ID

27699

Description

Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women; ODM derived from: https://clinicaltrials.gov/show/NCT01293344

Link

https://clinicaltrials.gov/show/NCT01293344

Keywords

Versions (1)
  1. 11/26/17 11/26/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Diseases NCT01293344

English

Eligibility Cardiovascular Diseases NCT01293344

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and premenopausal women from de quebec city metropolitan area.
Description

Gender | Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232969
slightly elevated ldl-cholesterol concentrations (3.4-4.9 mm) or total cholesterol to hdl-c ratio ≥ 5.0
Description

Low density lipoprotein increased Slightly | serum total cholesterol/high-density lipoprotein ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0549399
UMLS CUI [1,2]
C0750482
UMLS CUI [2]
C2021346
at least one of the four following factors of the metabolic syndrome: 1) waist circumference > 94 cm in men and > 80 cm in women; 2) tg > 1.7 mmol/l; 3) fasting glycemia between 6.1 and 6.9 mmol/l and 4) blood pressure concentrations ≥ 130 / 85 mm hg.
Description

Metabolic Syndrome Factor Quantity | Waist Circumference | Gender | Triglycerides measurement | Glucose measurement, fasting | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0524620
UMLS CUI [1,2]
C1521761
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0202236
UMLS CUI [5]
C0202045
UMLS CUI [6]
C0005824
age: between 25 to 50 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
in women, a regular menstrual cycle for the last 3 months
Description

Menstrual cycle Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0025329
UMLS CUI [1,2]
C0205272
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
Description

Endocrine System Diseases | Cardiovascular event | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Pharmaceutical Preparations Affecting Variables Dependent | Hypolipidemic Agents | Hypoglycemic Agents | Thiazolidinediones | Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C1320716
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0011860
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0439828
UMLS CUI [5,4]
C0851827
UMLS CUI [6]
C0086440
UMLS CUI [7]
C0020616
UMLS CUI [8]
C1257987
UMLS CUI [9]
C0003364
smokers
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
subjects with history of alcoholism
Description

Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0001973
subjects with food allergies or food aversion that could impede compliance to the mediterranean diet
Description

Food Allergy | Food aversion Preventing Mediterranean Diet

Data type

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2,1]
C0877173
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1138412
pregnant women and those using systemic hormonal contraceptives
Description

Pregnancy | Gender HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3653707
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Similar models

Eligibility Cardiovascular Diseases NCT01293344

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Premenopausal state
Item
men and premenopausal women from de quebec city metropolitan area.
boolean
C0079399 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
Low density lipoprotein increased Slightly | serum total cholesterol/high-density lipoprotein ratio
Item
slightly elevated ldl-cholesterol concentrations (3.4-4.9 mm) or total cholesterol to hdl-c ratio ≥ 5.0
boolean
C0549399 (UMLS CUI [1,1])
C0750482 (UMLS CUI [1,2])
C2021346 (UMLS CUI [2])
Metabolic Syndrome Factor Quantity | Waist Circumference | Gender | Triglycerides measurement | Glucose measurement, fasting | Blood pressure determination
Item
at least one of the four following factors of the metabolic syndrome: 1) waist circumference > 94 cm in men and > 80 cm in women; 2) tg > 1.7 mmol/l; 3) fasting glycemia between 6.1 and 6.9 mmol/l and 4) blood pressure concentrations ≥ 130 / 85 mm hg.
boolean
C0524620 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0202236 (UMLS CUI [4])
C0202045 (UMLS CUI [5])
C0005824 (UMLS CUI [6])
Age
Item
age: between 25 to 50 years
boolean
C0001779 (UMLS CUI [1])
Stable body weight
Item
stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
boolean
C0517386 (UMLS CUI [1])
Menstrual cycle Regular
Item
in women, a regular menstrual cycle for the last 3 months
boolean
C0025329 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Endocrine System Diseases | Cardiovascular event | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Pharmaceutical Preparations Affecting Variables Dependent | Hypolipidemic Agents | Hypoglycemic Agents | Thiazolidinediones | Antihypertensive Agents
Item
subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
boolean
C0014130 (UMLS CUI [1])
C1320716 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0439828 (UMLS CUI [5,3])
C0851827 (UMLS CUI [5,4])
C0086440 (UMLS CUI [6])
C0020616 (UMLS CUI [7])
C1257987 (UMLS CUI [8])
C0003364 (UMLS CUI [9])
Tobacco use
Item
smokers
boolean
C0543414 (UMLS CUI [1])
Alcoholic Intoxication, Chronic
Item
subjects with history of alcoholism
boolean
C0001973 (UMLS CUI [1])
Food Allergy | Food aversion Preventing Mediterranean Diet
Item
subjects with food allergies or food aversion that could impede compliance to the mediterranean diet
boolean
C0016470 (UMLS CUI [1])
C0877173 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1138412 (UMLS CUI [2,3])
Pregnancy | Gender HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
Item
pregnant women and those using systemic hormonal contraceptives
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3653707 (UMLS CUI [2,2])
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