ID

30967

Description

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

Link

https://clinicaltrials.gov/show/NCT00780455

Keywords

Versions (1)
  1. 7/8/18 7/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 8, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

English

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

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

Indication First Betaferon

Data type

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;
Description

Multiple sclerosis relapse Absent

Data type

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;
Description

Patients Walking EDSS

Data type

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;
Description

Childbearing Potential Contraceptive methods

Data type

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
Description

Protocol Compliance

Data type

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;
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Medical contraindication Betaferon

Data type

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;
Description

Orthopedic Surgical Procedure

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

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

Rebif | Avonex | Copaxone

Data type

boolean

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

Betaferon

Data type

boolean

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

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Back to the top of the page

Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial