ID

16346

Descripción

A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression; ODM derived from: https://clinicaltrials.gov/show/NCT00676793

Link

https://clinicaltrials.gov/show/NCT00676793

Palabras clave

  1. 11/7/16 11/7/16 -
Subido en

11 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00676793

Eligibility Breast Cancer NCT00676793

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
definitive biopsy demonstrating primary breast cancer
Descripción

primary breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C0006142
residual breast cancer requiring additional surgical resection
Descripción

residual breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0242594
stage i, ii or iii disease
Descripción

Stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2216702
patient has ability to give signed informed consent
Descripción

informed consent

Tipo de datos

boolean

normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
Descripción

Creatinine and transaminases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
UMLS CUI [2]
C0002594
ecog performance status of 0 or 1.
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 21 years and less than 75
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior hormonal or surgical therapy for breast cancer
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0279025
UMLS CUI [2,1]
C2114510
UMLS CUI [2,2]
C3714726
abnormal liver function test
Descripción

liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
liver or kidney problems that would interfere with metabolism of study drug
Descripción

liver or kidney problems that would interfere with metabolism of study drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3,1]
C1547774
UMLS CUI [3,2]
C0683140
any condition that would hamper informed consent or ability to comply with study protocol
Descripción

informed consent, compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
participation in another research study in the last three months
Descripción

study participation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1997894
known malignancy at any site other than breast
Descripción

Second primary malignant neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0751623
recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
Descripción

green tea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1384640
allergy or intolerance to any component of green tea
Descripción

Hypersensitivity to green tea

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1384640
inability or refusal to comply with definitive surgical therapy
Descripción

inability or refusal to comply with definitive surgical therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3714726
UMLS CUI [1,3]
C2986592

Similar models

Eligibility Breast Cancer NCT00676793

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
primary breast cancer
Item
definitive biopsy demonstrating primary breast cancer
boolean
C0405352 (UMLS CUI [1,1])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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])

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