Eligibility Ischemic Heart Disease NCT01847391

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StudyEvent: Eligibility
1. Eligibility Ischemic Heart Disease NCT01847391

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Body Weight | Body mass index

Item

weight of at least 50 kg with body mass index (bmi) between 18 and 30 kg/m2

boolean

C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])

Gender | Childbearing Potential Absent

Item

female subjects must be of non-childbearing potential as defined per the protocol

boolean

C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])

Gender Partner Childbearing Potential | Gender Contraceptive methods

Item

male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception

boolean

C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])

Protocol Compliance

Item

willing and able to comply with the requirements of the protocol and directions

boolean

C0525058 (UMLS CUI [1])

Avoidance Consumption Grapefruit | Avoidance Consumption GRAPEFRUIT JUICE | Avoidance Consumption Seville orange Fruit

Item

willing to avoid consumption of grapefruit, grapefruit juice and seville oranges

boolean

C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0995150 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0452456 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0330922 (UMLS CUI [3,3])
C0016767 (UMLS CUI [3,4])

Avoidance Consumption Nicotine | Avoidance Consumption Nicotine Chewing Gum | Avoidance Consumption Alcoholic Beverages

Item

willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages

boolean

C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0599654 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0001967 (UMLS CUI [3,3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Medical condition At risk Patient safety | Operative Surgical Procedure At risk Patient safety | Medical condition Interferes with Study Protocol | Operative Surgical Procedure Interferes with Study Protocol

Item

ongoing or history of any medical or surgical condition that, in the judgment of the investigator, might jeopardize the subject's safety or interfere with the study objectives

boolean

C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])

Item

history of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures

boolean

C0025289 (UMLS CUI [1])
C0014038 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0149931 (UMLS CUI [4])
C0040822 (UMLS CUI [5])
C0027066 (UMLS CUI [6])
C0851578 (UMLS CUI [7])
C0003467 (UMLS CUI [8])
C0039070 (UMLS CUI [9])
C0018674 (UMLS CUI [10])
C0241889 (UMLS CUI [11,1])
C0036572 (UMLS CUI [11,2])

ECG abnormal | Laboratory test result abnormal | Physical examination abnormal

Item

any abnormal ecg findings, abnormal laboratory value, or physical examination findings at screening judged to be clinically significant

boolean

C0522055 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0747585 (UMLS CUI [3])

Neurological examination abnormal

Item

any abnormal neurological examination findings at screening that is judged as clinically significant

boolean

C1112537 (UMLS CUI [1])

Hemoglobin measurement

Item

hemoglobin < 12 g/dl

boolean

C0518015 (UMLS CUI [1])

HIV Seropositivity | Serology positive Hepatitis B | Serology positive Hepatitis C

Item

serology test positive for hiv, or hepatitis b or c

boolean

C0019699 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])

Urine drug screen positive | Urine cotinine test positive | Urine drug screen ethanol Positive

Item

positive urine drug test (including cotinine or ethanol)

boolean

C0743300 (UMLS CUI [1])
C1699505 (UMLS CUI [2])
C2188602 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])

Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Multivitamin preparation | Dietary Supplements | Herbal Supplements

Item

use of systemic prescription medications or over the counter (otc) medication, including multivitamins, and dietary and herbal supplement

boolean

C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1504473 (UMLS CUI [5])

Investigational New Drugs | Investigational Medical Device

Item

use of any experimental or investigational drug or device within 30 days

boolean

C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])

Childbearing Potential | Pregnancy | Breast Feeding

Item

female subjects who are of childbearing potential, pregnant or lactating

boolean

C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Blood Donation | Blood Loss | Plasma Charitable contribution

Item

donation or loss of blood within 8 weeks and/or donation of plasma within 7 days

boolean

C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0032105 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])

Substance Use Disorders

Item

history of drug or alcohol abuse

boolean

C0038586 (UMLS CUI [1])

Psychosocial problem | Addictive Behavior

Item

psychosocial or addictive disorders

boolean

C0740697 (UMLS CUI [1])
C0085281 (UMLS CUI [2])

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Eligibility Ischemic Heart Disease NCT01847391