Michael D Hughes

Michael D Hughes

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Michael D Hughes

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Sample size estimation for stratified individual and cluster randomized trials with binary outcomes.

Stat Med 2020 May 31;39(10):1489-1513. Epub 2020 Jan 31.

Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

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http://dx.doi.org/10.1002/sim.8492DOI Listing
May 2020

Effect of the American College of Surgeons Oncology Group Z0011 trial on axillary management in breast cancer patients in the Australian setting.

Breast J 2019 09 27;25(5):853-858. Epub 2019 May 27.

Breast Multidisciplinary Team, Sydney Adventist Hospital, Sydney, New South Wales, Australia.

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http://dx.doi.org/10.1111/tbj.13343DOI Listing
September 2019

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.

PLoS Med 2019 08 15;16(8):e1002882. Epub 2019 Aug 15.

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.

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http://dx.doi.org/10.1371/journal.pmed.1002882DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6695091PMC
August 2019

Gastric band tubing causing cecal volvulus.

Surg Obes Relat Dis 2018 Dec 16;14(12):1914-1915. Epub 2018 Aug 16.

Department of General Surgery and Associated Subspecialties, Sydney Adventist Hospital (SAH), Wahroonga, Sydney, Australia.

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http://dx.doi.org/10.1016/j.soard.2018.08.011DOI Listing
December 2018

Estimation of the cumulative incidence function under multiple dependent and independent censoring mechanisms.

Lifetime Data Anal 2018 04 25;24(2):201-223. Epub 2017 Feb 25.

Department of Biostatistics, Harvard School of Public Health, 655 Huntington Avenue, Boston, MA, 02115, USA.

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http://dx.doi.org/10.1007/s10985-017-9393-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572121PMC
April 2018

Hyperlipidaemia in HIV-infected patients on lopinavir/ritonavir monotherapy in resource-limited settings.

Antivir Ther 2017 14;22(3):205-213. Epub 2016 Oct 14.

Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health, Boston, MA, USA.

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http://dx.doi.org/10.3851/IMP3101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5392175PMC
March 2018

Time to first positive HIV-1 DNA PCR may differ with antiretroviral regimen in infants infected with non-B subtype HIV-1.

AIDS 2017 11;31(18):2465-2474

aDepartment of Biostatistics and Epidemiology, University of Massachusetts-Amherst, Amherst, Massachusetts bDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland cDivision of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia dDivision of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston eDepartment of Immunology and Infectious Diseases, Harvard University, T. H. Chan School of Public Health, Boston, Massachusetts, USA fBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana gUniversity College Institute of Child Health, London, UK hInstitut de recherche pour le développement (IRD) UMI 174-PHPT, Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand iDepartment of Biostatistics, Harvard University T. H. Chan School of Public Health, Boston, Massachusetts, USA jVirus Reference Department, National Infection Service, Public Health England, London, UK kDepartment of HIV/AIDS, World Health Organization, Geneva, Switzerland lDepartment of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand and National Institute for Communicable Diseases, Johannesburg, South Africa mSection of Infectious Diseases and International Health, Geisel School of Medicine at Dartmouth, 1 Medical Center Dr, Lebanon, New Hampshire nCenter for Biostatistics in AIDS Research, Harvard University T. H. Chan School of Public Health. Boston, Massachusetts, USA.

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http://dx.doi.org/10.1097/QAD.0000000000001640DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710822PMC
November 2017

Evaluating predictors of competing risk outcomes when censoring depends on time-dependent covariates, with application to safety and efficacy of HIV treatment.

Stat Med 2016 06 14;35(13):2183-94. Epub 2016 Jan 14.

Department of Biostatistics, Harvard T.H. Chan School of Public Health, Huntington Avenue, Boston, MA, 65502115, U.S.A.

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http://dx.doi.org/10.1002/sim.6852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4853244PMC
June 2016

In-utero triple antiretroviral exposure associated with decreased growth among HIV-exposed uninfected infants in Botswana.

AIDS 2016 Jan;30(2):211-20

aDepartments of Medicine and Pediatrics, Massachusetts General Hospital, Boston bDepartment of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA cBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana dDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA eElizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe fFaculty of Medicine, University of Botswana, Gabarone, Botswana gDivisions of Infectious Diseases and General Medicine, Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine, Mount Sinai, New York City, New York, USA hDepartment of Epidemiology, Harvard T.H. Chan School of Public Health iInfectious Disease Division, Brigham and Women's Hospital, Boston jDepartments of Global Health and Population, Nutrition and Epidemiology, Harvard T.H. Chan School of Public Health kBeth Israel Deaconess Medical Center, Infectious Diseases Department, Boston, Massachusetts, USA.

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http://pdfs.journals.lww.com/aidsonline/2016/01140/In_utero_
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http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:land
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http://dx.doi.org/10.1097/QAD.0000000000000895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685731PMC
January 2016

An augmented SMS intervention to improve access to antenatal CD4 testing and ART initiation in HIV-infected pregnant women: a cluster randomized trial.

PLoS One 2015 18;10(2):e0117181. Epub 2015 Feb 18.

Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, United States of America; Harvard Medical School, Boston, Massachusetts, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0117181PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334487PMC
November 2015

Dietary diabetes risk reduction score, race and ethnicity, and risk of type 2 diabetes in women.

Diabetes Care 2015 Apr 15;38(4):596-603. Epub 2015 Jan 15.

Department of Epidemiology, Harvard School of Public Health, Boston, MA Department of Nutrition, Harvard School of Public Health, Boston, MA Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.2337/dc14-1986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4370327PMC
April 2015

Exposures and cross-shift lung function declines in wildland firefighters.

J Occup Environ Hyg 2014 ;11(9):591-603

a Department of Preventive Medicine and the Institute for Translational Epidemiology , Icahn School of Medicine at Mount Sinai , New York , New York.

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http://dx.doi.org/10.1080/15459624.2014.895372DOI Listing
March 2015

Vitamin D insufficiency in HIV-infected pregnant women receiving antiretroviral therapy is not associated with morbidity, mortality or growth impairment in their uninfected infants in Botswana.

Pediatr Infect Dis J 2014 Nov;33(11):1141-7

From the *Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital; †Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, MA; ‡Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; §Brigham and Women's Hospital, Infectious Disease Division; ¶Center for Biostatistics in AIDS Research, Harvard School of Public Health; ‖Department of Global Health and Population, Harvard School of Public Health; **Division of Endocrinology, Boston Children's Hospital; and ††Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA.

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https://insights.ovid.com/crossref?an=00006454-201411000-000
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http://dx.doi.org/10.1097/INF.0000000000000428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216630PMC
November 2014

Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission.

Pediatr Infect Dis J 2014 Aug;33(8):846-54

From the *Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA; †University of Witwatersrand, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Johannesburg, South Africa; ‡Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; §Department of Epidemiology, ICAP, Mailman School of Public Health and College of Physicians and Surgeons, Columbia University, New York, NY; ¶Department of Paediatrics and Child Health, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; ‖Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; **University of North Carolina Project, Lilongwe, Malawi; ††University Teaching Hospital, Lusaka, Zambia; ‡‡Division of Paediatrics and Infectious Diseases, Tygerberg Children's Hospital, Stellenbosch University, Tygerberg; §§University of the Witwatersrand Reproductive Health and HIV Institute, Faculty of Health Sciences, Johannesburg, South Africa; ¶¶Department of Pediatrics, BJ Medical College and Sassoon General Hospital, Pune, India; ‖‖Duke University-Kilimanjaro Christian Medical Center Collaboration, Moshi, Tanzania; ***Department of Paediatrics and Child Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; †††Frontier Science and Technology Research Foundation, Amherst, NY; ‡‡‡Social and Scientific Systems, Durham, NC; §§§Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD; ¶¶¶HJF-DAIDS, a Division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Contractor to NIAID, NIH, DHHS, Bethesda, MD; and ‖‖‖Division of Infectious Diseases and International Health, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH.

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http://dx.doi.org/10.1097/INF.0000000000000337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4166566PMC
August 2014

Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants.

PLoS One 2013 23;8(9):e74171. Epub 2013 Sep 23.

Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, United States of America ; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana ; Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, United States of America.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0074171PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3781096PMC
July 2014

Arterial stiffness, oxidative stress, and smoke exposure in wildland firefighters.

Am J Ind Med 2014 Jul 6;57(7):748-56. Epub 2014 Jun 6.

Department of Preventive Medicine and the Institute for Translational Epidemiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Environmental Health (Environmental and Occupational Medicine and Epidemiology Program), Harvard School of Public Health, Boston, Massachusetts.

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http://dx.doi.org/10.1002/ajim.22331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4629844PMC
July 2014

Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE).

J Acquir Immune Defic Syndr 2014 Jun;66(2):155-63

*Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; †U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD; ‡Harvard School of Public Health, Boston, MA; §Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD; ‖University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi; ¶Social & Scientific Systems, Inc., Silver Spring, MD; #Brigham and Women's Hospital, Boston, MA; **Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana; and ††University of California Los Angeles, Los Angeles, CA (Dr. Douglas Shaffer is now with the U.S. Centers for Disease Control and Prevention (CDC), Kigali, Rwanda).

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http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:land
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http://dx.doi.org/10.1097/QAI.0000000000000131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4109714PMC
June 2014

Stratified Weibull Regression Model for Interval-Censored Data.

R J 2014 Jun;6(1):31-40

Division of Biostatistics and Epidemiology. University of Massachusetts, Amherst, MA, USA,

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4729374PMC
June 2014

Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine.

AIDS 2014 May;28(8):1135-42

aUniversity of North Carolina Project, Kamuzu Central Hospital, Lilongwe bJohns Hopkins Project, Queen Elizabeth Central Hospital, Blantyre, Malawi cHarvard School of Public Health, Boston, Massachusetts dSocial & Scientific Systems, Inc., Silver Spring, Maryland, USA eUZ-UCSF Collaborative Research Programme, Harare, Zimbabwe fCenter for Infectious Disease Research, Lusaka, Zambia gMoi University (College of Health Sciences), Eldoret, Kenya hUniversity of California, Los Angeles, Los Angeles, California iBrigham and Women's Hospital, Boston, Massachusetts jUniversity of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.

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http://dx.doi.org/10.1097/QAD.0000000000000202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176616PMC
May 2014

Within- and between-child variation in repeated urinary pesticide metabolite measurements over a 1-year period.

Environ Health Perspect 2014 Feb 10;122(2):201-6. Epub 2013 Dec 10.

Department of Environmental Health, and.

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http://dx.doi.org/10.1289/ehp.1306737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915262PMC
February 2014

High hsCRP is associated with reduced lung function in structural firefighters.

Am J Ind Med 2014 Jan 20;57(1):31-7. Epub 2013 Sep 20.

Department of Preventive Medicine, Institute for Translational Epidemiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Environmental Health (Environmental and Occupational Medicine and Epidemiology Program), Harvard School of Public Health, Boston, Massachusetts.

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http://dx.doi.org/10.1002/ajim.22260DOI Listing
January 2014

Bone mineral density effects of randomized regimen and nucleoside reverse transcriptase inhibitor selection from ACTG A5142.

HIV Clin Trials 2013 Sep-Oct;14(5):224-34

Department of Pediatrics, University of California San Diego, La Jolla, California.

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http://dx.doi.org/10.1310/hct1405-224DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956746PMC
January 2014

Differential associations of leptin with adiposity across early childhood.

Obesity (Silver Spring) 2013 Jul 25;21(7):1430-7. Epub 2013 May 25.

Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.

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http://dx.doi.org/10.1002/oby.20314DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659179PMC
July 2013

Choline intake during pregnancy and child cognition at age 7 years.

Am J Epidemiol 2013 Jun 20;177(12):1338-47. Epub 2013 Feb 20.

Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.

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https://aje.oxfordjournals.org/content/early/2013/02/19/aje.
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http://aje.oxfordjournals.org/cgi/doi/10.1093/aje/kws395
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http://dx.doi.org/10.1093/aje/kws395DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3676149PMC
June 2013

The design of single-arm clinical trials of combination antiretroviral regimens for treatment-naive HIV-infected patients.

AIDS Res Hum Retroviruses 2013 Apr 9;29(4):652-7. Epub 2013 Jan 9.

Statistical Data Analysis Center, Harvard School of Public Health, Boston, MA 02115, USA.

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http://dx.doi.org/10.1089/AID.2012.0180DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607972PMC
April 2013

Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.

J Acquir Immune Defic Syndr 2012 Nov;61(3):326-33

Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, Boston, MA 20114, USA.

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http://dx.doi.org/10.1097/QAI.0b013e31826be75eDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3649850PMC
November 2012

The impact of psoriasis on pregnancy outcomes.

J Invest Dermatol 2012 Jan 15;132(1):85-91. Epub 2011 Sep 15.

Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.

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http://linkinghub.elsevier.com/retrieve/pii/S0022202X1535465
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http://dx.doi.org/10.1038/jid.2011.271DOI Listing
January 2012

Increased risk of severe infant anemia after exposure to maternal HAART, Botswana.

J Acquir Immune Defic Syndr 2011 Apr;56(5):428-36

Department of Medicine, Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA 02115, USA.

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http://dx.doi.org/10.1097/QAI.0b013e31820bd2b6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112252PMC
April 2011

Vitamin D deficiency and anthropometric indicators of adiposity in school-age children: a prospective study.

Am J Clin Nutr 2010 Dec 6;92(6):1446-51. Epub 2010 Oct 6.

Departments of Nutrition and Environmental Health Sciences, School of Public Health, University of Michigan, Ann Arbor, MI, USA.

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https://academic.oup.com/ajcn/article/92/6/1446/4597539
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http://dx.doi.org/10.3945/ajcn.2010.29746DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3131841PMC
December 2010

Dynamic calibration of pharmacokinetic parameters in dose-finding studies.

Biostatistics 2010 Jul 4;11(3):537-45. Epub 2010 Mar 4.

Institut National de la Santé et de la Recherche Médicale, LSTA, Université Pierre et Marie Curie-Paris 6, Paris, France.

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http://dx.doi.org/10.1093/biostatistics/kxq002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2883303PMC
July 2010

Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection.

AIDS 2010 Jul;24(12):1867-76

Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA.

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http://dx.doi.org/10.1097/QAD.0b013e32833adbcfDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3018341PMC
July 2010

Neurodevelopment and in utero antiretroviral exposure of HIV-exposed uninfected infants.

Pediatrics 2010 Feb 18;125(2):e250-60. Epub 2010 Jan 18.

Department of Biostatistics, Harvard School of Public Health, 665 Huntington Ave, Building I, 415, Boston, MA 02115-6017, USA.

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http://dx.doi.org/10.1542/peds.2009-1112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2951128PMC
February 2010

A statistical framework for quantile equivalence clinical trials with application to pharmacokinetic studies that bridge from HIV-infected adults to children.

Biometrics 2008 Dec 7;64(4):1117-25. Epub 2008 Feb 7.

Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA.

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http://dx.doi.org/10.1111/j.1541-0420.2007.00982.xDOI Listing
December 2008

Practical issues arising in an exploratory analysis evaluating progression-free survival as a surrogate endpoint for overall survival in advanced colorectal cancer.

Authors:
Michael D Hughes

Stat Methods Med Res 2008 Oct 19;17(5):487-95. Epub 2008 Feb 19.

Department of Biostatistics, Harvard School of Public Health, 655 Huntington Avenue, Boston, MA 02445, USA.

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http://dx.doi.org/10.1177/0962280207081860DOI Listing
October 2008

Insulin-like growth factor-1 and lean body mass in HIV-infected children.

J Acquir Immune Defic Syndr 2008 Aug;48(4):437-43

Department of Pediatrics, University of California Davis Medical Center, 2516 Stockton Boulevard, Sacramento, CA 95817, USA.

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http://dx.doi.org/10.1097/QAI.0b013e31817bbe6dDOI Listing
August 2008

Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy.

Pediatrics 2008 Jul 2;122(1):e129-38. Epub 2008 Jun 2.

Department of Pediatrics, University of California Davis Medical Center, Sacramento, California 95817, USA.

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http://dx.doi.org/10.1542/peds.2007-2467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2782494PMC
July 2008

The search for data on when to start treatment for HIV infection.

J Infect Dis 2008 Apr;197(8):1084-6

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http://dx.doi.org/10.1086/586712DOI Listing
April 2008

Long-term observation of adolescents initiating HAART therapy: three-year follow-up.

AIDS Res Hum Retroviruses 2007 Oct;23(10):1208-14

Department of Infectious Diseases, St. Jude Children's Research Hospital, University of Tennessee Health Science Center, Memphis, Tennessee 38105, USA.

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http://dx.doi.org/10.1089/aid.2006.0290DOI Listing
October 2007

A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis.

Clin Gastroenterol Hepatol 2007 Aug 5;5(8):946-51; quiz 886. Epub 2007 Jul 5.

Section of Gastroenterology, Boston University Medical Center, 85 East Concord Street, Room 7721, Boston, Massachusetts 02118, USA.

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http://dx.doi.org/10.1016/j.cgh.2007.04.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2034288PMC
August 2007