ID

14614

Description

Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months; ODM derived from: https://clinicaltrials.gov/show/NCT00200512

Link

https://clinicaltrials.gov/show/NCT00200512

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

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 Parkinson Disease NCT00200512

English

Eligibility Parkinson Disease NCT00200512

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with idiopathic parkinson's disease and classified as stage ii-iv of the hoehn and yahr scale for staging the severity of parkinson's disease
Description

Parkinson's disease and hoehn and yahr scale

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0451215
patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
Description

Pharmacotherapy regimen

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0360140
UMLS CUI [3]
C0178601
patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg
Description

Apomorphine subcutaneous injections dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0003596
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.)
Description

Medical therapy for psychoses or dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C0418981
UMLS CUI [1,2]
C0033975
UMLS CUI [2,1]
C0418981
UMLS CUI [2,2]
C0497327
patients with a history of drug or alcohol dependency within one year prior to study enrollment
Description

Substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.
Description

Allergy to pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013216
patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications
Description

Experimental drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection.
Description

Apomorphine regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0003596
UMLS CUI [1,2]
C0040808
patients who could not or would not sign an informed consent form.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Back to the top of the page

Similar models

Eligibility Parkinson Disease NCT00200512

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson's disease and hoehn and yahr scale
Item
patients diagnosed with idiopathic parkinson's disease and classified as stage ii-iv of the hoehn and yahr scale for staging the severity of parkinson's disease
boolean
C0030567 (UMLS CUI [1])
C0451215 (UMLS CUI [2])
Pharmacotherapy regimen
Item
patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization
boolean
C0023570 (UMLS CUI [1])
C0360140 (UMLS CUI [2])
C0178601 (UMLS CUI [3])
Apomorphine subcutaneous injections dosage
Item
patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg
boolean
C0003596 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical therapy for psychoses or dementia
Item
patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.)
boolean
C0418981 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0418981 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
Substance use disorder
Item
patients with a history of drug or alcohol dependency within one year prior to study enrollment
boolean
C0038586 (UMLS CUI [1])
Comorbidity
Item
patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study.
boolean
C0009488 (UMLS CUI [1])
Allergy to pharmacotherapy
Item
patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.
boolean
C0020517 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Experimental drug
Item
patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications
boolean
C0304229 (UMLS CUI [1])
Apomorphine regimen
Item
patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection.
boolean
C0003596 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
Informed consent
Item
patients who could not or would not sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
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