ID

31440

Description

Early Parkinson's Disease (PD) Cross-Sectional; ODM derived from: https://clinicaltrials.gov/show/NCT00817453

Lien

https://clinicaltrials.gov/show/NCT00817453

Mots-clés

Versions (1)
  1. 22/08/2018 22/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 août 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00817453

Anglais

Eligibility Parkinson's Disease NCT00817453

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 35-80 year old men & women
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with ipd or parkinsonian syndromes, or controls consisting of healthy subjects, or subjects who have a non-neurodegenerative diagnosis but are otherwise healthy.
Description

Parkinson Disease | Parkinsonian Disorders | Healthy Control | Study Subject Diagnosis Except Neurodegenerative Disorders | Study Subject General health good

Type de données

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0242422
UMLS CUI [3]
C2986479
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C0011900
UMLS CUI [4,3]
C0332300
UMLS CUI [4,4]
C0524851
UMLS CUI [5,1]
C0681850
UMLS CUI [5,2]
C1277245
3. gives written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
4. pregnant women are not excluded, but will be identified by hcg.
Description

Pregnancy Identified HCG pregnancy test

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0546577
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. parkinsonian symptoms not due to idiopathic (sporadic) pd, such as those that are medication induced, toxic substance induced or representative of an atypical parkinsonian syndrome will be categorized separately.
Description

Parkinsonian symptoms | Etiology Absent Idiopathic Parkinson Disease | Etiology Absent Sporadic Parkinson disease | Medication-induced parkinsonism | Parkinsonian symptoms Toxic substance Induced | Atypical Parkinsonism

Type de données

boolean

Alias
UMLS CUI [1]
C0242422
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0030567
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C4511452
UMLS CUI [4]
C4237315
UMLS CUI [5,1]
C0242422
UMLS CUI [5,2]
C0032346
UMLS CUI [5,3]
C0205263
UMLS CUI [6]
C4302185
2. any unstable or uncontrolled medical or psychiatric condition.
Description

Medical condition Unstable | Medical condition Uncontrolled | Mental condition Unstable | Mental condition Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0205318
3. renal (creatinine over 1.6) or hepatic insufficiency (lft three-fold higher than normal range), or a history of significant cardiac disease.
Description

Renal Insufficiency | Creatinine measurement, serum | Hepatic Insufficiency | Increased liver function tests | Heart Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1306571
UMLS CUI [4]
C0877359
UMLS CUI [5]
C0018799
4. if there is a history or evidence of coagulopathy, on medications such as plavix, aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these medications for at least 3 days, and have stable blood coagulation values prior to any lumbar puncture (lp).
Description

Blood Coagulation Disorders | Plavix | Aggrenox | Heparin | Coumadin | Aspirin Dose Large | Pharmaceutical Preparations Discontinue Ability | Blood coagulation Value Stable | Status pre- Lumbar puncture

Type de données

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0633084
UMLS CUI [3]
C0732282
UMLS CUI [4]
C0019134
UMLS CUI [5]
C0699129
UMLS CUI [6,1]
C0004057
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0549177
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1444662
UMLS CUI [7,3]
C0085732
UMLS CUI [8,1]
C0005778
UMLS CUI [8,2]
C1522609
UMLS CUI [8,3]
C0205360
UMLS CUI [9,1]
C0332152
UMLS CUI [9,2]
C0553794
5. significant dementia (mmse<25/30 or moca<25/30) that would interfere with study procedures or the giving of informed consent for the study .
Description

Dementia Mini-mental state examination | Dementia Montreal cognitive assessment | Dementia Interferes with Study Protocol | Dementia Interferes with Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C3496286
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0497327
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
6. active infections including skin, respiratory or gi infections, and hiv+ (if undergoing an lp).
Description

Communicable Diseases | Skin Diseases, Infectious | Respiratory Tract Infections | Gastrointestinal infection | HIV Seropositivity | Lumbar puncture

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0037278
UMLS CUI [3]
C0035243
UMLS CUI [4]
C4082764
UMLS CUI [5]
C0019699
UMLS CUI [6]
C0553794
7. any evidence of a different neurodegenerative disorder, for example, alzheimer's disease or huntington's disease.
Description

Neurodegenerative Disorders | Alzheimer's Disease | Huntington Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0020179
8. fmri will not be performed is screening questionnaire identifies a reason.
Description

fMRI | Reason Identified Screening questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C0376335
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C1134635
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Similar models

Eligibility Parkinson's Disease NCT00817453

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 35-80 year old men & women
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | Parkinsonian Disorders | Healthy Control | Study Subject Diagnosis Except Neurodegenerative Disorders | Study Subject General health good
Item
2. patients with ipd or parkinsonian syndromes, or controls consisting of healthy subjects, or subjects who have a non-neurodegenerative diagnosis but are otherwise healthy.
boolean
C0030567 (UMLS CUI [1])
C0242422 (UMLS CUI [2])
C2986479 (UMLS CUI [3])
C0681850 (UMLS CUI [4,1])
C0011900 (UMLS CUI [4,2])
C0332300 (UMLS CUI [4,3])
C0524851 (UMLS CUI [4,4])
C0681850 (UMLS CUI [5,1])
C1277245 (UMLS CUI [5,2])
Informed Consent
Item
3. gives written informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy Identified HCG pregnancy test
Item
4. pregnant women are not excluded, but will be identified by hcg.
boolean
C0032961 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0546577 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Parkinsonian symptoms | Etiology Absent Idiopathic Parkinson Disease | Etiology Absent Sporadic Parkinson disease | Medication-induced parkinsonism | Parkinsonian symptoms Toxic substance Induced | Atypical Parkinsonism
Item
1. parkinsonian symptoms not due to idiopathic (sporadic) pd, such as those that are medication induced, toxic substance induced or representative of an atypical parkinsonian syndrome will be categorized separately.
boolean
C0242422 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0030567 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4511452 (UMLS CUI [3,3])
C4237315 (UMLS CUI [4])
C0242422 (UMLS CUI [5,1])
C0032346 (UMLS CUI [5,2])
C0205263 (UMLS CUI [5,3])
C4302185 (UMLS CUI [6])
Medical condition Unstable | Medical condition Uncontrolled | Mental condition Unstable | Mental condition Uncontrolled
Item
2. any unstable or uncontrolled medical or psychiatric condition.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C3840291 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C3840291 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Renal Insufficiency | Creatinine measurement, serum | Hepatic Insufficiency | Increased liver function tests | Heart Diseases
Item
3. renal (creatinine over 1.6) or hepatic insufficiency (lft three-fold higher than normal range), or a history of significant cardiac disease.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
C0877359 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
Blood Coagulation Disorders | Plavix | Aggrenox | Heparin | Coumadin | Aspirin Dose Large | Pharmaceutical Preparations Discontinue Ability | Blood coagulation Value Stable | Status pre- Lumbar puncture
Item
4. if there is a history or evidence of coagulopathy, on medications such as plavix, aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these medications for at least 3 days, and have stable blood coagulation values prior to any lumbar puncture (lp).
boolean
C0005779 (UMLS CUI [1])
C0633084 (UMLS CUI [2])
C0732282 (UMLS CUI [3])
C0019134 (UMLS CUI [4])
C0699129 (UMLS CUI [5])
C0004057 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0549177 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
C0085732 (UMLS CUI [7,3])
C0005778 (UMLS CUI [8,1])
C1522609 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
C0332152 (UMLS CUI [9,1])
C0553794 (UMLS CUI [9,2])
Dementia Mini-mental state examination | Dementia Montreal cognitive assessment | Dementia Interferes with Study Protocol | Dementia Interferes with Informed Consent
Item
5. significant dementia (mmse<25/30 or moca<25/30) that would interfere with study procedures or the giving of informed consent for the study .
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2,1])
C3496286 (UMLS CUI [2,2])
C0497327 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0497327 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Communicable Diseases | Skin Diseases, Infectious | Respiratory Tract Infections | Gastrointestinal infection | HIV Seropositivity | Lumbar puncture
Item
6. active infections including skin, respiratory or gi infections, and hiv+ (if undergoing an lp).
boolean
C0009450 (UMLS CUI [1])
C0037278 (UMLS CUI [2])
C0035243 (UMLS CUI [3])
C4082764 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
C0553794 (UMLS CUI [6])
Neurodegenerative Disorders | Alzheimer's Disease | Huntington Disease
Item
7. any evidence of a different neurodegenerative disorder, for example, alzheimer's disease or huntington's disease.
boolean
C0524851 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
C0020179 (UMLS CUI [3])
fMRI | Reason Identified Screening questionnaire
Item
8. fmri will not be performed is screening questionnaire identifies a reason.
boolean
C0376335 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C1134635 (UMLS CUI [2,3])
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