ID

44383

Description

Caffeine for Excessive Daytime Somnolence in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00459420

Link

https://clinicaltrials.gov/show/NCT00459420

Keywords

Versions (2)
  1. 8/19/18 8/19/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Parkinson's Disease NCT00459420

English

Eligibility Parkinson's Disease NCT00459420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of idiopathic pd
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
excessive daytime somnolence (defined as an epworth sleepiness scale score of >10).
Description

Excessive daytime somnolence Epworth Sleepiness Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C4551761
UMLS CUI [1,2]
C3541276
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
estimated daily caffeine intake of more than 200 mg per day
Description

Caffeine consumption Estimated mg/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0948365
UMLS CUI [1,2]
C0750572
UMLS CUI [1,3]
C0439422
active peptic ulcer disease
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter)
Description

Supraventricular arrhythmia Cardiac | Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1,1]
C0428974
UMLS CUI [1,2]
C1522601
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
uncontrolled hypertension - defined as systolic bp >170 or diastolic bp >110 on two consecutive readings
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
eds is caused by sleep apnea, restless legs syndrome, narcolepsy, shift work, or sleep promoting agents.
Description

Excessive daytime somnolence caused by Sleep Apnea | Excessive daytime somnolence caused by Restless Legs Syndrome | Excessive daytime somnolence caused by Narcolepsy | Excessive daytime somnolence caused by Shift work | Excessive daytime somnolence caused by Sleep promoting agents.

Data type

boolean

Alias
UMLS CUI [1,1]
C4551761
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0037315
UMLS CUI [2,1]
C4551761
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0035258
UMLS CUI [3,1]
C4551761
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0027404
UMLS CUI [4,1]
C4551761
UMLS CUI [4,2]
C0015127
UMLS CUI [4,3]
C1658633
UMLS CUI [5,1]
C4551761
UMLS CUI [5,2]
C0015127
UMLS CUI [5,3]
C4042825
current use of prescribed alerting agents such as modafinil and methylphenidate
Description

Wakefulness-Promoting Agents | Modafinil | Methylphenidate

Data type

boolean

Alias
UMLS CUI [1]
C3658225
UMLS CUI [2]
C0066677
UMLS CUI [3]
C0025810
pre-menopausal women who are not using effective methods of birth control
Description

Premenopausal state Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
dementia, defined as mmse <24/30 and adl impairment secondary to cognitive loss, or inability to understand consent process
Description

Dementia Mini-mental state examination | Activities of daily living impaired Secondary to Impaired cognition | Comprehension Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C0740765
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0338656
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C1299582
depression, as defined by a beck depression inventory score of >15.
Description

Depressive disorder Beck depression inventory score

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C2960571
changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the study protocol.
Description

Antiparkinson Agents Change | Antiparkinson Agents Change Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1517001
Back to the top of the page

Similar models

Eligibility Parkinson's Disease NCT00459420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
a diagnosis of idiopathic pd
boolean
C0030567 (UMLS CUI [1])
Excessive daytime somnolence Epworth Sleepiness Scale
Item
excessive daytime somnolence (defined as an epworth sleepiness scale score of >10).
boolean
C4551761 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Caffeine consumption Estimated mg/day
Item
estimated daily caffeine intake of more than 200 mg per day
boolean
C0948365 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0439422 (UMLS CUI [1,3])
Peptic Ulcer
Item
active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1])
Supraventricular arrhythmia Cardiac | Atrial Fibrillation | Atrial Flutter
Item
supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter)
boolean
C0428974 (UMLS CUI [1,1])
C1522601 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension - defined as systolic bp >170 or diastolic bp >110 on two consecutive readings
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Excessive daytime somnolence caused by Sleep Apnea | Excessive daytime somnolence caused by Restless Legs Syndrome | Excessive daytime somnolence caused by Narcolepsy | Excessive daytime somnolence caused by Shift work | Excessive daytime somnolence caused by Sleep promoting agents.
Item
eds is caused by sleep apnea, restless legs syndrome, narcolepsy, shift work, or sleep promoting agents.
boolean
C4551761 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0037315 (UMLS CUI [1,3])
C4551761 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0035258 (UMLS CUI [2,3])
C4551761 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0027404 (UMLS CUI [3,3])
C4551761 (UMLS CUI [4,1])
C0015127 (UMLS CUI [4,2])
C1658633 (UMLS CUI [4,3])
C4551761 (UMLS CUI [5,1])
C0015127 (UMLS CUI [5,2])
C4042825 (UMLS CUI [5,3])
Wakefulness-Promoting Agents | Modafinil | Methylphenidate
Item
current use of prescribed alerting agents such as modafinil and methylphenidate
boolean
C3658225 (UMLS CUI [1])
C0066677 (UMLS CUI [2])
C0025810 (UMLS CUI [3])
Premenopausal state Contraceptive methods Absent
Item
pre-menopausal women who are not using effective methods of birth control
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Dementia Mini-mental state examination | Activities of daily living impaired Secondary to Impaired cognition | Comprehension Informed Consent Unable
Item
dementia, defined as mmse <24/30 and adl impairment secondary to cognitive loss, or inability to understand consent process
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0740765 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0338656 (UMLS CUI [2,3])
C0162340 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Depressive disorder Beck depression inventory score
Item
depression, as defined by a beck depression inventory score of >15.
boolean
C0011581 (UMLS CUI [1,1])
C2960571 (UMLS CUI [1,2])
Antiparkinson Agents Change | Antiparkinson Agents Change Expected
Item
changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the study protocol.
boolean
C0003405 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial