ID

38171

Beschrijving

Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT01938157

Link

https://clinicaltrials.gov/show/NCT01938157

Trefwoorden

  1. 24-09-19 24-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 september 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01938157

Eligibility Breast Cancer NCT01938157

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women at high-risk of breast cancer with an order for a clinical screening breast mri.
Beschrijving

Gender | High risk of Breast Carcinoma | MRI of breast Scheduled

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0344104
UMLS CUI [3,2]
C0205539
2. asymptomatic women.
Beschrijving

Gender Asymptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0231221
3. able to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
4. at least 21 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women with symptom such as palpable mass or nipple discharge.
Beschrijving

Symptoms | Palpable mass | Nipple discharge

Datatype

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0746412
UMLS CUI [3]
C0149741
2. women with mri/mra contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes.
Beschrijving

Medical contraindication MRI | Medical contraindication MRA | Artificial cardiac pacemaker | Aneurysm clip | Cochlear Implants | Metal foreign body in eye region

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0243032
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0179977
UMLS CUI [5]
C0009199
UMLS CUI [6]
C0562528
3. women who have had a moderate or severe contrast reaction to intravenous gadolinium-dtpa.
Beschrijving

Contrast media reaction Moderate Gadolinium DTPA Intravenous | Contrast media reaction Severe Gadolinium DTPA Intravenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853800
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0060933
UMLS CUI [1,4]
C1522726
UMLS CUI [2,1]
C0853800
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0060933
UMLS CUI [2,4]
C1522726
4. women who are not able to give consent.
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
5. women diagnosed with breast cancer within the last 6 months.
Beschrijving

Breast Carcinoma Newly Diagnosed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1518321
6. women who are pregnant.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
7. male patients.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399

Similar models

Eligibility Breast Cancer NCT01938157

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | High risk of Breast Carcinoma | MRI of breast Scheduled
Item
1. women at high-risk of breast cancer with an order for a clinical screening breast mri.
boolean
C0079399 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0344104 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Gender Asymptomatic
Item
2. asymptomatic women.
boolean
C0079399 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
Informed Consent
Item
3. able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. at least 21 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Symptoms | Palpable mass | Nipple discharge
Item
1. women with symptom such as palpable mass or nipple discharge.
boolean
C1457887 (UMLS CUI [1])
C0746412 (UMLS CUI [2])
C0149741 (UMLS CUI [3])
Medical contraindication MRI | Medical contraindication MRA | Artificial cardiac pacemaker | Aneurysm clip | Cochlear Implants | Metal foreign body in eye region
Item
2. women with mri/mra contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0243032 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
C0179977 (UMLS CUI [4])
C0009199 (UMLS CUI [5])
C0562528 (UMLS CUI [6])
Contrast media reaction Moderate Gadolinium DTPA Intravenous | Contrast media reaction Severe Gadolinium DTPA Intravenous
Item
3. women who have had a moderate or severe contrast reaction to intravenous gadolinium-dtpa.
boolean
C0853800 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0060933 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
C0853800 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0060933 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
Informed Consent Unable
Item
4. women who are not able to give consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Breast Carcinoma Newly Diagnosed
Item
5. women diagnosed with breast cancer within the last 6 months.
boolean
C0678222 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Pregnancy
Item
6. women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Gender
Item
7. male patients.
boolean
C0079399 (UMLS CUI [1])

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