ID

23464

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00484640

Trefwoorden

  1. 05-07-17 05-07-17 -
Geüploaded op

5 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00484640

Eligibility Atrial Fibrillation NCT00484640

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Caucasian | Hispanic white | Age

Datatype

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;
Beschrijving

Coumadin Started | Coumadin Dosage Stable Absent

Datatype

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;
Beschrijving

Target INR

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 40 years;
Beschrijving

Age

Datatype

boolean

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

Native Americans | Asians | African

Datatype

boolean

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

Thrombocytopenia | Platelet Count measurement

Datatype

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;
Beschrijving

Coumadin Dosage

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

Medical contraindication Coumadin

Datatype

boolean

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

Gender Pregnancy test positive | Breast Feeding

Datatype

boolean

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

Similar models

Eligibility Atrial Fibrillation NCT00484640

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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