ID

28465

Beschrijving

A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00540670

Link

https://clinicaltrials.gov/show/NCT00540670

Trefwoorden

  1. 15-01-18 15-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 januari 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00540670

Eligibility Coronary Artery Disease NCT00540670

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 45 - 80 years old (at time of informed consent).
Beschrijving

Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. male or female (females of childbearing potential must use contraception).
Beschrijving

Gender | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
3. confirmed coronary artery disease.
Beschrijving

Coronary Artery Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
4. all subjects must be receiving aspirin (75 - 325 mg).
Beschrijving

Aspirin Dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unwilling or unable to provide informed consent.
Beschrijving

Informed Consent Unwilling | Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
2. history of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
Beschrijving

Blood Coagulation Disorder Acquired | Congenital Bleeding Disorder | Coagulopathy | Platelet Disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0439661
UMLS CUI [2]
C3641106
UMLS CUI [3]
C0005779
UMLS CUI [4]
C0005818
3. recent trauma or major surgery.
Beschrijving

Trauma | Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C3714660
UMLS CUI [2]
C0679637
4. evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
Beschrijving

Hemorrhage Pathological | Hemorrhage | Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Exception Cause Corrected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1521733
UMLS CUI [2]
C0019080
UMLS CUI [3]
C0017181
UMLS CUI [4]
C0919591
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015127
UMLS CUI [5,3]
C0205202
5. history of intracranial bleeding or history of hemorrhagic retinopathy.
Beschrijving

Intracranial Hemorrhage | Retinopathy haemorrhagic

Datatype

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2]
C0948059
6. new york heart association class iii or iv congestive heart failure.
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
7. pregnant or lactating women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Coronary Artery Disease NCT00540670

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. 45 - 80 years old (at time of informed consent).
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Gender | Childbearing Potential Contraceptive methods
Item
2. male or female (females of childbearing potential must use contraception).
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Coronary Artery Disease
Item
3. confirmed coronary artery disease.
boolean
C1956346 (UMLS CUI [1])
Aspirin Dosage
Item
4. all subjects must be receiving aspirin (75 - 325 mg).
boolean
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling | Informed Consent Unable
Item
1. unwilling or unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Blood Coagulation Disorder Acquired | Congenital Bleeding Disorder | Coagulopathy | Platelet Disorder
Item
2. history of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
boolean
C0005779 (UMLS CUI [1,1])
C0439661 (UMLS CUI [1,2])
C3641106 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
C0005818 (UMLS CUI [4])
Trauma | Major surgery
Item
3. recent trauma or major surgery.
boolean
C3714660 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Hemorrhage Pathological | Hemorrhage | Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Exception Cause Corrected
Item
4. evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
boolean
C0019080 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0919591 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0015127 (UMLS CUI [5,2])
C0205202 (UMLS CUI [5,3])
Intracranial Hemorrhage | Retinopathy haemorrhagic
Item
5. history of intracranial bleeding or history of hemorrhagic retinopathy.
boolean
C0151699 (UMLS CUI [1])
C0948059 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
6. new york heart association class iii or iv congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
7. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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