ID

18794

Description

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa; ODM derived from: https://clinicaltrials.gov/show/NCT00381472

Link

https://clinicaltrials.gov/show/NCT00381472

Keywords

  1. 11/21/16 11/21/16 -
Uploaded on

November 21, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson Disease NCT00381472

Eligibility Parkinson Disease NCT00381472

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
modified hoehn and yahr scale stages ii - iv
Description

UPDRS - Modified Hoehn and Yahr Staging

Data type

boolean

Alias
UMLS CUI [1]
C3639878
stable dose of l-dopa for at least 4 weeks prior to screening.
Description

Levodopa Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
lack of control with l-dopa therapy.
Description

Levodopa | control Lack

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2,1]
C0243148
UMLS CUI [2,2]
C0332268
women of child-bearing potential must use a clinically accepted form of birth control.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant and/or uncontrolled medical conditions (excluding parkinson's disease) within 3 months of screening.
Description

Medical condition Significant | Medical condition Uncontrolled | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0030567
any abnormality, at screening, that is considered clinically relevant by the investigator.
Description

Abnormality Relevant Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
dementia
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
use of dopamine agonists within 4 weeks of screening visit.
Description

Dopamine Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0178601
participation in other investigational drug studies.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

Similar models

Eligibility Parkinson Disease NCT00381472

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
idiopathic parkinson's disease
boolean
C0030567 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
modified hoehn and yahr scale stages ii - iv
boolean
C3639878 (UMLS CUI [1])
Levodopa Dose Stable
Item
stable dose of l-dopa for at least 4 weeks prior to screening.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Levodopa | control Lack
Item
lack of control with l-dopa therapy.
boolean
C0023570 (UMLS CUI [1])
C0243148 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
women of child-bearing potential must use a clinically accepted form of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Significant | Medical condition Uncontrolled | Parkinson Disease
Item
significant and/or uncontrolled medical conditions (excluding parkinson's disease) within 3 months of screening.
boolean
C3843040 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0030567 (UMLS CUI [3])
Abnormality Relevant Clinical
Item
any abnormality, at screening, that is considered clinically relevant by the investigator.
boolean
C1704258 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Dementia
Item
dementia
boolean
C0497327 (UMLS CUI [1])
Dopamine Agonists
Item
use of dopamine agonists within 4 weeks of screening visit.
boolean
C0178601 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in other investigational drug studies.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

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