Please send comments, corrections and updates to Regina Minton.

Human Subjects (IRB) web site: http://research.utmb.edu/irb/

UTMB eYellow Sheet

http://research.utmb.edu/research/yellowsheet/ysonline.htm 

Active Protocols - Rev 8/10/2005

050824 Revisions: Grant’s 672 & 673 received final approval

050822 Revisions: Bell #D132 has been terminated

21 September 2005: Rescheduled to 05 Oct Due to Hurricane Rita

670 Cortes- Resting Energy Expenditure and Amino Acid Supplementation in Young and Healthy Adults

674 Calhoun- Severe Asthma Research Program (SARP)

D147 Gonzalez- Controlled Randomized US Study of Nexalin for Temporary Reduction of Pain on Osteoarthritis

D148 Bajaj An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

17 August 2005:

D146 Markowitz A Two-Part Phase II Study of Effects of RC-1291 HCL in Patients with Cancer Anorexia/Cachexia

671 Borsheim Transcapillary Insulin Transport & Aging

The following protocols were granted final approval
D143 O’Brien: on 07/26/05.
665 Prough: on 08/04/05.
672 Grant:  on 08/16/05.
673 Grant: on 08/16/05.

20 July 2005:

670 Cortes- Resting Energy Expenditure and Amino Acid Supplementation in Young and Healthy Adults

D142 Grant- Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema

D144 Grant- A Randomized, Placebo-Controlled, Double-Blind, Phase II Study of the Safety and Efficacy of Recombinant Human C 1 Inhibitor

D145 O'Brien- Open-Label, Safety of TMC 114 in Combination with Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients with Limited or No Treatment Options (TMC114-C209

The following protocols were granted final approval
669 Paddon-Jones, 663 Ronsen

Modifications to the following protocols were granted final approval
615 Urban , 499 Urban

15 June 2005:

669 Paddon-Jones - The Effect of Dose and Composition of Dietary Beef on Muscle Protein Anabolism in the Young and Elderly

The following protocols were granted final approval
667 Islam, 652 Duarte

Modifications to the following protocols were granted final approval
615 Urban, 631 Gelman, 622 Ferrando

01 June 2005:

664 Svensen - The Effect of Isoflurane on Transcapillary Fluid Redistribution Hemorrhage in Humans

665 Prough - Novel Optoacoustic Monitoring System for Non-invasive Measurement of Blood Oxygenation in Brain

D143 O’Brien - A Randomized, Controlled-Open-label Trial to Compare the The Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Subjects (TIBOTEC TMC114-C214)

18 May 2005:

666 Barzi - Pilot Study of Artificial Gravity as a Multi-System Counter-measure to Bed Rest Deconditioning

663 Ronsen - Impact of prior Biopsies on Subsequent Measurements of Muscle Protein Metabolism

667 Islam - The Role of Music Therapy in Alleviating Stress in Hip Surgery Patients

Modifications to the following protocols were granted final approval
554 Killewich, 629 Moore, 630 Sur, 632 Wolfe, 633 Lu,  D141 Grant

20 April 2005

661 Lau - "Evaluation of the Fibroscan for Liver Fibrosis Measurements in Patients with Chronic Liver Diseases'

662 Ware - "Encouraging and Studying the Effects of Exercise on Over-Weight Adolescents at Ball High School"

D140 Pasricha - "A Randomized, Open-label, two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide when Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablet in Subjects with Diabetic Gastroparesis"

D141Grant - "Clinical Study to Investigate the Efficacy and Safety of Purified C2 Esterase Inhibitor (Human) for the Treatment of Hereditary Angioedema (HAE) in Acute Attacks and as Prophylactic Treatment to Prevent HAE Attacks"

The following protocol was granted final approval
D134 Grant

Modifications to the following protocols were granted final approval
629 Moore, 500 Garfield, 624 Moore,639 Ferrando, 654 Ferrando, 633 Lu

9 March 2005

659 O'Brien - ACTG A5223: "Drug levels of lopinavir/ritonavir in men and women"

660 Paddon-Jones - "Beef ingestion and muscle metabolism"

D139 Bell - "A Rollover Study For Subjects On Capravirine"

2004-2005 Holiday Schedule

Emergency Weather Plan (GCRC ) Rev June 2004

Parking Tokens Posted 09/28/2004

The Informed Consent Process in the GCRC Rev 030918

Protocol & Consent Form Changes as of 041006

Protocol Submission and Pre-Review Rev 041028

GCRC Protocol #D146 (P.I. Markowitz)
Wednesday, October 19 at 3:00 p.m.
"A Two-Part Phase II Study of Effects of RC-1291 HCL in Patient with Cancer Anorexia/Cachexia"
Primary Nurse: Beth Carroll-Anthony RN
Secondary Nurse: Lerma Ukegbu RN

GCRC Protocol #662 (P.I. Ware)
Wednesday, August 3 at 3:00 p.m.
 "Encouraging and Studying the Effects of Exercise on Overweight Adolescents at Ball High School"
 Primary Nurse: Tammy Pfannenstiel RN

GCRC Protocol #663 (P.I. Ronson)
Thursday, July 7 at 3:00 p.m.
 "Impact of Prior Biopsies on Subsequent Measurements of Muscle Protein Metabolism"
 Primary Nurse: Hyacinth Lynch, RN

GCRC Protocol #669 (P.I. Paddon-Jones)
Thursday, July 14 at 3:00 p.m.
 "The effect of dose and composition of dietary beef on muscle protein anabolism in the young and elderly"
 Primary Nurse: Charlene Rogoski, RN

GCRC Protocol #615 (P.I. Urban)
Friday, July 15 at 3:00 p.m.
 "The Effects Of Cyclic Testosterone Administration On Muscle Function In Older Individuals"
 Primary Nurse: Lerma Ukegbu, RN

GCRC Protocol #D140 (P.I. Pasricha)
Friday, June 10 at 3:00 p.m.
 "A Randomized, Open-Label, two-way Crossover Trial to Determine Pharmacokinetics of Metoclopramide when Administered as the Orally Disintegrating Tablet compared to Reglan Tablet in Subjects with Diabetic Gastroparesis"
 Primary Nurse: TBD

GCRC Protocol #656 (P.I. McCauley)
Friday, May 27 at 1:00 p.m.
 "Comparison of Mercury vs. Aneroid Sphygmomanometer Blood Pressure Measurement in Human Subjects"
 Primary Nurse: Holly Paskell RN

April 2005

GCRC Protocol #654 (P.I. Ferrando)
 Thursday April 14 at 2:00 p.m.
 "Mechanisms of muscle protein loss after hip surgery/hip fracture."
 Primary Nurse:

March 2005

GCRC Protocol #657 (P.I. O'Brien)
Wednesday March 3 at 3:00 p.m.
"ACTG A5210: AMD11070 in HIV- Positive Subjects"
Primary Nurse: Becky Peek RN,

GCRC Protocol #659 (P.I. O'Brien)
Thursday March 17 at 11:30 a.m.
“ACTG A5223: Sex Differences in Lopinavir/Ritonavir Pharmacokinetics among HIV-1 Infected Men and Women”
Primary Nurse: Kathy Gainer RN
Secondary Nurse: Beth Carroll-Anthony RN

GCRC Protocol #660  (P.I. Paddon-Jones)
 Friday March 18 at 3:00 p.m.
“Beef Ingestion and Muscle Protein Metabolism”
Primary Nurse: Charlene Rogoski RN

GCRC Protocol #658 (P.I. Lau)
Wednesday March 18 at 4:00 p.m.
"The Pathogenesis of insulin resistance and hepatic steatosis in patients with chronic Hepatitis C"
Primary Nurse(s): Becky Peek RN, Lerma Ukegbu RN

GCRC Protocol #D139 (P.I. Bell)
Friday March 25 at 2:30 p.m.
“A Rollover Study for Subjects on Capravirine who wish to Continue Treatment with Open-Label Capravirine after Completing StudyA4311002 (Pfizer A4311025)”
Primary Nurse

GCRC Protocol #D138 (P.I. Lau)
Tuesday March 29 at 4:00 p.m.
"Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naïve adults with Chronic Hepatitis B Infection."
Primary Nurse: Sandra Moeller, RN

February 2005

GCRC Protocol #653 (P.I. Elena Volpi, MD. PhD)
Friday February 4 at 1:00 pm
 “Insulin and Sarcopenia in the Elderly”

GCRC Protocol #649 (P.I. Rasmussen)
“Nutritional and Contractile Regulation of Muscle Growth”
Friday February 4 at 2:00 p.m. 

Primary Nurse for both protocols:  Charlene Rogoski, RN
Secondary Nurses:  Hyacinth Lynch RN & Lerma Ukegbu RN

GCRC protocol #655 (NASA Campaign #3)
Monday February 14 from 2:30-5:00 p.m.
Primary Nurse: Eileen Langan RN
Secondary Nurses: Charlene Rogoski, Tammy Pfannenstiel, Cheryl Vining, RN

GCRC Protocol #D136 (P.I. Lau)
Friday February 18 at 3:00 pm
 “Open-Label, Efficacy Study of Pegasys® plus Copegus® in Treatment-Naïve Latino Patients with Chronic Hepatitis C Genotype 1 Compared to Non-Latino Caucasian Patients with Chroinic Hepatitis C Genotype 1”

Primary Nurse: Lerma Ukegbu RN
Secondary Nurse: Sandra Moeller RN

GCRC protocol #647  (P.I. Jiande Chen PhD)
Friday January 21 at 3:00 p.m.
“Gastrointestinal Motor Functions in Patients with Systemic Sclerosis”
Primary Nurse: Rebecca Peek, RN

GCRC protocol #651  (P.I. Elena Volpi, MD. PhD)
Thursday December 16 at 3:00 p.m.
“Skin Protein Turnover in Older Americans”
Primary Nurse: Charlene Rogoski, RN

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