ID

38005

Beskrivning

Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01434134

Länk

https://clinicaltrials.gov/show/NCT01434134

Nyckelord

Versioner (1)
  1. 2019-09-07 2019-09-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01434134

Engelsk

Eligibility Breast Cancer NCT01434134

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged 18-70 years
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
eastern cooperative oncology group (ecog) performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine < 140 μmol/l or estimated creatinine clearance > 60 ml/min (using the modification of diet and renal disease (mdrd) formula)
Beskrivning

Creatinine measurement, serum | Creatinine clearance Estimated MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0812399
UMLS CUI [2,2]
C0750572
UMLS CUI [2,3]
C3839656
systolic blood pressure >= 110 mghg and < 170 mmhg
Beskrivning

Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
lvef >= 50%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypotension, defined as systolic blood pressure < 110 mmhg
Beskrivning

Hypotension | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
bradycardia, defined as heart rate < 50 b.p.m.
Beskrivning

Bradycardia | Heart rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0018810
prior anthracycline chemotherapy regimen
Beskrivning

Anthracycline Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0392920
prior malignancy requiring chemotherapy or radiotherapy
Beskrivning

Malignant Neoplasms Requirement Chemotherapy | Malignant Neoplasms Requirement Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1522449
symptomatic heart failure
Beskrivning

Heart failure Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
systolic dysfunction (lvef < 50%)
Beskrivning

Systolic dysfunction | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0749225
UMLS CUI [2]
C0428772
clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays.
Beskrivning

Coronary Artery Disease | Heart valve disease | Cardiac Arrhythmia | Conduction delay

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0018824
UMLS CUI [3]
C0003811
UMLS CUI [4]
C1398354
uncontrolled arterial hypertension defined as systolic blood pressure > 170 mm hg
Beskrivning

Uncontrolled hypertension | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
treatment with acei, arb or beta-blocker within the last 4 weeks prior to study start
Beskrivning

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists

Datatyp

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
UMLS CUI [3]
C0304516
intolerance to acei, arb or beta-blocker
Beskrivning

Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003015
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0521942
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0304516
uncontrolled concomitant serious illness
Beskrivning

Comorbidity Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active abuse of drugs or alcohol
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
suspected poor compliance
Beskrivning

Poor compliance Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0750491
inability to tolerate the mri scanning protocol
Beskrivning

MRI scan Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Breast Cancer NCT01434134

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged 18-70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance Estimated MDRD
Item
serum creatinine < 140 μmol/l or estimated creatinine clearance > 60 ml/min (using the modification of diet and renal disease (mdrd) formula)
boolean
C0201976 (UMLS CUI [1])
C0812399 (UMLS CUI [2,1])
C0750572 (UMLS CUI [2,2])
C3839656 (UMLS CUI [2,3])
Systolic Pressure
Item
systolic blood pressure >= 110 mghg and < 170 mmhg
boolean
C0871470 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef >= 50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypotension | Systolic Pressure
Item
hypotension, defined as systolic blood pressure < 110 mmhg
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Bradycardia | Heart rate
Item
bradycardia, defined as heart rate < 50 b.p.m.
boolean
C0428977 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
Anthracycline Chemotherapy Regimen
Item
prior anthracycline chemotherapy regimen
boolean
C0282564 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Malignant Neoplasms Requirement Chemotherapy | Malignant Neoplasms Requirement Therapeutic radiology procedure
Item
prior malignancy requiring chemotherapy or radiotherapy
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
Heart failure Symptomatic
Item
symptomatic heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Systolic dysfunction | Left ventricular ejection fraction
Item
systolic dysfunction (lvef < 50%)
boolean
C0749225 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Coronary Artery Disease | Heart valve disease | Cardiac Arrhythmia | Conduction delay
Item
clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays.
boolean
C1956346 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C1398354 (UMLS CUI [4])
Uncontrolled hypertension | Systolic Pressure
Item
uncontrolled arterial hypertension defined as systolic blood pressure > 170 mm hg
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists
Item
treatment with acei, arb or beta-blocker within the last 4 weeks prior to study start
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists
Item
intolerance to acei, arb or beta-blocker
boolean
C1744706 (UMLS CUI [1,1])
C0003015 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0304516 (UMLS CUI [3,2])
Comorbidity Serious Uncontrolled
Item
uncontrolled concomitant serious illness
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
active abuse of drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Poor compliance Suspected
Item
suspected poor compliance
boolean
C0032646 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
MRI scan Receive Unable
Item
inability to tolerate the mri scanning protocol
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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