ID

14539

Description

Optimizing IFN Beta - 1B Dose; ODM derived from: https://clinicaltrials.gov/show/NCT00473213

Link

https://clinicaltrials.gov/show/NCT00473213

Keywords

Versions (1)
  1. 4/19/16 4/19/16 -
Uploaded on

April 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00473213

English

Eligibility Multiple Sclerosis NCT00473213

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent obtained.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. age between 18 and 50 years inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. male and female patients.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
4. clinically definite or laboratory supported definite rr ms (poser et al, 1983) for not less than 2 year.
Description

Multiple sclerosis relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
5. two clinically documented relapses during the preceding 24 months.
Description

Multiple sclerosis relapse: number

Data type

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0237753
6. no relapse or relapse related neurological deterioration for at least 30 days prior to entry in the study.
Description

Relapse and neurological deterioration

Data type

boolean

Alias
UMLS CUI [1]
C0856120
UMLS CUI [2]
C1536136
7. patients edss score from 1 to 3.5 (probably to be extended to 5.5).
Description

Edss

Data type

boolean

Alias
UMLS CUI [1]
C0451246
8. mri activity. at least one enhancing lesion during the baseline mri run-in study .
Description

MRI

Data type

boolean

Alias
UMLS CUI [1]
C0024485
9. women capable of having children must agree to use adequate con-traceptive methods (condoms with spermicides, iucd, oral contraceptives or other adequate barrier contraception).
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
10. caregivers agreement to assist the patient to comply with study requirements, if neces-sary (e.g. study drug administration, visits to center).
Description

Assistance by caregivers

Data type

boolean

Alias
UMLS CUI [1]
C2599975
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any form of multiple sclerosis other than relapsing-remitting.
Description

Multiple sclerosis specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C2348235
2. any other disease which could better explain the patient's signs and symptoms.
Description

Other neurological diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C2015799
3. any other disabling condition, which could interfere with the clinical evaluation.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
4. pregnancy or lactation.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. medical psychiatric, or other conditions that compromise patient's ability to give informed consent, to comply with the trial protocol, or to complete the study.
Description

Comorbidity specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2599718
6. alcohol or drug abuse in the 90 days preceding screening visit.
Description

Substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
7. uncontrolled clinically significant heart diseases, i.e., cardiac arrhythmias, uncon-trolled angina pectoris, uncompensated congestive heart failure
Description

Heart diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
8. clinically significant liver, renal and bone marrow dysfunction as defined by the ranges of laboratory evaluations. the following ranges (see table 1) for key laboratory evaluations will be considered as adequate for inclusion:
Description

Liver, renal and bone marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0005953
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Similar models

Eligibility Multiple Sclerosis NCT00473213

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age between 18 and 50 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
3. male and female patients.
boolean
C0079399 (UMLS CUI [1])
Multiple sclerosis relapse
Item
4. clinically definite or laboratory supported definite rr ms (poser et al, 1983) for not less than 2 year.
boolean
C0856120 (UMLS CUI [1])
Multiple sclerosis relapse: number
Item
5. two clinically documented relapses during the preceding 24 months.
boolean
C0856120 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Relapse and neurological deterioration
Item
6. no relapse or relapse related neurological deterioration for at least 30 days prior to entry in the study.
boolean
C0856120 (UMLS CUI [1])
C1536136 (UMLS CUI [2])
Edss
Item
7. patients edss score from 1 to 3.5 (probably to be extended to 5.5).
boolean
C0451246 (UMLS CUI [1])
MRI
Item
8. mri activity. at least one enhancing lesion during the baseline mri run-in study .
boolean
C0024485 (UMLS CUI [1])
Contraception
Item
9. women capable of having children must agree to use adequate con-traceptive methods (condoms with spermicides, iucd, oral contraceptives or other adequate barrier contraception).
boolean
C0700589 (UMLS CUI [1])
Assistance by caregivers
Item
10. caregivers agreement to assist the patient to comply with study requirements, if neces-sary (e.g. study drug administration, visits to center).
boolean
C2599975 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple sclerosis specification
Item
1. any form of multiple sclerosis other than relapsing-remitting.
boolean
C0026769 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other neurological diagnosis
Item
2. any other disease which could better explain the patient's signs and symptoms.
boolean
C2015799 (UMLS CUI [1])
Comorbidity
Item
3. any other disabling condition, which could interfere with the clinical evaluation.
boolean
C0009488 (UMLS CUI [1])
Gynaecological status
Item
4. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity specification
Item
5. medical psychiatric, or other conditions that compromise patient's ability to give informed consent, to comply with the trial protocol, or to complete the study.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2599718 (UMLS CUI [2,3])
Substance use disorder
Item
6. alcohol or drug abuse in the 90 days preceding screening visit.
boolean
C0038586 (UMLS CUI [1])
Heart diseases
Item
7. uncontrolled clinically significant heart diseases, i.e., cardiac arrhythmias, uncon-trolled angina pectoris, uncompensated congestive heart failure
boolean
C0018799 (UMLS CUI [1])
Liver, renal and bone marrow function
Item
8. clinically significant liver, renal and bone marrow dysfunction as defined by the ranges of laboratory evaluations. the following ranges (see table 1) for key laboratory evaluations will be considered as adequate for inclusion:
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3])
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