ID

22001

Description

Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01201343

Link

https://clinicaltrials.gov/show/NCT01201343

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing, Remitting NCT01201343

English

Eligibility Multiple Sclerosis, Relapsing, Remitting NCT01201343

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects aged ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with rrms
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
Description

Relapse Quantity | Relapse Last Ended

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C1272693
subjects with indication of ifn beta treatment determined by the investigator
Description

Indication Beta interferon therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0854622
other protocol-defined inclusion criteria may apply
Description

Inclusion criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with secondary progressive multiple sclerosis (ms) without relapse
Description

Multiple Sclerosis, Secondary Progressive | Recurrent disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0751965
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0332197
subjects with ongoing acute relapse
Description

Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0277556
subjects already being treated with interferon
Description

Interferon

Data type

boolean

Alias
UMLS CUI [1]
C3652465
subjects with corticoid therapy for less than 15 days
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
subjects presenting acute major depression or treated with anti-depressant therapy
Description

Major Depressive Disorder | Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0003289
subjects involved in another therapeutic study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subjects with any condition which could interfere with a good compliance of this study
Description

Condition Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
other protocol-defined exclusion criteria may apply
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Multiple Sclerosis, Relapsing, Remitting NCT01201343

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
subjects with rrms
boolean
C0751967 (UMLS CUI [1])
Relapse Quantity | Relapse Last Ended
Item
subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1272693 (UMLS CUI [2,3])
Indication Beta interferon therapy
Item
subjects with indication of ifn beta treatment determined by the investigator
boolean
C3146298 (UMLS CUI [1,1])
C0854622 (UMLS CUI [1,2])
Inclusion criteria Study Protocol
Item
other protocol-defined inclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis, Secondary Progressive | Recurrent disease Absent
Item
subjects with secondary progressive multiple sclerosis (ms) without relapse
boolean
C0751965 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Recurrent disease
Item
subjects with ongoing acute relapse
boolean
C0277556 (UMLS CUI [1])
Interferon
Item
subjects already being treated with interferon
boolean
C3652465 (UMLS CUI [1])
Adrenal Cortex Hormones
Item
subjects with corticoid therapy for less than 15 days
boolean
C0001617 (UMLS CUI [1])
Major Depressive Disorder | Antidepressive Agents
Item
subjects presenting acute major depression or treated with anti-depressant therapy
boolean
C1269683 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
Study Subject Participation Status
Item
subjects involved in another therapeutic study
boolean
C2348568 (UMLS CUI [1])
Condition Interferes with Protocol Compliance
Item
subjects with any condition which could interfere with a good compliance of this study
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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