ID

38744

Description

Single Oral Dose of BeneFlax to Healthy Young and Older Adults; ODM derived from: https://clinicaltrials.gov/show/NCT01531569

Link

https://clinicaltrials.gov/show/NCT01531569

Keywords

Versions (1)
  1. 10/31/19 10/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01531569

English

Eligibility Diabetes Mellitus, Type 2 NCT01531569

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy adults: 18-45 and 60-80 years of age
Description

Well adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0686750
UMLS CUI [2]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
Description

Strict vegetarian | Vegan | Lignans High Level

Data type

boolean

Alias
UMLS CUI [1]
C3241968
UMLS CUI [2]
C2987738
UMLS CUI [3,1]
C0064971
UMLS CUI [3,2]
C4321237
strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
Description

Strict vegetarian | Vegan | Lignans High Level

Data type

boolean

Alias
UMLS CUI [1]
C3241968
UMLS CUI [2]
C2987738
UMLS CUI [3,1]
C0064971
UMLS CUI [3,2]
C4321237
individuals who smoke
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
individuals who have experienced diarrhea in the last three months
Description

Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
individuals who have taken oral antibiotics in the last three months
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
individuals who are currently taking warfarin or any of its derivatives
Description

Warfarin | Warfarin Derivative

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C0043031
UMLS CUI [2,2]
C1527240
individuals with low haemoglobin (<121g/l for women and <137g/l for men)
Description

Hemoglobin low | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0162119
UMLS CUI [2]
C0079399
individuals with bmi under 19 or over 28
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women with child bearing potential not using contraceptives
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
current diagnosis of a bleeding disorder or at risk of bleeding
Description

Blood Coagulation Disorder | Bleeding risk

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C3251812
individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
Description

Gastrointestinal problem | Ulcers | Convulsive disorder | Depressive disorder | Liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0017187
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0234972
UMLS CUI [4]
C0011581
UMLS CUI [5]
C0023895
individuals with diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
individuals currently taking a flax seed supplement
Description

Flaxseed Supplement

Data type

boolean

Alias
UMLS CUI [1,1]
C0995001
UMLS CUI [1,2]
C0242295
individuals with an allergy to flax seed
Description

Hypersensitivity Flaxseed

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0995001
individuals who have donated blood or lost > 450 ml of blood within 56 days of study duration
Description

Blood Donation Amount Timespan | Blood Loss Amount Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0872291
individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01531569

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Well adult | Age
Item
healthy adults: 18-45 and 60-80 years of age
boolean
C0686750 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Strict vegetarian | Vegan | Lignans High Level
Item
strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
boolean
C3241968 (UMLS CUI [1])
C2987738 (UMLS CUI [2])
C0064971 (UMLS CUI [3,1])
C4321237 (UMLS CUI [3,2])
Strict vegetarian | Vegan | Lignans High Level
Item
strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
boolean
C3241968 (UMLS CUI [1])
C2987738 (UMLS CUI [2])
C0064971 (UMLS CUI [3,1])
C4321237 (UMLS CUI [3,2])
Tobacco use
Item
individuals who smoke
boolean
C0543414 (UMLS CUI [1])
Diarrhea
Item
individuals who have experienced diarrhea in the last three months
boolean
C0011991 (UMLS CUI [1])
Antidiabetics Oral
Item
individuals who have taken oral antibiotics in the last three months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Warfarin | Warfarin Derivative
Item
individuals who are currently taking warfarin or any of its derivatives
boolean
C0043031 (UMLS CUI [1])
C0043031 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
Hemoglobin low | Gender
Item
individuals with low haemoglobin (<121g/l for women and <137g/l for men)
boolean
C0162119 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Body mass index
Item
individuals with bmi under 19 or over 28
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women with child bearing potential not using contraceptives
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Blood Coagulation Disorder | Bleeding risk
Item
current diagnosis of a bleeding disorder or at risk of bleeding
boolean
C0005779 (UMLS CUI [1])
C3251812 (UMLS CUI [2])
Gastrointestinal problem | Ulcers | Convulsive disorder | Depressive disorder | Liver diseases
Item
individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
boolean
C0017187 (UMLS CUI [1])
C0041582 (UMLS CUI [2])
C0234972 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
Diabetes Mellitus
Item
individuals with diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Flaxseed Supplement
Item
individuals currently taking a flax seed supplement
boolean
C0995001 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
Hypersensitivity Flaxseed
Item
individuals with an allergy to flax seed
boolean
C0020517 (UMLS CUI [1,1])
C0995001 (UMLS CUI [1,2])
Blood Donation Amount Timespan | Blood Loss Amount Timespan
Item
individuals who have donated blood or lost > 450 ml of blood within 56 days of study duration
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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