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arXiv 2024年

作者： Soltanifar, Mohsen Lee, Chel Hee Shirazi, Amin Behnke, Martha Raymond-Loher, Ilfra Dagne, Getachew A. Analytics Division College of Professional Studies Northeastern University 1400-410 West Georgia Street VancouverBCV6B 1Z3 Canada Department of Mathematics and Statistics University of Calgary 2500 University Drive NW CalgaryABT2N 1N4 Canada Department of Statistics College of Liberal Arts and Sciences Iowa State University 2438 Osborn Dr AmesIA50011-1090 United States MPH Biostatistics Program College of Public Health University of South Florida 3010 USF Banyan Circle TampaFL United States Department of Critical Care Medicine Alberta Heath Services University of Calgary 3260 Hospital Dr NW CalgaryABT2N 4Z6 Canada Biostatistics & Programming Division Biometrics Department ClinChoice Inc. 750-2 Robert Speck Parkway MississaugaONL4Z 1H8 Canada Biostatistics & Programming Division Biometrics Department ClinChoice Inc. 11300 Virginia Dr. 4th Floor Fort WashingtonPA19034 United States

The precise calculation of sample sizes is a crucial aspect in the design of clinical trials particularly for pharmaceutical statisticians. While various R statistical software packages have been developed by researchers to estimate required sample sizes under different assumptions, there has been a notable absence of a standalone R statistical software package that allows researchers to comprehensively estimate sample sizes under generalized scenarios. This paper introduces the R statistical software package"GenTwoArmsTrialSize," available on the Comprehensive R Archive Network (CRAN), designed for estimating the required sample size in two-arm clinical trials. The package incorporates four endpoint types, two trial treatment designs, four types of hypothesis tests, as well as considerations for noncompliance and loss of follow-up, providing researchers with the capability to estimate sample sizes across 24 scenarios. To facilitate understanding of the estimation process and illuminate the impact of noncompliance and loss of follow-up on the size and variability of estimations, the paper includes four hypothetical examples and one applied example. The discussion encompasses the package’s limitations and outlines directions for future extensions and *** Codes 62-04, 62-08, 62K05 © 2024, CC BY-NC-SA.

关键词： Software packages

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Evaluation of Nutrition Surveys in Flood-affected Areas of Pakistan: Seeing the Unseen!

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IDS BULLETIN-INSTITUTE OF DEVELOPMENT STUDIES 2013年第3期44卷 10-20页

作者： Hossain, S. M. Moazzem Talat, Mah Boyd, Erin Chowdhury, Shamim Rafique Soofi, Sajid Bashir Hussain, Imtiaz Ahmed, Imran Salam, Rehana Abdus Bhutta, Zulfiqar A. Chief of Health and Nutrition in UNICEF Afghanistan having previously worked in UNICEF Pakistan Sri Lanka and the New York Headquarters. Certified Master Trainer with expertise in facilitation skills monitoring and programme management. Emergency Nutrition Specialist at the United Nations Children''s Fund (UNICEF) Headquarters with over ten years of experience in humanitarian response and policy related to emergency nutrition programming and data analysis. Has Been the Director General of the Bureau of Statistics (BOS) Planning and Development Department Government of Punjab Pakistan since 2007. Pediatrician and researcher. He is a Fellow of Pediatrics and has a long affiliation with the Department of Pediatrics and Child Health at the Aga Khan University Karachi where he is currently working as an Assistant Professor and Coordinator. Presently holds the position of Senior Social Scientist at the Aga Khan University Karachi. Working as Data Manager at the Department of Paediatrics Aga Khan University Karachi. Has been a Senior Instructor (Research) at the Aga Khan University Karachi since November 2012 and holds a master''s degree in Epidemiology and Biostatistics from the university. Professor and founding chair of the Division of Maternal and Child Health Aga Khan University Karachi

In 2010 Pakistan experienced the worst floods recorded in its history;millions of people were affected and thousands lost their lives. Nutrition assessment surveys led by UNICEF were conducted in flood-affected areas of Punjab and Sindh provinces to assess the nutrition status of children between 659 months while Aga Khan University (AKU) undertook a parallel assessment including micronutrient status in their project areas within Balochistan, Sindh and Punjab. Standardised Monitoring and Assessment of Relief and Transition (SMART) methodology was used. 881 children from Sindh, 1,143 from Punjab and 817 from AKU project areas were measured for anthropometry and their households were interviewed. The findings indicated that while immediate life-saving interventions were essential, there was also an urgent need to address chronic malnutrition. Through high-level dissemination of the survey results, treatment and prevention of malnutrition has become a priority for the provincial and federal government in Pakistan and for donors.

关键词： FLOODS NUTRITION surveys MALNUTRITION -- Treatment ANTHROPOMETRY PUNJAB (Pakistan) -- Environmental conditions

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Prenatal nitrate exposure from diet and drinking water and timing of puberty in sons and daughters: A nationwide cohort study

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Environment International 2022年 170卷 107659页

作者： Jul Clemmensen, Pernille Brix, Nis Schullehner, Jörg Lunddorf, Lea Lykke Harrits Ernst, Andreas Ebdrup, Ninna Hinchely Bjerregaard, Anne Ahrendt Hansen, Birgitte Thomas Stayner, Leslie Ingi Halldorsson, Thorhallur Frodi Olsen, Sjurdur Sigsgaard, Torben Kolstad, Henrik Albert Ramlau-Hansen, Cecilia Høst Department of Public Health Aarhus University Aarhus Denmark Department of Clinical Genetics Aarhus University Hospital Aarhus Denmark Geological Survey of Denmark and Greenland Aarhus Denmark Aarhus University Aarhus Denmark Fertility Clinic Horsens Regional Hospital Horsens Denmark Department of Epidemiology Research Center for Fetal Programming Statens Serum Institut Copenhagen Denmark Centre for Clinical Research and Prevention Bispebjerg and Frederiksberg Hospital Copenhagen Denmark Division of Epidemiology and Biostatistics University of Illinois at Chicago School of Public Health Chicago United States Faculty of Food Science and Nutrition School of Health Sciences University of Iceland Iceland Section of Epidemiology Institute of Public Health University of Copenhagen Denmark Cirrau -Centre for Integrated Register-based Research at Aarhus University Aarhus Denmark Department of Occupational Medicine Aarhus University Hospital Aarhus Denmark Department of Clinical Medicine Aarhus University Aarhus Denmark

Background: In Western countries, age at pubertal development has declined during the last century in girls, and probably also in boys. No studies have investigated whether nitrate, a widespread environmental exposure with teratogenic and hormone disrupting properties, might affect timing of puberty. Objectives: We investigated if prenatal exposure to nitrate from drinking water and diet was associated with timing of puberty. Methods: This cohort study included 15,819 children born from 2000 to 2003 within the Danish National Birth Cohort. Self-reported information on current status of various pubertal milestones was provided every six months by a questionnaire from 11 years of age until 18 years or full maturity, whichever came first. Maternal nitrate intake from diet (mg/day) was derived from a mid-pregnancy food frequency questionnaire and individual level nitrate exposure from drinking water (mg/L) was derived using measurements from Danish public waterworks. Adjusted average differences in months in age at attaining several pubertal milestones as well as the average age difference in age at attaining all the milestones were estimated separately for diet and water using a regression model for interval-censored data. C- and E-vitamin, red meat and processed meat intake were explored as potential effect modifiers in sub-analyses. Results: No strong associations were observed between prenatal exposure to nitrate and timing of puberty in children. However, sons born of mothers with a nitrate concentration in drinking water at their residential address of > 25 mg/L (half of the World Health Organisation (WHO) guideline value) compared with ≤ 1 mg/L showed a tendency towards earlier age at pubertal development with an average age difference of −1.2 months (95 % confidence interval,−3.0;0.6) for all the pubertal milestones combined. Discussion: Studies including more highly exposed children are needed before the current WHO drinking water guideline value for nitrate ca

关键词： Potable water

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Correction

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Statistics in Medicine 2007年第27期26卷

作者： Yujun Wu Weichung J. Shih Dirk F. Moore Biostat and Programming Sanofi-Aventis Bridgewater NJ U.S.A. Department of Biostatistics University of Medicine and Dentistry of New Jersey Piscataway NJ U.S.A. Department of Biometrics University of Medicine and Dentistry of New Jersey Piscataway NJ U.S.A.

‘Estimating a survival curve with unlinked entry and failure times’, by Yujun Wu, Weichung J. Shih and Dirk F. Moore ( Statistics in Medicine 2007; 26 :3624–3638). (1) Equation (5) on page 3629 reads which should r...

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MP-06.17: Efficacy and safety of dutasteride, tamsulosin and the combination in Asian men: 4-year results from the randomised, double-blind, CombAT trial

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Urology 2009年第4期74卷 S74-S74页

作者： Chung, B.H. Roehrborn, C. Siami, P. Major-Walker, K. Wilson, T. Montorsi, F. Department of Urology Yonsei University Health System Seoul Korea Department of Urology UT Southwestern Medical Center Dallas Texas Welborn Clinic Evansville Indiana USA Clinical Development GlaxoSmithKline Research Triangle Park North Carolina USA Biostatistics and Programming GlaxoSmithKline Research Triangle Park North Carolina USA Department of Urology Universita Vita Salute San Raffaele Milan Italy

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P0054 - An integrated analysis of the efficacy of desvenlafaxine succinate compared with placebo in the treatment of major depressive disorder

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European Psychiatry 2020年第S2期23卷 S208-S208页

作者： M.E. Thase S.G. Kornstein R. Tummala J.M. Germain Q. Jiang S. Ahmed P.T. Ninan Department of Psychiatry Mood and Anxiety Disorders Treatment and Research Program University of Pennsylvania Philadelphia PA USA Department of Psychiatry and Obstetrics and Gynecology Mood Disorders Institute and The Institute for Womens Health Virginia Commonwealth University School of Medicine Virginia Commonwealth University Richmond VA USA Department of Global Medical Affairs Wyeth Research Collegeville PA USA Department of Neuroscience Wyeth Research Paris France Department of Global Biostatistics and Programming Wyeth Research Collegeville PA USA

Objective:To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).Methods:Seven randomized, double-blind, placebo-controlled, short-term studies were pooled to evaluate the efficacy of DVS in MDD. Adult outpatients with DSM-IV MDD were enrolled in all studies. Eligible patients were randomly assigned to DVS (n=1186) at doses of 100–400 mg/d, or placebo (n=797) for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAM-D17) was the primary efficacy variable. Other efficacy variables were the Clinical Global Impressions scale (CGI), HAM-D6, Montgomery Åsberg Depression Rating Scale (MADRS), Covi Anxiety scale, Sheehan Disability Scale (SDS), WHO-5 Well-Being Index, and the Visual Analog Scale–Pain Intensity (VAS-PI). A mixed-effect model for repeated measures (MMRM) analysis was used to analyze continuous variables. Logistic regression was used to analyze response and remission ***:An adjusted mean difference of –2.8 points on HAM-D17 total score at end point for DVS vs placebo (95% confidence limits: –2.2, –3.4; P<0.001) was demonstrated. Response and remission rates were significantly elevated for DVS-treated patients compared with placebo (P<0.001) across rating scales (HAM-D17, MADRS, and CGI). For other secondary measures at end point, including the CGI, HAM-D6, MADRS, Covi, SDS, WHO-5, and VAS-PI, significant differences from placebo were also observed. No additional benefit was observed for DVS doses above 100 mg/d in analyses of fixed-dose ***:DVS was efficacious in treating MDD based on standard depression rating scales and measures of anxiety, global severity/improvement, functioning, well being, and pain.

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Baseline Characteristics Of Patients With Chronic Myeloid Leukemia In a Prospective Observational Study (SIMPLICITY)

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BLOOD 2013年第21期122卷 4026-4029页

作者： Cortes, Jorge E. Hehlmann, Rudiger Gambacorti-Passerini, Carlo Goldberg, Stuart Khoury, H. Jean Mauro, Michael Michallet, Mauricette Paquette, Ron Simonsson, Bengt Foreman, Aimee Mohamed, Hesham Zyczynski, Teresa Hirji, Ishan Davis, Catherine Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX USA Department of Hematology/ Oncology University of Heidelberg Mannheim Germany Department of Internal Medicine and Clinical Research Unit University of Milano-Bicocca Monza Italy Division of Leukemia John Theurer Cancer Center at Hackensack University Medical Center Hackensack NJ USA Department of Hematology and Medical Oncology Winship Cancer Institute of Emory University Emory University Atlanta GA USA Memorial Sloan Kettering Cancer Center New York NY USA Centre Hospitalier Lyon Sud Pierre Benite France Ronald Reagan UCLA Medical Center University of California Los Angeles Los Angeles CA USA Department of Medical Sciences Hematology Uppsala University Hospital Uppsala Sweden ICON Clinical Research Biostatistics & Programming San Francisco CA USA Bristol-Myers Squibb Plainsboro NJ USA Global Health Economics and Outcomes Research Bristol-Myers Squibb Co. Princeton NJ USA Oncology Global Health Outcomes Bristol-Myers Squibb Co. Wallingford CT USA

4026

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187P Impact of KRAS mutational status and primary tumor location on the efficacy of aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer: An exploratory analysis in a phase II study

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Annals of Oncology 2017年第SUPPL_10期28卷

作者： K Yamazaki T Satoh Y Komatsu T Taguchi Y Sunaga T Yoshino Gastroenterology Surgery Oncology Shizuoka Cancer Center Sunto Gun Japan Graduate School of Medicine Osaka University Suita Japan Cancer Center Hokkaido University Hospital Sapporo Japan Medical Sanofi Japan Tokyo Japan Biostatistics & Programming Sanofi Japan Tokyo Japan Department of Gastroenterology and Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan

187P Impact of KRAS mutational status and primary tumor location on the efficacy of aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer: An exploratory analysis in a phase II study K Yamazaki Gastroenterology, Surgery, Oncology, Shizuoka Cancer Center, Sunto Gun, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Yamazaki T Satoh Graduate School of Medicine, Osaka University, Suita, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Satoh Y Komatsu Cancer Center, Hokkaido University Hospital, Sapporo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Komatsu T Taguchi Medical, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Taguchi Y Sunaga biostatistics & programming, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Sunaga T Yoshino department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Yoshino Annals of Oncology, Volume 28, Issue suppl_10, 1 November 2017, mdx659.044, https://***/10.1093/annonc/mdx659.044 Published: 22 November 2017

关键词： k-ras oncogene kras2 gene

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214 Efficacy and safety of switching from adalimumab to sarilumab in an open-label extensionof a phase III monotherapy trial in patients with active rheumatoid arthritis

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Rheumatology 2018年第SUPPL_3期57卷

作者： Burmester, Gerd R Fiore, Stefano Hu, Chih-Chi Fay, Jon Lee, Eun Bong Genovese, Mark C Department of Rheumatology and Clinical Immunology Charité—University Medicine Berlin Berlin GERMANY US Global Medical Affairs Sanofi Genzyme Bridgewater NJ USA Biostatistics and Programming Sanofi Bridgewater NJ USA Medical Affairs Regeneron Pharmaceuticals Inc. Tarrytown NY USA Division of Rheumatology Department of Internal Medicine Seoul National University College of Medicine Seoul KOREA REPUBLIC OF Rheumatology Department Stanford University Medical Center Palo Alto CA USA

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519P Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study

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Annals of Oncology 2017年第SUPPL_10期28卷

作者： H Uemura T Kosaka M Sumitomo K Harada M Sugimoto N Hayashi K Yoshimura S Fukasawa E B Ecstein-Fraisse Y Sunaga M Oya Department of Urology/Renal Transplantation Yokohama City University Medical Center Yokohama Japan Department of Urology Keio University Hospital Tokyo Japan Department of Urology Aichi Medical University Hospital Aichi Japan Department of Urology Kobe University Hospital Kobe Japan Department of Urology Kagawa University Hospital Kagawa Japan Department of Urology Yokohama City University Hospital Yokohama Japan Department of Urology Kindai University Hospital Osaka Japan Department of Urology/Prostate Cancer Chiba Cancer Center Chiba Japan Medical Sanofi France Paris France Biostatistics & Programming Sanofi Japan Tokyo Japan

519P Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study H Uemura department of Urology/Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar H Uemura T Kosaka department of Urology, Keio University Hospital, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Kosaka M Sumitomo department of Urology, Aichi Medical University Hospital, Aichi, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar M Sumitomo K Harada department of Urology, Kobe University Hospital, Kobe, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Harada M Sugimoto department of Urology, Kagawa University Hospital, Kagawa, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar M Sugimoto N Hayashi department of Urology, Yokohama City University Hospital, Yokohama, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar N Hayashi K Yoshimura department of Urology, Kindai University Hospital, Osaka, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Yoshimura S Fukasawa department of Urology/Prostate Cancer, Chiba Cancer Center, Chiba, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar S Fukasawa E B Ecstein-Fraisse Medical, Sanofi France, Paris, France Search for other works by this author on: Oxford Academic PubMed Google Scholar E B Ecstein-Fraisse Y Sunaga biostatistics & programming, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Sunaga ... Show more M Oya department of Urology, Keio University Hospital, Tokyo, Japan Search for other works by this

关键词： prostate cancer, androgen-independent prevention japanese

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