ID

31342

Beskrivning

Development of Cognitive Assessment Tools in Parkinson Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00556764

Länk

https://clinicaltrials.gov/show/NCT00556764

Nyckelord

Versioner (1)
  1. 2018-08-16 2018-08-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00556764

Engelsk

Eligibility Parkinson Disease NCT00556764

1 Formulär  
Criteria
Beskrivning

Criteria

pd subjects
Beskrivning

Parkinson Disease Study Subject

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0681850
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participant is 30 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent is obtained.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
participants have a clinical diagnosis of parkinson's disease based on brain bank criteria.
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
mini-mental status examination (mmse) score ≥24 or significant cognitive dysfunction based clinical mental status exam.
Beskrivning

Mini-mental state examination | Impaired cognition Clinical psychologic mental status determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0204474
geriatric depression scales (gds) ≤ 10.
Beskrivning

Geriatric depression scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451184
for females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-i ibvm injection.
Beskrivning

Gender | Childbearing Potential Absent | Urine pregnancy test negative | Serum pregnancy test negative | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0430057
UMLS CUI [4]
C0430061
UMLS CUI [5]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
Beskrivning

Laboratory test result abnormal | Disease Unstable | Mental disorder Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0443343
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
Beskrivning

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1378698
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
UMLS CUI [5]
C0524722
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
healthy control subjects
Beskrivning

Healthy Control

Datatyp

boolean

Alias
UMLS CUI [1]
C2986479
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the participant is 50 years or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent is obtained.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
negative history of neurological or psychiatric illness based on evaluation by a research physician.
Beskrivning

Medical History Negative Nervous system disorder | Medical History Negative Mental disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0004936
mini-mental status exam score ≥28.
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
for females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-i ibvm injection.
Beskrivning

Gender | Childbearing Potential Absent | Urine pregnancy test negative | Serum pregnancy test negative | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0430057
UMLS CUI [4]
C0430061
UMLS CUI [5]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
Beskrivning

Laboratory test result abnormal | Disease Unstable | Mental disorder Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0443343
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
Beskrivning

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C1378698
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
UMLS CUI [5]
C0524722
the subject has received an investigational drug within 60 days before the screening visit.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Parkinson Disease NCT00556764

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Parkinson Disease Study Subject
Item
pd subjects
boolean
C0030567 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
C1512693 (UMLS CUI)
Age
Item
the participant is 30 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Parkinson Disease
Item
participants have a clinical diagnosis of parkinson's disease based on brain bank criteria.
boolean
C0030567 (UMLS CUI [1])
Mini-mental state examination | Impaired cognition Clinical psychologic mental status determination
Item
mini-mental status examination (mmse) score ≥24 or significant cognitive dysfunction based clinical mental status exam.
boolean
C0451306 (UMLS CUI [1])
C0338656 (UMLS CUI [2,1])
C0204474 (UMLS CUI [2,2])
Geriatric depression scale
Item
geriatric depression scales (gds) ≤ 10.
boolean
C0451184 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Urine pregnancy test negative | Serum pregnancy test negative | Other Coding
Item
for females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-i ibvm injection.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430057 (UMLS CUI [3])
C0430061 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal | Disease Unstable | Mental disorder Unstable
Item
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
boolean
C0438215 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure
Item
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1378698 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0524722 (UMLS CUI [5])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Healthy Control
Item
healthy control subjects
boolean
C2986479 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI)
Age
Item
the participant is 50 years or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Medical History Negative Nervous system disorder | Medical History Negative Mental disorder
Item
negative history of neurological or psychiatric illness based on evaluation by a research physician.
boolean
C0262926 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0027765 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
Mini-mental state examination
Item
mini-mental status exam score ≥28.
boolean
C0451306 (UMLS CUI [1])
Gender | Childbearing Potential Absent | Urine pregnancy test negative | Serum pregnancy test negative | Other Coding
Item
for females, non-child bearing potential a negative urine or serum pregnancy test on day of 123-i ibvm injection.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430057 (UMLS CUI [3])
C0430061 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal | Disease Unstable | Mental disorder Unstable
Item
the subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
boolean
C0438215 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination | Gastrointestinal Surgical Procedure
Item
the subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1378698 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0524722 (UMLS CUI [5])
Investigational New Drugs
Item
the subject has received an investigational drug within 60 days before the screening visit.
boolean
C0013230 (UMLS CUI [1])
Tillbaka till toppen 

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