ID

16452

Description

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

Lien

https://clinicaltrials.gov/show/NCT00243698

Mots-clés

  1. 17/07/2016 17/07/2016 -
Téléchargé le

17 juillet 2016

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Breast Tumors NCT00243698

Eligibility Breast Tumors NCT00243698

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

age

Type de données

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.
Description

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

Type de données

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.
Description

biopsy or surgery

Type de données

boolean

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

Exclusion Criteria

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

biopsy on the lesion

Type de données

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)
Description

contraindication to perform a contrast-enhanced mri examination

Type de données

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
Description

investigational drug, study subject participation status

Type de données

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)
Description

comorbidities

Type de données

boolean

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

pregnant or nursing female

Type de données

boolean

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

coronary syndrome

Type de données

boolean

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

unstable angina and myocardial infarction

Type de données

boolean

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

acute cardiac failure

Type de données

boolean

Alias
UMLS CUI [1]
C0264714
severe rhythm disorders
Description

arrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0003811
acute endocarditis
Description

acute endocarditis

Type de données

boolean

Alias
UMLS CUI [1]
C0014118
prosthetic valves
Description

prosthetic valves

Type de données

boolean

Alias
UMLS CUI [1]
C0336548

Similar models

Eligibility Breast Tumors NCT00243698

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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