ID

34788

Descripción

Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02072434

Link

https://clinicaltrials.gov/show/NCT02072434

Palabras clave

Versiones (1)
  1. 29/1/19 29/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02072434

Inglés

Eligibility Atrial Fibrillation NCT02072434

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female older than minimum legal adult age (country specific)
Descripción

Legal Adult More Than Minimum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1706450
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C1524031
ongoing af lasting at least 48 hrs but <= 12 months
Descripción

Atrial Fibrillation Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
subject planned for electrical cardioversion
Descripción

Electrical cardioversion Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C1301732
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
.af that is transient or reversible
Descripción

Atrial Fibrillation Transient | Atrial Fibrillation Reversible

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205374
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0205343
no other rhythm issues other than af
Descripción

Rhythm issue | Exception Atrial Fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0871269
UMLS CUI [1,2]
C0033213
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
mitral stenosis or rheumatic disease, unresected atrial myxoma or mechanical heart valve
Descripción

Mitral Stenosis | Rheumatism | Atrial myxoma Unresected | Mechanical heart valve

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026269
UMLS CUI [2]
C0035435
UMLS CUI [3,1]
C0151241
UMLS CUI [3,2]
C2986425
UMLS CUI [4]
C0493527
left atrial appendage closure or thrombus
Descripción

Atrial appendage closure Left | Thrombus of left atrium

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4523927
UMLS CUI [1,2]
C0205091
UMLS CUI [2]
C3532827
mi, stroke, acs, pci within 30 days
Descripción

Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0948089
UMLS CUI [4]
C1532338
high risk of bleeding within 10 days or randomization
Descripción

High risk of bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4039184
dual antiplatelet therapy
Descripción

Antiplatelet therapy Dual

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0205173
list of prohibited concomitant medication
Descripción

Illicit medication use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281875
active liver disease
Descripción

Liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
renal failure, crcl < 15 ml/min
Descripción

Kidney Failure | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0373595
hemoglobin < 10g/dl or platelet count < 100000 cells/microliter
Descripción

Hemoglobin measurement | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
taking other investigational drugs
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
women of childbearing potential with proper contraceptives measures
Descripción

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
active cancer requiring chemotherapy/radiation/surgery
Descripción

Malignant Neoplasms Requiring Chemotherapy | Malignant Neoplasms Requiring Therapeutic radiology procedure | Malignant Neoplasms Requiring Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0543467
investigator discretion based on examination
Descripción

Investigator Judgment Medical Examination Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0582103
UMLS CUI [1,4]
C0439849
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Similar models

Eligibility Atrial Fibrillation NCT02072434

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Legal Adult More Than Minimum
Item
male or female older than minimum legal adult age (country specific)
boolean
C1706450 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Atrial Fibrillation Duration
Item
ongoing af lasting at least 48 hrs but <= 12 months
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Electrical cardioversion Planned
Item
subject planned for electrical cardioversion
boolean
C0013778 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Transient | Atrial Fibrillation Reversible
Item
.af that is transient or reversible
boolean
C0004238 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0205343 (UMLS CUI [2,2])
Rhythm issue | Exception Atrial Fibrillation
Item
no other rhythm issues other than af
boolean
C0871269 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
Mitral Stenosis | Rheumatism | Atrial myxoma Unresected | Mechanical heart valve
Item
mitral stenosis or rheumatic disease, unresected atrial myxoma or mechanical heart valve
boolean
C0026269 (UMLS CUI [1])
C0035435 (UMLS CUI [2])
C0151241 (UMLS CUI [3,1])
C2986425 (UMLS CUI [3,2])
C0493527 (UMLS CUI [4])
Atrial appendage closure Left | Thrombus of left atrium
Item
left atrial appendage closure or thrombus
boolean
C4523927 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C3532827 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention
Item
mi, stroke, acs, pci within 30 days
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0948089 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
High risk of bleeding
Item
high risk of bleeding within 10 days or randomization
boolean
C4039184 (UMLS CUI [1])
Antiplatelet therapy Dual
Item
dual antiplatelet therapy
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Illicit medication use
Item
list of prohibited concomitant medication
boolean
C0281875 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Kidney Failure | Creatinine clearance measurement
Item
renal failure, crcl < 15 ml/min
boolean
C0035078 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Hemoglobin measurement | Platelet Count measurement
Item
hemoglobin < 10g/dl or platelet count < 100000 cells/microliter
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Investigational New Drugs
Item
taking other investigational drugs
boolean
C0013230 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential with proper contraceptives measures
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Malignant Neoplasms Requiring Chemotherapy | Malignant Neoplasms Requiring Therapeutic radiology procedure | Malignant Neoplasms Requiring Operative Surgical Procedures
Item
active cancer requiring chemotherapy/radiation/surgery
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
Investigator Judgment Medical Examination Related
Item
investigator discretion based on examination
boolean
C0035173 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
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