ID

39700

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01226797

Stichworte

  1. 10.02.20 10.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Februar 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hepatitis C, Chronic NCT01226797

Eligibility Hepatitis C, Chronic NCT01226797

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hcv infection
Beschreibung

Hepatitis C, Chronic

Datentyp

boolean

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

Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Decompensated liver disease | Liver disease Severe

Datentyp

boolean

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

Liver Cirrhosis Biopsy of liver

Datentyp

boolean

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

INR raised

Datentyp

boolean

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

Elevated total bilirubin | Elevated serum unconjugated bilirubin

Datentyp

boolean

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

Serum albumin level decreased below normal

Datentyp

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

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

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

Datentyp

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).
Beschreibung

HIV Present

Datentyp

boolean

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

HBV coinfection

Datentyp

boolean

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

Coinfection Epstein-Barr Virus | Coinfection Cytomegalovirus

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT01226797

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video