ID

37598

Description

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism; ODM derived from: https://clinicaltrials.gov/show/NCT01976507

Link

https://clinicaltrials.gov/show/NCT01976507

Keywords

Versions (1)
  1. 8/10/19 8/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 10, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT01976507

English

Eligibility Atrial Fibrillation NCT01976507

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female sex, age 18-85 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
negative pregnancy test for women of childbearing potential
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (nvaf), or left atrial flutter following prior left atrial ablation procedures
Description

Pulmonary vein isolation Radiofrequency Antral | Pulmonary vein isolation Cryosurgery | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Atrial Fibrillation | Atrial Flutter Left | Status post Atrial Ablation Left

Data type

boolean

Alias
UMLS CUI [1,1]
C3544330
UMLS CUI [1,2]
C0579006
UMLS CUI [1,3]
C0737254
UMLS CUI [2,1]
C3544330
UMLS CUI [2,2]
C0010408
UMLS CUI [3]
C0235480
UMLS CUI [4]
C2585653
UMLS CUI [5]
C0004238
UMLS CUI [6,1]
C0004239
UMLS CUI [6,2]
C0205091
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C2825182
UMLS CUI [7,3]
C0205091
chads2 score of 0-6 or chads2-vasc score 0-9
Description

CHADS2 score | CHA2DS2-VASc score

Data type

boolean

Alias
UMLS CUI [1]
C2585876
UMLS CUI [2]
C4049268
vascular hemostasis within 4-6 hours of sheath pull
Description

Hemostasis Vascular | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0019116
UMLS CUI [1,2]
C1801960
UMLS CUI [2]
C3846158
able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
currently participating in another clinical treatment trial
Description

Study Subject Participation Status | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
history of hereditary hemophilias
Description

Hemophilia Hereditary

Data type

boolean

Alias
UMLS CUI [1,1]
C0684275
UMLS CUI [1,2]
C0439660
presence of active bleeding
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
end stage renal disease, crcl<15 ml/min
Description

Kidney Failure, Chronic | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0373595
prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
Description

Dabigatran failed | Cerebrovascular accident | Thromboembolism Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C2348066
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0040038
UMLS CUI [3,2]
C0205373
known allergic reaction to dabigatran etexilate
Description

Allergic Reaction Dabigatran etexilate

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1571583
intolerance to dabigatran, if medication naïve, or other contra-indications as per the uspi.
Description

Intolerance to Dabigatran | Pharmaceutical Preparations Absent | Medical contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2348066
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1301624
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of non-compliance
Description

Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
inability to follow-up
Description

Follow-up Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
Back to the top of the page

Similar models

Eligibility Atrial Fibrillation NCT01976507

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female sex, age 18-85 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Pulmonary vein isolation Radiofrequency Antral | Pulmonary vein isolation Cryosurgery | Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Atrial Fibrillation | Atrial Flutter Left | Status post Atrial Ablation Left
Item
planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (nvaf), or left atrial flutter following prior left atrial ablation procedures
boolean
C3544330 (UMLS CUI [1,1])
C0579006 (UMLS CUI [1,2])
C0737254 (UMLS CUI [1,3])
C3544330 (UMLS CUI [2,1])
C0010408 (UMLS CUI [2,2])
C0235480 (UMLS CUI [3])
C2585653 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0004239 (UMLS CUI [6,1])
C0205091 (UMLS CUI [6,2])
C0231290 (UMLS CUI [7,1])
C2825182 (UMLS CUI [7,2])
C0205091 (UMLS CUI [7,3])
CHADS2 score | CHA2DS2-VASc score
Item
chads2 score of 0-6 or chads2-vasc score 0-9
boolean
C2585876 (UMLS CUI [1])
C4049268 (UMLS CUI [2])
Hemostasis Vascular | Other Coding
Item
vascular hemostasis within 4-6 hours of sheath pull
boolean
C0019116 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Therapy, Investigational
Item
currently participating in another clinical treatment trial
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hemophilia Hereditary
Item
history of hereditary hemophilias
boolean
C0684275 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Hemorrhage
Item
presence of active bleeding
boolean
C0019080 (UMLS CUI [1])
Kidney Failure, Chronic | Creatinine clearance measurement
Item
end stage renal disease, crcl<15 ml/min
boolean
C0022661 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Dabigatran failed | Cerebrovascular accident | Thromboembolism Systemic
Item
prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
boolean
C2348066 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0040038 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Allergic Reaction Dabigatran etexilate
Item
known allergic reaction to dabigatran etexilate
boolean
C1527304 (UMLS CUI [1,1])
C1571583 (UMLS CUI [1,2])
Intolerance to Dabigatran | Pharmaceutical Preparations Absent | Medical contraindication
Item
intolerance to dabigatran, if medication naïve, or other contra-indications as per the uspi.
boolean
C1744706 (UMLS CUI [1,1])
C2348066 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Compliance behavior Lacking
Item
history of non-compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Follow-up Unable
Item
inability to follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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