ID

26888

Description

Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00955890

Link

https://clinicaltrials.gov/show/NCT00955890

Keywords

Versions (1)
  1. 10/27/17 10/27/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00955890

English

Eligibility Breast Cancer NCT00955890

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease characteristics:
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
histologically confirmed primary infiltrating adenocarcinoma of the breast
Description

Breast adenocarcinoma Invasive Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0205225
confirmed by core needle biopsy or incisional biopsy or surgery
Description

Core needle biopsy | Incisional biopsy | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C1318309
UMLS CUI [2]
C0184922
UMLS CUI [3]
C0543467
experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
Description

Cardiotoxicity CTCAE Grades | Chemotherapy | Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C0876994
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0282564
at least 2 cycles same anthracycline based chemotherapy are needed
Description

Chemotherapy cycle Quantity | Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0282564
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
accumulated dose of epi ≥1000mg/m2,adm≥550mg/m2
Description

Epinephrine Dosage Accumulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0014563
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C4055506
with the following risk factors: uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); prior or concurrent radiation to heart
Description

Risk factors | Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Pharmacotherapy Congestive heart failure | Uncontrolled hypertension | Irradiation of heart

Data type

boolean

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0018802
UMLS CUI [6]
C1868885
UMLS CUI [7]
C2169053
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other currently active malignancy except nonmelanoma skin cancer
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
uncontrolled or severe bleeding,diarrhea,intestinal obstruction
Description

Bleeding uncontrolled | Hemorrhage Severe | Diarrhea | Intestinal Obstruction

Data type

boolean

Alias
UMLS CUI [1]
C3842135
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0011991
UMLS CUI [4]
C0021843
grade 2 or more cardiac toxicity (ctc ae3.0)
Description

Cardiotoxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0876994
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Breast Cancer NCT00955890

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
disease characteristic
Item
disease characteristics:
boolean
C0599878 (UMLS CUI [1])
Breast adenocarcinoma Invasive Primary
Item
histologically confirmed primary infiltrating adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Core needle biopsy | Incisional biopsy | Operative Surgical Procedures
Item
confirmed by core needle biopsy or incisional biopsy or surgery
boolean
C1318309 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Cardiotoxicity CTCAE Grades | Chemotherapy | Anthracyclines
Item
experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
boolean
C0876994 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0282564 (UMLS CUI [3])
Chemotherapy cycle Quantity | Anthracyclines
Item
at least 2 cycles same anthracycline based chemotherapy are needed
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Epinephrine Dosage Accumulation
Item
accumulated dose of epi ≥1000mg/m2,adm≥550mg/m2
boolean
C0014563 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C4055506 (UMLS CUI [1,3])
Risk factors | Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Pharmacotherapy Congestive heart failure | Uncontrolled hypertension | Irradiation of heart
Item
with the following risk factors: uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); prior or concurrent radiation to heart
boolean
C0035648 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0013216 (UMLS CUI [5,1])
C0018802 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
C2169053 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma
Item
other currently active malignancy except nonmelanoma skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Bleeding uncontrolled | Hemorrhage Severe | Diarrhea | Intestinal Obstruction
Item
uncontrolled or severe bleeding,diarrhea,intestinal obstruction
boolean
C3842135 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0011991 (UMLS CUI [3])
C0021843 (UMLS CUI [4])
Cardiotoxicity CTCAE Grades
Item
grade 2 or more cardiac toxicity (ctc ae3.0)
boolean
C0876994 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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