ID

18295

Descripción

Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks; ODM derived from: https://clinicaltrials.gov/show/NCT00418145

Link

https://clinicaltrials.gov/show/NCT00418145

Palabras clave

Versiones (1)
  1. 28/10/16 28/10/16 -
Subido en

28 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00418145

Inglés

Eligibility Multiple Sclerosis NCT00418145

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
between the ages of 18 and 50 years, inclusive.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
acute symptomatic exacerbation of ms present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
Descripción

Multiple Sclerosis Worsening Symptomatic | New or Worsening Symptom | Fever Absent | Communicable Disease Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0332271
UMLS CUI [1,3]
C0231220
UMLS CUI [2]
C3898139
UMLS CUI [3,1]
C0015967
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0332197
diagnosis of a relapsing form of multiple sclerosis before randomization as determined by poser or mcdonald criteria.
Descripción

Multiple Sclerosis, Acute Relapsing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393664
expanded disability status scale (edss) score between 2 and 6.5, inclusive at entry.
Descripción

EDSS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451246
episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
Descripción

Optic Neuritis | Cerebellar Diseases | Brain Stem Dysfunction | Myelitis | brain dysfunction Focal | Dysfunction Sensory Focal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029134
UMLS CUI [2]
C0007760
UMLS CUI [3,1]
C0006121
UMLS CUI [3,2]
C3887504
UMLS CUI [4]
C0026975
UMLS CUI [5,1]
C0262405
UMLS CUI [5,2]
C0205234
UMLS CUI [6,1]
C3887504
UMLS CUI [6,2]
C0445254
UMLS CUI [6,3]
C0205234
new objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. sensory deficits alone will not qualify except for optic neuritis.
Descripción

Signs and Symptoms New | Worsening Sensory | Intestines Signs and Symptoms | Bladder Signs and Symptoms | Optic Neuritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0445254
UMLS CUI [3,1]
C0021853
UMLS CUI [3,2]
C0037088
UMLS CUI [4,1]
C0005682
UMLS CUI [4,2]
C0037088
UMLS CUI [5]
C0029134
subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
Descripción

Immunomodulation | Interferons | glatiramer acetate | Pregnancy Immunomodulation To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0021747
UMLS CUI [3]
C0289884
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C1963758
UMLS CUI [4,3]
C1272691
understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Descripción

Informed Consent | Screening test | Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0871311
UMLS CUI [3]
C1261322
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any patients treated with systemic corticosteroid use within one month of the index episode at screening.
Descripción

Systemic Corticosteroid Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4053960
prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, ivig) or plasmapheresis.
Descripción

Therapeutic immunosuppression | Mitoxantrone | Azathioprine | Immunoglobulins, Intravenous | Plasmapheresis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0004482
UMLS CUI [4]
C0085297
UMLS CUI [5]
C0032134
any patient who is pregnant or breastfeeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to perform the multiple sclerosis functional composite consisting of: timed 25-foot walk, 9-hole peg test, and paced auditory serial addition test (3 second).
Descripción

Multiple Sclerosis Test Functional | Timed 25-Foot Walk Functional Test Unable | Time to Complete 9-Hole Peg Test Unable | Paced auditory serial addition test Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0205245
UMLS CUI [2,1]
C3897356
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C3898195
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0589060
UMLS CUI [4,2]
C1299582
peripheral or cranial neuropathy as sole problem of acute episode.
Descripción

Peripheral Neuropathy | Cranial nerve diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0010266
history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
Descripción

Heart Disease Significant | Gastrointestinal Disease Significant | Liver disease Significant | Lung disease Significant | Kidney Disease Significant | Immune Deficiency Disease | Medical condition Excludes Steroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C0750502
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0750502
UMLS CUI [6]
C1855771
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0332196
UMLS CUI [7,3]
C0149783
primary progressive multiple sclerosis (ppms).
Descripción

Multiple Sclerosis, Primary Progressive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751964
previous participation in this study.
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Sclerosis NCT00418145

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between the ages of 18 and 50 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis Worsening Symptomatic | New or Worsening Symptom | Fever Absent | Communicable Disease Absent
Item
acute symptomatic exacerbation of ms present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
boolean
C0026769 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C3898139 (UMLS CUI [2])
C0015967 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Multiple Sclerosis, Acute Relapsing
Item
diagnosis of a relapsing form of multiple sclerosis before randomization as determined by poser or mcdonald criteria.
boolean
C0393664 (UMLS CUI [1])
EDSS
Item
expanded disability status scale (edss) score between 2 and 6.5, inclusive at entry.
boolean
C0451246 (UMLS CUI [1])
Optic Neuritis | Cerebellar Diseases | Brain Stem Dysfunction | Myelitis | brain dysfunction Focal | Dysfunction Sensory Focal
Item
episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
boolean
C0029134 (UMLS CUI [1])
C0007760 (UMLS CUI [2])
C0006121 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0026975 (UMLS CUI [4])
C0262405 (UMLS CUI [5,1])
C0205234 (UMLS CUI [5,2])
C3887504 (UMLS CUI [6,1])
C0445254 (UMLS CUI [6,2])
C0205234 (UMLS CUI [6,3])
Signs and Symptoms New | Worsening Sensory | Intestines Signs and Symptoms | Bladder Signs and Symptoms | Optic Neuritis
Item
new objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. sensory deficits alone will not qualify except for optic neuritis.
boolean
C0037088 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332271 (UMLS CUI [2,1])
C0445254 (UMLS CUI [2,2])
C0021853 (UMLS CUI [3,1])
C0037088 (UMLS CUI [3,2])
C0005682 (UMLS CUI [4,1])
C0037088 (UMLS CUI [4,2])
C0029134 (UMLS CUI [5])
Immunomodulation | Interferons | glatiramer acetate | Pregnancy Immunomodulation To be stopped
Item
subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
boolean
C1963758 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C1963758 (UMLS CUI [4,2])
C1272691 (UMLS CUI [4,3])
Informed Consent | Screening test | Evaluation
Item
understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
boolean
C0021430 (UMLS CUI [1])
C0871311 (UMLS CUI [2])
C1261322 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systemic Corticosteroid Therapy
Item
any patients treated with systemic corticosteroid use within one month of the index episode at screening.
boolean
C4053960 (UMLS CUI [1])
Therapeutic immunosuppression | Mitoxantrone | Azathioprine | Immunoglobulins, Intravenous | Plasmapheresis
Item
prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, ivig) or plasmapheresis.
boolean
C0021079 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
C0032134 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
any patient who is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Multiple Sclerosis Test Functional | Timed 25-Foot Walk Functional Test Unable | Time to Complete 9-Hole Peg Test Unable | Paced auditory serial addition test Unable
Item
unable to perform the multiple sclerosis functional composite consisting of: timed 25-foot walk, 9-hole peg test, and paced auditory serial addition test (3 second).
boolean
C0026769 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
C3897356 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C3898195 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0589060 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Peripheral Neuropathy | Cranial nerve diseases
Item
peripheral or cranial neuropathy as sole problem of acute episode.
boolean
C0031117 (UMLS CUI [1])
C0010266 (UMLS CUI [2])
Heart Disease Significant | Gastrointestinal Disease Significant | Liver disease Significant | Lung disease Significant | Kidney Disease Significant | Immune Deficiency Disease | Medical condition Excludes Steroid therapy
Item
history of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0024115 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0750502 (UMLS CUI [5,2])
C1855771 (UMLS CUI [6])
C3843040 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0149783 (UMLS CUI [7,3])
Multiple Sclerosis, Primary Progressive
Item
primary progressive multiple sclerosis (ppms).
boolean
C0751964 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation in this study.
boolean
C2348568 (UMLS CUI [1])
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