ID

22321

Description

Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00397696

Lien

https://clinicaltrials.gov/show/NCT00397696

Mots-clés

  1. 29/05/2017 29/05/2017 -
Téléchargé le

29 mai 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Parkinson Disease NCT00397696

Eligibility Parkinson Disease NCT00397696

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the presence of idiopathic parkinson disease
Description

Parkinson Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0030567
a clear clinical response to dopaminergic therapy treatment
Description

Dopaminergic Agents | Clinical Response Clear

Type de données

boolean

Alias
UMLS CUI [1]
C0013036
UMLS CUI [2,1]
C4055223
UMLS CUI [2,2]
C2963144
hoehn and yahr stages < 3;
Description

Hoehn and Yahr Stage

Type de données

boolean

Alias
UMLS CUI [1]
C3639483
2-7 year duration from time of diagnosis.
Description

disease length

Type de données

boolean

Alias
UMLS CUI [1]
C0872146
mini-mental status exam score of >24,
Description

Mini-mental state examination score

Type de données

boolean

Alias
UMLS CUI [1]
C2960235
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] 5-ia injection.
Description

Gender Childbearing Potential Lacking | Childbearing Potential Urine pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary parkinsonism;
Description

Secondary Parkinson Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0030569
nicotine dependence or use within the previous 12 months prior to enrollment;
Description

Nicotine Dependence | Nicotine Use Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0028043
UMLS CUI [2]
C0376384
treatment with aricept (donepezil), exelon (rivastigmine), cognex (tacrine) within the past 30 days; treatment with medications that bind to the nicotinic receptor.
Description

Aricept | donepezil | Exelon | rivastigmine | Cognex | Tacrine

Type de données

boolean

Alias
UMLS CUI [1]
C0527315
UMLS CUI [2]
C0527316
UMLS CUI [3]
C0730987
UMLS CUI [4]
C0649350
UMLS CUI [5]
C0699954
UMLS CUI [6]
C0039245
clinically significant clinical laboratory value and/or medical or psychiatric illness;
Description

Laboratory Results Clinical Significance | Illness | Mental disorders

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0221423
UMLS CUI [3]
C0004936
mini-mental status exam score of ≤24.
Description

Mini-mental state examination score

Type de données

boolean

Alias
UMLS CUI [1]
C2960235
the subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
Description

Thyroid Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Neoplastic disease | Endocrine System Diseases | nervous system disorder | Immunologic Deficiency Syndromes | Lung diseases | Illness | Mental disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0040128
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0018939
UMLS CUI [7]
C1882062
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0021051
UMLS CUI [11]
C0024115
UMLS CUI [12]
C0221423
UMLS CUI [13]
C0004936
the subject has received an investigational drug within 30 days of the screening visit;
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
pregnancy
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Parkinson Disease NCT00397696

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
the presence of idiopathic parkinson disease
boolean
C0030567 (UMLS CUI [1])
Dopaminergic Agents | Clinical Response Clear
Item
a clear clinical response to dopaminergic therapy treatment
boolean
C0013036 (UMLS CUI [1])
C4055223 (UMLS CUI [2,1])
C2963144 (UMLS CUI [2,2])
Hoehn and Yahr Stage
Item
hoehn and yahr stages < 3;
boolean
C3639483 (UMLS CUI [1])
disease length
Item
2-7 year duration from time of diagnosis.
boolean
C0872146 (UMLS CUI [1])
Mini-mental state examination score
Item
mini-mental status exam score of >24,
boolean
C2960235 (UMLS CUI [1])
Gender Childbearing Potential Lacking | Childbearing Potential Urine pregnancy test negative
Item
for females, non-child bearing potential or negative urine pregnancy test on day of [123i] 5-ia injection.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary Parkinson Disease
Item
secondary parkinsonism;
boolean
C0030569 (UMLS CUI [1])
Nicotine Dependence | Nicotine Use Disorder
Item
nicotine dependence or use within the previous 12 months prior to enrollment;
boolean
C0028043 (UMLS CUI [1])
C0376384 (UMLS CUI [2])
Aricept | donepezil | Exelon | rivastigmine | Cognex | Tacrine
Item
treatment with aricept (donepezil), exelon (rivastigmine), cognex (tacrine) within the past 30 days; treatment with medications that bind to the nicotinic receptor.
boolean
C0527315 (UMLS CUI [1])
C0527316 (UMLS CUI [2])
C0730987 (UMLS CUI [3])
C0649350 (UMLS CUI [4])
C0699954 (UMLS CUI [5])
C0039245 (UMLS CUI [6])
Laboratory Results Clinical Significance | Illness | Mental disorders
Item
clinically significant clinical laboratory value and/or medical or psychiatric illness;
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Mini-mental state examination score
Item
mini-mental status exam score of ≤24.
boolean
C2960235 (UMLS CUI [1])
Thyroid Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Neoplastic disease | Endocrine System Diseases | nervous system disorder | Immunologic Deficiency Syndromes | Lung diseases | Illness | Mental disorders
Item
the subject has evidence of clinically significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
boolean
C0040128 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C1882062 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0021051 (UMLS CUI [10])
C0024115 (UMLS CUI [11])
C0221423 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
Investigational New Drugs
Item
the subject has received an investigational drug within 30 days of the screening visit;
boolean
C0013230 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])

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