Age
Item
age 18 years or above, male or female
boolean
C0001779 (UMLS CUI [1])
Hepatitis C virus RNA assay | Anti HCV | Anti HCV Absent
Item
presence of hcv rna (with or without anti-hcv) in serum at levels of at least 10,000 iu/ml.
boolean
C1272251 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0166049 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Biopsy of liver | PEGINTERFERON Injection
Item
willingness to undergo liver biopsy before or 6 hours after an initial injection of peginterferon.
boolean
C0193388 (UMLS CUI [1])
C0982327 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Interferon Type I | Interferon-alpha | PEGINTERFERON | Interferon-beta
Item
previous adequate treatment with any form of type i interferon (standard alpha interferon, peginterferon, beta interferon). adequate treatment is considered at least 12 weeks of therapy.
boolean
C0021743 (UMLS CUI [1])
C0002199 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
C0015980 (UMLS CUI [4])
Antiviral Therapy
Item
other antiviral therapy within the last 6 months.
boolean
C0280274 (UMLS CUI [1])
Liver Cirrhosis | Decompensated liver disease | Serum total bilirubin measurement | Albumin measurement | Prolonged prothrombin time | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy
Item
if cirrhosis is present, decompensated liver disease, as marked by bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
boolean
C0023890 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C2673577 (UMLS CUI [5])
C0155789 (UMLS CUI [6])
C0003962 (UMLS CUI [7])
C0019151 (UMLS CUI [8])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
serum alt or ast levels greater than 1000 micro/l (greater than 25 times uln). such patients will not be enrolled but may be followed until three consecutive determinations are below this level.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Spouse Childbearing Potential Contraceptive methods Unable | Vasectomy | Tubal Ligation | Condoms | Spermatocidal Agents | Contraceptives, Oral | Intrauterine Devices | Ribavirin | Teratogenesis
Item
pregnancy or current breastfeeding. in women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device until 6 months after the end of treatment with ribavirin given the potential for teratogenicity.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0162409 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
C0042387 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
C0677582 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0035525 (UMLS CUI [11])
C0232910 (UMLS CUI [12])
Systemic disease | Illness Major | Congestive heart failure | Organ Transplantation | Mental disorders Serious | Depressive disorder Serious | HIV Infection | Angina Pectoris
Item
significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (hiv) infection, and angina pectoris.
boolean
C0442893 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0029216 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0011581 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0019693 (UMLS CUI [7])
C0002962 (UMLS CUI [8])
Anemia Pre-existing | Hematocrit level | Anemia, Hemolytic | Biopsy of liver | Hemoglobin measurement | Ribavirin | Epoetin Alfa | darbepoetin alfa
Item
pre-existing anemia (hematocrit less than 33 percent) or known history of hemolytic anemia. in patients in groups c and d, liver biopsy will not be performed if hemoglobin levels fall to below 11 g/dl during ribavirin monotherapy. epopoetin alfa or darbopoietin alfa therapy will be available to achieve an adequate hematocrit if clinically indicated for patients in all groups.
boolean
C0002871 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0518014 (UMLS CUI [2])
C0002878 (UMLS CUI [3])
C0193388 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0035525 (UMLS CUI [6])
C0357126 (UMLS CUI [7])
C0937950 (UMLS CUI [8])
Therapeutic immunosuppression | Adrenal Cortex Hormones | Prednisone U/day chronic | Immunosuppressive Agents Major | Azathioprine | 6-mercaptopurine
Item
immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily on a chronic basis) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine). patients receiving a short-course of corticosteroids for acute allergic reactions or asthma or chronic obstructive pulmonary disease exacerbations (less than 2 weeks of therapy) will be eligible for the study after 4 weeks off therapy.
boolean
C0021079 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C0021081 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0004482 (UMLS CUI [5])
C0000618 (UMLS CUI [6])
Liver diseases | Viral hepatitis | Autoimmune liver disease | Hepatolenticular Degeneration | Alcoholic Liver Diseases | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis eligible
Item
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency). patients with concomitant non-alcoholic steatohepatitis but no other form of chronic liver disease will not be excluded from this study.
boolean
C0023895 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0400936 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0221757 (UMLS CUI [7])
C3241937 (UMLS CUI [8,1])
C1548635 (UMLS CUI [8,2])
Coronary Artery Disease | Cerebrovascular Disorders | EXERCISE STRESS TEST ABNORMAL | Risk factors
Item
evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
boolean
C1956346 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0743633 (UMLS CUI [3])
C0035648 (UMLS CUI [4])
Substance Use Disorders
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
boolean
C0038586 (UMLS CUI [1])
Liver carcinoma | Alpha one fetoprotein measurement | Mass Suggestive of Malignant neoplasm of liver Ultrasonography | Mass Suggestive of Malignant neoplasm of liver Imaging study
Item
evidence of hepatocellular carcinoma; either alpha-fetoprotein (afp) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0577559 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0345904 (UMLS CUI [3,3])
C0041618 (UMLS CUI [3,4])
C0577559 (UMLS CUI [4,1])
C0332299 (UMLS CUI [4,2])
C0345904 (UMLS CUI [4,3])
C1881134 (UMLS CUI [4,4])
Gout
Item
clinical gout.
boolean
C0018099 (UMLS CUI [1])
Autoimmune Disease Serious | Lupus Erythematosus, Systemic | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis | Worsening Possible caused by Interferon-alpha
Item
active, serious autoimmune disease such as systemic lupus erythematosis, ulcerative colitis, crohn s disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alpha interferon.
boolean
C0004364 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0332271 (UMLS CUI [6,1])
C0332149 (UMLS CUI [6,2])
C0015127 (UMLS CUI [6,3])
C0002199 (UMLS CUI [6,4])
Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin
Item
these exclusion criteria are considered the standard relative contraindications to peginterferon and ribavirin therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])