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ID

18274

Beschreibung

The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00094068

Link

https://clinicaltrials.gov/show/NCT00094068

Stichworte

  1. 27.10.16 27.10.16 -
  2. 27.10.16 27.10.16 -
Hochgeladen am

27. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Multiple Sclerosis NCT00094068

    Eligibility Multiple Sclerosis NCT00094068

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the nih volunteer office will be eligible for this study.
    Beschreibung

    Healthy Volunteers | Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2]
    C0001779
    all healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of cns disease, contraindications to a mri and have a "normal age appropriate" mri of the brain.
    Beschreibung

    Healthy Volunteers | CNS disorder Sign or Symptom | Medical contraindication Magnetic Resonance Imaging | MRI brain procedure Normal

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2,1]
    C0007682
    UMLS CUI [2,2]
    C3540840
    UMLS CUI [3,1]
    C1301624
    UMLS CUI [3,2]
    C0024485
    UMLS CUI [4,1]
    C0412675
    UMLS CUI [4,2]
    C0205307
    patients seen in the neuroimmunology ms clinic with a confirmed diagnosis of multiple sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of clinical and mri findings of a single enhancing lesion in the brain or spine along with multiple t2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the mcdonald criteria will be included in this study.
    Beschreibung

    Multiple Sclerosis | Attack Neurologic Quantity | Magnetic Resonance Imaging | Lesion of brain | Spinal Injuries | Focal T2 hyperintense brainstem lesion | White matter Cerebral cortex Adjacent | Periventricular white matter | White matter Infratentorial

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0026769
    UMLS CUI [2,1]
    C1304680
    UMLS CUI [2,2]
    C0205494
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3]
    C0024485
    UMLS CUI [4]
    C0221505
    UMLS CUI [5]
    C0037937
    UMLS CUI [6]
    C4022748
    UMLS CUI [7,1]
    C0682708
    UMLS CUI [7,2]
    C0007776
    UMLS CUI [7,3]
    C0205117
    UMLS CUI [8]
    C0228157
    UMLS CUI [9,1]
    C0682708
    UMLS CUI [9,2]
    C0441939
    relapsing-remitting or secondary progressive ms who have had more than one relapse within 18 months preceding study enrollment will be recruited from the ms 7th floor clinic in the ninds at the nih. ms patients will have edss score between 1.0 - 6.5, inclusive. ms patients seen and treated in the ninds ms clinic are representative of the general ms population that is female: male ratio of approximately 3:2, caucasian and african american, between ages of 18-55 years old.
    Beschreibung

    Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Relapse Quantity | Kurtzke multiple sclerosis rating scale | Gender | Caucasian American | African American | Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0751967
    UMLS CUI [2]
    C0751965
    UMLS CUI [3,1]
    C0035020
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [4]
    C0451246
    UMLS CUI [5]
    C0079399
    UMLS CUI [6]
    C0221786
    UMLS CUI [7]
    C0085756
    UMLS CUI [8]
    C0001779
    give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    healthy controls and ms patients will be excluded if they have contraindications to mr scanning, such as the following:
    Beschreibung

    Medical contraindication Magnetic Resonance Imaging

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    1. aneurysm clip
    Beschreibung

    Aneurysm clip

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0179977
    2. implanted neural stimulator
    Beschreibung

    Neurostimulator

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0582124
    3. implanted cardiac pacemaker or autodefibrillator
    Beschreibung

    Artificial cardiac pacemaker | cardiac defibrillator

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    UMLS CUI [2]
    C1391956
    4. cochlear implant
    Beschreibung

    Cochlear Implants

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009199
    5. ocular foreign body (e.g., metal shavings)
    Beschreibung

    Ocular Foreign Body

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3898107
    6. insulin pump
    Beschreibung

    insulin pump

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1140609
    healthy controls and ms patients will be excluded from this study if they have the following:
    Beschreibung

    Healthy Control Exclusion Criteria | Multiple Sclerosis Exclusion Criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2986479
    UMLS CUI [1,2]
    C0680251
    UMLS CUI [2,1]
    C0026769
    UMLS CUI [2,2]
    C0680251
    1. history of heart attack
    Beschreibung

    Myocardial Infarction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    2. history of treatment with nitrates for heart condition
    Beschreibung

    Nitrates Heart condition

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0028125
    UMLS CUI [1,2]
    C3842523
    3. history of carotid artery stenosis or evidence of greater than 50% carotid stenosis on screening mr angiogram
    Beschreibung

    Carotid Stenosis | Carotid Stenosis Percentage Evidence | Magnetic Resonance Angiography

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0007282
    UMLS CUI [2,1]
    C0007282
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [2,3]
    C3887511
    UMLS CUI [3]
    C0243032
    4. history of known vascular disease
    Beschreibung

    Vascular Diseases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042373
    5. history of stroke
    Beschreibung

    Cerebrovascular accident

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    6. history of migraine
    Beschreibung

    Migraine Disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149931
    7. subjects who have a history of a reaction to mr contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol.
    Beschreibung

    Allergic Reaction Magnetic resonance imaging contrast media | Allergic Reaction Gadopentetate Dimeglumine

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0180108
    UMLS CUI [2,1]
    C1527304
    UMLS CUI [2,2]
    C0060934
    8. healthy controls will be excluded if have history of alcohol or drug abuse.
    Beschreibung

    Substance Use Disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    9. healthy controls will be excluded if concurrent, clinically significant (as determined by the investigator) gastrointestinal, immunologic, pulmonary, neurologic, renal, and/or other major disease.
    Beschreibung

    Gastrointestinal Diseases Clinical Significance | Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0017178
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2,1]
    C0021053
    UMLS CUI [2,2]
    C2826293
    UMLS CUI [3,1]
    C0024115
    UMLS CUI [3,2]
    C2826293
    UMLS CUI [4,1]
    C0027765
    UMLS CUI [4,2]
    C2826293
    UMLS CUI [5,1]
    C0022658
    UMLS CUI [5,2]
    C2826293
    UMLS CUI [6,1]
    C0012634
    UMLS CUI [6,2]
    C0205164
    10. healthy controls will be excluded if they have a previous known abnormality on brain mri examination.
    Beschreibung

    MRI brain procedure Abnormality

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0412675
    UMLS CUI [1,2]
    C1704258
    11. pregnant and lactating women will be excluded from the study.
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    12. since certain drugs may interfere with the ability of the vessels in your brain to respond to viagra, subjects taking steroids or sildenafil (within 24 hours) will be excluded from this study.
    Beschreibung

    Steroids | sildenafil | Viagra

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038317
    UMLS CUI [2]
    C0529793
    UMLS CUI [3]
    C0663448
    ms patients will also be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
    Beschreibung

    Exclusion Criteria Multiple Sclerosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0026769
    1. pregnant and lactating women who are ms patients will be excluded from the study.
    Beschreibung

    Pregnancy | Breast Feeding | Multiple Sclerosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0026769
    2. diagnosis of primary progressive ms, defined as gradual progression of disability from the onset without relapses.
    Beschreibung

    Multiple Sclerosis, Primary Progressive | Gradual progression Disability | Relapse

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0751964
    UMLS CUI [2,1]
    C1854645
    UMLS CUI [2,2]
    C0231170
    UMLS CUI [3]
    C0035020
    3. concurrent, clinically significant (as determined by the investigator) immunologic, pulmonary, gastrointestinal, neurologic, renal, and/or other major disease in ms patients.
    Beschreibung

    Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | Gastrointestinal Diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major | Multiple Sclerosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021053
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2,1]
    C0024115
    UMLS CUI [2,2]
    C2826293
    UMLS CUI [3,1]
    C0017178
    UMLS CUI [3,2]
    C2826293
    UMLS CUI [4,1]
    C0027765
    UMLS CUI [4,2]
    C2826293
    UMLS CUI [5,1]
    C0022658
    UMLS CUI [5,2]
    C2826293
    UMLS CUI [6,1]
    C0012634
    UMLS CUI [6,2]
    C0205164
    UMLS CUI [7]
    C0026769
    treatment history in ms patients
    Beschreibung

    Therapeutic procedure Multiple Sclerosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0026769
    if prior treatment with steroids was received, the subject must have been off treatment for the required period prior to enrollment (see below).
    Beschreibung

    Steroids To be stopped

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0038317
    UMLS CUI [1,2]
    C1272691
    agent: corticosteroids
    Beschreibung

    Adrenal Cortex Hormones

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    time required off agent prior to enrollment: 8 weeks
    Beschreibung

    Period Requirement Pharmaceutical Preparations To be stopped

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1948053
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0013227
    UMLS CUI [1,4]
    C1272691
    unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits to the ninds, neuroimmunology clinic will be sufficient reason to exclude a subject.
    Beschreibung

    Protocol Compliance Unwilling | Condition Affecting Follow-up visits

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0589121

    Ähnliche Modelle

    Eligibility Multiple Sclerosis NCT00094068

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Healthy Volunteers | Age
    Item
    any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the nih volunteer office will be eligible for this study.
    boolean
    C1708335 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Healthy Volunteers | CNS disorder Sign or Symptom | Medical contraindication Magnetic Resonance Imaging | MRI brain procedure Normal
    Item
    all healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of cns disease, contraindications to a mri and have a "normal age appropriate" mri of the brain.
    boolean
    C1708335 (UMLS CUI [1])
    C0007682 (UMLS CUI [2,1])
    C3540840 (UMLS CUI [2,2])
    C1301624 (UMLS CUI [3,1])
    C0024485 (UMLS CUI [3,2])
    C0412675 (UMLS CUI [4,1])
    C0205307 (UMLS CUI [4,2])
    Multiple Sclerosis | Attack Neurologic Quantity | Magnetic Resonance Imaging | Lesion of brain | Spinal Injuries | Focal T2 hyperintense brainstem lesion | White matter Cerebral cortex Adjacent | Periventricular white matter | White matter Infratentorial
    Item
    patients seen in the neuroimmunology ms clinic with a confirmed diagnosis of multiple sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of clinical and mri findings of a single enhancing lesion in the brain or spine along with multiple t2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the mcdonald criteria will be included in this study.
    boolean
    C0026769 (UMLS CUI [1])
    C1304680 (UMLS CUI [2,1])
    C0205494 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C0024485 (UMLS CUI [3])
    C0221505 (UMLS CUI [4])
    C0037937 (UMLS CUI [5])
    C4022748 (UMLS CUI [6])
    C0682708 (UMLS CUI [7,1])
    C0007776 (UMLS CUI [7,2])
    C0205117 (UMLS CUI [7,3])
    C0228157 (UMLS CUI [8])
    C0682708 (UMLS CUI [9,1])
    C0441939 (UMLS CUI [9,2])
    Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Relapse Quantity | Kurtzke multiple sclerosis rating scale | Gender | Caucasian American | African American | Age
    Item
    relapsing-remitting or secondary progressive ms who have had more than one relapse within 18 months preceding study enrollment will be recruited from the ms 7th floor clinic in the ninds at the nih. ms patients will have edss score between 1.0 - 6.5, inclusive. ms patients seen and treated in the ninds ms clinic are representative of the general ms population that is female: male ratio of approximately 3:2, caucasian and african american, between ages of 18-55 years old.
    boolean
    C0751967 (UMLS CUI [1])
    C0751965 (UMLS CUI [2])
    C0035020 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0451246 (UMLS CUI [4])
    C0079399 (UMLS CUI [5])
    C0221786 (UMLS CUI [6])
    C0085756 (UMLS CUI [7])
    C0001779 (UMLS CUI [8])
    Informed Consent
    Item
    give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication Magnetic Resonance Imaging
    Item
    healthy controls and ms patients will be excluded if they have contraindications to mr scanning, such as the following:
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    Aneurysm clip
    Item
    1. aneurysm clip
    boolean
    C0179977 (UMLS CUI [1])
    Neurostimulator
    Item
    2. implanted neural stimulator
    boolean
    C0582124 (UMLS CUI [1])
    Artificial cardiac pacemaker | cardiac defibrillator
    Item
    3. implanted cardiac pacemaker or autodefibrillator
    boolean
    C0030163 (UMLS CUI [1])
    C1391956 (UMLS CUI [2])
    Cochlear Implants
    Item
    4. cochlear implant
    boolean
    C0009199 (UMLS CUI [1])
    Ocular Foreign Body
    Item
    5. ocular foreign body (e.g., metal shavings)
    boolean
    C3898107 (UMLS CUI [1])
    insulin pump
    Item
    6. insulin pump
    boolean
    C1140609 (UMLS CUI [1])
    Healthy Control Exclusion Criteria | Multiple Sclerosis Exclusion Criteria
    Item
    healthy controls and ms patients will be excluded from this study if they have the following:
    boolean
    C2986479 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    C0026769 (UMLS CUI [2,1])
    C0680251 (UMLS CUI [2,2])
    Myocardial Infarction
    Item
    1. history of heart attack
    boolean
    C0027051 (UMLS CUI [1])
    Nitrates Heart condition
    Item
    2. history of treatment with nitrates for heart condition
    boolean
    C0028125 (UMLS CUI [1,1])
    C3842523 (UMLS CUI [1,2])
    Carotid Stenosis | Carotid Stenosis Percentage Evidence | Magnetic Resonance Angiography
    Item
    3. history of carotid artery stenosis or evidence of greater than 50% carotid stenosis on screening mr angiogram
    boolean
    C0007282 (UMLS CUI [1])
    C0007282 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C3887511 (UMLS CUI [2,3])
    C0243032 (UMLS CUI [3])
    Vascular Diseases
    Item
    4. history of known vascular disease
    boolean
    C0042373 (UMLS CUI [1])
    Cerebrovascular accident
    Item
    5. history of stroke
    boolean
    C0038454 (UMLS CUI [1])
    Migraine Disorders
    Item
    6. history of migraine
    boolean
    C0149931 (UMLS CUI [1])
    Allergic Reaction Magnetic resonance imaging contrast media | Allergic Reaction Gadopentetate Dimeglumine
    Item
    7. subjects who have a history of a reaction to mr contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol.
    boolean
    C1527304 (UMLS CUI [1,1])
    C0180108 (UMLS CUI [1,2])
    C1527304 (UMLS CUI [2,1])
    C0060934 (UMLS CUI [2,2])
    Substance Use Disorders
    Item
    8. healthy controls will be excluded if have history of alcohol or drug abuse.
    boolean
    C0038586 (UMLS CUI [1])
    Gastrointestinal Diseases Clinical Significance | Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major
    Item
    9. healthy controls will be excluded if concurrent, clinically significant (as determined by the investigator) gastrointestinal, immunologic, pulmonary, neurologic, renal, and/or other major disease.
    boolean
    C0017178 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0021053 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    C0024115 (UMLS CUI [3,1])
    C2826293 (UMLS CUI [3,2])
    C0027765 (UMLS CUI [4,1])
    C2826293 (UMLS CUI [4,2])
    C0022658 (UMLS CUI [5,1])
    C2826293 (UMLS CUI [5,2])
    C0012634 (UMLS CUI [6,1])
    C0205164 (UMLS CUI [6,2])
    MRI brain procedure Abnormality
    Item
    10. healthy controls will be excluded if they have a previous known abnormality on brain mri examination.
    boolean
    C0412675 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding
    Item
    11. pregnant and lactating women will be excluded from the study.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Steroids | sildenafil | Viagra
    Item
    12. since certain drugs may interfere with the ability of the vessels in your brain to respond to viagra, subjects taking steroids or sildenafil (within 24 hours) will be excluded from this study.
    boolean
    C0038317 (UMLS CUI [1])
    C0529793 (UMLS CUI [2])
    C0663448 (UMLS CUI [3])
    Exclusion Criteria Multiple Sclerosis
    Item
    ms patients will also be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
    boolean
    C0680251 (UMLS CUI [1,1])
    C0026769 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding | Multiple Sclerosis
    Item
    1. pregnant and lactating women who are ms patients will be excluded from the study.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0026769 (UMLS CUI [3])
    Multiple Sclerosis, Primary Progressive | Gradual progression Disability | Relapse
    Item
    2. diagnosis of primary progressive ms, defined as gradual progression of disability from the onset without relapses.
    boolean
    C0751964 (UMLS CUI [1])
    C1854645 (UMLS CUI [2,1])
    C0231170 (UMLS CUI [2,2])
    C0035020 (UMLS CUI [3])
    Immune System Diseases Clinical Significance | Lung diseases Clinical Significance | Gastrointestinal Diseases Clinical Significance | nervous system disorder Clinical Significance | Kidney Diseases Clinical Significance | Disease Major | Multiple Sclerosis
    Item
    3. concurrent, clinically significant (as determined by the investigator) immunologic, pulmonary, gastrointestinal, neurologic, renal, and/or other major disease in ms patients.
    boolean
    C0021053 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0024115 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    C0017178 (UMLS CUI [3,1])
    C2826293 (UMLS CUI [3,2])
    C0027765 (UMLS CUI [4,1])
    C2826293 (UMLS CUI [4,2])
    C0022658 (UMLS CUI [5,1])
    C2826293 (UMLS CUI [5,2])
    C0012634 (UMLS CUI [6,1])
    C0205164 (UMLS CUI [6,2])
    C0026769 (UMLS CUI [7])
    Therapeutic procedure Multiple Sclerosis
    Item
    treatment history in ms patients
    boolean
    C0087111 (UMLS CUI [1,1])
    C0026769 (UMLS CUI [1,2])
    Steroids To be stopped
    Item
    if prior treatment with steroids was received, the subject must have been off treatment for the required period prior to enrollment (see below).
    boolean
    C0038317 (UMLS CUI [1,1])
    C1272691 (UMLS CUI [1,2])
    Adrenal Cortex Hormones
    Item
    agent: corticosteroids
    boolean
    C0001617 (UMLS CUI [1])
    Period Requirement Pharmaceutical Preparations To be stopped
    Item
    time required off agent prior to enrollment: 8 weeks
    boolean
    C1948053 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    C1272691 (UMLS CUI [1,4])
    Protocol Compliance Unwilling | Condition Affecting Follow-up visits
    Item
    unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits to the ninds, neuroimmunology clinic will be sufficient reason to exclude a subject.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0348080 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0589121 (UMLS CUI [2,3])

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