Reprinted from http://www.haltctrial.org/

Purpose

The Hepatitis C Antivi...
...o patients concerning the current status of the trial. Some questionnaires, blood tests, and an ultrasonogram will be performed.

Quarterly (every 3 months)

• Interval history of complications, adverse events
• Current medications
• Brief physical examination
• Laboratory tests: liver panel, CBC, INR, AFP
• Child-Pugh Score
• Stored serum

Annual

• Complete physical examination
• Ultrasound of liver

1.5 years (M24 visit, middle of study)

• Liver biopsy: formalin fixed histology, frozen liver tissue (subset of patients)

3.5 years (M48, end of study)

• Liver biopsy: formalin fixed histology, frozen liver tissue (subset of patients)
• Endoscopy: evaluate esophageal varices and portal hypertension

After Month 48

• Observation only (no treatment) to determine clinical outcomes
• Clinic visit every 6 months with current medications, brief PE, liver panel, CBC, AFP, stored
• Serum
• Ultrasound of liver every 6 months

Outcome Variables

Primary outcome variables to be assessed in the two groups of patients include:

• Development of cirrhosis on liver biopsy (progression of Ishak fibrosis score by 2 points or more)
• Development of hepatic decompensation, as shown by:
• Sustained increase in the Child-Turcotte-Pugh score to 7 points or higher
• Variceal hemorrhage
• Ascites
• Spontaneous bacterial peritonitis
• Hepatic encephalopathy
• Development of hepatocellular carcinoma
• Death

In this paper (Gibbs et al., 2010, PMID: 20485568) we ...
...studied the cerebellum, frontal cortex, temporal cortex and pons regions of 150 individuals (600 tissue samples). In each tissue we assessed 27,57...

The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is ...
.... The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 19...

The Atherosclerosis Risk in Communities (ARIC) Study, sponsored by the National Heart, Lung and Blood Institute (NHLBI), is ...
... The Cohort Component began in 1987, and each ARIC field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. A total of 15,792 participants received an extensive examination, including medical, social, and demographic data. These participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98...

Startup of Framingham Heart Study. Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. In 1948, the Framingham Heart Study (FHS) -- under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institut...