
Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
Hepatic EncephalopathyCirrhosis2 moreInvestigating the impact of hepatic encephalopathy on default mode networks within the brain to provide more clues with understanding the physiology of consciousness and predicting the reversibility of comatose states.

Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
Hepatitis CHepatitis B2 moreLiver fibrosis is an important public health problem, with a substantial morbidity and mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for assessing the severity of liver disease prior to therapy. However, liver biopsy has several limitations: cost, sampling error, and procedure-related morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic liver disease severity. Our team has the expertise to investigate ultrasound-based and magnetic resonance-based elastographic methods for the noninvasive staging of liver fibrosis. The primary objective of this cross-sectional study is to compare the sensitivity of elastographic methods for detecting histology-determined significant fibrosis. The secondary objectives are to compare the diagnostic accuracy of these elastographic methods and the influence of potential confounders (inflammation, steatosis and iron deposition) on their diagnostic accuracy.

Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
Hepatitis CThe major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
HIVHepatitis C2 moreThe purpose of this research study is to explore what role immune cells within the gut (the sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or HCV/ HIV co-infection.

PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic...
Hepatitis CChronicThis observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study...
Hepatitis CHepatitis C1 moreThe goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.

Risk Assessment of Long-Haul Truck Drivers
GonorrheaChlamydia Infections7 moreInternational studies have repeatedly documented a substantial prevalence of sexual risk behaviors and high rates of human immunodeficiency virus (HIV) and other sexually transmitted infections (STI) ranging from 5%-56% amongst long-distance truck drivers ("truckers") living in diverse international settings including India, Bangladesh, South Africa, China, Laos and Thailand. The prevalence of sexual risk factors and STI/HIV in US drivers is unknown. This proposal will provide both qualitative and quantitative data on HIV risk behaviors by interviewing and testing truckers working for established long-distance trucking firms, the sector which accounts for most of the jobs in the trucking and warehousing industry in the United States. The data obtained from this study will be used to inform the development of an HIV prevention intervention for long-haul truck drivers.

Screening for Hepatitis C During Pregnancy at a Toronto Inner City Prenatal Clinic
Hepatitis CPregnancyThe first part of this study will investigate the incidence of Hepatitis C in pregnant women attending an inner city health clinic in downtown Toronto. All women attending the clinic who give their consent to participate will be screened by a standardized questionnaire as well as by a blood test. Blood testing will tell us how many of these women have Hepatitis C. We will then be able to compare the specificities and sensitivities of targeted screening (risk behaviour questionnaires) versus universal screening (blood tests). In the second part of the study we will follow the pregnancies of those women who were identified as Hepatitis C positive on the screening test. Follow- up will include liver enzymes and viral load quantifications (amounts) in the first, second and third trimesters as well as during delivery and six weeks post-partum. We will also document pregnancy outcomes with regard to type of delivery and complications. Pregnancy outcomes will be compared to an age and race matched group of women who do not have Hepatitis C. Study Hypothesis: We expect a higher incidence of Hepatitis C in this inner city population compared to the general Canadian pregnant population (0.9%). We predict an HCV seroprevalence (rate) ranging between 2-6% in this population and we also predict that targeted screening by standardized questionnaire will fail to identify half of the Hepatitis C positive cases. By following this group of Hepatitis C positive women through pregnancy, we expect to lend further support to previous data showing significant decrease and/or normalization of serum transaminases as well as significant increase in HCV viral load by third trimester. We also expect to see no significant differences in pregnancy outcomes or obstetrical complications between HCV positive women and the HCV negative women.

Association Between Hepatitis C Virus Infection and Hematologic and Thyroid Cancers
Hepatitis C VirusThis study will investigate the possible relationship between infection with hepatitis C virus (HCV) and the development of certain hematologic cancers (Non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, multiple myeloma) and thyroid cancer. HCV causes chronic hepatitis, cirrhosis, and liver cancer. It is transmitted primarily through injection drug use and transfusion of infected blood. Studies have shown that HCV may also be linked to hematologic cancers and thyroid cancer. This retrospective study will examine medical records from veterans with and without HCV infection who previously received treatment in the Veterans Administration medical system. Data collected on each subject will include the subject's race, sex, age and era of military service, presence of liver disease or thyroiditis at their baseline clinic visit, number of inpatient visits in the past 5 years and outpatient visits in the past year, and the presence of various specified cancers. The prevalence of cancer and other conditions among HCV-infected subjects and non-HCV infected subjects at baseline and the subsequent development of the cancers of interest in these two groups will be compared and analyzed for a possible causal relationship.

Racial Difference in HCV/Host Interactions
Hepatitis CThe purpose of this study is to evaluate a group of African Americans and Caucasians with hepatitis C virus (HCV), compare their response rates to combination treatment with pegylated interferon alfa-2b and ribavirin, and identify possible causes for racial differences in response to therapy. The study will enroll a total of 260 participants, age 18 or older, over a 10 period. In the next 5 years 132 subjects will be studied locally, including 112 African Americans and 20 Caucasians. Participants will be recruited from the clinical practices of the hepatologists (liver doctors) at the University of Tennessee Health Science Center and will also be selected from referrals at local hepatology clinics and the Memphis VA Hospital. Volunteers will be treated with pegylated interferon alfa-2b injections once weekly and oral ribavirin 2 times a day for up to 72 weeks. Study procedures include multiple blood draws. Participants may be involved in study related procedures for up to 72 weeks.