ID

44539

Description

Green Tea and Reduction of Breast Cancer Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00917735

Link

https://clinicaltrials.gov/show/NCT00917735

Keywords

  1. 8/22/19 8/22/19 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00917735

Eligibility Breast Cancer NCT00917735

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
healthy postmenopausal women aged 50-70 years
Description

Gender | Healthy | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3898900
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0001779
"heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
Description

Breast Heterogeneous Dense | Extremely Dense Breast | Percentage Glandular

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0019409
UMLS CUI [1,3]
C0439794
UMLS CUI [2]
C1268647
UMLS CUI [3,1]
C0439165
UMLS CUI [3,2]
C0225353
willing to avoid consumption of green tea for 1 year
Description

Avoidance Consumption of Green tea

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C1384640
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive serological markers of hepatitis b or hepatitis c infections
Description

Serology positive Hepatitis B | Serology positive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
elevated levels of liver enzymes
Description

Elevated liver enzymes level

Data type

boolean

Alias
UMLS CUI [1]
C0857093
recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, serms and aromatase inhibitors
Description

Hormone Therapy | Hormone Modification Therapy | Hormone replacement therapy Systemic | SERMs | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0019932
UMLS CUI [2,2]
C3840684
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C0205373
UMLS CUI [4]
C0732611
UMLS CUI [5]
C0593802
current smoker of cigarettes or other tobacco products
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
bmi <19 or >40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
weight change > 10 lbs during the previous year
Description

Body Weight Change Amount Past Year

Data type

boolean

Alias
UMLS CUI [1,1]
C0005911
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C4086728
history of breast cancer or proliferative breast disease
Description

Medical History Breast Carcinoma | Breast Disease Proliferative

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0006145
UMLS CUI [2,2]
C0334094
regular consumption of > 7 alcoholic drinks/wk
Description

Alcohol consumption Regular Drinks per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0001967
UMLS CUI [1,4]
C0332174
regular consumption of green tea (>1 cup/wk)
Description

Consumption of Green tea Regular | Green tea Cup Quantity per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C1384640
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C1384640
UMLS CUI [2,2]
C3853579
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0332174
recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
Description

Chemopreventive Agent | Tamoxifen | Raloxifene | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1516463
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0244404
UMLS CUI [4]
C0593802
participation in any weight loss or weight gain studies
Description

Study Subject Participation Status | Weight loss Clinical Trials | Weight Gain Clinical Trials

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C0043094
UMLS CUI [3,2]
C0008976
currently taking methotrexate or enbrel
Description

Methotrexate | Enbrel

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0720193
history of ovarian cancer
Description

Ovarian Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0029925
any form of cancer in the last 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
presence of implants
Description

Implants

Data type

boolean

Alias
UMLS CUI [1]
C0021102

Similar models

Eligibility Breast Cancer NCT00917735

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Healthy | Postmenopausal state | Age
Item
healthy postmenopausal women aged 50-70 years
boolean
C0079399 (UMLS CUI [1])
C3898900 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Breast Heterogeneous Dense | Extremely Dense Breast | Percentage Glandular
Item
"heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
boolean
C0006141 (UMLS CUI [1,1])
C0019409 (UMLS CUI [1,2])
C0439794 (UMLS CUI [1,3])
C1268647 (UMLS CUI [2])
C0439165 (UMLS CUI [3,1])
C0225353 (UMLS CUI [3,2])
Avoidance Consumption of Green tea
Item
willing to avoid consumption of green tea for 1 year
boolean
C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C1384640 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Serology positive Hepatitis B | Serology positive Hepatitis C
Item
positive serological markers of hepatitis b or hepatitis c infections
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Elevated liver enzymes level
Item
elevated levels of liver enzymes
boolean
C0857093 (UMLS CUI [1])
Hormone Therapy | Hormone Modification Therapy | Hormone replacement therapy Systemic | SERMs | Aromatase Inhibitors
Item
recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, serms and aromatase inhibitors
boolean
C0279025 (UMLS CUI [1])
C0019932 (UMLS CUI [2,1])
C3840684 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0282402 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0732611 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
Tobacco use
Item
current smoker of cigarettes or other tobacco products
boolean
C0543414 (UMLS CUI [1])
Body mass index
Item
bmi <19 or >40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Body Weight Change Amount Past Year
Item
weight change > 10 lbs during the previous year
boolean
C0005911 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,3])
Medical History Breast Carcinoma | Breast Disease Proliferative
Item
history of breast cancer or proliferative breast disease
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0006145 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
Alcohol consumption Regular Drinks per week
Item
regular consumption of > 7 alcoholic drinks/wk
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001967 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Consumption of Green tea Regular | Green tea Cup Quantity per week
Item
regular consumption of green tea (>1 cup/wk)
boolean
C0009830 (UMLS CUI [1,1])
C1384640 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C1384640 (UMLS CUI [2,1])
C3853579 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332174 (UMLS CUI [2,4])
Chemopreventive Agent | Tamoxifen | Raloxifene | Aromatase Inhibitors
Item
recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
boolean
C1516463 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0244404 (UMLS CUI [3])
C0593802 (UMLS CUI [4])
Study Subject Participation Status | Weight loss Clinical Trials | Weight Gain Clinical Trials
Item
participation in any weight loss or weight gain studies
boolean
C2348568 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0043094 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
Methotrexate | Enbrel
Item
currently taking methotrexate or enbrel
boolean
C0025677 (UMLS CUI [1])
C0720193 (UMLS CUI [2])
Ovarian Carcinoma
Item
history of ovarian cancer
boolean
C0029925 (UMLS CUI [1])
Malignant Neoplasms
Item
any form of cancer in the last 5 years
boolean
C0006826 (UMLS CUI [1])
Implants
Item
presence of implants
boolean
C0021102 (UMLS CUI [1])

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