ID

27911

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01340573

Nyckelord

Versioner (1)
  1. 2017-12-05 2017-12-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 december 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Chronic Hepatitis C NCT01340573

Engelsk

Eligibility Chronic Hepatitis C NCT01340573

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Protocol Compliance | Informed Consent

Datatyp

boolean

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

Age

Datatyp

boolean

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

Hepatitis C, Chronic | Hepatitis C RNA positive Plasma

Datatyp

boolean

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

Pen Pegintron Absent

Datatyp

boolean

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

Exclusion Criteria

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

Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon | Hypersensitivity Excipient

Datatyp

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.
Beskrivning

Pregnancy

Datatyp

boolean

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

Breast Feeding

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Hepatitis, Autoimmune | Autoimmune Diseases

Datatyp

boolean

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

Liver Dysfunction Severe | Decompensated cirrhosis of liver

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Epilepsy | Central nervous system function Impaired

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0683212
UMLS CUI [2,2]
C0221099
Tillbaka till toppen

Similar models

Eligibility Chronic Hepatitis C NCT01340573

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial