ID

29713

Description

Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba; ODM derived from: https://clinicaltrials.gov/show/NCT00926614

Link

https://clinicaltrials.gov/show/NCT00926614

Keywords

Versions (1)
  1. 4/15/18 4/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis c NCT00926614

English

Eligibility Hepatitis c NCT00926614

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gt 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy
Description

Hepatitis C virus genotype determination | PEGINTERFERON | Ribavirin | Unresponsive to Treatment | Recurrent disease Post Therapy cessation

Data type

boolean

Alias
UMLS CUI [1]
C1533728
UMLS CUI [2]
C0982327
UMLS CUI [3]
C0035525
UMLS CUI [4]
C0205269
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C1699848
insulin resistance
Description

Insulin Resistance

Data type

boolean

Alias
UMLS CUI [1]
C0021655
compensated liver disease
Description

Compensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C3839044
wbc < 3,000/ mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
neutrophil count < 1,500/mm3
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelets < 65,000/ mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
albumin > 3 gm/dl
Description

Albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201838
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants on metformin or other thiazolidinedione must have 3month wash-out period
Description

Metformin | Thiazolidinediones | Washout Period Required

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C1257987
UMLS CUI [3,1]
C1710661
UMLS CUI [3,2]
C1514873
women who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
males with pregnant partners
Description

Gender | Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0032961
co-infection with hav, hbv, or hiv
Description

HAV Coinfection | HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2242656
UMLS CUI [3]
C4062778
ophthalmic abnormalities such as severe retinopathy
Description

Eye Abnormalities | Retinal Disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C0015393
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205082
poorly controlled thyroid dysfunction
Description

Thyroid dysfunction Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0348024
UMLS CUI [1,2]
C3853134
serum creatinine concentration > 1.5 times uln
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
severe psychiatric or neuropsychiatric disorders
Description

Mental Disorders, Severe | Neuropsychiatric syndrome Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2,1]
C3203509
UMLS CUI [2,2]
C0205082
history of alcoholism or drug addiction 1 year prior to screening
Description

Alcoholic Intoxication, Chronic | Drug Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C1510472
seizure disorders not controlled with medication
Description

Epilepsy Without Controlled medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0742801
significant cardiovascular dysfunction within the past 12 months
Description

Dysfunction Cardiovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C3887504
UMLS CUI [1,2]
C3887460
chronic pulmonary disease
Description

Chronic lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0746102
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Similar models

Eligibility Hepatitis c NCT00926614

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C virus genotype determination | PEGINTERFERON | Ribavirin | Unresponsive to Treatment | Recurrent disease Post Therapy cessation
Item
gt 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy
boolean
C1533728 (UMLS CUI [1])
C0982327 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C1699848 (UMLS CUI [5,3])
Insulin Resistance
Item
insulin resistance
boolean
C0021655 (UMLS CUI [1])
Compensated liver disease
Item
compensated liver disease
boolean
C3839044 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc < 3,000/ mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophil count < 1,500/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 65,000/ mm3
boolean
C0032181 (UMLS CUI [1])
Albumin measurement
Item
albumin > 3 gm/dl
boolean
C0201838 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metformin | Thiazolidinediones | Washout Period Required
Item
participants on metformin or other thiazolidinedione must have 3month wash-out period
boolean
C0025598 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C1710661 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender | Partner Pregnancy
Item
males with pregnant partners
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
HAV Coinfection | HBV coinfection | HIV coinfection
Item
co-infection with hav, hbv, or hiv
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
Eye Abnormalities | Retinal Disease Severe
Item
ophthalmic abnormalities such as severe retinopathy
boolean
C0015393 (UMLS CUI [1])
C0035309 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Thyroid dysfunction Poorly controlled
Item
poorly controlled thyroid dysfunction
boolean
C0348024 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine concentration > 1.5 times uln
boolean
C0700225 (UMLS CUI [1])
Mental Disorders, Severe | Neuropsychiatric syndrome Severe
Item
severe psychiatric or neuropsychiatric disorders
boolean
C4046029 (UMLS CUI [1])
C3203509 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Alcoholic Intoxication, Chronic | Drug Dependence
Item
history of alcoholism or drug addiction 1 year prior to screening
boolean
C0001973 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Epilepsy Without Controlled medication
Item
seizure disorders not controlled with medication
boolean
C0014544 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0742801 (UMLS CUI [1,3])
Dysfunction Cardiovascular
Item
significant cardiovascular dysfunction within the past 12 months
boolean
C3887504 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Chronic lung disease
Item
chronic pulmonary disease
boolean
C0746102 (UMLS CUI [1])
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