ID

35179

Descripción

Soybean Oil Trial of cArdiovascular Risk; ODM derived from: https://clinicaltrials.gov/show/NCT02404207

Link

https://clinicaltrials.gov/show/NCT02404207

Palabras clave

Versiones (1)
  1. 22/2/19 22/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de febrero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02404207

Inglés

Eligibility Cardiovascular Disease NCT02404207

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30 to 70 years at beginning of study
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ldl-cholesterol between 120 and 160 mg/dl
Descripción

Low density lipoprotein cholesterol measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202117
less than 2+ risk factors for coronary heart disease (risk factors include: blood pressure > 140/90 mm hg or on blood pressure medication; hdl-cholesterol < 40 mg/dl; age greater than 45 yrs for males & greater than 55 yrs for females; family history of premature coronary heart disease (chd in male first degree relative <55 years; chd in female first degree relative <65 years)
Descripción

Risk factors Quantity Coronary heart disease | Blood pressure determination | Antihypertensive Agents | Serum HDL cholesterol measurement | Age | Gender | FH: premature coronary heart disease | Coronary heart disease First Degree Relative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0010068
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0003364
UMLS CUI [4]
C0428472
UMLS CUI [5]
C0001779
UMLS CUI [6]
C0079399
UMLS CUI [7]
C1277208
UMLS CUI [8,1]
C0010068
UMLS CUI [8,2]
C1517194
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Descripción

Kidney Diseases | Liver diseases | Gout | Hyperthyroidism | Hypothyroidism Untreated | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic 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]
C0020550
UMLS CUI [5,1]
C0020676
UMLS CUI [5,2]
C0332155
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C0443343
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0030286
UMLS CUI [10]
C0025517
UMLS CUI [11]
C0024523
use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
Descripción

Pharmaceutical Preparations Changing Lipid Metabolism | Non-Prescription Drugs Changing Lipid Metabolism | Supplements Changing Lipid Metabolism

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0598783
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0598783
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0598783
women who have given birth during the previous 12 months
Descripción

Birth

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005615
pregnant women or women who plan to become pregnant or become pregnant during the study
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
lactating women
Descripción

Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
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 bariatric or certain other surgeries related to weight control
Descripción

Bariatric Surgery | Operative Surgical Procedures Weight loss Related

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1262477
UMLS CUI [2,3]
C0439849
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 a history of a surgical intervention for obesity
Descripción

Anti-Obesity Agents Prescription | Anti-Obesity Agents Non-Prescription | Dietary Supplements Against Obesity | Phenylpropanolamine | Ephedrine | Caffeine | Obesity surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376607
UMLS CUI [1,2]
C0033080
UMLS CUI [2,1]
C0376607
UMLS CUI [2,2]
C0013231
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0028754
UMLS CUI [4]
C0031495
UMLS CUI [5]
C0014479
UMLS CUI [6]
C0006644
UMLS CUI [7]
C1167841
unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
Descripción

Avoidance Herbal Supplements Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C1504473
UMLS CUI [1,3]
C0558080
smokers or other tobacco users (during 6 months prior to the start of the study)
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
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 | Vegetarians | Very low fat diet | Diet, High-Protein

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013473
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0086153
UMLS CUI [2,1]
C1517289
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0086153
UMLS CUI [3]
C0042441
UMLS CUI [4]
C0452296
UMLS CUI [5]
C0425403
known (self-reported) allergy or adverse reaction to study foods
Descripción

Hypersensitivity Clinical Trial Food | Adverse reaction Clinical Trial Food

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0016452
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0016452
active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months)
Descripción

Cardiovascular Disease | Myocardial Infarction | Procedure on heart | 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]
C0700431
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0007787
UMLS CUI [8]
C0034065
unable or unwilling to give informed consent or communicate with study staff
Descripción

Informed Consent Unable | Informed Consent Unwilling | Communication Research Personnel Unable | Communication Research Personnel Unwilling

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]
C0009452
UMLS CUI [3,2]
C0035173
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0009452
UMLS CUI [4,2]
C0035173
UMLS CUI [4,3]
C0558080
self-report of alcohol or substance abuse within the past 12 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 | Substance Abuse Treatment | Alcohol-substance abuse rehabilitation treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C2551443
UMLS CUI [3]
C0947090
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 | Mental condition Interferes with Study Subject Participation Status | Factor Behavioral Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Factor Behavioral Interferes 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]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0004927
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C1521761
UMLS CUI [6,2]
C0004927
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0525058
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Similar models

Eligibility Cardiovascular Disease NCT02404207

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30 to 70 years at beginning of study
boolean
C0001779 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
ldl-cholesterol between 120 and 160 mg/dl
boolean
C0202117 (UMLS CUI [1])
Risk factors Quantity Coronary heart disease | Blood pressure determination | Antihypertensive Agents | Serum HDL cholesterol measurement | Age | Gender | FH: premature coronary heart disease | Coronary heart disease First Degree Relative
Item
less than 2+ risk factors for coronary heart disease (risk factors include: blood pressure > 140/90 mm hg or on blood pressure medication; hdl-cholesterol < 40 mg/dl; age greater than 45 yrs for males & greater than 55 yrs for females; family history of premature coronary heart disease (chd in male first degree relative <55 years; chd in female first degree relative <65 years)
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0010068 (UMLS CUI [1,3])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
C0428472 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0079399 (UMLS CUI [6])
C1277208 (UMLS CUI [7])
C0010068 (UMLS CUI [8,1])
C1517194 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Kidney Diseases | Liver diseases | Gout | Hyperthyroidism | Hypothyroidism Untreated | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic Diseases | Metabolic Diseases | Malabsorption Syndrome
Item
presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C0020676 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C0020676 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0006826 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0030286 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0024523 (UMLS CUI [11])
Pharmaceutical Preparations Changing Lipid Metabolism | Non-Prescription Drugs Changing Lipid Metabolism | Supplements Changing Lipid Metabolism
Item
use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C0242295 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0598783 (UMLS CUI [3,3])
Birth
Item
women who have given birth during the previous 12 months
boolean
C0005615 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnant women or women who plan to become pregnant or become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
lactating women
boolean
C0006147 (UMLS CUI [1])
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])
Bariatric Surgery | Operative Surgical Procedures Weight loss Related
Item
history of bariatric or certain other surgeries related to weight control
boolean
C1456587 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1262477 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Anti-Obesity Agents Prescription | Anti-Obesity Agents Non-Prescription | Dietary Supplements Against Obesity | 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 a history of a surgical intervention for obesity
boolean
C0376607 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0376607 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0028754 (UMLS CUI [3,3])
C0031495 (UMLS CUI [4])
C0014479 (UMLS CUI [5])
C0006644 (UMLS CUI [6])
C1167841 (UMLS CUI [7])
Avoidance Herbal Supplements Unwilling
Item
unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
boolean
C0870186 (UMLS CUI [1,1])
C1504473 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Tobacco use
Item
smokers or other tobacco users (during 6 months prior to the start of the study)
boolean
C0543414 (UMLS CUI [1])
Eating Disorders Inconsistent Dietary intervention | Dietary Patterns Inconsistent Dietary intervention | Vegetarians | Very low fat diet | Diet, High-Protein
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])
C1517289 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0086153 (UMLS CUI [2,3])
C0042441 (UMLS CUI [3])
C0452296 (UMLS CUI [4])
C0425403 (UMLS CUI [5])
Hypersensitivity Clinical Trial Food | Adverse reaction Clinical Trial Food
Item
known (self-reported) allergy or adverse reaction to study foods
boolean
C0020517 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0016452 (UMLS CUI [1,3])
C0559546 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
Cardiovascular Disease | Myocardial Infarction | Procedure on heart | Cardiac rehabilitation | Cerebrovascular accident | Transient Ischemic Attack | Therapeutic procedure Transient Ischemic Attack | Pulmonary Embolism
Item
active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months)
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1279986 (UMLS CUI [3])
C0700431 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0007787 (UMLS CUI [7,2])
C0034065 (UMLS CUI [8])
Informed Consent Unable | Informed Consent Unwilling | Communication Research Personnel Unable | Communication Research Personnel Unwilling
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])
C0009452 (UMLS CUI [3,1])
C0035173 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0009452 (UMLS CUI [4,1])
C0035173 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Substance Use Disorders | Substance Abuse Treatment | Alcohol-substance abuse rehabilitation treatment
Item
self-report of alcohol or substance abuse within the past 12 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])
C2551443 (UMLS CUI [2])
C0947090 (UMLS CUI [3])
Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Factor Behavioral Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Factor Behavioral Interferes 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])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0004927 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C1521761 (UMLS CUI [6,1])
C0004927 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
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