0 Ratings
ID

44171

Description

Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01672840

Link

https://clinicaltrials.gov/show/NCT01672840

Keywords

Versions (2)
  1. 3/12/20 3/12/20 -
  2. 9/20/21 9/20/21 -
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See clinicaltrials.gov

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September 20, 2021

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License

Creative Commons BY 4.0
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    Eligibility Hypertension NCT01672840

    English

    Eligibility Hypertension NCT01672840

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    men and women age 18-75 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    stage 1 hypertension (i.e. 140-159/90-99 mmhg) without anti-hypertensive medication or with only one anti-hypertensive medicaion
    Description

    Hypertensive disease Stage | Blood pressure determination | Antihypertensive Agents Absent | Antihypertensive Agents Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020538
    UMLS CUI [1,2]
    C0699749
    UMLS CUI [2]
    C0005824
    UMLS CUI [3,1]
    C0003364
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0003364
    UMLS CUI [4,2]
    C1265611
    body mass index < 35 kg/m²
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    willing to discontinue the use of chocolate/cocoa products at least 4 weeks prior to intervention.
    Description

    Intake Chocolate Discontinue | Intake Cocoa Discontinue

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C0008299
    UMLS CUI [1,3]
    C1444662
    UMLS CUI [2,1]
    C1512806
    UMLS CUI [2,2]
    C4521844
    UMLS CUI [2,3]
    C1444662
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    anticipated inability to complete or comply with study protocol
    Description

    Completion of clinical trial Unable | Protocol Compliance Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2732579
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C1299582
    use of lipid-lowering or aspirin unless stable on medication for at least 1 month and willing to refrain from taking medication for 12 hours prior to endothelial function scanning
    Description

    Hypolipidemic Agents | Aspirin | Exception Medication Stable | Exception Medication Discontinuation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0086440
    UMLS CUI [2]
    C0004057
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0013227
    UMLS CUI [3,3]
    C0205360
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0013227
    UMLS CUI [4,3]
    C1444662
    severe hypertension (systolic blood pressure >160mmhg or diastolic blood pressure >100 mmhg), or use more than one anti-hypertensive medications
    Description

    Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4013784
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    UMLS CUI [4,1]
    C0003364
    UMLS CUI [4,2]
    C1265611
    allergic to cocoa products (chocolate or cocoa powder)
    Description

    Hypersensitivity Cocoa | Hypersensitivity Chocolate | Hypersensitivity Cocoa Powder

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C4521844
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0008299
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0009209
    regular use of vitamin c, vitamin e, fish oil, flax seed oil, omega-3 fatty acids, coenzyme q10, fiber supplements, garlic pills, arginine, red yeast rice, and/or any kind of antioxidant and unwilling to discontinue supplementation for at least 4 weeks prior to study initiation and for the study duration. use of a multi-vitamin containing no more than two times the recommended daily allowance for vitamins c and e is permissible
    Description

    Ascorbic Acid Regular | Vitamin E Regular | Fish Oil Regular | Flax Seed Oil Regular | Omega-3 Fatty Acids Regular | Coenzyme Q10 Regular | Fiber Supplements Regular | Garlic Pills Regular | Arginine Regular | Red yeast rice Regular | Antioxidants Regular | Supplementation Discontinue Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003968
    UMLS CUI [1,2]
    C0205272
    UMLS CUI [2,1]
    C0042874
    UMLS CUI [2,2]
    C0205272
    UMLS CUI [3,1]
    C0016157
    UMLS CUI [3,2]
    C0205272
    UMLS CUI [4,1]
    C1170277
    UMLS CUI [4,2]
    C0205272
    UMLS CUI [5,1]
    C0015689
    UMLS CUI [5,2]
    C0205272
    UMLS CUI [6,1]
    C0041536
    UMLS CUI [6,2]
    C0205272
    UMLS CUI [7,1]
    C0012173
    UMLS CUI [7,2]
    C0242295
    UMLS CUI [7,3]
    C0205272
    UMLS CUI [8,1]
    C0993630
    UMLS CUI [8,2]
    C0994475
    UMLS CUI [8,3]
    C0205272
    UMLS CUI [9,1]
    C0003765
    UMLS CUI [9,2]
    C0205272
    UMLS CUI [10,1]
    C0763533
    UMLS CUI [10,2]
    C0205272
    UMLS CUI [11,1]
    C0003402
    UMLS CUI [11,2]
    C0205272
    UMLS CUI [12,1]
    C0242297
    UMLS CUI [12,2]
    C1444662
    UMLS CUI [12,3]
    C0558080
    diagnosed eating disorder
    Description

    Eating Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013473
    on any specific diet, weight control diet, and/or vegan diet
    Description

    Diet Specific | Diet Weight Control | Vegan diet

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012155
    UMLS CUI [1,2]
    C0205369
    UMLS CUI [2,1]
    C0012155
    UMLS CUI [2,2]
    C0005910
    UMLS CUI [2,3]
    C2587213
    UMLS CUI [3]
    C0344353
    substance abuse (chronic alcoholism and/or other chemical dependency)
    Description

    Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0001973
    UMLS CUI [3]
    C0038580
    any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, aids, tuberculosis, psychotic disorder)
    Description

    Medical condition Unstable | Ability Limited Completion of clinical trial | Malignant Neoplasms | AIDS | Tuberculosis | Psychotic Disorder

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [2,1]
    C0085732
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C2732579
    UMLS CUI [3]
    C0006826
    UMLS CUI [4]
    C0001175
    UMLS CUI [5]
    C0041296
    UMLS CUI [6]
    C0033975
    current or impending pregnancy. in premenopausal women, pregnancy will be excluded by pregnancy test at the time of each study visit.
    Description

    Pregnancy | Pregnancy Impending | Premenopausal state Pregnancy Test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0332190
    UMLS CUI [3,1]
    C0232969
    UMLS CUI [3,2]
    C0032976
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    Similar models

    Eligibility Hypertension NCT01672840

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    men and women age 18-75 years
    boolean
    C0001779 (UMLS CUI [1])
    Hypertensive disease Stage | Blood pressure determination | Antihypertensive Agents Absent | Antihypertensive Agents Quantity
    Item
    stage 1 hypertension (i.e. 140-159/90-99 mmhg) without anti-hypertensive medication or with only one anti-hypertensive medicaion
    boolean
    C0020538 (UMLS CUI [1,1])
    C0699749 (UMLS CUI [1,2])
    C0005824 (UMLS CUI [2])
    C0003364 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0003364 (UMLS CUI [4,1])
    C1265611 (UMLS CUI [4,2])
    Body mass index
    Item
    body mass index < 35 kg/m²
    boolean
    C1305855 (UMLS CUI [1])
    Intake Chocolate Discontinue | Intake Cocoa Discontinue
    Item
    willing to discontinue the use of chocolate/cocoa products at least 4 weeks prior to intervention.
    boolean
    C1512806 (UMLS CUI [1,1])
    C0008299 (UMLS CUI [1,2])
    C1444662 (UMLS CUI [1,3])
    C1512806 (UMLS CUI [2,1])
    C4521844 (UMLS CUI [2,2])
    C1444662 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Completion of clinical trial Unable | Protocol Compliance Unable
    Item
    anticipated inability to complete or comply with study protocol
    boolean
    C2732579 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
    Hypolipidemic Agents | Aspirin | Exception Medication Stable | Exception Medication Discontinuation
    Item
    use of lipid-lowering or aspirin unless stable on medication for at least 1 month and willing to refrain from taking medication for 12 hours prior to endothelial function scanning
    boolean
    C0086440 (UMLS CUI [1])
    C0004057 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0013227 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0013227 (UMLS CUI [4,2])
    C1444662 (UMLS CUI [4,3])
    Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity
    Item
    severe hypertension (systolic blood pressure >160mmhg or diastolic blood pressure >100 mmhg), or use more than one anti-hypertensive medications
    boolean
    C4013784 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    C0003364 (UMLS CUI [4,1])
    C1265611 (UMLS CUI [4,2])
    Hypersensitivity Cocoa | Hypersensitivity Chocolate | Hypersensitivity Cocoa Powder
    Item
    allergic to cocoa products (chocolate or cocoa powder)
    boolean
    C0020517 (UMLS CUI [1,1])
    C4521844 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0008299 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0009209 (UMLS CUI [3,2])
    Ascorbic Acid Regular | Vitamin E Regular | Fish Oil Regular | Flax Seed Oil Regular | Omega-3 Fatty Acids Regular | Coenzyme Q10 Regular | Fiber Supplements Regular | Garlic Pills Regular | Arginine Regular | Red yeast rice Regular | Antioxidants Regular | Supplementation Discontinue Unwilling
    Item
    regular use of vitamin c, vitamin e, fish oil, flax seed oil, omega-3 fatty acids, coenzyme q10, fiber supplements, garlic pills, arginine, red yeast rice, and/or any kind of antioxidant and unwilling to discontinue supplementation for at least 4 weeks prior to study initiation and for the study duration. use of a multi-vitamin containing no more than two times the recommended daily allowance for vitamins c and e is permissible
    boolean
    C0003968 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    C0042874 (UMLS CUI [2,1])
    C0205272 (UMLS CUI [2,2])
    C0016157 (UMLS CUI [3,1])
    C0205272 (UMLS CUI [3,2])
    C1170277 (UMLS CUI [4,1])
    C0205272 (UMLS CUI [4,2])
    C0015689 (UMLS CUI [5,1])
    C0205272 (UMLS CUI [5,2])
    C0041536 (UMLS CUI [6,1])
    C0205272 (UMLS CUI [6,2])
    C0012173 (UMLS CUI [7,1])
    C0242295 (UMLS CUI [7,2])
    C0205272 (UMLS CUI [7,3])
    C0993630 (UMLS CUI [8,1])
    C0994475 (UMLS CUI [8,2])
    C0205272 (UMLS CUI [8,3])
    C0003765 (UMLS CUI [9,1])
    C0205272 (UMLS CUI [9,2])
    C0763533 (UMLS CUI [10,1])
    C0205272 (UMLS CUI [10,2])
    C0003402 (UMLS CUI [11,1])
    C0205272 (UMLS CUI [11,2])
    C0242297 (UMLS CUI [12,1])
    C1444662 (UMLS CUI [12,2])
    C0558080 (UMLS CUI [12,3])
    Eating Disorder
    Item
    diagnosed eating disorder
    boolean
    C0013473 (UMLS CUI [1])
    Diet Specific | Diet Weight Control | Vegan diet
    Item
    on any specific diet, weight control diet, and/or vegan diet
    boolean
    C0012155 (UMLS CUI [1,1])
    C0205369 (UMLS CUI [1,2])
    C0012155 (UMLS CUI [2,1])
    C0005910 (UMLS CUI [2,2])
    C2587213 (UMLS CUI [2,3])
    C0344353 (UMLS CUI [3])
    Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence
    Item
    substance abuse (chronic alcoholism and/or other chemical dependency)
    boolean
    C0038586 (UMLS CUI [1])
    C0001973 (UMLS CUI [2])
    C0038580 (UMLS CUI [3])
    Medical condition Unstable | Ability Limited Completion of clinical trial | Malignant Neoplasms | AIDS | Tuberculosis | Psychotic Disorder
    Item
    any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, aids, tuberculosis, psychotic disorder)
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C2732579 (UMLS CUI [2,3])
    C0006826 (UMLS CUI [3])
    C0001175 (UMLS CUI [4])
    C0041296 (UMLS CUI [5])
    C0033975 (UMLS CUI [6])
    Pregnancy | Pregnancy Impending | Premenopausal state Pregnancy Test
    Item
    current or impending pregnancy. in premenopausal women, pregnancy will be excluded by pregnancy test at the time of each study visit.
    boolean
    C0032961 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C0332190 (UMLS CUI [2,2])
    C0232969 (UMLS CUI [3,1])
    C0032976 (UMLS CUI [3,2])
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