Eligibility Hepatitis C, Chronic NCT00718172

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StudyEvent: Eligibility
1. Eligibility Hepatitis C, Chronic NCT00718172

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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])

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])

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])

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])

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])

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])

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Eligibility Hepatitis C, Chronic NCT00718172