ID

16346

Description

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

Lien

https://clinicaltrials.gov/show/NCT00676793

Mots-clés

  1. 11/07/2016 11/07/2016 -
Téléchargé le

11 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00676793

Eligibility Breast Cancer NCT00676793

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
definitive biopsy demonstrating primary breast cancer
Description

primary breast cancer

Type de données

boolean

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

residual breast cancer

Type de données

boolean

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

Stage

Type de données

boolean

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

informed consent

Type de données

boolean

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

Creatinine and transaminases

Type de données

boolean

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

ecog performance status

Type de données

boolean

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

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

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

ID.8

Type de données

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
Description

liver function

Type de données

boolean

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

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

Type de données

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
Description

informed consent, compliance

Type de données

boolean

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

study participation

Type de données

boolean

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

Second primary malignant neoplasm

Type de données

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)
Description

green tea

Type de données

boolean

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

Hypersensitivity to green tea

Type de données

boolean

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

inability or refusal to comply with definitive surgical therapy

Type de données

boolean

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

Similar models

Eligibility Breast Cancer NCT00676793

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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