ID

16796

Description

China Plant Sterol Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00145717

Link

https://clinicaltrials.gov/show/NCT00145717

Keywords

  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Hypercholesterolemia NCT00145717

Eligibility Hypercholesterolemia NCT00145717

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the key inclusion criteria will be:
Description

Inclusion

Data type

boolean

Alias
UMLS CUI [1]
C1512693
age between 18 and 65 years old (inclusive) at baseline
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
able to provide informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
usual diet that includes significant fat consumption at the main meals eaten each week and/or a history of hypercholesterolemia
Description

significant fat consumption and/or a history of hypercholesterolemia

Data type

boolean

Alias
UMLS CUI [1]
C0425440
UMLS CUI [2]
C0020443
participant is likely to comply with the study treatment during the study period
Description

Participant is likely to comply with the study treatment

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants will be excluded on the basis of:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
known serious gastrointestinal disease or other serious illness. individuals with stable cardiovascular disease will, however, be eligible
Description

serious gastrointestinal disease or other serious illness

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0009488
known lactose intolerance or diet that excludes dairy products
Description

Lactose intolerance or diet that excludes dairy products

Data type

boolean

Alias
UMLS CUI [1]
C0022951
UMLS CUI [2]
C0860073
known sitosterolaemia (a very rare genetic condition causing very high blood sitosterol levels)
Description

Sitosterolaemia

Data type

boolean

Alias
UMLS CUI [1]
C0342907
current hospitalisation
Description

Hospitalisation

Data type

boolean

Alias
UMLS CUI [1]
C0019993
current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol (e.g. ezetimibe, bile acid-binding resins, or orlistat)
Description

current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021826
participant is currently using or is planning to use non-trial plant sterol/stanol-containing products for the seven week study period
Description

currently using or is planning to use non-trial plant sterol/stanol-containing products

Data type

boolean

Alias
UMLS CUI [1]
C0031866
UMLS CUI [2]
C0872973
participation in another study within last 3 months
Description

participation in another study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or planning to become pregnant in next three months
Description

pregnant or planning to become pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2081645

Similar models

Eligibility Hypercholesterolemia NCT00145717

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion
Item
the key inclusion criteria will be:
boolean
C1512693 (UMLS CUI [1])
Age
Item
age between 18 and 65 years old (inclusive) at baseline
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
significant fat consumption and/or a history of hypercholesterolemia
Item
usual diet that includes significant fat consumption at the main meals eaten each week and/or a history of hypercholesterolemia
boolean
C0425440 (UMLS CUI [1])
C0020443 (UMLS CUI [2])
Participant is likely to comply with the study treatment
Item
participant is likely to comply with the study treatment during the study period
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
participants will be excluded on the basis of:
boolean
C0680251 (UMLS CUI [1])
serious gastrointestinal disease or other serious illness
Item
known serious gastrointestinal disease or other serious illness. individuals with stable cardiovascular disease will, however, be eligible
boolean
C0017178 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Lactose intolerance or diet that excludes dairy products
Item
known lactose intolerance or diet that excludes dairy products
boolean
C0022951 (UMLS CUI [1])
C0860073 (UMLS CUI [2])
Sitosterolaemia
Item
known sitosterolaemia (a very rare genetic condition causing very high blood sitosterol levels)
boolean
C0342907 (UMLS CUI [1])
Hospitalisation
Item
current hospitalisation
boolean
C0019993 (UMLS CUI [1])
current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol
Item
current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol (e.g. ezetimibe, bile acid-binding resins, or orlistat)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021826 (UMLS CUI [1,3])
currently using or is planning to use non-trial plant sterol/stanol-containing products
Item
participant is currently using or is planning to use non-trial plant sterol/stanol-containing products for the seven week study period
boolean
C0031866 (UMLS CUI [1])
C0872973 (UMLS CUI [2])
participation in another study
Item
participation in another study within last 3 months
boolean
C2348568 (UMLS CUI [1])
pregnant or planning to become pregnant
Item
pregnant or planning to become pregnant in next three months
boolean
C0032961 (UMLS CUI [1])
C2081645 (UMLS CUI [2])

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