Association of overweight/obesity and insulin resistance with activation of circulating innate lymphoid cells in women after gestational diabetes mellitus by Julia Sbierski-Kind, Julia Sbierski-Kind, Julia Sbierski-Kind, Julia Sbierski-Kind, Stephan Schlickeiser, Stephan Schlickeiser, Lorenzo Semeia, Lorenzo Semeia, Saori Harada, Saori Harada, Eleni Pappa, Eleni Pappa, Javier Villamizar Cujar, Minh-Thuy Katschke, Minh-Thuy Katschke, Christina Gar, Andreas Lechner, Andreas L. Birkenfeld, Andreas L. Birkenfeld, Andreas L. Birkenfeld, Uta Ferrari, Uta Ferrari, Jochen Seissler, Jochen Seissler

“…IntroductionWomen with a history of gestational diabetes mellitus (GDM) are at high risk of developing prediabetes or type 2 diabetes later in life. …”
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Maternal B-vitamin and vitamin D status before, during, and after pregnancy and the influence of supplementation preconception and during pregnancy: Prespecified secondary analysis... by Keith M Godfrey, Philip Titcombe, Sarah El-Heis, Benjamin B Albert, Elizabeth Huiwen Tham, Sheila J Barton, Timothy Kenealy, Mary Foong-Fong Chong, Heidi Nield, Yap Seng Chong, Shiao-Yng Chan, Wayne S Cutfield, NiPPeR Study Group

“…In the control group, 54.2% of participants developed low late-pregnancy vitamin B6 concentrations (pyridoxal 5-phosphate <20 nmol/L). …”
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The first generic tirzepatide GP30931: physicochemical and biological similarity to the reference drug by I. A. Lugovik, A. V. Babina, S. S. Arutyunyan, D. О. Ermolaeva, V. B. Saparova, T. N. Kobeleva, P. G. Zaikin, A. D. Mikushina, A. S. Bukatin, I. E. Eliseev, B. Ts. Zajchik, Y. S. Keruchenko, I. S. Ohrimenko, E. V. Bocharov, A. Kh. Taldaev, V. A. Lushpa, I. E. Makarenko, R. V. Drai

“…The obtained data make a significant contribution to the scientific substantiation of the equivalence of the reproduced drug tirzepatide and the reference original drug, thereby providing a reliable basis for further registration and clinical use of Sejaro® without conducting additional clinical studies.…”
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Exploring the factors that influence engagement with and experiences of integrated care for adults at risk of cardiovascular disease and mild-to-moderate mental health concerns in... by Alison R. McKinlay, Neil Howlett, Vivi Antonopoulou, Fabiana Lorencatto, Laura J. McGowan, David Osborn, Amy O’Donnell, Emily J. Oliver, Ivo Vlaev, Falko F. Sniehotta, Michael P. Kelly, Susan Michie, Caroline Kemp, Yannis Pappas, Gurch Randhawa, Nasreen Ali, Emily Munro, Angel M Chater

“…Systematic review registration: PROSPERO (CRD42024554282.…”
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Catalonia Suicide Risk Code Epidemiology (CSRC-Epi) study: protocol for a population-representative nested case–control study of suicide attempts in Catalonia, Spain by Lars Mehlum, Ronald C Kessler, Rosa Morros, Gemma Vilagut, Jordi Alonso, Philippe Mortier, Beatriz Puértolas Gracia, Ana De Inés Trujillo, Itxaso Alayo Bueno, Laura Ballester Coma, María Jesús Blasco Cubedo, Narcís Cardoner, Cristina Colls, Matilde Elices, Anna Garcia-Altes, Manel Gené Badia, Javier Gómez Sánchez, Mario Martín Sánchez, Bibiana Prat Pubill, Ping Qin, Diego Palao, Víctor Pérez Sola

“…Dissemination will include peer-reviewed scientific publications, scientific reports for hospital and government authorities, and updated clinical guidelines.Trial registration number NCT04235127.…”
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The anti-circumsporozoite antibody response to repeated, seasonal booster doses of the malaria vaccine RTS,S/AS01E by M. Sanni Ali, Lisa Stockdale, Issaka Sagara, Issaka Zongo, Rakiswendé Serge Yerbanga, Almahamoudou Mahamar, Frédéric Nikièma, Amadou Tapily, Frédéric Sompougdou, Modibo Diarra, Duncan Bellamy, Samuel Provstgaard-Morys, Charles Zoungrana, Djibrilla Issiaka, Alassane Haro, Koualy Sanogo, Abdoul Aziz Sienou, Mahamadou Kaya, Seydou Traore, Oumar M. Dicko, Youssouf Kone, Hama Yalcouye, Ismaila Thera, Kalifa Diarra, Paul Snell, Opokua Ofori-Anyinam, Chris Ockenhouse, Cynthia Lee, Katie Ewer, Halidou Tinto, Abdoulaye Djimde, Jean-Bosco Ouedraogo, Alassane Dicko, Daniel Chandramohan, Brian Greenwood

“…Anti-CSP antibody titres were measured in sera obtained from a randomly selected subset of children enrolled in this trial collected before and one month after three priming and four annual booster doses of vaccine using the GSK ELISA developed at the University of Ghent and, in a subset of these samples, by a multiplex assay developed at the University of Oxford. …”
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Low-added sugar dietary intervention study to mitigate glucose intolerance and improve body composition in adults with cystic fibrosis: a protocol of a double-blind, randomised stu... by Priyathama Vellanki, Kirk Easley, Terryl J Hartman, Thomas R Ziegler, Puneet Sharma, Swati Zaveri, Arlene Stecenko, William R Hunt, Amy Goss, Joshua D Chandler, Tasha M Burley, Chris Driggers, Amy Ciccarella, Heather Zhou, Kristen Narlow, Tanicia Daley, Jessica Alvarez

“…Introduction People with cystic fibrosis (PwCF) are at high risk for developing cystic fibrosis (CF)-related diabetes (CFRD), which worsens morbidity and mortality. …”
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Effects of sedatives on diaphragm activity monitored by ultrasound: a systematic review and meta-analysis by Jiaren Luo, Luhao Wang, Bilin Wei, Zhikun Huang, Huifang Zheng, Bin Gu, Fei Pei, Zenan Chang, Yang Liu, Xiangdong Guan, Xuyu Zhang, Zimeng Liu

“…The strength of evidence was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) Pro Guideline Development Tool (GDT). …”
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Effects of nutritional intervention strategies in the primary prevention of overweight and obesity in school settings: systematic review and network meta-analysis by Joerg J Meerpohl, Lukas Schwingshackl, Guido Schwarzer, Jürgen M Steinacker, Edris Nury, Blin Nagavci, Georg Hoffmann, Jakub Morze, Janine Wendt, Julia Stadelmaier, Kathrin Grummich, Claudia M Angele, Johanna Conrad, Daniela Schmid

“…The results of the network meta-analysis could be used by policy makers in developing and implementing effective, evidence based nutritional intervention strategies in the school setting.Systematic review registration PROSPERO CRD42020220451.…”
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Patient and surgeon perspectives of a large-scale system for automated, real-time monitoring and feedback of shared decision-making integrated into surgical practice: a qualitative... by Leila Rooshenas, Jane M Blazeby, Andrew Smith, Angus G K McNair, Andrew Judge, Michael R Whitehouse, Christie Cabral, Jessica Preshaw, Barnaby Reeves, Shelley Potter, Kerry N L Avery, Philip Braude, Adam Williams, Ben Gibbison, Hilary L Bekker, Rhiannon C Macefield, Christin Hoffmann, Val Snelgrove, Della Hopkins, Shireen Hickey, Archana Lingampalli, Paul Cresswell, Timothy Beckitt, Timothy Whittlestone, Jon Aning

“…Findings will be used to guide refinement and implementation of SDM monitoring and feedback prior to formal development, evaluation and implementation of an SDM intervention in the NHS.Trial registration number ISRCTN17951423.The original protocol doi: 10.1136/bmjopen-2023-079155.…”
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Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized... by Ana Clara da C. Pinaffi-Langley, Camila B. Pinto, Zsofia Szarvas, Anna Peterfi, Zalan Kaposzta, Peter Mukli, Mihaly Muranyi, Cameron D. Owens, Cheryl Adams, Ali Shahriari, Henry Kinnard, Jr., Bryan Ticer, Leah Anderson, Stefano Tarantini, Yan Daniel Zhao, Norman G. Hord, Andriy Yabluchanskiy

“…Summary: Background &amp; Aims: Obesity-related mitochondrial dysfunction initiates and exacerbates endothelial dysfunction, which in turn contributes to the development of several diseases, such as cardiovascular disease and cognitive impairment. …”
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Acute pain pathways: protocol for a prospective cohort study by Christine Lee, Joseph S Ross, Molly Moore Jeffery, Nilay D Shah, David B Page, Nancy Chang, Fernanda Bellolio, Sam Torbati, Jessica D Ritchie, Gregg H Gilbert, Lindsay Emanuel, Mitra Ahadpour, Summer Allen, Richardae Araojo, Laura Ciaccio, Jonathan Fillmore, Patricia Koussis, Heather Lipkind, Celeste Mallama, Tamra Meyer, Megan Moncur, Teryl Nuckols, Michael A Pacanowski, Elektra Papadopoulos, Mat Soukup, Christopher O St. Clair, Stephen Tamang, Douglas W Wallace, Yueqin Zhao, Rebekah Heckmann

“…Results will be made available to participants, funders, the research community and the public.Trial registration number NCT04509115.…”
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Influence of social determinants on lifestyle modification adherence in people with prediabetes: a sequential explanatory mixed-methods study protocol by Ana Carvalho-Azevedo, Ana Carvalho-Azevedo, Ana Carvalho-Azevedo, Manuela Abbate, Manuela Abbate, Manuela Abbate, Sergio Fresneda, Sergio Fresneda, Sergio Fresneda, María Arias-Fernández, María Arias-Fernández, María Arias-Fernández, Marina Torres-Carballo, Marina Torres-Carballo, Aina M. Yañez, Aina M. Yañez, Aina M. Yañez, Aina M. Yañez, Aina M. Yañez, Cristina Moreno-Mulet, Cristina Moreno-Mulet, Cristina Moreno-Mulet, Miquel Bennasar-Veny, Miquel Bennasar-Veny, Miquel Bennasar-Veny, Miquel Bennasar-Veny, Miquel Bennasar-Veny

“…Our study can guide the development of health interventions tailored to individuals with prediabetes, focusing on addressing social disparities in lifestyle modification.Patient or public contributionParticipants will contribute through semi-structured interviews and discussion groups, providing insights into their experiences on adherence to lifestyle changes.Clinical trial registrationClinicalTrials.gov, identifier NCT06488677.…”
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Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics by Michael Kreuter, Fabian N Fries, Titus J Brinker, Ute Mons, David A Groneberg, Anil Batra, Werner Seeger, Felix Herth, Julia Holzapfel, Tanja G Baudson, Katharina Sies, Lena Jakob, Hannah Maria Baumert, Marlene Heckl, Ana Cirac, Janina L Suhre, Verena Mathes, Hannah Spielmann, Nancy Rigotti, Tobias Raupach, Henning Gall, Claudia Bauer, Pat Marek, Chase H Harrison, Lava Taha, Andreas Owczarek, Felix J Hofmann, Roger Thomas

“…We took advantage of the widespread availability of mobile phones and adolescents’ interest in appearance to develop a free photoaging app which is promoted via a poster campaign in secondary schools. …”
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Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study by Andrew Ng, Esther W Chan, Duo Huang, Cheung Chi Lam, Ning Tan, Chung Wah Siu, Jo Jo Hai, Ji-yan Chen, Chun Ka Wong, Mi Zhou, Yuk Ming LAU, Chor Cheung Frankie Tam, Yiu Tung Anthony Wong, See Yue Arthur Yung, Ki Wan Kelvin Chan, Yingqing Feng, Chi Yui Yung, Kwok Lun Lee, Chun Wai Choi, Ho Lam, Katherine Fan, Man Hong Jim, Kai Hang Yiu, Bryan P. Yan

“…Results will be published in peer-reviewed journals.Trial registration number ClinicalTrials.gov Registry (NCT04045093); pre-results.…”
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Machine learning for the rElapse risk eValuation in acute biliary pancreatitis: The deep learning MINERVA study protocol by Mauro Podda, Adolfo Pisanu, Gianluca Pellino, Adriano De Simone, Lucio Selvaggi, Valentina Murzi, Eleonora Locci, Matteo Rottoli, Giacomo Calini, Stefano Cardelli, Fausto Catena, Carlo Vallicelli, Raffaele Bova, Gabriele Vigutto, Fabrizio D’Acapito, Giorgio Ercolani, Leonardo Solaini, Alan Biloslavo, Paola Germani, Camilla Colutta, Savino Occhionorelli, Domenico Lacavalla, Maria Grazia Sibilla, Stefano Olmi, Matteo Uccelli, Alberto Oldani, Alessio Giordano, Tommaso Guagni, Davina Perini, Francesco Pata, Bruno Nardo, Daniele Paglione, Giusi Franco, Matteo Donadon, Marcello Di Martino, Dario Bruzzese, Daniela Pacella

“…The MINERVA study aims to develop and validate a machine learning (ML) model to predict the risk of RAP (at 30, 60, 90 days, and at 1-year) in MABP patients, enhancing decision-making processes. …”
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Mechanism-based modular psychotherapy versus cognitive behavioural therapy for adolescents and young adults with childhood trauma experiences: study protocol for a feasibility tria... by Till Bärnighausen, Hanna Zimmermann, Christian Schmahl, Stephanie Bauer, Beate Ditzen, Hans-Christoph Friederich, Markus W Haun, Astrid Berner-Rodoreda, Elisabeth Schramm, Svenja Taubner, Corina Aguilar-Raab, Sabine C Herpertz, Manuel Feisst, Frank Enning, Katja I Seitz, Niklas Schouler, Jan Hundertmark, Maximilian Wilhelm, Svea Franz, Christoph W Korn, Ruben Vonderlin, Eva Vonderlin, Josef Bailer, Elias Bopp, Sophia von Stockert, Laura Tabea Kristalis, Claudia Calvano

“…Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.Trial registration number German Clinical Trials Register DRKS00034058.…”
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Study protocol for the BRAIN Training Trial: a randomised controlled trial of Balance, Resistance, And INterval training on cognitive function in older adults with mild cognitive i... by Teresa Liu-Ambrose, Ulrik Wisløff, Maria Fiatarone Singh, Yorgi Mavros, Perminder S Sachdev, Ryan S Falck, Dorthe Stensvold, Jeff S Coombes, Trinidad Valenzuela, Nicole Kochan, Wei Wen, Jeffrey Hausdorff, Jiyang Jiang, Emily C Smith, Matthew Hollings, Tess C Hawkins, Nicholas J Ashley, Natan Feter, Guy C Wilson, Isabel Hui En Shih, Yareni Guerrero, Tom Bailey

“…Dissemination will be via publications, conference presentations, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.It is expected that communication of results will allow for the development of more effective evidence-based exercise prescription guidelines in this population while investigating the benefits of HIIT and POWER on subclinical markers of disease.Trial registration number ACTRN12617001440314 Australian New Zealand Clinical Trials Registry.…”
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Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study by Howard L McLeod, A Dimitrios Colevas, Georges Azzi, Kevin C Flanagan, Douglas Adkins, Jessica Ley, Ezra E W Cohen, James Wade, Jon Earls, Jeffrey Hiken, Rachel L Wellinghoff, Michelle M Ponder, William H Westra, Vera Vavinskaya, Leisa Sutton, Ida Deichaite, Orlan K Macdonald, Karim Welaya, Andrew W Pippas, Jennifer Slim, Bruce Bank, Xingwei Sui, Steven E Kossman, Todd D Shenkenberg, Warren L Alexander, Katharine A Price, David N Messina, Jarret I Glasscock, Eric J Duncavage

“…Background Despite advances in cancer care and detection, &gt;65% of patients with squamous cell cancer of the head and neck (HNSCC) will develop recurrent and/or metastatic disease. The prognosis for these patients is poor with a 5-year overall survival of 39%. …”
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A Phase IB Trial of Selinexor in Combination With Immune Checkpoint Blockade in Patients With Advanced Renal Cell Carcinoma by Omar Alhalabi, Mohamed A. Gouda, Denái R. Milton, Hassan Ahmed Momin, Bulent Yilmaz, Bettzy Stephen, Chinenye Lynette Ejezie, Justin Tyler Moyers, Serdar A. Gurses, Jeffrey How, Siqing Fu, Jordi Rodon, David S. Hong, Sarina A. Piha‐Paul, Vivek Subbiah, Ecaterina Elena Dumbrava, Daniel D. Karp, Filip Janku, Funda Meric‐Bernstam, Nizar M. Tannir, Aung Naing

“…All patients (100%) developed at least one treatment‐emergent adverse event, and 93% had a treatment‐related adverse event (TRAE). …”
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