ID

23464

Description

Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing; ODM derived from: https://clinicaltrials.gov/show/NCT00484640

Lien

https://clinicaltrials.gov/show/NCT00484640

Mots-clés

Versions (1)
  1. 05/07/2017 05/07/2017 -
Téléchargé le

5 juillet 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00484640

Anglais

Eligibility Atrial Fibrillation NCT00484640

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
caucasian male and female patients(including hispanic white) greater than or equal to 40 years of age;
Description

Caucasian | Hispanic white | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2]
C1533020
UMLS CUI [3]
C0001779
patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
Description

Coumadin Started | Coumadin Dosage Stable Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0699129
UMLS CUI [1,2]
C1272689
UMLS CUI [2,1]
C0699129
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0332197
target inr of 2 to 3.5;
Description

Target INR

Type de données

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0525032
women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.
Description

Childbearing Potential Contraceptive methods | Female Condoms | Oral contraception | Intrauterine Devices | Sexual Abstinence

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0221829
UMLS CUI [3]
C0029151
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0036899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 40 years;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patients of known native american, asian, or african descent;
Description

Native Americans | Asians | African

Type de données

boolean

Alias
UMLS CUI [1]
C0282204
UMLS CUI [2]
C0078988
UMLS CUI [3]
C0027567
patients with thrombocytopenia(platelet count<50x10 cells/ml);
Description

Thrombocytopenia | Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
Description

Coumadin Dosage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0699129
UMLS CUI [1,2]
C0178602
patients with severe to moderate hepatic insufficiency (ast or alt less than 2x the upper limit of normal;
Description

Hepatic Insufficiency Severe | Hepatic Insufficiency Moderate | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1306571
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
clinical contraindication for coumadin therapy;
Description

Medical contraindication Coumadin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0699129
female patients with a positive pregnancy test or women who are breastfeeding
Description

Gender Pregnancy test positive | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
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Similar models

Eligibility Atrial Fibrillation NCT00484640

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Caucasian | Hispanic white | Age
Item
caucasian male and female patients(including hispanic white) greater than or equal to 40 years of age;
boolean
C0043157 (UMLS CUI [1])
C1533020 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Coumadin Started | Coumadin Dosage Stable Absent
Item
patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
boolean
C0699129 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Target INR
Item
target inr of 2 to 3.5;
boolean
C1521840 (UMLS CUI [1,1])
C0525032 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Female Condoms | Oral contraception | Intrauterine Devices | Sexual Abstinence
Item
women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0221829 (UMLS CUI [2])
C0029151 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 40 years;
boolean
C0001779 (UMLS CUI [1])
Native Americans | Asians | African
Item
patients of known native american, asian, or african descent;
boolean
C0282204 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
Thrombocytopenia | Platelet Count measurement
Item
patients with thrombocytopenia(platelet count<50x10 cells/ml);
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Coumadin Dosage
Item
patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
boolean
C0699129 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Hepatic Insufficiency Severe | Hepatic Insufficiency Moderate | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients with severe to moderate hepatic insufficiency (ast or alt less than 2x the upper limit of normal;
boolean
C1306571 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1306571 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Medical contraindication Coumadin
Item
clinical contraindication for coumadin therapy;
boolean
C1301624 (UMLS CUI [1,1])
C0699129 (UMLS CUI [1,2])
Gender Pregnancy test positive | Breast Feeding
Item
female patients with a positive pregnancy test or women who are breastfeeding
boolean
C0079399 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
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