ID

36156

Description

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes; ODM derived from: https://clinicaltrials.gov/show/NCT02240030

Link

https://clinicaltrials.gov/show/NCT02240030

Keywords

Versions (1)
  1. 4/18/19 4/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 18, 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.

Back to model comments
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 Idiopathic Parkinson's Disease NCT02240030

English

Eligibility Idiopathic Parkinson's Disease NCT02240030

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
Description

Parkinson Disease | Age

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
hoehn and yahr stage 1-3 in an "on" state;
Description

MDS-UPDRS - Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
require levodopa-containing medication regimen at least 4 times during the waking day;
Description

Pharmacotherapy Containing Levodopa | Requirement Pharmaceutical Preparation times/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0023570
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439511
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
Description

Motor fluctuations hours/day Minimum | Levodopa | Disease Response

Data type

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0556974
UMLS CUI [1,3]
C1524031
UMLS CUI [2]
C0023570
UMLS CUI [3]
C1704632
are on stable pd medication regimen;
Description

Antiparkinson Agents Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
total daily ld dose <1600 mg/day;
Description

Levodopa Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
able to perform a spirometry maneuver in the on and off states
Description

Ability Perform Spirometry

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0037981
normal cognition confirmed by mmse score ≥25 ;
Description

Normal cognition Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C2712133
UMLS CUI [1,2]
C0451306
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous surgery for pd or plan to have stereotactic surgery during the study period;
Description

Operative Surgical Procedures Parkinson Disease | Stereotactic surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C1735594
UMLS CUI [2,2]
C1301732
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
Description

Psychotic symptom Treatment required for | Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0038663
known contraindication to the use of levodopa;
Description

Medical contraindication Levodopa

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0023570
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
Description

Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition compromises Patient safety | Comorbidity Severe compromises Patient safety | Abnormality compromises Patient safety | Finding compromises Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C0243095
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C2945640
UMLS CUI [6,4]
C1113679
UMLS CUI [7,1]
C1704258
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C0243095
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C1113679
any any contraindication to performing routine spirometry.
Description

Medical contraindication Routine Spirometry

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205547
UMLS CUI [1,3]
C0037981
Back to the top of the page

Similar models

Eligibility Idiopathic Parkinson's Disease NCT02240030

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Age
Item
idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 80 years;
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
MDS-UPDRS - Hoehn and Yahr Stage
Item
hoehn and yahr stage 1-3 in an "on" state;
boolean
C3639483 (UMLS CUI [1])
Pharmacotherapy Containing Levodopa | Requirement Pharmaceutical Preparation times/day
Item
require levodopa-containing medication regimen at least 4 times during the waking day;
boolean
C0013216 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
Motor fluctuations hours/day Minimum | Levodopa | Disease Response
Item
experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
boolean
C1868976 (UMLS CUI [1,1])
C0556974 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0023570 (UMLS CUI [2])
C1704632 (UMLS CUI [3])
Antiparkinson Agents Stable
Item
are on stable pd medication regimen;
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Levodopa Dose U/day
Item
total daily ld dose <1600 mg/day;
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Ability Perform Spirometry
Item
able to perform a spirometry maneuver in the on and off states
boolean
C0085732 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
Normal cognition Mini-mental state examination
Item
normal cognition confirmed by mmse score ≥25 ;
boolean
C2712133 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Operative Surgical Procedures Parkinson Disease | Stereotactic surgery Planned
Item
previous surgery for pd or plan to have stereotactic surgery during the study period;
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1735594 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Psychotic symptom Treatment required for | Feeling suicidal | Suicide attempt
Item
history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
boolean
C0871189 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2])
C0038663 (UMLS CUI [3])
Medical contraindication Levodopa
Item
known contraindication to the use of levodopa;
boolean
C1301624 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Condition Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Finding Study Subject Participation Status Inappropriate | Condition compromises Patient safety | Comorbidity Severe compromises Patient safety | Abnormality compromises Patient safety | Finding compromises Patient safety
Item
any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C1704258 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0243095 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2945640 (UMLS CUI [6,3])
C1113679 (UMLS CUI [6,4])
C1704258 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C0243095 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
Medical contraindication Routine Spirometry
Item
any any contraindication to performing routine spirometry.
boolean
C1301624 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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