ID

27513

Beskrivning

The Purple Grape Juice Study; ODM derived from: https://clinicaltrials.gov/show/NCT00551746

Länk

https://clinicaltrials.gov/show/NCT00551746

Nyckelord

Versioner (1)
  1. 2017-11-19 2017-11-19 -
Rättsinnehavare

See clinicaqltrials.gov

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19 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Cardiovascular Disease NCT00551746

Engelsk

Eligibility Cardiovascular Disease NCT00551746

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the volunteer (male or non-pregnant female, any ethnicity) must be > 18 years of age.
Beskrivning

Age | Pregnancy Absent | Ethnicity Any

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
2. the volunteer has no history of a physician diagnosis of atherosclerosis such as carotid, peripheral, or coronary artery disease (cad).
Beskrivning

Atherosclerosis Absent | Carotid Artery Disease Absent | Peripheral Arterial Disease Absent | Coronary Artery Disease Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004153
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007273
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1704436
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0332197
3. the volunteer has no history of a physician diagnosis of pulmonary embolism (pe), mi, or stroke.
Beskrivning

Pulmonary Embolism Absent | Myocardial Infarction Absent | Cerebrovascular accident Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0038454
UMLS CUI [3,2]
C0332197
4. the volunteer must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a diagnosis if diabetes mellitus.
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
2. the limitations for specific medications, supplements and food items are exceeded as follows:
Beskrivning

Pharmaceutical Preparations Limitation ignored | Supplements Limitation ignored | Food Limitation ignored

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0449295
UMLS CUI [1,3]
C1554079
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0449295
UMLS CUI [2,3]
C1554079
UMLS CUI [3,1]
C0016452
UMLS CUI [3,2]
C0449295
UMLS CUI [3,3]
C1554079
more than 1 normal dose of the following medications and/or supplements once a week during the 3 months prior to enrollment:
Beskrivning

Pharmaceutical Preparations Dose Quantity Frequency | Supplements Dose Quantity Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439603
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0439603
aspirin • ibuprofen • fish-oil extracts
Beskrivning

Aspirin | Ibuprofen | Fish oil Extract

Datatyp

boolean

Alias
UMLS CUI [1]
C0004057
UMLS CUI [2]
C0020740
UMLS CUI [3,1]
C0556145
UMLS CUI [3,2]
C1705851
antioxidants • vitamins
Beskrivning

Antioxidants | Vitamins

Datatyp

boolean

Alias
UMLS CUI [1]
C0003402
UMLS CUI [2]
C0042890
more than 1 normal serving per week in the 3 months prior to enrollment:
Beskrivning

Serving Normal Quantity Weekly

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519269
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332174
other grape juices • tea • wine
Beskrivning

Grape juice | Tea | Wine

Datatyp

boolean

Alias
UMLS CUI [1]
C0452455
UMLS CUI [2]
C0039400
UMLS CUI [3]
C0043188
beer • alcoholic drinks • grapes
Beskrivning

Beer | Alcoholic drinks | Grapes

Datatyp

boolean

Alias
UMLS CUI [1]
C0004922
UMLS CUI [2]
C0001967
UMLS CUI [3]
C0018208
more than 5 servings per day in any combination in the 7 days (1 weeks prior to enrollment:
Beskrivning

Serving Combination Quantity per day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519269
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
non-grape juices • garlic • broccoli
Beskrivning

Juice Except for Grape juice | Garlic | Broccoli

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1268568
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0452455
UMLS CUI [2]
C0993630
UMLS CUI [3]
C0330499
apples • any type of berries • onions volunteer is pregnant or lactating at the time of enrollment.
Beskrivning

Apple | Berries Type Any | Onions

Datatyp

boolean

Alias
UMLS CUI [1]
C1095830
UMLS CUI [2,1]
C0005135
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
UMLS CUI [3]
C0029035
secondary exclusions:
Beskrivning

Exclusion Secondary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0175668
1. use of any of the above listed items during the 12 week course of study treatment will be documented and excess use 3 times or more will result in an administrative withdrawal of the volunteer from the study prior to the measurement of the next monthly platelet aggregation laboratory values (although those values will be measured for exploratory evaluation and the participant will remain under treatment until the end of the 12 week period).
Beskrivning

Use Excessive Resulting in Patient withdrawn from trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0422727
2. routine consumption of fruit juices, or of >5 servings per day of referenced fruits or vegetables, will result in administrative withdrawal of the participant from the study's primary aim.
Beskrivning

Fruit Juices Regular | Fruit Serving Quantity per day | Vegetables Serving Quantity per day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0452453
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0016767
UMLS CUI [2,2]
C1519269
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0439505
UMLS CUI [3,1]
C0042440
UMLS CUI [3,2]
C1519269
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0439505
3. although it is unlikely the use of pgj or look alike/ taste alike (placebo) beverage will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. women of child bearing potential, therefore, will meet a secondary exclusion if they become pregnant.
Beskrivning

POMEGRANATE JUICE | POMEGRANATE JUICE Similar

Datatyp

boolean

Alias
UMLS CUI [1]
C1327962
UMLS CUI [2,1]
C1327962
UMLS CUI [2,2]
C2348205
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Similar models

Eligibility Cardiovascular Disease NCT00551746

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy Absent | Ethnicity Any
Item
1. the volunteer (male or non-pregnant female, any ethnicity) must be > 18 years of age.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Atherosclerosis Absent | Carotid Artery Disease Absent | Peripheral Arterial Disease Absent | Coronary Artery Disease Absent
Item
2. the volunteer has no history of a physician diagnosis of atherosclerosis such as carotid, peripheral, or coronary artery disease (cad).
boolean
C0004153 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007273 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1704436 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Pulmonary Embolism Absent | Myocardial Infarction Absent | Cerebrovascular accident Absent
Item
3. the volunteer has no history of a physician diagnosis of pulmonary embolism (pe), mi, or stroke.
boolean
C0034065 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
4. the volunteer must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
1. a diagnosis if diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
Pharmaceutical Preparations Limitation ignored | Supplements Limitation ignored | Food Limitation ignored
Item
2. the limitations for specific medications, supplements and food items are exceeded as follows:
boolean
C0013227 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C1554079 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
C1554079 (UMLS CUI [2,3])
C0016452 (UMLS CUI [3,1])
C0449295 (UMLS CUI [3,2])
C1554079 (UMLS CUI [3,3])
Pharmaceutical Preparations Dose Quantity Frequency | Supplements Dose Quantity Frequency
Item
more than 1 normal dose of the following medications and/or supplements once a week during the 3 months prior to enrollment:
boolean
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,4])
C0242295 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439603 (UMLS CUI [2,4])
Aspirin | Ibuprofen | Fish oil Extract
Item
aspirin • ibuprofen • fish-oil extracts
boolean
C0004057 (UMLS CUI [1])
C0020740 (UMLS CUI [2])
C0556145 (UMLS CUI [3,1])
C1705851 (UMLS CUI [3,2])
Antioxidants | Vitamins
Item
antioxidants • vitamins
boolean
C0003402 (UMLS CUI [1])
C0042890 (UMLS CUI [2])
Serving Normal Quantity Weekly
Item
more than 1 normal serving per week in the 3 months prior to enrollment:
boolean
C1519269 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Grape juice | Tea | Wine
Item
other grape juices • tea • wine
boolean
C0452455 (UMLS CUI [1])
C0039400 (UMLS CUI [2])
C0043188 (UMLS CUI [3])
Beer | Alcoholic drinks | Grapes
Item
beer • alcoholic drinks • grapes
boolean
C0004922 (UMLS CUI [1])
C0001967 (UMLS CUI [2])
C0018208 (UMLS CUI [3])
Serving Combination Quantity per day
Item
more than 5 servings per day in any combination in the 7 days (1 weeks prior to enrollment:
boolean
C1519269 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Juice Except for Grape juice | Garlic | Broccoli
Item
non-grape juices • garlic • broccoli
boolean
C1268568 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0452455 (UMLS CUI [1,3])
C0993630 (UMLS CUI [2])
C0330499 (UMLS CUI [3])
Apple | Berries Type Any | Onions
Item
apples • any type of berries • onions volunteer is pregnant or lactating at the time of enrollment.
boolean
C1095830 (UMLS CUI [1])
C0005135 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0029035 (UMLS CUI [3])
Exclusion Secondary
Item
secondary exclusions:
boolean
C2828389 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
Use Excessive Resulting in Patient withdrawn from trial
Item
1. use of any of the above listed items during the 12 week course of study treatment will be documented and excess use 3 times or more will result in an administrative withdrawal of the volunteer from the study prior to the measurement of the next monthly platelet aggregation laboratory values (although those values will be measured for exploratory evaluation and the participant will remain under treatment until the end of the 12 week period).
boolean
C1524063 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,4])
Fruit Juices Regular | Fruit Serving Quantity per day | Vegetables Serving Quantity per day
Item
2. routine consumption of fruit juices, or of >5 servings per day of referenced fruits or vegetables, will result in administrative withdrawal of the participant from the study's primary aim.
boolean
C0452453 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0016767 (UMLS CUI [2,1])
C1519269 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
C0042440 (UMLS CUI [3,1])
C1519269 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0439505 (UMLS CUI [3,4])
POMEGRANATE JUICE | POMEGRANATE JUICE Similar
Item
3. although it is unlikely the use of pgj or look alike/ taste alike (placebo) beverage will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. women of child bearing potential, therefore, will meet a secondary exclusion if they become pregnant.
boolean
C1327962 (UMLS CUI [1])
C1327962 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
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