ID

30956

Description

Assessment of Patient Use of a New Device: RebiSmart; ODM derived from: https://clinicaltrials.gov/show/NCT01195870

Link

https://clinicaltrials.gov/show/NCT01195870

Keywords

Versions (1)
  1. 7/7/18 7/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01195870

English

Eligibility Multiple Sclerosis NCT01195870

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have relapsing remitting multiple sclerosis
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
between 18 to 65 years old inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have been prescribed rebif for the first time but not yet started treatment
Description

Rebif prescribed | Therapeutic procedure Start Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0752980
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0439659
UMLS CUI [2,3]
C0332197
rebismart as chosen device
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
be under review by ms nurse
Description

Review of Multiple Sclerosis Nurse

Data type

boolean

Alias
UMLS CUI [1,1]
C0699752
UMLS CUI [1,2]
C0026769
UMLS CUI [1,3]
C0028661
having given written informed consent to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
injections of rebif given by someone other than the patient
Description

Rebif Injection | Self Administration Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0752980
UMLS CUI [1,2]
C1533685
UMLS CUI [2,1]
C0036589
UMLS CUI [2,2]
C0332197
patients unable to use the rebismart device due to visual or physical impairment
Description

Other Coding | Visual Impairment | Physical impairment

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C3665347
UMLS CUI [3]
C0231171
patients unwilling to give informed consent
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
contra-indications to rebif as defined in the summary of product characteristics (spc).
Description

Medical contraindication Rebif

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0752980
allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms
Description

Hypersensitivity Antipyretics | Prophylactic treatment flu-like symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003419
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0392171
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Similar models

Eligibility Multiple Sclerosis NCT01195870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
have relapsing remitting multiple sclerosis
boolean
C0751967 (UMLS CUI [1])
Age
Item
between 18 to 65 years old inclusive
boolean
C0001779 (UMLS CUI [1])
Rebif prescribed | Therapeutic procedure Start Absent
Item
have been prescribed rebif for the first time but not yet started treatment
boolean
C0752980 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Other Coding
Item
rebismart as chosen device
boolean
C3846158 (UMLS CUI [1])
Review of Multiple Sclerosis Nurse
Item
be under review by ms nurse
boolean
C0699752 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0028661 (UMLS CUI [1,3])
Informed Consent
Item
having given written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rebif Injection | Self Administration Absent
Item
injections of rebif given by someone other than the patient
boolean
C0752980 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0036589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Other Coding | Visual Impairment | Physical impairment
Item
patients unable to use the rebismart device due to visual or physical impairment
boolean
C3846158 (UMLS CUI [1])
C3665347 (UMLS CUI [2])
C0231171 (UMLS CUI [3])
Informed Consent Unwilling
Item
patients unwilling to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Medical contraindication Rebif
Item
contra-indications to rebif as defined in the summary of product characteristics (spc).
boolean
C1301624 (UMLS CUI [1,1])
C0752980 (UMLS CUI [1,2])
Hypersensitivity Antipyretics | Prophylactic treatment flu-like symptoms
Item
allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms
boolean
C0020517 (UMLS CUI [1,1])
C0003419 (UMLS CUI [1,2])
C0199176 (UMLS CUI [2,1])
C0392171 (UMLS CUI [2,2])
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