ID

35090

Beschreibung

Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection; ODM derived from: https://clinicaltrials.gov/show/NCT02411760

Link

https://clinicaltrials.gov/show/NCT02411760

Stichworte

  1. 15.02.19 15.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. Februar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Neoplasms NCT02411760

Eligibility Breast Neoplasms NCT02411760

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with breast imaging-reporting and data system (bi-rads) 4 or 5 age ≥ 18 years ability to understand and the willingness to sign a written informed consent.
Beschreibung

Gender | BIRADS | Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1511314
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have had a needle biopsy of the suspicious area within the last 6 weeks subjects who have contraindication to contrast enhanced mri examination.
Beschreibung

Needle biopsy Area Suspicious | Medical contraindication Contrast-enhanced MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005560
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0750493
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1707501
contraindications to mri examinations include:
Beschreibung

Medical contraindications MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
medically unstable
Beschreibung

Unstable status Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205476
heart failure
Beschreibung

Heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
unstable angina
Beschreibung

Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
child bearing
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
lactating any contraindication per mri screening form (appendix a attached).
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
implants contraindicated at 3t, pacemakers
Beschreibung

Implants | Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
poorly controlled diabetes
Beschreibung

Poorly controlled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0554876
body weight greater than 300 pounds
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
claustrophobic since each patient is receiving a gadolinium based contrast agent intravenously:
Beschreibung

Claustrophobia | Gadolinium-based Contrast Agent Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C3249258
UMLS CUI [2,2]
C1522726
egfr < 60 ml/min/1.73m2
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
sickle cell disease
Beschreibung

Sickle Cell Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0002895
hemolytic anemia
Beschreibung

Anemia, Hemolytic

Datentyp

boolean

Alias
UMLS CUI [1]
C0002878
subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Breast Neoplasms NCT02411760

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | BIRADS | Age | Informed Consent
Item
women with breast imaging-reporting and data system (bi-rads) 4 or 5 age ≥ 18 years ability to understand and the willingness to sign a written informed consent.
boolean
C0079399 (UMLS CUI [1])
C1511314 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Needle biopsy Area Suspicious | Medical contraindication Contrast-enhanced MRI
Item
subjects who have had a needle biopsy of the suspicious area within the last 6 weeks subjects who have contraindication to contrast enhanced mri examination.
boolean
C0005560 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1707501 (UMLS CUI [2,2])
Medical contraindications MRI
Item
contraindications to mri examinations include:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Unstable status Medical
Item
medically unstable
boolean
C0443343 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Pregnancy
Item
child bearing
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactating any contraindication per mri screening form (appendix a attached).
boolean
C0006147 (UMLS CUI [1])
Implants | Artificial cardiac pacemaker
Item
implants contraindicated at 3t, pacemakers
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
Body Weight
Item
body weight greater than 300 pounds
boolean
C0005910 (UMLS CUI [1])
Claustrophobia | Gadolinium-based Contrast Agent Intravenous
Item
claustrophobic since each patient is receiving a gadolinium based contrast agent intravenously:
boolean
C0008909 (UMLS CUI [1])
C3249258 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Estimated Glomerular Filtration Rate
Item
egfr < 60 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Sickle Cell Disease
Item
sickle cell disease
boolean
C0002895 (UMLS CUI [1])
Anemia, Hemolytic
Item
hemolytic anemia
boolean
C0002878 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video