ID

36515

Descripción

In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging; ODM derived from: https://clinicaltrials.gov/show/NCT02511028

Link

https://clinicaltrials.gov/show/NCT02511028

Palabras clave

Versiones (1)
  1. 19/5/19 19/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02511028

Inglés

Eligibility Multiple Sclerosis NCT02511028

1 formularios  
Criteria
Descripción

Criteria

age between 18 and 55, inclusive
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
able to give informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of multiple sclerosis according to revised mcdonald criteria (polman, reingold et al. 2011)
Descripción

Multiple Sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026769
a 7 tesla brain mri demonstrating at least one ms lesion with evidence of a paramagnetic rim
Descripción

MRI brain Tesla Quantity | Multiple Sclerosis Lesion Quantity | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0412675
UMLS CUI [1,2]
C1551055
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C3846158
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria:
Descripción

Exclusion Criteria General

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
screening labs demonstrating any value for hepatic or renal function levels out of the range of normal, to include ast, alt, bilirubin, alkaline phosphatase, creatinine, egfr
Descripción

Liver Dysfunction | Abnormal renal function | Aspartate aminotransferase abnormal | Alanine aminotransferase abnormal | Bilirubin abnormal | Alkaline phosphatase abnormal | Serum creatinine abnormal | Estimated Glomerular Filtration Rate Abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
UMLS CUI [3]
C0855623
UMLS CUI [4]
C0855619
UMLS CUI [5]
C1142335
UMLS CUI [6]
C0740888
UMLS CUI [7]
C0438243
UMLS CUI [8,1]
C3811844
UMLS CUI [8,2]
C0205161
evidence of polycythemia vera with hemoglobin levels more than 1 standard deviation above the nih laboratory s normal level
Descripción

Polycythemia Vera | Hemoglobin increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032463
UMLS CUI [2]
C0549448
iron overload syndromes, including hemochromatosis, or subjects with evidence of iron overload with a baseline ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%.
Descripción

Iron Overload | Hemochromatosis | Ferritin level | Transferrin saturation measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282193
UMLS CUI [2]
C0018995
UMLS CUI [3]
C0427405
UMLS CUI [4]
C1277709
previous or current alcohol and/or substance abuse per medical history or medical records
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
medical contraindications for mri (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not mri-compatible or cannot be removed)
Descripción

Medical contraindication MRI | Implants | Artificial cardiac pacemaker | Infusion Pump | Metallic implant | Metallic Object | Body Piercing Inconsistent MRI

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0021102
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0021436
UMLS CUI [5]
C3693688
UMLS CUI [6]
C2826620
UMLS CUI [7,1]
C0848128
UMLS CUI [7,2]
C0442809
UMLS CUI [7,3]
C0024485
psychological contraindications for mri (e.g., claustrophobia), to be assessed at the time the medical history is collected
Descripción

Contraindication Psychological MRI | Claustrophobia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0205486
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0008909
pregnancy or current breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
reported history of clinically significant impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the mri scanner
Descripción

Hearing impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1384666
known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions, anaphylaxis, to any drug
Descripción

Dextran allergy | Hypersensitivity Pharmaceutical Preparations Containing Iron salt | Severe allergic reaction Pharmaceutical Preparations | Anaphylaxis Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571755
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0302206
UMLS CUI [3,1]
C2220378
UMLS CUI [3,2]
C0013227
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0013227
clinically significant medical or neurological disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to diagnosis of certain types of cancer, cardiopulmonary conditions such as congestive heart failure, or uncontrolled hypertension
Descripción

Disease At risk Patient Harm | Nervous system disorder At risk Patient Harm | Disease Interferes with Research results | Nervous system disorder Interferes with Research results | Disease Preventing Completion of clinical trial | Nervous system disorder Preventing Completion of clinical trial | Malignant Neoplasms | Condition Cardiopulmonary | Congestive heart failure | Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C3658342
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C3658342
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C2732579
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0553534
UMLS CUI [9]
C0018802
UMLS CUI [10]
C1868885
additional patient exclusion criterion:
Descripción

Exclusion Criteria Additional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
4 or more gadolinium-enhancing lesions on the screening scan
Descripción

Gadolinium-Enhancing Lesion Quantity Screening CT scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0220908
UMLS CUI [1,4]
C0040405
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Similar models

Eligibility Multiple Sclerosis NCT02511028

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
age between 18 and 55, inclusive
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis
Item
diagnosis of multiple sclerosis according to revised mcdonald criteria (polman, reingold et al. 2011)
boolean
C0026769 (UMLS CUI [1])
MRI brain Tesla Quantity | Multiple Sclerosis Lesion Quantity | Other Coding
Item
a 7 tesla brain mri demonstrating at least one ms lesion with evidence of a paramagnetic rim
boolean
C0412675 (UMLS CUI [1,1])
C1551055 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0026769 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Liver Dysfunction | Abnormal renal function | Aspartate aminotransferase abnormal | Alanine aminotransferase abnormal | Bilirubin abnormal | Alkaline phosphatase abnormal | Serum creatinine abnormal | Estimated Glomerular Filtration Rate Abnormal
Item
screening labs demonstrating any value for hepatic or renal function levels out of the range of normal, to include ast, alt, bilirubin, alkaline phosphatase, creatinine, egfr
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
C0855623 (UMLS CUI [3])
C0855619 (UMLS CUI [4])
C1142335 (UMLS CUI [5])
C0740888 (UMLS CUI [6])
C0438243 (UMLS CUI [7])
C3811844 (UMLS CUI [8,1])
C0205161 (UMLS CUI [8,2])
Polycythemia Vera | Hemoglobin increased
Item
evidence of polycythemia vera with hemoglobin levels more than 1 standard deviation above the nih laboratory s normal level
boolean
C0032463 (UMLS CUI [1])
C0549448 (UMLS CUI [2])
Iron Overload | Hemochromatosis | Ferritin level | Transferrin saturation measurement
Item
iron overload syndromes, including hemochromatosis, or subjects with evidence of iron overload with a baseline ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%.
boolean
C0282193 (UMLS CUI [1])
C0018995 (UMLS CUI [2])
C0427405 (UMLS CUI [3])
C1277709 (UMLS CUI [4])
Substance Use Disorders
Item
previous or current alcohol and/or substance abuse per medical history or medical records
boolean
C0038586 (UMLS CUI [1])
Medical contraindication MRI | Implants | Artificial cardiac pacemaker | Infusion Pump | Metallic implant | Metallic Object | Body Piercing Inconsistent MRI
Item
medical contraindications for mri (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not mri-compatible or cannot be removed)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0021436 (UMLS CUI [4])
C3693688 (UMLS CUI [5])
C2826620 (UMLS CUI [6])
C0848128 (UMLS CUI [7,1])
C0442809 (UMLS CUI [7,2])
C0024485 (UMLS CUI [7,3])
Contraindication Psychological MRI | Claustrophobia
Item
psychological contraindications for mri (e.g., claustrophobia), to be assessed at the time the medical history is collected
boolean
C0522473 (UMLS CUI [1,1])
C0205486 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or current breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hearing impairment
Item
reported history of clinically significant impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the mri scanner
boolean
C1384666 (UMLS CUI [1])
Dextran allergy | Hypersensitivity Pharmaceutical Preparations Containing Iron salt | Severe allergic reaction Pharmaceutical Preparations | Anaphylaxis Pharmaceutical Preparations
Item
known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions, anaphylaxis, to any drug
boolean
C0571755 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0302206 (UMLS CUI [2,4])
C2220378 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
Disease At risk Patient Harm | Nervous system disorder At risk Patient Harm | Disease Interferes with Research results | Nervous system disorder Interferes with Research results | Disease Preventing Completion of clinical trial | Nervous system disorder Preventing Completion of clinical trial | Malignant Neoplasms | Condition Cardiopulmonary | Congestive heart failure | Uncontrolled hypertension
Item
clinically significant medical or neurological disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to diagnosis of certain types of cancer, cardiopulmonary conditions such as congestive heart failure, or uncontrolled hypertension
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C3658342 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C3658342 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0027765 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0027765 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])
C0006826 (UMLS CUI [7])
C0348080 (UMLS CUI [8,1])
C0553534 (UMLS CUI [8,2])
C0018802 (UMLS CUI [9])
C1868885 (UMLS CUI [10])
Exclusion Criteria Additional
Item
additional patient exclusion criterion:
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Gadolinium-Enhancing Lesion Quantity Screening CT scan
Item
4 or more gadolinium-enhancing lesions on the screening scan
boolean
C1333400 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
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