ID

27614

Beschrijving

Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction; ODM derived from: https://clinicaltrials.gov/show/NCT00938340

Link

https://clinicaltrials.gov/show/NCT00938340

Trefwoorden

Versies (1)
  1. 22-11-17 22-11-17 -
Houder van rechten

See clinicaltrials.gov

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22 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00938340

Engels

Eligibility Cardiovascular Disease NCT00938340

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 21 - 60 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
body mass index 25-39 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
ldl cholesterol >110 mg/dl
Beschrijving

Low density lipoprotein cholesterol measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202117
<95 percentile for age and gender for both (based on nhanes data)
Beschrijving

Age Percentile | Gender Percentile

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1264641
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C1264641
tg < 350 mg/dl
Beschrijving

Serum Triglyceride Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0542495
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
high alcohol consumption > 21 units/week (female subjects) or > 28 units/week (male subjects)
Beschrijving

Alcohol consumption High U/week | Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205250
UMLS CUI [1,3]
C0560588
UMLS CUI [2]
C0079399
intake of vitamin and mineral supplements within the past 3 weeks or unwillingness to discontinue for 3 weeks prior to screening and for entire study.
Beschrijving

Vitamin supplement | Mineral supplements | Vitamin supplement Discontinue Unwilling | Mineral supplements Discontinue Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0681579
UMLS CUI [2]
C0556112
UMLS CUI [3,1]
C0681579
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0556112
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C0558080
use of prescription cholesterol-lowering or blood pressure-lowering medications during the study
Beschrijving

Anticholesteremic Agents Prescription | Antihypertensive Agents Prescription

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003277
UMLS CUI [1,2]
C0033080
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0033080
intake of other putative cholesterol-lowering supplements (excl. psyllium, fish oil capsules, soy lecithin, phytoestrogens)
Beschrijving

Anticholesteremic Agents | Psyllium Exclusive | Fish Oil Oral Capsule Exclusive | Soy Lecithin Exclusive | Phytoestrogens Exclusive

Datatype

boolean

Alias
UMLS CUI [1]
C0003277
UMLS CUI [2,1]
C0033979
UMLS CUI [2,2]
C1548966
UMLS CUI [3,1]
C1617119
UMLS CUI [3,2]
C1548966
UMLS CUI [4,1]
C0872912
UMLS CUI [4,2]
C1548966
UMLS CUI [5,1]
C0071011
UMLS CUI [5,2]
C1548966
intake of anti-inflammatory medications (containing aspirin or nsaids) on a regular basis or if an acute intake, within 48 hours of a test day
Beschrijving

Anti-Inflammatory Agents Containing Aspirin | Anti-Inflammatory Agents Containing NSAIDs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003209
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0004057
UMLS CUI [2,1]
C0003209
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0003211
diabetes, liver, kidney, thyroid (unless controlled and stable on replacement medication) or other endocrine disorders from self-reported medical history
Beschrijving

Diabetes Mellitus | Liver diseases | Kidney Diseases | Thyroid Diseases | Exception Disease Controlled | Exception Thyroid Disease Stable | Exception Replacement Medication | Endocrine System Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0040128
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2911690
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0040128
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0559956
UMLS CUI [7,3]
C0013227
UMLS CUI [8]
C0014130
treatment with drugs acting on the gut, such as ezetimibe, bile acid-binding resins, orlistat
Beschrijving

Pharmaceutical Preparations Affecting Gut | ezetimibe | Bile-acid Binding Resin | orlistat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0699819
UMLS CUI [2]
C1142985
UMLS CUI [3]
C2266924
UMLS CUI [4]
C0076275
dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the trial
Beschrijving

Restricted diet | Prescribed dietary intake | Slimming diet

Datatype

boolean

Alias
UMLS CUI [1]
C0425422
UMLS CUI [2]
C1261371
UMLS CUI [3]
C0521973
weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination.
Beschrijving

Weight decreased Percent of body weight | Weight Gain Percent of body weight

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C3476809
UMLS CUI [2,1]
C0043094
UMLS CUI [2,2]
C3476809
blood/plasma donation for reason(s) other than the present study prior to the study (1 month for a male subject or 2 months for a female subject), or during the study
Beschrijving

Blood Donation | Exception Clinical Trial Present

Datatype

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0150312
lactation 6 weeks before the start of and during study, pregnant or wishing to become pregnant 3 months before or during the study
Beschrijving

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
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Similar models

Eligibility Cardiovascular Disease NCT00938340

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 21 - 60 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index 25-39 kg/m2
boolean
C1305855 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
ldl cholesterol >110 mg/dl
boolean
C0202117 (UMLS CUI [1])
Age Percentile | Gender Percentile
Item
<95 percentile for age and gender for both (based on nhanes data)
boolean
C0001779 (UMLS CUI [1,1])
C1264641 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C1264641 (UMLS CUI [2,2])
Serum Triglyceride Measurement
Item
tg < 350 mg/dl
boolean
C0542495 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Alcohol consumption High U/week | Gender
Item
high alcohol consumption > 21 units/week (female subjects) or > 28 units/week (male subjects)
boolean
C0001948 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Vitamin supplement | Mineral supplements | Vitamin supplement Discontinue Unwilling | Mineral supplements Discontinue Unwilling
Item
intake of vitamin and mineral supplements within the past 3 weeks or unwillingness to discontinue for 3 weeks prior to screening and for entire study.
boolean
C0681579 (UMLS CUI [1])
C0556112 (UMLS CUI [2])
C0681579 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0556112 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Anticholesteremic Agents Prescription | Antihypertensive Agents Prescription
Item
use of prescription cholesterol-lowering or blood pressure-lowering medications during the study
boolean
C0003277 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0033080 (UMLS CUI [2,2])
Anticholesteremic Agents | Psyllium Exclusive | Fish Oil Oral Capsule Exclusive | Soy Lecithin Exclusive | Phytoestrogens Exclusive
Item
intake of other putative cholesterol-lowering supplements (excl. psyllium, fish oil capsules, soy lecithin, phytoestrogens)
boolean
C0003277 (UMLS CUI [1])
C0033979 (UMLS CUI [2,1])
C1548966 (UMLS CUI [2,2])
C1617119 (UMLS CUI [3,1])
C1548966 (UMLS CUI [3,2])
C0872912 (UMLS CUI [4,1])
C1548966 (UMLS CUI [4,2])
C0071011 (UMLS CUI [5,1])
C1548966 (UMLS CUI [5,2])
Anti-Inflammatory Agents Containing Aspirin | Anti-Inflammatory Agents Containing NSAIDs
Item
intake of anti-inflammatory medications (containing aspirin or nsaids) on a regular basis or if an acute intake, within 48 hours of a test day
boolean
C0003209 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0003209 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0003211 (UMLS CUI [2,3])
Diabetes Mellitus | Liver diseases | Kidney Diseases | Thyroid Diseases | Exception Disease Controlled | Exception Thyroid Disease Stable | Exception Replacement Medication | Endocrine System Diseases
Item
diabetes, liver, kidney, thyroid (unless controlled and stable on replacement medication) or other endocrine disorders from self-reported medical history
boolean
C0011849 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C2911690 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0040128 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0559956 (UMLS CUI [7,2])
C0013227 (UMLS CUI [7,3])
C0014130 (UMLS CUI [8])
Pharmaceutical Preparations Affecting Gut | ezetimibe | Bile-acid Binding Resin | orlistat
Item
treatment with drugs acting on the gut, such as ezetimibe, bile acid-binding resins, orlistat
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0699819 (UMLS CUI [1,3])
C1142985 (UMLS CUI [2])
C2266924 (UMLS CUI [3])
C0076275 (UMLS CUI [4])
Restricted diet | Prescribed dietary intake | Slimming diet
Item
dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the trial
boolean
C0425422 (UMLS CUI [1])
C1261371 (UMLS CUI [2])
C0521973 (UMLS CUI [3])
Weight decreased Percent of body weight | Weight Gain Percent of body weight
Item
weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination.
boolean
C1262477 (UMLS CUI [1,1])
C3476809 (UMLS CUI [1,2])
C0043094 (UMLS CUI [2,1])
C3476809 (UMLS CUI [2,2])
Blood Donation | Exception Clinical Trial Present
Item
blood/plasma donation for reason(s) other than the present study prior to the study (1 month for a male subject or 2 months for a female subject), or during the study
boolean
C0005794 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
lactation 6 weeks before the start of and during study, pregnant or wishing to become pregnant 3 months before or during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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