ID

36507

Beskrivning

The Use of Technology to Improve MS Clinical Trials and Patient Care; ODM derived from: https://clinicaltrials.gov/show/NCT02454907

Länk

https://clinicaltrials.gov/show/NCT02454907

Nyckelord

Versioner (1)
  1. 2019-05-18 2019-05-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02454907

Engelsk

Eligibility Multiple Sclerosis NCT02454907

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
english speakers
Beskrivning

Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
relapsing-remitting ms (2010 criteria)
Beskrivning

Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
expanded disability status scale (edss) ≤6.0
Beskrivning

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
possession of a smartphone or of a mobile telephone with text messaging and an e-mail account and web access or willingness to be provided with, and utilize, a smartphone for the duration of the study
Beskrivning

Availability of Smartphone | Availability of Mobile Phone | Availability of Text Messaging | Availability of Email | Internet Access

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3204335
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1136360
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C3178908
UMLS CUI [4,1]
C0470187
UMLS CUI [4,2]
C0013849
UMLS CUI [5,1]
C0282111
UMLS CUI [5,2]
C0444454
in the two years before screening:
Beskrivning

Status pre- Screening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0220908
at least two relapses, or one relapse and two new lesions (unrelated to relapse symptoms) on magnetic resonance imaging (mri), or rrms (magnims 2010 criteria) onset within the past year with no exposure to disease modifying therapies (dmt)
Beskrivning

Relapse Quantity | Lesion New Quantity MRI | Relapsing-Remitting Multiple Sclerosis Past Year | Disease Modification Therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C0751967
UMLS CUI [3,2]
C4086728
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C3840684
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0332197
patient is starting one of the following ms therapies: injectable (subcutaneous interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl fumarate) therapies
Beskrivning

Therapy Multiple Sclerosis | Therapy Injectable | Interferon-beta Subcutaneous | Glatiramer acetate Subcutaneous | Therapy Oral | fingolimod | teriflunomide | dimethyl fumarate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1828121
UMLS CUI [3,1]
C0015980
UMLS CUI [3,2]
C1522438
UMLS CUI [4,1]
C0289884
UMLS CUI [4,2]
C1522438
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1527415
UMLS CUI [6]
C1699926
UMLS CUI [7]
C1718383
UMLS CUI [8]
C0058218
relapse and mri activity occurred while untreated or despite one single treatment, and no change in therapy since that activity
Beskrivning

Relapse | MRI | Therapy Absent | Therapy Single | Therapy unchanged

Datatyp

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2]
C0024485
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205171
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0442739
lives within 100 miles of johns hopkins medical center (baltimore, md)
Beskrivning

Residence Geographic region Nearby

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0017446
UMLS CUI [1,3]
C1706276
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of dmt exposure if magnims 2010 criteria used to enroll patients with disease onset in the past year, or change in ms therapy since qualifying relapse/mri criteria occurred
Beskrivning

Disease Modification Therapy | Therapy changed Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C1141862
UMLS CUI [2,2]
C0026769
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Similar models

Eligibility Multiple Sclerosis NCT02454907

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Able to speak English Language
Item
english speakers
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing-remitting ms (2010 criteria)
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
expanded disability status scale (edss) ≤6.0
boolean
C0451246 (UMLS CUI [1])
Availability of Smartphone | Availability of Mobile Phone | Availability of Text Messaging | Availability of Email | Internet Access
Item
possession of a smartphone or of a mobile telephone with text messaging and an e-mail account and web access or willingness to be provided with, and utilize, a smartphone for the duration of the study
boolean
C0470187 (UMLS CUI [1,1])
C3204335 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1136360 (UMLS CUI [2,2])
C0470187 (UMLS CUI [3,1])
C3178908 (UMLS CUI [3,2])
C0470187 (UMLS CUI [4,1])
C0013849 (UMLS CUI [4,2])
C0282111 (UMLS CUI [5,1])
C0444454 (UMLS CUI [5,2])
Status pre- Screening
Item
in the two years before screening:
boolean
C0332152 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Relapse Quantity | Lesion New Quantity MRI | Relapsing-Remitting Multiple Sclerosis Past Year | Disease Modification Therapy Absent
Item
at least two relapses, or one relapse and two new lesions (unrelated to relapse symptoms) on magnetic resonance imaging (mri), or rrms (magnims 2010 criteria) onset within the past year with no exposure to disease modifying therapies (dmt)
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0751967 (UMLS CUI [3,1])
C4086728 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C3840684 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Therapy Multiple Sclerosis | Therapy Injectable | Interferon-beta Subcutaneous | Glatiramer acetate Subcutaneous | Therapy Oral | fingolimod | teriflunomide | dimethyl fumarate
Item
patient is starting one of the following ms therapies: injectable (subcutaneous interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl fumarate) therapies
boolean
C0087111 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0015980 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
C0289884 (UMLS CUI [4,1])
C1522438 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C1699926 (UMLS CUI [6])
C1718383 (UMLS CUI [7])
C0058218 (UMLS CUI [8])
Relapse | MRI | Therapy Absent | Therapy Single | Therapy unchanged
Item
relapse and mri activity occurred while untreated or despite one single treatment, and no change in therapy since that activity
boolean
C0035020 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
Residence Geographic region Nearby
Item
lives within 100 miles of johns hopkins medical center (baltimore, md)
boolean
C0237096 (UMLS CUI [1,1])
C0017446 (UMLS CUI [1,2])
C1706276 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Disease Modification Therapy | Therapy changed Multiple Sclerosis
Item
history of dmt exposure if magnims 2010 criteria used to enroll patients with disease onset in the past year, or change in ms therapy since qualifying relapse/mri criteria occurred
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1141862 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
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