ID

27911

Beschrijving

Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896); ODM derived from: https://clinicaltrials.gov/show/NCT01340573

Link

https://clinicaltrials.gov/show/NCT01340573

Trefwoorden

Versies (1)
  1. 05-12-17 05-12-17 -
Houder van rechten

See clinicaltrials.gov

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5 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT01340573

Engels

Eligibility Chronic Hepatitis C NCT01340573

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
equal to or greater than 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
confirmed chronic hepatitis c with hepatitis c virus (hcv) rna positive in plasma.
Beschrijving

Hepatitis C, Chronic | Hepatitis C RNA positive Plasma

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0855842
UMLS CUI [2,2]
C0032105
no previous use of pegintron pen.
Beschrijving

Pen Pegintron Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C4058415
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to the active substance or to any interferon or to any of the excipients.
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon | Hypersensitivity Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3652465
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
pregnant women.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
women who are breastfeeding.
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Beschrijving

Mental condition Severe | Severe depression | Feeling suicidal | Suicide attempt

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0588008
UMLS CUI [3]
C0424000
UMLS CUI [4]
C0038663
a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
Beschrijving

Heart Disease Pre-existing | Heart Disease Unstable | Heart Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
Beschrijving

Medical condition Debilitation Severe | Kidney Failure, Chronic | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0742985
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0373595
auto immune hepatitis or a history of autoimmune disease.
Beschrijving

Hepatitis, Autoimmune | Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2]
C0004364
severe hepatic dysfunction or decompensated cirrhosis of the liver.
Beschrijving

Liver Dysfunction Severe | Decompensated cirrhosis of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1619727
pre-existing thyroid disease unless it can be controlled with conventional treatment.
Beschrijving

Thyroid Disease Pre-existing | Exception Disease control Standard of Care

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0920467
UMLS CUI [2,3]
C2936643
epilepsy and/or compromised central nervous system (cns) function.
Beschrijving

Epilepsy | Central nervous system function Impaired

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0683212
UMLS CUI [2,2]
C0221099
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Similar models

Eligibility Chronic Hepatitis C NCT01340573

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Informed Consent
Item
demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
equal to or greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C RNA positive Plasma
Item
confirmed chronic hepatitis c with hepatitis c virus (hcv) rna positive in plasma.
boolean
C0524910 (UMLS CUI [1])
C0855842 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
Pen Pegintron Absent
Item
no previous use of pegintron pen.
boolean
C4058415 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon | Hypersensitivity Excipient
Item
hypersensitivity to the active substance or to any interferon or to any of the excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3652465 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
women who are breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Mental condition Severe | Severe depression | Feeling suicidal | Suicide attempt
Item
existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
boolean
C3840291 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
Heart Disease Pre-existing | Heart Disease Unstable | Heart Disease Uncontrolled
Item
a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
boolean
C0018799 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Medical condition Debilitation Severe | Kidney Failure, Chronic | Creatinine clearance measurement
Item
severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance < 50 ml/minute.
boolean
C3843040 (UMLS CUI [1,1])
C0742985 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0022661 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Hepatitis, Autoimmune | Autoimmune Diseases
Item
auto immune hepatitis or a history of autoimmune disease.
boolean
C0241910 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Liver Dysfunction Severe | Decompensated cirrhosis of liver
Item
severe hepatic dysfunction or decompensated cirrhosis of the liver.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1619727 (UMLS CUI [2])
Thyroid Disease Pre-existing | Exception Disease control Standard of Care
Item
pre-existing thyroid disease unless it can be controlled with conventional treatment.
boolean
C0040128 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0920467 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Epilepsy | Central nervous system function Impaired
Item
epilepsy and/or compromised central nervous system (cns) function.
boolean
C0014544 (UMLS CUI [1])
C0683212 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
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