ID

16452

Beschrijving

A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00243698

Link

https://clinicaltrials.gov/show/NCT00243698

Trefwoorden

  1. 17-07-16 17-07-16 -
Geüploaded op

17 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Tumors NCT00243698

Eligibility Breast Tumors NCT00243698

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or mri and/or united states (us) examination performed within 1 month before the study.
Beschrijving

enlarging fibroadenoma, suspect malignant nodule, microcalcification or a malignant nodule

Datatype

boolean

Alias
UMLS CUI [1]
C0178421
UMLS CUI [2]
C0948627
UMLS CUI [3]
C0520594
woman scheduled for biopsy or surgery within 1 month from the examination.
Beschrijving

biopsy or surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0405352
UMLS CUI [2]
C3714726
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have already performed a biopsy on the lesion during investigation
Beschrijving

biopsy on the lesion

Datatype

boolean

Alias
UMLS CUI [1]
C0405352
any contraindication to perform a contrast-enhanced mri examination for the patients presenting with a malignant nodule (size greater than 3 cm)
Beschrijving

contraindication to perform a contrast-enhanced mri examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C1707501
patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
Beschrijving

investigational drug, study subject participation status

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
Beschrijving

comorbidities

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or nursing female
Beschrijving

pregnant or nursing female

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
patient known to have a coronary syndrome
Beschrijving

coronary syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
unstable angina and myocardial infarction
Beschrijving

unstable angina and myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
acute cardiac failure, class iii/iv cardiac failure
Beschrijving

acute cardiac failure

Datatype

boolean

Alias
UMLS CUI [1]
C0264714
severe rhythm disorders
Beschrijving

arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
acute endocarditis
Beschrijving

acute endocarditis

Datatype

boolean

Alias
UMLS CUI [1]
C0014118
prosthetic valves
Beschrijving

prosthetic valves

Datatype

boolean

Alias
UMLS CUI [1]
C0336548

Similar models

Eligibility Breast Tumors NCT00243698

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
enlarging fibroadenoma, suspect malignant nodule, microcalcification or a malignant nodule
Item
woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or mri and/or united states (us) examination performed within 1 month before the study.
boolean
C0178421 (UMLS CUI [1])
C0948627 (UMLS CUI [2])
C0520594 (UMLS CUI [3])
biopsy or surgery
Item
woman scheduled for biopsy or surgery within 1 month from the examination.
boolean
C0405352 (UMLS CUI [1])
C3714726 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
biopsy on the lesion
Item
patients who have already performed a biopsy on the lesion during investigation
boolean
C0405352 (UMLS CUI [1])
contraindication to perform a contrast-enhanced mri examination
Item
any contraindication to perform a contrast-enhanced mri examination for the patients presenting with a malignant nodule (size greater than 3 cm)
boolean
C0522473 (UMLS CUI [1,1])
C1707501 (UMLS CUI [1,2])
investigational drug, study subject participation status
Item
patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
comorbidities
Item
patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons)
boolean
C0009488 (UMLS CUI [1])
pregnant or nursing female
Item
pregnant or nursing female
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
coronary syndrome
Item
patient known to have a coronary syndrome
boolean
C0948089 (UMLS CUI [1])
unstable angina and myocardial infarction
Item
unstable angina and myocardial infarction
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
acute cardiac failure
Item
acute cardiac failure, class iii/iv cardiac failure
boolean
C0264714 (UMLS CUI [1])
arrhythmia
Item
severe rhythm disorders
boolean
C0003811 (UMLS CUI [1])
acute endocarditis
Item
acute endocarditis
boolean
C0014118 (UMLS CUI [1])
prosthetic valves
Item
prosthetic valves
boolean
C0336548 (UMLS CUI [1])

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