ID

13781

Description

Intranasal Glutathione in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01398748

Link

https://clinicaltrials.gov/show/NCT01398748

Keywords

Versions (1)
  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease (PD) NCT01398748

English

Eligibility Parkinson's Disease (PD) NCT01398748

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of parkinson's disease made by neurologist within previous 10 years
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
2. modified hoehn and yahr stage <3
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
3. age >20
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
5. subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
Description

compliance; drug administration

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C3469597
6. dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.
Description

dosis

Data type

boolean

Alias
UMLS CUI [1]
C3174092
7. diet, exercise and supplementation must be kept constant throughout participation in study
Description

diet; exercise; supplementation

Data type

boolean

Alias
UMLS CUI [1]
C0012155
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0242297
8. ability to read and speak english
Description

english

Data type

boolean

Alias
UMLS CUI [1]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. dementia as evidenced by montreal cognitive assessment (moca) <24
Description

dementia; montreal cognitive assessment

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C3496286
2. diseases with features common to parkinson's disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
Description

essential tremor; multiple system atrophy; progressive supranuclear palsy

Data type

boolean

Alias
UMLS CUI [1]
C0270736
UMLS CUI [2]
C0393571
UMLS CUI [3]
C0038868
3. epilepsy
Description

epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
4. history of stroke, cva
Description

medical history stroke

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0038454
5. elevated levels of alt, ast, bun or creatinine
Description

alt and ast; Blood urea nitrogen; creatinine

Data type

boolean

Alias
UMLS CUI [1,1]
C0001899
UMLS CUI [1,2]
C0004002
UMLS CUI [2]
C0005845
UMLS CUI [3]
C0201975
6. chronic sinusitis as defined by snot-20 score >1.0 on items 1-10.
Description

chronic sinusitis

Data type

boolean

Alias
UMLS CUI [1]
C0149516
7. presence of other serious illness
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
8. history of brain surgery
Description

brain surgery

Data type

boolean

Alias
UMLS CUI [1]
C0195775
9. history of structural brain damage
Description

brain damage

Data type

boolean

Alias
UMLS CUI [1]
C0270611
10. history of intranasal telangiectasia
Description

telangiectasia

Data type

boolean

Alias
UMLS CUI [1]
C0039446
11. supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.
Description

glutathione

Data type

boolean

Alias
UMLS CUI [1]
C0017817
12. pregnant or at risk of becoming pregnant.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Parkinson's Disease (PD) NCT01398748

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
1. diagnosis of parkinson's disease made by neurologist within previous 10 years
boolean
C0030567 (UMLS CUI [1])
Hoehn and Yahr Stage
Item
2. modified hoehn and yahr stage <3
boolean
C3639483 (UMLS CUI [1])
age
Item
3. age >20
boolean
C0001779 (UMLS CUI [1])
compliance
Item
4. subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16
boolean
C1321605 (UMLS CUI [1])
compliance; drug administration
Item
5. subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.
boolean
C1321605 (UMLS CUI [1])
C3469597 (UMLS CUI [2])
dosis
Item
6. dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.
boolean
C3174092 (UMLS CUI [1])
diet; exercise; supplementation
Item
7. diet, exercise and supplementation must be kept constant throughout participation in study
boolean
C0012155 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0242297 (UMLS CUI [3])
english
Item
8. ability to read and speak english
boolean
C0376245 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dementia; montreal cognitive assessment
Item
1. dementia as evidenced by montreal cognitive assessment (moca) <24
boolean
C0497327 (UMLS CUI [1])
C3496286 (UMLS CUI [2])
essential tremor; multiple system atrophy; progressive supranuclear palsy
Item
2. diseases with features common to parkinson's disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)
boolean
C0270736 (UMLS CUI [1])
C0393571 (UMLS CUI [2])
C0038868 (UMLS CUI [3])
epilepsy
Item
3. epilepsy
boolean
C0014544 (UMLS CUI [1])
medical history stroke
Item
4. history of stroke, cva
boolean
C0262926 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
alt and ast; Blood urea nitrogen; creatinine
Item
5. elevated levels of alt, ast, bun or creatinine
boolean
C0001899 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0005845 (UMLS CUI [2])
C0201975 (UMLS CUI [3])
chronic sinusitis
Item
6. chronic sinusitis as defined by snot-20 score >1.0 on items 1-10.
boolean
C0149516 (UMLS CUI [1])
comorbidity
Item
7. presence of other serious illness
boolean
C0009488 (UMLS CUI [1])
brain surgery
Item
8. history of brain surgery
boolean
C0195775 (UMLS CUI [1])
brain damage
Item
9. history of structural brain damage
boolean
C0270611 (UMLS CUI [1])
telangiectasia
Item
10. history of intranasal telangiectasia
boolean
C0039446 (UMLS CUI [1])
glutathione
Item
11. supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.
boolean
C0017817 (UMLS CUI [1])
pregnancy
Item
12. pregnant or at risk of becoming pregnant.
boolean
C0032961 (UMLS CUI [1])
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