ID

22706

Description

Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study); ODM derived from: https://clinicaltrials.gov/show/NCT00799396

Link

https://clinicaltrials.gov/show/NCT00799396

Keywords

Versions (1)
  1. 6/10/17 6/10/17 -
Uploaded on

June 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Platelet Aggregation Inhibitors NCT00799396

English

Eligibility Platelet Aggregation Inhibitors NCT00799396

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
of old order amish descent
Description

old order amish descent

Data type

boolean

Alias
UMLS CUI [1]
C0238622
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant or less than 6 months have passed since delivery
Description

pregnancy, postpartum

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032804
has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
Description

has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C1321132
UMLS CUI [2,2]
C0030920
UMLS CUI [2,3]
C0743553
UMLS CUI [2,4]
C0151699
has severe hypertension, defined by a blood pressure above 160/95 mm hg, making it unethical not to recommend prompt treatment
Description

severe hypertension

Data type

boolean

Alias
UMLS CUI [1]
C4013784
takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
Description

takes medications that would affect the outcome(s) to be measured and cannot willingly and safely discontinue these medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0457454
UMLS CUI [2,3]
C1299582
is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
Description

supplements, unwilling to discontinue

Data type

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0457454
UMLS CUI [2,3]
C0242295
has a coexisting malignancy
Description

coexisting malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (ast) or alanine transaminase (alt) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (tsh) less than 0.4 or greater than 5.5 miu/l
Description

creatinine, ast, alt, hematocrit, thyroid-stimulating hormone

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0518014
UMLS CUI [5]
C0202230
has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
Description

bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0017181
UMLS CUI [3,1]
C0205164
UMLS CUI [3,2]
C0019080
is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or gpiib/iiia antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
Description

anti-coagulant therapy, aspirin, clopidogrel, warfarin, heparin, gpiib/iiia antagonists, unstable angina, heart attack, angioplasty, coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0043031
UMLS CUI [5]
C0019134
UMLS CUI [6]
C3640054
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0027051
UMLS CUI [9]
C0162577
UMLS CUI [10]
C0010055
UMLS CUI [11]
C0004238
UMLS CUI [12]
C0038454
UMLS CUI [13]
C0007787
UMLS CUI [14]
C0011849
UMLS CUI [15]
C0149871
UMLS CUI [16]
C2586211
has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
Description

polycythemia, thrombocytosis, platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032463
UMLS CUI [2,1]
C0836924
UMLS CUI [2,2]
C0032181
has thrombocytopenia, defined by a platelet count less than 75,000
Description

thrombocytopenia, platelet count

Data type

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0032181
has had surgery within the last 6 months
Description

history of surgery

Data type

boolean

Alias
UMLS CUI [1]
C0543467
has an aspirin or clopidogrel allergy
Description

hypersensitivity aspirin, hypersensitivity clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
currently breast feeding
Description

breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Platelet Aggregation Inhibitors NCT00799396

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
old order amish descent
Item
of old order amish descent
boolean
C0238622 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy, postpartum
Item
currently pregnant or less than 6 months have passed since delivery
boolean
C0032961 (UMLS CUI [1])
C0032804 (UMLS CUI [2])
has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
Item
has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
boolean
C0005779 (UMLS CUI [1])
C1321132 (UMLS CUI [2,1])
C0030920 (UMLS CUI [2,2])
C0743553 (UMLS CUI [2,3])
C0151699 (UMLS CUI [2,4])
severe hypertension
Item
has severe hypertension, defined by a blood pressure above 160/95 mm hg, making it unethical not to recommend prompt treatment
boolean
C4013784 (UMLS CUI [1])
takes medications that would affect the outcome(s) to be measured and cannot willingly and safely discontinue these medications
Item
takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
supplements, unwilling to discontinue
Item
is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
boolean
C0242295 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0457454 (UMLS CUI [2,2])
C0242295 (UMLS CUI [2,3])
coexisting malignancy
Item
has a coexisting malignancy
boolean
C0006826 (UMLS CUI [1])
creatinine, ast, alt, hematocrit, thyroid-stimulating hormone
Item
has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (ast) or alanine transaminase (alt) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (tsh) less than 0.4 or greater than 5.5 miu/l
boolean
C0201976 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0518014 (UMLS CUI [4])
C0202230 (UMLS CUI [5])
bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
Item
has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
boolean
C0005779 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0205164 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
anti-coagulant therapy, aspirin, clopidogrel, warfarin, heparin, gpiib/iiia antagonists, unstable angina, heart attack, angioplasty, coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
Item
is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or gpiib/iiia antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
boolean
C0150457 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
C0019134 (UMLS CUI [5])
C3640054 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0162577 (UMLS CUI [9])
C0010055 (UMLS CUI [10])
C0004238 (UMLS CUI [11])
C0038454 (UMLS CUI [12])
C0007787 (UMLS CUI [13])
C0011849 (UMLS CUI [14])
C0149871 (UMLS CUI [15])
C2586211 (UMLS CUI [16])
polycythemia, thrombocytosis, platelet count
Item
has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
boolean
C0032463 (UMLS CUI [1])
C0836924 (UMLS CUI [2,1])
C0032181 (UMLS CUI [2,2])
thrombocytopenia, platelet count
Item
has thrombocytopenia, defined by a platelet count less than 75,000
boolean
C0040034 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
history of surgery
Item
has had surgery within the last 6 months
boolean
C0543467 (UMLS CUI [1])
hypersensitivity aspirin, hypersensitivity clopidogrel
Item
has an aspirin or clopidogrel allergy
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
breast feeding
Item
currently breast feeding
boolean
C0006147 (UMLS CUI [1])
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