ID

36778

Description

Caffeine as a Therapy for Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01738178

Link

https://clinicaltrials.gov/show/NCT01738178

Keywords

Versions (1)
  1. 6/7/19 6/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01738178

English

Eligibility Parkinson's Disease NCT01738178

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have idiopathic pd diagnosed as parkinsonism according to the uk brain bank criteria, and pd considered the likeliest underlying cause according to the treating physician. other inclusion criteria include:
Description

Parkinson Disease | Parkinsonian Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0242422
1. pd diagnosis: between 6 months and 6 years
Description

Parkinson Disease Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
2. hoehn and yahr stage i-iii
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
3. age at least 45 and less than 75 (to optimize survival over the 5-year trial).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. receiving symptomatic therapy for pd for at least 6 months. dose must have been stable over the previous 3 months.
Description

Therapy Symptomatic Parkinson Disease | Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. caffeine intake >150 mg per day (i.e. more than one cup of filtered coffee per day) or prescribed adenosine antagonists - caffeine intake will be measured by a standardized intake questionnaire. intake will be converted into estimated caffeine mg dose by standard caffeine-content charts.
Description

Caffeine intake U/day | Adenosine receptor antagonist | Caffeine intake Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C4062719
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0815050
UMLS CUI [3,1]
C4062719
UMLS CUI [3,2]
C0034394
2. active peptic ulcer disease, or symptomatic gastroesophageal reflux disease.
Description

Peptic Ulcer | Gastroesophageal reflux disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017168
UMLS CUI [2,2]
C0231220
3. 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]
C0018787
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
electrocardiogram will be measured at baseline to rule out supraventricular tachycardia.
Description

Electrocardiography out ruling Supraventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0039240
4. uncontrolled hypertension - systolic bp >170 or diastolic bp >110 on two 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
5. 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
6. cognitive impairment, defined as moca <23/30.
Description

Impaired cognition MoCA

Data type

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C3496286
7. moderate-severe depression, as defined by a beck depression inventory score of >19.
Description

Moderate depression Beck depression inventory | Severe depression Beck depression inventory

Data type

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C0451022
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C0451022
8. changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the next six months.
Description

Antiparkinson Agents Change | Antiparkinson Agents Change Anticipated

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]
C3840775
9. current use of lithium or clozapine (pharmacokinetic interactions).
Description

Lithium | Clozapine | Pharmacokinetic interaction

Data type

boolean

Alias
UMLS CUI [1]
C0023870
UMLS CUI [2]
C0009079
UMLS CUI [3]
C1868980
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Similar models

Eligibility Parkinson's Disease NCT01738178

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Parkinsonian Disorders
Item
all patients must have idiopathic pd diagnosed as parkinsonism according to the uk brain bank criteria, and pd considered the likeliest underlying cause according to the treating physician. other inclusion criteria include:
boolean
C0030567 (UMLS CUI [1])
C0242422 (UMLS CUI [2])
Parkinson Disease Disease length
Item
1. pd diagnosis: between 6 months and 6 years
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hoehn and Yahr Stage
Item
2. hoehn and yahr stage i-iii
boolean
C3639483 (UMLS CUI [1])
Age
Item
3. age at least 45 and less than 75 (to optimize survival over the 5-year trial).
boolean
C0001779 (UMLS CUI [1])
Therapy Symptomatic Parkinson Disease | Dose Stable
Item
4. receiving symptomatic therapy for pd for at least 6 months. dose must have been stable over the previous 3 months.
boolean
C0087111 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Caffeine intake U/day | Adenosine receptor antagonist | Caffeine intake Questionnaire
Item
1. caffeine intake >150 mg per day (i.e. more than one cup of filtered coffee per day) or prescribed adenosine antagonists - caffeine intake will be measured by a standardized intake questionnaire. intake will be converted into estimated caffeine mg dose by standard caffeine-content charts.
boolean
C4062719 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0815050 (UMLS CUI [2])
C4062719 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
Peptic Ulcer | Gastroesophageal reflux disease Symptomatic
Item
2. active peptic ulcer disease, or symptomatic gastroesophageal reflux disease.
boolean
C0030920 (UMLS CUI [1])
C0017168 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Supraventricular arrhythmia cardiac | Atrial Fibrillation | Atrial Flutter
Item
3. supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter) -
boolean
C0428974 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
Electrocardiography out ruling Supraventricular tachycardia
Item
electrocardiogram will be measured at baseline to rule out supraventricular tachycardia.
boolean
C1623258 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0039240 (UMLS CUI [1,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
4. uncontrolled hypertension - systolic bp >170 or diastolic bp >110 on two readings.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Premenopausal state Contraceptive methods Absent
Item
5. 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])
Impaired cognition MoCA
Item
6. cognitive impairment, defined as moca <23/30.
boolean
C0338656 (UMLS CUI [1,1])
C3496286 (UMLS CUI [1,2])
Moderate depression Beck depression inventory | Severe depression Beck depression inventory
Item
7. moderate-severe depression, as defined by a beck depression inventory score of >19.
boolean
C0588007 (UMLS CUI [1,1])
C0451022 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C0451022 (UMLS CUI [2,2])
Antiparkinson Agents Change | Antiparkinson Agents Change Anticipated
Item
8. changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the next six months.
boolean
C0003405 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Lithium | Clozapine | Pharmacokinetic interaction
Item
9. current use of lithium or clozapine (pharmacokinetic interactions).
boolean
C0023870 (UMLS CUI [1])
C0009079 (UMLS CUI [2])
C1868980 (UMLS CUI [3])
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