ID

43820

Description

Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01684787

Link

https://clinicaltrials.gov/show/NCT01684787

Keywords

Versions (2)
  1. 2/3/17 2/3/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT01684787

English

Eligibility Chronic Hepatitis C NCT01684787

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hepatitis c co infected with stable hiv-1 and normal alt (case) or elevated levels of alt (control)
Description

HCV coinfection HIV-1 Stable | Alanine aminotransferase normal | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0019704
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0855620
UMLS CUI [3]
C0151905
cd4 > 200 cel/ml
Description

CD4 Count

Data type

boolean

Alias
UMLS CUI [1]
C0243009
stable anti-retroviral treatment for hiv during at least, the 6 previous months to the inclusion
Description

Antiretroviral therapy Stable HIV Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0019693
negative contraception test
Description

Contraceptive methods Test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C1513916
informed consent signed
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
any previous treatment for chc
Description

Therapeutic procedure Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0524910
any experimental treatment in the 6 previous weeks to the inclusion
Description

Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
cirrhosis grade b or c (child-pugh)
Description

Liver Cirrhosis Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
Description

Colony-Stimulating Factors | Didanosine | Zidovudine | Immunomodulators | isoniazid | Rifampin

Data type

boolean

Alias
UMLS CUI [1]
C0009392
UMLS CUI [2]
C0012133
UMLS CUI [3]
C0043474
UMLS CUI [4]
C1527392
UMLS CUI [5]
C0022209
UMLS CUI [6]
C0035608
hepatic cancer
Description

Malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0345904
neutrophils < 1500 cel/ml, platelets < 70000 cel/ml, hemoglobin < 11 g/dl (men) or < 12 g/dl (women) previous to inclusion
Description

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
severe psychiatric illness background
Description

Mental Disorders, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
serum creatinin > 1,5 times the upper normal limit
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
background of pulmonary or cardiovascular disease
Description

Lung disease | Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0007222
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Similar models

Eligibility Chronic Hepatitis C NCT01684787

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients over 18 years old
boolean
C0001779 (UMLS CUI [1])
HCV coinfection HIV-1 Stable | Alanine aminotransferase normal | Alanine aminotransferase increased
Item
hepatitis c co infected with stable hiv-1 and normal alt (case) or elevated levels of alt (control)
boolean
C1698259 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0855620 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
CD4 Count
Item
cd4 > 200 cel/ml
boolean
C0243009 (UMLS CUI [1])
Antiretroviral therapy Stable HIV Infection
Item
stable anti-retroviral treatment for hiv during at least, the 6 previous months to the inclusion
boolean
C1963724 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
Contraceptive methods Test Negative
Item
negative contraception test
boolean
C0700589 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Therapeutic procedure Chronic Hepatitis C
Item
any previous treatment for chc
boolean
C0087111 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Therapies, Investigational
Item
any experimental treatment in the 6 previous weeks to the inclusion
boolean
C0949266 (UMLS CUI [1])
Liver Cirrhosis Child-Pugh Classification
Item
cirrhosis grade b or c (child-pugh)
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Colony-Stimulating Factors | Didanosine | Zidovudine | Immunomodulators | isoniazid | Rifampin
Item
treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
boolean
C0009392 (UMLS CUI [1])
C0012133 (UMLS CUI [2])
C0043474 (UMLS CUI [3])
C1527392 (UMLS CUI [4])
C0022209 (UMLS CUI [5])
C0035608 (UMLS CUI [6])
Malignant neoplasm of liver
Item
hepatic cancer
boolean
C0345904 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Gender
Item
neutrophils < 1500 cel/ml, platelets < 70000 cel/ml, hemoglobin < 11 g/dl (men) or < 12 g/dl (women) previous to inclusion
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Mental Disorders, Severe
Item
severe psychiatric illness background
boolean
C4046029 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinin > 1,5 times the upper normal limit
boolean
C0201976 (UMLS CUI [1])
Lung disease | Cardiovascular Disease
Item
background of pulmonary or cardiovascular disease
boolean
C0024115 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
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