Michalek CV (24 August 2016)

CURRICULUM VITAE

Joel Edmund Michalek

GENERAL INFORMATION

PERSONAL DATA: Date of Preparation: 08/22/2016

Address:

The University of Texas Health Science Center

Department of Epidemiology and Biostatistics, MSC 7933

7703 Floyd Curl Drive, MSN 7933

San Antonio, TX 78229-3900

Phone Number: (210) 567-0886

Fax Number: (210) 567-0921

Email Address: [email protected]

SELF DESCRIPTION:

I have 40 years experience in the analysis and reporting of clinical and epidemiological studies and

30 years experience as a consultant to the pharmaceutical industry, I have published papers in

statistical methodology, clinical trials, and epidemiology, and my current interests include methods

to analyze survival and count data in cross-over studies.

EDUCATION:

Year Degree Discipline Institution/Location

1973 PhD Mathematical Statistics Wayne State University, Detroit, MI

1968 MS Mathematics Wayne State University, Detroit, MI

1966 BS Mathematics Wayne State University, Detroit, MI

ACADEMIC APPOINTMENTS:

06/2015 - Present Professor UT Health Science Center at San Antonio, Department of

Epidemiology and Biostatistics, San Antonio, TX

06/2006 - 06/2015 Professor and Vice

Chairman UT Health Science Center at San Antonio, Department of

Epidemiology & Biostatistics, San Antonio, TX

05/2005 - 05/2006 Professor and Co-

Director UT Health Science Center at San Antonio, Center for


03/2005 - 05/2005 Clinical Professor UT Health Science Center at San Antonio, Department of


09/1993 - Present Adjunct Professor The University of Texas at San Antonio, Department of

Management Science and Statistics, San Antonio, TX

09/1973 - 06/1976 Assistant

Professor Syracuse University, Department of Mathematics,

Syracuse, NY

Details: I taught undergraduate and graduate courses in mathematical statistics and

probability theory.

NON-ACADEMIC APPOINTMENTS:

03/1977 - 05/2005 Mathematical Statistician

GS-15 Air Force Research Laboratory, Brooks City-

Base, TX

Details: Directed Energy Bioeffects Division. Principal Investigator, Air Force Health Study (The

Ranch Hand Study): 1994 to 2005.

07/1976 - 02/1977 Mathematical Statistician

GS-12 Transportation Systems Center, Cambridge,

MA

HONORS AND AWARDS:

06/2016 Fellow of the American Statistical Association: For contributions to survival analysis and

pharmacokinetics, for novel applications of statistics in assessing adverse health effects of

dioxin exposure in Vietnam veterans, for consulting service in private industry, and for service

to the nation and the profession.

09/1997 CDC and ATSDR Statistical Science Award: Paper Finalist in recognition of "Pharmacokinetics

of TCDD in Veterans of Operation Ranch Hand: 10-Year Follow-up." Journal of Toxicology and

Environmental Health.

06/1993 CDC & ATSDR Statistics Award: For statistical excellence demonstrated by the publication of

"Effects of Measurement Error on Estimating Biological Half-Life." Journal of Exposure Analysis

and Environmental Epidemiology 1993; 2:463-476.

PROFESSIONAL DEVELOPMENT:

Administrative

Date Description

C.E.

Units/Hours

07/21/1997 - 08/01/1997 Science, Technology & Public Policy - U.S. Office

of Personnel Management

0.00 / 0.00

11/06/1992 - 11/11/1992 Science, Technology & Public Policy - U.S. Office

of Personnel Management

0.00 / 0.00

05/19/1989 - 05/24/1989 Executive Development Seminar - U.S. Office of

Personnel Management

0.00 / 0.00

09/24/1982 - 09/28/1982 Personnel Management for Executives, U.S.

Department of Defense

0.00 / 0.00

11/11/1981 - 11/14/1981 Theory Z. Institute for Professional Education 0.00 / 0.00

11/30/1978 - 12/02/1978 Laboratory Management of Research &

Development, Air Force Institute of Technology

0.00 / 0.00

Other

Date Description

C.E.

Units/Hours

10/30/2000 - 10/31/2000 Preparing and Delivering Congressional Testimony 0.00 / 0.00

Research

Date Description

C.E.

Units/Hours

04/25/2007 CITI Certification 0.00 / 0.00

09/25/2004 Human Participant Protections Education for

Research Teams, NCI

0.00 / 0.00

04/17/2003 HIPAA Certification Privacy101: Privacy

Awareness

0.00 / 0.00

09/13/1985 - 09/15/1985 Future Uses of Medical Databases 0.00 / 0.00

TEACHING

COURSE BASED TEACHING:

Date Course Name Level Role

08/2007 - 10/2007 STA 6973 Clinical Trials Undergraduate/Graduate Instructor

3 Credits

08/2006 - 09/2007 MEDI6060 Patient Orient Clin Res

Method-2 Undergraduate/Graduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Patient Oriented Clinical Research Methods 2,

Masters of Clinical Investigations

09/2004 - 12/2004 PH 1730 Statistical Methods in

Epidemiological Research Graduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Statistical methods in epidemiology

09/2004 - 12/2004 STA 3513 Probability and

Statistics Undergraduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Probability and statistics

05/2004 - 08/2004 STA 1053 Basic statistics Undergraduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Elementary statistics

05/2004 - 08/2004 STA 4133 Introductory Data

Analysis with Statistical Software Undergraduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Data analysis with statistical software



Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Probability and statistics

01/2004 - 05/2004 STA 5133 Data Analysis with

Statistical Software Graduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Data analysis with statistical software

09/2003 - 12/2003 STA 5133 Data Analysis with

Statistical Software Graduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Statistical software and applications

05/2003 - 08/2003 STA 3523 Statistical Methods Undergraduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Mathematical statistics



Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Probability theory and statistics

09/2002 - 12/2002 STA 4953 Special Studies in


Teacher


09/2002 - 12/2002 STA 6953 Independent Study Graduate Sole

Teacher


05/2002 - 08/2002 STA 1053 Basic Statistics Undergraduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Elementary statistical methods



Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; Probability theory and statistics

09/2000 - 12/2000 STA 5073 Methods of Statistics I Graduate Sole

Teacher

Preparation Hrs: 3, Student Contact Hrs: 3 ; mathematical statistics

09/1999 - 12/1999 STA 5083 Methods of Statistics II Graduate Sole

Teacher


01/1999 - 05/1999 STA 5073 Methods of Statistics Graduate Sole

Teacher



Teacher



Teacher



Teacher



Teacher



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RESEARCH

EXPERTISE:

NIH Study Sections - Clinical Oncology Study Section, 19 May 2008, Bethesda, MD.

Signal processing methods in cardiology - A recent study of admittance technology to measure left

ventricular volume employed repeated measures statistical modelling and signal processing methods.

The results were published in 2015 in Larson, Erik R, Porterfield, John E., Marmol-Velez, Juan, Panday,

Manoj, Sagar, Sandeep, Escobedo, Daniel, Michalek JE, Ouyang, Yongjian, Valvano, Jonathan, Pearce,

John A, Feldman MD. Admittance to Detect Alterations in Left Ventricular Stroke Volume Heart Rhythm

2014 Nov;11(11):2075-2083.

PROJECTS:

Clinical Research

03/2012-

09/2012 Prevalence of Demyelinating Polyneuropathy, in Patients with Primary Fibromyalgia

Russell IJ, Michalek JE. AxelaCare Health Solutions Inc, Lenexa KS

06/2010-

Present A Diagnostic Device for Lung Cancer, Cancer Prevention and Cure, Michigan City,

Indiana

02/2000-

11/2000 Antipolymer antibodies in the serum of patients with fibromyalgia syndrome, Autoimmune

Technologies, LLC 144 Elks Place, Suite 1402, New Orleans, Louisiana 70112

Clinical Trials

01/2013-

06/2013 A Pivotal, Phase III Trial of Detecting Generalized, Tonic-Clonic Seizures with a Seizure

Detection and Warning System in Epilepsy Patients. Brain Sentinel, San Antonio, Texas

12/2012-

06/2014 A randomized phase 2 study of G-pen, A randomized, phase 2, double blind, 3-way

crossover study with G-PEN (Glucagon for injection) to evaluate safety, tolerability and

comparative pharmacokinetics and pharmacodynamics to Lilly Glucagon in healthy

volunteers. Xeris Pharmaceuticals, Austin, Texas

06/2012-

Present Diabetic foot ulcer healing, A Prospective, Randomized, Double-Blind Multicenter Study

Comparing Continuous Diffusion of Oxygen (CDO) Therapy to standard Moist Wound

Therapy (MWT) in the Treatment of Diabetic Foot Ulcers. Electrochemical Oxygen

Concepts Inc, San Antonio, Texas

06/2010-

06/2013 A randomized controlled study of bracing in the knee, Outcomes of Bracing in the

Treatment of Knee Osteoarthritis. Össur hf. Grjothals 3-5 110 Reykjavik Iceland

09/2009-

12/2009 Investigational Device Exemption - G060062/S007, Investigator's Manual/Protocol Study

#CP-PYD-001. Ascension Orthopedics Inc, 8700 Cameron Road, Austin TX 78764

06/2008-

06/2010 Probe-based Confocal Endomicroscopy, Sharma P, Meining Am, Coron E, Lightdale C,

Wolfsen H, Bansal A, Bajbouj M, Galmiche JP, Abrams J, Lauwers G, Michalek JE,

Wallace M. Detection of neoplastic tissue in Barrett‘s esophagus with in vivo probe-based

confocal endomicroscopy (DONT BIOPCE). Final results of a prospective international

randomized controlled trial: image guided versus 4 quadrant random biopsies. Mauna Kea

Technologies, Paris, France

06/2008-

Present Effects of Lyrica, [Pregabaline] on Cerebralspinal Fluid Substance P in Human Subjects

with Fibromyalgia Syndrome. Pfizer, New York, New York

01/2007-

12/2007 Phase III laboratory studyof a topical gel formulation, nitroglycerin, MQX-503, in treatment

of Raynaud's phenomenon. Clinical study protocol number 03-001. Mediquest

Therapeutics, Inc. Seattle, WA

01/2007-

12/2007 Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose, Vasopressin

versus Placebo in Traumatic Shock Resuscitation

01/2005-

12/2005 A randomized trial of a strategy for increasing high-density lipoprotein, cholesterol levels:

effects on progression of coronary heart disease and clinical events. Annals of Internal

Medicine

01/2005-

12/2005 Randomized, Double Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Trial

Comparing the Effects of Orally Administered Xyrem (sodium oxybate) with Placebo for

the Treatment of Fibromyalgia Orphan Medical Inc. Minnetonka MN

01/2004-

12/2004 Determination of the levels of dioxins and dioxin-like compounds, in the Australian

population by analysis of pooled human breast milk. Australian Government Department

of the Environment and Heritage

01/2002-

12/2002 Alpha-2 adrenergic agonists: evidence and experience examined, Round Table Series 75,

The Royal Society of Medicine Press, Ltd

02/2000-

02/2005 Effects of zanaflex® [tizanidine hcl] tablets on, cerebrospinal fluid substance p in human

subjects with fibromyalgia syndrome. Elan Pharmaceuticals, Inc. 800 Gateway Boulevard,

South San Francisco, CA 94080.

02/2000-

12/2000 Effects on morning stiffness and pain, in the treatment of fibromyalgia syndrome with low

dose interferon alpha administered by the oral mucosal route. Veldona USA, Inc.,

Amarillo, Texas

01/2000-

12/2000 A single-blind, randomized, usual therapy-controlled, double-crossover, study to evaluate

the sleep efficacy and safety of the cuddle ewe underquilt in fibromyalgia syntrome. The

Cuddle Ewe Company, LLC Maple Grove, MN

05/1999-

07/1999 A double-blind, placebo-controlled study, to evaluate the efficacy and safety of oral

glyconutrient supplementation in subjects with fibromyalgia syndrome.

02/1998-

01/1999 A randomized, parallel, placebo-controlled study, of the treatment of Sjogren’s syndrome

with low dose interferon alpha administered by the oral mucosal route. Veldona USA, Inc.,

Amarillo, Texas

01/1998-

12/1998 Treatment of Sjogren‘s syndrome with low dose interferon alpha adminstered, by the oral

mucosal route: a randomized, parallel, placebo controlled study. Veldona USA, Inc.

Amarillo, TX

02/1993-

02/1994 Treatment of fibromyalgia syndrome with Super Malic, a double-blind placebo controlled

crossover pilot study. Optimox Corporation, Torrence, California

11/1991-

04/1992 A Randomized Controlled Clinical Trial to Evaluate the Effect of Intra-Arti, Michalek JE.

Pharmacia Orthopedics, Inc. Piscataway, NJ

01/1987-

06/1987 Effects of Ibuprofen and Alprazolam in the Treatment of Fibrositis Syndrome, Russell IJ,

Michalek JE, McBroom P, Hester G, Fletcher H, Mauldin M, Miketen S, Tsui-Wu J,

Henerson G, Delgado B, Vipraio G, Craighead P. Upjohn, Kalamazoo, MI. Protocol 4105.

Collaborative Research

06/2010-

11/2012 Resource Sharing and Cost Recovery Across the CTSA Enterprise, A statistical summary

and narrative describing the results of a survey sent to CTSAs.

06/2007-

10/2008 Projecto Bienestar Laredo (PBL), Social Health Research Center, San Antonio, TX

01/2007-

12/2007 Health Canada (CANTOX Environmental). Task 3A-1, Tier 3, Toxicological Risk

Assessment Pertaining to Potential Occupational and Related Exposures Associated with

Herbicide Spraying Operations at CFB Gagetown

01/2006-

12/2006 Health Canada (CANTOX Environmental) Task 3A-1, Tier 1, Toxicological Risk


Herbicide Spraying Operations at CFB Gagetown-Tier 1-1966-67 U.S. Trials-

Manufacturing Impurities (Contaminants).

01/2006-

02/2006 Health Canada (CANTOX Environmental). Task 3A-1, Tier 2, The Toxicological Risk


Herbicide Spraying Operations at Canadian Forces Base (CFB) Gagetown from 1952 to

Present

02/2005-

12/2009 Cognitive Assessment, in the fibromyalgia syndrome using a modified trail making test.

Russell IJ, Michalek JE. University Clinical Research Center, San Antonio, Texas

02/2005-

02/2005 Hypocretin in Fibromyalgia Syndrome, Russell IJ, Michalek JE. University Clinical

Research Center, San Antonio, Texas

01/1993-

12/1993 Biomarkers for Exposure Assesssment, Scientific Workshop on Exposure Assessment,

Institute of Medicine, National Academy of Sciences, Washington, DC

Departmental Projects

05/1997-

02/2000 Air Force Health Study - Final Report, An Epidemiologic Investigation of Health Effects in

Air Force Personnel Following Exposure to Herbicides. 1997 Follow-up Examination

Results. Contract Number: F41624-96-C-1012.

01/1993-

12/1993 The Air Force Health Study, An Epidemiologic Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides. Mortality Update - 1993. Prepared for: The

Surgeon General United States Air Force Washington, DC 20314

05/1992-

05/1995 Air Force Health Study - 1992 Follow-up Examination Results, An Epidemiologic

Investigation of Health Effects in Air Force Personnel Following Exposure to Herbicides.

Contract Number F41624-91-C-1006

01/1992-

01/1994 Air Force Health Study, An Epidemiologic Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides - Mortality Update 1994. Report Prepared for:

The Surgeon General United States Air Force, DC 20332-6188

01/1992-

08/1992 Air Force Health Study, An Epidemiologic Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides. Reproductive Outcomes - August 31, 1992.

Prepared for: The Surgeon General United States Air Force, Bolling Air Force Base, DC

20332

01/1992-

01/1992 The Air Force Health Study, An epidemiologic Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides. Reproductive Outcomes. Armstrong

Laboratory, Brooks Air Force Base, Texas 1992

02/1991-


Personnel Following Exposure to Herbicides. Serum Dioxin Analysis of 1987 Follow-up

Examination Results. USAF School of Aerospace Medicine, Brooks Air Force Base Texas.

(NTIS AD A 237 517 through AD A 237 524), 1991.

01/1991-

12/1991 Air Force Health Study, An Epidemiology Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides. Mortality Update 1991. Prepared for: The

Surgeon General United States Air Force Washington, DC 20314

02/1990-


Personnel Following Exposure to Herbicides, 1987 Follow-up Examination Results. USAF

School of Aerospace Medicine.

02/1989-


Personnel Following exposure to Herbicides: Mortality Update - 1988. USAF School of

Aerospace Medicine.

01/1989-

04/1989 Air Force Health Study (Project Ranch Hand II), An Epidemiologic Investigation of Health

Effects in Air Force Personnel Following Exposure to Herbicides. Summary Mortality

Update - April 17, 1989. Prepared for: The Surgeon General United States Air Force

Bolling AFB, D.C. 20332-6188

02/1987-


Personnel Following Exposure to Herbicides. First Follow-up Examination Results. Final

Report. USAF School of Aerospace Medicine

01/1986-

12/1986 Air Force Health Study (Project Ranch Hand II), An Epidemiology Investigation of Health

Effects in Air Force Personnel Following Exposure to Herbicides. Mortality Update -

December 26, 1986. Prepared for: The Surgeon General United States Air Force

Washington, D.C

02/1985-


Personnel Following Exposure to Herbicides: Mortality Update - 1985. USAF School of

Aerospace Medicine

01/1985-

11/1985 Project Ranch Hand II, An Epidemiologic Investigation of Health Effects in Air Force

Personnel Following Exposure to Herbicides. Mortality Update - November 29, 1985.

Prepared for: The Surgeon General United States Air Force Washington, D.C. 20314

02/1984-


Personnel Following Exposure to Herbicides: Mortality Update-1984. USAF School of

Aerospace Medicine

01/1984-

12/1984 Project Ranch Hand II - Mortality Update - 1984, An Epidemiologic Investigation of Health

Effects in Air Force Personnel Following Exposure to Herbicides. Prepared for The

Surgeon General United States Air Force Washington, D.C. 20314

Exploratory Grant

01/2012-

Present Monoclonal gammopathy, Monoclonal gammopathy of uncertain significance and

microRNAs in Ranch Hand veterans. Funded by the Institute of Medicine

Other

06/2009-

06/2010 A rebuttal for the plaintiff against the defendant, James Carter PC, Peoria Illinois

09/2006-

09/2007 A rebuttal for the defendant against the plaintiff, Fulbright and Jaworski, San Antonio,

Texas

Research Projects

06/2013-

Present Impact of Ticagrelor, Impact of Ticagrelor and Aspirin versus Clopidogrel and Aspirin in

Patients with Claudication and Lower Extremity Arterial Disease (LEAD): Thrombus

Burden Assessed by Optical Coherence Tomography Funded by AstraZeneca

PUBLICATIONS: ('*' indicates Peer Reviewed)

Abstract

* 1. McHale MJ, Schlechter AK, Torres FM, Michalek JE, McManus LM, Shireman PK.

Gender-specific differences in skeletal muscle regeneration, presented at the

Academic Surgical Congress, Association for Academic Surgery, 2010 Feb. p. 218. (J

Surg Res; vol. 158, no. 2).

* 2. McHale M, Schlechter AK, Torres FM, Michalek JE, McManus LM, Shireman PK.

Increased fat accumulation in regenerating skeletal muscle in females 2009 Aug.

(Annual Meeting of the San Antonio Vascular Surgery Society).

* 3. McHale M, Schlechter AK, Torres FM, Michalek JE, McManus LM, Shireman PK.

Gender-dependent fat accumulation in regenerating skeletal muscle. 2009 Jan. (Aust

Surgical Society).

* 4. Martinez CO, Sun D, Waite LL, Michalek JE, McManus LM, Shireman PK. Differential

regulation of skeletal muscle regeneration by CCR2-activating chemokines and in vivo

characteristics of myogenic progenitor cells 2008 Oct. (Annual Meeting of the San

Antonio Vascular Surgery Society).

* 5. Ochoa O, Martinez C, Torres FM, Ruiz-Willhite L, Michalek JE, McManus LM,

Shireman PK. Differential regulation of skeletal muscle regeneration and angiogenesis

by CCR2-activating chemokines, presented at the Academic Surgical Congress,

Association for Academic Surgery, 2008 Feb. p. 218-219. (J Surg Res; vol. 144, no. 2).

* 6. Sun D, Wetzel MD, Waite LL, Michalek JE, Shireman PK. Environmental factors

determine in vivo myogenic progenitor cell function, presented at the Academic

Surgical Congress, Society of University Surgeons, 2008 Feb. p. 217-218. (J Surg

Res; vol. 144, no. 2).

* 7. Sanchez J, Angel LF, Levine DJ, Johnson SB, Michalek JE, Zarzabal LA, Sako E,

Pelaez A, Mehta A, Calhoon J, Levine SM, Lyu D. Using Post-Lung Transplant FEV1

To Predict Survival in COPD Patients Undergoing Single Lung Transplantation (SLT)

2007 Oct. p. 596. (CHEST; vol. 132, no. 4).

* 8. Shireman PK, Sun D, Ochoa O, Bonilla JR, Waite LL, Michalek JE, McManus LM.

Increased myogenic progenitor cell accumulation in CCR2 -/- mice despite bone

marrow-dependent impairments in muscle regeneration and macrophage recruitment

2007 Jul. (Skeletal Muscle Satellite & Stem Cells, FASEB Summer Meeting).

* 9. Sanchez, JF, Angel LF, Levine DJ, Johnson SB, Calhoon JH, Sako EY, Carpenter AJ,

Michalek JE, Levine SM. A Mathematical Model to Predict the Best FEV1 Post Single

Lung Transplantation 2007 May. p. A765. (2007 Proceedings of the American Thoracic

Society).

* 10. Ochoa O, Solomon D, Michalek JE, McManus LM, Shireman PK. Similar capillary

density despite decreased vascular endothelial growth factor (VEGF) levels and

impaired skeletal muscle regeneration in CC chemokine receptor 2 (CCR2) -/- mice,

presented at the Academic Surgical Congress, Society of University Surgeons 2007

Feb. p. 211-212. (J Surg Res; vol. 137, no. 2).

* 11. Sanchez J, Angel L, Levine D, Johnson S, Calhoon JH, Sako E, Carpenter A, Michalek

JE, Levine SM. A mathematical model to predict the best fev1 post single lung

transplantation 2007 Jan. p. A765. (Am J Respir Critical Care Medicine; vol. 175).

* 12. Shireman PK, Sun D, Ochoa O, Bonilla JR, Waite LL, Michalek JE, McManus LM.

Bone marrow-derived cell regulation of skeletal muscle regeneration. Bandera, TX:

2007. (Proceedings of the International Conference on Age-related Muscle Atrophy:

Causes and Mechanisms).

* 13. Levine DJ, Angel LF, Coalson JJ, Cline, A, Calhoon JH, Michalek JE, Johnson SB,

Sako EY, Carpenter AJ, Levine SM. Histologic Evidence of Pulmonary Arterial

Hypertension in Explants of Lung Transplant Recipients With Normal Pre-operative

Cardiac Catheterization and Echocardiography 2006. (American Journal of Respiratory

and Critical Care Medicine).

* 14. Michalek J. Insulin sensitivity following Agent Orange exposure in Vietnam veterans

with high blood levels of 2,3,7,8-tetrachlorodibenzo-p-dioxin. 2004 Nov.

* 15. Pavuk M, Michalek JE and Schecter A. Incidence of prostate cancer in Vietnam US Air

Force veterans. 2004 Mar.

* 16. Pavuk M, Michalek JE, Jackson Jr W, and Ketchum NS. The metabolic syndrome and

cardiovascular mortality in US Air Force veterans of the Vietnam War. 2004. p. 3651-

3656. (Organohalogen Compounds; vol. 66).

* 17. Ketchum NS and Michalek JE. Mortality of Air Force veterans exposed to herbicides

during the Vietnam War. 2004. p. 3645-3660. (Organohalogen Compounds; vol. 66).

* 18. Pavuk M, Michalek J, Ketchum N and Akhtar F. Cancer in US Air Force veterans not

involved with spraying herbicides during the Vietnam War. 2004. p. 3639-3644.

(Organohalogen Compounds; vol. 66).

* 19. Kern P, Said S, Jackson Jr W, Michalek J.. Insulin sensitivity and serum TCDD in Air

Force veterans occupationally exposed to herbicides during the Vietnam War. 2004. p.

3166-3173. (Organohalogen Compounds; vol. 66).

* 20. Emond C, Michalek JE, Birnbaum LS and DeVito MJ. Use of a PBPK model with dose-

dependent elimination rates predicts higher peak dioxin exposures than previously

estimated. 2004. p. 2655-2659. (Organohalogen Compounds; vol. 66).

* 21. Michalek J. Cancer findings from Air Force veterans who sprayed Agent Orange:

Correlation of blood TCDD with cancers. 2003 Nov.

* 22. Pavuk M, Schecter A and Michalek J. Correlation of TCDD blood levels with adverse

prostate outcome in Air Force veterans who sprayed Agent Orange. 2003 Nov.

* 23. Pavuk M, Michalek JE and Schecter A. TCDD and prostate cancer in US Air Force

veterans of the Vietnam War. 2003 Sep.

* 24. Pavuk M, Schecter A and Michalek JE. Association between diseases of the prostate

and TCDD in US Air Force veterans of the Vietnam War. 2003. p. 239-241.


* 25. Akhtar F, Garabrant D and Michalek J. Cancer in US Air Force veterans of the

Vietnam War. 2003. p. 243-246. (Organohalogen Compounds; vol. 64).

* 26. Kern P, Said S, Jackson Jr W and Michalek J. Insulin sensitivity and 2,3,7,8-

tetrachlorodibenzo-p-dioxin in US Air Force veterans of the Vietnam War. 2003. p.

182-185. (Organohalogen Compounds; vol. 65).

* 27. Dwyer JH, Jackson Jr WH and Michalek JE. Hypertension and 2,3,7,8-

tetrachlorodibenzo-p-dioxin. 2002 Nov.

* 28. Pavuk M, Schecter A, Akhtar F, Michalek J. Thyroid changes in relation to TCDD in

Ranch Hand veterans of the US Air Force. 2002 Nov.

* 29. Russell IJ, Michalek JE, Xiao YM, Haynes W and Lawrence RA. Like morning stiffness

in rheumatoid arthritis, morning stiffness in fibromyalgia is related to serum hyaluronic

acid. 2002 Oct. (American College of Rhematology).

* 30. Russell IJ, Michalek JE, Xiao YM, Haynes W, Vertiz R and Lawrence RA. Therapy with

a central alpha-2-adrenergic agonist [tizanidine] decreases cerebrospinal fluid

substance P, and may reduce serum hyaluronic acid as it improves the clinical

symptoms of the fibromyalgia syndrome. 2002 Oct. (American College of

Rheumatology).

* 31. Wilson RB, Xiao YM, Michalek JE and Russell IJ. Correlation of Anti-Polymer

Antibodies with Clinical Measures in Fibromyalgia Syndrome. 2002 Oct. (American

College of Rheumatology).

* 32. Dwyer JH, Jackson Jr W, Michalek JE. Hypertension and serum 2,3,7,8-

tetrachlorodibenzo-p-dioxin (TCDD) and hypertension in the Air Force veterans of the

Vietnam War. 2002. p. 331-334. (Organohalogen Compounds; vol. 59).

* 33. Pavuk M, Schecter AJ, Akhtar FZ, Michalek JE. Effects of TCDD on thyroid

metabolism in US Air Force herbicide sprayers. 2002. p. 347-350. (Organohalogen

Compounds; vol. 59).

* 34. Michalek J, Pirkle JL, Needham LL, Patterson Jr DG and Caudill SP.

Pharmacokinetics of 2,3,7,8-tetrachlorodibenzo-p-dioxin in Seveso adults and veterans

of Operation Ranch Hand. 2001 Nov.

* 35. Russell IJ, Michalek JE, Haynes WL and Vertiz R. A single blind, randomized, three

period, three treatments, crossover study to evaluate the sleep efficacy of the cuddle

ewe under quilt™ for treatment of fibromyalgia. 2001 Feb. (J Musculoske Pain; vol. 9,

no. Suppl).

* 36. Michalek JE, Akhtar FZ, Ketchum NS and Jackson Jr WG. The Air Force Health Study:

A summary of results. 2001. p. 396-399. (Organohalogen Compounds; vol. 54).

* 37. Barrett DH, Morris RD, Akhtar FZ and Michalek JE. Serum TCDD and cognitive

functioning in Veterans of Operation Ranch Hand. 2001. p. 145-148. (Organohalogen

Compounds; vol. 53).

* 38. Michalek JE, Ketchum NS and Longnecker MP. Serum TCDD and hepatic

abnormalities in Veterans of Operation Ranch Hand. 2001. p. 159-162.


* 39. Michalek JE, Akhtar FZ, Longnecker MP, Burton JE. Serum TCDD and hematological

examination results in Veterans of Operation Ranch Hand. 2001. p. 172-175.


* 40. Barrett DH, Morris RD, Jackson Jr WG and Michalek JE. Serum TCDD and

psychological functioning in Veterans of Operation Ranch Hand. 2001. p. 176-179.


* 41. Michalek JE, Pirkle JL, Needham LL, Patterson DG, Caudill SP, Tripathi RC, Mocarelli

P. Pharmacokinetics of 2,3,7,8-Tetrachlorodibenzo-P-dioxin in Seveso adults and

Veterans of Operation Ranch Hand. 2001. p. 340-344. (Organohalogen Compounds;

vol. 52).

* 42. Xiao Y-M, Russell IJ, Michalek JE and Wilson RB. Anti-polymer antibodies in the

serum of patients with fibromyalgia syndrome. 2001. (J Musculoske Pain; vol. 6, no.

S5).

* 43. Michalek J, Longnecker MP and Akhtar FZ. Dioxin and hematological function in

veterans of Operation Ranch Hand. 2000 Nov.

* 44. Michalek JE and Ketchum N. Serum dioxin and cancer in veterans of Operation Ranch

Hand. 2000. p. 99-102. (Organohalogen Compounds; vol. 48).

* 45. Akhtar FZ and Michalek JE. Serum dioxin and peripheral neuropathy in veterans of

Operation Ranch Hand. 2000. p. 179-182. (Organohalogen Compounds; vol. 48).

* 46. Jackson Jr WG and Michalek JE. Herbicide exposure and heart disease in veterans of

operation Ranch Hand. 2000. p. 183-186. (Organohalogen Compounds; vol. 48).

* 47. Ketchum N and Michalek JE. Serum dioxin and diabetes mellitus in veterans of


* 48. Ketchum NS, Michalek JE and Burton JE. Serum dioxin and cancer in veterans of

operation Ranch Hand. 1999. p. 363-366. (Organohalogen Compounds; vol. 44).

* 49. Longnecker MP and Michalek JE. Serum dioxin level in relation to diabetes mellitus

and glucose intolerance among Air Force veterans with background levels of

exposure. 1999. p. 401-404. (Organohalogen Compounds; vol. 44).

* 50. Michalek JE and Boyle CA. Paternal serum dioxin, preterm birth, intrauterine growth

retardation and infant death. 1998. p. 223-226. (Organohalogen Compounds; vol. 38).

* 51. Michalek JE, Ketchum NS and Akhtar FZ. Post-service mortality of Air Force veterans

occupationally exposed to herbicides in Vietnam: 15 Year Follow-up. 1998. p. 235-238.

* 52. Michalek JE and Ketchum NS. Serum dioxin and diabetes mellitus in veterans of


* 53. Russell IJ, Michalek JE and Vipraio GA. Serotonin (5HT) in serum and platelets (PLT)

from fibromyalgia patients (FM) and normal controls (NC). 1995 Jul. (Third World

Congress on Myofascial Pain and Fibromyalgia (abst)).

* 54. Russell IJ, Vodjani A, Michalek JE, Vipraio GA, Lopez Y and MacKillip F. Circulating

antibodies to serotonin (ASA) in fibromyalgia syndrome (FS) rheumatoid arthritis (RA)

osteoarthrosis (OA) and healthy normal controls (NC). 1995 Jul. (Third World

Congress on Myofascial Pain and Fibromyalgia).

* 55. Michalek J, Russell I, Vipraio GA. Serotonin (5HT) in serum and platelets (PLT) from

fibromyalgia patients (FM) and normal controls (NC). 1995. p. 144-144. (J Musculoske

Pain; vol. 3, no. S1).

* 56. Russell IJ, Orr MD, Michalek JE, Nyberg F, Eriksson U. Substance P (SP), SP

endopeptidase activity (SPE), and SP N-terminal peptide (SP1-7) in fibromyalgia

syndrome cerebrospinal fluid (CSF). 1995. p. 5-5. (J Musculoske Pain; vol. 3, no. S1).

* 57. Russell IJ, Orr MD, Vipraio GA, Alboukrek D, Michalek JE and Lopez YM.

Cerebrospinal fluid (CSF) substance P (SP) is elevated in fibromyalgia syndrome (FS).

1993. (Arthritis and Rheumatism; vol. 36, no. S223).

* 58. Russell IJ, Vipraio GA, Michalek JE and Lopez YG. Insulin-like growth factor (IGF1) in

fibromyalgia (FS), rheumatoid arthritis (RA), osteoarthritis (OA) and healthy normal

controls (NC): Roles of diagnosis, age, sex and ethnic origin. 1992. (Arthritis Rheum;

vol. 35, no. S160).

* 59. Russell IJ, Michalek JE, Vipraio GA, Lawrence VA, Lessard JA and Briggs BT.

Automated reading of joint space on osteoarthritis X-rays: Correlation with clinical

manifestations. 1992. (Arthritis Rheum; vol. 35, no. S133).

* 60. Russell IJ, Michalek JE, Lawrence VA, Lessard JA, Briggs BT and May GS. A

randomized, placebo (PL) and no-intervention (NI) controlled, trial of intra-articular (IA)

1% sodium hyaluronate (HA) in the treatment of knee osteoarthritis. 1992. (Arthritis

Rheum; vol. 35, no. S132).

* 61. Russell IJ, Russell SJ, Cuevas RE and Michalek JE. Early life traumas and confiding in

fibromyalgia syndrome (FS). 1992. (Scand J Rheumatol; vol. 94, no. S14).

* 62. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM and Wall K. Serum amino acids in

fibrositis/fibromyalgia syndrome. 1989. (Arthritis Rheum; vol. 32, no. S70).

* 63. Russell IJ, Fletcher EM, Tsui J and Michalek JE. Comparisons of rheumatoid arthritis

and fibrositis/fibromyalgia syndrome using functional and psychological outcome

measures. 1989. (Arthritis Rheum; vol. 32, no. S70).

* 64. Russell IJ, Fletcher EM, Michalek JE, McBroom PC and Hester GG. Efficacy and

safety of ibuprofen and alprazolam in the treatment of primary fibrositis/fibromyalgia

syndrome. 1989. (Arthritis Rheum; vol. 32, no. S69).

* 65. Russell IJ, Bowden CL, Michalek JE, Fletcher EM and Vipraio GA. A metabolic basis

for fibrositis syndrome (FS): The serotonin deficiency hypothesis. 1988 May. (ARA

Meeting).

* 66. Russell IJ, Vipraio GA, Michalek J and Fletcher E. Abnormal T cell subpopulations in

fibrositis syndrome. 1988. (Arthritis Rheum; vol. S99).

* 67. Russell IJ, Vipraio GA, Tovar Z, Michalek J, and Fletcher E. Abnormal natural killer cell

activity in fibrositis syndrome is responsive in vitro to IL-2. 1988. (Arthritis Rheum; vol.

S24).

* 68. Russell IJ, Bowden CL, Michalek J, Fletcher E and Hester GA. Imipramine receptor

density on platelets of patients with fibrositis syndrome: Correlation with disease

severity and response to therapy. 1987 Apr. p. 563. (Arthritis Rheum; vol. 30, no. S4).

Book Chapter

1. Michalek JE, Cornell JE, Pollock BH. Understanding the Elements that Comprise

Evidence-Based Medicine In: Elective General Surgery: An Evidence-Based

Approach. Shelton, CT: PMPH-USA Ltd.; 2011.

2. Xiao YM, Michalek JE and Russell IJ. Effects of tizanidine on cerebrospinal fluid

substance P in patients with fibromyalgia In: Round Table Series-75. Worcester, UK:

The Royal Society of Medicine Press, The Trinity Press; 2001. p. 23 - 28.

Journal Article

* 1. Simpson, CB, Lee CT, Hatcher JL, Michalek JE. Botulinum toxin treatment of false

vocal folds in adductor spasmodic dysphonia: functional outcomes Laryngoscope

2016;126:118-121.

* 2. Ha CS, Michalek JE, Elledge R, Kelley KR, Ganapathy S, Su H, Jenkins CA, Agiris A,

Swords R, Eng TY, Karnad A, Crownover RL, Swanson GP, Goros M, Pollock BH,

Yuan Z. p53-based strategy to reduce hematological toxicity of chemotherapy: A proof

of principle study Molecular Oncology 2015 Oct;XXX(YYY)

* 3. Landgren, O, Shim, Y, Michalek JE, Costello, R, Burton, D, Ketchum, N, Calvo, K,

Caporaso, N, Raveche, E, Middleton, D, Marti, G, Vogt, R. Agent Orange Exposure

and Monoclonal Gammopathy of Undetermined Significance. An Operation Ranch

Hand Veteran Cohort Study JAMA Oncology 2015 Sep:E1-E8.

* 4. Strandberg G, Larsson A, Lipcsey M, Michalek JE, Eriksson M. Intraosseous and

intravenous administration of antibiotics yields comparable plasma concentrations

during experimental septic shock Acta Anaesthesiol Scan 2015 Jan

* 5. Bartanusz Viktor, Jezova Daniela, Sordo Salvador, Gildea Marianne, Michalek JE,

Stewart Ronald M, Corneille Michael G.. Diurnal Salivary Cortisol Levels in Acute

Trauma Patients at the Surgical-Neurosurgical Intensive Care Unit J Clin Neurosci

2014 Dec;21(12):2150-2154.

* 6. Larson, Erik R, Porterfield, John E., Marmol-Velez, Juan, Panday, Manoj, Sagar,

Sandeep, Escobedo, Daniel, Michalek JE, Ouyang, Yongjian, Valvano, Jonathan,

Pearce, John A, Feldman MD. Admittance to Detect Alterations in Left Ventricular

Stroke Volume Heart Rhythm 2014 Nov;11(11):2075-2083.

* 7. Shi Q, Hodara V, Meng Q, Voruganti VS, Rice K, Michalek JE, Carmuzzie AG,

VandeBerg JL. Early endothelial damage detected by circulating particles in baboons

fed a diet high in simple carbohydrates in conjunction with saturated or unsaturated fat

Am J Cardiovasc Dis 2014 Oct;4(3):123-132.

* 8. Abraham J, Nunez-Alvarez Y, Hettmer S, Carrio E, Chen HI, Nishijo K, Huang ET,

Prapjapati SI, Walker RL, Davis S, Rebeles J, Wiebush H, McCleish AT, Hampton ST,

Bjornson CR, Brack AS, Wagers AJ, Rando TA, Capecchi MR, Marini FC, Ehler BR,

Zarzabal LA, Goros MW, Michalek JE, Meltzer PS, Langenau DM, LeGallo RD,

Mansool A, Chen Y, Suelves M, Rubin BP, Keller C. Lineage of origin in

rhabdomyscarcoma informs pharmacological response Genes Dev 2014

Jul;25(14):1578-1591.

* 9. Kilpadi KL, ElDabaje R, Schmitz JE, Ehler B, Thames TA, Joshi AP, Simmons JW,

Michalek JE, Fajardo RJ. Type 2 diabetes is associated with vertebral fractures in a

sample of clinic- and hospital-based latinos. J Immigr Minor Health 2014

Jun;16(3):440-449.

* 10. Mahalingam D, Malik L, Beeram M, Rodon J, Sankhala K, Mita AC, Benjamin D,

Ketchum N, Michalek JE, Tolcher A, Wright J, Sarantopoulos J. Phase II Study

Evaluating the Effcacy, Safety, and Pharmacodynamic Correlative Study of Dual

Antiangiogenic Inhibition Using Bevaciumab in Combination with Sorafenib in Patients

with Advanced Malignant Melanoma Cancer Chemother Pharmacol 2014 May

* 11. Cohn SM, DeRosa M, Kumar A, Harrison C, Dent DL, Sivam S, McCarthy MJ, Warner

SC, Williams S, Michalek JE, Spinella P. Impact of the Age of Transfused Red Blood

Cells in the Trauma Population: A Feasibility Study Injury 2014 Mar;45(3):605-611.

* 12. Kikuchi, Hettmer S, Aslam MI, Michalek JE, Laub W, Wilky BA, Loeb DM, Rubin BP,

Wagers AJ, Keller C. Cell-cycle dependent expression of a translocation-mediated

fusion oncogene mediates checkpoint adaptation in rhabdomyosarcoma PLos Genet

2014 Jan;10(1)

* 13. Rowe J, Patel S, Mazo-Canola M, Parra A, Goros M, Michalek JE, Kelly KR, Weitman

SD, Karnad AB. An Evaluation of Elderly Patients (> 70 years old) Enrolled in Phase I

clinical trials at University of Texas Health Science Center at San Antonio Cancer

Therapy Research Center from 2009-2011 J Geriatr Oncol 2014 Jan;5(1):65-70.

* 14. Hummers LK, Dugowson CE, Dechow FJ, Wise RA, Gregory J, Michalek JE,

Yenokyan G, McGready J, Wigley FM. A Multi-Centre, Blinded, Randomsied, Placebo-

Controlled, Laboratory-Based Study of MQX-503, a Novel Topical Gel Formulation of

Nitroglycerine in Patients with Raynaud Phenomenon Ann Rheum Dis 2013

Dec;72(12):1962-1967.

* 15. Kikuchi k, Taniguchi E, Chen HI, Svalina MN, Abraham J, Huang ET, Nishijo K, Davis

S, Louden C, Zarzabal LA, Recht O, Bajwa A, Berlow N, Suelves M, Perkins SL,

Meltzer PS, Mansoor A, Michalek JE, Chen Y, Rubin BP, Keller C. RB1 Loss Modifies

but does not Initiate Alveolar Rhabdomyosarcoma Skelet Muscles 2013 Nov;3(1)

* 16. Aslam MI, Hettmer S, Abraham J, Latocha D, Soundararajan A, Huang ET, Goros

MW, Michalek JE, Wang S, Mansoor A, Druker BJ, Wagers AJ, Tyner JW, Keller C.

Dynamic and Nuclear Expression of PDGFRa and IGF-1R in Alveolar

Rhabdomyosarcoma Mol Cancer Res. 2013 Nov;11(11):1303-1313.

* 17. Cohn SM, DeRosa M, McCarthy J, Song J, White C, Louden C, Ehler B, Michalek JE,

Landry DW. Characterizing Vasopressin and other Vasoactive Mediators Released

During Resuscitation of Truama Patients J Trauma Acute Care Surg 2013

Oct;75(4):620-628.

* 18. Xiao Y, Haynes W, Russell IJ, Michalek JE. Elevated serum high-sensitivity c-reactive

protein levels in fibromyalgia syndrome patients correlate with body mass index,

interleukin-6, interleukin-8, erythrocyte sedimentation rate Rheumatol Int 2013

May;33(5):1259-1264.

* 19. Schwartz JA, Olarte KT, Michalek JL, Jandu GS, Michel SL, Bruno VM, Michalek JE.

Regulation of copper toxicity by Candida albicans GPA2. Eukaryot Cell 2013 Apr

* 20. Thompson PM, Bernardo CG, Cruz D, Ketchum N, Michalek JE. Transl Psychiatry

Transl Psychiatry 2013 Jan;3:214-214.

* 21. Kikuchi K, Soundararajan A, Zarzabal LA, Weems CR, Nelon LD, Hampton ST,

Michalek JE, Rubin BP, Fields AP, Keller C. Protein kinase C iota as a therapeutic

target in alveolar rhabdomyosarcoma Oncogene 2013 Jan;32(3):286-295.

* 22. Garcia-Dominic O, Trevino RP, Echon RM, Mobley C, Block T, Bizzari A, Michalek JE.

Improving Quality of Food Frequency Questionnaire Response in Low-Income

Mexican American Children Health Promot Pract 2012 Nov;13(6):763-771.

* 23. Soundararajan A, Abraham J, Nelon LD, Prajapati SI, Zarzabal LA, Michalek JE,

McHardy SF, Hawkins DS, Malempati S, Keller C. 18F-FDG microPET imaging detects

early transient response to an IGF1R inhibitor in genetically engineered

rhabdomyosarcoma models Pediatr Blood Cancer 2012 Sep;59(3):485-492.

* 24. Husain SA, Maldonado E, Rasch D, Michalek JE, Taylor R, Curzon C, Neish S,

Calhoon JH. Total anomalous pulmonary venous connection: factors associated with

mortality and recurrent pulmonary venous obstruction Ann Thorac Surg 2012

Sep;94(3):825-831.

* 25. Cornejo A, Sahar DE, Stephenson SM, Chang S, Nguyen S, Guda T, Wenke JC,

Vasquez, A, Michalek JE, Sharma R, Krishnegowda NK, Wang HT. Effect of Adipose

Tissue-Derived Osteogenic and Endothelial Cells on Bone Allograft Osteogenesis and

Vascularization in Critical-Sized Calvarial Defects. Tissue Eng Part A 2012 May;18(15-

16):1-10.

* 26. McHale MJ, Sarwar ZU, Cardenas DP, Porter L, Salinas AS, Michalek JE, McManus

LM, Shireman PK. Increased fat deposition in injured skeletal muscle is regulated by

sex-specific hormones. PMCID: PMC3289262 Am J Physiol Regul Integr Comp

Physiol 2012 Jan;302:R331-339.

* 27. Abraham J, Chua YX, Glover JM, Tyner JW, Loriaux MM, Kilcoyne A, Giles FJ, Nelon

LD, Carew JS, Ouyang Y, Michalek JE, Pal R, Druker BJ, Rubin BP, Keller C. An

adaptive Src-PDGFRA-Raf axis in rhabdomyosarcoma Biochem Biophys Res

Commun 2012;426:363-368.

* 28. Izbicka E, Streeper RT, Michalek JE, Louden CL, Diaz A, Campos DR. Plasma

biomarkers distinguish non-small cell lung cancer from asthma and differ in men and

women. Cancer Genomics Proteomics 2012 Jan;9(1):27-35.

* 29. Salhanick M, Higgins RA, Olson JD, Michalek JE, Harrison CR, Corneille MG, Stewart

RM, Harrison C,Dent DL,. Autotransfusion of Hemothorax Blood In Trauma Patients: Is

It the Same as Fresh Whole Blood? Am J Surg 2011 Dec;202(6):817-822.

* 30. Meining A, Chen YK, Pleskow D, Stevens P, Shah RJ, Chuttani R, Michalek J, Slivka

A. Direct visualization of indeterminate pancreaticobiliary strictures with probe-based

confocal laser endomicroscopy: a multicenter experience Gastrointest Endosc 2011

Nov;74(5):961-968.

* 31. Cornejo A, Rodriguez T, Steigelman M, Stephenson S, Sahar D, Cohn SM, Michalek

JE, Wang HT. The use of visible light spectroscopy to measure tissue oxygenation in

free flap reconstruction. Journal of Reconstructive Microsurgery 2011 Sep;27(7):397-

402.

* 32. Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M,

Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace

MB. Real-time increased detection of neoplastic tissue in Barrett‘s esophagus with

probe-based confocal laser endomicroscopy: final results of an international

multicenter, prospective, randomized, controlled trial Gastrointest Endosc 2011

Sep;74(3):465-472.

* 33. Sambasivan, CH, Kunio, NR, Nair, PV, Zink, KA, Michalek JE, Holcomb, JB,

Schreiber, MA, Trauma Outcomes Group, Wade CE, Brasel KJ, Vercruysse G,

MacLeod J, Dutton RP, Hess JR, Duchesne JC, Muskat P, Johannigamn J, Cryer HM,

Tillou A, Cohen MJ, Pittet JF, Knudsen P, DeMoya MA, Tieu B, Brundage S,

Napolitano LM, Brunsvold M, Sihler KC, Bielman G, Peitzman AB, Zenalt MS, Sperry

J, Alarcon L, Croce MA, Minei JP, Kozar R, Gonzales EA, Stewart RM, Cohn SM,

Bulgar EM, Cotton BA, Nunez TC, Ivatury R, Meredith JW, Miller P, Propper GJ, Marin

B. High Ratios of Plasma and Platelets to Packed Red Blood Cells Do Not Affect

Mortality in Nonmassively Transfused Patients Journal of Trauma 2011

Aug;71(2):S329-S336.

* 34. Li X, Villard JW, Ouyang Y, Michalek JE, Jabara R, Sims D, Kemp N, Glynn T, Banas

C, Bailey SR, Feldman MD. Safety and efficacy of frequency domain optical coherence

tomography in pigs. EuroIntervention 2011 Aug;7(4):497-504.

* 35. Holcomb JB, Zarzabal LA, Michalek JE, ozar RA, Spinella PC, Perkins JG, Matijevic N,

Dong JF, Pati S, Wade CE, Trauma Outcomes Group, Holcomb JB, Wade CE, Cotton

BA, Kozar RA, Brasel KJ, Vercruysse GA, MacLeod JB, Dutton RP, Hess, JR,

Duchesne JC, McSwain NE, Muskat PC, Johannigamn JA, Cryer HM, Tillou A, Cohen

MJ, Pittet JF, Knudson P, DeMoya MA, Schreiber MA, Tieu BH, Brundage SL,

Napolitano LM, Brunsvold ME, Sihler KC, Beilman GJ, Peitzman, AB, Zenati, MS,

Sperry JL, Alarcon LH, Croce MA, Minei JP, Steward RM, Cohn SM, Michalek JE,

Bulger EM, Nunez TC, Ivatury RR, Meredith JW, Miller PR, Propper GJ, Marin B.

Increased Platelet:RBC ratios are associated withimproved survival after massive

transfusion J Trauma 2011 Aug;71(2s3):s318-s328.

* 36. Spoerke N, Michalek JE, Schreiner JM, Trauma Outcomes Group, Brasel KJ,

Vercruysse G, MacLeod J, Dutton RP, Duchesne JC, McSwain NE, Muskat P,

Johannigamn J, Cryer HM, Tillou A, Cohen MJ, Pittet JF, Knudson P, De Moya MA,

Tieu B, Brudage S, Napolitano LM, Brunsvold MA, Sihler KC, Peitzman AB, Zenait

MX, Sperry J, Alarcon L, Croce MA, Minei JP, Stewart RM, Cohn SM, Buger EM,

Cotton BA, Nunez TC, Ivatury R, Meredith JW, Miller P, Propper GJ. Crystalloid

resuscitation improves survival in trauma patient receiving low ratios of fresh frozen

plasma to packed red blood cells J Trauma 2011 Aug;71(2S3):S380-S383.

* 37. Corneille MG, Nicholsen, S, Richa, J, Son, C, Michalek JE, Wolf SE, Stewart RM. Liver

Dysfunction by Model for End-Stage Liver Disease Score Improves Mortality Prediction

in Injured With Cirrhosis The Journal of Trauma 2011 Jul;71(1)

* 38. McNeil JD, Brandon Propper, Joshua Walker, Lauren Holguin, Lauren Evans, Kihak

Lee, Fox PT, Michalek JE, Baisden CE. A bovine hemoglobin-based oxygen carrier as

pump prime for cardiopulmonary bypass: reduced systemic lactic acidosis and

improved cerebral oxygen metabolism during low-flow in a porcine model Journal of

Thoracic and Cardiovascular Surgery 2011 Jun;142(2):411-417.

* 39. Prajapati SI, Kilcoyne A, Samano AK, Green DP, McCarthy SC, Blackman BA, Brady

MM, Zarzabal LA, Tatiparthy AK, Sledz TJ, Duong T, Ohshima-Hosoyama S, Giles FJ,

Michalek JE, Rubin BP, Keller C. MicroCT-based virtual histology evaluation of

preclinical medulloblastoma Mol Imaging Biol 2011 Jun;13(3):493-499.

* 40. Streeper RT, Diaz A, Campos D, Michalek JE, Louden C, Furmaga W, Izbicka E.

Syntra-5 Downregulates Inflammatory In Obese Type 2 Diabetes Murine Model In

Vivo. Curr Top Nutraceutical Res 2011 May;9(1/2):1-12.

* 41. Hosoyama T, Aslam MI, Abraham J, Prajapati SI, Nishijo K, Michalek JE, Zarzabal LA,

Nelon LD, Guttridge DC, Rubin BP, Keller C. IL-4R drives dedifferentiation,

mitogenesis in rhabdomyosarcoma Clin Cancer 2011 May;17(9):2757-2766.

* 42. Swanson GP, Du F, Michalek JE, Hermans M. Long-term follow-up and risk of cancer

death after radiation for post-prostatectomy rishing prostate-specific antigen Int J

Radiat Oncol Biol Phys 2011 May;80(1):62-68.

* 43. Abraham J, Nelon LD, Kubicek CB, Kilcoyne A, Hampton ST, Zarzabal LA, Giles FJ,

Michalek JE, Rubin BP, Keller C. Preclinical testing of erlotinib in a transgenic alveolar

rhabdomyosarcoma mouse model. Sarcoma 2011 Apr;2011:130484-130484.

* 44. Michalek JE, Preuss HG, Croft HA, Keith PL, Keith SC, Dapilmoto M, Perricone NV,

Leckie RB, Kaats GR. Changes in total body bone mineral density following a common

bone health plan with two versions of a unique bone health supplement: a comparative

effectiveness research study Nutr J 2011 Apr;10(32)

* 45. Bini JK, Cohn SM, Acosta SM, McFarland MJ, Muir MT, Michalek JE. Mortality,

Mauling, and Maiming by Vicious Dogs Ann Surg 2011 Apr;253(4):791-797.

* 46. Mueller DL, Hatab M, Al-Senan R, Cohn SM, Corneille MG, Dent DL, Michalek JE,

Myers JG, Wolf SE, Stewart RM. Pediatric Radiation Exposure During the Initial

Evaluation for Blunt Trauma J Trauma 2011 Mar;70(3):724-731.

* 47. Woodward CS, Son MG, Calhoon JH, Michalek JE, Husain SA. Sternal Wound

Infections in Pediatric Congential Cardiac Surgery: A Survey of Incidence and

Preventative Practice Ann Thorac Surg 2011 Mar;91(3):799-804.

* 48. Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE, UTHSCSA

Clinical Trials Group (Mueller D, member of the investigative group). Impact of Low-

dose Vasopressin on Trauma Outcome: Prospective Randomized Study. World J Surg

2011 Feb;35(2):430-439.

* 49. Rubin BP, Nishijo K, Chen HI, Yi X, Schuetze DP, Pal R, Prajapati SI, Abraham J,

Arenkiel BR, Chen QR, Davis S, McCleish AT, Capecchi MR, Michalek JE, Zarzabal,

LA, Khan J, Yu Z, Parham DM, Barr FG, Meltzer PS, Chen Y, Keller C. Evidence for

an Unanticipated Relationship between Undifferentiated Pleomorphic Sarcoma and

Embryonal Rhabdomyosarcoma Cancer Cell 2011 Feb;19(2):177-191.

* 50. Holcomb JB, Weiskopf R, Champion H, Gould SA, Sauer RM, Brasel K, Bochicchio G,

Cotton BA, Davis D, Dutton R, Hauser CJ, Hess JR, Hides GA, Knudson P,

MacKenzie E, McGinnis RL, Michalek JE, Moore FA, Omert L, Pollock BH, Tortella B,

Sugarman J, Schreiber MA, Wade CE. Challenges to effective research in acute

trauma resuscitation: consent and endpoints Shock 2011 Feb;35(2):107-113.

* 51. Corneille MG, Villa, C, Wolf SE, Michalek JE, Jung I, Wade CE, Myers JG, Dent DL,

Mueller DL, Stewart RM. Time and Degree of Glycemic Derangement Are Associated

with Increased Mortality in Trauma Patients in the Setting of Tight Glycemic Control

Am J Surg 2010 Dec;200(6):832-837.

* 52. Cohn SM, Pearl SM, Nowlin MU, Hernandez A, Guta C, Michalek JE, NIRF Clinical

Trials Group. A Prospective Randomized Pilot Study of Near-Infrared Spectroscopy

Directed Restricted Fluid Therapy versus Standard Fluid Therapy in Patients

undergoing Elective Colorectal Surgery (in press) American Surgery 2010

Dec;76(12):1384-1392.

* 53. Martinez CO, McHale MJ, Wells JT, Ochoa O, Michalek JE, McManus LM, Shireman

PK. Regulation of skeletal muscle regeneration by CCR2-activating chemokines is

directly related to macrophage recruitment. PMCID: PMC2944434 Am J Physiol Regul

Integr Comp Physiol 2010 Sep;299(3):R832-R842.

* 54. Prajapati SI, Martinez CO, Abraham J, McCleish AT, Michalek JE, McManus LM,

Rubin B, Shireman PK, Keller C. Crimson carrier, a long-acting contrast agent for in

vivo near-infrared imaging of injured and diseased muscle. PMCID: PMC2910161

Muscle and Nerve 2010 Aug;42(2):245-251.

* 55. Schaffer BS, Grayson MH, Wortham JM, Kubicek CB, McCleish AT, Prajapati SI,

Nelon LD, Brady MM, Jung I, Hosoyama T, Sarro LM, Hanes MA, Rubin BP, Michalek

JE, Clifford CB, Infante AJ, Keller C. Immune competency of a hairless mouse strain

for improved preclinical studies in genetically engineered mice. Mol Cancer Ther 2010

Aug;9(8):2354-2364.

* 56. Gifford SM, Aidinian G, Clouse WD, Fox CJ, Porras CA, Jones WT, Zarzabal LA,

Michalek JE, Propper BW, Burkhardt GE, Rasmussen TE. Effect of temporary

shunting on extremity vascular injury: an outcome analysis from the Global War on

Terror vascular injury initiative J Vasc Surg 2009 Sep;50(3):549-555.

* 57. Schecter A, Needham L, Pavuk M, Michalek JE, Colacino J, Ryan J, Papke O,

Birnbaum L. Agent Orange expoure,Vietnam war veterans, and the risk of prostate

cancer Cancer 2009 Jul;115(14):3369-3371.

* 58. Stewart RM, Park PK, Hunt JP, McIntyre RC, McCarthy J, Zarzabal LA, Michalek JE.

Less is more: improved outcomes in surgical patients with conservative fluid

administration and central venous catheter monitoring. Journal of the American

College of Surgeons 2009 May;208(5):725-735.

* 59. Nishijo K, Chen QR, Zhang L, McCleish AT, Rodriguez A, Cho MJ, Prajapati SI,

Gelfond JA, Chisholm GB, Michalek JE, Aronow BJ, Barr FG, Randall RL, Ladanyi M,

Qualman SJ, Rubin BP, LeGallo RD, Wang C, Khan J, Keller C. Credentialing a

preclinical mouse model of alveolar rhabdomyosarcoma. Cancer Res 2009

Apr;69(7):2902-2911.

* 60. Sun D, Martinez C, Ochoa O, Ruiz-Willhite L, Bonilla JR, Centonze VE, Waite LL,

Michalek JE, McManus LM, Shireman PK. Bone marrow-derived cell regulation of

skeletal muscle regeneration. PMCID: PMC2630778 FASEB J 2009 Feb;23(2):382-

395.

* 61. Sun D, Martinez CO, Ochoa O, Ruiz-Willhite L, Bonilla JR, Centonze VE, Waite LL,

Michalek JE, McManus LM, Shireman PK. Bone marrow-derived cell regulation of

skeletal muscle regeneration. FASEB J 2009 Feb;23(2):382-395.

* 62. Russell IJ, Perkins AT, Michalek JE. Oxybate SXB-26 FMS Study Group. Sodium

Oxybate [Xyrem] Improves Sleep and Relieves Pain in Patients with the Fibromyalgia

Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical

Trial. In submission to Arthritis and Rheumatism 2009 Jan;60(1):299-309.

* 63. Cadena J, Levine DJ, Angel LF, Maxwell PR, Brady R, Sanchez JF, Michalek JE,

Levine SM, Restrepo MI. Antifungal prophylaxis with voriconazole or itraconazole in

lung transplant recipients: hepatotoxicity and effectiveness American Journal of

Transplantation 2009;9(9):2085-2091.

* 64. Prajapati SI, Martinez CO, Bahadur AN, Wu IQ, Zheng W, Lechleiter JD, McManus

LM, Chisholm GB, Michalek JE, Shireman PK, Keller C. Near-infrared imaging of

injured tissue in living subjects using IR-820. Mol Imaging 2009 Jan;8(1):45-54.

* 65. Bingener J, Krishnegowda NK, Michalek JE. Immunologic parameters during NOTES

compared with laparoscopy in a randomized blinded porcine trial Surg Endosc 2009

Jan;23(1):178-181.

* 66. Bingener-Casey J, Buck, Lauren A, Schwesinger WH, Van Sickle KR, Michalek JE.

Can Gastric Irrigation Prevent Infection During NOTES Mesh Placement? Epub 2008

Aug 13 J Gastrointest Surg 2008 Nov;12(11):2010-2014.

* 67. Taniguchi E, Nishijo K, McCleish AT, Michalek JE, Grayson MH, Infante AJ, Abboud

HE, Legallo RD, Qualman SJ, Rubin BP, Keller C. PDGFR-A is a therapeutic target in

alveolar rhabdomyosarcoma. Oncogene 2008 Nov;27(51):6550-6560.

* 68. Boyd, T, Jung I, Van Sickle KR, Schwesinger WH, Michalek JE, Bingener-Casey J.

Music Experience influences Laparoscopic Skills Performance Journal of the Society

of Laparoendoscopic Surgeons 2008 Sep;12(3):292-294.

* 69. Holcomb JB, Wade CE, Michalek JE, Chisholm GB, Zarzabal LA, Schreiber MA,

Gonzalez EA, Pomper GJ, Perkins JG, Spinella PC, Williams KL, Park MS. Increased

plasma and platelet to red blood cell ratios improves outcome in 466 massively

transfused civilian trauma patients Ann Surg 2008 Sep;248(3):447-458.

* 70. Bingener J, Michalek J, Van Sickle K, Schwesinger W. Randomized blinded trial

shows relative thrombocytopenia in natural orifice translumenal endoscopic surgery

compared with standard laparoscopy in a porcine survival model Surg Endosc 2008

Sep;22(9):2067-2071.

* 71. Bingener-Casey J, Michalek JE, Winston JH, Van Sickle KR, Haines V, Schwesinger

WH, Lawrence VA. Randomized Blinded Trial Comparing the Cardiopulmonary Effects

of NOTES with Standard Laparoscopy in a Porcine Survival Model Epub 2008 Apr 9

Surg Endosc 2008 Jun;195(2):1430-1434.

* 72. Michalek JE, Pavuk M. Diabetes and Cancer in Veterans of Operation Ranch Hand

after adjustment for calendar period, days of spraying, and time spent in Southeast

Asia. The Journal of Occupational and Environmental Medicine 2008 Mar;50:330-340.

* 73. Bingener J, Michalek JE, Winston J, Van Sickle K, Haines V, Schwesinger W,

Lawrence V. Randomized blinded trial comparing the cardiopulmonary effects of

NOTES with standard larparoscopy in a porcine survival model Surgical Endoscopy

(DOI 10.1007/x00464-008-9898-8) 2008 Feb

* 74. Bingener J, Cox D, Michalek JE, Mejia A. Can the MELD score predict perioperative

morbidity for patients with liver cirrhosis undergoing laparoscopic cholecystectomy?

Am Surg 2008 Feb;74(2):156-159.

* 75. Lopez PP, Cohn SM, Popkin CA, Jackowski J, Michalek JE. The use of a computed

tomography scan to rule out appendicitis in women of childbearing age is as accurate

as clinical examination: a prospective randomized trial. Am Surg 2007

Dec;73(12):1232-1236.

* 76. Ochoa O, Sun D, Reyes-Reyna SM, Waite LL, Michalek JE, McManus LM, Shireman

PK. Delayed angiogenesis and VEGF production in CCR2-/- mice during impaired

skeletal muscle regeneration. PMID: 17522124 Am J Physiol Regul Integr Comp

Physiol 2007 Aug;293(2):651-661.

* 77. Bingener-Casey J, Buck L, Richards ML, Michalek JE, Schwesinger WH, Sirinek KR.

Long-term outcomes in laparoscopic vs. open ventral hernia repair. Arch Surg 2007

Jun;142(6):562-567.

* 78. Ochoa O, Sun, D, Reyes-Reyna, SM, Waite, LL, Michalek JE, McManus LM, Shireman

PK. Delayed angiogenesis and VEGF production in CCR2 -/- mice during impaired

skeletal muscle regeneration. Am J Physiol Reg Int Comp Physiol 2007 May;ePub

* 79. Cohn SM, Price MA, Stewart RM, Michalek JE, Dent DL, McFarland MJ, Pruitt BA. A

Crisis in the Delivery of Care to Patients with Brain injuries in South Texas. J Trauma

2007 Apr;62(4):951-963.

80. Taiwo OB, Russell IJ, Mignot E, Lin L, Michalek JE, Haynes W, Xiao Y, Zeitzer JM,

Larson AA. Normal cerebrospinal fluid levels of hypocretin-1 (orexin A) in patients with

fibromyalgia syndrome. Sleep Med 2007 Apr;8(3):260-265.

* 81. Shireman PK, Contreras-Shannon V, Ochoa O, Karia BP, Michalek JE, McManus LM.

MCP-1 deficiency causes altered inflammation with impaired skeletal muscle

regeneration. J Leukoc Biol 2007 Mar;81:775-785.

* 82. Contreras-Shannon V, Ochoa O, Reyes-Reyna SM, Sun D, Michalek JE, Kuziel WA,

McManus LM, Shireman PK. Fat accumulation with altered inflammation and

regeneration in skeletal muscle of CCR2-/- mice following ischemic injury. PMID:

17020936 Am J Physiol Cell Physiol 2007 Feb;292(2):c953-c967.

* 83. Ketchum NS, Michalek JE, and Pavuk M. Mortality, length of life, and physical

examination attendance in participants of the Air Force Health Study Military Medicine

2007 Jan;172(1):53-57.

* 84. Bingerer J, Buck L, Richards M, Michalek JE, Schwesinger W, Sirinek K. Long-term

Outcomes in Laparoscopic vs Open Ventral Hernia Repair Archives of Surgery 2007

Jan;142:562-567.

* 85. Fujiyoshi P, Michalek JE, and Matsumura F. Molecular epidemiologic evidence for

diabetogenic effects of dioxin exposure in US Air Force veterans of the Vietnam War

Environmental Health Perspectives 2006 Nov;114(11):1-7.

* 86. Gupta A, Ketchum N, Roehrborn CG, Schecter A, Aragaki CC, Michalek JE. Serum

dioxin, testosterone, and subsequent risk of benign prostatic hyperplasia: a

prospective cohort study of Air Force veterans Environmental Health Perspectives

2006 Nov;114(11):1649-1654.

* 87. Fujiyoshi PT, Michalek JE, Matsumura F. Molecular epidemiologic evidence for

diabetogenic effects of dioxin exposure in U.S. Air force veterans of the Vietnam war.

Environ Health Perspect 2006 Nov;114(11):1677-1683.

* 88. Boyle SH, Michalek JE, Suarez EC. Covariation of psychological attributes and

incident coronary heart disease in U.S. Air Force veterans of the Vietnam war.

Psychosom Med 2006 Nov;68(6):844-850.

* 89. Cohn SM, Price MA, Stewart RM, Michalek JE, Dent DL, Pruitt BA. A crisis in the

delivery of care to brain injured patients Proceedings of the Texas Surgical Society

2006 Oct

* 90. Kaats GR, Michalek JE, Preuss HG. Evaluating efficacy of a chitosan product using a

double-blinded, placebo-controlled protocol Journal of the American College of

Nutrition 2006 Oct;25(5):389-394.

* 91. Boyle SH, Suarez EC and Michalek JE. Covariation of Psychological Attributes and

Incident coronary heart disease. Psychosomatic Medicine 2006;68(6):844-850.

* 92. Ketchum NS, Michalek JE. Postservice mortality of Air Force veterans occupationally

exposed to herbicides during the Vietnam War: 20-year follow-up results Military

Medicine 2005 May;170(5):406-413.

* 93. Pavuk M, Michalek JE, Schecter A, Ketchum NS, Akhtar FZ, Fox KA. Did TCDD

exposure or service in Southeast Asia increase the risk of cancer in air force Vietnam

veterans who did not spray agent orange? J Occup Environ Med 2005 Apr;47(4):335-

342.

* 94. Kingman, Albert, Albers, James W, Arezzo, Joseph C, Garabrant, David H, Michalek

JE. Amalgam exposure and neurological function Neurotoxicology 2005

Mar;26(2):241-255.

* 95. Whitney EJ, Krasuski RA, Personius BE, Michalek JE, Maranian AM, Kolasa MW,

Monick E, Brown BG, Gotto AM. A randomized trial of a strategy for increasing high-

density lipoprotein cholesterol levels: effects on progression of coronary heart disease

and clinical events. Ann Intern Med 2005 Jan;142(2):95-104.

* 96. Ketchum NS and Michalek JE. Post-service mortality of Air Force veterans

occupationally exposed to herbicides during the Vietnam War. Military Medicine

2005;170(5):406-413.

* 97. Emond C, Michalek J, Birnbaum LS, DeVito MJ. Comparison of the use of a

physiologically based pharmacokinetic model and a classical pharmacokinetic model

for dioxin exposure assessments Environmental Health Perspectives

2005;113(12):1666-1668.

* 98. Kingman A, Albers JW, Arezzo JC, Garabrant DH, Michalek JE. Amalgam exposure

and neurological function. Neurotoxicology 2005;26(2):241-255.

* 99. Pavuk M, Michalek JE, Schecter A, Ketchum NS, Akhtar FZ, Fox KA. Did dioxin or

service in Southeast Asia increase the risk of cancer in Air Force Vietnam veterans

who did not spray Agent Orange? Journal of Occupational and Environmental

Medicine 2005;47(4):335-342.

* 100. Kern PA, Said S, Jackson WG, Michalek JE. Insulin sensitivity following agent orange

exposure in Vietnam veterans with high blood levels of 2,3,7,8-tetrachlorodibenzo-p-

dioxin. J Clin Endocrinol Metab 2004 Sep;89(9):4665-4672.

* 101. Akhtar FZ, Garabrant DH, Ketchum NS, Michalek JE. Cancer in US Air Force veterans

of the Vietnam War. J Occup Environ Med 2004 Feb;46(2):123-136.

* 102. Xiao Y, Russell IJ, Michalek JE, and Lawrence R. Changes in hyaluronate levels

correlate with subjective stiffness in fibromyalgia. (In Submission) 2004 Feb

* 103. Pavuk M, Schecter AJ, Akhtar FZ, Michalek JE. Serum 2,3,7,8-tetrachlorodibenzo-p-

dioxin (TCDD) levels and thyroid function in Air Force veterans of the Vietnam War.

Ann Epidemiol 2003 May;13(5):335-343.

* 104. Michalek JE, Barrett DH, Morris RD, Jackson WG. Serum dioxin and psychological

functioning in U.S. Air Force veterans of the Vietnam War. Mil Med 2003

Feb;168(2):153-159.

* 105. Michalek JE, Ketchum NS, Tripathi RC. Diabetes mellitus and 2,3,7,8-

tetrachlorodibenzo-p-dioxin elimination in veterans of Operation Ranch Hand. J Toxicol

Environ Health A 2003 Feb;66(3):211-221.

* 106. Michalek JE, Pirkle JL, Needham LL, Patterson DG, Caudill SP, Tripathi RC, Mocarelli

P. Pharmacokinetics of 2,3,7,8-tetrachlorodibenzo-p-dioxin in Seveso adults and

veterans of operation Ranch Hand. J Expo Anal Environ Epidemiol 2002 Jan;12(1):44-

53.

* 107. Steenland K, Calvert G, Ketchum N and Michalek JE. Dioxin and diabetes mellitus: an

analysis of the combined NIOSH and Ranch Hand data. Occupational and

Environmental Medicine 2001 Oct;58:641-648.

* 108. Barrett DH, Morris RD, Akhtar FZ, Michalek JE. Serum dioxin and cognitive functioning

among veterans of Operation Ranch Hand. Neurotoxicology 2001 Aug;22(4):491-502.

* 109. Michalek JE, Akhtar FZ, Arezzo JC, Garabrant DH, Albers JW. Serum dioxin and

peripheral neuropathy in veterans of Operation Ranch Hand. Neurotoxicology 2001

Aug;22(4):479-490.

* 110. Michalek JE, Ketchum NS, Longnecker MP. Serum dioxin and hepatic abnormalities in

veterans of Operation Ranch Hand. Ann Epidemiol 2001 Jul;11(5):304-311.

* 111. Guo X, Longnecker MP, Michalek JE. Relation of serum tetrachlorodibenzo-p-dioxin

concentration to diet among veterans in the Air Force Health Study with background-

level exposure. J Toxicol Environ Health A 2001 Jun;63(3):159-172.

* 112. Jackson WG, Michalek JE. Temporal changes in TCDD levels in 1419 Air Force

Vietnam-era veterans not occupationally exposed to herbicides. J Expo Anal Environ

Epidemiol 2001;11(1):50-55.

* 113. Michalek JE, Akhtar FZ, Longnecker MP, Burton JE. Relation of serum 2,3,7,8-

tetrachlorodibenzo-p-dioxin (TCDD) level to hematological examination results in

veterans of Operation Ranch Hand. Arch Environ Health 2001;56(5):396-405.

* 114. Larson AA, Giovengo SL, Russell IJ, Michalek JE. Changes in the concentrations of

amino acids in the cerebrospinal fluid that correlate with pain in patients with

fibromyalgia: implications for nitric oxide pathways. Pain 2000 Aug;87(2):201-211.

* 115. Longnecker MP, Michalek JE. Serum dioxin level in relation to diabetes mellitus

among Air Force veterans with background levels of exposure. Epidemiology 2000

Jan;11(1):44-48.

* 116. Selvavel K, Nanthakumar A and Michalek JE. On the estimation of P(X less than Y) for

truncated bivariate exponential distribution and its application. Journal of Applied

Statistical Science 2000;10:47-56.

* 117. Mehrotra KG, Kulkarni PM, Tripathi RC, and Michalek JE. Maximum likelihood

estimation for longitudinal data with truncated observations. Statistics in Medicine

2000;19:2975-2988.

* 118. Russell IJ, Vipraio GA, Michalek JE, Craig FE, Kang YK, Richards AB. Lymphocyte

markers and natural killer cell activity in fibromyalgia syndrome: effects of low-dose,

sublingual use of human interferon-alpha. J Interferon Cytokine Res 1999

Aug;19(8):969-978.

* 119. Russell IJ, Michalek JE, Kang YK, Richards AB. Reduction of morning stiffness and

improvement in physical function in fibromyalgia syndrome patients treated

sublingually with low doses of human interferon-alpha. J Interferon Cytokine Res 1999

Aug;19(8):961-968.

* 120. Ship JA, Fox PC, Michalek JE, Cummins MJ, Richards AB. Treatment of primary

Sjogren's syndrome with low-dose natural human interferon-alpha administered by the

oral mucosal route: a phase II clinical trial. IFN Protocol Study Group. J Interferon

Cytokine Res 1999 Aug;19(8):943-951.

* 121. Longnecker MP and Michalek JE. Weight history, glucose intolerance, and insulin

levels in middle-aged Swedish men. Am J Epidemiol 1999 Aug;150(4):430-432.

122. Longnecker MP, Michalek JE. Re: "Weight history, glucose intolerance, and insulin

levels in middle-aged Swedish men". Am J Epidemiol 1999 Aug;150(4):430-432.

* 123. Michalek JE, Tripathi RC. Pharmacokinetics of TCDD in veterans of Operation Ranch

Hand: 15-year follow-up. J Toxicol Environ Health A 1999 Jul;57(6):369-378.

* 124. Michalek JE, Ketchum NS, Check IJ. Serum dioxin and immunologic response in

veterans of Operation Ranch Hand. Am J Epidemiol 1999 Jun;149(11):1038-1046.

* 125. Michalek JE, Akhtar FZ, Kiel JL. Serum dioxin, insulin, fasting glucose, and sex

hormone-binding globulin in veterans of Operation Ranch Hand. J Clin Endocrinol

Metab 1999 May;84(5):1540-1543.

* 126. Ketchum NS, Michalek JE, Burton JE. Serum dioxin and cancer in veterans of

Operation Ranch Hand. Am J Epidemiol 1999 Apr;149(7):630-639.

* 127. Michalek JE, Ketchum NS, Akhtar FZ. Postservice mortality of US Air Force veterans

occupationally exposed to herbicides in Vietnam: 15-year follow-up. Am J Epidemiol

1998 Oct;148(8):786-792.

* 128. Michalek JE, Rahe AJ, Boyle CA. Paternal dioxin and the sex of children fathered by

veterans of Operation Ranch Hand. Epidemiology 1998 Jul;9(4):474-475.

* 129. Michalek JE, Rahe AJ, Boyle CA. Paternal dioxin, preterm birth, intrauterine growth

retardation, and infant death. Epidemiology 1998 Mar;9(2):161-167.

* 130. van der Molen GW, Kooijman SA, Michalek JE, Slob W. The estimation of elimination

rates of persistent compounds: a re-analysis of 2,3,7,8-tetrachlorodibenzo-p-dioxin

levels in Vietnam veterans. Chemosphere 1998;37(9-12):1833-1844.

* 131. Burton JE, Michalek JE, Rahe AJ. Serum dioxin, chloracne, and acne in veterans of

Operation Ranch Hand. Arch Environ Health 1998;53(3):199-204.

* 132. Michalek JE, Rahe AJ, Kulkarni PM, Tripathi RC. Levels of 2,3,7,8-tetrachlorodibenzo-

p-dioxin in 1,302 unexposed Air Force Vietnam-era veterans. J Expo Anal Environ

Epidemiol 1998;8(1):59-64.

* 133. Kulkarni PM, Tripathi RC, Michalek JE. Maximum (Max) and Mid-P confidence

intervals and p values for the standardized mortality and incidence ratios. Am J

Epidemiol 1998 Jan;147(1):83-86.

* 134. Michalek JE, Tripathi RC, Kulkarni PM, Gupta PL and Selvavel K. Correction for bias

introduced by truncation in pharmacokinetic studies of environmental contaminants.

Environmetrics 1998;9:165-174.

* 135. Mazur A and Michalek JE. Marriage, divorce, and male testosterone. Social Forces

1998;77:315-330.

* 136. Michalek JE. Letter to the editor. Epidemiology 1998;9:359-360.

* 137. Schecter AJ, Michalek JE, May J and Papke O. Dioxin and dibenzofuran congeners in

2,4-dichlorophenoxyacetic acid, 2,4,5-trichlorophenoxyacetic acid, and Agent Orange.

Organohalogen Compounds 1998;36:285-288.

* 138. Michalek JE, Caudill SP, Tripathi RC. Pharmacokinetics of TCDD in veterans of

Operation Ranch Hand: 10-year follow-up. Erratum. J Toxicol Environ Health 1997

Dec;52(6):557-558.

* 139. Henriksen GL, Ketchum NS, Michalek JE, Swaby JA. Serum dioxin and diabetes

mellitus in veterans of Operation Ranch Hand. Epidemiology 1997 May;8(3):252-258.

* 140. Henriksen GL, Michalek JE, Swaby JA, Rahe AJ. Serum dioxin, testosterone, and

gonadotropins in veterans of Operation Ranch Hand. Epidemiology 1996 Jul;7(4):352-

357.

* 141. Michalek JE, Pirkle JL, Caudill SP, Tripathi RC, Patterson DG, Needham LL.

Pharmacokinetics of TCDD in veterans of Operation Ranch Hand: 10-year follow-up. J

Toxicol Environ Health 1996 Feb;47(3):209-220.

* 142. Michalek JE, Tripathi RC, Kulkarni PM, Pirkle JL. The reliability of the serum dioxin

measurement in veterans of Operation Ranch Hand. J Expo Anal Environ Epidemiol

1996;6(3):327-338.

* 143. Henriksen GL and Michalek JE. Letter to the editor. Epidemiology 1996;7(4):454-455.

* 144. Russell IJ, Orr MD, Michalek JE, Nyberg F and Eriksson U. Substance P (SP), SP

endopeptidase activity (SPE), and SP N-terminal peptide (SP1-7) in fibromyalgia

syndrome cerebrospinal fluid (CSF). Third World Congress on Myofascial Pain and

Fibromyalgia (abst) 1995 Jul

* 145. Russell IJ, Michalek JE, Flechas JD, Abraham GE. Treatment of fibromyalgia

syndrome with Super Malic: a randomized, double blind, placebo controlled, crossover

pilot study. J Rheumatol 1995 May;22(5):953-958.

* 146. Michalek JE, Wolfe WH, Miner JC, Papa TM, Pirkle JL. Indices of TCDD exposure and

TCDD body burden in veterans of Operation Ranch Hand. J Expo Anal Environ

Epidemiol 1995;5(2):209-223.

* 147. Wolfe WH, Michalek JE, Miner JC, Rahe AJ, Moore CA, Needham LL, Patterson DG.

Paternal serum dioxin and reproductive outcomes among veterans of Operation Ranch

Hand. Epidemiology 1995 Jan;6(1):17-22.

* 148. Tiwary CM, Michalek JE. Incidence of diabetes among dependents of the U.S. military

forces admitted to U.S. Army treatment facilities, 1971-1991. Diabetes Care 1995

Jan;18(1):90-92.

* 149. Wolfe WH, Michalek JE, Miner JC, Pirkle JL, Caudill SP, Patterson DG, Needham LL.

Determinants of TCDD half-life in veterans of Operation Ranch Hand. J Toxicol

Environ Health 1994 Apr;41(4):481-488.

* 150. Russell IJ, Orr MD, Littman B, Vipraio GA, Alboukrek D, Michalek JE, Lopez Y and

Mackillip F. Elevated cerebral spinal fluid levels of substance P in patients with the

fibromyalgia syndrome. Arthritis and Rheumatism 1994;37:1593-1601.

* 151. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Javors MA and Bowden CA. Reply

to letter regarding manuscript entitled: Platelet 3H-imipramine uptake receptor density

and serum serotonin levels in patients with fibromyalgia/fibrositis syndrome Journal of

Rheumatology 1993;20:1986-1988.

* 152. Wolfe WH, Miner JC, Michalek JE. Immunological parameters in current and former

US Air Force personnel. Vaccine 1993 Jan;11(5):545-547.

* 153. Wolfe WH, Miner JC, Michalek JE. Immunological parameters in current and former

US Air Force personnel. Vaccine 1992;11(5):545-547.

* 154. Michalek JE, Tripathi RC, Caudill SP, Pirkle JL. Investigation of TCDD half-life

heterogeneity in veterans of Operation Ranch Hand. J Toxicol Environ Health 1992

Jan;35(1):29-38.

* 155. Caudill SP, Pirkle JL, Michalek JE. Effects of measurement error on estimating

biological half-life. J Expo Anal Environ Epidemiol 1992;2(4):463-476.

* 156. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Javors MA, Bowden CA. Platelet

3H-imipramine uptake receptor density and serum serotonin levels in patients with

fibromyalgia/fibrositis syndrome. J Rheumatol 1992 Jan;19(1):104-109.

* 157. Wolfe WH, Michalek JE, Miner JC, Pirkle J, Caudill S, Needham L and Patterson Jr

DG. Dioxin half-life in veterans of Operation Ranch Hand. Organohalogen Compounds

1992;10:239-242.

* 158. Wolfe WH, Michalek JE, Miner JC, Needham LL and Patterson Jr, DG. Diabetes

versus dioxin body burden in veterans of Operation Ranch Hand. Organohalogen

Compounds 1992;10:279-282.

* 159. Wolfe WH, Michalek JE, Miner JC, Rahe A, Moore CA, Needham LL and Patterson Jr

DG. Reproductive outcomes versus paternal dioxin body burden in veterans of

Operation Ranch Hand. Organohalogen Compounds 1992;10:283-286.

* 160. Russell IJ, Russell SJ, Cuevas RE, Michalek JE. Early life traumas and confiding in

fibromyalgia syndrome (FS). Scandanavian Journal of Rheumatology 1992;94(S14)

* 161. Russell IJ, Vipraio GA, Michalek JE and Lopez YG. Insulin-like growth factor (IGF1) in

fibromyalgia (FS), rheumatoid arthritis (RA), osteoarthritis (OA) and healthy normal

controls (NC): Roles of diagnosis, age, sex and ethnic origin. Arthritis and Rheumatism

1992;35(S160)

* 162. Russell IJ, Michalek JE, Vipraio GA, Lawrence VA, Lessard JA, Briggs BT. Automated

reading of joint space on osteoarthritis X-rays: Correlation with clinical manifestations.

Arthritis and Rheumatism 1992;35(S133)

* 163. Russell IJ, Michalek JE, Lawrence VA, Lessard JA, Briggs BT and May GS. A

randomized, placebo (PL) and no-intervention (NI) controlled, trial of intra-articular (IA)

1% sodium hyaluronate (HA) in the treatment of knee osteoarthritis. Arthritis and

Rheumatism 1992;35(S132)

* 164. Russell IJ, Fletcher EM, Michalek JE, McBroom PC, Hester GG. Treatment of primary

fibrositis/fibromyalgia syndrome with ibuprofen and alprazolam. A double-blind,

placebo-controlled study. Arthritis Rheum 1991 May;34(5):552-560.

* 165. Michalek JE, Wolfe WH, Miner JC. Health status of Air Force veterans occupationally

exposed to herbicides in Vietnam. II. Mortality. JAMA 1990 Oct;264(14):1832-1836.

* 166. Wolfe WH, Michalek JE, Miner JC, Rahe A, Silva J, Thomas WF, Grubbs WD, Lustik

MB, Karrison TG, Roegner RH. Health status of Air Force veterans occupationally

exposed to herbicides in Vietnam. I. Physical health. JAMA 1990 Oct;264(14):1824-

1831.

* 167. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in

fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989 Nov;19:158-163.

* 168. Michalek JE, Mihalko D, Tripathi RC. Cautions on the reanalysis of epidemiologic

databases. Stat Med 1989 Jun;8(6):653-664.

* 169. Pirkle JL, Wolfe WH, Patterson DG, Needham LL, Michalek JE, Miner JC, Peterson

MR, Phillips DL. Estimates of the half-life of 2,3,7,8-tetrachlorodibenzo-p-dioxin in

Vietnam Veterans of Operation Ranch Hand. J Toxicol Environ Health 1989;27(2):165-

171.

* 170. Michalek JE. The value of epidemiology. Applied Industrial Hygiene, Special Issue

1989:68-72.

* 171. Russell IJ, Fletcher EM, Tsui J and Michalek JE. Comparisons of rheumatoid arthritis

and fibrositis/fibromyalgia syndrome using functional and psychological outcome

measures. Arthritis and Rheumatism 1989;32(S70)

* 172. Russell IJ, Fletcher EM, Michalek JE, McBroom PC and Hester GG. Efficacy and

safety of ibuprofen and alprazolam in the treatment of primary fibrositis/fibromyalgia

syndrome. Arthritis and Rheumatism 1989;32(S69)

* 173. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM and Wall K. Serum amino acids in

fibrositis/fibromyalgia syndrome. Arthritis and Rheumatism 1989;32(S70)

* 174. Wolfe WH, Michalek JE, Miner JC, Patterson DG, Needham LL and Pirkle JL. Serum

dioxin levels in Air Force Health Study participants preliminary report. Morbidity

Mortality Weekly Report 1988;37:309-311.

* 175. Russell IJ, Vipraio GA, Michalek JE and Fletcher E. Abnormal T cell subpopulations in

fibrositis syndrome. Arthritis and Rheumatism 1988:S99-S99.

* 176. Russell IJ, Vipraio GA, Tovar Z, Michalek JE and Fletcher E. Abnormal natural killer

cell activity in fibrositis syndrome is responsive in vitro to IL-2. Arthritis and

Rheumatism 1988:S24-S24.

* 177. Gupta RC, Tripathi RC, Michalek JE and White T. An exact test for the mean of a

normal distribution with a known coefficient of variation. Computational Statistics and

Data Analysis 1986;3:219-226.

* 178. Gupta RC and Michalek JE. On the relationship between the proportional hazard and

accelerated failure time models in survival analysis. Statistics and Probability Letters

1985;3:231-234.

* 179. Michalek JE, Mihalko D and White T. A Monte Carlo comparison of logrank, Wilcoxon

and normal scores procedures on matched and censored data. Communications in

Statistics 1985;14(2):449-465.

* 180. Michalek JE and Mihalko D. Linear rank procedures for matched data. Biometrics

1984;40:487-491.

* 181. Gupta RC, Mehrotra KG and Michalek JE. A small sample test for an absolutely

continuous bivariate exponential model. Communications in Statistics

1984;13(14):1735-1740.

* 182. Gupta RC and Michalek JE. On Gehan‘s Wilcoxon extension and the accelerated

failure time model. Communications in Statistics 1984;13(5):563-566.

* 183. Gupta RC and Michalek JE. On the determination of reliability functions via the TTT

transform. IEEE Transactions on Reliability 1984;R-(34):175-176.

* 184. Michalek JE, Mihalko D. On the use of logrank scores in the analysis of litter-matched

data on time to tumour appearance. Stat Med 1983 Jul;2(3):315-326.

* 185. Mehrotra KG, Michalek JE, Mihalko D, White T. Score computation for linear rank

procedures. Journal of Statistical Computation and Simulation 1983;16:201-211.

* 186. Keating JP, Michalek JE and Riley JT. A note on the optimality of the Karhunen-Loeve

expansion. Pattern Recognition Letters 1983;1:203-204.

* 187. Eisenberg B, Decosse J, Harford F and Michalek JE. Carcinoma of the colon and

rectum: the natural history reviewed in 1704 cases. Cancer 1982;49:1131-1134.

* 188. Mehrotra KG, Michalek JE and Mihalko D. A relationship between two forms of linear

rank procedures for censored data. Biometrika 1982;69:674-676.

* 189. Michalek JE, Tripathi RC. The effect of errors in diagnosis and measurement on the

estimation of the probability of an event. Journal of the American Statistical

Association 1980;75:713-721.

* 190. Hensler GL, Mehrotra KG, Michalek JE. A goodness of fit test for multivariate

normality. Communications in Statistics 1977;A6(1):33-41.

* 191. Michalek JE. Uniform convergence of an empirical CDF based on a relatively small

number of order statistics. Communications in Statistics 1976;5(3):241-250.

* 192. Hensler GL, Mehrotra KG, Michalek JE. A note on some exact efficiency calculations

for survival distributions. Biometrika 1976;64:635-637.

Papers Submitted

* 1. Muir T, Michalek JE. Contrasting toxicology and epidemiology on safe levels of

persistent organic pollutants 2013 Feb

PRESENTATIONS:

02/2005 On the Disposition of the Air Force Health Study: An Overview, Board Room NAS Building,

Washington, DC (Invited Speaker)

10/2002 Like morning stiffness in rheumatoid arthritis, morning stiffness in fibromyalgia is related to

serum hyaluronic acid., American College of Rheumatology, New Orleans, LA (Co-Presenter)

10/2002 Therapy with a central alpha-2-adrenergic agonist [tizanidine] decreases cerebrospinal fluid

substance P, and may reduce serum hyaluronic acid as it improves the clinical symptoms of the

fibromyalgia syndrome., American College of Rheumatology, New Orleans, LA (Co-Presenter)

10/2002 Correlation of Anti-Polymer Antibodies with Clinical Measures in Fibromyalgia Syndrome.,

American College of Rheumatology, New Orleans, LA (Co-Presenter)

04/2002 Veterans and Agent Orange: Update 2002 (2003), National Academy of Sciences, Washington,

DC (Sole Presenter)

Details: First Public Meeting in the 2002 Update Series: "Recent Data from Ranch Hand

Studies"

04/2002 Dioxins and Dioxin-like Compounds in the Food Supply: Strategies to Decrease Exposure

(2003), National Academy os Sciences (Sole Presenter)

Details: Workshop #2–Implication of Dioxin in the Food Supply, Session on Accumulation and

Elimination of Dioxins in Humans: “Kinetics of Dioxin Elimination in the Ranch Hand Cohort”

04/2002 Workshop #2-Implication of Dioxin in the Food Supply, Session on Accumulation and

Elimination of Dioxins in Humans: "Kinetics of Dioxin Elimination in the Ranch Hand Cohort"

(Invited Speaker)

01/2002 Alpha-2 adrenergic agonists: evidence and experience examined, Round Table Series 75, The

Royal Society of Medicine Press, Ltd (Co-Presenter)

06/2000 Public Workshop 2: "Dioxin and Diabetes in Ranch Hand Veterans", National Academy of

Sciences, Washington, DC (Sole Presenter)

03/2000 Agent Orange:Status of the Air Force Ranch Hand Study, House of Representatives

subcommittee on National Security, Veterans Affairs, and International Relations, of the

Committee on Government Reform, United States Congress (Invited Speaker)

Details: Defended the study against claims that the Air Force, the Food and Drug

Administration, and the National Academy of Sciences had collaborated to encumber scientific

aspects of the study

07/1999 Veterans and Agent Orange: Herbicide/Dioxin Exposure and Type 2 Diabetes (2000), National

Academy of Sciences, Washington, DC (Sole Presenter)

Details: Public Workshop 1: "Diabetes and TCDD in the Air Force Health Study"

09/1996 Health Effects in Veterans Exposed to Agent Orange in Vietnam, Committee on Veteran's

Affairs, United States Senate (Invited Speaker)

Details: Information gathering hearing at which a short summary of results and response to

questions from the Committee.

08/1996 Characteristics of the elevated spinal fluid substance P in fibromyalgia syndrome., 8th World

Congress on Pain, Vancouver, BC, Canada (Co-Presenter)

04/1996 Health Effects in Children of Individuals Exposed to Agent Orange in Vietnam, Committee on

Veterans' Affairs Subcommittee on Hospitals and Health Care, United States House of

Representatives (Invited Speaker)

01/1994 Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam, National Academy

of Sciences (Sole Presenter)

12/1992 Scientific Workshop on Exposure Assessment, Session 4: Biomarkers for Exposure

Assessment, National Academy of Sciences (Sole Presenter)

11/1989 A rebuttal to "How the military misled Vietnam veterans and their families about the health risks

of Agent Orange", House and Senate Committees on Veterean's Affairs staffers, United States

Congress (Invited Speaker)

Details: Defended the Air Force Health Study against a claim that study investigators had

withheld information.

05/1988 A metabolic basis for fibrositis syndrome (FS): The serotonin deficiency hypothesis., ARA

Meeting, Nonarticular Rheumatism Study Group (NARSG) Meeting, Houston, TX (Co-

Presenter)

Details: Accepted for presentation.

05/1988 Agent Orange Legislation and Oversight Hearing, Committee on Veterans' Affairs, One

Hundredth Congress, Second Session on S.1692, United States Senate (Invited Speaker)

Details: The proposed "Agent Orange Disability Benefits Act of 1987"; S. 1781, The Proposed

"Veterans Agent Orange Disability Act of 1987"; and Agent Orange Oversight Issues May 12,

1988. U.S. Government Printing Office, Washington: 1989 Hearing to assess Federal efforts to

address the Agent Orange issue.

RESEARCH GRANTS:

Project #:

Funding Agency: VA

Title: IPAA for Joel E Michalek(Cadena)

Status: Active

Period: 06/2014 - 05/2016

Role: Co-Investigator % Effort: 3

Total Costs: $6,788.00

Grant Detail: Failure to isolate patients with pulmonary tuberculosis as a patient safety issue:

Defining the problem and estimating its associated costs

Despite advances in its control and prevention, tuberculosis (TB) is an important patient safety issue

in the US. Texas and other three states account for over half of the US cases. Healthcare Associated

TB exposure cohorts continue to occur despite implementation of the CDC’s recommendations for

infection prevention, causing significant costs for healthcare systems. However, recent data on

factors predicting the clinical features of TB cases leading to exposures, and the costs of contact

tracings for healthcare systems are not available. This should be researched in order ensure a safe

environment for patients.

Project #: 3UL1TR001120-01

Funding Agency: NIH/NCRR

Title: Institute For Integration of Medicine & Science: A Partnership to Improve

Health(3UL1TR00120-01/Biostatistics)(Clark, Robert)

Status: Complete

Period: 05/2008 - 04/2015



Grant Detail: Our mission is to achieve optimal integration of clinical and translational research,

education, training, and career development across all UTHSCSA schools and among our partner

organizations in the South Texas region. IIMS will focus existing and newly developing resources and

intellectual capital on advancing the discipline of clinical and translational research for the

improvement of human health. Key function working groups have developed many innovative

approaches to providing optimal support for IIMS investigators and programs. Distinctive features of

IIMS include: 1) thriving partnerships with key public and private organizations (academic, health

care, public health, military), 2) major investments in research resources and infrastructure, 3) the

largest cadre of military health care and biomedical research operations in the US, 4) one of the

world’s largest primate research colonies, 5) a 46,000 square mile service area populated by

predominantly Hispanic residents comprising some of the country’s poorest people, plagued by high

rates of health disparities, providing an opportunity, challenge and obligation for us to make a

significant impact on human health.

Project #: 5M01 RR 001346-2

Funding Agency: NIH

Title: General Clinical Research Center: Biostat Core (PI: Clark, Robert)

Status: Complete

Period: 12/2003 - 04/2009



Grant Detail: The Biostatistics and Informatics Core of the Frederic C. Bartter General Clinical

Research Center (GCRC) provides bio-statistical and data management support for protocols and

participates in Educational/training activities for junior investigators.

Federal

Project #: W911QY-14-1-0005

Funding Agency: Army Med Research Acquisition Activity

Title: Evaluation of the Efficacy of a Novel Soft Tissue Clamp

Status: Complete

Period: 09/2014 - 03/2015

Role: Contributor % Effort: 10

Total Costs:

Grant Detail: This is a non-inferiority study of a novel, FDA approved, externally-applied, soft-tissue

clamp (iTClamp®, Innovative Trauma Care, Inc., San Antonio, TX, USA) as compared to a properly-

placed hasty tourniquet for intact extremity penetrating trauma hemorrhage control, during the “care

under fire” phase of the Tactical Combat Casualty Care (TCCC) paradigm. The goal is to determine

whether the temporary wound closure clamp provides hemorrhage control comparable to a hasty

tourniquet when applied to a non-amputation arterial extremity hemorrhage model.

Project #: RP 140685

Funding Agency: CPRIT

Title: Modulation of Autophagy - Phase II Study

Status: Active

Period: 08/2014 - 08/2015


Total Costs:

Grant Detail: This will be a randomized, controlled phase II clinical trial of pts with histological

documentation of primary colon or rectal adenocarcinoma with metastases, who have received

locally and currently approved standard therapies, excluding RGF. Pts will be randomized to RGF or

VOR/HCQ, and crossover will be allowed after first progression on the initial therapy. In the single-

arm phase study, VOR/HCQ was given daily in 3-week cycles. In this proposed study, we will give

VOR/HCQ daily in 4-week cycles, such that this is comparable to the 4-week cycle of RGF (daily for

3 weeks, 1 week off).

Project #: 1 R01 FD004400-0

Funding Agency: FDA

Title: Phase 2 Study of TH-302 for the Treatment of Glioblastoma

Status: Active

Period: 08/2014 - 06/2015


Total Costs:

Grant Detail: This application attempts to challenge the current clinical paradigm [38] in glioblastoma

of uniform treatment for all patients with an anitangiogenic agent to a more individualized treatment

regimen based on molecular biomarkers that define the individual tumor’s level of hypoxia, and uses

that hypoxia as a target of therapy. This approach is novel, and attempts to refine the potential

integration of molecular imaging and biomarker analysis as predictive tools. Moreover, this proposal

makes use of a new category of therapeutic; the hypoxia activated pro-drug TH-302, in an attempt to

improve survival of an orphan disease with dismal outcomes.

Project #: 2 P30 CA054174-1


Title: Cancer Therapy and Research Center at UTHSCSA/Cancer Center Admin(Thompson)

Status: Active

Period: 08/2009 - 07/2014


Total Costs: $1,029,650.00

Grant Detail: This is a P30 Cancer Center Support Grant at the University of Texas Health Science

Center at San Antonio. This grant provides funding for the conduct of cancer clinical trials, prevention

studies and assistance with statistical design and analysis of translational cancer research projects.

Specifically, this is for support of the biostatistics and medical informatics core which has the

following aims: provide flexible, cost-efficient services to CTRC basic, clinical and translational

researchers; provides services to aid in the administration of the CTRC including monitoring and

reporting functions for compliance with local and Federal regulatory requirements, quality assurance

review, preparation of reports and analyses for administrative meetings; to provide informatics

components for the Protocol Review Committee, the Data Safety Monitoring Committee and to

provide statistical assistance with the development and conduct of clinical protocol-based research.

Project #: 2 P30 CA054174-1

Funding Agency: NIH/NCI

Title: Cancer Therapy and Research Center/Cancer Center Admin

Status: Complete

Period: 08/2009 - 07/2013

Role: Consultant % Effort: 6

Total Costs:

Grant Detail: This is a P30 Cancer Center Support Grant at the University of Texas Health Science

Center at San Antonio. This grant provides funding for the conduct of cancer clinical trials, prevention

studies and assistance with statistical design and analysis of translational cancer research projects.

Specifically, this is for support of the biostatistics and medical informatics core which has the

following aims: provide flexible, cost-efficient services to SACI basic, clinical and translational

researchers; provides services to aid in the administration of the SACI including monitoring and

reporting functions for compliance with local and Federal regulatory requirements, quality assurance

review, preparation of reports and analyses for administrative meetings; to provide informatics

components for the Protocol Review Committee, the Data Safety Monitoring Committee and to

provide statistical assistance with the development and conduct of clinical protocol-based research.

Project #: W81XWH-08-2-0109

Funding Agency: Psychological Health and TBI Research Program, Congressionally Directed

Medical Research Program

Title: The STRONG STAR Multidisciplinary PTSD Research Consortium

Status: Complete

Period: 09/2008 - 08/2015

Role: Consultant % Effort:

Total Costs: $35,000,000.00

Grant Detail: This is a multidisciplinary and multi-institutional proposal to establish a PTSD research

consortium in San Antonio focused on the development and evaluation of prevention and treatment

programs for combat-related PTSD in active-duty military personnel and recently discharged military

veterans.

Project #: 1UL1RR025767-01


Title: Institute for Integration of Medicine & Science: A Partnership to Improve Health

Status: Complete

Period: 05/2008 - 04/2013

Role: Consultant % Effort: 15

Total Costs:

Grant Detail: Prinicipal Investigator: Robert Clark, MD

Our mission is to achieve optimal integration of clinical and translational research, education,

training, and career development across all UTHSCSA schools and among our partner organizations

in the South Texas region. IIMS will focus existing and newly developing resources and intellectual

capital on advancing the discipline of clinical and translational research for the improvement of

human health. Meaningful bidirectional community participation has promoted buy-in from all

stakeholders and will remain a key principle as IIMS continues to evolve. IIMS partners have brought

together major talent and a broad array of resources to create synergies that add value to all

participating organizations, residents of our region and the CTSA network. Key function working

groups have developed many innovative approaches to providing optimal support for IIMS

investigators and programs. Distinctive features of IIMS include: 1) thriving partnerships with key

public and private organizations (academic, health care, public health, military), 2) major investments

in research resources and infrastructure, 3) the largest cadre of military health care and biomedical

research operations in the US, 4) one of the world’s largest primate research colonies, 5) a 46,000

square mile service area populated by predominantly Hispanic residents comprising some of the

country’s poorest people, plagued by high rates of health disparities, providing an opportunity,

challenge and obligation for us to make a significant impact on human health.

Project #: R01CA 133229-01

Funding Agency: NIH/NCI

Title: Therapeutic Targets in Alveolar Rhabdomyosarcoma

Status: Complete

Period: 04/2008 - 03/2013


Total Costs: $1,539,045.00

Grant Detail: The primary objective for this project will be to delineate the PDGFR-A signaling

pathway to rhabdomyosarcome by functional testing in vitro with the second aim to determine the

pathophysiologicl impact of specific and exclusive PDGFR-A blockade for rhabdomyosarcome in

vivo.

Project #: 5K23DA022297-04

Funding Agency: NIDA

Title: Treatment of Opioid Dependence and Chronic Pain

Status: Complete

Period: 04/2008 - 03/2013

Role: Consultant % Effort:

Total Costs:

Grant Detail: The goal of this project is to obtain advanced training in the treatmetn of chronic pain

and opioid dependence in order to conduct treatment-related research on co-occurring chronic pain

and opioid dependence. The primary research objective is to develop an integrated psychosocial

treatmetn for co-occurring chronic pain and opioid dependence based on formative research

conducted during the award period.

Project #: 1R01MH080127-01

Funding Agency: NIMH

Title: Gene-Environment Interactions and Risk of Depression in Youth with Diabetes (PI: Delgado,

Pedro)

Status: Not Funded

Period: 10/2007 - 09/2012

Role: Co-Investigator % Effort:

Total Costs: $2,535,090.00

Grant Detail: The major goals of this project are to examine how genetic factors, environmental

stressors and brain development interact to determine the onset of mood disorders.

Project #: W81XWH-07-0717

Funding Agency: Dept of the Army

Title: A Civilian/Military Trauma Institute: Resuscitation-Monitoring-Metabolic Control

Status: Complete

Period: 09/2007 - 09/2013


Total Costs: $5,275,068.00

Grant Detail: Establish procedures to identify upon admission to the emergency department those

patients who may require a blood transusion. These procedures will be uniformly implemented at all

three Level 1 trauma centers, UTHSCSA, BAMC AND WHMC. The measures to be employed to

asses coagulation status of patients with traumatic injuries upon admission will include point of care

assessment of aactivated clotting time (ACT) and INR, and laboratory thrombelastography (TEG).

The purpose of this effort is to improve patient care and reduce resource utilization. A Department of

Defense grant supporting a wide variety of research projects directed towards resuscitation,

metabolic control and physiologic monitoring during critical illness.

Project #: DAMD17-03-C-0071

Funding Agency: Dept. of the Army

Title: Feasibility Study and Demonstration Project for a Joint Military/Civilian Trauma Institute with a

Burn Center

Status: Complete

Period: 09/2005 - 10/2008


Total Costs: $1,847,713.93

Grant Detail: A grant supporting the research, clinical and educational collaboration between

UTHSCSA, Brooke Army Medical Center, the U.S. Army Institute for Surgical Research, Wilford Hall

Medical Center and University Hospital.

Project #: 117549

Funding Agency: NIH/NIAID

Title: New Animal Models for Invasive Aspergillosis (N01-AI-30041)

Status: Complete

Period: 08/2003 - 08/2010


Total Costs: $7,149,604.00

Grant Detail: The overall objective of this proposal is to establish and standardize animal models of

invasive aspergillosis that can be used to evaluate genomic information on the pathogenicity and

virulence of Aspergillus in order to improve diagnosis and therapy of invasive aspergillosis. We are

the lead site for this multi-center collaboration involving sub-contracts at UCLA, MD Anderson, McGill

(Montreal, Canada) & Univ of Manchester (UK).

Project #: 276700F1

Funding Agency: United States Air Force

Title: The Air Force Health Study (PI: Michalek, Joel)

Status: Complete

Period: 01/1980 - 10/2006

Role: Principal Investigator % Effort: 100

Total Costs: 140,000,000.00

Grant Detail: The purpose of this cohort study was to determine whether adverse health was

associated with exposure to Agent Orange in US Air Force veterans of Operation Ranch Hand.

Funded under program element 0605306F in the United States Federal Budget. Oversight by the

House and Senate Veterans Affairs Committees of the United States Congress and peer-reviewed

by the National Academy of Sciences and the US Food and Drug Administration.

SERVICE

01/2010-12/2010 Prostate Cancer Peer Review

Committee Member

Clinical Trial Award/Innovative Treatment Evaluation Award (CTA/ITEA) peer review panel

01/1998-12/1998 A metabolic basis for fibrositis syndrome

(FS): Consultant

The serotonin deficiency hypothesis. Accepted for presentation at the Nonarticular Rheumatism

Study Group (NARSG) meeting during the ARA meeting, Houston, TX

01/1992-12/1992 Early life traumas and confiding in

fibromyalgia syndrome(FS) Consultant

rheumatoid arthritis (RA), osteoarthritis (OA) and healthy normal controls (NC): Roles of diagnosis,

age, sex and ethnic origin. Arthritis and Rheumatism

01/1992-12/1992 Insulin-like growth factor (IGFI) in

fibromyalgia (FS) Consultant

rheumatoid arthritis (RA), osteoarthritis (OA) and healthy normal controls (NC): Roles of diagnosis,

age, sex and ethnic origin. Arthritis and Rheumatism

01/1992-12/1992 Automated reading of joint space on

oseoarthritis X-rays: Consultant

Correlation with clinical manifestations. Arthritis and Rheumatism

01/1992-12/1992 A randomized, placebo (PL) and no-

intervention(NI) Consultant

controlled, trial of intra-articular (IA) 1% sodium hyaluranate (HA) in the treatment of knee

oseoarthritis. Arthritis and Rheumatism

01/1991-12/1991 Treatment of primary fibrositis/fibromyalgia

syndrome with ibuprofen and alprazolam. Consultant

A double-blind placebo-controlled study. Arthritis and Rheumatism

01/1989-12/1989 Serum amino acids in fibrositis/fribromyalgia

syndrome Consultant

Journal of Rheumatology

01/1989-12/1989 Efficacy and safety of ibuprofen and

alprazolam in the treatment of primary

fibrositis/fibromyalgia syndrome

Consultant

Arthritis and Rheumatism

01/1988-12/1988 Abnormal T cell subpopulations in fibrositis

syndrome Consultant


01/1988-12/1988 Abnormal natural killer cell activity in

fibrositis syndrome is responive in vitro to IL-

2

Consultant


SERVICE TO GOVERNMENT:

Dates Type Description Role

05/2008-05/2008 Federal

Government NIH Study Sections Ad Hoc Reviewer

Clinical Oncology Study Section, Bethesda, MD.

08/2004-08/2004 Local

Government Kelly Restoration Advisory Board Advisor

Presented a talk entitled "The Air Force Health Study: Overview and Update" - San Antonio, Texas

01/2004-01/2004 Reviewed Report for Australian Government

Department of the Environment and

Heritage

Consultant

Determination of the levels of dioxins in the Australian population by analysis of blood serum

01/2004-01/2004 Reviewed Reports for Australian

Government Department of the Environment

and Heritage

Consultant

Determination of the levels of dioxins and dioxin-like compounds in the Australian population by

analysis of pooled human breast milk

03/2002-03/2002 Federal

Government Vietnam-United States Scientific

Conference Invited Participant

Presented “Diabetes mellitus elimination in veterans of Operation Ranch Hand” on Human Health

and Environmental Effects of Agent Orange/Dioxin. Hanoi, Vietnam

09/2000-09/2000 Federal

Government Working Group Advisor

Advising the Secretary of the Department of Veterans Affairs regarding possible studies to address

in-country effects. This meeting took place at Department of Veterans Affairs headquarters,

Washington, DC

06/2000-06/2000 Federal

Government Overview of the Air Force Health Study Advisor

Gave a talk to professional staff of the House and Senate Veterans Affairs Committees. The talk

covered protocol development, purpose, scope, exposure metrics, findings, and critical reviews.

03/2000-03/2000 Federal

Government Press Conference at the Pentagon Invited Participant

Announced an association between Agent Orange exposure and diabetes in Air Force veterans at a

nationally televised press conference. The content of this presentation contributed to a decision by

the US Department of Veterans‘ Affairs to service-connect type 2 diabetes mellitus in Vietnam

veterans.

03/2000-03/2000 Federal

Government Presentation to the House of

Representatives subcommittee on National

Security, Veterans Affairs, and International

Relations, of the Committee on Gov

Advisor

"Agent Orange: Status of the Air Force Ranch Hand Study". I defended the study against claims that

the Air Force, the Food and Drug Administration, and the National Academy of Sciences had

collaborated to encumber scientific aspects of the study.

03/2000-03/2000 Federal

Government "Agent Orange: Status of the Air Force

Ranch Hand Study". Advisor

Presentation to the House of Representatives subcommittee on National Security, Veterans Affairs,

and International Relations, of the Committee on Government Reform, United States Congress, 15

March 2000.

12/1999-12/1999 Federal

Government Served on a panel of invited scientists Invited Participant

Entitled “Gulf War Veterans: Measuring Health”, sponsored by the National Academy of Sciences,

Washington DC.

09/1999-09/1999 Local

Government US Army Medical Research and Material

Command Liaison

Congressionally Directed Medical Research Program Breast Cancer Research Program. Brook

Army Hospital, San Antonio, Texas

07/1999-07/1999 Federal

Government Institute of Medicine, National Academy of

Sciences Guest Lecturer

Presentation to the Committee to Review Health Effects in Vietnam Veterans of Exposed to

Herbicides, Washington, DC

11/1998-11/1998 Federal

Government Presentation to the House and Senate

Committees on Veteran‘s Affairs staffers,

United States Congress

Presenter

A Rebuttal to “How the military misled Vietnam veterans and their families about the health risks of

Agent Orange”. I defended the Air Force Health Study against a claim that study investigators had

withheld information

09/1996-09/1996 Federal

Government Presentation to the Committee on Veterans‘

Affairs, United States Senate Presenter

Health Effects in Veterans Exposed to Agent Orange in Vietnam. This was an information gathering

hearing at which I presented a short summary of results and responded to questions from the

Committee.

04/1996-04/1996 Federal

Government Presentation to the House Veterans‘ Affairs

Subcommittee Presenter

Gave a presentation to the Subcommittee on Hospitals and Health Care, United States House of

Representatives. Health Effects in Children of Individuals Exposed to Agent Orange in Vietnam.

05/1988-05/1988 Federal

Government Agent Orange Legislation and Oversight

Hearing Before the Committee on Veterans‘

Affairs, United States Senate

Presenter

One Hundredth Congress, Second Session on S. 1692, The Proposed "Agent Orange Disability

Benefits Act of 1987"; S. 1781, The Proposed "Veterans Agent Orange Disability Act of 1987"; and

Agent Orange Oversight Issues May 12, 1988. US Government Printing Office, Washington: 1989.

This was a hearing to assess Federal efforts to address the Agent Orange issue.

08/1985-08/1985 Federal

Government Veterans Administration Agent Orange

Continuing Education Workshop Member

Washington Plaza Hotel, Washington, DC

SERVICE TO THE PROFESSION:


06/2014-Present National Edorium Journal of Biostatistics Editor

Edorium Journal of Biostatistics

03/2002-03/2002 National Ad Hoc Panel Member

Convened to Assist the NIEHS with Developing a Preliminary Research Strategy Relating to Health

and Environmental Aspects of Exposure to Dioxin and Related Compounds in Vietnam. Sponsored

by the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina

06/2000-06/2000 National Presented a talk to the Institute of Medicine

at the National Academy of Sciences Advisor

Talk entitled "Dioxin and Diabetes in Ranch Hand Veterans."

01/1999-01/2000 Local San Antonio Chapter of the American

Statistical Association President


Statistical Association Vice-President

06/1990-05/2005 National National Research Council Advisor

01/1990-Present Epidemiology Reviewer

Journal

01/1990-Present International Environmental Health Perspectives Reviewer

Journal

01/1990-Present International Journal of Toxicology and Environmental

Health Reviewer

01/1990-Present International Chemosphere Reviewer

Journal

01/1987-12/1987 International Imipramine receptor density on platelets of

patients with fibrositis syndrome: Correlation

with disease severity and response to

therapy

Consultant



Statistical Association President


Statistical Association Vice-President

SERVICE TO THE PUBLIC:


01/2009-12/2009 Community Gulf War Illness Peer Review

Committee Member

Clinical Trial Award/Innovative Treatment Evaluation Award (CTA/ITEA) peer review panel

06/2004-06/2004 Health

Education Workshop entitled "Healthy Neighborhoods,

Strong Economy, Clean Environment" Advisor

Presented an overview of the Air Force Health Study at a Southwest San Antonio Community

Workshop at Our Lady of the Lake University, San Antonio, Texas. This workshop was devoted to

presentations regarding toxic chemical exposures in the local San Antonio community. I answered

questions regarding dioxin and health and provided advice concerning possible exposures near

Kelly Air Force Base.

01/1982-01/1989 Community Oak Hollow Park Neighborhood Association Secretary

PROFESSIONAL AFFILIATIONS:

Dates Organization

06/2013-Present Society of Toxicology

02/2013-Present Society for Complexity in Acute Illness

01/2000-12/2004 ASA Media Expert Program

01/1998-01/2008 American Public Health Association

01/1998-Present International Society for Exposure Analysis

01/1996-12/2003 National Research Council

Additional Details: Advisor

01/1994-12/2005 Air Force Health Study

Additional Details: Principal Investigator

01/1985-12/1989 San Antonio YMCA Indian Guides

Additional Details: Tribe leader

01/1982-12/1999 San Antonio Chapter of the American Statistical Association

Additional Details: Vice-President-1982, 1983, 1996, 1997,1998 President-1984,

1999

01/1982-12/1989 San Antonio Oak Hollow Park Neighborhood Association

Additional Details: Secretary

01/1980-Present Biometrics Society

01/1976-Present American Statistical Association

COMMITTEES (OTHER):

DEPARTMENT

Dates Committee Role

01/2006-Present

DEB Promotions, Tenure and Appointments Committee,

University of Texas Health Science Center, Medicine,

Epidemiology & Biostatistics

Chair

OTHER


09/2005-Present CTRC Protocol Review Member

UNIVERSITY


08/2006-Present

CTSA Key Function Group for Biostatistics and Study Design,

University of Texas Health Science Center at San Antonio

Member

08/2006-Present

CTSA Key Function Group for Informatics, University of Texas

Health Science Center at San Antonio

Member

06/2006-Present

DEB Executive Committee, University of Texas Health Science

Center at San Antonio

Member

11/2005-06/2006

SACI Protocol Review Committee, University of Texas Health

Science Center at San Antonio

Member

08/2005-08/2012

Surgery Research Committee, University of Texas Health


Member

05/2005-06/2006

GCRC Science Advisory Committee, University of Texas Health


Member

Documents

Michalek CV (24 August 2016)