ID

16665

Descripción

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

Palabras clave

Versiones (1)
  1. 30/7/16 30/7/16 -
Subido en

30 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00199719

Inglés

Eligibility Chronic Hepatitis C NCT00199719

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients >18 years of age and <65 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
génotype non2 non3
Descripción

Hepatitis C virus genotype determination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1533728
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)
Descripción

Chronic liver disease | Hepatitis C, Chronic | Biopsy of liver | Metavir score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0524910
UMLS CUI [3]
C0193388
UMLS CUI [4]
C3888527
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
Descripción

Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0850355
UMLS CUI [2,3]
C0205160
UMLS CUI [3]
C0013230
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with ongoing pregnancy or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
ifn or ribavirin therapy at any previous time
Descripción

interferon | Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2]
C0035525
positive test at screening for anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab
Descripción

Intravascular Anti-Hav IgM Test Positive | Hepatitis B surface antigen positive | Anti-HBc IgM antibody positive | HIV antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254836
UMLS CUI [1,2]
C1446409
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1096146
UMLS CUI [4]
C0920548
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)
Descripción

medical condition Associated with Chronic liver disease | Hepatitis C | Hemochromatosis | Hepatitis, Autoimmune | Alcoholic Liver Diseases | Exposure to toxin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0241910
UMLS CUI [5]
C0023896
UMLS CUI [6]
C0040537
serum creatinine level >1.5 times the upper limit of normal at screening
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
history of severe psychiatric disease, especially depression
Descripción

Mental disorders Severe | Severe depression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0588008
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Similar models

Eligibility Chronic Hepatitis C NCT00199719

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
interferon | Ribavirin
Item
ifn or ribavirin therapy at any previous time
boolean
C0733470 (UMLS CUI [1])
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])
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])
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])
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