ID

14907

Beschreibung

Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older Adults: Interactions With Genotype and Proteome; ODM derived from: https://clinicaltrials.gov/show/NCT02379403

Link

https://clinicaltrials.gov/show/NCT02379403

Stichworte

Versionen (2)
  1. 06.05.16 06.05.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

6. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02379403

Englisch

Eligibility Cardiovascular Disease NCT02379403

1 Formulare  
Criteria
Beschreibung

Criteria

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

Eligibility Determination Checklist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C1707357
men and women between the ages 55-70 years
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
in good general health as determined by physical exam and normal ranges obtained during screening
Beschreibung

General health good Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0031809
post-menopausal women (no menses within 12 months)
Beschreibung

Postmenopausal state | Menstruation

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0025344
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)
Beschreibung

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

Datentyp

boolean

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

Hyperlipidemia Normal | Hyperlipidemia Mild | Total cholesterol | Low-Density Lipoproteins | Triglycerides | High Density Lipoproteins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0020473
UMLS CUI [2,2]
C2945599
UMLS CUI [3]
C0543421
UMLS CUI [4]
C0023823
UMLS CUI [5]
C0041004
UMLS CUI [6]
C0023821
bmi between 18.5 to 25kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
willing and ability to sign consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
willing to make time commitment for study
Beschreibung

Time commitment Study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0870312
UMLS CUI [1,3]
C2603343
individuals who are fluent in english
Beschreibung

Able to speak fluently English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
progressive or unstable known disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders
Beschreibung

Progressive Disease | Disease Unstable status | Cardiovascular Diseases | Lung diseases | Gastrointestinal Diseases | CNS disorder | Mental disorders | Endocrine System Diseases | Hematological Disease | Kidney Diseases | Immune System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0007682
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0022658
UMLS CUI [11]
C0021053
known acute and chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematous, hepatitis)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0019158
elevated c-reactive protein level (> 3.0mg/l)
Beschreibung

Elevated C-reactive protein level

Datentyp

boolean

Alias
UMLS CUI [1]
C4023452
current (or within the last 3 months) smoking of any tobacco products, i.e., cigarettes, pipe
Beschreibung

Smoking

Datentyp

boolean

Alias
UMLS CUI [1]
C0037369
abnormal complete metabolic panel (cmp), complete blood count (cbc), cholesterol panel, thyroid stimulating hormone (tsh), erythrocyte sedimentation rate (esr) --
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0519825
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0009555
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0008377
UMLS CUI [3,2]
C0205161
UMLS CUI [4,1]
C0202230
UMLS CUI [4,2]
C0205161
UMLS CUI [5]
C0438217
(laboratory values outside of acceptable reference range for older adults if determined to
Beschreibung

Laboratory Results abnormal | older adults

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0001792
be clinically significant)
Beschreibung

Laboratory Test Result Clinically Significant

Datentyp

boolean

Alias
UMLS CUI [1]
C2826633
indications of current or within last 3 years substance or alcohol abuse
Beschreibung

Indication Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0038586
alcohol consumption > 1 drink/day, i.e., 1 bottle of beer, half glass of wine, 1 shot hard liquor
Beschreibung

Alcohol consumption | Beer | Wine | Hard liquor intake

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0004922
UMLS CUI [3]
C0043188
UMLS CUI [4]
C0559433
known sensitivity or allergy to tart cherry or aroniaberry
Beschreibung

Hypersensitivity Cherry cake | Hypersensitivity Aronia Berries

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0452601
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1215581
UMLS CUI [2,3]
C0005135
currently on cholesterol-lowering, anti-hypertensive, thyroid, steroid or hormonal medications
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0003277
UMLS CUI [2]
C0003364
UMLS CUI [3]
C0279175
UMLS CUI [4]
C0260264
UMLS CUI [5]
C0019928
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.
Beschreibung

Continuous use of drugs | Vitamins | oral supplement | Drugs, Non-Prescription | Aspirin or aspirin-containing product | Anti-Inflammatory Agents, Non-Steroidal | Motrin | Advil | Aleve

Datentyp

boolean

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

Eligibility Cardiovascular Disease NCT02379403

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
Hyperlipidemia Normal | Hyperlipidemia Mild | Total cholesterol | Low-Density Lipoproteins | Triglycerides | High Density Lipoproteins
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])
Item Group
C0680251 (UMLS CUI)
Progressive Disease | Disease Unstable status | Cardiovascular Diseases | Lung diseases | Gastrointestinal Diseases | CNS disorder | Mental disorders | Endocrine System Diseases | Hematological Disease | Kidney Diseases | Immune System Diseases
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])
C0019928 (UMLS CUI [5])
Continuous use of drugs | Vitamins | oral supplement | Drugs, Non-Prescription | Aspirin or aspirin-containing product | Anti-Inflammatory Agents, Non-Steroidal | Motrin | Advil | Aleve
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])
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