Eligibility Cardiovascular Disease NCT02379403

1 Formulários

StudyEvent: Eligibility
1. Eligibility Cardiovascular Disease NCT02379403

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Criteria

Item Group

Eligibility Determination Checklist

Item

an associate investigator will examine participants and determine their eligibility according to the inclusion and exclusion criteria as documented by the eligibility checklist.

boolean

C0013893 (UMLS CUI [1,1])
C1707357 (UMLS CUI [1,2])

Gender | Age

Item

men and women between the ages 55-70 years

boolean

C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

General health good Physical Examination

Item

in good general health as determined by physical exam and normal ranges obtained during screening

boolean

C1277245 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])

Postmenopausal state | Menstruation

Item

post-menopausal women (no menses within 12 months)

boolean

C0232970 (UMLS CUI [1])
C0025344 (UMLS CUI [2])

Normal blood pressure | Prehypertension | Systolic Pressure | Diastolic blood pressure

Item

normal or pre-hypertensive blood pressure (e.g., sbp less than or equal to 139 mmhg and dbp less than or equal to 89 mmhg)

boolean

C2712122 (UMLS CUI [1])
C1696708 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])

Item

normal or mild hyperlipidemia (e.g., tc less than or equal to 239, ldl less than or equal to159, triglycerides less than or equal to 199, hdl < 45 mg/dl)

boolean

C0020473 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0020473 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0543421 (UMLS CUI [3])
C0023823 (UMLS CUI [4])
C0041004 (UMLS CUI [5])
C0023821 (UMLS CUI [6])

Body mass index

Item

bmi between 18.5 to 25kg/m2

boolean

C1305855 (UMLS CUI [1])

Informed Consent

Item

willing and ability to sign consent

boolean

C0021430 (UMLS CUI [1])

Time commitment Study

Item

willing to make time commitment for study

boolean

C0040223 (UMLS CUI [1,1])
C0870312 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])

Able to speak fluently English Language

Item

individuals who are fluent in english

boolean

C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Item

progressive or unstable known disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders

boolean

C1335499 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0007682 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0022658 (UMLS CUI [10])
C0021053 (UMLS CUI [11])

Inflammatory disorder | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Hepatitis

Item

known acute and chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematous, hepatitis)

boolean

C1290884 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0019158 (UMLS CUI [4])

Elevated C-reactive protein level

Item

elevated c-reactive protein level (> 3.0mg/l)

boolean

C4023452 (UMLS CUI [1])

Smoking

Item

current (or within the last 3 months) smoking of any tobacco products, i.e., cigarettes, pipe

boolean

C0037369 (UMLS CUI [1])

Comprehensive metabolic panel abnormal | Complete Blood Count abnormal | Cholesterol abnormal | Thyroid stimulating hormone measurement abnormal | ESR abnormal

Item

abnormal complete metabolic panel (cmp), complete blood count (cbc), cholesterol panel, thyroid stimulating hormone (tsh), erythrocyte sedimentation rate (esr) --

boolean

C0519825 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0009555 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0008377 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0202230 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0438217 (UMLS CUI [5])

Laboratory Results abnormal | older adults

Item

(laboratory values outside of acceptable reference range for older adults if determined to

boolean

C1254595 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0001792 (UMLS CUI [2])

Laboratory Test Result Clinically Significant

Item

be clinically significant)

boolean

C2826633 (UMLS CUI [1])

Indication Substance Use Disorders

Item

indications of current or within last 3 years substance or alcohol abuse

boolean

C3146298 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])

Alcohol consumption | Beer | Wine | Hard liquor intake

Item

alcohol consumption > 1 drink/day, i.e., 1 bottle of beer, half glass of wine, 1 shot hard liquor

boolean

C0001948 (UMLS CUI [1])
C0004922 (UMLS CUI [2])
C0043188 (UMLS CUI [3])
C0559433 (UMLS CUI [4])

Hypersensitivity Cherry cake | Hypersensitivity Aronia Berries

Item

known sensitivity or allergy to tart cherry or aroniaberry

boolean

C0020517 (UMLS CUI [1,1])
C0452601 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1215581 (UMLS CUI [2,2])
C0005135 (UMLS CUI [2,3])

Anticholesteremic Agents | Antihypertensive Agents | Thyroid preparations | Steroid drugs | Hormone preparation

Item

currently on cholesterol-lowering, anti-hypertensive, thyroid, steroid or hormonal medications

boolean

C0003277 (UMLS CUI [1])
C0003364 (UMLS CUI [2])
C0279175 (UMLS CUI [3])
C0260264 (UMLS CUI [4])
C0019932 (UMLS CUI [5])

Item

routine use of vitamins, supplements, or over the counter medications including aspirin, aspirin-containing products, non-steroidal anti-inflammatory drugs (nsaids), i.e., motrin, advil, aleve, unless they were discontinued 14 days prior to their first visit.

boolean

C1562611 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
C0351437 (UMLS CUI [3])
C0013231 (UMLS CUI [4])
C3843719 (UMLS CUI [5])
C0003211 (UMLS CUI [6])
C0699203 (UMLS CUI [7])
C0593507 (UMLS CUI [8])
C0718343 (UMLS CUI [9])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (2)

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

Eligibility Cardiovascular Disease NCT02379403