ID

27901

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00944684

Palabras clave

Versiones (1)
  1. 4/12/17 4/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00944684

Inglés

Eligibility Chronic Hepatitis C NCT00944684

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Elevated liver enzymes level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0857093
compensated liver disease
Descripción

Compensated liver disease

Tipo de datos

boolean

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

Liver Histology METAVIR Fibrosis Score

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18, >65
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
prior ribavirin treatment
Descripción

Ribavirin

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Cardiovascular Disease | Lung disease

Tipo de datos

boolean

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

Renal Insufficiency | Creatinine clearance measurement

Tipo de datos

boolean

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

HIV coinfection | HBV coinfection

Tipo de datos

boolean

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

Comorbidity Hepatic | Hemochromatosis | Hepatolenticular Degeneration | Autoimmune Diseases

Tipo de datos

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
Descripción

Alcohol consumption U/day

Tipo de datos

boolean

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

Mental disorders

Tipo de datos

boolean

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

Malignant Neoplasms | Exception Basal cell carcinoma

Tipo de datos

boolean

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

Illicit drug use

Tipo de datos

boolean

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

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
lack of consent
Descripción

Informed Consent Lacking

Tipo de datos

boolean

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

Eligibility Chronic Hepatitis C NCT00944684

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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