ID

27284

Description

Soy, Selenium and Breast Cancer Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00555386

Link

https://clinicaltrials.gov/show/NCT00555386

Keywords

Versions (1)
  1. 11/7/17 11/7/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer Risk NCT00555386

English

Eligibility Breast Cancer Risk NCT00555386

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pre menopausal women (age 35-50)at moderate to high risk of breast cancer based on family history (nice guidelines)
Description

Premenopausal state | Age | Family history Breast Carcinoma Moderate risk of | At high risk for breast cancer Family history

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0241889
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0332166
UMLS CUI [4,1]
C4047809
UMLS CUI [4,2]
C0241889
attending breast clinic at nnuh
Description

Attending Breast clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C1999232
UMLS CUI [1,2]
C3810844
willing to consume 6g of chocolate per day for 25-35 days
Description

Willing Consumption Chocolate U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C0008299
UMLS CUI [1,4]
C0456683
regular menstrual cycle of 25-35 days in length
Description

Menstrual cycle Duration Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0025329
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0205272
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous diagnosis of breast cancer or cancer of any other site
Description

Breast Carcinoma | Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1707251
diagnosis of hypertension (requiring active treatment)/diabetes/ coronary heart disease/ gastrointestinal disease/ any other systemic disease requiring treatment
Description

Hypertensive disease Treatment required for | Diabetes Mellitus | Coronary heart disease | Gastrointestinal Diseases | Systemic disease Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0010068
UMLS CUI [4]
C0017178
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0332121
regularly taking any prescribed medication within the last six months (including oral contraceptives)
Description

Takes medication as prescribed Regular | Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C1822607
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0009905
fitted with a hormone releasing device
Description

Medical Device releasing hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C0815016
pregnant or lactating in the previous 12 months
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
using laxatives or antacids more than once a week
Description

Laxatives Use of Frequency | Antacids Use of Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0282090
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0003138
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0439603
routinely taking soy or selenium supplements in the last twelve months
Description

Soy Dietary Supplements Regular | Selenium supplement Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C2756587
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C0521939
UMLS CUI [2,2]
C0205272
regularly taking any dietary or herbal supplements in the last six months
Description

Dietary Supplements Regular | Herbal supplement Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C1504473
UMLS CUI [2,2]
C0205272
participation in any intervention study (soy or selenium) in the previous twelve months
Description

Study Subject Participation Status | Interventional procedure | Soy | Selenium

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
UMLS CUI [3]
C2756587
UMLS CUI [4]
C0036581
parallel participation in another research study involving either dietary or medical intervention or sampling of biological fluids/materials
Description

Study Subject Participation Status | Dietary Modification | Interventional procedure | Sampling Fluids biological | Sampling Materials biological

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0086153
UMLS CUI [3]
C0184661
UMLS CUI [4,1]
C0870078
UMLS CUI [4,2]
C0302908
UMLS CUI [4,3]
C0205460
UMLS CUI [5,1]
C0870078
UMLS CUI [5,2]
C0520510
UMLS CUI [5,3]
C0205460
blood donation within sixteen weeks of study start/finish
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
bmi <18.5 or >35
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
allergy to any chocolate/dairy/soy-based food products
Description

Chocolate allergy | Allergy to dairy product | Allergy to soya

Data type

boolean

Alias
UMLS CUI [1]
C0577624
UMLS CUI [2]
C1960715
UMLS CUI [3]
C4075590
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Similar models

Eligibility Breast Cancer Risk NCT00555386

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Premenopausal state | Age | Family history Breast Carcinoma Moderate risk of | At high risk for breast cancer Family history
Item
pre menopausal women (age 35-50)at moderate to high risk of breast cancer based on family history (nice guidelines)
boolean
C0232969 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0241889 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0332166 (UMLS CUI [3,3])
C4047809 (UMLS CUI [4,1])
C0241889 (UMLS CUI [4,2])
Attending Breast clinic
Item
attending breast clinic at nnuh
boolean
C1999232 (UMLS CUI [1,1])
C3810844 (UMLS CUI [1,2])
Willing Consumption Chocolate U/day
Item
willing to consume 6g of chocolate per day for 25-35 days
boolean
C0600109 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0008299 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Menstrual cycle Duration Regular
Item
regular menstrual cycle of 25-35 days in length
boolean
C0025329 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma | Cancer Other
Item
current or previous diagnosis of breast cancer or cancer of any other site
boolean
C0678222 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Hypertensive disease Treatment required for | Diabetes Mellitus | Coronary heart disease | Gastrointestinal Diseases | Systemic disease Treatment required for
Item
diagnosis of hypertension (requiring active treatment)/diabetes/ coronary heart disease/ gastrointestinal disease/ any other systemic disease requiring treatment
boolean
C0020538 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
Takes medication as prescribed Regular | Contraceptives, Oral
Item
regularly taking any prescribed medication within the last six months (including oral contraceptives)
boolean
C1822607 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
Medical Device releasing hormones
Item
fitted with a hormone releasing device
boolean
C0025080 (UMLS CUI [1,1])
C0815016 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating in the previous 12 months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Laxatives Use of Frequency | Antacids Use of Frequency
Item
using laxatives or antacids more than once a week
boolean
C0282090 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0003138 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Soy Dietary Supplements Regular | Selenium supplement Regular
Item
routinely taking soy or selenium supplements in the last twelve months
boolean
C2756587 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0521939 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
Dietary Supplements Regular | Herbal supplement Regular
Item
regularly taking any dietary or herbal supplements in the last six months
boolean
C0242295 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C1504473 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
Study Subject Participation Status | Interventional procedure | Soy | Selenium
Item
participation in any intervention study (soy or selenium) in the previous twelve months
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C2756587 (UMLS CUI [3])
C0036581 (UMLS CUI [4])
Study Subject Participation Status | Dietary Modification | Interventional procedure | Sampling Fluids biological | Sampling Materials biological
Item
parallel participation in another research study involving either dietary or medical intervention or sampling of biological fluids/materials
boolean
C2348568 (UMLS CUI [1])
C0086153 (UMLS CUI [2])
C0184661 (UMLS CUI [3])
C0870078 (UMLS CUI [4,1])
C0302908 (UMLS CUI [4,2])
C0205460 (UMLS CUI [4,3])
C0870078 (UMLS CUI [5,1])
C0520510 (UMLS CUI [5,2])
C0205460 (UMLS CUI [5,3])
Blood Donation
Item
blood donation within sixteen weeks of study start/finish
boolean
C0005794 (UMLS CUI [1])
Body mass index
Item
bmi <18.5 or >35
boolean
C1305855 (UMLS CUI [1])
Chocolate allergy | Allergy to dairy product | Allergy to soya
Item
allergy to any chocolate/dairy/soy-based food products
boolean
C0577624 (UMLS CUI [1])
C1960715 (UMLS CUI [2])
C4075590 (UMLS CUI [3])
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