ID

20000

Descripción

Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin; ODM derived from: https://clinicaltrials.gov/show/NCT00491179

Link

https://clinicaltrials.gov/show/NCT00491179

Palabras clave

Versiones (3)
  1. 3/2/17 3/2/17 -
  2. 3/2/17 3/2/17 -
  3. 20/9/21 20/9/21 -
Subido en

3 de febrero de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Chronic Hepatitis C NCT00491179

Inglés

Eligibility Chronic Hepatitis C NCT00491179

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-responders or relapsers of dialysis patients to conventional interferon or pegylated interferon monotherapy
Descripción

Patients Dialysis | Interferon conventional Disease Response failed | Interferon conventional Recurrent disease | pegylated interferon alfa conventional Disease Response failed | pegylated interferon alfa conventional Recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0011946
UMLS CUI [2,1]
C0021747
UMLS CUI [2,2]
C0439858
UMLS CUI [2,3]
C1704632
UMLS CUI [2,4]
C0231175
UMLS CUI [3,1]
C0021747
UMLS CUI [3,2]
C0439858
UMLS CUI [3,3]
C0277556
UMLS CUI [4,1]
C0907160
UMLS CUI [4,2]
C0439858
UMLS CUI [4,3]
C1704632
UMLS CUI [4,4]
C0231175
UMLS CUI [5,1]
C0907160
UMLS CUI [5,2]
C0439858
UMLS CUI [5,3]
C0277556
age 18~65 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
creatinine clearance (ccr) < 10 ml/min/1.73 m2
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
Descripción

Hepatitis C Antibodies Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C1514241
detectable serum quantitative hcv-rna (cobas taqman hcv monitor v2.0, roche diagnostics) with dynamic range 25- 391000000 iu/ml
Descripción

Hepatitis C RNA positive Quantitative Dynamic Range

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0855842
UMLS CUI [1,2]
C0392762
UMLS CUI [1,3]
C2986743
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe anemia (hemoglobin < 10 g/dl) or hemoglobinopathy
Descripción

Anemia, severe | Hemoglobin measurement | Hemoglobinopathies

Tipo de datos

boolean

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

Neutropenia | Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0948762
thrombocytopenia (platelet <90,000/ mm3)
Descripción

Thrombocytopenia | Platelet Count measurement

Tipo de datos

boolean

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

HBV coinfection | HIV coinfection

Tipo de datos

boolean

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

Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
autoimmune liver disease
Descripción

Autoimmune liver disease

Tipo de datos

boolean

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

Decompensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C2347612
neoplastic disease
Descripción

Neoplastic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Descripción

Organ Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Descripción

Therapeutic immunosuppression

Tipo de datos

boolean

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

Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | nervous system disorders Poorly controlled | poorly controlled diabetes mellitus

Tipo de datos

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
Descripción

Drug abuse Evidence of

Tipo de datos

boolean

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

Contraceptive methods Unwilling

Tipo de datos

boolean

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

Eligibility Chronic Hepatitis C NCT00491179

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Patients Dialysis | Interferon conventional Disease Response failed | Interferon conventional Recurrent disease | pegylated interferon alfa conventional Disease Response failed | pegylated interferon alfa conventional Recurrent disease
Item
non-responders or relapsers of dialysis patients to conventional interferon or pegylated interferon monotherapy
boolean
C0030705 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0021747 (UMLS CUI [2,1])
C0439858 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
C0021747 (UMLS CUI [3,1])
C0439858 (UMLS CUI [3,2])
C0277556 (UMLS CUI [3,3])
C0907160 (UMLS CUI [4,1])
C0439858 (UMLS CUI [4,2])
C1704632 (UMLS CUI [4,3])
C0231175 (UMLS CUI [4,4])
C0907160 (UMLS CUI [5,1])
C0439858 (UMLS CUI [5,2])
C0277556 (UMLS CUI [5,3])
Age
Item
age 18~65 years old
boolean
C0001779 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance (ccr) < 10 ml/min/1.73 m2
boolean
C0373595 (UMLS CUI [1])
Hepatitis C Antibodies Positive
Item
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
boolean
C0166049 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Hepatitis C RNA positive Quantitative Dynamic Range
Item
detectable serum quantitative hcv-rna (cobas taqman hcv monitor v2.0, roche diagnostics) with dynamic range 25- 391000000 iu/ml
boolean
C0855842 (UMLS CUI [1,1])
C0392762 (UMLS CUI [1,2])
C2986743 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Anemia, severe | Hemoglobin measurement | Hemoglobinopathies
Item
severe anemia (hemoglobin < 10 g/dl) or hemoglobinopathy
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0019045 (UMLS CUI [3])
Neutropenia | Absolute neutrophil count
Item
neutropenia (neutrophil count, <1,500/mm3)
boolean
C0027947 (UMLS CUI [1])
C0948762 (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 Gram per day
Item
chronic alcohol abuse (daily consumption > 20 g/day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (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])
C2347612 (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 disorders 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 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])
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