ID

33828

Description

THISTLE - The HIV-HCV Silibinin Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01816490

Link

https://clinicaltrials.gov/show/NCT01816490

Keywords

Versions (1)
  1. 1/2/19 1/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility HIV NCT01816490

English

Eligibility HIV NCT01816490

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01816490
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater or equal 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hiv-hcv co-infection
Description

HIV coinfection | HCV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
hcv genotype 1 infection
Description

Hepatitis C genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1148363
at least one liver biopsy since diagnosis of hcv-infection
Description

Biopsy of liver Quantity | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0019196
fibrosis score metavir = 2 documented by biopsy or a stiffness greater or equal 7.0 kpa documented by fibroscan during the previous 12 months.
Description

Metavir Fibrosis Score Biopsy | Stiffness Fibroscan

Data type

boolean

Alias
UMLS CUI [1,1]
C3897040
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0427008
UMLS CUI [2,2]
C4522043
documented previous null-response or partial-response to soc
Description

Unresponsive to Standard of Care | Standard of Care Partial response

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C2936643
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1521726
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to the study drug under study, e.g. known hypersensitivity or allergy to any ingredient of the study drug
Description

Medical contraindication Investigational New Drug | Hypersensitivity Ingredient Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0013230
patients in need of art with hiv virological failure (= 400 copies/ml) in the last 3 months
Description

Patient need for Antiretroviral therapy | HIV Failure virological

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1963724
UMLS CUI [2,1]
C0019682
UMLS CUI [2,2]
C0231174
UMLS CUI [2,3]
C0205466
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Similar models

Eligibility HIV NCT01816490

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility HIV NCT01816490
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater or equal 18 years
boolean
C0001779 (UMLS CUI [1])
HIV coinfection | HCV coinfection
Item
hiv-hcv co-infection
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
Hepatitis C genotype
Item
hcv genotype 1 infection
boolean
C0019196 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
Biopsy of liver Quantity | Hepatitis C
Item
at least one liver biopsy since diagnosis of hcv-infection
boolean
C0193388 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2])
Metavir Fibrosis Score Biopsy | Stiffness Fibroscan
Item
fibrosis score metavir = 2 documented by biopsy or a stiffness greater or equal 7.0 kpa documented by fibroscan during the previous 12 months.
boolean
C3897040 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0427008 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
Unresponsive to Standard of Care | Standard of Care Partial response
Item
documented previous null-response or partial-response to soc
boolean
C0205269 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C1521726 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Investigational New Drug | Hypersensitivity Ingredient Investigational New Drug
Item
contraindications to the study drug under study, e.g. known hypersensitivity or allergy to any ingredient of the study drug
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Patient need for Antiretroviral therapy | HIV Failure virological
Item
patients in need of art with hiv virological failure (= 400 copies/ml) in the last 3 months
boolean
C0686904 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C0019682 (UMLS CUI [2,1])
C0231174 (UMLS CUI [2,2])
C0205466 (UMLS CUI [2,3])
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