ID

34782

Descrição

Prolongation of the Interval Between Prothrombin Time Tests in Stable Patients II; ODM derived from: https://clinicaltrials.gov/show/NCT01654042

Link

https://clinicaltrials.gov/show/NCT01654042

Palavras-chave

Versões (1)
  1. 28/01/2019 28/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01654042

Inglês

Eligibility Atrial Fibrillation NCT01654042

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
long-term warfarin for prophylaxis of arterial embolism due to atrial fibrillation or mechanical heart valve replacement or secondary prophylaxis after vte
Descrição

Warfarin Long-term | Prophylactic treatment Arterial embolism | Etiology Atrial Fibrillation | Etiology Mechanical heart valve replacement | Prophylactic treatment Secondary Post Venous Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0549124
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0004238
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C3697840
UMLS CUI [5,1]
C0199176
UMLS CUI [5,2]
C0175668
UMLS CUI [5,3]
C0687676
UMLS CUI [5,4]
C1861172
therapeutic inr range of 2.0-3.0 or 2.5-3.5
Descrição

INR Therapeutic range

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C0460097
anticoagulation therapy has been managed by the study site for at least 6 months prior to enrollment
Descrição

Anticoagulation Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003281
warfarin maintenance dose has remained unchanged for the previous 6 months or longer
Descrição

Warfarin Maintenance dose unchanged

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C3714445
UMLS CUI [1,3]
C0442739
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of less than 1 year
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
congestive heart failure or other diagnosis where the condition or its treatment is expected to affect the stability of inr (e.g. cancer requiring chemotherapy)
Descrição

Congestive heart failure Affecting Stability INR | Condition Affecting Stability INR | Malignant Neoplasms Requiring Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0525032
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0525032
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0392920
attending physician believes that patient is not suitable for the study (for instance, psychiatric disorder; history of non-compliance; newly diagnosed disease which by itself, via the treatment required or the effects thereof may cause instability of inrs)
Descrição

Study Subject Participation Status Inappropriate | Mental disorders | Compliance behavior Lacking | Disease Causing Unstable status INR

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0443343
UMLS CUI [4,4]
C0525032
patients who perform self-testing
Descrição

Self Testing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036588
UMLS CUI [1,2]
C0039593
geographic inaccessibility
Descrição

Patient unavailable Due to Geographic Factors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0017444
failure to obtain written consent
Descrição

Informed Consent failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Atrial Fibrillation NCT01654042

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Warfarin Long-term | Prophylactic treatment Arterial embolism | Etiology Atrial Fibrillation | Etiology Mechanical heart valve replacement | Prophylactic treatment Secondary Post Venous Thromboembolism
Item
long-term warfarin for prophylaxis of arterial embolism due to atrial fibrillation or mechanical heart valve replacement or secondary prophylaxis after vte
boolean
C0043031 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0199176 (UMLS CUI [2,1])
C0549124 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C3697840 (UMLS CUI [4,2])
C0199176 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C1861172 (UMLS CUI [5,4])
INR Therapeutic range
Item
therapeutic inr range of 2.0-3.0 or 2.5-3.5
boolean
C0525032 (UMLS CUI [1,1])
C0460097 (UMLS CUI [1,2])
Anticoagulation Therapy
Item
anticoagulation therapy has been managed by the study site for at least 6 months prior to enrollment
boolean
C0003281 (UMLS CUI [1])
Warfarin Maintenance dose unchanged
Item
warfarin maintenance dose has remained unchanged for the previous 6 months or longer
boolean
C0043031 (UMLS CUI [1,1])
C3714445 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of less than 1 year
boolean
C0023671 (UMLS CUI [1])
Congestive heart failure Affecting Stability INR | Condition Affecting Stability INR | Malignant Neoplasms Requiring Chemotherapy
Item
congestive heart failure or other diagnosis where the condition or its treatment is expected to affect the stability of inr (e.g. cancer requiring chemotherapy)
boolean
C0018802 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0525032 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0525032 (UMLS CUI [2,4])
C0006826 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Study Subject Participation Status Inappropriate | Mental disorders | Compliance behavior Lacking | Disease Causing Unstable status INR
Item
attending physician believes that patient is not suitable for the study (for instance, psychiatric disorder; history of non-compliance; newly diagnosed disease which by itself, via the treatment required or the effects thereof may cause instability of inrs)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0443343 (UMLS CUI [4,3])
C0525032 (UMLS CUI [4,4])
Self Testing
Item
patients who perform self-testing
boolean
C0036588 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
Patient unavailable Due to Geographic Factors
Item
geographic inaccessibility
boolean
C1301818 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0017444 (UMLS CUI [1,3])
Informed Consent failed
Item
failure to obtain written consent
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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