ID

44171

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01672840

Nyckelord

Versioner (2)
  1. 2020-03-12 2020-03-12 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT01672840

Engelsk

Eligibility Hypertension NCT01672840

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Body mass index

Datatyp

boolean

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

Intake Chocolate Discontinue | Intake Cocoa Discontinue

Datatyp

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
Beskrivning

Exclusion Criteria

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

Completion of clinical trial Unable | Protocol Compliance Unable

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

Hypersensitivity Cocoa | Hypersensitivity Chocolate | Hypersensitivity Cocoa Powder

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Eating Disorder

Datatyp

boolean

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

Diet Specific | Diet Weight Control | Vegan diet

Datatyp

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)
Beskrivning

Substance Use Disorders | Alcoholic Intoxication, Chronic | Substance Dependence

Datatyp

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)
Beskrivning

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

Datatyp

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.
Beskrivning

Pregnancy | Pregnancy Impending | Premenopausal state Pregnancy Test

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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