ID

22341

Description

Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00224263

Link

https://clinicaltrials.gov/show/NCT00224263

Keywords

Versions (2)
  1. 5/30/17 5/30/17 -
  2. 5/30/17 5/30/17 -
Uploaded on

May 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Parkinson's Disease NCT00224263

English

Eligibility Parkinson's Disease NCT00224263

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age 30 years or older at time of diagnosis of parkinson's disease
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have idiopathic parkinson's disease, defined as:
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
having at least 2 of the following 4 signs: resting tremor, bradykinesia, rigidity, or postural reflex impairment, at least one of which must be resting tremor or bradykinesia
Description

Signs Quantity | Resting Tremor | Bradykinesia | Rigidity | Postural reflex impairment

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0234379
UMLS CUI [3]
C0233565
UMLS CUI [4]
C0026837
UMLS CUI [5]
C1868839
no secondary or atypical parkinsonism
Description

Secondary Parkinson Disease Absent | Atypical Parkinson Disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030569
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1868596
UMLS CUI [2,2]
C0332197
asymmetric features (current signs or history of asymmetric onset)
Description

Feature Asymmetric | Signs Asymmetric | Onset Asymmetric

Data type

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0332514
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332514
UMLS CUI [3,1]
C0332162
UMLS CUI [3,2]
C0332514
response to l-dopa, by patient self-report
Description

Levodopa | Disease Response Patient Self-Report

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0681906
parkinson's disease duration of no more than 5 years
Description

Parkinson Disease Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0449238
receiving stable therapy of l-dopa/dci for at least 3 months; acceptable dose range: 250 mg - 1000 mg l-dopa/dci daily
Description

Levodopa Stable Dose U/day | Decarboxylase inhibitor Stable Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0360140
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0456683
hoehn and yahr stage < 4 on stable l-dopa/dci treatment
Description

Hoehn and Yahr Stage | Levodopa Stable | Decarboxylase inhibitor Stable

Data type

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0360140
UMLS CUI [3,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
undefined item
Description

undefined item

Data type

text

have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
Description

Atypical Parkinson Disease Due to Pharmaceutical Preparations | Atypical Parkinson Disease Due to Metabolic Diseases | Atypical Parkinson Disease Due to Encephalitis | Atypical Parkinson Disease Due to Neurodegenerative Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1868596
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1868596
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0025517
UMLS CUI [3,1]
C1868596
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0014038
UMLS CUI [4,1]
C1868596
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0524851
have any other known medical or psychiatric condition that may compromise their participation in the study
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348568
have taken another investigational drug within 90 days of baseline
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
have a change in dosage of any other antiparkinsonian drug (eg, pramipexole, ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or amantadine) during the study or within 90 days prior to baseline
Description

Antiparkinson Agents Dose Change | Pramipexole | ropinirole | Pergolide | Bromocriptine | Methylphenidate | Anticholinergic Agents | Amantadine

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C0074710
UMLS CUI [3]
C0244821
UMLS CUI [4]
C0031007
UMLS CUI [5]
C0006230
UMLS CUI [6]
C0025810
UMLS CUI [7]
C0242896
UMLS CUI [8]
C0002403
have received treatment with dopamine blocking agents (including neuroleptic agents, antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine) within 90 days prior to baseline
Description

Dopamine Antagonists | Antipsychotic Agents | Antiemetics | Dopamine Depletion Pharmaceutical Preparations | Reserpine | Tetrabenazine

Data type

boolean

Alias
UMLS CUI [1]
C0242702
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003297
UMLS CUI [4,1]
C0013030
UMLS CUI [4,2]
C0333668
UMLS CUI [4,3]
C0013227
UMLS CUI [5]
C0035179
UMLS CUI [6]
C0039623
do not consent to participate
Description

Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
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Similar models

Eligibility Parkinson's Disease NCT00224263

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age 30 years or older at time of diagnosis of parkinson's disease
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
have idiopathic parkinson's disease, defined as:
boolean
C0030567 (UMLS CUI [1])
Signs Quantity | Resting Tremor | Bradykinesia | Rigidity | Postural reflex impairment
Item
having at least 2 of the following 4 signs: resting tremor, bradykinesia, rigidity, or postural reflex impairment, at least one of which must be resting tremor or bradykinesia
boolean
C0311392 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0234379 (UMLS CUI [2])
C0233565 (UMLS CUI [3])
C0026837 (UMLS CUI [4])
C1868839 (UMLS CUI [5])
Secondary Parkinson Disease Absent | Atypical Parkinson Disease Absent
Item
no secondary or atypical parkinsonism
boolean
C0030569 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1868596 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Feature Asymmetric | Signs Asymmetric | Onset Asymmetric
Item
asymmetric features (current signs or history of asymmetric onset)
boolean
C2348519 (UMLS CUI [1,1])
C0332514 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0332514 (UMLS CUI [2,2])
C0332162 (UMLS CUI [3,1])
C0332514 (UMLS CUI [3,2])
Levodopa | Disease Response Patient Self-Report
Item
response to l-dopa, by patient self-report
boolean
C0023570 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0681906 (UMLS CUI [2,2])
Parkinson Disease Duration
Item
parkinson's disease duration of no more than 5 years
boolean
C0030567 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Levodopa Stable Dose U/day | Decarboxylase inhibitor Stable Dose U/day
Item
receiving stable therapy of l-dopa/dci for at least 3 months; acceptable dose range: 250 mg - 1000 mg l-dopa/dci daily
boolean
C0023570 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0360140 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Hoehn and Yahr Stage | Levodopa Stable | Decarboxylase inhibitor Stable
Item
hoehn and yahr stage < 4 on stable l-dopa/dci treatment
boolean
C3639483 (UMLS CUI [1])
C0023570 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0360140 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
undefined item
Item
text
Atypical Parkinson Disease Due to Pharmaceutical Preparations | Atypical Parkinson Disease Due to Metabolic Diseases | Atypical Parkinson Disease Due to Encephalitis | Atypical Parkinson Disease Due to Neurodegenerative Disorders
Item
have atypical parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
boolean
C1868596 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1868596 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0025517 (UMLS CUI [2,3])
C1868596 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0014038 (UMLS CUI [3,3])
C1868596 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0524851 (UMLS CUI [4,3])
Medical condition compromises Study Subject Participation Status | Mental condition compromises Study Subject Participation Status
Item
have any other known medical or psychiatric condition that may compromise their participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Investigational New Drugs
Item
have taken another investigational drug within 90 days of baseline
boolean
C0013230 (UMLS CUI [1])
Antiparkinson Agents Dose Change | Pramipexole | ropinirole | Pergolide | Bromocriptine | Methylphenidate | Anticholinergic Agents | Amantadine
Item
have a change in dosage of any other antiparkinsonian drug (eg, pramipexole, ropinirole, pergolide, bromocriptine, methylphenidate, anticholinergics, or amantadine) during the study or within 90 days prior to baseline
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0074710 (UMLS CUI [2])
C0244821 (UMLS CUI [3])
C0031007 (UMLS CUI [4])
C0006230 (UMLS CUI [5])
C0025810 (UMLS CUI [6])
C0242896 (UMLS CUI [7])
C0002403 (UMLS CUI [8])
Dopamine Antagonists | Antipsychotic Agents | Antiemetics | Dopamine Depletion Pharmaceutical Preparations | Reserpine | Tetrabenazine
Item
have received treatment with dopamine blocking agents (including neuroleptic agents, antiemetic agents), dopamine-depleting agents (including reserpine or tetrabenazine) within 90 days prior to baseline
boolean
C0242702 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0003297 (UMLS CUI [3])
C0013030 (UMLS CUI [4,1])
C0333668 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0035179 (UMLS CUI [5])
C0039623 (UMLS CUI [6])
Informed Consent Refused
Item
do not consent to participate
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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