ID

21190

Description

Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427); ODM derived from: https://clinicaltrials.gov/show/NCT00724854

Link

https://clinicaltrials.gov/show/NCT00724854

Keywords

  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT00724854

Eligibility Hepatitis C, Chronic NCT00724854

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing to participate in the study and sign the informed consent form
Description

Study participation status and informed consent

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0021430
established hcv infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [pcr] test)
Description

HCV PCR

Data type

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0032520
can be treatment-naïve, have retreatment, or co-infected with hiv
Description

Treatment, HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C4062778
be under treatment with pegintron in combination with ribavirin, starting up to 14 days before the screening visit
Description

Pegintron and Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1527737
UMLS CUI [1,2]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have not confirmed their willingness to participate in the study or have refused to sign the free and informed consent form
Description

Study participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
prior treatment with pegintron (combined with ribavirin or not)
Description

Prior treatment with pegintron

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1527737
history of alcohol abuse in the past 6 months
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
decompensated liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
severe heart disease
Description

Heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
decompensated thyroid disorder
Description

Thyroid disorder

Data type

boolean

Alias
UMLS CUI [1]
C0040128
neoplasia
Description

Neoplasia

Data type

boolean

Alias
UMLS CUI [1]
C1882062
type 1 diabetes mellitus - uncontrolled or hardly controlled
Description

Diabetes mellitus type 1

Data type

boolean

Alias
UMLS CUI [1]
C0011854
seizures - uncontrolled
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
primary immune deficiency
Description

Primary immune deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0398686
men and women not using appropriate contraceptive methods
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
pregnancy or lactation
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for participants co-infected with hiv: hiv-related opportunistic disease in the past 6 months or cd4 count lower than 200 cells/mm^3
Description

HIV Coinfection: HIV-related opportunistic disease or CD4 count

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C0162526
UMLS CUI [3]
C0243009

Similar models

Eligibility Hepatitis C, Chronic NCT00724854

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study participation status and informed consent
Item
willing to participate in the study and sign the informed consent form
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
HCV PCR
Item
established hcv infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [pcr] test)
boolean
C0220847 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Treatment, HIV coinfection
Item
can be treatment-naïve, have retreatment, or co-infected with hiv
boolean
C0087111 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Pegintron and Ribavirin
Item
be under treatment with pegintron in combination with ribavirin, starting up to 14 days before the screening visit
boolean
C1527737 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study participation status
Item
participants who have not confirmed their willingness to participate in the study or have refused to sign the free and informed consent form
boolean
C2348568 (UMLS CUI [1])
Prior treatment with pegintron
Item
prior treatment with pegintron (combined with ribavirin or not)
boolean
C1514463 (UMLS CUI [1,1])
C1527737 (UMLS CUI [1,2])
Substance Use Disorder
Item
history of alcohol abuse in the past 6 months
boolean
C0038586 (UMLS CUI [1])
Liver disease
Item
decompensated liver disease
boolean
C0023895 (UMLS CUI [1])
Heart disease
Item
severe heart disease
boolean
C0018799 (UMLS CUI [1])
Thyroid disorder
Item
decompensated thyroid disorder
boolean
C0040128 (UMLS CUI [1])
Neoplasia
Item
neoplasia
boolean
C1882062 (UMLS CUI [1])
Diabetes mellitus type 1
Item
type 1 diabetes mellitus - uncontrolled or hardly controlled
boolean
C0011854 (UMLS CUI [1])
Seizures
Item
seizures - uncontrolled
boolean
C0036572 (UMLS CUI [1])
Primary immune deficiency
Item
primary immune deficiency
boolean
C0398686 (UMLS CUI [1])
Contraceptive methods
Item
men and women not using appropriate contraceptive methods
boolean
C0700589 (UMLS CUI [1])
Gynaecological status
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Coinfection: HIV-related opportunistic disease or CD4 count
Item
for participants co-infected with hiv: hiv-related opportunistic disease in the past 6 months or cd4 count lower than 200 cells/mm^3
boolean
C4062778 (UMLS CUI [1])
C0162526 (UMLS CUI [2])
C0243009 (UMLS CUI [3])

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