ID

29734

Beschrijving

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

Trefwoorden

  1. 16-04-18 16-04-18 -
  2. 16-04-18 16-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 april 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT00553930

Eligibility Hepatitis C, Chronic NCT00553930

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age older than 18 years
Beschrijving

Age

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Childbearing Potential Pregnancy test negative

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous interferon treatment
Beschrijving

Interferon therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0279030
pregnancy or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
decompensated liver disease
Beschrijving

Decompensated liver disease

Datatype

boolean

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

Organ Transplantation

Datatype

boolean

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

Immunomodulators | Didanosine

Datatype

boolean

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

Substance Use Disorders

Datatype

boolean

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

Mental disorders Severe

Datatype

boolean

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

Autoimmune Diseases

Datatype

boolean

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

Informed Consent Unable

Datatype

boolean

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

Similar models

Eligibility Hepatitis C, Chronic NCT00553930

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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