ID

34788

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02072434

Nyckelord

Versioner (1)
  1. 2019-01-29 2019-01-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 januari 2019

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 Atrial Fibrillation NCT02072434

Engelsk

Eligibility Atrial Fibrillation NCT02072434

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

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

Legal Adult More Than Minimum

Datatyp

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
Beskrivning

Atrial Fibrillation Duration

Datatyp

boolean

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

Electrical cardioversion Planned

Datatyp

boolean

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

Exclusion Criteria

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

Atrial Fibrillation Transient | Atrial Fibrillation Reversible

Datatyp

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
Beskrivning

Rhythm issue | Exception Atrial Fibrillation

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Atrial appendage closure Left | Thrombus of left atrium

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

High risk of bleeding

Datatyp

boolean

Alias
UMLS CUI [1]
C4039184
dual antiplatelet therapy
Beskrivning

Antiplatelet therapy Dual

Datatyp

boolean

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

Illicit medication use

Datatyp

boolean

Alias
UMLS CUI [1]
C0281875
active liver disease
Beskrivning

Liver disease

Datatyp

boolean

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

Kidney Failure | Creatinine clearance measurement

Datatyp

boolean

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

Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

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

Investigational New Drugs

Datatyp

boolean

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

Childbearing Potential Contraceptive methods

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Investigator Judgment Medical Examination Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C0582103
UMLS CUI [1,4]
C0439849
Tillbaka till toppen

Similar models

Eligibility Atrial Fibrillation NCT02072434

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