ID

29719

Description

Study the Relationship Between Obesity and Hepatitis C Replication; ODM derived from: https://clinicaltrials.gov/show/NCT01157975

Link

https://clinicaltrials.gov/show/NCT01157975

Keywords

Versions (1)
  1. 4/16/18 4/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01157975

English

Eligibility Hepatitis C NCT01157975

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
infection with hcv genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
Description

Hepatitis C HCV genotype determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
bmi greater than 25 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hcv-infected subjects naïve to treatment: subjects who either have never been treated for hcv infection or who previously received hcv treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
Description

Hepatitis C Therapy naive | Prior Therapy Hepatitis C Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0019196
UMLS CUI [2,3]
C1444662
plasma hcv rna concentration of >10,000 iu/ml at the screening evaluation
Description

Plasma HCV RNA assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C1272251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous intolerance to pioglitazone, rosiglitazone, troglitazone or corticosteroids
Description

Intolerance to Pioglitazone | Intolerance to Rosiglitazone | Intolerance to Troglitazone | Intolerance to Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0071097
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0289313
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0245514
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0001617
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of diabetes mellitus requiring treatment other than diet
Description

Diabetes Mellitus Treatment required for | Exception Diet therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012159
decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
Description

Decompensated liver disease | Causes Liver disease | Hepatitis, Autoimmune | Hepatolenticular Degeneration | Hemochromatosis | Primary biliary cirrhosis | Schistosomiasis | Cholangitis, Sclerosing | Alcohol-related liver disease | Drug-Induced Liver Injury | alpha 1-Antitrypsin Deficiency

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0023895
UMLS CUI [3]
C0241910
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0018995
UMLS CUI [6]
C0008312
UMLS CUI [7]
C0036323
UMLS CUI [8]
C0008313
UMLS CUI [9]
C0810031
UMLS CUI [10]
C0860207
UMLS CUI [11]
C0221757
concurrent hepatitis b virus (hbv) infection
Description

HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
Description

Immunodeficiency Disease | Autoimmune Diseases | Gastrointestinal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0017178
abuse of alcohol or illicit drugs within 6 months before enrollment
Description

Alcohol abuse | DRUG ABUSE ILLICIT

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0743253
use of an investigational drug within 4 weeks before the screening visit or during the screening period.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
use of systemic immunosuppressants
Description

Immunosuppressive Agents Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205373
history of poorly controlled psychiatric disease or poorly controlled pulmonary disease
Description

Mental disorders Poorly controlled | Lung disease Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C3853134
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Similar models

Eligibility Hepatitis C NCT01157975

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C HCV genotype determination
Item
infection with hcv genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Body mass index
Item
bmi greater than 25 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hepatitis C Therapy naive | Prior Therapy Hepatitis C Discontinued
Item
hcv-infected subjects naïve to treatment: subjects who either have never been treated for hcv infection or who previously received hcv treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
boolean
C0019196 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Plasma HCV RNA assay
Item
plasma hcv rna concentration of >10,000 iu/ml at the screening evaluation
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Intolerance to Pioglitazone | Intolerance to Rosiglitazone | Intolerance to Troglitazone | Intolerance to Adrenal Cortex Hormones
Item
previous intolerance to pioglitazone, rosiglitazone, troglitazone or corticosteroids
boolean
C1744706 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0289313 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0245514 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus Treatment required for | Exception Diet therapy
Item
history of diabetes mellitus requiring treatment other than diet
boolean
C0011849 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0012159 (UMLS CUI [2,2])
Decompensated liver disease | Causes Liver disease | Hepatitis, Autoimmune | Hepatolenticular Degeneration | Hemochromatosis | Primary biliary cirrhosis | Schistosomiasis | Cholangitis, Sclerosing | Alcohol-related liver disease | Drug-Induced Liver Injury | alpha 1-Antitrypsin Deficiency
Item
decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
boolean
C4075847 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0023895 (UMLS CUI [2,2])
C0241910 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0008312 (UMLS CUI [6])
C0036323 (UMLS CUI [7])
C0008313 (UMLS CUI [8])
C0810031 (UMLS CUI [9])
C0860207 (UMLS CUI [10])
C0221757 (UMLS CUI [11])
HBV coinfection
Item
concurrent hepatitis b virus (hbv) infection
boolean
C2242656 (UMLS CUI [1])
Immunodeficiency Disease | Autoimmune Diseases | Gastrointestinal Diseases
Item
known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
boolean
C0021051 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
Alcohol abuse | DRUG ABUSE ILLICIT
Item
abuse of alcohol or illicit drugs within 6 months before enrollment
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Investigational New Drugs
Item
use of an investigational drug within 4 weeks before the screening visit or during the screening period.
boolean
C0013230 (UMLS CUI [1])
Immunosuppressive Agents Systemic
Item
use of systemic immunosuppressants
boolean
C0021081 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Mental disorders Poorly controlled | Lung disease Poorly controlled
Item
history of poorly controlled psychiatric disease or poorly controlled pulmonary disease
boolean
C0004936 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
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