ID

30967

Beskrivning

Rehabilitation Study in MS Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00780455

Länk

https://clinicaltrials.gov/show/NCT00780455

Nyckelord

Versioner (1)
  1. 2018-07-08 2018-07-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

Engelsk

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male patients aged 18 and more;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of rrms according to the macdonald or poser criteria;
Beskrivning

Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
first indication for betaferon treatment (as described in summary of product characteristics (smpc));
Beskrivning

Indication First Betaferon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0592527
no relapse of multiple sclerosis (ms) in the last two months before the inclusion;
Beskrivning

Multiple sclerosis relapse Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0332197
walking patients having an expanded disability status scale (edss) score between > 1 and </= 4 at the inclusion visit;
Beskrivning

Patients Walking EDSS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0080331
UMLS CUI [1,3]
C0451246
female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
patient can follow all the study and comply with all procedures of the trial protocol
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
laboratory evaluations (i.e. evaluation of hepatic enzymes gammagt, full blood count and differential white blood cell [wbc]) must be available and the results must be normal;
Beskrivning

Evaluation of laboratory test data | Measurement of liver enzyme Gamma-glutamyltransferase normal | Full blood count normal | Differential white blood cell count normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0262707
UMLS CUI [2,1]
C0428321
UMLS CUI [2,2]
C0855631
UMLS CUI [3]
C0427692
UMLS CUI [4]
C0860797
written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to betaferon as described in the smpc of the product;
Beskrivning

Medical contraindication Betaferon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0592527
patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
Beskrivning

Orthopedic Surgical Procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1136201
patient previously included in this study;
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patient previously treated within the past 3 months with rebif, avonex or copaxone;
Beskrivning

Rebif | Avonex | Copaxone

Datatyp

boolean

Alias
UMLS CUI [1]
C0752980
UMLS CUI [2]
C0594372
UMLS CUI [3]
C0528175
patient previously treated within the past 12 months with betaferon;
Beskrivning

Betaferon

Datatyp

boolean

Alias
UMLS CUI [1]
C0592527
participation in any clinical trial within the past 30 days involving the investigational drug intake.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
female and male patients aged 18 and more;
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
confirmed diagnosis of rrms according to the macdonald or poser criteria;
boolean
C0751967 (UMLS CUI [1])
Indication First Betaferon
Item
first indication for betaferon treatment (as described in summary of product characteristics (smpc));
boolean
C3146298 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0592527 (UMLS CUI [1,3])
Multiple sclerosis relapse Absent
Item
no relapse of multiple sclerosis (ms) in the last two months before the inclusion;
boolean
C0856120 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Patients Walking EDSS
Item
walking patients having an expanded disability status scale (edss) score between > 1 and </= 4 at the inclusion visit;
boolean
C0030705 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods
Item
female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
patient can follow all the study and comply with all procedures of the trial protocol
boolean
C0525058 (UMLS CUI [1])
Evaluation of laboratory test data | Measurement of liver enzyme Gamma-glutamyltransferase normal | Full blood count normal | Differential white blood cell count normal
Item
laboratory evaluations (i.e. evaluation of hepatic enzymes gammagt, full blood count and differential white blood cell [wbc]) must be available and the results must be normal;
boolean
C0262707 (UMLS CUI [1])
C0428321 (UMLS CUI [2,1])
C0855631 (UMLS CUI [2,2])
C0427692 (UMLS CUI [3])
C0860797 (UMLS CUI [4])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Betaferon
Item
any contraindication to betaferon as described in the smpc of the product;
boolean
C1301624 (UMLS CUI [1,1])
C0592527 (UMLS CUI [1,2])
Orthopedic Surgical Procedure
Item
patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
boolean
C1136201 (UMLS CUI [1])
Study Subject Participation Status
Item
patient previously included in this study;
boolean
C2348568 (UMLS CUI [1])
Rebif | Avonex | Copaxone
Item
patient previously treated within the past 3 months with rebif, avonex or copaxone;
boolean
C0752980 (UMLS CUI [1])
C0594372 (UMLS CUI [2])
C0528175 (UMLS CUI [3])
Betaferon
Item
patient previously treated within the past 12 months with betaferon;
boolean
C0592527 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in any clinical trial within the past 30 days involving the investigational drug intake.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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