ID

30949

Beskrivning

Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00854750

Länk

https://clinicaltrials.gov/show/NCT00854750

Nyckelord

Versioner (1)
  1. 2018-07-06 2018-07-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00854750

Engelsk

Eligibility Multiple Sclerosis NCT00854750

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject has clinically or laboratory supported multiple sclerosis with evidence of ino by quantitative neurophysiologic criteria or has a history of on.
Beskrivning

Multiple Sclerosis | Internuclear Ophthalmoplegia | Optic Neuritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0152134
UMLS CUI [3]
C0029134
2. subject is between the ages of 18-65.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. subject is able to understand the demands of the protocol, has had any questions answered and has voluntarily signed the informed consent prior to any study procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. subject has a peak saccadic acceleration ratio (abducting eye/adducting eye) of greater than 2s.d. above the mean derived form a normal control group.
Beskrivning

Peak Saccadic Acceleration Ratio

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0444505
UMLS CUI [1,2]
C0036019
UMLS CUI [1,3]
C0000894
UMLS CUI [1,4]
C0456603
5. subject is otherwise in good health, based on complete medical history and physical examination, including vital signs and ecg.
Beskrivning

General health good Medical History | General health good Physical Examination | General health good Vital signs | General health good Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C0518766
UMLS CUI [4,1]
C1277245
UMLS CUI [4,2]
C1623258
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method.
Beskrivning

Pregnancy Urine pregnancy test | Breast Feeding | Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Injectable contraception | Contraceptive implant | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430056
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0015787
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0009905
UMLS CUI [6]
C1262153
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0004764
2. subject has a history of hypertension or diabetes.
Beskrivning

Hypertensive disease | Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0011849
3. subject has known allergy to acth.
Beskrivning

Hypersensitivity ACTH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001655
4. the subject has any medical condition, including psychiatric disease that might interfere with the interpretation of the results or with the conduct of the study.
Beskrivning

Medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Medical condition Interferes with Completion of clinical trial | Mental disorder Interferes with Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2732579
5. subject has a history of drug or ethanol abuse within the past year.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
6. subject has a history of ischemic heart disease.
Beskrivning

Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0151744
7. subject has received an investigational drug within 30 days of screening.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
8. in opinion of investigator, subject is unlikely to complete study for any reason.
Beskrivning

Study Subject Completion of clinical trial Unlikely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C0750558
9. the subject has abnormal clinical laboratory values or an abnormal ecg, without approval of the study monitor.
Beskrivning

Laboratory test result abnormal | Electrocardiogram abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
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Similar models

Eligibility Multiple Sclerosis NCT00854750

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis | Internuclear Ophthalmoplegia | Optic Neuritis
Item
1. subject has clinically or laboratory supported multiple sclerosis with evidence of ino by quantitative neurophysiologic criteria or has a history of on.
boolean
C0026769 (UMLS CUI [1])
C0152134 (UMLS CUI [2])
C0029134 (UMLS CUI [3])
Age
Item
2. subject is between the ages of 18-65.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. subject is able to understand the demands of the protocol, has had any questions answered and has voluntarily signed the informed consent prior to any study procedures.
boolean
C0021430 (UMLS CUI [1])
Peak Saccadic Acceleration Ratio
Item
4. subject has a peak saccadic acceleration ratio (abducting eye/adducting eye) of greater than 2s.d. above the mean derived form a normal control group.
boolean
C0444505 (UMLS CUI [1,1])
C0036019 (UMLS CUI [1,2])
C0000894 (UMLS CUI [1,3])
C0456603 (UMLS CUI [1,4])
General health good Medical History | General health good Physical Examination | General health good Vital signs | General health good Electrocardiography
Item
5. subject is otherwise in good health, based on complete medical history and physical examination, including vital signs and ecg.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C1623258 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy Urine pregnancy test | Breast Feeding | Childbearing Potential Female Sterilization Absent | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Injectable contraception | Contraceptive implant | Contraception, Barrier
Item
1. subject is a pregnant female (as determined by a urine pregnancy test), a lactating female, or a female of child-bearing potential, not sterilized and not using one of the following methods of birth control: oral or injectable contraceptive agent, implantable contraceptive device, or barrier method.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0015787 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0009905 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Hypertensive disease | Diabetes Mellitus
Item
2. subject has a history of hypertension or diabetes.
boolean
C0020538 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Hypersensitivity ACTH
Item
3. subject has known allergy to acth.
boolean
C0020517 (UMLS CUI [1,1])
C0001655 (UMLS CUI [1,2])
Medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Medical condition Interferes with Completion of clinical trial | Mental disorder Interferes with Completion of clinical trial
Item
4. the subject has any medical condition, including psychiatric disease that might interfere with the interpretation of the results or with the conduct of the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Substance Use Disorders
Item
5. subject has a history of drug or ethanol abuse within the past year.
boolean
C0038586 (UMLS CUI [1])
Myocardial Ischemia
Item
6. subject has a history of ischemic heart disease.
boolean
C0151744 (UMLS CUI [1])
Investigational New Drugs
Item
7. subject has received an investigational drug within 30 days of screening.
boolean
C0013230 (UMLS CUI [1])
Study Subject Completion of clinical trial Unlikely
Item
8. in opinion of investigator, subject is unlikely to complete study for any reason.
boolean
C0681850 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Laboratory test result abnormal | Electrocardiogram abnormal
Item
9. the subject has abnormal clinical laboratory values or an abnormal ecg, without approval of the study monitor.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
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