Study protocol for a stepped-wedge implementation study investigating the intersectoral collaboration of implementing the TREAT INTERACT intervention for primary school teachers an... by Ane-Marthe Solheim Skar, Ingunn Marie S. Engebretsen, Nora Braathu, Harriet Aber, Harald Bækkelund, Melf-Jakob Kühl, Marjorie Mukisa, Joyce Sserunjogi Nalugya, Norbert Skokauskas, Vilde Skylstad, Tore Wentzel-Larsen, TREAT research consortium, Juliet Ndimwibo Babirye

“…Trial registration ClinicalTrials, NCT06275672, 28.12.2023, retrospectively registered.…”
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Molecular Mechanisms of Neurodegeneration Related to C9orf72 Hexanucleotide Repeat Expansion by Mirjana Babić Leko, Vera Župunski, Jason Kirincich, Dinko Smilović, Tibor Hortobágyi, Patrick R. Hof, Goran Šimić

“…Although the exact molecular mechanisms through which C9orf72 repeat expansions account for neurodegeneration have not been elucidated, some potential therapeutics, such as antisense oligonucleotides targeting hexanucleotide GGGGCC repeats in mRNA, were successful in preclinical trials and are awaiting phase 1 clinical trials. In this review, we critically discuss each proposed mechanism and provide insight into the most recent studies aiming to elucidate the molecular underpinnings of C9FTD/ALS.…”
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Exploration of the quantitative-effectiveness association between acupuncture temporal parameters and chemotherapy-induced peripheral neuropathy in cancer patients: a dose-response... by Hao Tian, Qin Luo, Liuyang Huang, Liuyang Huang, Liuyang Huang, Guang Chen, Mingsheng Sun, Fanrong Liang

“…Future high-quality studies and large-scale multicenter clinical trials are needed to validate these findings.…”
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Japi 2.0, a gaming platform to stimulate cognitive and non-cognitive skills in early childhood: protocol for a pilot randomized controlled trial by Jorge Gaete, Saray Ramírez, Cristian A. Rojas-Barahona, Valentina Romo, Natalia Ríos, Ricardo Araya

“…Trial registration Clinical Trials NCT06420544, May 20, 2024 [ https://www.clinicaltrials.gov/study/NCT06420544 ].…”
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Treatable traits in idiopathic pulmonary fibrosis: focus on respiratory tract infections—a systematic review and a meta-analysisResearch in context by Zsombor Matics, Anna Bardóczi, Csongor Galkó, Bence Szabó, Noémi Gede, Zsolt Molnár, Gábor Duray, Caner Turan, Péter Hegyi, Gábor Horváth, Veronika Müller

“…Interpretation: RTIs are frequently reported adverse events in IPF patients over a one-year period, with different investigated treatments showing no profound impact compared to placebo. Future clinical trials should focus on targeting treatable traits like RTIs. …”
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Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis by Maurizio Paciaroni, Birsen Ince, Bo Hu, Jiann-Shing Jeng, Kursad Kutluk, Liping Liu, Min Lou, Vladimir Parfenov, Ka Sing Lawrence Wong, Babak Zamani, Dara Paek, Jung Min Han, Michael del Aguila, Shalini Girotra

“…PubMed, Embase, and CENTRAL databases were searched from inception to May 2018 to identify clinical trials and observational studies comparing clopidogrel versus aspirin for secondary prevention in patients with recent ischemic stroke within 12 months. …”
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Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study by João Carlos Rodrigues, Mario Lenza, Laercio Alberto Rosemberg, Durval do Carmo Santos Barros, Mario Ferretti, Alexandre Leme Godoy Santos, Marcelo Pires Prado, José Felipe Marion Alloza, Renato Amaral Masagão, Adham do Amaral e Castro, Marco Kawamura Demange

“…The results will be presented at national and international conferences and published in peer-reviewed journals and social media.Trial registration number ClinicalTrials.gov Registry (NCT04095598; preresults).…”
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Pembrolizumab plus Pemetrexed and Platinum in Metastatic Non-Squamous Non-Small Cell Lung Cancer: A Real-Life Study at a Portuguese Centre by Maria João Santos, Filipa Ferro, Andrea Machado, Ana Sofia Vilariça, Direndra Hasmucrai, Paula Alves

“…With median progression-free survival and overall survival of 6.7 and 12.2 months, respectively, and no new safety signals, these results complement data from clinical trials, providing information from a real-world setting. …”
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Incremental long-term benefit of drug therapies for chronic obstructive pulmonary disease in quality of life but not mortality: a network meta-analysis by Qiong Pan, Jiongzhou Sun, Shiyuan Gao, Zian Liu, Yiwen Huang, Yixin Lian

“…Material and methods This study retrieved randomised clinical trials (RCTs) with follow-up ≥ 48 weeks on long-acting β-agonists (LABAs), long-acting muscarinic receptor antagonists (LAMAs), inhaled corticosteroids (ICSs), and dupilumab in the PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases. …”
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Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol by Nicolas Penel, Dominique Vaur, Juliette Thariat, Alexandre Escande, Jennifer le Guevelou, Colin Debaigt, Esma Saada-Bouzid, Julien Viotti, Nazim Khalladi, David Thibouw, Marie Pierre Sunyach, Laurence Moureau-Zabotto, Mohamed Benchalal, Ovidiu Veresezan, Anne Ducassou, Cecile le Pechoux, Maria Jolnerovski, Celine Bazille, Raphael Serre, Christine Lovera

“…The total number of included patients should be 103.Trial registration The trial is registered on ClinicalTrials.gov (ID: NCT03548428).Ethics and dissemination This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. …”
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Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation – protocol for the randomised trial ‘SDM Lung... by Karina Dahl Steffensen, Signe Timm, Torben Frøstrup Hansen, Thomas Leth Fink, Charlotte Kristiansen, Torben Schjødt Hansen, Rune Slot Thing

“…Results from this study will be presented at scientific meetings and published in English peer-reviewed journals.Trial registration number ClinicalTrials.gov (NCT04940936).…”
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Comparing acceptance of smoking cessation and smoke-free home intervention offers and associated factors among people with low income in the USA: baseline results of a randomised c... by Matthew W Kreuter, Michelle C Kegler, Jennifer Wolff, Amy McQueen, Lauren Grimes, Enguday Teshome, Rachel Garg, Tess Thompson, Kelly Carpenter

“…Future trial results will assess intervention engagement and effects on cessation.Trial registration number ClinicalTrials.gov identifier NCT04311983.…”
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mHealth-based intervention by community workers to support family caregivers of persons with dementia living at home: study protocol for a cluster randomised controlled trial by Pankaj Bhardwaj, Hanne Konradsen, Manoj Kumar Gupta, Abhik Sinha, Nitin Kumar Joshi, Suresh K Sharma, Naresh Nebhinani, Marie Tyrrell, Åsa G Craftman, Zarina Nahar Kabir

“…Additionally, usability and cost analyses will be conducted to evaluate the practicality and economic feasibility of the intervention.The expected outcomes of this study include the creation of a scalable mHealth platform that facilitates remote support, bridges geographical gaps and enhances the well-being of caregivers in India’s evolving healthcare landscape.Ethics and dissemination Ethical approval has been obtained from the Institutional Ethical Committee of AIIMS Jodhpur (AIIMS/IEC/2022/4245).Trial registration number Clinical Trials Registry: CTRI/2022/12/048320.…”
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Depressive symptoms in older adults are associated with changes in stress-related markers, functional connectivity and brain volume by Edelweiss Touron, Robin de Flores, Laurent Coulbault, Cassandre Palix, Anne Chocat, Elizabeth Kuhn, Brigitte Landeau, Florence Mézenge, Daniel Roquet, Léa Chauveau, Sacha Haudry, Denis Vivien, Vincent de La Sayette, Natalie L. Marchant, Gaël Chételat, Géraldine Poisnel, for the Medit-Ageing Research Group

“…Trial registration ClinicalTrials.gov Identifier: NCT02977819, Registration Date: 2016–11-25.…”
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Prevalence and Characterization of Psychological Trauma in Patients with Fibromyalgia: A Cross-Sectional Study by Itxaso Gardoki-Souto, Diego Redolar-Ripoll, Marta Fontana, Bridget Hogg, María José Castro, Josep M. Blanch, Fabiola Ojeda, Aleix Solanes, Joaquim Radua, Alicia Valiente-Gómez, Roser Cirici, Víctor Pérez, Benedikt L. Amann, Ana Moreno-Alcázar

“…Trial registration: ClinicalTrials.gov NCT04476316. Registered on July 20th, 2020.…”
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Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) by Heather M Foran, Marija Raleva, Nina Heinrichs, Graham Moore, Yulia Shenderovich, Xiang Zhao, Judith Simon, Antonio Piolanti, Viorel Babii, Janina Mueller, Franziska Waller, Dennis Wienand, Swetha Sampathkumar, Ivo Kunovski

“…Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.Trial registration details Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.html…”
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Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic... by Michael Schmoeckel, Matthias Thielmann, Keti Vitanova, Thomas Eberle, Nandor Marczin, Kambiz Hassan, Andreas Liebold, Sandra Lindstedt, Georg Mächler, Marijana Matejic-Spasic, Daniel Wendt, Efthymios N. Deliargyris, Robert F. Storey

“…Clinical registration number ClinicalTrials.gov identifier: NCT05077124.…”
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Differences in catheter-related complications to insertion site selection for long peripheral intravenous catheters in antimicrobial therapy: a randomized controlled trial by Linfang Zhao, Xianghong Jin, Xiangyun Li, Chang Liu, Jie Wang, Xiuzhu Cao, Xufen Zeng, Yiyu Zhuang

“…Trial registration ClinicalTrials.gov identifier: NCT06455228 (Initial Release: 05/30/2024).…”
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Sacubitril/Valsartan for Blood Pressure Lowering in Non‐Dialysis‐Dependent Chronic Kidney Disease Stage 3–5 Patients With Hypertension: A Multicenter Clinical Study by Yu Yan, Xiaomin Li, Juan Cao, Jingyuan Cao, Yao Wang, Liang Wang, Jirong Yu, Lianhua Chen, Min Yang, Xinzhong Huang, Lei Shen, Hong Ding, Manzhi Li, Di Yin, Linglin Jiang, Liang Tang, Yujia Jiang, Ling Hu, Jiyi Si, Hui Zhang, Liqin Cui, Xiameng Gu, Kun Hu, Dongxing Mu, Bicheng Liu, Xiaoliang Zhang, Dong Sun, Xin Wan, Bin Wang

“…Trial Registration: ClinicalTrials.gov identifier: ChiCTR2400086079…”
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Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial by Kaori Ito, Kazuhiko Sekine, Hiroaki Iijima, Yutaka Kondo, Takashi Tagami, Mineji Hayakawa, Daisuke Kudo, Takayuki Ogura, Tetsuya Yumoto, Akira Endo, Yosuke Matsumura, Shigeki Kushimoto

“…The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.Trial registration number UMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018.…”
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