ID

27889

Beschrijving

Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00778843

Link

https://clinicaltrials.gov/show/NCT00778843

Trefwoorden

Versies (1)
  1. 04-12-17 04-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00778843

Engels

Eligibility Chronic Hepatitis C NCT00778843

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcv infection confirmed on a positive test for anti-hcv antibody and hcv rna detectable in serum by polymerase chain reaction.
Beschrijving

Hepatitis C | Hepatitis C antibody positive | Hepatitis C virus RNA Detectable Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0281863
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C3830527
UMLS CUI [3,3]
C0032520
histological diagnosis of chronic hepatitis.
Beschrijving

Hepatitis, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0019189
patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment.
Beschrijving

Pegylated interferon alfa Unresponsive to Treatment | Ribavirin Unresponsive to Treatment | Medical contraindication Antiviral Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0907160
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0280274
age between 18 and 65 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ability to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
Beschrijving

Alcohol consumption Significant Absent | Alcohol consumption U/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0560588
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency).
Beschrijving

Liver diseases | Viral hepatitis | Hepatitis, Autoimmune | Drug-Induced Liver Disease | Nonalcoholic Steatohepatitis | Liver diseases Metabolic | Liver diseases Hereditary | alpha 1-Antitrypsin Deficiency

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0241910
UMLS CUI [4]
C0860207
UMLS CUI [5]
C3241937
UMLS CUI [6,1]
C0023895
UMLS CUI [6,2]
C0311400
UMLS CUI [7,1]
C0023895
UMLS CUI [7,2]
C0439660
UMLS CUI [8]
C0221757
pregnancy or lactation.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
decompensated cirrhosis.
Beschrijving

Decompensated cirrhosis

Datatype

boolean

Alias
UMLS CUI [1]
C1619727
absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
Beschrijving

Malignant neoplasm of liver Evidence Absent | Malignant neoplasm of liver Absent Ultrasonography | Alpha fetoprotein measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0345904
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0345904
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0041618
UMLS CUI [3]
C0201539
refusal to participate in the study.
Beschrijving

Study Subject Participation Status Refusal to Participate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1136454
concomitant disease with reduced life expectancy.
Beschrijving

Comorbidity Reduced life expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1858274
severe psychiatric conditions.
Beschrijving

Mental condition Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0205082
drug dependence.
Beschrijving

Drug Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C1510472
co-infection with hepatitis a or b or hiv.
Beschrijving

Hepatitis A Coinfection | HBV coinfection | HIV coinfection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019159
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
pregnancy.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Hepatitis C NCT00778843

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C | Hepatitis C antibody positive | Hepatitis C virus RNA Detectable Polymerase Chain Reaction
Item
hcv infection confirmed on a positive test for anti-hcv antibody and hcv rna detectable in serum by polymerase chain reaction.
boolean
C0019196 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C0032520 (UMLS CUI [3,3])
Hepatitis, Chronic
Item
histological diagnosis of chronic hepatitis.
boolean
C0019189 (UMLS CUI [1])
Pegylated interferon alfa Unresponsive to Treatment | Ribavirin Unresponsive to Treatment | Medical contraindication Antiviral Therapy
Item
patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment.
boolean
C0907160 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0280274 (UMLS CUI [3,2])
Age
Item
age between 18 and 65 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Alcohol consumption Significant Absent | Alcohol consumption U/week
Item
absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
boolean
C0001948 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0001948 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Liver diseases | Viral hepatitis | Hepatitis, Autoimmune | Drug-Induced Liver Disease | Nonalcoholic Steatohepatitis | Liver diseases Metabolic | Liver diseases Hereditary | alpha 1-Antitrypsin Deficiency
Item
presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency).
boolean
C0023895 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0241910 (UMLS CUI [3])
C0860207 (UMLS CUI [4])
C3241937 (UMLS CUI [5])
C0023895 (UMLS CUI [6,1])
C0311400 (UMLS CUI [6,2])
C0023895 (UMLS CUI [7,1])
C0439660 (UMLS CUI [7,2])
C0221757 (UMLS CUI [8])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Decompensated cirrhosis
Item
decompensated cirrhosis.
boolean
C1619727 (UMLS CUI [1])
Malignant neoplasm of liver Evidence Absent | Malignant neoplasm of liver Absent Ultrasonography | Alpha fetoprotein measurement
Item
absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
boolean
C0345904 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0345904 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0201539 (UMLS CUI [3])
Study Subject Participation Status Refusal to Participate
Item
refusal to participate in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
Comorbidity Reduced life expectancy
Item
concomitant disease with reduced life expectancy.
boolean
C0009488 (UMLS CUI [1,1])
C1858274 (UMLS CUI [1,2])
Mental condition Severe
Item
severe psychiatric conditions.
boolean
C3840291 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Drug Dependence
Item
drug dependence.
boolean
C1510472 (UMLS CUI [1])
Hepatitis A Coinfection | HBV coinfection | HIV coinfection
Item
co-infection with hepatitis a or b or hiv.
boolean
C0019159 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
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