ID

39909

Beskrivning

Effects of Buttermilk on Serum LDL Cholesterol Concentrations; ODM derived from: https://clinicaltrials.gov/show/NCT01566305

Länk

https://clinicaltrials.gov/show/NCT01566305

Nyckelord

Versioner (1)
  1. 2020-03-03 2020-03-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypercholesterolemia NCT01566305

Engelsk

Eligibility Hypercholesterolemia NCT01566305

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged between 18 and 70 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
fasting serum total cholesterol between 5.5 - 8.0 mmol/l
Beskrivning

Serum total cholesterol measurement Fasting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1445957
UMLS CUI [1,2]
C0015663
fasting plasma glucose < 7.0 mmol/l
Beskrivning

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
bmi between 25-30 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
non-smoking
Beskrivning

Non-smoker

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
willingness to abstain for the duration of the study from egg consumption
Beskrivning

Abstinence Consumption of egg-based foods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C2107826
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable body weight (weight gain or loss >3 kg in the past 3 months)
Beskrivning

Body Weight Unstable | Weight Gain Amount Timespan | Weight loss Amount Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0043094
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0872291
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0872291
allergic for eggs or egg-rich products
Beskrivning

Allergy to eggs | Hypersensitivity Egg product

Datatyp

boolean

Alias
UMLS CUI [1]
C0559469
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1532666
allergic or intolerant for cow-milk (lactose) based products
Beskrivning

Cow milk allergy | Intolerance to Cow's milk

Datatyp

boolean

Alias
UMLS CUI [1]
C0266815
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0349374
indication for treatment with cholesterol-lowering drugs according to the dutch cholesterol consensus
Beskrivning

Indication Anticholesteremic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0003277
use of medication or a diet known to affect serum lipid or glucose metabolism -
Beskrivning

Medication use Affecting Lipid Metabolism | Diet Affecting Lipid Metabolism | Medication use Affecting Glucose metabolism | Diet Affecting Glucose metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0598783
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0598783
UMLS CUI [3,1]
C0240320
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0596620
UMLS CUI [4,1]
C0012155
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0596620
active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
Beskrivning

Cardiovascular Disease | Congestive heart failure | Cardiovascular event Recent | Myocardial Infarction | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C1320716
UMLS CUI [3,2]
C0332185
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
Beskrivning

Vitamin supplement Discontinue Unwilling | Fish Oil Oral Capsule Discontinue Unwilling | Plant stanol ester Product Discontinue Unwilling | Plant sterol ester Product Discontinue Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681579
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C1617119
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0872973
UMLS CUI [3,2]
C1254351
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C0558080
UMLS CUI [4,1]
C3714410
UMLS CUI [4,2]
C1254351
UMLS CUI [4,3]
C1444662
UMLS CUI [4,4]
C0558080
men: consumption of >21 alcohol consumptions a week
Beskrivning

Gender | Alcohol consumption Quantity per week

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
women: consumption of >14 alcohol consumptions a week
Beskrivning

Gender | Alcohol consumption Quantity per week

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
abuse of drugs
Beskrivning

Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
pregnant or breastfeeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another biomedical study within 1 month prior to the screening visit
Beskrivning

Study Subject Participation Status | Biomedical Research

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005540
having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
Beskrivning

Blood Donation Recent | Blood Donation Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
impossible or difficult venipuncture as evidenced during the screening visits
Beskrivning

Venipuncture Unsuccessful | Venipuncture Difficult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600406
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0600406
UMLS CUI [2,2]
C0332218
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Similar models

Eligibility Hypercholesterolemia NCT01566305

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged between 18 and 70 years
boolean
C0001779 (UMLS CUI [1])
Serum total cholesterol measurement Fasting
Item
fasting serum total cholesterol between 5.5 - 8.0 mmol/l
boolean
C1445957 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose < 7.0 mmol/l
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
bmi between 25-30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Non-smoker
Item
non-smoking
boolean
C0337672 (UMLS CUI [1])
Abstinence Consumption of egg-based foods
Item
willingness to abstain for the duration of the study from egg consumption
boolean
C3843422 (UMLS CUI [1,1])
C2107826 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Body Weight Unstable | Weight Gain Amount Timespan | Weight loss Amount Timespan
Item
unstable body weight (weight gain or loss >3 kg in the past 3 months)
boolean
C0005910 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0043094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
C1262477 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Allergy to eggs | Hypersensitivity Egg product
Item
allergic for eggs or egg-rich products
boolean
C0559469 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1532666 (UMLS CUI [2,2])
Cow milk allergy | Intolerance to Cow's milk
Item
allergic or intolerant for cow-milk (lactose) based products
boolean
C0266815 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0349374 (UMLS CUI [2,2])
Indication Anticholesteremic Agents
Item
indication for treatment with cholesterol-lowering drugs according to the dutch cholesterol consensus
boolean
C3146298 (UMLS CUI [1,1])
C0003277 (UMLS CUI [1,2])
Medication use Affecting Lipid Metabolism | Diet Affecting Lipid Metabolism | Medication use Affecting Glucose metabolism | Diet Affecting Glucose metabolism
Item
use of medication or a diet known to affect serum lipid or glucose metabolism -
boolean
C0240320 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0012155 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C0240320 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])
C0012155 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
Cardiovascular Disease | Congestive heart failure | Cardiovascular event Recent | Myocardial Infarction | Cerebrovascular accident
Item
active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1320716 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Vitamin supplement Discontinue Unwilling | Fish Oil Oral Capsule Discontinue Unwilling | Plant stanol ester Product Discontinue Unwilling | Plant sterol ester Product Discontinue Unwilling
Item
not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
boolean
C0681579 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C1617119 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0872973 (UMLS CUI [3,1])
C1254351 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
C3714410 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
Gender | Alcohol consumption Quantity per week
Item
men: consumption of >21 alcohol consumptions a week
boolean
C0079399 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Gender | Alcohol consumption Quantity per week
Item
women: consumption of >14 alcohol consumptions a week
boolean
C0079399 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Drug abuse
Item
abuse of drugs
boolean
C0013146 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Biomedical Research
Item
participation in another biomedical study within 1 month prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C0005540 (UMLS CUI [2])
Blood Donation Recent | Blood Donation Planned
Item
having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Venipuncture Unsuccessful | Venipuncture Difficult
Item
impossible or difficult venipuncture as evidenced during the screening visits
boolean
C0600406 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0600406 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
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