ID

31451

Description

Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00875316

Link

https://clinicaltrials.gov/show/NCT00875316

Keywords

Versions (1)
  1. 8/23/18 8/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00875316

English

Eligibility Parkinson's Disease NCT00875316

1 forms  
Criteria
Description

Criteria

male & female healthy volunteers aged between 40 and 80 years at the time of informed consent
Description

Healthy Volunteers | Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
females of non-childbearing potential
Description

Gender | Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
general good health
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
key exclusion criteria (healthy volunteers):
Description

Exclusion Criteria Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1708335
no clinically significant and relevant medical history
Description

Medical History Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826293
smoked within the 3 months prior to screening
Description

Tobacco use Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332185
use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration
Description

Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Pharmaceutical Preparations Topical | Non-Prescription Drugs Topical | Herbal medicine

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1710439
UMLS CUI [4,1]
C0013231
UMLS CUI [4,2]
C1710439
UMLS CUI [5]
C2240391
key inclusion criteria (parkinson's disease patients):
Description

Inclusion criteria Parkinson Disease Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0030705
male & female parkinson's disease patients aged between 40 and 80 years at the time of informed consent
Description

Parkinson Disease | Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
must have a diagnosis of idiopathic parkinson's disease according to the uk parkinson's disease society brain bank criteria
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
subjects who are taking parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening
Description

Therapeutic procedure Stable Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0030567
key exclusion criteria (parkinson's disease patients):
Description

Exclusion Criteria Parkinson Disease Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C0030705
diagnosis of dementia
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
parkinson's disease of a known genetic cause
Description

Parkinson Disease Cause Genetic Known

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0314603
UMLS CUI [1,4]
C0205309
history of surgical intervention for parkinson's disease
Description

Operative Surgical Procedures Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030567
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Similar models

Eligibility Parkinson's Disease NCT00875316

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Healthy Volunteers | Age | Informed Consent
Item
male & female healthy volunteers aged between 40 and 80 years at the time of informed consent
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Gender | Childbearing Potential Absent
Item
females of non-childbearing potential
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
General health good
Item
general good health
boolean
C1277245 (UMLS CUI [1])
Exclusion Criteria Healthy Volunteers
Item
key exclusion criteria (healthy volunteers):
boolean
C0680251 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Medical History Clinical Significance
Item
no clinically significant and relevant medical history
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Tobacco use Recently
Item
smoked within the 3 months prior to screening
boolean
C0543414 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Pharmaceutical Preparations Topical | Non-Prescription Drugs Topical | Herbal medicine
Item
use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1710439 (UMLS CUI [3,2])
C0013231 (UMLS CUI [4,1])
C1710439 (UMLS CUI [4,2])
C2240391 (UMLS CUI [5])
Inclusion criteria Parkinson Disease Patients
Item
key inclusion criteria (parkinson's disease patients):
boolean
C1512693 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
Parkinson Disease | Age | Informed Consent
Item
male & female parkinson's disease patients aged between 40 and 80 years at the time of informed consent
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Parkinson Disease
Item
must have a diagnosis of idiopathic parkinson's disease according to the uk parkinson's disease society brain bank criteria
boolean
C0030567 (UMLS CUI [1])
Therapeutic procedure Stable Parkinson Disease
Item
subjects who are taking parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Exclusion Criteria Parkinson Disease Patients
Item
key exclusion criteria (parkinson's disease patients):
boolean
C0680251 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
Dementia
Item
diagnosis of dementia
boolean
C0497327 (UMLS CUI [1])
Parkinson Disease Cause Genetic Known
Item
parkinson's disease of a known genetic cause
boolean
C0030567 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0314603 (UMLS CUI [1,3])
C0205309 (UMLS CUI [1,4])
Operative Surgical Procedures Parkinson Disease
Item
history of surgical intervention for parkinson's disease
boolean
C0543467 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
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