ID

42869

Beschrijving

Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00495131

Link

https://clinicaltrials.gov/show/NCT00495131

Trefwoorden

Versies (2)
  1. 31-03-17 31-03-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis C, Chronic NCT00495131

Engels

Eligibility Hepatitis C, Chronic NCT00495131

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naïve
Beschrijving

Therapy naive

Datatype

boolean

Alias
UMLS CUI [1]
C0919936
age 18 and older than 18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
Beschrijving

Hepatitis C antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0281863
detectable serum quantitative hcv-rna (cobas amplicor hcv monitor v2.0, roche molecular systems, pleasanton, ca) with dynamic range 600~<500,000 iu/ml
Beschrijving

Serum HCV viral load Quantitative Detectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C1868902
UMLS CUI [1,3]
C0392762
UMLS CUI [1,4]
C3830527
hcv genotype 1 (inno-lipa hcv ii, innogenetics, ghent, belgium)
Beschrijving

Hepatitis C virus genotype

Datatype

boolean

Alias
UMLS CUI [1]
C1148363
serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
Beschrijving

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
a liver biopsy consistent with the diagnosis of chronic hepatitis c
Beschrijving

Biopsy of liver Consistent with Chronic Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
Beschrijving

Anemia | Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
neutropenia (neutrophil count <1,500 per cubic milliliter)
Beschrijving

Neutropenia | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0948762
thrombocytopenia (platelet <90,000 per cubic milliliter)
Beschrijving

Thrombocytopenia | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Beschrijving

HBV coinfection | HIV coinfection

Datatype

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
chronic alcohol abuse (daily consumption > 20 gram per day)
Beschrijving

Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day

Datatype

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
decompensated liver disease (child-pugh class b or c)
Beschrijving

Decompensated liver disease Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C4050412
serum creatinine level more than 1.5 times the upper limit of normal
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
autoimmune liver disease
Beschrijving

Autoimmune liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0400936
neoplastic disease
Beschrijving

Neoplastic disease

Datatype

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Beschrijving

Organ Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Beschrijving

Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C0021079
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
Beschrijving

Autoimmune Diseases Poorly controlled | Lung diseases | Heart Diseases | Mental disorders | nervous system disorder | Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0011849
evidence of drug abuse
Beschrijving

Drug abuse Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0332120
unwilling to have contraception
Beschrijving

Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
Terug naar het begin van de pagina

Similar models

Eligibility Hepatitis C, Chronic NCT00495131

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive
Item
treatment naïve
boolean
C0919936 (UMLS CUI [1])
Age
Item
age 18 and older than 18 years old
boolean
C0001779 (UMLS CUI [1])
Hepatitis C antibody positive
Item
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
boolean
C0281863 (UMLS CUI [1])
Serum HCV viral load Quantitative Detectable
Item
detectable serum quantitative hcv-rna (cobas amplicor hcv monitor v2.0, roche molecular systems, pleasanton, ca) with dynamic range 600~<500,000 iu/ml
boolean
C0229671 (UMLS CUI [1,1])
C1868902 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
Hepatitis C virus genotype
Item
hcv genotype 1 (inno-lipa hcv ii, innogenetics, ghent, belgium)
boolean
C1148363 (UMLS CUI [1])
Alanine aminotransferase increased
Item
serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
boolean
C0151905 (UMLS CUI [1])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
a liver biopsy consistent with the diagnosis of chronic hepatitis c
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Neutropenia | Absolute neutrophil count
Item
neutropenia (neutrophil count <1,500 per cubic milliliter)
boolean
C0027947 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000 per cubic milliliter)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day
Item
chronic alcohol abuse (daily consumption > 20 gram per day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine level more than 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Neoplastic disease
Item
neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Organ Transplantation
Item
an organ transplant
boolean
C0029216 (UMLS CUI [1])
Therapeutic immunosuppression
Item
immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
Autoimmune Diseases Poorly controlled | Lung diseases | Heart Diseases | Mental disorders | nervous system disorder | Diabetes Mellitus
Item
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
boolean
C0004364 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
Drug abuse Evidence of
Item
evidence of drug abuse
boolean
C0013146 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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