ID

16224

Description

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148668

Link

https://clinicaltrials.gov/show/NCT00148668

Keywords

Versions (1)
  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 NCT00148668

English

Eligibility Breast Cancer NCT00148668

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with stage ii or iii breast cancer
Description

Breast Carcinoma | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C3258246
her-2 positive tumors
Description

Malignant Neoplasms HER-2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1446409
older than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of greater or equal to 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
anc > 1,500/mm3
Description

Absolute neutrophil count

Data type

boolean

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

Hemoglobin

Data type

boolean

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

Blood Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
creatinine < 2mg/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 uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
Description

Herceptin | Taxanes, antineoplastic | Doxorubicin | Anthracycline Antibiotics | Navelbine | Therapeutic procedure Platinum-Based

Data type

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2]
C3541958
UMLS CUI [3]
C0013089
UMLS CUI [4]
C0003234
UMLS CUI [5]
C0131965
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1514162
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Illness Serious | medical condition | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3843040
UMLS CUI [3]
C0004936
uncontrolled infections
Description

Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
active or severe cardiovascular or pulmonary disease
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205177
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0205082
patients with left ventricular ejection fraction < 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
peripheral neuropathy of any etiology that exceeds grade 1
Description

Peripheral Neuropathy Etiology aspects 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
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Similar models

Eligibility Breast Cancer NCT00148668

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | TNM clinical staging
Item
patients with stage ii or iii breast cancer
boolean
C0678222 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Malignant Neoplasms HER-2 Positive
Item
her-2 positive tumors
boolean
C0006826 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
Age
Item
older than 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of greater or equal to 1.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
anc > 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin > 9gm/dl
boolean
C0019046 (UMLS CUI [1])
Blood Platelets
Item
platelets > 100,000mm3
boolean
C0005821 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 2mg/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 uln
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Herceptin | Taxanes, antineoplastic | Doxorubicin | Anthracycline Antibiotics | Navelbine | Therapeutic procedure Platinum-Based
Item
previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
boolean
C0338204 (UMLS CUI [1])
C3541958 (UMLS CUI [2])
C0013089 (UMLS CUI [3])
C0003234 (UMLS CUI [4])
C0131965 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1514162 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious | medical condition | Mental disorders
Item
serious illness, or medical or psychiatric condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Communicable Diseases Uncontrolled
Item
uncontrolled infections
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiovascular Disease Active | Cardiovascular Disease Severe | Lung disease Active | Lung disease Severe
Item
active or severe cardiovascular or pulmonary disease
boolean
C0007222 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Left ventricular ejection fraction
Item
patients with left ventricular ejection fraction < 50%
boolean
C0428772 (UMLS CUI [1])
Peripheral Neuropathy Etiology aspects 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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