Informações:
Falhas:
ID
16665
Descrição
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM; ODM derived from: https://clinicaltrials.gov/show/NCT00199719
Link
https://clinicaltrials.gov/show/NCT00199719
Palavras-chave
Versões (1)
- 30/07/2016 30/07/2016 -
Transferido a
30 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00199719
Eligibility Chronic Hepatitis C NCT00199719
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Hepatitis C NCT00199719
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
male and female patients >18 years of age and <65 years of age
boolean
C0001779 (UMLS CUI [1])
Hepatitis C virus genotype determination
Item
génotype non2 non3
boolean
C1533728 (UMLS CUI [1])
Chronic liver disease | Hepatitis C, Chronic | Biopsy of liver | Metavir score
Item
chronic liver disease consistent with chronic hepatitis c infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (metavir >a1and >f1)
boolean
C0341439 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
C3888527 (UMLS CUI [4])
C0524910 (UMLS CUI [2])
C0193388 (UMLS CUI [3])
C3888527 (UMLS CUI [4])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative | Investigational New Drugs
Item
negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
interferon | Ribavirin
Item
ifn or ribavirin therapy at any previous time
boolean
C0733470 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0035525 (UMLS CUI [2])
Intravascular Anti-Hav IgM Test Positive | Hepatitis B surface antigen positive | Anti-HBc IgM antibody positive | HIV antibody positive
Item
positive test at screening for anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab
boolean
C1254836 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
C1096146 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
C1446409 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
C1096146 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
medical condition Associated with Chronic liver disease | Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Diseases | Exposure to toxin
Item
history or other evidence of a medical condition associated with chronic liver disease other than hcv (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0040537 (UMLS CUI [6])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
C0241910 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0040537 (UMLS CUI [6])
Creatinine measurement, serum
Item
serum creatinine level >1.5 times the upper limit of normal at screening
boolean
C0201976 (UMLS CUI [1])
Mental disorders Severe | Severe depression
Item
history of severe psychiatric disease, especially depression
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2])
C0205082 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2])