ID

43642

Beskrivning

Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00491244

Länk

https://clinicaltrials.gov/show/NCT00491244

Nyckelord

  1. 2017-07-13 2017-07-13 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C NCT00491244

Eligibility Chronic Hepatitis C NCT00491244

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-65 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
creatinine clearance (ccr) < 15 ml/min/1.73 m2
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
anti-hcv (abbott hcv eia 3.0, abbott diagnostic, chicago, il) positive > 6 months
Beskrivning

Hepatitis C antibody positive Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0281863
UMLS CUI [1,2]
C0449238
detectable serum quantitative hcv-rna (cobas taqman hcv test, version 2, roche diagnostics) with a dynamic range of 25-391000000 iu/ml
Beskrivning

HCV RNA Serum Quantitative Detectable | Hepatitis C virus test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0392762
UMLS CUI [1,4]
C3830527
UMLS CUI [2]
C2363789
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving interferon-based therapy for chronic hepatitis c
Beskrivning

Interferon therapy Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0524910
severe anemia (hemoglobin < 10 g/dl) or hemoglobinopathy
Beskrivning

Anemia, severe | Hemoglobin measurement | Hemoglobinopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0019045
neutropenia (neutrophil count, <1,500/mm3)
Beskrivning

Neutropenia | Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0200633
thrombocytopenia (platelet <90,000/ mm3)
Beskrivning

Thrombocytopenia | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
co-infection with hbv or hiv
Beskrivning

HBV coinfection | HIV coinfection

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
chronic alcohol abuse (daily consumption > 20 g/day)
Beskrivning

Alcoholic Intoxication, Chronic | Alcohol consumption U/day

Datatyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0456683
autoimmune liver disease
Beskrivning

Autoimmune liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0400936
decompensated liver disease (child classification b or c)
Beskrivning

Decompensated liver disease Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C4050412
neoplastic disease
Beskrivning

Neoplastic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Beskrivning

Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Beskrivning

Therapeutic immunosuppression

Datatyp

boolean

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

Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0027765
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0554876
evidence of drug abuse
Beskrivning

Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
unwilling to have contraception
Beskrivning

Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080

Similar models

Eligibility Chronic Hepatitis C NCT00491244

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-65 years old
boolean
C0001779 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance (ccr) < 15 ml/min/1.73 m2
boolean
C0373595 (UMLS CUI [1])
Hepatitis C antibody positive Duration
Item
anti-hcv (abbott hcv eia 3.0, abbott diagnostic, chicago, il) positive > 6 months
boolean
C0281863 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
HCV RNA Serum Quantitative Detectable | Hepatitis C virus test
Item
detectable serum quantitative hcv-rna (cobas taqman hcv test, version 2, roche diagnostics) with a dynamic range of 25-391000000 iu/ml
boolean
C1868902 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
C3830527 (UMLS CUI [1,4])
C2363789 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Interferon therapy Chronic Hepatitis C
Item
receiving interferon-based therapy for chronic hepatitis c
boolean
C0279030 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Anemia, severe | Hemoglobin measurement | Hemoglobinopathy
Item
severe anemia (hemoglobin < 10 g/dl) or hemoglobinopathy
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0019045 (UMLS CUI [3])
Neutropenia | Neutrophil count
Item
neutropenia (neutrophil count, <1,500/mm3)
boolean
C0027947 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000/ mm3)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infection with hbv or hiv
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Alcohol consumption U/day
Item
chronic alcohol abuse (daily consumption > 20 g/day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child classification b or c)
boolean
C4075847 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
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 Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled 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 [2,1])
C3853134 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0554876 (UMLS CUI [6])
Drug abuse
Item
evidence of drug abuse
boolean
C0013146 (UMLS CUI [1])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])

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