ID

39643

Description

Identification of Hepatitis C Virus (HCV) Specific T Cells; ODM derived from: https://clinicaltrials.gov/show/NCT01534728

Link

https://clinicaltrials.gov/show/NCT01534728

Keywords

Versions (1)
  1. 2/7/20 2/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2020

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01534728

English

Eligibility Hepatitis C NCT01534728

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age between 18 and 60 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient affiliated to social security
Description

Patient Affiliated Social Security

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C0037435
infection with hcv genotype 1 or 4 : infection defined by the presence of hcv antibodies and hcv rna in plasma allowing a measure of the circulating viral load, or resolved infection as defined by the presence of antibodies hcv, normal transaminases and negative hcv rna measured by pcr (two consecutive tests)
Description

Hepatitis C Genotype | Hepatitis C Antibodies Present | Hepatitis C virus RNA Present Plasma | Viral load measurement | Infection resolved | Transaminases Normal | Hepatitis C RNA negative | Polymerase chain reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0150312
UMLS CUI [3,3]
C0032105
UMLS CUI [4]
C1261478
UMLS CUI [5,1]
C3714514
UMLS CUI [5,2]
C1514893
UMLS CUI [6,1]
C0002594
UMLS CUI [6,2]
C0205307
UMLS CUI [7]
C0855841
UMLS CUI [8]
C0200931
normal ecg in the judgment of the investigator
Description

ECG normal

Data type

boolean

Alias
UMLS CUI [1]
C0522054
venous access allowing a leukapheresis
Description

Venous access allowing Leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C3164222
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0023416
review hematologic allowing the realization of a leukapheresis to investigator assessment.
Description

Hematology allowing Leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C0200627
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0023416
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients being treated for hcv
Description

Patients Treated Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0220847
hbv infection defined by the presence of hbsag (serology already known, test not done specifically for research)
Description

Hepatitis B | Hepatitis B Surface Antigens Present

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
hiv infection defined by the detection of hiv antibodies (serology already known, test not done specifically for research)
Description

HIV Infection | HIV Antibodies Detection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019683
UMLS CUI [2,2]
C1511790
patients with cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
patients addicted to narcotics use
Description

Narcotic Dependence

Data type

boolean

Alias
UMLS CUI [1]
C1527402
patients with excessive alcohol consumption (more than 3 units per day)
Description

Alcohol intake above recommended sensible limits Alcohol units/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0560219
UMLS CUI [1,2]
C0560578
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
contraindications to leukapheresis
Description

Medical contraindication Leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0023416
history of vasculitis related or unrelated to hcv
Description

Vasculitis Relationship Hepatitis C virus | Vasculitis Independent of Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0042384
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0220847
UMLS CUI [2,1]
C0042384
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0220847
a person deprived of liberty by judicial or administrative decision.
Description

Person Deprivation Freedom

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
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Similar models

Eligibility Hepatitis C NCT01534728

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male or female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
age between 18 and 60 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed consent form
boolean
C0021430 (UMLS CUI [1])
Patient Affiliated Social Security
Item
patient affiliated to social security
boolean
C0030705 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0037435 (UMLS CUI [1,3])
Hepatitis C Genotype | Hepatitis C Antibodies Present | Hepatitis C virus RNA Present Plasma | Viral load measurement | Infection resolved | Transaminases Normal | Hepatitis C RNA negative | Polymerase chain reaction
Item
infection with hcv genotype 1 or 4 : infection defined by the presence of hcv antibodies and hcv rna in plasma allowing a measure of the circulating viral load, or resolved infection as defined by the presence of antibodies hcv, normal transaminases and negative hcv rna measured by pcr (two consecutive tests)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0166049 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0032105 (UMLS CUI [3,3])
C1261478 (UMLS CUI [4])
C3714514 (UMLS CUI [5,1])
C1514893 (UMLS CUI [5,2])
C0002594 (UMLS CUI [6,1])
C0205307 (UMLS CUI [6,2])
C0855841 (UMLS CUI [7])
C0200931 (UMLS CUI [8])
ECG normal
Item
normal ecg in the judgment of the investigator
boolean
C0522054 (UMLS CUI [1])
Venous access allowing Leukapheresis
Item
venous access allowing a leukapheresis
boolean
C3164222 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0023416 (UMLS CUI [1,3])
Hematology allowing Leukapheresis
Item
review hematologic allowing the realization of a leukapheresis to investigator assessment.
boolean
C0200627 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0023416 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Patients Treated Hepatitis C virus
Item
patients being treated for hcv
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
Hepatitis B | Hepatitis B Surface Antigens Present
Item
hbv infection defined by the presence of hbsag (serology already known, test not done specifically for research)
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
HIV Infection | HIV Antibodies Detection
Item
hiv infection defined by the detection of hiv antibodies (serology already known, test not done specifically for research)
boolean
C0019693 (UMLS CUI [1])
C0019683 (UMLS CUI [2,1])
C1511790 (UMLS CUI [2,2])
Liver Cirrhosis
Item
patients with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Narcotic Dependence
Item
patients addicted to narcotics use
boolean
C1527402 (UMLS CUI [1])
Alcohol intake above recommended sensible limits Alcohol units/day
Item
patients with excessive alcohol consumption (more than 3 units per day)
boolean
C0560219 (UMLS CUI [1,1])
C0560578 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical contraindication Leukapheresis
Item
contraindications to leukapheresis
boolean
C1301624 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
Vasculitis Relationship Hepatitis C virus | Vasculitis Independent of Hepatitis C virus
Item
history of vasculitis related or unrelated to hcv
boolean
C0042384 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0042384 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Person Deprivation Freedom
Item
a person deprived of liberty by judicial or administrative decision.
boolean
C0027361 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
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