ID

24887

Beschreibung

A Study of MK0657 in Parkinson's Disease Patients (0657-006); ODM derived from: https://clinicaltrials.gov/show/NCT00505843

Link

https://clinicaltrials.gov/show/NCT00505843

Stichworte

Versionen (1)
  1. 22.08.17 22.08.17 -
Hochgeladen am

22. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00505843

Englisch

Eligibility Parkinson's Disease NCT00505843

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
parkinson's disease patients between the ages of 40 and 80 inclusive
Beschreibung

Parkinson Disease | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
patient is in general good health based on screening assessments
Beschreibung

General health good

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing
Beschreibung

Antiparkinson Agents Discontinue Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
patient is levodopa responsive with levodopa-induced peak-dose dyskinesias
Beschreibung

Levodopa Responsive | Levodopa-induced dyskinesias Dose Peak

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0205342
UMLS CUI [2,1]
C1970038
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0444505
patient taking selective serotonin inhibitors (ssris), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any cns-related side effects
Beschreibung

Selective Serotonin Reuptake Inhibitors | taking medication to help sleep | Antipsychotic Agents | Pharmaceutical Preparations Dose Stable | Adverse effects CNS Related Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0360105
UMLS CUI [2]
C2054158
UMLS CUI [3]
C0040615
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0879626
UMLS CUI [5,2]
C3714787
UMLS CUI [5,3]
C0439849
UMLS CUI [5,4]
C0332197
patient is not a heavy smoker or drinker
Beschreibung

Heavy smoker Absent | Alcoholic Intoxication Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0857118
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0001969
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has atypical parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome
Beschreibung

Atypical Parkinson Disease Due to Pharmaceutical Preparations | Atypical Parkinson Disease Due to Metabolic Diseases | Atypical Parkinson Disease Due to Nervous system disorder | Atypical Parkinson Disease Due to Encephalitis | Atypical Parkinson Disease Due to Degenerative disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868596
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1868596
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0025517
UMLS CUI [3,1]
C1868596
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0027765
UMLS CUI [4,1]
C1868596
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0014038
UMLS CUI [5,1]
C1868596
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1285162
patient has known intolerance or hypersensitivity to levodopa or carbidopa
Beschreibung

Intolerance to Levodopa | Levodopa allergy | Intolerance to Carbidopa | Hypersensitivity Carbidopa

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0023570
UMLS CUI [2]
C0570730
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0006982
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0006982
patient has been on anticholinergics or memantine within 30 days prior to dosing
Beschreibung

Anticholinergic Agents | Memantine

Datentyp

boolean

Alias
UMLS CUI [1]
C0242896
UMLS CUI [2]
C0025242
patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by hba1c of greater than 8%
Beschreibung

Epilepsy | Cerebrovascular accident | Craniocerebral Trauma | Impaired cognition Marked | Mental disorders | Cardiovascular Diseases | Malignant Neoplasms | Diabetes Mellitus | Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0018674
UMLS CUI [4,1]
C0338656
UMLS CUI [4,2]
C1706089
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0011849
UMLS CUI [9]
C0019018
patient has a systolic bp or less than 80 mm hg or greater than 150 mm hg
Beschreibung

Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT00505843

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Age
Item
parkinson's disease patients between the ages of 40 and 80 inclusive
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
General health good
Item
patient is in general good health based on screening assessments
boolean
C1277245 (UMLS CUI [1])
Antiparkinson Agents Discontinue Willing
Item
patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing
boolean
C0003405 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Levodopa Responsive | Levodopa-induced dyskinesias Dose Peak
Item
patient is levodopa responsive with levodopa-induced peak-dose dyskinesias
boolean
C0023570 (UMLS CUI [1,1])
C0205342 (UMLS CUI [1,2])
C1970038 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0444505 (UMLS CUI [2,3])
Selective Serotonin Reuptake Inhibitors | taking medication to help sleep | Antipsychotic Agents | Pharmaceutical Preparations Dose Stable | Adverse effects CNS Related Absent
Item
patient taking selective serotonin inhibitors (ssris), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any cns-related side effects
boolean
C0360105 (UMLS CUI [1])
C2054158 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0879626 (UMLS CUI [5,1])
C3714787 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
C0332197 (UMLS CUI [5,4])
Heavy smoker Absent | Alcoholic Intoxication Absent
Item
patient is not a heavy smoker or drinker
boolean
C0857118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001969 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Atypical Parkinson Disease Due to Pharmaceutical Preparations | Atypical Parkinson Disease Due to Metabolic Diseases | Atypical Parkinson Disease Due to Nervous system disorder | Atypical Parkinson Disease Due to Encephalitis | Atypical Parkinson Disease Due to Degenerative disorder
Item
patient has atypical parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome
boolean
C1868596 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1868596 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0025517 (UMLS CUI [2,3])
C1868596 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0027765 (UMLS CUI [3,3])
C1868596 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0014038 (UMLS CUI [4,3])
C1868596 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1285162 (UMLS CUI [5,3])
Intolerance to Levodopa | Levodopa allergy | Intolerance to Carbidopa | Hypersensitivity Carbidopa
Item
patient has known intolerance or hypersensitivity to levodopa or carbidopa
boolean
C1744706 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0570730 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0006982 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0006982 (UMLS CUI [4,2])
Anticholinergic Agents | Memantine
Item
patient has been on anticholinergics or memantine within 30 days prior to dosing
boolean
C0242896 (UMLS CUI [1])
C0025242 (UMLS CUI [2])
Epilepsy | Cerebrovascular accident | Craniocerebral Trauma | Impaired cognition Marked | Mental disorders | Cardiovascular Diseases | Malignant Neoplasms | Diabetes Mellitus | Glycosylated hemoglobin A
Item
patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by hba1c of greater than 8%
boolean
C0014544 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0018674 (UMLS CUI [3])
C0338656 (UMLS CUI [4,1])
C1706089 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0011849 (UMLS CUI [8])
C0019018 (UMLS CUI [9])
Systolic Pressure
Item
patient has a systolic bp or less than 80 mm hg or greater than 150 mm hg
boolean
C0871470 (UMLS CUI [1])
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