ID

27901

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00944684

Nyckelord

  1. 2017-12-04 2017-12-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 december 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Chronic Hepatitis C NCT00944684

Eligibility Chronic Hepatitis C NCT00944684

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Elevated liver enzymes level

Datatyp

boolean

Alias
UMLS CUI [1]
C0857093
compensated liver disease
Beskrivning

Compensated liver disease

Datatyp

boolean

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

Liver Histology METAVIR Fibrosis Score

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18, >65
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
prior ribavirin treatment
Beskrivning

Ribavirin

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Cardiovascular Disease | Lung disease

Datatyp

boolean

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

Renal Insufficiency | Creatinine clearance measurement

Datatyp

boolean

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

HIV coinfection | HBV coinfection

Datatyp

boolean

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

Comorbidity Hepatic | Hemochromatosis | Hepatolenticular Degeneration | Autoimmune Diseases

Datatyp

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
Beskrivning

Alcohol consumption U/day

Datatyp

boolean

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

Mental disorders

Datatyp

boolean

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

Malignant Neoplasms | Exception Basal cell carcinoma

Datatyp

boolean

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

Illicit drug use

Datatyp

boolean

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

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
lack of consent
Beskrivning

Informed Consent Lacking

Datatyp

boolean

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

Similar models

Eligibility Chronic Hepatitis C NCT00944684

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial