ID

33221

Beskrivning

Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00782015

Länk

https://clinicaltrials.gov/show/NCT00782015

Nyckelord

Versioner (1)
  1. 2018-12-02 2018-12-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 december 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Vascular Disease NCT00782015

Engelsk

Eligibility Vascular Disease NCT00782015

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable cad patients (men & postmenopausal women)
Beskrivning

Coronary Artery Disease Stable | Gender | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0232970
aged 20-80 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
weighing less than 115 kg (bmi range 18.5-35 kg/m2)
Beskrivning

Body Weight | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
with coronary artery disease defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
Beskrivning

Coronary Artery Disease | Lesion Coronary angiography | Myocardial Infarction | Stress Test Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0085532
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C3494508
UMLS CUI [4,2]
C1514241
subjects are eligible to participate after a stent procedure only after they have been stable for one month after the stent procedure.
Beskrivning

Stenting Status post Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0205360
all ethnic groups.
Beskrivning

Ethnic group All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0444868
languages: english
Beskrivning

English Language

Datatyp

boolean

Alias
UMLS CUI [1]
C0376245
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with heart failure are not eligible for participation in this study.
Beskrivning

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
history or known allergy to nuts of any kind
Beskrivning

Nut Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0577620
women with a positive urine beta hcg pregnancy test and lactating women or women who are planning to become pregnant.
Beskrivning

Urine pregnancy test Beta HCG positive | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0813152
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
Beskrivning

Consumption Nuts oz/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0028723
UMLS CUI [1,3]
C0556977
clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
Beskrivning

Illness Major | End stage cancer | Kidney Failure | Liver Failure | Gastrointestinal Diseases Impairing Absorption | Condition Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0741884
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0085605
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C0237442
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1548788
regular use of oral steroids
Beskrivning

Steroids Oral Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205272
cigarette smoking and/or nicotine replacement use
Beskrivning

Tobacco use | Nicotine Replacement Products

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C3179143
regular daily intake of ≥ 2 alcoholic drinks
Beskrivning

Alcohol consumption Drinks U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
illicit drug use
Beskrivning

Illicit medication use

Datatyp

boolean

Alias
UMLS CUI [1]
C0281875
history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Beskrivning

Psychological disease Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1658764
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
no dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
Beskrivning

Dietary Supplements Containing Phenolics | Plant Preparations | Berry preparation | Cranberry Capsule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0359916
UMLS CUI [2]
C0949854
UMLS CUI [3]
C3495134
UMLS CUI [4]
C1249096
treatment with an investigational new drug within the last 30 days.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
treatment with vitamin e, vitamin c, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment (subjects taking multivitamins or other forms of vitamin e and c in doses that do not exceed two times the rda will not be excluded).
Beskrivning

Vitamin E | Ascorbic Acid | Beta Carotene | Thioctic Acid | Dietary Supplements | Herbal Supplements

Datatyp

boolean

Alias
UMLS CUI [1]
C0042874
UMLS CUI [2]
C0003968
UMLS CUI [3]
C0053396
UMLS CUI [4]
C0023791
UMLS CUI [5]
C0242295
UMLS CUI [6]
C1504473
the following medications will be withheld in the morning of each ultrasound study visit as follows:
Beskrivning

Pharmaceutical Preparations Absent Ultrasonography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0041618
all vasoactive medications (nitrates, calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors, and other vasodilators). subjects will take their medications immediately after the ultrasound measurements are taken.
Beskrivning

Vasoactive agent | Nitrates | Calcium Channel Blockers | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Vasodilator Agents | Pharmaceutical Preparations Intake Post Ultrasonography

Datatyp

boolean

Alias
UMLS CUI [1]
C0597639
UMLS CUI [2]
C0028125
UMLS CUI [3]
C0006684
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0003015
UMLS CUI [6]
C0042402
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1512806
UMLS CUI [7,3]
C0687676
UMLS CUI [7,4]
C0041618
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Similar models

Eligibility Vascular Disease NCT00782015

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Coronary Artery Disease Stable | Gender | Postmenopausal state
Item
stable cad patients (men & postmenopausal women)
boolean
C1956346 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Age
Item
aged 20-80 years
boolean
C0001779 (UMLS CUI [1])
Body Weight | Body mass index
Item
weighing less than 115 kg (bmi range 18.5-35 kg/m2)
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Coronary Artery Disease | Lesion Coronary angiography | Myocardial Infarction | Stress Test Positive
Item
with coronary artery disease defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
boolean
C1956346 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0085532 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C3494508 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Stenting Status post Stable
Item
subjects are eligible to participate after a stent procedure only after they have been stable for one month after the stent procedure.
boolean
C2348535 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Ethnic group All
Item
all ethnic groups.
boolean
C0015031 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
English Language
Item
languages: english
boolean
C0376245 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart failure
Item
subjects with heart failure are not eligible for participation in this study.
boolean
C0018801 (UMLS CUI [1])
Nut Hypersensitivity
Item
history or known allergy to nuts of any kind
boolean
C0577620 (UMLS CUI [1])
Urine pregnancy test Beta HCG positive | Breast Feeding | Pregnancy, Planned
Item
women with a positive urine beta hcg pregnancy test and lactating women or women who are planning to become pregnant.
boolean
C0430056 (UMLS CUI [1,1])
C0813152 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Consumption Nuts oz/week
Item
regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
boolean
C0009830 (UMLS CUI [1,1])
C0028723 (UMLS CUI [1,2])
C0556977 (UMLS CUI [1,3])
Illness Major | End stage cancer | Kidney Failure | Liver Failure | Gastrointestinal Diseases Impairing Absorption | Condition Study Subject Participation Status Inappropriate
Item
clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0741884 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0085605 (UMLS CUI [4])
C0017178 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
Steroids Oral Regular
Item
regular use of oral steroids
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Tobacco use | Nicotine Replacement Products
Item
cigarette smoking and/or nicotine replacement use
boolean
C0543414 (UMLS CUI [1])
C3179143 (UMLS CUI [2])
Alcohol consumption Drinks U/day
Item
regular daily intake of ≥ 2 alcoholic drinks
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Illicit medication use
Item
illicit drug use
boolean
C0281875 (UMLS CUI [1])
Psychological disease Interferes with Comprehension Study Protocol | Mental condition Interferes with Comprehension Study Protocol
Item
history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
boolean
C1658764 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Dietary Supplements Containing Phenolics | Plant Preparations | Berry preparation | Cranberry Capsule
Item
no dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
boolean
C0242295 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0359916 (UMLS CUI [1,3])
C0949854 (UMLS CUI [2])
C3495134 (UMLS CUI [3])
C1249096 (UMLS CUI [4])
Investigational New Drugs
Item
treatment with an investigational new drug within the last 30 days.
boolean
C0013230 (UMLS CUI [1])
Vitamin E | Ascorbic Acid | Beta Carotene | Thioctic Acid | Dietary Supplements | Herbal Supplements
Item
treatment with vitamin e, vitamin c, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment (subjects taking multivitamins or other forms of vitamin e and c in doses that do not exceed two times the rda will not be excluded).
boolean
C0042874 (UMLS CUI [1])
C0003968 (UMLS CUI [2])
C0053396 (UMLS CUI [3])
C0023791 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C1504473 (UMLS CUI [6])
Pharmaceutical Preparations Absent Ultrasonography
Item
the following medications will be withheld in the morning of each ultrasound study visit as follows:
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Vasoactive agent | Nitrates | Calcium Channel Blockers | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Vasodilator Agents | Pharmaceutical Preparations Intake Post Ultrasonography
Item
all vasoactive medications (nitrates, calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors, and other vasodilators). subjects will take their medications immediately after the ultrasound measurements are taken.
boolean
C0597639 (UMLS CUI [1])
C0028125 (UMLS CUI [2])
C0006684 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0003015 (UMLS CUI [5])
C0042402 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C1512806 (UMLS CUI [7,2])
C0687676 (UMLS CUI [7,3])
C0041618 (UMLS CUI [7,4])
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