ID

31349

Description

Safety of Urate Elevation in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00833690

Link

https://clinicaltrials.gov/show/NCT00833690

Keywords

Versions (1)
  1. 8/17/18 8/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00833690

English

Eligibility Parkinson Disease NCT00833690

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic pd with at least two of the cardinal signs of pd (resting tremor, bradykinesia, rigidity)
Description

Parkinson Disease | Signs Main Quantity | Resting Tremor | Bradykinesia | Muscle Rigidity

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0233565
UMLS CUI [5]
C0026837
currently not taking or needing any treatment for pd other than an monoamine oxidase-b (mao-b) inhibitor
Description

Therapeutic procedure Absent Parkinson Disease | Exception MAO-B Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2917433
age 30 or older at the time of pd diagnosis
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of pd made within past 3 years
Description

Parkinson Disease Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0872146
serum urate ≤ 5.8 mg/dl at initial screening
Description

Serum urate measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455272
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of kidney stones, gout, stroke, or heart attack
Description

Kidney Calculi | Gout | Cerebrovascular accident | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0022650
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0027051
history of renal disease or certain cardiovascular problems within the past year
Description

Kidney Diseases | Cardiovascular problems

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0850760
acidic urine (ph ≤ 5.0), uric acid, or urate crystalluria at screening
Description

Urine Acidic pH measurement | Uric acid measurement | Urate crystalluria

Data type

boolean

Alias
UMLS CUI [1,1]
C0042036
UMLS CUI [1,2]
C0001128
UMLS CUI [1,3]
C0202165
UMLS CUI [2]
C0202239
UMLS CUI [3]
C0151582
use of certain medications including co-enzyme q, creatine, more than 50 iu of vitamin e daily, and more than 300 mg of vitamin c daily. (a standard daily multivitamin is permitted.)
Description

Ubiquinone | Creatine | Vitamin E U/day | Ascorbic Acid U/day | Multivitamin Standard allowed

Data type

boolean

Alias
UMLS CUI [1]
C0041536
UMLS CUI [2]
C0010286
UMLS CUI [3,1]
C0042874
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0003968
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0301532
UMLS CUI [5,2]
C1442989
UMLS CUI [5,3]
C0683607
use of anti-pd and other medications targeting central nervous system dopamine transmission
Description

Antiparkinson Agents | Pharmaceutical Preparations Targeting Dopamine

Data type

boolean

Alias
UMLS CUI [1]
C0003405
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0013030
known unstable medical or psychiatric condition that may compromise participation in the study
Description

Medical condition Unstable compromises Study Subject Participation Status | Mental condition Unstable compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2348568
women who are pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Parkinson Disease NCT00833690

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease | Signs Main Quantity | Resting Tremor | Bradykinesia | Muscle Rigidity
Item
idiopathic pd with at least two of the cardinal signs of pd (resting tremor, bradykinesia, rigidity)
boolean
C0030567 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
Therapeutic procedure Absent Parkinson Disease | Exception MAO-B Inhibitor
Item
currently not taking or needing any treatment for pd other than an monoamine oxidase-b (mao-b) inhibitor
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2917433 (UMLS CUI [2,2])
Age
Item
age 30 or older at the time of pd diagnosis
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Disease length
Item
diagnosis of pd made within past 3 years
boolean
C0030567 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Serum urate measurement
Item
serum urate ≤ 5.8 mg/dl at initial screening
boolean
C0455272 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Kidney Calculi | Gout | Cerebrovascular accident | Myocardial Infarction
Item
history of kidney stones, gout, stroke, or heart attack
boolean
C0022650 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Kidney Diseases | Cardiovascular problems
Item
history of renal disease or certain cardiovascular problems within the past year
boolean
C0022658 (UMLS CUI [1])
C0850760 (UMLS CUI [2])
Urine Acidic pH measurement | Uric acid measurement | Urate crystalluria
Item
acidic urine (ph ≤ 5.0), uric acid, or urate crystalluria at screening
boolean
C0042036 (UMLS CUI [1,1])
C0001128 (UMLS CUI [1,2])
C0202165 (UMLS CUI [1,3])
C0202239 (UMLS CUI [2])
C0151582 (UMLS CUI [3])
Ubiquinone | Creatine | Vitamin E U/day | Ascorbic Acid U/day | Multivitamin Standard allowed
Item
use of certain medications including co-enzyme q, creatine, more than 50 iu of vitamin e daily, and more than 300 mg of vitamin c daily. (a standard daily multivitamin is permitted.)
boolean
C0041536 (UMLS CUI [1])
C0010286 (UMLS CUI [2])
C0042874 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0003968 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0301532 (UMLS CUI [5,1])
C1442989 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Antiparkinson Agents | Pharmaceutical Preparations Targeting Dopamine
Item
use of anti-pd and other medications targeting central nervous system dopamine transmission
boolean
C0003405 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0013030 (UMLS CUI [2,3])
Medical condition Unstable compromises Study Subject Participation Status | Mental condition Unstable compromises Study Subject Participation Status
Item
known unstable medical or psychiatric condition that may compromise participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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