ID

43866

Description

Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00146016

Link

https://clinicaltrials.gov/show/NCT00146016

Keywords

Versions (2)
  1. 3/20/16 3/20/16 -
  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 NCT00146016

English

Eligibility Chronic Hepatitis C NCT00146016

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
anti-hcv positivity >6 months
Description

HCV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0201485
alt and/or ast elevation on at least once in the previous 6 months
Description

ALT and/or AST elevation

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
positive hcv-rna
Description

HCV-RNA

Data type

boolean

Alias
UMLS CUI [1]
C0369335
liver biopsy within one year before the start of therapy in non- cirrhosis. in the case of known cirrhosis, liver biopsy is not necessary
Description

Liver biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0193388
intention to be treated and participate treatment
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
obtained written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
Description

Male contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C1869110
life expectancy < 1 year
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
child pugh b or c (appendix iii)
Description

Child-Pugh-Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
creatinine > 150 μmol/l or > 1.70 mg/dl
Description

Creatinine measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
haemoglobulin < 6.5 mmol/l or < 10.5 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
white blood cell count < 2,5 x 109/l, neutrophil < 1,5 x 109/l
Description

White blood cell count and neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
platelet count < 70 x 109/l
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hiv positivity
Description

HIV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
Description

chemotherapy, systematical antiviral treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C2363964
other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
active uncontrolled psychiatric disorders and suicidal leanings
Description

Psychiatric disorders and suicidal leanings

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0563664
patients with a history of uncontrolled seizure or other significant cns dysfunction
Description

Seizure or cns dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0007682
any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
Description

Comorbidity affecting study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Chronic Hepatitis C NCT00146016

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
HCV positivity
Item
anti-hcv positivity >6 months
boolean
C0201485 (UMLS CUI [1])
ALT and/or AST elevation
Item
alt and/or ast elevation on at least once in the previous 6 months
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
HCV-RNA
Item
positive hcv-rna
boolean
C0369335 (UMLS CUI [1])
Liver biopsy
Item
liver biopsy within one year before the start of therapy in non- cirrhosis. in the case of known cirrhosis, liver biopsy is not necessary
boolean
C0193388 (UMLS CUI [1])
Compliance
Item
intention to be treated and participate treatment
boolean
C1321605 (UMLS CUI [1])
Written informed consent
Item
obtained written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Gynaecological status
Item
pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Male contraceptive methods
Item
men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
boolean
C1869110 (UMLS CUI [1])
Life expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Child-Pugh-Classification
Item
child pugh b or c (appendix iii)
boolean
C4050412 (UMLS CUI [1])
Creatinine measurement
Item
creatinine > 150 μmol/l or > 1.70 mg/dl
boolean
C0201976 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobulin < 6.5 mmol/l or < 10.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White blood cell count and neutrophil count
Item
white blood cell count < 2,5 x 109/l, neutrophil < 1,5 x 109/l
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Platelet count
Item
platelet count < 70 x 109/l
boolean
C0032181 (UMLS CUI [1])
HIV positivity
Item
hiv positivity
boolean
C0019699 (UMLS CUI [1])
chemotherapy, systematical antiviral treatment
Item
chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
boolean
C0392920 (UMLS CUI [1])
C2363964 (UMLS CUI [2])
Comorbidity
Item
other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
boolean
C0009488 (UMLS CUI [1])
Psychiatric disorders and suicidal leanings
Item
active uncontrolled psychiatric disorders and suicidal leanings
boolean
C0004936 (UMLS CUI [1])
C0563664 (UMLS CUI [2])
Seizure or cns dysfunction
Item
patients with a history of uncontrolled seizure or other significant cns dysfunction
boolean
C0036572 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
Comorbidity affecting study participation
Item
any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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