ID

16226

Description

Preoperative Cisplatin in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148694

Link

https://clinicaltrials.gov/show/NCT00148694

Keywords

  1. 7/6/16 7/6/16 -
Uploaded on

July 6, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00148694

Eligibility Breast Cancer NCT00148694

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all tumors must be er-, pr- and her-2 negative.
Description

Triple Negative Breast Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C3539878
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of less than or equal to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count (anc) > 1,500/mm3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin > 9mm/dl
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
platelets > 100,000/mm3
Description

Blood Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
creatinine < 1.5mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
glucose < 200mg/dl
Description

Plasma Glucose Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202042
bilirubin < 1.5 x upper limit of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
sgot < 3.0 x uln
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy treatment
Description

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of serious illness, medical or psychiatric condition requiring medical management
Description

Illness Serious Requirement Disease Management | medical condition Requirement Disease Management | Mental disorders Requirement Disease Management

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0376636
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0376636
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0376636
uncontrolled infection
Description

Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
renal dysfunction
Description

Renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3279454
active or severe cardiovascular or pulmonary disease
Description

Cardiovascular Disease | Cardiovascular Disease Severe | Lung disease | Lung disease Severe

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0024115
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0205082
peripheral neuropathy of any etiology that exceeds grade 1
Description

Peripheral Neuropathy Etiology Grading

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0441800
prior history of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled diabetes
Description

DIABETES MELLITUS NOS UNCONTROLLED

Data type

boolean

Alias
UMLS CUI [1]
C0743131

Similar models

Eligibility Breast Cancer NCT00148694

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Triple Negative Breast Neoplasms
Item
all tumors must be er-, pr- and her-2 negative.
boolean
C3539878 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin > 9mm/dl
boolean
C0019046 (UMLS CUI [1])
Blood Platelets
Item
platelets > 100,000/mm3
boolean
C0005821 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 1.5mg/dl
boolean
C0201976 (UMLS CUI [1])
Plasma Glucose Measurement
Item
glucose < 200mg/dl
boolean
C0202042 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
sgot < 3.0 x uln
boolean
C0201899 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior chemotherapy
Item
prior chemotherapy treatment
boolean
C1514457 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Requirement Disease Management | medical condition Requirement Disease Management | Mental disorders Requirement Disease Management
Item
history of serious illness, medical or psychiatric condition requiring medical management
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0376636 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0376636 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0376636 (UMLS CUI [3,3])
Communicable Diseases Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Renal dysfunction
Item
renal dysfunction
boolean
C3279454 (UMLS CUI [1])
Cardiovascular Disease | Cardiovascular Disease Severe | Lung disease | Lung disease Severe
Item
active or severe cardiovascular or pulmonary disease
boolean
C0007222 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3])
C0024115 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Peripheral Neuropathy Etiology Grading
Item
peripheral neuropathy of any etiology that exceeds grade 1
boolean
C0031117 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Malignant Neoplasms
Item
prior history of malignancy
boolean
C0006826 (UMLS CUI [1])
DIABETES MELLITUS NOS UNCONTROLLED
Item
uncontrolled diabetes
boolean
C0743131 (UMLS CUI [1])

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