ID

22395

Description

European Compliance Study in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00466739

Link

https://clinicaltrials.gov/show/NCT00466739

Keywords

Versions (1)
  1. 6/1/17 6/1/17 -
Uploaded on

June 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00466739

English

Eligibility Parkinson's Disease NCT00466739

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women between 18 and 80 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient has idiopathic parkinson's disease according to brain bank criteria. -
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
reference hughes a j, daniel s e, kilford l, lees a j, accuracy of clinical -
Description

Bibliographic Reference

Data type

boolean

Alias
UMLS CUI [1]
C1514811
diagnosis of idiopathic parkinson's disease; a clinical pathological study of 100 cases, jnnp 1992, 55(3): 181 - 184
Description

Bibliographic Reference

Data type

boolean

Alias
UMLS CUI [1]
C1514811
patient is on stable doses of anti-parkinson's disease medication, which are not expected to change during the study period.
Description

Antiparkinson Agents Dose Stable | Antiparkinson Agents unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0442739
patient is taking levodopa and/or dopamine agonist treatment.
Description

Levodopa | Dopamine Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
patient (assisted by a carer where appropriate) is able to take their medication using the mems (electronic monitoring) containers.
Description

Pharmaceutical Preparations Intake Using Electronic monitor System

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0336646
UMLS CUI [1,5]
C0449913
patients using a dosette box or similar device for their medication are willing to use the mems containers for their pd medication
Description

Dosette Use of | Pharmaceutical Preparations Intake Using Electronic monitor System

Data type

boolean

Alias
UMLS CUI [1,1]
C1553470
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C1524063
UMLS CUI [2,4]
C0336646
UMLS CUI [2,5]
C0449913
the investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the mems device.
Description

Patient care | Symptom control | Study Subject Participation Status | Pharmaceutical Preparations Intake Using Electronic monitor System

Data type

boolean

Alias
UMLS CUI [1]
C0017313
UMLS CUI [2]
C1274136
UMLS CUI [3]
C2348568
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1512806
UMLS CUI [4,3]
C1524063
UMLS CUI [4,4]
C0336646
UMLS CUI [4,5]
C0449913
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is taking anti-parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). intermittent domperidone is allowed.
Description

Therapeutic procedure Intermittent Parkinson Disease | Domperidone

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205267
UMLS CUI [1,3]
C0030567
UMLS CUI [2]
C0013015
severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the parkinson's disease in terms of life expectancy and levels of care required.
Description

Comorbidity Severe | Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Malignant Neoplasms | Parkinson Disease | Life Expectancy | Level of Care Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0030567
UMLS CUI [7]
C0023671
UMLS CUI [8,1]
C1547668
UMLS CUI [8,2]
C0686904
patient is expected to undergo hospital admission during the study period (such as elective surgery).
Description

Hospital admission Expected | Elective Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C1517001
UMLS CUI [2]
C0206058
patient is on non standard drug treatment / combination therapy. this would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
Description

Pharmacotherapy Investigational | Combined Modality Therapy | Dopamine Agonists Different Quantity | Dopamine Agonists High dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0178601
UMLS CUI [3,2]
C1705242
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0178601
UMLS CUI [4,2]
C0444956
new antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
Description

Antiparkinson Agents new therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C3242274
patient is taking only adjunct therapy (eg. selegiline, amantadine, anticholinergic therapy).
Description

Adjuvant therapy | Selegiline | Amantadine | Anticholinergic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C0036579
UMLS CUI [3]
C0002403
UMLS CUI [4]
C0242896
patient is taking part in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Parkinson's Disease NCT00466739

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women between 18 and 80 years.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
patient has idiopathic parkinson's disease according to brain bank criteria. -
boolean
C0030567 (UMLS CUI [1])
Bibliographic Reference
Item
reference hughes a j, daniel s e, kilford l, lees a j, accuracy of clinical -
boolean
C1514811 (UMLS CUI [1])
Bibliographic Reference
Item
diagnosis of idiopathic parkinson's disease; a clinical pathological study of 100 cases, jnnp 1992, 55(3): 181 - 184
boolean
C1514811 (UMLS CUI [1])
Antiparkinson Agents Dose Stable | Antiparkinson Agents unchanged
Item
patient is on stable doses of anti-parkinson's disease medication, which are not expected to change during the study period.
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003405 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Levodopa | Dopamine Agonists
Item
patient is taking levodopa and/or dopamine agonist treatment.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
Pharmaceutical Preparations Intake Using Electronic monitor System
Item
patient (assisted by a carer where appropriate) is able to take their medication using the mems (electronic monitoring) containers.
boolean
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0336646 (UMLS CUI [1,4])
C0449913 (UMLS CUI [1,5])
Dosette Use of | Pharmaceutical Preparations Intake Using Electronic monitor System
Item
patients using a dosette box or similar device for their medication are willing to use the mems containers for their pd medication
boolean
C1553470 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
C0336646 (UMLS CUI [2,4])
C0449913 (UMLS CUI [2,5])
Patient care | Symptom control | Study Subject Participation Status | Pharmaceutical Preparations Intake Using Electronic monitor System
Item
the investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the mems device.
boolean
C0017313 (UMLS CUI [1])
C1274136 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C1512806 (UMLS CUI [4,2])
C1524063 (UMLS CUI [4,3])
C0336646 (UMLS CUI [4,4])
C0449913 (UMLS CUI [4,5])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Intermittent Parkinson Disease | Domperidone
Item
patient is taking anti-parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). intermittent domperidone is allowed.
boolean
C0087111 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0013015 (UMLS CUI [2])
Comorbidity Severe | Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Malignant Neoplasms | Parkinson Disease | Life Expectancy | Level of Care Patient need for
Item
severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the parkinson's disease in terms of life expectancy and levels of care required.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5])
C0030567 (UMLS CUI [6])
C0023671 (UMLS CUI [7])
C1547668 (UMLS CUI [8,1])
C0686904 (UMLS CUI [8,2])
Hospital admission Expected | Elective Surgical Procedures
Item
patient is expected to undergo hospital admission during the study period (such as elective surgery).
boolean
C0184666 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2])
Pharmacotherapy Investigational | Combined Modality Therapy | Dopamine Agonists Different Quantity | Dopamine Agonists High dose
Item
patient is on non standard drug treatment / combination therapy. this would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
boolean
C0013216 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0009429 (UMLS CUI [2])
C0178601 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0178601 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
Antiparkinson Agents new therapy
Item
new antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
boolean
C0003405 (UMLS CUI [1,1])
C3242274 (UMLS CUI [1,2])
Adjuvant therapy | Selegiline | Amantadine | Anticholinergic Agents
Item
patient is taking only adjunct therapy (eg. selegiline, amantadine, anticholinergic therapy).
boolean
C0677850 (UMLS CUI [1])
C0036579 (UMLS CUI [2])
C0002403 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
Study Subject Participation Status
Item
patient is taking part in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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