ID

12098

Description

Randomized Safety Study of CVT-301 Compared to an Observational Control Group; ODM derived from: https://clinicaltrials.gov/show/NCT02352363

Link

https://clinicaltrials.gov/show/NCT02352363

Keywords

Versions (2)
  1. 9/22/15 9/22/15 - Julian Varghese
  2. 9/22/15 9/22/15 - Julian Varghese
Uploaded on

September 22, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
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 :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Idiopathic Parkinson's Disease NCT02352363

English

Eligibility Idiopathic Parkinson's Disease NCT02352363

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
Description

contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1960468
UMLS CUI [3]
C2208823
patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
Description

united kingdom; diseases; other; brain; drugs; age

Data type

boolean

Alias
UMLS CUI [1]
C0747270
patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
Description

severity; staging; stage; state

Data type

boolean

Alias
UMLS CUI [1]
C3639483
patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
Description

screening; confirmed; daily; motor; time; self; day; per

Data type

boolean

Alias
UMLS CUI [1]
C1868976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
Description

procedure(s); procedures; severity; study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0439793
pregnant or lactating females or females wishing to become pregnant.
Description

pregnant or lactating females

Data type

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
Description

malignant melanoma; glaucoma; levodopa

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0522473
UMLS CUI [2]
C0025202
UMLS CUI [3]
C0017605
patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
Description

transplantation; not limited; surgery; brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0038894
UMLS CUI [1,2]
C0030567
patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
Description

anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low

Data type

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C1821181
Back to the top of the page

Similar models

Eligibility Idiopathic Parkinson's Disease NCT02352363

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
boolean
C0021430 (UMLS CUI [1])
contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg
Item
women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
boolean
C0700589 (UMLS CUI [1])
C1960468 (UMLS CUI [2])
C2208823 (UMLS CUI [3])
united kingdom; diseases; other; brain; drugs; age
Item
patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
boolean
C0747270 (UMLS CUI [1])
severity; staging; stage; state
Item
patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
boolean
C3639483 (UMLS CUI [1])
screening; confirmed; daily; motor; time; self; day; per
Item
patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
boolean
C1868976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
procedure(s); procedures; severity; study
Item
patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
boolean
C0013384 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
pregnant or lactating females
Item
pregnant or lactating females or females wishing to become pregnant.
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
malignant melanoma; glaucoma; levodopa
Item
patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
boolean
C0023570 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0025202 (UMLS CUI [2])
C0017605 (UMLS CUI [3])
transplantation; not limited; surgery; brain
Item
patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
boolean
C0038894 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low
Item
patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
boolean
C0871189 (UMLS CUI [1])
C1821181 (UMLS CUI [2])
Back to the top of the page 

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