ID

36495

Description

Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02403570

Link

https://clinicaltrials.gov/show/NCT02403570

Keywords

Versions (1)
  1. 5/17/19 5/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02403570

English

Eligibility Multiple Sclerosis NCT02403570

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the diagnosis of relapsing remitting ms made according to the poser, mcdonald's or revised mcdonald's criteria (group i) before participating in the study
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
initial ms diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (group ii).
Description

Relapsing-Remitting Multiple Sclerosis Initial | Conversion | Multiple Sclerosis, Secondary Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0205265
UMLS CUI [2]
C0439836
UMLS CUI [3]
C0751965
mental status: patients must be able to understand the meaning of the study
Description

Mental state | Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0278060
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other autoimmune disease than ms requiring immunomodulatory or immunosuppressive medication
Description

Autoimmune Disease Requirement Biological Response Modifiers | Autoimmune Disease Requirement Immunosuppressive Agents | Exception Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0005525
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026769
high-dose corticosteroid treatment within 30 days before participating in the study
Description

Steroid therapy High dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0444956
prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease
Description

Cardiovascular Disease Serious | Liver disease Serious | Kidney Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205404
any psychiatric condition that compromises the subject's ability to participate in the study
Description

Mental condition compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
infections: patient must not have an uncontrolled serious infection
Description

Communicable Disease Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
no contraindications for mri (cardiac pacemaker, intracranial clips etc)
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Clips Intracranial

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0175722
UMLS CUI [3,2]
C0524466
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Similar models

Eligibility Multiple Sclerosis NCT02403570

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
the diagnosis of relapsing remitting ms made according to the poser, mcdonald's or revised mcdonald's criteria (group i) before participating in the study
boolean
C0751967 (UMLS CUI [1])
Relapsing-Remitting Multiple Sclerosis Initial | Conversion | Multiple Sclerosis, Secondary Progressive
Item
initial ms diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (group ii).
boolean
C0751967 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0439836 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
Mental state | Comprehension Study Protocol
Item
mental status: patients must be able to understand the meaning of the study
boolean
C0278060 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Informed Consent
Item
informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Requirement Biological Response Modifiers | Autoimmune Disease Requirement Immunosuppressive Agents | Exception Multiple Sclerosis
Item
any other autoimmune disease than ms requiring immunomodulatory or immunosuppressive medication
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005525 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
Steroid therapy High dose
Item
high-dose corticosteroid treatment within 30 days before participating in the study
boolean
C0149783 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Cardiovascular Disease Serious | Liver disease Serious | Kidney Disease Serious
Item
prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Mental condition compromises Study Subject Participation Status
Item
any psychiatric condition that compromises the subject's ability to participate in the study
boolean
C3840291 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Communicable Disease Serious Uncontrolled
Item
infections: patient must not have an uncontrolled serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Medical contraindication MRI | Artificial cardiac pacemaker | Clips Intracranial
Item
no contraindications for mri (cardiac pacemaker, intracranial clips etc)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0175722 (UMLS CUI [3,1])
C0524466 (UMLS CUI [3,2])
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