ID

43536

Description

Embryonic Dopamine Cell Implants for Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00038116

Link

https://clinicaltrials.gov/show/NCT00038116

Keywords

  1. 2/7/16 2/7/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Parkinson Disease NCT00038116

Eligibility Parkinson Disease NCT00038116

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease of at least 7 years duration and responsive to levodopa. other parkinson syndromes excluded.
Description

idiopathic parkinson, responsive do levodopa

Data type

boolean

Alias
UMLS CUI [1]
C0747270
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0521982
patients previously tried on other available forms of medical treatment.
Description

prior therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
age between 20 and 75 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
Description

intractable problems

Data type

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0009488
no serious depression and no cognitive impairment.
Description

depression, cognitive impairment

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0009241
successful completion of home diary by patient or responsible party.
Description

completion of home diary

Data type

boolean

Alias
UMLS CUI [1]
C1321605
successful videotape recordings at home of "on" and "off" status.
Description

videotape recordings of on and off status

Data type

boolean

Alias
UMLS CUI [1]
C1321605
normal mri of brain within the last 18 months.
Description

mri of brain

Data type

boolean

Alias
UMLS CUI [1]
C0412675
fluorodopa pet scan compatible with idiopathic parkinson's disease.
Description

fluorodopa pet scan

Data type

boolean

Alias
UMLS CUI [1]
C0412496
UMLS CUI [2]
C0244672
medically fit to undergo implant surgery with certification by the patient's physician.
Description

fit to undergo implant surgery

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0038894
able to financially cover expenses not paid for by nih grant (between $1,000 and
Description

able to financially cover expenses

Data type

boolean

Alias
UMLS CUI [1]
C1321605
$2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.
Description

$2,000 costs

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe or moderately severe depression or cognitive impairment.
Description

severe or moderately severe depression or cognitive impairment

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0009241
previous brain surgery.
Description

brain surgery

Data type

boolean

Alias
UMLS CUI [1]
C0195775
presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or mri evidence of cerebrovascular disease.
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
not medically cleared to undergo a surgical procedure.
Description

not ready to undergo a surgical procedure, informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Parkinson Disease NCT00038116

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
idiopathic parkinson, responsive do levodopa
Item
idiopathic parkinson's disease of at least 7 years duration and responsive to levodopa. other parkinson syndromes excluded.
boolean
C0747270 (UMLS CUI [1])
C0023570 (UMLS CUI [2,1])
C0521982 (UMLS CUI [2,2])
prior therapy
Item
patients previously tried on other available forms of medical treatment.
boolean
C1514463 (UMLS CUI [1])
age
Item
age between 20 and 75 years.
boolean
C0001779 (UMLS CUI [1])
intractable problems
Item
presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
boolean
C0009566 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
depression, cognitive impairment
Item
no serious depression and no cognitive impairment.
boolean
C0011581 (UMLS CUI [1])
C0009241 (UMLS CUI [2])
completion of home diary
Item
successful completion of home diary by patient or responsible party.
boolean
C1321605 (UMLS CUI [1])
videotape recordings of on and off status
Item
successful videotape recordings at home of "on" and "off" status.
boolean
C1321605 (UMLS CUI [1])
mri of brain
Item
normal mri of brain within the last 18 months.
boolean
C0412675 (UMLS CUI [1])
fluorodopa pet scan
Item
fluorodopa pet scan compatible with idiopathic parkinson's disease.
boolean
C0412496 (UMLS CUI [1])
C0244672 (UMLS CUI [2])
fit to undergo implant surgery
Item
medically fit to undergo implant surgery with certification by the patient's physician.
boolean
C1321605 (UMLS CUI [1])
C0038894 (UMLS CUI [2])
able to financially cover expenses
Item
able to financially cover expenses not paid for by nih grant (between $1,000 and
boolean
C1321605 (UMLS CUI [1])
$2,000 costs
Item
$2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
severe or moderately severe depression or cognitive impairment
Item
severe or moderately severe depression or cognitive impairment.
boolean
C0011581 (UMLS CUI [1])
C0009241 (UMLS CUI [2])
brain surgery
Item
previous brain surgery.
boolean
C0195775 (UMLS CUI [1])
Comorbidities
Item
presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or mri evidence of cerebrovascular disease.
boolean
C0009488 (UMLS CUI [1])
not ready to undergo a surgical procedure, informed consent
Item
not medically cleared to undergo a surgical procedure.
boolean
C0021430 (UMLS CUI [1])

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