ID

39700

Beskrivning

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes; ODM derived from: https://clinicaltrials.gov/show/NCT01226797

Länk

https://clinicaltrials.gov/show/NCT01226797

Nyckelord

  1. 2020-02-10 2020-02-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 februari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT01226797

Eligibility Hepatitis C, Chronic NCT01226797

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv infection
Beskrivning

Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
alt >1.5 but <10 times upper limit of normal
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated or severe liver disease defined by one or more of the following criteria:
Beskrivning

Decompensated liver disease | Liver disease Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
prior liver biopsy showing cirrhosis.
Beskrivning

Liver Cirrhosis Biopsy of liver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
international normalized ratio (inr) greater than or equal to 1.5.
Beskrivning

INR raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0853225
total bilirubin greater than or equal to 1.5x uln, or >2x uln for unconjugated bilirubin.
Beskrivning

Elevated total bilirubin | Elevated serum unconjugated bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0241024
serum albumin below normal.
Beskrivning

Serum albumin level decreased below normal

Datatyp

boolean

Alias
UMLS CUI [1]
C3665623
alt or aspartate aminotransferase (ast) >10 x uln.
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
Beskrivning

Hypertension, Portal | Splenomegaly | Ascites | Encephalopathy | Esophageal Varices

Datatyp

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0038002
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0085584
UMLS CUI [5]
C0014867
presence of human immunodeficiency virus (hiv).
Beskrivning

HIV Present

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0150312
co-infection with hepatitis b virus (hbv).
Beskrivning

HBV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
co-infection with epstein barr virus (ebv) and/or cytomegalovirus (cmv).
Beskrivning

Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0014644
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0010825

Similar models

Eligibility Hepatitis C, Chronic NCT01226797

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic
Item
chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >1.5 but <10 times upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease | Liver disease Severe
Item
decompensated or severe liver disease defined by one or more of the following criteria:
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Liver Cirrhosis Biopsy of liver
Item
prior liver biopsy showing cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
INR raised
Item
international normalized ratio (inr) greater than or equal to 1.5.
boolean
C0853225 (UMLS CUI [1])
Elevated total bilirubin | Elevated serum unconjugated bilirubin
Item
total bilirubin greater than or equal to 1.5x uln, or >2x uln for unconjugated bilirubin.
boolean
C0741494 (UMLS CUI [1])
C0241024 (UMLS CUI [2])
Serum albumin level decreased below normal
Item
serum albumin below normal.
boolean
C3665623 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or aspartate aminotransferase (ast) >10 x uln.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Hypertension, Portal | Splenomegaly | Ascites | Encephalopathy | Esophageal Varices
Item
evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
boolean
C0020541 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0014867 (UMLS CUI [5])
HIV Present
Item
presence of human immunodeficiency virus (hiv).
boolean
C0019682 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
HBV coinfection
Item
co-infection with hepatitis b virus (hbv).
boolean
C2242656 (UMLS CUI [1])
Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus
Item
co-infection with epstein barr virus (ebv) and/or cytomegalovirus (cmv).
boolean
C0275524 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0010825 (UMLS CUI [2,2])

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