ID

21983

Beskrivning

Neuroprotection With Riluzole Patients With Early Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00501943

Länk

https://clinicaltrials.gov/show/NCT00501943

Nyckelord

Versioner (1)
  1. 2017-05-12 2017-05-12 -
Uppladdad den

12 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00501943

Engelsk

Eligibility Multiple Sclerosis NCT00501943

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must give written informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with a early ms or clinically isolated syndromes (cis) in the past 12 months as defined by an acute or sub-acute episode suggestive of demyelination affecting the optic nerves, brain stem or spinal cord or other central nervous system location.
Beskrivning

Multiple Sclerosis Early | Clinically isolated syndrome | Episode Suggestive of Demyelination | Demyelination Affecting Optic Nerve | Demyelination Affecting Brain Stem | Demyelination Affecting Spinal Cord | Demyelination Affecting Central Nervous System Location

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C1279919
UMLS CUI [2]
C2921627
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0011304
UMLS CUI [4,1]
C0011304
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0029130
UMLS CUI [5,1]
C0011304
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0006121
UMLS CUI [6,1]
C0011304
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0037925
UMLS CUI [7,1]
C0011304
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C3714787
UMLS CUI [7,4]
C0450429
3. entry age 18-55
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. males and females
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
5. at least 2 silent t2 bright areas in the deep white matter on screening brain mri.
Beskrivning

Magnetic resonance imaging of brain: T2 weighted White matter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2238849
UMLS CUI [1,2]
C0682708
6. no riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label immunosuppressive drugs for ms prior to study entry
Beskrivning

Riluzole | Interferon | Copaxone | Cyclophosphamide | Mitoxantrone | Immunosuppressive Agents Off-label | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0073379
UMLS CUI [2]
C0021747
UMLS CUI [3]
C0528175
UMLS CUI [4]
C0010583
UMLS CUI [5]
C0026259
UMLS CUI [6,1]
C0021081
UMLS CUI [6,2]
C2986467
UMLS CUI [7]
C0026769
7. no corticosteroid during the 4 weeks prior to baseline mri exam
Beskrivning

Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
8. no prior exposure to total lymphoid irradiation
Beskrivning

Lymphatic Irradiation Total Exposure to

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024230
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0332157
9. no history of substance abuse, including documented alcohol dependence within 6 months prior to screening or alcohol liver damage with ast , alt > twice upper normal limits
Beskrivning

Substance Use Disorders | Alcoholic Intoxication, Chronic | Alcoholic liver damage | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0001973
UMLS CUI [3]
C1442981
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
10. no pregnant or nursing patients
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. no history of systemic illness or medical condition that would limit the likelihood of completing the gadolinium-enhanced mri procedures. automatic exclusionary conditions will include hypersensitivity reaction to riluzole or any of the tablets components, uncontrolled hypertension, epilepsy, and insulin dependent diabetes, asthma, known malignancy other than skin cancer, symptomatic cardiac disease or metallic objects on or inside the body.
Beskrivning

Systemic disease MRI gadolinium-enhanced Limited | Medical condition MRI gadolinium-enhanced Limited | Hypersensitivity Riluzole | Hypersensitivity Riluzole Component | Uncontrolled hypertension | Epilepsy | Diabetes Mellitus, Insulin-Dependent | Asthma | Malignant Neoplasms | Skin carcinoma | Heart Disease Symptomatic | Metallic Object Body

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0855566
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0855566
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0073379
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0073379
UMLS CUI [4,3]
C1705248
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0014544
UMLS CUI [7]
C0011854
UMLS CUI [8]
C0004096
UMLS CUI [9]
C0006826
UMLS CUI [10]
C0699893
UMLS CUI [11,1]
C0018799
UMLS CUI [11,2]
C0231220
UMLS CUI [12,1]
C2826620
UMLS CUI [12,2]
C0242821
12. patients willing to use birth control during the study.
Beskrivning

Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
13. patients willing to go on avonex therapy 3 months after being randomized to study drug and no contra-indication to use of interferon therapy.
Beskrivning

Avonex Willing | Medical contraindication Interferon therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0594372
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0279030
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a history of major depression or psychosis.
Beskrivning

Major Depressive Disorder | Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0033975
2. a clinically significant ms exacerbation within 30 days of the screening
Beskrivning

Exacerbation of multiple sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0581392
3. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
4. abnormal screening liver function (ast or alt > twice the upper normal limit).
Beskrivning

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
5. patients receiving hepatotoxic medications such as drugs interfering with cyp 1a2.
Beskrivning

Pharmaceutical Preparations Hepatotoxic effect | Pharmaceutical Preparations Interfere with Cytochrome P-450 CYP1A2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0207509
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Similar models

Eligibility Multiple Sclerosis NCT00501943

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. patient must give written informed consent;
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis Early | Clinically isolated syndrome | Episode Suggestive of Demyelination | Demyelination Affecting Optic Nerve | Demyelination Affecting Brain Stem | Demyelination Affecting Spinal Cord | Demyelination Affecting Central Nervous System Location
Item
2. patients with a early ms or clinically isolated syndromes (cis) in the past 12 months as defined by an acute or sub-acute episode suggestive of demyelination affecting the optic nerves, brain stem or spinal cord or other central nervous system location.
boolean
C0026769 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C2921627 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0011304 (UMLS CUI [3,3])
C0011304 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0029130 (UMLS CUI [4,3])
C0011304 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0006121 (UMLS CUI [5,3])
C0011304 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0037925 (UMLS CUI [6,3])
C0011304 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C3714787 (UMLS CUI [7,3])
C0450429 (UMLS CUI [7,4])
Age
Item
3. entry age 18-55
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. males and females
boolean
C0079399 (UMLS CUI [1])
Magnetic resonance imaging of brain: T2 weighted White matter
Item
5. at least 2 silent t2 bright areas in the deep white matter on screening brain mri.
boolean
C2238849 (UMLS CUI [1,1])
C0682708 (UMLS CUI [1,2])
Riluzole | Interferon | Copaxone | Cyclophosphamide | Mitoxantrone | Immunosuppressive Agents Off-label | Multiple Sclerosis
Item
6. no riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label immunosuppressive drugs for ms prior to study entry
boolean
C0073379 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0528175 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C0021081 (UMLS CUI [6,1])
C2986467 (UMLS CUI [6,2])
C0026769 (UMLS CUI [7])
Adrenal Cortex Hormones
Item
7. no corticosteroid during the 4 weeks prior to baseline mri exam
boolean
C0001617 (UMLS CUI [1])
Lymphatic Irradiation Total Exposure to
Item
8. no prior exposure to total lymphoid irradiation
boolean
C0024230 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
Substance Use Disorders | Alcoholic Intoxication, Chronic | Alcoholic liver damage | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
9. no history of substance abuse, including documented alcohol dependence within 6 months prior to screening or alcohol liver damage with ast , alt > twice upper normal limits
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C1442981 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
10. no pregnant or nursing patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease MRI gadolinium-enhanced Limited | Medical condition MRI gadolinium-enhanced Limited | Hypersensitivity Riluzole | Hypersensitivity Riluzole Component | Uncontrolled hypertension | Epilepsy | Diabetes Mellitus, Insulin-Dependent | Asthma | Malignant Neoplasms | Skin carcinoma | Heart Disease Symptomatic | Metallic Object Body
Item
11. no history of systemic illness or medical condition that would limit the likelihood of completing the gadolinium-enhanced mri procedures. automatic exclusionary conditions will include hypersensitivity reaction to riluzole or any of the tablets components, uncontrolled hypertension, epilepsy, and insulin dependent diabetes, asthma, known malignancy other than skin cancer, symptomatic cardiac disease or metallic objects on or inside the body.
boolean
C0442893 (UMLS CUI [1,1])
C0855566 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0855566 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0073379 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0073379 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C1868885 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0011854 (UMLS CUI [7])
C0004096 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0699893 (UMLS CUI [10])
C0018799 (UMLS CUI [11,1])
C0231220 (UMLS CUI [11,2])
C2826620 (UMLS CUI [12,1])
C0242821 (UMLS CUI [12,2])
Contraceptive methods Willing
Item
12. patients willing to use birth control during the study.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Avonex Willing | Medical contraindication Interferon therapy
Item
13. patients willing to go on avonex therapy 3 months after being randomized to study drug and no contra-indication to use of interferon therapy.
boolean
C0594372 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Major Depressive Disorder | Psychotic Disorders
Item
1. a history of major depression or psychosis.
boolean
C1269683 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Exacerbation of multiple sclerosis
Item
2. a clinically significant ms exacerbation within 30 days of the screening
boolean
C0581392 (UMLS CUI [1])
Pregnancy
Item
3. pregnancy
boolean
C0032961 (UMLS CUI [1])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
4. abnormal screening liver function (ast or alt > twice the upper normal limit).
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Pharmaceutical Preparations Hepatotoxic effect | Pharmaceutical Preparations Interfere with Cytochrome P-450 CYP1A2
Item
5. patients receiving hepatotoxic medications such as drugs interfering with cyp 1a2.
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0207509 (UMLS CUI [2,3])
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