Improving clinical management of colon cancer through CONNECTION, a nation-wide colon cancer registry and stratification effort (CONNECTION II trial): rationale and protocol of a s... by I. van den Berg, S. van de Weerd, J. M. L. Roodhart, G. R. Vink, R. R. J. Coebergh van den Braak, C. R. Jimenez, S. G. Elias, D. van Vliet, M. Koelink, E. Hong, W. M. U. van Grevenstein, M. G. H. van Oijen, R. G. H. Beets-Tan, J. H. J. M. van Krieken, J. N. M. IJzermans, J. P. Medema, M. Koopman, on behalf of the CONNECTION-study group

“…The study has been approved by the medical ethics committee Utrecht (MEC18/712).…”
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Shaping outcome of ProTaper NEXT for root canal preparation in mandibular incisors: a micro-CT study by Hao Wang, Xueqin Yang, Ling Zou, Dingming Huang, Xuedong Zhou, Jialei Xu, Yuan Gao

“…Methods This experiment was approved by the School Medical Ethics Committee. The sample size calculation was conducted using G*Power software. …”
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Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nat... by Suzanne Polinder, Detlef van der Velde, Taco Gosens, Esther M M van Lieshout, Michael H J Verhofstad, Pieter Joosse, K de Vries, Dennis Den Hartog, J. Jansen, Ruth E Pel-Littel, Henk Jan Schuijt, Miliaan L Zeelenberg, Paulieke C Oosterwijk, Hanna C Willems, Sverre A I Loggers, Thomas MP Nijdam, Hugo H Wijnen, E. Sohl, J.A. Jansen, M. Leijnen, W.A.H. Van der Stappen, M Peters-Kop, A.H. Van der Veen, N.C. Schepel, J.A.M. Wilmer, J. Steens, J. Winkelhagen, N.M.F. Noorda, H.A.A.M. Maas, O. Wijers, V. Vis, D. Van der Stap, G.R. Roukema, E. Bosma, T.M. Van Raaij, A.M. Van der Knaap, R. De Groot, A.V.C.M. Zeegers, H.A. Formijne Jonkers, D.H.R. Kempen, A.F Pull ter Gunne, M.P. Somford, E. Tanis, J.H. Duits, R.A. Zandbergen, N.C. Leegwater, O.C. Geraghty, J.H. Hegeman, E.M. Regtuijt

“…Phase 4 will focus on upscaling to nationwide implementation and the effect of the implementation on NOM rate will be measured using data from the Dutch Hip Fracture Audit.Ethics and dissemination The study was exempted by the local Medical Research Ethics Committee (MEC-2023-0270, 10 May 2023) and Medical Ethics Committee United (W23.083, 26 April 2023). The study’s results will be submitted to an open access international peer-reviewed journal. …”
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Dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatment: protocol for a systematic review and individual participant data me... by Trine Moholdt, Rui Wang, Ben W Mol, Henk Groen, Kyra Sim, Zheng Wang, Christina Bergh, Joop S E Laven, Jean-Patrice Baillargeon, Annemieke Hoek, Richard S Legro, Amy E Rothberg, Stefano Palomba, Emily Evans-Hoeker, Astrid E P Cantineau, Ann Thurin‐Kjellberg, Alexandra Dietz de Loos, Geranne Jiskoot, Lisa J Moran, Juan J Espinós, Donna Shoupe

“…We will then explore treatment–covariate interactions for important participant-level characteristics.Ethics and dissemination Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). …”
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Protocol for Multi-modality MEdical imaging sTudy bAsed on KaiLuan Study (META-KLS): rationale, design and database building by Jing Li, Rui Li, Jing Sun, Ning Wu, Wenjuan Liu, Yuntao Wu, Shouling Wu, Xinyu Zhao, Qian Chen, Aijun Xing, Pengfei Zhao, Ying Hui, Xiaoshuai Li, Mingze Xu, Huijing Shi, Shun Zhang, Xiaoliang Liang, Yongxin Wang, Han Lv, Zhenchang Wang

“…Researches based on META-KLS will provide a series of state-of-the-art evidence for the prevention of neurological diseases and common chronic diseases.Ethics and dissemination The Kailuan Study and META-KLS have been approved by the Medical Ethics Committee of Kailuan General Hospital (IRB number: 2008 No. 1 and 2021002, respectively). …”
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An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Prot... by Itske Fraterman, Barbara M Wollersheim, Valentina Tibollo, Savannah Lucia Catherina Glaser, Stephanie Medlock, Ronald Cornet, Matteo Gabetta, Vitali Gisko, Ella Barkan, Nicola di Flora, David Glasspool, Alexandra Kogan, Giordano Lanzola, Roy Leizer, Henk Mallo, Manuel Ottaviano, Mor Peleg, Lonneke V van de Poll-Franse, Nicole Veggiotti, Konrad Śniatała, Szymon Wilk, Enea Parimbelli, Silvana Quaglini, Mimma Rizzo, Laura Deborah Locati, Annelies Boekhout, Lucia Sacchi, Sofie Wilgenhof

“…Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22). …”
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Correlation of PCSK1 with nonalcoholic fatty liver disease in a Han Chinese population: a case-control observational study by Xiao Yang, Fan Yuan, Na Wu, Decheng Ren, Liangjie Liu, Yan Bi, Lei Ji, Ke Han, Mofan Feng, Kai Su, Fengping Yang, Xi Wu, Qing Lu, Siran Yue, Fengyan Jiang, Ruirui Wang, Guang He, Baocheng Liu, Xingwang Li, Yi Shi

“…This study was approved by the Medical Ethics Committee of Shanghai University of Traditional Chinese Medicine (approved No. 2017LCSY069). …”
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Study protocol for a multicentre nationwide prospective cohort study to investigate the natural course and clinical outcome in benign liver tumours and cysts in the Netherlands: th... by Joanne Verheij, Marc G Besselink, Vincent E de Meijer, Jan N M IJzermans, D Ramsoekh, C van der Leij, Otto M van Delden, Geert Kazemier, Robert A de Man, Frans J C Cuperus, Martijn P D Haring, Evelien W Duiker, Robbert J de Haas, R Bart Takkenberg, Alicia Furumaya, Belle V van Rosmalen, Anne J Klompenhouwer, Maarten G J Thomeer, Matthijs Kramer, Mariëlle M E Coolsen, Maarten E Tushuizen, Alexander F Schaapherder, Joris I Erdmann, ID Munsterman, MD Doukas, JC Beckervordersandforth, R Miclea, ETTL Tjwa, PB van den Boezem, JHW de Wilt, S van Koeverden, AE Braat, MJ Coenraad, SSLP Crobach, S Feshtali, MC Burgmans, TM van Gulik, R Swijnenburg, KP de Jong

“…Multivariable analysis will be performed to identify patient and tumour characteristics associated with significant improvement in PROs or a complicated postoperative course.Ethics and dissemination The study was assessed by the Medical Ethics Committee of the University Medical Center Groningen and the Amsterdam UMC. …”
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Protocol for the combined cardiometabolic deep phenotyping and registry-based 20-year follow-up study of the Inter99 cohort by Allan Linneberg, Torben Hansen, Lars Køber, Mette Aadahl, Allan Vaag, Michael Kjaer, Michael Larsen, Niels Grarup, Freja Bach Kampmann, Kirsten Nørgaard, Charlotte Suetta, Niklas Rye Jørgensen, Charlotte Brøns, Klaus Fuglsang Kofoed, Christian Stevns Hansen, Rasmus Wibaek, Line Lund Kårhus, Kirsten Schroll Bjørnsbo, Camilla Friis Bryde Nielsen, Bjørn Lundbergh, Anja Lykke Madsen, Jørgen Kanters, Ruth JF Loos

“…A main purpose is to investigate whether low birth weight independent of genetics, lifestyle and glucose tolerance predicts later common T2D cardiometabolic comorbidities.Ethics and dissemination The study was approved by the Medical Ethics Committee, Capital Region, Denmark (H-20076231) and by the Danish Data Protection Agency through the Capital Region of Denmark’s registration system (P-2020-1074). …”
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Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial by John Bradley, Alphonse Ouedraogo, Issiaka Soulama, Chris Drakeley, Teun Bousema, Alfred B Tiono, Denise Hien, Sodiomon Bienvenu Sirima, Issa N Ouedraogo, Jean Baptist Yaro, Aïssata Barry, Seyi Soremekun, Marta Moreno, Jean Sawadogo, Markus Gmeiner, Samuel S Sermé, Isabel Byrne, Jordache Ramjith, Lynn Grignard, Simon Koele, Rob ter Heine, Amidou Z Ouedraogo, Edith Sanogo

“…Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.Ethics and dissemination The London School of Hygiene & Tropical Medicine’s Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. …”
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Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase I... by Jacobus W A Burger, Cornelis Verhoef, Eva V E Madsen, Robin J Lurvink, Joost Nederend, Onno Kranenburg, Geert-Jan M Creemers, Simon W Nienhuijs, Alexandra R M Brandt-Kerkhof, Esther van Meerten, Stijn L W Koolen, Ignace H J T de Hingh, Ron H J Mathijssen, Niels A D Guchelaar, Vincent C J van de Vlasakker, Teun B M van den Heuvel, Ramon J F Bax, Irene E G van Hellemond

“…It is hypothesised that the trial treatment will lead to a 4 month increase in overall survival; from a median of 12.2 to 16.2 months.Ethics and dissemination This study is approved by the Dutch Authority (CCMO, the Hague, the Netherlands), by a central medical ethics committee (MEC-U, Nieuwegein, the Netherlands) and by the institutional research boards of both research centres. …”
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Alirocumab effect on preventing periprocedural ischaemic events in coronary heart disease patients undergoing coronary stenting (APPEASE trial): study protocol of a multicentre, op... by Yang Chen, Suhua Li, Lianxiong Yuan, Zhenyu Xiong, Jinlai Liu, Xiaoxian Qian, Longgen Xiong, Leile Tang, Zhuoshan Huang, Xiaodong Zhuang, Shaozhao Zhang, Yiquan Huang, Aiwen Lin, Odong Christopher, Bingyuan Wu, Yesheng Ling, Qiang Jie, Xinxue Liao

“…Incidence of PCI-related MI or major periprocedural myocardial injury, and MACE in 3 months after PCI will be compared between control group and alirocumab group.Ethics and dissemination Ethics approval has been obtained from the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University with approval number: (2022)02-140-01. …”
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The efficacy of three-ball breathing apparatus exercise based on the concept of pulmonary rehabilitation in patients after lung cancer surgery by Qiang Xu, Zi-Qing Shen, Kun-Peng Feng, Chun Xu, Cheng Ding, Chang Li, Sheng Ju, Jun Chen, Shu Pan, Jun Zhao

“…There was a significant benefit for the use of three-ball apparatus in patients after thoracoscopic lobectomy, whereas there was no significant benefit for the use of respiratory trainers after wedge resection. Registry: Medical Ethics Committee of the First Affiliated Hospital of Soochow University. …”
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A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation an... by Yaxin Liu, Wei Wang, Rutie Yin, Youzhong Zhang, Yu Zhang, Keqiang Zhang, Hongming Pan, Ke Wang, Ge Lou, Guiling Li, Ruyan Zhang, Kun Li, Jing Rao, Ben Zhang, Yuting Wang, Quanren Wang, Yunong Gao, Huiping Li

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Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial by Miangela M Lacle, Sjoerd G Elias, Leon M G Moons, Helena M Verkooijen, Manon N G J A Braat, Myriam Chalabi, Corrie A M Marijnen, Femke P Peters, Brechtje A Grotenhuis, Miriam Koopman, Petur Snaebjornsson, Esther Consten, Wilhelmina M U van Grevenstein, Maaike E Verweij, Max D Tanaka, Chavelli M Kensen, Uulke A van der Heide, Tomas Janssen, Tineke Vijlbrief, Monique Maas, Inge L Huibregtse, Remond Fijneman, Apollo Pronk, Anke B Smits, Joost T Heikens, Hidde Eijkelenkamp, Maartje M C Schoenmakers, Gert J Meijer, Martijn Intven

“…Imaging and laboratory biomarkers are explored for early response prediction.Ethics and dissemination The trial protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. …”
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Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority... by N Roescher, JM Prins, JTM van der Meer, HI Bax, R Soetekouw, MGJ de Boer, LBS Gelinck, JJ Oosterheert, MA van Agtmael, M Berrevoets, DTP Buis, CH van Werkhoven, MJM Bonten, JE Bosmans, J Branger, S Douiyeb, E Jong, AJJ Lammers, E Sieswerda, JE Stalenhoef, TW Van der Vaart, EA Bij de Vaate, NJ Verkaik, MGA Van Vonderen, PJ De Vries, KCE Sigaloff, E Botman, A Van den Broek, L Buitenhuis, E Buitenwerf, A S Cents, N Engels, J L J Hanssen, A J Meinders, F P N Mollema, L Nagelmaker, M L M van Doorn-Schepens, P Thomopoulos, M Timmer, B van der Wiel

“…This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). …”
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The effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19: a structured summary of a... by Nahid Ramezani-Jolfaie, Ebrahim Eftekhar, Mohadese Dadinasab, Zahra Ghaeini Hesarooeyeh, Pooria Pakdaman, Farkhondeh Razmpour, Gholamali Javedan, Mahmood Khayatian, Mehdi Hassani Azad, Parivash Davoodian, Elham Brahimi, Shideh Rafati, Sara Nikoofal-Sahlabadi, Mohammad Mohammadi

“…Trial status Ethical approval of the first version of the study protocol was obtained from the medical ethics committee of Hormozgan University of Medical Sciences, Bandar Abbas, Iran on May 30, 2021 (IR.HUMS.REC.1400.085). …”
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Efficacy, metabolic characteristics, safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer: a multicenter... by LUO Yang, SUN Tao, SHAO Zhimin, CUI Jiuwei, PAN Yueyin, ZHANG Qingyuan, CHENG Ying, LI huiping, YANG Yan, YE Changsheng, YU Guohua, WANG Jingfen, LIU Yunjiang, LIU Xinlan, ZHOU Yuhong, BAI Yuju, GU Yuanting, WANG Xiaojia, XU Binghe, SONG Lihua

“…It was approved by the hospital's medical ethics committee. The clinical trial registration agency is the State Food and Drug Administration (clinical trial approval number: 2015L04224; clinical trial registration number: CTR20170516). …”
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Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht) by Joachim Wildberger, Jeanette Tas, Rob J J van Gassel, Serge J H Heines, Mark M G Mulder, Nanon F L Heijnen, Melanie J Acampo-de Jong, Julia L M Bels, Frank C Bennis, Marcel Koelmann, Rald V M Groven, Moniek A Donkers, Frank van Rosmalen, Ben J M Hermans, Steven JR Meex, Alma Mingels, Otto Bekers, Paul Savelkoul, Astrid M L Oude Lashof, Fabian H Tijssen, Wolfgang Buhre, Jan-Willem E M Sels, Chahinda Ghossein-Doha, Rob G H Driessen, Pieter L Kubben, Gerry A F Nicolaes, Ulrich Strauch, Zafer Geyik, Thijs S R Delnoij, Kim H M Walraven, Coen DA Stehouwer, Jeanine A M C F Verbunt, Walther N.K.A Van Mook, Susanne van Santen, Ronny M Schnabel, Marcel C G van de Poll, Dennis Bergmans, Sander van Kuijk, Bas C T van Bussel

“…This paper describes the design of the MaastrICCht.Ethics and dissemination Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. …”
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The Effect of Probiotic Dietary Supplementation on Ethanol-Induced White and Grey Matter Damage to the Brain in Male Wistar Rats by Hadis Soleimani, Aliakbar Malekirad, Hamid Reza Mohajerani, Parvaneh Jafari1, Neda Akbari

“…ETHICAL PERMISSIONS The method of this research was approved by the Medical Ethics Committee of Arak, Iran Azad University with code IR.IAU.ARAK.REC.1399.009. …”
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