ID

42690

Description

Oslo Antioxidant Study; ODM derived from: https://clinicaltrials.gov/show/NCT00520819

Link

https://clinicaltrials.gov/show/NCT00520819

Keywords

Versions (2)
  1. 7/25/16 7/25/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00520819

English

Eligibility Cardiovascular Disease NCT00520819

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men aged 45-75 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
daily smoker of a minimum of 5 cigarettes a day
Description

Smokes tobacco daily Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C3266136
UMLS CUI [1,2]
C3694146
bmi <35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet)
Description

Body mass index | Obesity, Morbid | Diet following Problem

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0028756
UMLS CUI [3,1]
C0559897
UMLS CUI [3,2]
C0033213
stable weight range of 4 kg or less during the previous 12 weeks
Description

Body Weight Range Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any symptomatic cvd (myocardial infarction, angina pectoris, cabg, pci, chf, nyha class iii-iv)
Description

Cardiovascular Diseases Symptomatic | Myocardial Infarction | Angina Pectoris | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Congestive heart failure | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0010055
UMLS CUI [5]
C1532338
UMLS CUI [6]
C0018802
UMLS CUI [7]
C1275491
diabetes type i or type ii taking drugs for diabetes
Description

Insulin-Dependent Diabetes Mellitus Pharmacotherapy | Non-Insulin-Dependent Diabetes Mellitus Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0013216
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0013216
following a vegetarian diet or near-vegetarian diet currently
Description

Vegetarian diet

Data type

boolean

Alias
UMLS CUI [1]
C0311164
allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes
Description

Hypersensitivity Nuts | Hypersensitivity kiwi fruit | Hypersensitivity Chocolate | Hypersensitivity Strawberries | Hypersensitivity Tomatoes

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0028723
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0971874
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0008299
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0457802
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0242772
clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations
Description

Disease Impairing Compliance Recommendation Dietary | Gastrointestinal Diseases Impairing Compliance Recommendation Dietary

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C3714738
UMLS CUI [1,4]
C0034866
UMLS CUI [1,5]
C0012155
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C3714738
UMLS CUI [2,4]
C0034866
UMLS CUI [2,5]
C0012155
history of serious or unstable medical or psychiatric disorder
Description

Disease Serious | Disease Unstable | Mental disorders Serious | Mental disorders Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0205404
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0443343
current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (nsaid), according to assessment of the primary clinical investigator. any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. these are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. paracetamol, however, can be taken as an alternative if required
Description

Antilipemic agent | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Non-Prescription Drugs Headache | Non-Prescription Drugs Pain | Non-Prescription Drugs Common Cold | Ibuprofen | Platelet function | Acetaminophen

Data type

boolean

Alias
UMLS CUI [1]
C0086440
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0003211
UMLS CUI [4,1]
C0013231
UMLS CUI [4,2]
C0018681
UMLS CUI [5,1]
C0013231
UMLS CUI [5,2]
C0030193
UMLS CUI [6,1]
C0013231
UMLS CUI [6,2]
C0009443
UMLS CUI [7]
C0020740
UMLS CUI [8]
C1254881
UMLS CUI [9]
C0000970
history of alcohol/or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
participation in a drug trial during the previous 30 days
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
use of drugs (xenical, reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program
Description

Weight-Loss Agents | Xenical | Reductil | Dietary Supplements | Medicinal Herbs | participation Weight Reduction Programs

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0732649
UMLS CUI [3]
C1956165
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0025125
UMLS CUI [6,1]
C0679823
UMLS CUI [6,2]
C3179079
use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2)
Description

Vitamin Single | Antioxidants

Data type

boolean

Alias
UMLS CUI [1,1]
C0042890
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C0003402
individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.
Description

Study Protocol Compliance behavior Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Cardiovascular Disease NCT00520819

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men aged 45-75 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Smokes tobacco daily Number of cigarettes per day
Item
daily smoker of a minimum of 5 cigarettes a day
boolean
C3266136 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Body mass index | Obesity, Morbid | Diet following Problem
Item
bmi <35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet)
boolean
C1305855 (UMLS CUI [1])
C0028756 (UMLS CUI [2])
C0559897 (UMLS CUI [3,1])
C0033213 (UMLS CUI [3,2])
Body Weight Range Stable
Item
stable weight range of 4 kg or less during the previous 12 weeks
boolean
C0005910 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases Symptomatic | Myocardial Infarction | Angina Pectoris | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Congestive heart failure | New York Heart Association Classification
Item
any symptomatic cvd (myocardial infarction, angina pectoris, cabg, pci, chf, nyha class iii-iv)
boolean
C0007222 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C1275491 (UMLS CUI [7])
Insulin-Dependent Diabetes Mellitus Pharmacotherapy | Non-Insulin-Dependent Diabetes Mellitus Pharmacotherapy
Item
diabetes type i or type ii taking drugs for diabetes
boolean
C0011854 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
Vegetarian diet
Item
following a vegetarian diet or near-vegetarian diet currently
boolean
C0311164 (UMLS CUI [1])
Hypersensitivity Nuts | Hypersensitivity kiwi fruit | Hypersensitivity Chocolate | Hypersensitivity Strawberries | Hypersensitivity Tomatoes
Item
allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes
boolean
C0020517 (UMLS CUI [1,1])
C0028723 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0971874 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0008299 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0457802 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0242772 (UMLS CUI [5,2])
Disease Impairing Compliance Recommendation Dietary | Gastrointestinal Diseases Impairing Compliance Recommendation Dietary
Item
clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations
boolean
C0012634 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
C0034866 (UMLS CUI [1,4])
C0012155 (UMLS CUI [1,5])
C0017178 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C3714738 (UMLS CUI [2,3])
C0034866 (UMLS CUI [2,4])
C0012155 (UMLS CUI [2,5])
Disease Serious | Disease Unstable | Mental disorders Serious | Mental disorders Unstable
Item
history of serious or unstable medical or psychiatric disorder
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
Antilipemic agent | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Non-Prescription Drugs Headache | Non-Prescription Drugs Pain | Non-Prescription Drugs Common Cold | Ibuprofen | Platelet function | Acetaminophen
Item
current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (nsaid), according to assessment of the primary clinical investigator. any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. these are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. paracetamol, however, can be taken as an alternative if required
boolean
C0086440 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0013231 (UMLS CUI [4,1])
C0018681 (UMLS CUI [4,2])
C0013231 (UMLS CUI [5,1])
C0030193 (UMLS CUI [5,2])
C0013231 (UMLS CUI [6,1])
C0009443 (UMLS CUI [6,2])
C0020740 (UMLS CUI [7])
C1254881 (UMLS CUI [8])
C0000970 (UMLS CUI [9])
Substance Use Disorders
Item
history of alcohol/or drug abuse
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a drug trial during the previous 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Weight-Loss Agents | Xenical | Reductil | Dietary Supplements | Medicinal Herbs | participation Weight Reduction Programs
Item
use of drugs (xenical, reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program
boolean
C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C1956165 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0025125 (UMLS CUI [5])
C0679823 (UMLS CUI [6,1])
C3179079 (UMLS CUI [6,2])
Vitamin Single | Antioxidants
Item
use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2)
boolean
C0042890 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0003402 (UMLS CUI [2])
Study Protocol Compliance behavior Unable
Item
individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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