ID

27615

Descripción

Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00942656

Link

https://clinicaltrials.gov/show/NCT00942656

Palabras clave

Versiones (1)
  1. 22/11/17 22/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de noviembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00942656

Inglés

Eligibility Cardiovascular Disease NCT00942656

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi between 20 and 38 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
age 25 to 65 years during the intervention
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
fasting glucose < 126 mg/dl
Descripción

Glucose measurement, fasting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202045
blood pressure < 160/100 mm hg (controlled with certain medications)
Descripción

Blood Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005823
total plasma cholesterol < 280 mg/dl
Descripción

Plasma total cholesterol level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272107
fasting triglycerides < 300 mg/dl
Descripción

Serum fasting triglyceride measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0582824
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
Descripción

Pharmaceutical Preparations prescribed Changing Lipid Metabolism | OTC Drugs Changing Lipid Metabolism | Supplement Changing Lipid Metabolism

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0598783
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0598783
UMLS CUI [3,1]
C2348609
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0598783
history or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
Descripción

Kidney Diseases | Liver diseases | Gout | Malignant Neoplasms | Thyroid Diseases | Gastrointestinal Diseases | Metabolic Diseases | Malabsorption Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0040128
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0024523
type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
Descripción

Non-Insulin-Dependent Diabetes Mellitus Requirement Antidiabetics Oral | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0935929
UMLS CUI [1,4]
C1527415
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
Descripción

Eating Disorders Inconsistent Dietary intervention | Dietary Patterns Inconsistent Dietary intervention | Vegetarian | Very low fat diet | Increased protein diet

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013473
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0086153
UMLS CUI [2,1]
C0449774
UMLS CUI [2,2]
C0012155
UMLS CUI [2,3]
C0442809
UMLS CUI [2,4]
C0086153
UMLS CUI [3]
C0042441
UMLS CUI [4]
C0452296
UMLS CUI [5]
C0425403
women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.
Descripción

Gender | Birth | Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0005615
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0032992
UMLS CUI [5]
C0006147
volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
Descripción

Exercise Severe | Exercise Program Initiation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C3484370
UMLS CUI [2,3]
C1704686
volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months.
Descripción

Percentage weight loss | Weight Reduction Program Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424661
UMLS CUI [2,1]
C3179079
UMLS CUI [2,2]
C1301732
use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
Descripción

Anti-Obesity Agents prescribed | Anti-Obesity Agents OTC Drugs | Phenylpropanolamine | Ephedrine | Caffeine | Obesity surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376607
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0376607
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0031495
UMLS CUI [4]
C0014479
UMLS CUI [5]
C0006644
UMLS CUI [6]
C1167841
active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
Descripción

Cardiovascular Diseases | Myocardial Infarction | Procedure on heart | Participation Cardiac rehabilitation | Cerebrovascular accident | Transient Ischemic Attack | Therapeutic procedure Transient Ischemic Attack | Pulmonary Embolism

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1279986
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C0700431
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0007787
UMLS CUI [8]
C0034065
smokers or other tobacco users (during the 6 months prior to the start of the study).
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
unable or unwilling to give informed consent or communicate with study staff.
Descripción

Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2364293
UMLS CUI [3,3]
C0035173
self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion).
Descripción

Substance Use Disorders | Therapeutic procedure Substance Use Disorders | Rehabilitation program Substance Use Disorders | Exception Participation Long-term Alcoholics Anonymous

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0038586
UMLS CUI [3,1]
C0034991
UMLS CUI [3,2]
C0038586
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0679823
UMLS CUI [4,3]
C0443252
UMLS CUI [4,4]
C0001972
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
Descripción

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental disorders Interfere with Study Subject Participation Status | Mental disorders Interfere with Protocol Compliance | Behavior Disorders Interfere with Study Subject Participation Status | Behavior Disorders Interfere with Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0004930
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C0004930
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
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Similar models

Eligibility Cardiovascular Disease NCT00942656

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi between 20 and 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age 25 to 65 years during the intervention
boolean
C0001779 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose < 126 mg/dl
boolean
C0202045 (UMLS CUI [1])
Blood Pressure
Item
blood pressure < 160/100 mm hg (controlled with certain medications)
boolean
C0005823 (UMLS CUI [1])
Plasma total cholesterol level
Item
total plasma cholesterol < 280 mg/dl
boolean
C1272107 (UMLS CUI [1])
Serum fasting triglyceride measurement
Item
fasting triglycerides < 300 mg/dl
boolean
C0582824 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations prescribed Changing Lipid Metabolism | OTC Drugs Changing Lipid Metabolism | Supplement Changing Lipid Metabolism
Item
use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
boolean
C0013227 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0598783 (UMLS CUI [1,4])
C0013231 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C2348609 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0598783 (UMLS CUI [3,3])
Kidney Diseases | Liver diseases | Gout | Malignant Neoplasms | Thyroid Diseases | Gastrointestinal Diseases | Metabolic Diseases | Malabsorption Syndrome
Item
history or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0040128 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0025517 (UMLS CUI [7])
C0024523 (UMLS CUI [8])
Non-Insulin-Dependent Diabetes Mellitus Requirement Antidiabetics Oral | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin
Item
type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
boolean
C0011860 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0935929 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
C0011860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Eating Disorders Inconsistent Dietary intervention | Dietary Patterns Inconsistent Dietary intervention | Vegetarian | Very low fat diet | Increased protein diet
Item
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
boolean
C0013473 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0086153 (UMLS CUI [1,3])
C0449774 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C0442809 (UMLS CUI [2,3])
C0086153 (UMLS CUI [2,4])
C0042441 (UMLS CUI [3])
C0452296 (UMLS CUI [4])
C0425403 (UMLS CUI [5])
Gender | Birth | Pregnancy | Pregnancy, Planned | Breast Feeding
Item
women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.
boolean
C0079399 (UMLS CUI [1])
C0005615 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
Exercise Severe | Exercise Program Initiation
Item
volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
boolean
C0015259 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C3484370 (UMLS CUI [2,2])
C1704686 (UMLS CUI [2,3])
Percentage weight loss | Weight Reduction Program Planned
Item
volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months.
boolean
C0424661 (UMLS CUI [1])
C3179079 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Anti-Obesity Agents prescribed | Anti-Obesity Agents OTC Drugs | Phenylpropanolamine | Ephedrine | Caffeine | Obesity surgery
Item
use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
boolean
C0376607 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0376607 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0031495 (UMLS CUI [3])
C0014479 (UMLS CUI [4])
C0006644 (UMLS CUI [5])
C1167841 (UMLS CUI [6])
Cardiovascular Diseases | Myocardial Infarction | Procedure on heart | Participation Cardiac rehabilitation | Cerebrovascular accident | Transient Ischemic Attack | Therapeutic procedure Transient Ischemic Attack | Pulmonary Embolism
Item
active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1279986 (UMLS CUI [3])
C0679823 (UMLS CUI [4,1])
C0700431 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0007787 (UMLS CUI [7,2])
C0034065 (UMLS CUI [8])
Tobacco use
Item
smokers or other tobacco users (during the 6 months prior to the start of the study).
boolean
C0543414 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel
Item
unable or unwilling to give informed consent or communicate with study staff.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2364293 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
Substance Use Disorders | Therapeutic procedure Substance Use Disorders | Rehabilitation program Substance Use Disorders | Exception Participation Long-term Alcoholics Anonymous
Item
self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion).
boolean
C0038586 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0038586 (UMLS CUI [2,2])
C0034991 (UMLS CUI [3,1])
C0038586 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C0001972 (UMLS CUI [4,4])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental disorders Interfere with Study Subject Participation Status | Mental disorders Interfere with Protocol Compliance | Behavior Disorders Interfere with Study Subject Participation Status | Behavior Disorders Interfere with Protocol Compliance
Item
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0004930 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0004930 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
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