ID

20970

Description

Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00305383

Lien

https://clinicaltrials.gov/show/NCT00305383

Mots-clés

Versions (1)
  1. 31/03/2017 31/03/2017 -
Téléchargé le

31 mars 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00305383

Anglais

Eligibility Hepatitis C, Chronic NCT00305383

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment-naive, genotype 1 only, compensated, chronic hepatitis c infected caucasian or african-american patients
Description

Therapy naive | Hepatitis C virus genotype | Chronic Hepatitis C Compensated | Caucasians | African American

Type de données

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C1148363
UMLS CUI [3,1]
C0524910
UMLS CUI [3,2]
C0205432
UMLS CUI [4]
C0043157
UMLS CUI [5]
C0085756
body weight greater than 61 kg and not more than 87.3 kg
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
hcv rna greater than 2 million copies/ml
Description

HCV viral load

Type de données

boolean

Alias
UMLS CUI [1]
C1868902
elevated measured or historical alanine aminotransferase
Description

Alanine aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0151905
hemoglobin at least 12.0 g/dl for females and at least 13.0 g/dl for males
Description

Hemoglobin measurement | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
calculated creatinine clearance greater than 70 ml/min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cirrhosis of the liver
Description

Liver Cirrhosis

Type de données

boolean

Alias
UMLS CUI [1]
C0023890
alanine aminotransferase greater than 3 times the upper limit of normal
Description

Alanine aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0151905
severe neuropsychiatric disorders
Description

Neuropsychiatric syndrome Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C3203509
UMLS CUI [1,2]
C0205082
history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
Description

Metabolic Diseases | Hematological Disease | Lung diseases | Myocardial Ischemia | Heart Diseases Unstable | Gastrointestinal Diseases | nervous system disorder | Kidney Diseases | Urologic Diseases | Endocrine System Diseases | Disorder of eye | Retinal Diseases Severe | Immune System Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0151744
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0042075
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0015397
UMLS CUI [12,1]
C0035309
UMLS CUI [12,2]
C0205082
UMLS CUI [13]
C0021053
other co-morbid chronic viral infections including hepatitis b and the human immunodeficiency virus (hiv)
Description

Comorbidity | Virus Diseases chronic | Hepatitis B | HIV Infection

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019693
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Similar models

Eligibility Hepatitis C, Chronic NCT00305383

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive | Hepatitis C virus genotype | Chronic Hepatitis C Compensated | Caucasians | African American
Item
treatment-naive, genotype 1 only, compensated, chronic hepatitis c infected caucasian or african-american patients
boolean
C0919936 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
C0524910 (UMLS CUI [3,1])
C0205432 (UMLS CUI [3,2])
C0043157 (UMLS CUI [4])
C0085756 (UMLS CUI [5])
Body Weight
Item
body weight greater than 61 kg and not more than 87.3 kg
boolean
C0005910 (UMLS CUI [1])
HCV viral load
Item
hcv rna greater than 2 million copies/ml
boolean
C1868902 (UMLS CUI [1])
Alanine aminotransferase increased
Item
elevated measured or historical alanine aminotransferase
boolean
C0151905 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin at least 12.0 g/dl for females and at least 13.0 g/dl for males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance greater than 70 ml/min
boolean
C2711451 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis
Item
cirrhosis of the liver
boolean
C0023890 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine aminotransferase greater than 3 times the upper limit of normal
boolean
C0151905 (UMLS CUI [1])
Neuropsychiatric syndrome Severe
Item
severe neuropsychiatric disorders
boolean
C3203509 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metabolic Diseases | Hematological Disease | Lung diseases | Myocardial Ischemia | Heart Diseases Unstable | Gastrointestinal Diseases | nervous system disorder | Kidney Diseases | Urologic Diseases | Endocrine System Diseases | Disorder of eye | Retinal Diseases Severe | Immune System Diseases
Item
history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
boolean
C0025517 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0017178 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0042075 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0015397 (UMLS CUI [11])
C0035309 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0021053 (UMLS CUI [13])
Comorbidity | Virus Diseases chronic | Hepatitis B | HIV Infection
Item
other co-morbid chronic viral infections including hepatitis b and the human immunodeficiency virus (hiv)
boolean
C0009488 (UMLS CUI [1])
C0042769 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
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