Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled tria... by Jonatan R Ruiz, Federico Garcia, Idoia Labayen, Rocio Cupeiro, Alba Camacho-Cardenosa, Antonio Clavero-Jimeno, Juan J Martin-Olmedo, Francisco Amaro-Gahete, María Trinidad González Cejudo, Patricia Virginia García Pérez, Carlos Hernández-Martínez, Raquel Sevilla-Lorente, Alejandro De-la-O, Alejandro López-Vázquez, Marcos Molina-Fernandez, Almudena Carneiro-Barrera, Alba Rodríguez-Nogales, Julio Juan Gálvez Peralta, Rafael Cabeza, José L Martín-Rodríguez, Araceli Muñoz-Garach, Manuel Muñoz-Torres

“…The findings will be disseminated in scientific journals and at international scientific conferences.Trial registration number NCT05897073.…”
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Efficacy of Chinese Medicine on Postoperative Rehabilitation of Non-small Cell Lung Cancer (NSCLC), a Randomized Controlled Study by Yifeng Gu MD, Yichao Wang MD, Huiling Zhou MD, Ao Qi PhD, Guanjin Wu MM, Jiaqi Li MMed, Congmeng Zhang MMed, Yong Yang MD, Jialin Yao MD, Wenxiao Yang PhD, Lingzi Su MMed, Yi Liu MMed, Xueqi Tian MMed, Jiajun Song MMed, Yabin Gong MD, Xiong Qin MD, Lijing Jiao PhD, Ling Xu PhD

“…Methods: A randomized, parallel-group clinical trial assigned 50 patients to receive Chinese herbal medicine and Liuzijue exercise plus symptomatic treatment, and 49 to symptomatic treatment alone. …”
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Midodrine for the early liberation from vasopressor support in the ICU (LIBERATE): a feasibility study by Sebastian J. Kilcommons, Fadi Hammal, Dawn L. Opgenorth, Kirsten M. Fiest, Constantine J. Karvellas, Vincent I. Lau, Erika MacIntyre, Janek Senaratne, Jocelyn Slemko, Wendy Sligl, Fernando Zampieri, D.’Arcy Duquette, Lily T. Guan, Nadia Baig, Sean M. Bagshaw, Oleksa G. Rewa

“…Methods We conducted a single-center, concealed-allocation, parallel-group, blinded feasibility randomized controlled trial (RCT) evaluating the effect of oral midodrine versus placebo on IV vasopressor-dependent shock in the intensive care unit (ICU). …”
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impHFrEF trial: study protocol for an open-label, multicentre study of improvement the outcome of patients with heart failure in China using a mobile hEalth-supported platForm by Xinxin Zhang, Fangfang Wang, Bing Xu, Qin Shen, Junhong Wang, Xiaoyu Dong, Yu Zou, Fuzhong Chen, Guangjuan Li, Wensen Chen

“…We will ensure that the dissemination of study results is accurate, clear and timely.Trial registration number ChiCTR2200056527.…”
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Milk free of A1 β-casein supports superior gains in cognition and quality of life, relative to conventional milk, in older adults with mild cognitive impairment by Keming Zhang, Jianqin Sun, Mingming Han, Yingfei Diao, Yan Xia, Congqing Yang, Stephen R. Robinson

“…Design: A multi-centre, double-blind, randomised controlled trial with two parallel arms, conducted from 7 March 2023 to 13 October 2023. …”
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Effect of a ketogenic diet, time-restricted eating, or alternate-day fasting on weight loss in adults with obesity: a randomized clinical trial by José Ignacio Martínez-Montoro, Borja Bandera, Mario Gutiérrez-Bedmar, Ana María Gómez-Pérez, Manuel Macías-González, Isabel Moreno-Indias, Francisco J. Tinahones

“…Methods Three-month, parallel-arm, randomized clinical trial including 160 adults with obesity. …”
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Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol by Esther van Sluijs, Helen Elizabeth Brown, Justin M Guagliano, Emma Coombes, Elizabeth S Haines, Claire Hughes, Andrew P Jones, Katie L Morton

“…Findings will be disseminated via peer-reviewed publications, conferences and to participating families.Trial registration number ISRCTN12789422…”
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Lifestyle Advice Combined with Personalized Estimates of Genetic or Phenotypic Risk of Type 2 Diabetes, and Objectively Measured Physical Activity: A Randomized Controlled Trial. by Job G Godino, Esther M F van Sluijs, Theresa M Marteau, Stephen Sutton, Stephen J Sharp, Simon J Griffin

“…We examined the effect of communicating an estimate of genetic or phenotypic risk of type 2 diabetes in a parallel group, open, randomized controlled trial.<h4>Methods and findings</h4>We recruited 569 healthy middle-aged adults from the Fenland Study, an ongoing population-based, observational study in the east of England (Cambridgeshire, UK). …”
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Impact of daily fasting duration on body composition and cardiometabolic risk factors during a time-restricted eating protocol: a randomized controlled trial by A. Sampieri, A. Paoli, G. Spinello, E. Santinello, T. Moro

“…Thus, we aimed to compare the effects of 8 weeks of different fasting durations on body composition and biochemical parameters in metabolically healthy, non-trained individuals using a parallel randomized controlled trial. Methods Forty-one volunteers were randomly assigned to one of the four experimental groups: TRE 16:8 (16 h of fasting,8 h of eating), TRE 14:10 (14 h of fasting,10 h of eating), TRE 12:12 (12 h of fasting,12 h of eating) or a normal diet group (ND; no dietary restriction). …”
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A protocol for a systematic review and meta-analysis to identify measures of breakthrough pain and evaluate their psychometric properties by Margaret Johnson, Katie Greenfield, Simone Holley, Daniel Eric Schoth, Richard Howard, Julie Bayliss, Satbir Jassal, Ian Wong, Christina Liossi, Anna-Karenia Anderson, Lorna Katharine Fraser, Dilini Rajapakse

“…For search 2, data will be extracted in parallel with the quality assessment process, as recommended by COSMIN. …”
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Comparative analysis of fatty acid profiles across omnivorous, flexitarians, vegetarians, and vegans: insights from the NuEva study by Lea Klein, Claudia Lenz, Karsten Krüger, Stefan Lorkowski, Kristin Kipp, Christine Dawczynski

“…Methods The Nutritional Evaluation (NuEva) study is a is a parallel-designed trial. Here screening data was used to investigate differences in plasma and erythrocyte fatty acid profiles across omnivores (Western diet; n = 62), flexitarians (n = 69), vegetarians (n = 64) and vegans (n = 57). …”
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Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial by Shan Chen, Jian Zhang, Ben W Mol, Ying Shen, Qian Zhu, Ding Huang, Min Zeng, Yanqing Cai, Hongjie Pan, Weiwei Cheng, Yiru Shi, Liye Shi, Jin Yu

“…The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.Trial registration number ChiCTR-INR-17013272.…”
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Effect of multimodal home-based prehabilitation on objectively measured physical activity in patients undergoing elective cardiac or non-cardiac major surgery: secondary outcomes f... by Thomas Vetsch, Simone Wen-Shi Dueblin, Prisca Eser, Christian M. Beilstein, Patrick Y. Wuethrich, Matthias Wilhelm, Dominque Engel

“…Study design It is an analysis of secondary outcome data of a prospective, two-arm parallel group, randomised controlled trial. Setting It is a single university hospital in Switzerland. …”
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Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED stu... by Steve Goodacre, Praveen Thokala, Neil Grubb, Chris Lang, Rachel O’Brien, Christopher J Weir, Trudie Lobban, Matthew J Reed, Nicola Freeman, Julia Boyd, Lynn Dinsmore, Caroline Blackstock, Imad Adamestam, Pam Macrae, Robert Hannigan

“…Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration number ISRCTN 10278811.…”
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Effects of a SWELE program for improving mental wellbeing in children and adolescents with special educational needs: protocol of a quasi-experimental study by Regina Lai Tong Lee, Sally Wai Chi Chan, Yuen Yu Chong, Steven Wai Ho Chau, Kai Chow Choi, Wai Tong Chien

“…From the evaluation and observation, the pre-set aim and objectives on the improvement of mental wellbeing in children and adolescents with SEN can be confirmed. Trial registration ClinicalTrial.gov, NCT06112483. Registered on 31 October 2023.…”
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Interactive "Video Doctor" counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings. by Paul Gilbert, Daniel Ciccarone, Stuart A Gansky, David R Bangsberg, Kathleen Clanon, Stephen J McPhee, Sophia H Calderón, Alyssa Bogetz, Barbara Gerbert

“…<h4>Methodology and findings</h4>We conducted a parallel groups randomized controlled trial (December 2003-September 2006) at 5 San Francisco area outpatient HIV clinics. …”
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Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for... by Hugo Hille, Aurélie Le Thuaut, Pierre Asfar, Quentin Quelven, Emmanuelle Mercier, Anthony Le Meur, Jean-Pierre Quenot, Virginie Lemiale, Grégoire Muller, Martin Cour, Alexis Ferré, Asael Berge, Anaïs Curtiaud, Maxime Touron, Gaetan Plantefeve, Jean-Charles Chakarian, Jean-Damien Ricard, Gwenhael Colin, Arthur Orieux, Patrick Girardie, Mathieu Jozwiak, Manon Rouaud, Camille Juhel, Jean Reignier, Jean-Baptiste Lascarrou, CRICS-TRIGGERSEP Network

“…We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. …”
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Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study protocol for a process evaluation of a complex intervention in home... by Ellen Thea Gjelseth Dalbak, Anette Væringstad, Bjørn Lichtwarck, Janne Myhre, Daniela Holle, Sverre Bergh, Øyvind Kirkevold

“…The findings will provide comprehensive knowledge of areas and factors of importance for the implementation of TIME in home care services. Trial registration Parent trial NCT05651659 (ClinicalTrials.gov), first registered on 15th December 2022.…”
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Effectiveness and safety of hominis placental pharmacopuncture for chronic temporomandibular disorder: A multi-center randomized controlled trial by Kyoung Sun Park, Eun-San Kim, Koh-Woon Kim, Jae-Heung Cho, Yoon Jae Lee, Jinho Lee, In-Hyuk Ha

“…Methods: This study is a 2-arm parallel, multi-center, randomized controlled trial. …”
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Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal... by Lehana Thabane, Marek Smieja, Quynh Doan, Jeffrey M Pernica, April J Kam, David M Goldfarb, Sarah Khan, Fiona Smaill, Amy Bartholomew, Melani Sung

“…Data from this trial will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines.Trial registration number NCT04247243.…”
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