Effects of a physical activity-enhanced curriculum on increasing physical activity and improving physical fitness in preschoolers: Study protocol for a cluster randomized controlle... by Whitney W. Au, Chit K. Leung, Shine H. Lin, Angus P. Yu, Daniel Y. Fong, Stephen H.S. Wong, Derwin K.C. Chan, Catherine M. Capio, Clare C.W. Yu, Sam W.S. Wong, Ya-Jun Chen, Walter R. Thompson, Parco M. Siu

“…Objective: Physical activity (PA) is critical for healthy development in preschoolers, with long-lasting benefits that can affect later life. …”
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A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Ps... by Burhan Engin, Müge Güler Özden, Özge Sevil Karstarlı Bakay, Selda Pelin Kartal, İlkin Zindancı, Salih Levent Çınar, Recep Dursun, Gizem Pehlivan Ulutaş, Tuğba Özkök Özkök Akbulut, Fatma Aslı Hapa, Emel Bülbül Başkan, Mehmet Melikoğlu, Algün Polat Ekinci, Neslihan Demirel Öğüt, Pelin Hızlı, Zafer Türkoğlu, Özlem Su Küçük, Zeynep Topkarcı, Ümit Türsen, Filiz Canpolat, Hanife Uçgun, Şirin Yaşar, Selami Aykut Temiz, Asena Çiğdem Doğramacı, Sedat Altuğ, Serhat Kozlu, Nadir Ulu, Server Serdaroğlu

“…A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit–risk ratio. …”
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Long-term safety and effectiveness of roxadustat in Chinese patients with chronic kidney disease-associated anemia: The ROXSTAR registry by Xiaoying Du, Yaomin Wang, Haifeng Yu, Jurong Yang, Weiming He, Zunsong Wang, Dongwen Zheng, Xiaowei Li, Shuijuan Shen, Dong Sun, Weimin Yu, Detian Li, Changyun Qian, Yiqing Wu, Shuting Pan, Jianghua Chen, Sihan Zhou

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Concordance and agreement between different activity scores in polymyalgia rheumatica by Bruno Fautrel, Eric Toussirot, Renaud Felten, Emmanuel Nowak, Christophe Richez, Jacques-Eric Gottenberg, Isabelle Chary-Valckenaere, Alain Saraux, Aleth Perdriger, Emanuelle Dernis, Thierry Marhadour, Marie-Elise Truchetet, Divi Cornec, Valérie Devauchelle-Pensec, Daniel Wendling, Guillaume Direz, Anne Lohse, Laurent Chiche, PASCAL HILLIQUIN, Guillermo Carvajal Alegria, Dewi Guellec, Justine D'Agostino, Aghiles Souki, Catherine Le Henaff, Benjamin Dervieux

“…Objective The C reactive protein polymyalgia rheumatica activity score (CRP-PMR-AS) is a composite index that includes CRP levels and was developed specifically for PMR. As treatments such as interleukin-6 antagonists can normalise CRP levels, the erythrocyte sedimentation rate (ESR) of PMR-AS, the clinical (clin)-PMR-AS and the imputed-CRP (imp-CRP)-PMR-AS have been developed to avoid such bias. …”
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Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: protocol for a pilot fractional factorial trial by Samuel G Smith, David P French, Galina Velikova, Amanda Farrin, Robbie Foy, Nikki Rousseau, Daniel Howdon, Jane Clark, Michelle Collinson, Christopher D Graham, Rebecca Walwyn, Emma McNaught, Ellen Mason, Sophie M C Green, Rachel Ellison, Louise H Hall, Hollie Wilkes, Erin Raine, Jacqueline Buxton, Sally J L Moore, Catherine Parbutt

“…The results of this trial will be disseminated in a peer-reviewed journal.Trial registration number ISRTCN10487576.…”
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Neoantigen-specific stimulation of tumor-infiltrating lymphocytes enables effective TCR isolation and expansion while preserving stem-like memory phenotypes by Yong Li, Steven A Rosenberg, Paul F Robbins, Zhiya Yu, Maria Parkhurst, Billel Gasmi, Nikolaos Zacharakis, Todd D Prickett, Jared J Gartner, Sri Krishna, Stephanie L Goff, Satyajit Ray, Frank J Lowery, Sivasish Sindiri, Alakesh Bera, Noam Levin, Sanghyun P Kim, Charles A Marquardt, Nolan R Vale, Lior Levy, Tiffany Benzine, Robert V Masi, Rafiqul Islam

“…Our data warrant its clinical evaluation.Trial registration number NCT00068003, NCT01174121, and NCT03412877.…”
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Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON‐HF Trial by Henri Lu, Brian L. Claggett, Masatoshi Minamisawa, John W. Ostrominski, Alberto Foà, Maria A. Pabón, Arzu Kalayci, Muthiah Vaduganathan, Maja Cikes, Amil M. Shah, Akshay S. Desai, John J. V. McMurray, Pardeep S. Jhund, Milton Packer, Martin Lefkowitz, Jean L. Rouleau, Michael R. Zile, Faiez Zannad, Sheila M. Hegde, Scott D. Solomon, Hicham Skali

“…Among the remaining 3675 patients, 1405 (38.2%) developed at least 1 abnormal score over a median follow‐up of 2.9 years. …”
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Is grip strength linked to body composition and cardiovascular risk markers in primary schoolchildren? Cross-sectional data from three African countries by Juerg Utzinger, Nicole Probst-Hensch, Honorati Masanja, Uwe Pühse, Bassirou Bonfoh, Ivan Müller, Cheryl Walter, Rosa Du Randt, Stefanie Gall, Siphesihle Nqweniso, Peter Steinmann, Markus Gerber, Fredros O Okumu, Serge Ayekoé, Jean T Coulibaly, Dao Daouda, Bomey Clément Gba, Benal Kouassi, Sylvain G Traoré, Marceline F Finda, Elihaika G Minja, Getrud J Mollel, Johanna Beckmann, Christin Lang, Kurt Z Long

“…There is a great need for further studies to examine whether our findings can be replicated, to develop reference values for African children, to establish links to other health outcomes, and to explore whether HGS is associated with later development of cardiovascular risk markers.Trial registration number ISRCTN29534081.…”
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Psychotherapies for adults with complex presentations of PTSD: a clinical guideline and five systematic reviews with meta-analyses by Ole Jakob Storebø, Sophie Juul, Stephen Fitzgerald Austin, Maria Quistgaard, Julie Perrine Schaug, Lise Møller, Nina Reinholt, Dyveke Bové Illum, Frida Lau Græbe, Line Bang Mikkelsen, Nina Nørrelykke Paulsen, Adrian Maria Tremel Porsing, Oliver Rumle Hovmand, Mie Sedoc Jørgensen, Ida-Marie Terese Pereira Arendt, Magnus Tang Kristensen, Sidsel Christine Buskbjerg Døssing, Bent Rosenbaum, Nicole Gremaud Rosenberg, Sidse Marie Arnfred

“…Objective To develop a clinician-guided, research-based guideline for adult outpatient psychotherapy for complex presentations of post-traumatic stress disorder (PTSD).Methods We used state-of-the-art methods to develop clinical guideline recommendations and conduct systematic reviews with meta-analyses for five research questions: (Q1) When treating adults with PTSD, should trauma-focused psychotherapy include exposure? …”
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Towards a national registry for Alzheimer’s disease and related dementias: rationale, design, and initial observations of the ABOARD cohort by Casper de Boer, Hanneke F. M. Rhodius-Meester, Sophie M. van der Landen, Jurgen Claassen, Romy de Haan, Janne M. Papma, Harro Seelaar, Marleen Kloppenburg-Lagendijk, Barbara van Munster, Marjolein de Vugt, Derk Arts, Marco Blom, Tanja J. de Rijke, Miriam Beusink, Robbert Huijsman, Evert-Ben van Veen, Argonde van Harten, Jort Vijverberg, Marissa Zwan, Henk-Jan Mutsaerts, Sven J. van der Lee, Wiesje M. van der Flier

“…Abstract Background Alzheimer’s disease and related dementias (ADRD) take 20 to 30 years to develop, yet setting up studies or registries that take into account the entire disease trajectory is difficult and time consuming. …”
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Early versus delayed enteral nutrition in critically ill children under 12 years of age: A systematic review and meta-analysis of randomised controlled trials by Marianne E. Visser, Roselyn Chipojola, Sarah Gordon, Amanda Brand, Nyanyiwe Mbeye, Gertrude Kunje, Talitha Mpando, Suzgika Lakudzala, Elodie Besnier, Celeste E. Naude

“…Guided by Cochrane methods, we conducted random-effects meta-analyses to obtain pooled effect estimates for outcomes selected by the guideline development group, assessed risk of bias using Cochrane's Risk-of-Bias-2 tool and assessed certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). …”
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‘Making Moves’: Protocol for a hybrid effectiveness-implementation pre-post trial of a co-designed online physical activity program for childhood cancer survivors by Lauren Ha, Claire E. Wakefield, Jacqueline Jacovou, Karen Johnston, Donna Drew, Mark W. Donoghoe, David Mizrahi, Richard De Abreu Lourenco, Richard J. Cohn, Natalie Taylor, Christina Signorelli, Kiarn Roughley, Callum Joyner, Aj Wright

“…Background: Childhood cancer survivors are at increased risk of developing chronic health conditions, including cardiovascular disease. …”
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School-level prediction and management of myopia in children and adolescents by Shengsong Xu, Linling Li, Yingting Zhu, Zhenbang Ruan, Yiwen Qu, Zhuandi Zhou, Yin Hu, Zhidong Li, Fei Hou, Xiaohua Zhuo, Yunxia Leng, Xuelin Huang, Yamei Lu, Zhirong Wang, Shuifeng Deng, Yehong Zhuo, Guoming Zhang, Min Fu, Xiao Yang

“…Trial registration chictr.org Identifier: ChiCTR2200057391.…”
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Swarm learning network for privacy-preserving and collaborative deep learning assisted diagnosis of fracture: a multi-center diagnostic study by Yi Xie, Yi Xie, Xinmeng Wang, Huiwen Yang, Huiwen Yang, Jiayao Zhang, Honglin Wang, Zineng Yan, Jiaming Yang, Zhiyuan Yan, Zhiwei Hao, Pengran Liu, Yijie Kuang, Zhewei Ye, Zhewei Ye

“…However, no prior studies have specifically developed distributed learning models for fracture recognition due to challenges in multi-institutional data harmonization. …”
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Impact of digital health management on clinical outcomes during post-PCI outpatient care in patients with acute coronary syndrome: study protocol for a multicentre, randomized cont... by Hang Yu, Wei Zhang, Wei Zhang, Guoliang Li, Tao Chen, Shaonong Dang, Xiaofeng Ma, XiaoWei Zhang, Xiaofeng Ma, Zhibin Hong, Pengyi He, Xiaohui Xu, Xiuying Chen, Yanyan Geng, Xinjun Lei, Xinjun Lei

“…IntroductionCoronary heart disease is becoming more common in developing nations. Acute coronary syndrome (ACS) poses a major challenge to global health; however, access to cardiac rehabilitation and preventative measures is limited. …”
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Clinical evaluation of adults undergoing elective surgery utilizing intraoperative incisional wound irrigation (CLEAN Wound): protocol for a randomised controlled trial by Nick Daneman, Dean A Fergusson, David Gomez, Ahmed Kayssi, Erin Lillie, Stephanie A Mason, Jad Abou Khalil, Avery B Nathens, Megan Delisle, Kelly Vogt, David E Smith, John C Marshall, George Tomlinson, Grace Ma, Sameer S Apte, Sean Bennett, Andrew J Smith, Paul Jack Karanicolas, Rachel Roke, Melanie Tsang, Pablo E. Serrano, Karim Shiraz Ladha, Erin Kennedy, Yidi Jiang, Jonah Shiroky, Sudarshani Puran, Brian Pinchuk, Tyler Lamb, Kenneth Leslie, Dorotea Mutabdzic, Shahnoor M Ullah, Jessica Holland, Michael Calderone, Judith Herriott, Ed Voltan, Barbara Sloan, Hala Muaddi, C. David Mazer, Mary-Anne Aarts

“…Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov.Trial registration number The study is registered with http://clinicaltrial.gov (NCT04548661; 14 September 2020).…”
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Sensitivity, specificity, and diagnostic accuracy of WHO 2013 criteria for diagnosis of gestational diabetes mellitus in low risk early pregnancies: international, prospective, mul... by Irene Hoesli, Anne Richter, Christian S Göbl, Peter Husslein, Bettina Winzeler, Mirjam Kunze, Monya Todesco Bernasconi, Evelyn A Huhn, Thorsten Fischer, Martina Kreft, Deborah R Vogt, Eva Dölzlmüller, Heidi Jaksch-Bogensperger, Sandra Heldstab, Wolfgang Eppel, Nicole Ochsenbein Kölble, Elke Bäz

“…Results from randomised controlled trials showing a beneficial effect of early intervention are unclear.Trial registration ClinicalTrials.gov NCT02035059.…”
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Oral–gut microbiome axis in a Korean cohort with inflammatory bowel disease and ankylosing spondylitis (INTEGRATE): a prospective and observational study protocol by June-Young Lee, Tae-Hwan Kim, Sungsin Jo, Yeon-Ah Lee, Sang Won Lee, Chang Kyun Lee, Bora Nam, Soo-Kyung Park, Hyun Sik Kim, Bo-Hyung Kim, Shin Ju Oh, Jae-Yun Lee, Dong Il Park

“…Recent research has highlighted the importance of the gut microbiota in the pathogenesis of these diseases, suggesting that shared microbial dysbiosis may contribute to their development. Comprehensive research focusing on the gut and oral microbial characteristics and environmental factors is essential to elucidate the fundamental pathophysiology and develop personalised management strategies for IBD and AS. …”
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Robust COVID-19 Vaccine Responses Despite Filarial Co-Infection: Insights from a Lymphatic Filariasis Cohort in Ghana by Julia Meyer, Jennifer Nadal, Linda Batsa Debrah, Alexander Yaw Debrah, Jubin Osei-Mensah, Derrick Adu Mensah, Patricia Jebett Korir, Janina M. Kuehlwein, Ute Klarmann-Schulz, Achim Hoerauf, Tomabu Adjobimey

“…All vaccinated participants received the COVID-19 vaccine ChAdOx1-S (also known as Vaxzevria) developed by the University of Oxford and AstraZenca. …”
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Lymphatic mapping Of Oropharyngeal Cancer (LOOC): protocol for a phase II surgical imaging trial to evaluate contralateral drainage and occult metastasis in oropharyngeal cancer by David Walker, Gareth Ambler, Chris Brew-Graves, Jason Fleming, Vinidh Paleri, Richard Shaw, Mark McGurk, Enyi Ofo, Clare Schilling, Karl Payne, Simon Wan, Alex Weller, Gopinath Gnanasegaran, Mandeep Bajwa

“…An imaging substudy (n=20) aims to develop a secondary imaging protocol in the event of <94% sensitivity of intraoperative fhSPECT. …”
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