ID

34047

Description

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02224664

Link

https://clinicaltrials.gov/show/NCT02224664

Keywords

  1. 1/12/19 1/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 12, 2019

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.

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 Parkinson`s Disease NCT02224664

Eligibility Parkinson`s Disease NCT02224664

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of idiopathic parkinson's disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
Description

Parkinson Disease | Characteristics Main Quantity | Tremor | Rigidity | Bradykinesia

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1521970
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0040822
UMLS CUI [4]
C0026837
UMLS CUI [5]
C0233565
mini-mental state examination (mmse) ≥ 25
Description

Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
hoehn & yahr stage i-iii inclusive
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
documented history of end of l-dopa wearing off
Description

End Levodopa Wearing off

Data type

boolean

Alias
UMLS CUI [1,1]
C2746065
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C1504539
cohort 5 only: history of dyskinesia following l-dopa dosing and score of at least 2 on part iv, item 4.2 (functional impact of dyskinesia) of the mds-updrs
Description

Dyskinesia Following Levodopa Dosage | MDS-UPDRS - Functional Impact of Dyskinesias

Data type

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0023570
UMLS CUI [1,4]
C0178602
UMLS CUI [2]
C3639485
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
atypical/secondary parkinsonism
Description

Atypical Parkinsonism | Secondary Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C4302185
UMLS CUI [2]
C0030569
history of surgical intervention for parkinson's disease
Description

Surgical intervention Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0030567
dementia/cognitive impairment that can interfere with study assessments
Description

Dementia Interferes with Clinical Trial Assessment | Impaired cognition Interferes with Clinical Trial Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C1516048

Similar models

Eligibility Parkinson`s Disease NCT02224664

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Characteristics Main Quantity | Tremor | Rigidity | Bradykinesia
Item
clinical diagnosis of idiopathic parkinson's disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
boolean
C0030567 (UMLS CUI [1])
C1521970 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040822 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
C0233565 (UMLS CUI [5])
Mini-mental state examination
Item
mini-mental state examination (mmse) ≥ 25
boolean
C0451306 (UMLS CUI [1])
Hoehn and Yahr Stage
Item
hoehn & yahr stage i-iii inclusive
boolean
C3639483 (UMLS CUI [1])
End Levodopa Wearing off
Item
documented history of end of l-dopa wearing off
boolean
C2746065 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C1504539 (UMLS CUI [1,3])
Dyskinesia Following Levodopa Dosage | MDS-UPDRS - Functional Impact of Dyskinesias
Item
cohort 5 only: history of dyskinesia following l-dopa dosing and score of at least 2 on part iv, item 4.2 (functional impact of dyskinesia) of the mds-updrs
boolean
C0013384 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C3639485 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinsonism | Secondary Parkinson Disease
Item
atypical/secondary parkinsonism
boolean
C4302185 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
Surgical intervention Parkinson Disease
Item
history of surgical intervention for parkinson's disease
boolean
C0549433 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
Dementia Interferes with Clinical Trial Assessment | Impaired cognition Interferes with Clinical Trial Assessment
Item
dementia/cognitive impairment that can interfere with study assessments
boolean
C0497327 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0338656 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])

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

Fields marked with * are required.

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