ID

38216

Description

Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02472353

Link

https://clinicaltrials.gov/show/NCT02472353

Keywords

Versions (1)
  1. 9/28/19 9/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02472353

English

Eligibility Breast Cancer NCT02472353

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin
Description

Breast Carcinoma | Requirement Doxorubicin Neoadjuvant Therapy | Requirement Doxorubicin Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013089
UMLS CUI [2,3]
C0600558
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0013089
UMLS CUI [3,3]
C0677850
complete metabolic panel demonstrating adequate organ functions as defined by the following: ast less than 2.5 times uln; alt less than 2.5 times uln; alkaline phosphatase less than 2.5 times uln; serum creatinine less than 1.5 mg/dl; serum bilirubin less than uln
Description

Metabolic Panel Complete | Organ function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C4281808
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0678852
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0201976
UMLS CUI [7]
C1278039
ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age greater than or equal to 21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
history of cardiac arrhythmias or symptomatic cardiac disease
Description

Cardiac Arrhythmia | Heart Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0231220
currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications
Description

Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists | Pharmaceutical Preparations Heart rate Control

Data type

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2]
C0304516
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0018810
UMLS CUI [3,3]
C2587213
currently taking metformin and/or sulfonylureas
Description

Metformin | Sulfonylureas

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
known hypersensitivity or intolerance to metformin
Description

Metformin allergy | intolerance to Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
baseline ejection fraction of less than 50% measured by echocardiogram
Description

Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
known hypersensitivity to contrast used during echocardiogram
Description

Contrast media allergy | Contrast echocardiography Related

Data type

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2,1]
C0013518
UMLS CUI [2,2]
C0439849
risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day)
Description

Risk factors | Risk Lactic Acidosis Metformin Induced | Congestive heart failure | Acidosis | Alcoholic Beverages U/day

Data type

boolean

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0001125
UMLS CUI [2,3]
C0025598
UMLS CUI [2,4]
C0205263
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0001122
UMLS CUI [5,1]
C0001967
UMLS CUI [5,2]
C0456683
pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02472353

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Requirement Doxorubicin Neoadjuvant Therapy | Requirement Doxorubicin Adjuvant therapy
Item
breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin
boolean
C0678222 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013089 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0013089 (UMLS CUI [3,2])
C0677850 (UMLS CUI [3,3])
Metabolic Panel Complete | Organ function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Serum total bilirubin measurement
Item
complete metabolic panel demonstrating adequate organ functions as defined by the following: ast less than 2.5 times uln; alt less than 2.5 times uln; alkaline phosphatase less than 2.5 times uln; serum creatinine less than 1.5 mg/dl; serum bilirubin less than uln
boolean
C4281808 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age greater than or equal to 21 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
known diabetes
boolean
C0011849 (UMLS CUI [1])
Cardiac Arrhythmia | Heart Disease Symptomatic
Item
history of cardiac arrhythmias or symptomatic cardiac disease
boolean
C0003811 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists | Pharmaceutical Preparations Heart rate Control
Item
currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications
boolean
C0003195 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0018810 (UMLS CUI [3,2])
C2587213 (UMLS CUI [3,3])
Metformin | Sulfonylureas
Item
currently taking metformin and/or sulfonylureas
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
Metformin allergy | intolerance to Metformin
Item
known hypersensitivity or intolerance to metformin
boolean
C0571648 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Cardiac ejection fraction Echocardiography
Item
baseline ejection fraction of less than 50% measured by echocardiogram
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Contrast media allergy | Contrast echocardiography Related
Item
known hypersensitivity to contrast used during echocardiogram
boolean
C0570562 (UMLS CUI [1])
C0013518 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Risk factors | Risk Lactic Acidosis Metformin Induced | Congestive heart failure | Acidosis | Alcoholic Beverages U/day
Item
risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day)
boolean
C0035648 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0001125 (UMLS CUI [2,2])
C0025598 (UMLS CUI [2,3])
C0205263 (UMLS CUI [2,4])
C0018802 (UMLS CUI [3])
C0001122 (UMLS CUI [4])
C0001967 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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