ID

36746

Description

Hereditary Parkinson s Disease Natural History Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT02511015

Link

https://clinicaltrials.gov/show/NCT02511015

Keywords

Versions (1)
  1. 6/5/19 6/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson Disease 6, Early-Onset NCT02511015

English

Eligibility Parkinson Disease 6, Early-Onset NCT02511015

1 forms  
Criteria
Description

Criteria

parkinson subjects
Description

Parkinson Disease Study Subject

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0681850
age 18 years to 80 years old with a history of early onset parkinson disease or parkinsonism (presentation within the first five decades of life).
Description

Age | Early onset Parkinson disease | Parkinsonian Disorders Early-onset

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C4275179
UMLS CUI [3,1]
C0242422
UMLS CUI [3,2]
C1833334
healthy control subjects
Description

Healthy Control

Data type

boolean

Alias
UMLS CUI [1]
C2986479
age 18 years to 80 years old with no history or family history of parkinson disease or parkinsonism.
Description

Age | Parkinson Disease Absent | Parkinsonian Disorders Absent | Family history of Parkinson's disease Absent | Family history Parkinsonism Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0242422
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0574092
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C2939151
UMLS CUI [5,2]
C0332197
family member control subjects
Description

Family member Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C0009932
family members, of enrolled eopd subjects, who themselves do not have
Description

Family member Study Subject Early onset Parkinson disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C4275179
parkinson disease or parkinsonism can be enrolled as controls on this study.
Description

Family member Without Parkinson Disease | Family member Without Parkinsonian Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0242422
all subjects
Description

Study Subject All

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
willingness and legal ability to give and sign informed study consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willingness to have blood or tissue samples studied, and potentially stored for future research
Description

Collection of blood specimen for laboratory procedure | Tissue specimen Research

Data type

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0035168
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all subjects
Description

Study Subject All

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
subjects who are unable or unwilling to sign an informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
subjects with genetic defects associated with diseases including other neurologic syndromes.
Description

Genetic Abnormality Associated with Disease | Genetic Abnormality Associated with Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0262496
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C0262496
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0027765
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Parkinson Disease 6, Early-Onset NCT02511015

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Parkinson Disease Study Subject
Item
parkinson subjects
boolean
C0030567 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Age | Early onset Parkinson disease | Parkinsonian Disorders Early-onset
Item
age 18 years to 80 years old with a history of early onset parkinson disease or parkinsonism (presentation within the first five decades of life).
boolean
C0001779 (UMLS CUI [1])
C4275179 (UMLS CUI [2])
C0242422 (UMLS CUI [3,1])
C1833334 (UMLS CUI [3,2])
Healthy Control
Item
healthy control subjects
boolean
C2986479 (UMLS CUI [1])
Age | Parkinson Disease Absent | Parkinsonian Disorders Absent | Family history of Parkinson's disease Absent | Family history Parkinsonism Absent
Item
age 18 years to 80 years old with no history or family history of parkinson disease or parkinsonism.
boolean
C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0242422 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0574092 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2939151 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Family member Control Group
Item
family member control subjects
boolean
C0086282 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Family member Study Subject Early onset Parkinson disease
Item
family members, of enrolled eopd subjects, who themselves do not have
boolean
C0086282 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C4275179 (UMLS CUI [1,3])
Family member Without Parkinson Disease | Family member Without Parkinsonian Disorders
Item
parkinson disease or parkinsonism can be enrolled as controls on this study.
boolean
C0086282 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0086282 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0242422 (UMLS CUI [2,3])
Study Subject All
Item
all subjects
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Informed Consent
Item
willingness and legal ability to give and sign informed study consent
boolean
C0021430 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure | Tissue specimen Research
Item
willingness to have blood or tissue samples studied, and potentially stored for future research
boolean
C0005834 (UMLS CUI [1])
C1292533 (UMLS CUI [2,1])
C0035168 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject All
Item
all subjects
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
subjects who are unable or unwilling to sign an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Genetic Abnormality Associated with Disease | Genetic Abnormality Associated with Nervous system disorder
Item
subjects with genetic defects associated with diseases including other neurologic syndromes.
boolean
C0262496 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0262496 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0027765 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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