ID

27918

Description

Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00910975

Link

https://clinicaltrials.gov/show/NCT00910975

Keywords

  1. 12/5/17 12/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
anti-hcv positive for > 6 months
Description

Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
genotype 1
Description

Hepatitis C virus genotype 1

Data type

boolean

Alias
UMLS CUI [1]
C3532919
clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
Description

Indication Therapeutic procedure | Inflammation Biopsy of liver | Fibrosis Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0021368
UMLS CUI [2,2]
C0193388
UMLS CUI [3,1]
C0016059
UMLS CUI [3,2]
C0193388
negative pregnancy test (for fertile women)
Description

Gender Fertile Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
antiviral or immune modulating treatment the last 6 months
Description

Antiviral Therapy | Immunomodulation

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1963758
hepatitis b or hiv infection (hbsag, anti-hiv)
Description

Hepatitis B | HIV Infection | Hepatitis B Surface Antigens | HIV Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019168
UMLS CUI [4]
C0019683
other significant chronic liver disease
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
history of bleeding esophageal varices or other signs of decompensation
Description

Bleeding esophageal varices | Signs Decompensation

Data type

boolean

Alias
UMLS CUI [1]
C0155789
UMLS CUI [2,1]
C0220912
UMLS CUI [2,2]
C0231187
neutrophiles < 1.0 x 109/l or platelets < 50 x 109/l. s-creatinine > 2 x uln
Description

Neutrophil count | Platelet Count measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
history of severe psychiatric disorder
Description

Mental Disorders, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
Description

Autoimmune Disease | Heart Disease Severe | Organ Transplantation | Stem cell transplant | Malignant Neoplasms | Thyroid Disease | Retinal Disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0029216
UMLS CUI [4]
C1504389
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0040128
UMLS CUI [7,1]
C0035309
UMLS CUI [7,2]
C0205082
drug abuse, current or during the last year
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146

Similar models

Eligibility Chronic Hepatitis C, Genotype 1 NCT00910975

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C antibody positive
Item
anti-hcv positive for > 6 months
boolean
C0281863 (UMLS CUI [1])
Hepatitis C virus genotype 1
Item
genotype 1
boolean
C3532919 (UMLS CUI [1])
Indication Therapeutic procedure | Inflammation Biopsy of liver | Fibrosis Biopsy of liver
Item
clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0021368 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0016059 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Gender Fertile Pregnancy test negative
Item
negative pregnancy test (for fertile women)
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Antiviral Therapy | Immunomodulation
Item
antiviral or immune modulating treatment the last 6 months
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
Hepatitis B | HIV Infection | Hepatitis B Surface Antigens | HIV Antibodies
Item
hepatitis b or hiv infection (hbsag, anti-hiv)
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019168 (UMLS CUI [3])
C0019683 (UMLS CUI [4])
Chronic liver disease
Item
other significant chronic liver disease
boolean
C0341439 (UMLS CUI [1])
Bleeding esophageal varices | Signs Decompensation
Item
history of bleeding esophageal varices or other signs of decompensation
boolean
C0155789 (UMLS CUI [1])
C0220912 (UMLS CUI [2,1])
C0231187 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Creatinine measurement, serum
Item
neutrophiles < 1.0 x 109/l or platelets < 50 x 109/l. s-creatinine > 2 x uln
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Mental Disorders, Severe
Item
history of severe psychiatric disorder
boolean
C4046029 (UMLS CUI [1])
Autoimmune Disease | Heart Disease Severe | Organ Transplantation | Stem cell transplant | Malignant Neoplasms | Thyroid Disease | Retinal Disease Severe
Item
autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
boolean
C0004364 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0029216 (UMLS CUI [3])
C1504389 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0040128 (UMLS CUI [6])
C0035309 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Drug abuse
Item
drug abuse, current or during the last year
boolean
C0013146 (UMLS CUI [1])

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