Information:
Fel:
ID
16346
Beskrivning
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression; ODM derived from: https://clinicaltrials.gov/show/NCT00676793
Länk
https://clinicaltrials.gov/show/NCT00676793
Nyckelord
Versioner (1)
- 2016-07-11 2016-07-11 -
Uppladdad den
11 juli 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00676793
Eligibility Breast Cancer NCT00676793
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00676793
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
primary breast cancer
Item
definitive biopsy demonstrating primary breast cancer
boolean
C0405352 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,2])
residual breast cancer
Item
residual breast cancer requiring additional surgical resection
boolean
C0006142 (UMLS CUI [1,1])
C0242594 (UMLS CUI [1,2])
C0242594 (UMLS CUI [1,2])
Stage
Item
stage i, ii or iii disease
boolean
C2216702 (UMLS CUI [1])
informed consent
Item
patient has ability to give signed informed consent
boolean
Creatinine and transaminases
Item
normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
boolean
C0600061 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C0002594 (UMLS CUI [2])
ecog performance status
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 21 years and less than 75
boolean
C0001779 (UMLS CUI [1])
ID.8
Item
prior hormonal or surgical therapy for breast cancer
boolean
C2114510 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C2114510 (UMLS CUI [2,1])
C3714726 (UMLS CUI [2,2])
C0279025 (UMLS CUI [1,2])
C2114510 (UMLS CUI [2,1])
C3714726 (UMLS CUI [2,2])
liver function
Item
abnormal liver function test
boolean
C0232741 (UMLS CUI [1])
liver or kidney problems that would interfere with metabolism of study drug
Item
liver or kidney problems that would interfere with metabolism of study drug
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C1547774 (UMLS CUI [3,1])
C0683140 (UMLS CUI [3,2])
C0022658 (UMLS CUI [2])
C1547774 (UMLS CUI [3,1])
C0683140 (UMLS CUI [3,2])
informed consent, compliance
Item
any condition that would hamper informed consent or ability to comply with study protocol
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C1321605 (UMLS CUI [2])
study participation
Item
participation in another research study in the last three months
boolean
C1997894 (UMLS CUI [1])
Second primary malignant neoplasm
Item
known malignancy at any site other than breast
boolean
C1515974 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C0751623 (UMLS CUI [1,2])
green tea
Item
recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
boolean
C1384640 (UMLS CUI [1])
Hypersensitivity to green tea
Item
allergy or intolerance to any component of green tea
boolean
C0020517 (UMLS CUI [1,1])
C1384640 (UMLS CUI [1,2])
C1384640 (UMLS CUI [1,2])
inability or refusal to comply with definitive surgical therapy
Item
inability or refusal to comply with definitive surgical therapy
boolean
C1321605 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
C2986592 (UMLS CUI [1,3])
C3714726 (UMLS CUI [1,2])
C2986592 (UMLS CUI [1,3])