ID

29732

Beschreibung

Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00553930

Link

https://clinicaltrials.gov/show/NCT00553930

Stichworte

Versionen (2)
  1. 16.04.18 16.04.18 -
  2. 16.04.18 16.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Hepatitis C, Chronic NCT00553930

Englisch

Eligibility Hepatitis C, Chronic NCT00553930

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age older than 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hiv infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis c virus (both anti-hcv antibodies and hcv rna levels detectable in serum) not previously treated.
Beschreibung

HIV Infection | Chronic Hepatitis C untreated | Cirrhosis due to hepatitis C Compensated untreated | Hepatitis C Antibodies Detectable | Hepatitis C virus RNA Detectable

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0524910
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C2075271
UMLS CUI [3,2]
C0205432
UMLS CUI [3,3]
C0332155
UMLS CUI [4,1]
C0166049
UMLS CUI [4,2]
C3830527
UMLS CUI [5,1]
C0369335
UMLS CUI [5,2]
C3830527
women of child-bearing age: negative pregnancy test
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
ability to understand and sign a written consent form
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous interferon treatment
Beschreibung

Interferon therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279030
pregnancy or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute or chronic hepatitis b infection (positivity for hepatitis b surface antigen or plasma dna)
Beschreibung

Hepatitis B | Hepatitis B, Chronic | Hepatitis B surface antigen positive | Plasma Hepatitis B DNA assay positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0149709
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C1168040
creatinine clearance < 50 ml/min, according to cockcroft-gault
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
decompensated liver disease
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
history of organ transplantation
Beschreibung

Organ Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
concomitant treatment with immunomodulators or didanosine
Beschreibung

Immunomodulators | Didanosine

Datentyp

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2]
C0012133
alcohol abuse or use of other recreational drugs
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
history of severe psychiatric conditions
Beschreibung

Mental disorders Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
autoimmune diseases
Beschreibung

Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
inability to understand and sign a written consent form
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT00553930

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age older than 18 years
boolean
C0001779 (UMLS CUI [1])
HIV Infection | Chronic Hepatitis C untreated | Cirrhosis due to hepatitis C Compensated untreated | Hepatitis C Antibodies Detectable | Hepatitis C virus RNA Detectable
Item
hiv infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis c virus (both anti-hcv antibodies and hcv rna levels detectable in serum) not previously treated.
boolean
C0019693 (UMLS CUI [1])
C0524910 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C2075271 (UMLS CUI [3,1])
C0205432 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0166049 (UMLS CUI [4,1])
C3830527 (UMLS CUI [4,2])
C0369335 (UMLS CUI [5,1])
C3830527 (UMLS CUI [5,2])
Childbearing Potential Pregnancy test negative
Item
women of child-bearing age: negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and sign a written consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Interferon therapy
Item
previous interferon treatment
boolean
C0279030 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B | Hepatitis B, Chronic | Hepatitis B surface antigen positive | Plasma Hepatitis B DNA assay positive
Item
acute or chronic hepatitis b infection (positivity for hepatitis b surface antigen or plasma dna)
boolean
C0019163 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0032105 (UMLS CUI [4,1])
C1168040 (UMLS CUI [4,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance < 50 ml/min, according to cockcroft-gault
boolean
C2711451 (UMLS CUI [1])
Decompensated liver disease
Item
decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Immunomodulators | Didanosine
Item
concomitant treatment with immunomodulators or didanosine
boolean
C1527392 (UMLS CUI [1])
C0012133 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol abuse or use of other recreational drugs
boolean
C0038586 (UMLS CUI [1])
Mental disorders Severe
Item
history of severe psychiatric conditions
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Autoimmune Diseases
Item
autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Informed Consent Unable
Item
inability to understand and sign a written consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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