ID

44383

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00459420

Palabras clave

Versiones (2)
  1. 19/8/18 19/8/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00459420

Inglés

Eligibility Parkinson's Disease NCT00459420

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of idiopathic pd
Descripción

Parkinson Disease

Tipo de datos

boolean

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

Excessive daytime somnolence Epworth Sleepiness Scale

Tipo de datos

boolean

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

Exclusion Criteria

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

Caffeine consumption Estimated mg/day

Tipo de datos

boolean

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

Peptic Ulcer

Tipo de datos

boolean

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

Supraventricular arrhythmia Cardiac | Atrial Fibrillation | Atrial Flutter

Tipo de datos

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
Descripción

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de datos

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.
Descripción

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.

Tipo de datos

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
Descripción

Wakefulness-Promoting Agents | Modafinil | Methylphenidate

Tipo de datos

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
Descripción

Premenopausal state Contraceptive methods Absent

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

Depressive disorder Beck depression inventory score

Tipo de datos

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.
Descripción

Antiparkinson Agents Change | Antiparkinson Agents Change Expected

Tipo de datos

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
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Similar models

Eligibility Parkinson's Disease NCT00459420

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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