ID

28716

Description

Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01038362

Lien

https://clinicaltrials.gov/show/NCT01038362

Mots-clés

Versions (1)
  1. 27/01/2018 27/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 janvier 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Coronary Artery Disease NCT01038362

Anglais

Eligibility Coronary Artery Disease NCT01038362

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female subjects.
Description

Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
2. age range: 21-80 years old.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. weight less than 115 kg.
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
4. clinically defined coronary artery disease that is clinical stable and compensated with appropriate treatment. coronary disease (cvd) is defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
Description

Therapeutic procedure Coronary Artery Disease Stable | CVD | Lesion Coronary angiography | Myocardial Infarction | Stress Test Positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1956346
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0007222
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0085532
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C3494508
UMLS CUI [5,2]
C1514241
5. willingness to give written informed consent and willingness and ability to understand, to participate to and to comply with the study requirements.
Description

Informed Consent | Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of nut allergy.
Description

Nut Hypersensitivity

Type de données

boolean

Alias
UMLS CUI [1]
C0577620
2. pregnant or lactating women. pregnancy will be excluded by urine pregnancy test.
Description

Pregnancy | Breast Feeding | Urine pregnancy test

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430056
3. 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.
Description

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

Type de données

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]
C0021826
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1548788
4. treatment with an investigational new drug within the last 30 days.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
5. history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Description

Mental disorder Interferes with Comprehension Study Protocol | Condition Interferes with Comprehension Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C2348563
6. unwillingness to comply with the requirements of study including refraining from consumption of nuts and refraining from use of vitamin e, vitamin c, and beta carotene, lipoic acid, and/or other dietary or herbal supplements during the study.
Description

Protocol Compliance Unwilling | Avoidance Nuts | Avoidance Vitamin E | Avoidance Vitamin C | Avoidance Beta Carotene | Avoidance Lipoic Acid | Avoidance Dietary Supplements | Avoidance Herbal supplement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0028723
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0042874
UMLS CUI [4,1]
C0870186
UMLS CUI [4,2]
C0003968
UMLS CUI [5,1]
C0870186
UMLS CUI [5,2]
C0053396
UMLS CUI [6,1]
C0870186
UMLS CUI [6,2]
C0023791
UMLS CUI [7,1]
C0870186
UMLS CUI [7,2]
C0242295
UMLS CUI [8,1]
C0870186
UMLS CUI [8,2]
C1504473
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Similar models

Eligibility Coronary Artery Disease NCT01038362

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. male and female subjects.
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. age range: 21-80 years old.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
3. weight less than 115 kg.
boolean
C0005910 (UMLS CUI [1])
Therapeutic procedure Coronary Artery Disease Stable | CVD | Lesion Coronary angiography | Myocardial Infarction | Stress Test Positive
Item
4. clinically defined coronary artery disease that is clinical stable and compensated with appropriate treatment. coronary disease (cvd) is defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
boolean
C0087111 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0085532 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C3494508 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Informed Consent | Protocol Compliance
Item
5. willingness to give written informed consent and willingness and ability to understand, to participate to and to comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Nut Hypersensitivity
Item
1. history of nut allergy.
boolean
C0577620 (UMLS CUI [1])
Pregnancy | Breast Feeding | Urine pregnancy test
Item
2. pregnant or lactating women. pregnancy will be excluded by urine pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3])
Illness Major | End stage cancer | Kidney Failure | Liver Failure | Gastrointestinal Diseases Impairing Intestinal Absorption | Condition Study Subject Participation Status Inappropriate
Item
3. 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])
C0021826 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
Investigational New Drugs
Item
4. treatment with an investigational new drug within the last 30 days.
boolean
C0013230 (UMLS CUI [1])
Mental disorder Interferes with Comprehension Study Protocol | Condition Interferes with Comprehension Study Protocol
Item
5. history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Protocol Compliance Unwilling | Avoidance Nuts | Avoidance Vitamin E | Avoidance Vitamin C | Avoidance Beta Carotene | Avoidance Lipoic Acid | Avoidance Dietary Supplements | Avoidance Herbal supplement
Item
6. unwillingness to comply with the requirements of study including refraining from consumption of nuts and refraining from use of vitamin e, vitamin c, and beta carotene, lipoic acid, and/or other dietary or herbal supplements during the study.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C0028723 (UMLS CUI [2,2])
C0870186 (UMLS CUI [3,1])
C0042874 (UMLS CUI [3,2])
C0870186 (UMLS CUI [4,1])
C0003968 (UMLS CUI [4,2])
C0870186 (UMLS CUI [5,1])
C0053396 (UMLS CUI [5,2])
C0870186 (UMLS CUI [6,1])
C0023791 (UMLS CUI [6,2])
C0870186 (UMLS CUI [7,1])
C0242295 (UMLS CUI [7,2])
C0870186 (UMLS CUI [8,1])
C1504473 (UMLS CUI [8,2])
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