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Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial

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Trials 2021年第1期22卷 187页

作者： Iwein Gyselinck Laurens Liesenborghs Ewout Landeloos Ann Belmans Geert Verbeke Peter Verhamme Robin Vos W Janssens Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven Leuven Belgium. iwein.gyselinck@kuleuven.be. Katholieke Universiteit Leuven Universitaire Ziekenhuizen Leuven Leuven Belgium. Interuniversity Institute for Biostatistics and Statistical Bioinformatics Leuven Belgium.

An amendment to this paper has been published and can be accessed via the original article.

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Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis (vol 20, pg 361, 2019)

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LANCET ONCOLOGY 2019年第3期20卷 E132-E132页

作者： Saad, E. D. Squifflet, P. Burzykowski, T. [a]International Drug Development Institute Louvain-la-Neuve Belgium [b]Interuniversity Institute for Biostatistics and Statistical Bioinformatics Hasselt University Diepenbeek Belgium [c]Unicancer Breast Group Paris France [d]University of Crete Heraklion Greece [e]Mayo Clinic Jacksonville FL USA [f]Institut Jules Bordet Université Libre de Bruxelles Brussels Belgium [g]Indiana University Indianapolis IN USA [h]University of California Los Angeles (UCLA) Los Angeles CA USA [i]NRG Oncology/Pittsburgh Pittsburgh PA USA [j]International Drug Development Institute San Francisco CA USA

Summary Background Although frequently used as a primary endpoint, disease-free survival has not been validated as a surrogate for overall survival in early breast cancer. We investigated this surrogacy in the adjuvant setting of treatment with anti-HER2 *** In a systematic review and meta-analysis, we identified published and non-published randomised controlled trials with completed accrual and available disease-free survival and overall survival results for the intention-to-treat population as of September 2016. Bibliographic databases (MEDLINE, Embase, and Cochrane Central Register of Controlled Trials), clinical trial registries (***, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, and ***), and trial registries from relevant pharmaceutical companies were searched. Eligibility for treatment of HER2-positive early breast cancer required at least one group to have an anti-HER antibody treatment (ie, trastuzumab, pertuzumab, or trastuzumab emtansine) planned for 12 months, and at least one control arm with chemotherapy without the antibody, a lower total dose or duration of the antibody, or observation alone. Units of analysis were contrasts: two-group trials gave rise to one contrast, whereas trials with more than two groups gave rise to more than one contrast. We excluded trials enrolling patients with recurrent, metastatic, or non-invasive disease, and those testing neoadjuvant therapy exclusively. Our primary objective was to estimate patient-level and trial-level correlations between disease-free survival and overall survival. We measured the association between disease-free survival and overall survival using Spearman’s correlation coefficient (r_s), and the association between hazard ratios (HRs) for disease-free survival and overall survival using R². We computed the surrogate threshold effect, the maximum HR for disease-free survival that statistically predicts a

关键词： overall survival Meta-Analysis Review, Systematic human epidermal growth factor receptor 2 positive Disease-Free Survival Breast Cancer Trials experimentation Herceptin

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Trends and determinants of health facility childbirth service utilization among mothers in urban slums of Nairobi, Kenya

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Global Epidemiology 2020年 2卷

作者： Atahigwa, Catherine Kadengye, Damazo T. Iddi, Samuel Abrams, Steven Van Rie, Annelies University of Antwerp Global Health Institute Campus Drie Eiken Universiteitsplein 1 Wilrijk 2610 Belgium African Population and Health Research Center APHRC Campus Manga Close Off Kirawa Road P.O. Box 10787-00100 Nairobi Kenya Center for Statistics Interuniversity Institute for Biostatistics and statistical Bioinformatics Data Science Institute UHasselt Agoralaan Gebouw D Diepenbeek Belgium Department of Statistics and Actuarial Science Accra Ghana

High maternal mortality remains a challenge for the attainment of the third Sustainable Development Goal in Sub-Saharan Africa. In Kenya, maternal mortality ratio remains high at 362 deaths per 100,000 live births. Utilization of health facility childbirth services ensures safe birth and is vital for the reduction of maternal mortality. However, this can be greatly affected by socioeconomic and geographical inequalities. In this study, we assess the trends and determinants of health facility childbirth service utilization among women giving birth in the urban slums of Nairobi, Kenya. Data were obtained from the Nairobi Urban Health and Demographic Surveillance System (NUHDSS) comprising 19,469 births observed between 2003 and [19]. A logistic regression model, with parameter estimation using a generalized estimating equations (GEE) approach, was used to assess factors associated with health facility childbirth. About 81% of the births occurred at health facilities while 19% were occurring at home or outside a health facility. The results further indicated that, education, parity, and relationship to head of households were associated with health facility childbirth. Increasing awareness of the mothers about the benefits of health facility childbirth service utilization and the risks of home childbirth should be given extra attention by health practitioners during antenatal care visits. © 2020 The Authors

关键词： Healthcare childbirth Maternal mortality Nairobi NUHDSS Slums

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P-152 Transoral Robotic Surgery (TORS) Using the Da Vinci Xi: a Prospective Analysis of Feasibility and Safety

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Oral Oncology 2021年 118卷 14-14页

作者： Meulemans, Jeroen Vanermen, Margaux Goeleven, Ann Clement, Paul Nuyts, Sandra Laenen, Annouschka Delaere, Pierre Poorten, Vincent Vander Otorhinolaryngology Head and Neck Surgery University Hospitals Leuven Leuven Department of Oncology Section Head and Neck Oncology KU Leuven Leuven Belgium Otorhinolaryngology Head and Neck Surgery Swallowing Clinic University Hospitals Leuven Leuven Medical Oncology University Hospitals Leuven Leuven Belgium Radiation Oncology University Hospitals Leuven Leuven Belgium Department of Oncology Section Experimental Radiotherapy KU Leuven Leuven Belgium Interuniversity Institute for Biostatistics and statistical Bioinformatics Leuven Belgium

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693TiP LOBSTER LOng term Better than Short-TErm ADT with salvage radiotherapy

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Annals of Oncology 2020年 31卷 S548-S548页

作者： C. Berghen S. Joniau A. Laenen G. Devos K. Rans K. Goffin K.M. Haustermans G. De Meerleer Radiation Oncology Department University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium Urology University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium Department of Public Health and Primary Care Interuniversity Institute for Biostatistics and Statistical Bioinformatics Catholic University Leuven Leuven Belgium Radiation Oncology University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium

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Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety – Lot 1: Comparative statistical analysis (2017)

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EFSA Supporting Publications 2019年第5期16卷

作者： Liesbeth Bruckers Center for Statistics Hasselt University Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BIOSTAT) Universiteit Hasselt & KU Leuven Agoralaan Bldg. D 3590 Diepenbeek Belgium

To guide and assist applicants for the preparation and presentation of genetically modified (GM) plant market authorization applications, the GMO Panel of EFSA has developed guidance for the risk assessment of GM plants and derived food and feed, which describes principles, concepts, data requirements and issues to be considered when performing the risk assessment of GM plants and derived food and feed. The objective of this framework contract is to provide statistical support to the EFSA GMO Panel for the evaluation of GMO application dossiers with respect to the statistical analysis of collected data from field trials carried out for the comparative assessment according to the requirements described in the EFSA guidance on statistical considerations for the safety evaluation of GMOs and EFSA guidance on the risk assessment of food and feed from genetically modified plants (EFSA, 2011).This report describes the tasks performed in 2017 under this framework contract and their outcome. The evaluation of the statistical analysis of applications during 2017 fulfilled to a large extent the requirements described in the guidance documents. However, a few non-compliances were reported for most of the applications evaluated and actions were undertaken.

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47P Serum thymidine kinase activity in older patients with hormone receptor-positive and HER2-negative advanced breast cancer treated with ribociclib and letrozole in the RibOB trial

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ESMO Open 2025年 10卷 104601-104601页

作者： Van Houdt, M. Kenis, C. Hatse, S. Laenen, A. Bergqvist, M. Ponde, N.F. Decoster, L. de Azambuja, E. Quaghebeur, C. Cornelis, F. Verhoeven, D.M.E.C. Barbeaux, A. Verschaeve, V. Mebis, J. Neven, P. Wildiers, H. Dept. Gynaecological Oncology/Multidisciplinary Breast Center UZ Leuven - University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium General Medical Oncology Department University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium Oncology KU Leuven - Laboratory of Experimental Oncology Leuven Belgium Interuniversity Institute for Biostatistics and Statistical Bioinformatics KU Leuven Leuven Belgium Biovica International AB Uppsala Sweden Clinical Development Daiichi Sankyo Inc. Basking Ridge United States of America Department of Medical Oncology UZ Brussel - Universitair Ziekenhuis Brussel Jette Belgium Medical Oncology Department Institute Jules Bordet Hôpital Universitaire de Bruxelles (H.U.B) and l’Université Libre de Bruxelles (U.L.B) Brussels Belgium Department of Medical Oncology CHU UCL Namur site Sainte-Elisabeth Namur Belgium Department of Medical Oncology Cliniques Universitaires Saint-Luc (UCLouvain) Woluwe-Saint-Lambert Belgium Medical Oncology Department AZ Klina Brasschaat Belgium Medical Oncology Department CHR Verviers Verviers Belgium Medical Oncology Department GHdC - Grand Hopital de Charleroi - - Site Les Viviers Charleroi Belgium Department of Medical Oncology Jessa Hospital Hasselt Belgium

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327P A phase IV prospective study of efficacy and safety of Ribociclib and letrozole in first-line in Older women (≥70 years) with hormone receptor-positive HER2-negative advanced Breast cancer: The RibOB study

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ESMO Open 2025年 10卷 104899-104899页

作者： M. Van Houdt L. De Nys C. Kenis S. Hatse P. Neven A. Laenen J. Mebis E. de Azambuja N.F. Ponde L. Decoster C. Quaghebeur F. Cornelis D.M.E.C. Verhoeven A. Barbeaux V. Verschaeve H. Wildiers Dept.Gynaecological Oncology/Multidisciplinary Breast Center UZ Leuven - University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium KU Leuven UZ Leuven - University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium General Medical Oncology Department University Hospitals Leuven - Campus Gasthuisberg Leuven Belgium Oncology KU Leuven - Laboratory of Experimental Oncology Leuven Belgium Interuniversity Institute for Biostatistics and Statistical Bioinformatics KU Leuven Leuven Belgium Department of Medical Oncology Jessa hospital Hasselt Belgium Medical Oncology Department Institute Jules Bordet Hôpital Universitaire de Bruxelles (H.U.B) and l’Université Libre de Bruxelles (U.L.B) Brussels Belgium Clinical Development Daiichi Sankyo Inc. Basking Ridge United States of America Department of Medical Oncology UZ Brussel - Universitair Ziekenhuis Brussel Jette Belgium Department of Medical Oncology CHU UCL Namur site Sainte-Elisabeth Namur Belgium Department of Medical oncology Cliniques Universitaires Saint-Luc (UCLouvain) Woluwe-Saint-Lambert Belgium Department of medical oncology AZ Klina Brasschaat Belgium Department of Medical Oncology CHR Verviers Verviers Belgium Medical Oncology Department GHdC - Grand Hopital de Charleroi - Site Les Viviers Charleroi Belgium

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Machine learning techniques for the automation of literature reviews and systematic reviews in EFSA

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EFSA Supporting Publications 2018年第6期15卷

作者： Stijn Jaspers Ewoud De Troyer Marc Aerts Interuniversity Institute for Biostatistics and statistical Bioinformatics UHASSELT Diepenbeek Belgium

This Report presents the results from EFSA project RC/EFSA/AMU/2016/01 related to the implementation of machine learning techniques for literature reviews and systematic reviews in EFSA. An overview of the different steps of a systematic review is provided, along with possible ways for automation. Although it was found that most steps could benefit from automation, it was also observed that some steps require more sophisticated methods than those encompassed within the machine learning framework. Availability of data and methodology allowed for the development of an automatic screening tool based on several machine learning techniques. The developed shiny R application can be used for the screening of abstracts and full texts. Properties of machine learning techniques are discussed in this Report together with their most important advantages and disadvantages. The latter discussion includes both general properties, as well as context-specific properties based on their performance in three case studies. Although creating a universal automatic data extraction tool was considered to be infeasible in this stage, this step of the systematic review was addressed to allow the reviewer to scan the uploaded pdf files for certain words or string of words. Based on observations from the performed case studies, recommendations were made regarding which methods are preferred in specific situations. More explicitly, a discussion is made about the performance of the classifiers with respect to the magnitude of the pool of papers to be screened as well as to the amount of imbalance, referring to the proportion of relevant and irrelevant papers. Finally, it was concluded that the results presented in this report provide proof that the developed shiny application could be efficiently used in combination with other software such as DistillerSR.

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High prevalence of epilepsy in onchocerciasis endemic health areas in Democratic Republic of the Congo

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Infectious Diseases of Poverty 2018年第1期7卷 663-676页

作者： Evy Lenaerts Michel Mandro Deby Mukendi Patrick Suykerbuyk Housseini Dolo Deogratias Wonya’Rossi Françoise Ngave Chellafe Ensoy-Musoro Anne Laudisoit An Hotterbeekx Robert Colebunders Global Health Institute University of AntwerpAntwerpBelgium Provincial Health Division of Ituri Ministry of HealthBuniaDemocratic Republic of Congo Centre Neuro Psycho Pathologique Universitede Kinshasa(CNPP-UNIKIN)KinshasaDemocratic Republic of Congo International Center of Excellence in Research Faculty of Medicine and OdontostomatologyBamakoMali Neglected Tropical Diseases Control program Ministry of HealthBuniaDemocratic Republic of the Congo Centre de Recherche en Maladies Tropicales Hopital General de Reference de RethyRethyDemocratic Republic of Congo Interuniversity Institute for Biostatistics and statistical Bioinformatics University of HasseltHasseltBelgium EcoHealth Alliance New YorkUSA Global Health Institute Faculty of Medicine and Health SciencesGouverneur Kinsbergen CentrumDoornstraat 3312610 WilrijkBelgium

Background:A high prevalence of epilepsy has been observed in many onchocerciasis endemic *** study is to estimate the prevalence of active epilepsy and exposure to Onchocerca volvulus infection in a rural population in Ituri province,Democratic Republic of ***:In August 2016,a community-based cross-sectional study was conducted in an onchocerciasis endemic area in the rural health zone of Logo,Ituri *** within two neighbouring health areas were randomly *** identify persons with epilepsy,a three-stage approach was *** the first stage,all individuals of the selected households were screened for epilepsy by non-medical field workers using a validated 5-item *** the second and third stage,suspected cases of epilepsy were examined by non-specialist medical doctors,and by a neurologist,respectively.A case of epilepsy was defined according to the 2014 International League Against Epilepsy(ILAE)*** to *** was assessed by testing for IgG4 antibodies to an *** antigen(OV16 Rapid Test,)in individuals aged 3 years and ***:Out of 1389 participants included in the survey,64 were considered to have active epilepsy(prevalence 4.6%)(95%confidence interval[CI]:3.6-5.8).The highest age-specific epilepsy prevalence estimate was observed in those aged 20 to 29 years(8.2%).Median age of epilepsy onset was 10 years,with a peak incidence of epilepsy in the 10 to 15 year-old age ***16 test results were available for 912 participants,of whom 30.5%(95%CI,27.6-33.6)tested *** prevalence of OV16 positivity in a village ranged from 8.6 to 68.0%.After adjusting for age,gender and ivermectin use,a significant association between exposure to onchocerciasis and epilepsy was observed(adjusted odds ratio=3.19,95%CI:1.63-5.64)(P<0.001).Conclusions:A high prevalence of epilepsy and a significant association between epilepsy and exposure to *** were observed in the population in Ituri

关键词： Onchocerciasis epilepsy Prevalence Democratic Republic of Congo

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