ID

27901

Beschrijving

High Dose Ribavirin in the Treatment of Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00944684

Link

https://clinicaltrials.gov/show/NCT00944684

Trefwoorden

  1. 04-12-17 04-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 december 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C NCT00944684

Eligibility Chronic Hepatitis C NCT00944684

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients aged 18-65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
elevated liver enzymes levels
Beschrijving

Elevated liver enzymes level

Datatype

boolean

Alias
UMLS CUI [1]
C0857093
compensated liver disease
Beschrijving

Compensated liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C3839044
available liver histology confirming metavir f2 fibrosis
Beschrijving

Liver Histology METAVIR Fibrosis Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0344441
UMLS CUI [1,3]
C3897040
written consent to participation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18, >65
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
prior ribavirin treatment
Beschrijving

Ribavirin

Datatype

boolean

Alias
UMLS CUI [1]
C0035525
intolerance towards ribavirin, pegifn or erythropoetin
Beschrijving

Intolerance to Ribavirin | Intolerance to pegylated interferon alfa | Intolerance to Erythropoietin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0035525
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0907160
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0014822
pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
relevant cardiovascular or pulmonary disease
Beschrijving

Cardiovascular Disease | Lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0024115
kidney insufficiency (creatinine clearance <50ml/min)
Beschrijving

Renal Insufficiency | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
coinfection with hiv or hepatitis b virus
Beschrijving

HIV coinfection | HBV coinfection

Datatype

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
hepatic comorbidities (hemochromatosis, wilson's disease, autoimmune disorders)
Beschrijving

Comorbidity Hepatic | Hemochromatosis | Hepatolenticular Degeneration | Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205054
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0019202
UMLS CUI [4]
C0004364
alcohol consumption > 40g/day
Beschrijving

Alcohol consumption U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0456683
psychiatric disorders
Beschrijving

Mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
malignancy (except for basalioma)
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
active consumption of illicit drugs
Beschrijving

Illicit drug use

Datatype

boolean

Alias
UMLS CUI [1]
C0281875
participation in another trial shorter than 3 months prior to inclusion
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
lack of consent
Beschrijving

Informed Consent Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268

Similar models

Eligibility Chronic Hepatitis C NCT00944684

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients aged 18-65 years
boolean
C0001779 (UMLS CUI [1])
Elevated liver enzymes level
Item
elevated liver enzymes levels
boolean
C0857093 (UMLS CUI [1])
Compensated liver disease
Item
compensated liver disease
boolean
C3839044 (UMLS CUI [1])
Liver Histology METAVIR Fibrosis Score
Item
available liver histology confirming metavir f2 fibrosis
boolean
C0023884 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C3897040 (UMLS CUI [1,3])
Informed Consent
Item
written consent to participation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18, >65
boolean
C0001779 (UMLS CUI [1])
Ribavirin
Item
prior ribavirin treatment
boolean
C0035525 (UMLS CUI [1])
Intolerance to Ribavirin | Intolerance to pegylated interferon alfa | Intolerance to Erythropoietin
Item
intolerance towards ribavirin, pegifn or erythropoetin
boolean
C1744706 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0907160 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0014822 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease | Lung disease
Item
relevant cardiovascular or pulmonary disease
boolean
C0007222 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Renal Insufficiency | Creatinine clearance measurement
Item
kidney insufficiency (creatinine clearance <50ml/min)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
HIV coinfection | HBV coinfection
Item
coinfection with hiv or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Comorbidity Hepatic | Hemochromatosis | Hepatolenticular Degeneration | Autoimmune Diseases
Item
hepatic comorbidities (hemochromatosis, wilson's disease, autoimmune disorders)
boolean
C0009488 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
C0018995 (UMLS CUI [2])
C0019202 (UMLS CUI [3])
C0004364 (UMLS CUI [4])
Alcohol consumption U/day
Item
alcohol consumption > 40g/day
boolean
C0001948 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Mental disorders
Item
psychiatric disorders
boolean
C0004936 (UMLS CUI [1])
Malignant Neoplasms | Exception Basal cell carcinoma
Item
malignancy (except for basalioma)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Illicit drug use
Item
active consumption of illicit drugs
boolean
C0281875 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another trial shorter than 3 months prior to inclusion
boolean
C2348568 (UMLS CUI [1])
Informed Consent Lacking
Item
lack of consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])

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