Development and validation of an intensive care unit acquired weakness prediction model: A cohort study by Zi Yang, Zi Yang, Xiaohui Wang, Guangming Chang, Qiuli Cao, Faying Wang, Faying Wang, Zeyu Peng, Zeyu Peng, Yuying Fan, Yuying Fan

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Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia by Jiang-hua Shen, Min Ye, Qian Chen, Yan Chen, Hai-lin Zhao, Ameena Khan, Bin Yi, Jiao-lin Ning, Kai-zhi Lu, Jian-teng Gu

“…Trial registration The present study was registered on the ClinicalTrials.gov website ( NCT02440269 ) and approved by the Medical Ethics Committee of Southwest Hospital of Third Military Medical University (ethics lot number: 2016 Research No. 93). …”
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Validating a clinical laboratory parameter-based deisolation algorithm for patients with COVID-19 in the intensive care unit using viability PCR: the CoLaIC multicentre cohort stud... by Albert Wolthuis, Petra F G Wolffs, Tim Frenzel, Mathie P G Leers, Frank van Rosmalen, Steven JR Meex, Otto Bekers, Bas C T van Bussel, Inge H M van Loo, Guy JM Mostard, Rémy LM Mostard, Arjen-Kars Boer, Ruben Deneer, Tom Schoenmakers, Stefan H M Gorissen, Wilhelmine P H G Verboeket-van de Venne, Walter N K A van Mook, Stephanie MC Ament, M Sesmu Arbous, Miranda van Berkel, Dirck W van Dam, William PTM van Doorn, Tom P Dormans, Silvia MAA Evers, Judith Gillis, Iwan CC van der Horst, W Nadia H Koek, Kitty CFM Linssen, Luuk C Otterspoor, Natal AW van Riel, Frans Stals

“…Finally, a third multicentre cohort, consisting of retrospectively collected data from patients with COVID-19 admitted to the ICU, will be used to validate the algorithm.Ethics and dissemination This study was approved by the Medical Ethics Committee from Maastricht University Medical Centre+ (cohort I: 2020-1565/300523) and Zuyderland MC (cohorts II and III: METCZ20200057). …”
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Contralateral acupuncture for migraine without aura: a randomized trial protocol with multimodal MRI by Ziwen Chen, Qifu Li, Yi Lu, Gaoyangzi Huang, Ya Huang, Xianmei Pei, Yi Gong, Bingkui Zhang, Xin Tang, Zili Liu, Taipin Guo, Fanrong Liang

“…The findings will provide scientific evidence for CAT in the treatment of MWoA.Ethics and disseminationThe Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine has given study approval (approval no. 2022-006). …”
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Prediction of recurrent ischaemic stroke using radiomics data and machine learning methods in patients with acute ischaemic stroke: protocol for a multicentre, large sample, prospe... by Bin Wu, Jingyi Li, Pengfei Yu, Yifan Wu, Weijie Jia, Mengqi Han, Yongsen Chen, JianMo Liu, Haowen Luo, Jianglong Tu, Jie Kuang, Yingping Yi

“…Calibration, receiver operating characteristic and decision curve analyses will be evaluated.Ethics and dissemination This study has received ethical approval from the Medical Ethics Committee of the Second Affiliated Hospital of Nanchang University (medical research review No.34/2021), and informed consent will be obtained voluntarily. …”
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Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary... by Fei Ma, Cheng Cheng, Li Huang, Qi Wu, Guowei Huang, Huan Liu, Wen Li, Jing Yan, Yongjie Chen, Yue Du, Tongtong Li, Liyang Zhang, Xukun Chen, Shanshan Bian, Zhenshu Li, Meilin Zhang, Lichun Cao

“…The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). …”
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ESOPHAGEAL REFLUX DISEASE, PEPTIC ULCER AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED STUDY by Pavel Skok, Igor Križman, Marija Skok

“…Study was approved in 1998 by the Slovenian Medical Ethics Committee (No. 90/09/98). Prospective, controlled and randomized, carried out between 1998– 2000.The study included 80 patients (50 male and 30 female, av. age 57.5 years, SD ± 17.1, range 22–80 years) in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and HP infection. …”
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Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and childr... by Ellen E Blaak, Marta del Álamo, Yannis Manios, Graham Finlayson, Edith J M Feskens, Anne Raben, Jason C G Halford, Joanne A Harrold, Louise Kjølbæk, J. Alfredo Martínez, Sabina S H Andersen, Kyriakos Reppas, Santiago Navas-Carretero, Tanja C Adam, Charo E Hodgkins, Tony Lam, Hariklia Moshoyiannis

“…Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity.Ethics and dissemination The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. …”
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The effects of prehabilitation versus usual care to reduce postoperative complications in high-risk patients with colorectal cancer or dysplasia scheduled for elective colorectal r... by Annefleur E. M. Berkel, Bart C. Bongers, Marie-Janne S. van Kamp, Hayke Kotte, Paul Weltevreden, Frans H. C. de Jongh, Michiel M. M. Eijsvogel, A. N. Machteld Wymenga, Marloes Bigirwamungu-Bargeman, Job van der Palen, Marc J. van Det, Nico L. U. van Meeteren, Joost M. Klaase

“…Trial registration Medical Ethics Committee Twente, Enschede, the Netherlands (NL45001.044.13, September 3, 2013); Netherlands Trial Register (NTR; NTR4032, June 14, 2013).…”
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Early nonreactivity in the conjunctival provocation test predicts beneficial outcome of sublingual immunotherapy by Janina Köther, Alicia Mandl, Silke Allekotte, Anatoli Astvatsatourov, Janin Chwieralski, Jan-Patrick Liedtke, Ursula Pieper-Fürst, Esther Raskopf, Kija Shah-Hosseini, Ralph Mösges

“…Trial registration Both trials registered with the Medical Ethics Committee of the North Rhine Medical Council (EudraCT numbers 2012-004916-79 (grass pollen trial) and 2013-002129-43 (tree pollen trial)) and the German Federal Ministry of Health (Paul-Ehrlich-Institut).…”
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Tranexamic acid in patients with post-traumatic elbow stiffness: protocol for a randomised, double-blind, placebo-controlled trial investigating the effectiveness of tranexamic aci... by Yin Wang, Wei Wang, Shuai Chen, Haomin Cui, Gang Luo, Ziyang Sun, Cunyi Fan, Min Luan, Kuangyu He, Jihao Ruan, Juehong Li, Tengfei Lou, Shiyang Yu

“…The results of this study should determine whether TXA can reduce the rates of HO occurrence after OEA.Ethics and dissemination Ethical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (reference number 2022-123-(1)). …”
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The impact of COVID-19 prevention and control policy adjustment on anxiety, depression and coping behavior in China: a cross-sectional online survey, 21–28 December, 2022 by Mingyu Gu, Tingting Qin, Kun Qiao, Xinyuan Bai, Yao Wang, Yutong Yang, Yu Bai, Jie Gao, Xingming Li

“…Trial registration This study has been approved by the Medical Ethics Committee of Capital Medical University (2023SY086), and informed consent was obtained from the study subjects before the investigation.…”
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EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial by Anne M May, Maike G Sweegers, Wim H Van Harten, Martijn M Stuiver, Alina Vrieling, Richard P Meijer, Antoine G van der Heijden, Wim G Groen, Emine Akdemir, Helene Rundqvist, Annemarie M Leliveld-Kors, Vera C Rutten, Evert L Koldewijn, Siebe D Bos, Carl J Wijburg, Tom A T Marcelissen, Bart C Bongers, Valesca P Retèl

“…Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery.Ethics and dissemination Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22–595/NL78792.031.22. …”
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RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands by Rudolf A de Boer, Johannes B Reitsma, Frans H Rutten, Folkert W Asselbergs, Tiny Jaarsma, Ewoud Schuit, Eric Wierda, Marco C Post, Kim Luijken, Stefan Koudstaal, Jaap C A Trappenburg, Geert W J Frederix, Jeroen Schaap, Gerard CM Linssen, Jorna van Eijk, Lineke Derks, Jasper Brugts, C Jan Borleffs, Dirk H Dalen, Ayten Erol-Yilmaz, M Louis Handoko, Gerardus PJ Hout, Jaco Houtgraaf, Wouter W Klomp, Manon G van Meer, Sandra Sanders Wijk, Stijn CW Wouter

“…The effects of telemedicine components are assessed by fitting separate models for component contrasts.Ethics and dissemination The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). …”
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The effect of capnography on the incidence of hypoxia during sedation for EGD and colonoscopy in mildly obese patients: a randomized, controlled study by Yingjie Wang, Fang Liu, Yuan Zhang, Xiaomei Yang, Jianbo Wu

“…Trial registration Ethical approval was granted by the Medical Ethics Committee (Chairperson Professor Tian Hui) of Qilu Hospital, Shandong University ((Ke) Lun Audit 2021 (186)) on 15/07/2021. …”
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Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being in ICU survivors: study protocol for an international, multicentre, randomised c... by Fabio Taccone, Annemieke Dijkstra, Diederik Gommers, Jasper van Bommel, Evert-Jan Wils, Anna FC Schut, Joost AM Labout, Margo MC van Mol, Michel E van Genderen, Johan Hendrik Vlake, Tim IM Korevaar, Jan H Elderman, Adrienne MTJ Raben, Sefanja Achterberg, Amber L Jurriens

“…Secondary objectives are to determine optimal timing for ICU-VR, to assess the effects on anxiety-related and depression-related symptoms and health-related quality of life, and to assess patient satisfaction with ICU aftercare and perspectives on ICU-VR.Ethics and dissemination The Medical Ethics Committee United, Nieuwegein, the Netherlands, approved this study and local approval was obtained from each participating centre (NL78555.100.21). …”
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Pioglitazone in spontaneous subarachnoid hemorrhage: study protocol of a multicenter, double-blind, randomized trial (PSSH) by Junhui Chen, Junhui Chen, Junhui Chen, Mingchang Li, Lei Chen, Lei Chen, Qinyi Xu, Tengfeng Yan, Chunlei Zhang, Ping Hu, Jianqing He, Xun Zhu, Xingen Zhu, Yuhai Wang

“…In addition, this pilot trial is the first to prospectively investigate the effectiveness and safety of pioglitazone in patients with SAH.Ethics and dissemination: Ethics approval was obtained from the Medical Ethics Committee of 904th Hospital of Joint Logistic Support Force of PLA (Wuxi Taihu Hospital, approval No. 20220701). …”
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Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placeb... by Zoran Trogrlic, Lisa Smit, Robert-Jan Osse, Huibert H Ponssen, Arjen J C Slooter, Nicole G M Hunfeld, Wim J R Rietdijk, M. van den Boogaard, A.J.B.W. Brouwers, J.A. Lens, B.J.M. van der Meer, H. Ponssen, F.J. Schoonderbeek, K.S. Simons, E. Berger, A. Bouman, M. Campo, D. van Duijn, H. Embden – van Donk, D. van de Graaf, E. Hoogendoorn, P. Ormskerk, N. Roovers, E. Toscano, A. Vileito, T. van Zuylen, C. Exler, E. van den Berg, J. van Meeteren, M. Koopmanschap, I. Nutma, E. Kuijper

“…Study recruitment started in February 2018 and continues.Ethics and dissemination The study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. …”
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Treatment with add-on IVIg in Myositis Early In the diSease course May be sUperior to Steroids alone for reaching CLinical improvEment (TIME IS MUSCLE): study protocol of a phase-2... by Mario Maas, Anneke J van der Kooi, Joost Raaphorst, Ivo N van Schaik, Marianne de Visser, Johannes A Bogaards, Camiel Verhamme, Hannah A W Walter, Renske G Kamperman, Filip Eftimov, Sanne W Evers, Corianne de Borgie, Jantine C A Colen - de Koning

“…At baseline, and after 4, 8, 12, 26 and 52 weeks, relevant secondary outcomes will be assessed, including time to moderate improvement (TIS≥40), mean daily prednisone dosage, physical activity, health-related quality of life, fatigue and MRI muscle imaging parameters.Ethics and dissemination Ethical approval was obtained from the medical ethics committee of the Academic Medical Centre, University of Amsterdam, the Netherlands (2020_180; including a first amendment approval at the 12 April 2023; A2020_180_0001). …”
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Glucose-insulin-potassium alleviates uterine cramping pain following cesarean delivery: A randomized, controlled trial by Guiying Yang, Yu Cui, Xiaohang Bao, Zhuoxi Wu, Qin Chen, Feng Chen, Wenjun Liu, Mingming Wang, Li Luo, Hong Li

“…Our results provide information to facilitate the development of novel approaches for managing UCP.Clinical Trial Registration: This study was approved by the Medical Ethics Committee of Second Affiliated Hospital of Army Medical University (2020-109-01, 19/11/2020) and registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn, ChiCTR2100041607,01/01/2021).…”
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