burton, Ann-Marie Towers, Stacey Rand, Nick Smith, Sinead Palmer, Stephen Allan, Lucy Anne Webster

“…All permanent residents, aged 65 years or older, were eligible to participate, including those lacking capacity to consent. Temporary residents and residents in their last weeks of life were excluded.Outcome measures and analysis The English language versions of Adult Social Care Outcomes Toolkit (ASCOT)-Proxy-Resident, ICEpop CAPability measure for Older people (ICECAP-O), EQ-5D-5L proxy and the QUALIDEM were added to the digital record. …”
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Improving community-based first response to out of hospital cardiac arrest (FirstCPR): protocol for a cluster randomised controlled trial by Sandra Ware, Blake Angell, Julie Redfern, Clara Chow, Cate Ferry, Lee Taylor, Christopher Semsarian, Adrian Bauman, Janet E Bray, Simone Marschner, Michael Nelson, Saurabh Kumar, Matthew Vukasovic, Kevin Lai, Paul M Middleton, Pramesh Kovoor, Garry Jennings, Sonali Munot, Andrew Coggins, Alan Robert Denniss, Sarah Khanlari, Ian Opperman

“…It will be assessed through surveys of group members that consent in intervention versus control groups and administered prior to control groups receiving the intervention. …”
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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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