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Eligibility Locally Advanced Malignant Neoplasm NCT01566799

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women older than 18 years old and younger than 70 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
invasive breast cancer confirmed by core biopsy, any histology
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
tumor ≥2 cm and/or lymph node positive (proven by fna)(t2-4b, n0-3, m0)
Description

Tumor size | Positive Lymph Node Fine needle aspiration biopsy | TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C1510483
UMLS CUI [3]
C0474926
must have er/pr positive and her2 negative
Description

Estrogen receptor positive | Progesterone receptor positive | HER2 Negative

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
UMLS CUI [3]
C2348908
must have full staging and extent disease and clinically and radiographically tumor measure
Description

Disease TNM Breast tumor staging | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0475440
without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
Description

Prior Therapy Absent Breast Carcinoma | Operative Surgical Procedure Absent | Hormone Therapy Absent | Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
normal liver, kidney and blood tests
Description

Liver function tests normal | Kidney Function Tests Normal | Blood test normal

Data type

boolean

Alias
UMLS CUI [1]
C0438235
UMLS CUI [2,1]
C0022662
UMLS CUI [2,2]
C0205307
UMLS CUI [3]
C0919709
performance status ecog 0-2 o karnofsky ≥70%
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
fasten glucose levels <125 mg/dl
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
signed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous use of metformin for any indication
Description

metformin

Data type

boolean

Alias
UMLS CUI [1]
C0025598
presence of diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
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Similar models

Eligibility Locally Advanced Malignant Neoplasm NCT01566799

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women older than 18 years old and younger than 70 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast
Item
invasive breast cancer confirmed by core biopsy, any histology
boolean
C0853879 (UMLS CUI [1])
Tumor size | Positive Lymph Node Fine needle aspiration biopsy | TNM Breast tumor staging
Item
tumor ≥2 cm and/or lymph node positive (proven by fna)(t2-4b, n0-3, m0)
boolean
C0475440 (UMLS CUI [1])
C0746319 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C0474926 (UMLS CUI [3])
Estrogen receptor positive | Progesterone receptor positive | HER2 Negative
Item
must have er/pr positive and her2 negative
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
C2348908 (UMLS CUI [3])
Disease TNM Breast tumor staging | Tumor size
Item
must have full staging and extent disease and clinically and radiographically tumor measure
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
Prior Therapy Absent Breast Carcinoma | Operative Surgical Procedure Absent | Hormone Therapy Absent | Chemotherapy Absent
Item
without previous treatment for breast cancer (including surgery, hormonotherapy or chemotherapy)
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Liver function tests normal | Kidney Function Tests Normal | Blood test normal
Item
normal liver, kidney and blood tests
boolean
C0438235 (UMLS CUI [1])
C0022662 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0919709 (UMLS CUI [3])
ECOG performance status | Karnofsky Performance Status
Item
performance status ecog 0-2 o karnofsky ≥70%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Glucose measurement, fasting
Item
fasten glucose levels <125 mg/dl
boolean
C0202045 (UMLS CUI [1])
Informed Consent
Item
signed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
metformin
Item
previous use of metformin for any indication
boolean
C0025598 (UMLS CUI [1])
Diabetes Mellitus
Item
presence of diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
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