ID

22359

Descripción

Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD); ODM derived from: https://clinicaltrials.gov/show/NCT00282152

Link

https://clinicaltrials.gov/show/NCT00282152

Palabras clave

Versiones (1)
  1. 31/5/17 31/5/17 -
Subido en

31 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00282152

Inglés

Eligibility Parkinson's Disease NCT00282152

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a clinical diagnosis of probable idiopathic pd.
Descripción

Parkinson Disease Probable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0332148
demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the updrs motor examination subscore, following the administration of their da drug(s) during the screening neurological examination.
Descripción

Dopaminergic drug therapy Disease Response | Parkinsonian features motor Improvement UPDRS - Motor Examination Sub-total

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3267134
UMLS CUI [1,2]
C1704632
UMLS CUI [2,1]
C0582422
UMLS CUI [2,2]
C1513492
UMLS CUI [2,3]
C2986411
UMLS CUI [2,4]
C3827704
hoehn and yahr (h&y) stage ii when off medication.
Descripción

Hoehn and Yahr Stage | Pharmaceutical Preparations Off

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1518543
no contraindications to surgery.
Descripción

Operative Surgical Procedures Medical contraindication Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0332197
age between 50 and 75 years old.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
available for follow-up for four years.
Descripción

Clinical Study Follow-up Patient Available

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
informed consent: the subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
mri within normal range for age.
Descripción

MRI normal Age Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0436481
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0439849
levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.
Descripción

Levodopa | Dopamine Agonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
Descripción

Diagnosis Alternative Evidence of | Secondary Parkinson Disease Evidence of | Parkinsonian features Early Unusual | Postural instability Prominent | Freezing phenomenon | Hallucinations Post Symptoms Onset | Motor symptoms Before Dementia | Supranuclear gaze palsy | Upward gaze Restricted | Slowing of vertical saccades | Dysautonomia Symptomatic Severe | Condition Causing Parkinsonian Disorders | Lesion of brain Focal | Antipsychotic Agents Use of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1523987
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0030569
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0582422
UMLS CUI [3,2]
C1279919
UMLS CUI [3,3]
C2700116
UMLS CUI [4,1]
C1843921
UMLS CUI [4,2]
C0205402
UMLS CUI [5]
C1262022
UMLS CUI [6,1]
C0018524
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C1457887
UMLS CUI [6,4]
C0332162
UMLS CUI [7,1]
C0426980
UMLS CUI [7,2]
C0332152
UMLS CUI [7,3]
C0497327
UMLS CUI [8]
C1720037
UMLS CUI [9,1]
C0439774
UMLS CUI [9,2]
C0443288
UMLS CUI [10]
C4011795
UMLS CUI [11,1]
C0013363
UMLS CUI [11,2]
C0231220
UMLS CUI [11,3]
C0205082
UMLS CUI [12,1]
C0348080
UMLS CUI [12,2]
C0678227
UMLS CUI [12,3]
C0242422
UMLS CUI [13,1]
C0221505
UMLS CUI [13,2]
C0205234
UMLS CUI [14,1]
C0040615
UMLS CUI [14,2]
C1524063
uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
Descripción

Medical condition Uncontrolled | Disease Clinical Significance | Risk Increase Complication Preoperative | Risk Increase Postoperative Complications | Heart Disease | Lung disease | Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0442805
UMLS CUI [3,3]
C0009566
UMLS CUI [3,4]
C0445204
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0442805
UMLS CUI [4,3]
C0032787
UMLS CUI [5]
C0018799
UMLS CUI [6]
C0024115
UMLS CUI [7]
C1868885
evidence of dementia
Descripción

Dementia Evidence of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332120
major psychiatric disorder
Descripción

Mental disorder Major

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
previous brain operation or injury.
Descripción

Operation on brain | Brain Injury

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0195775
UMLS CUI [2]
C0270611
active participation in another clinical trial for the treatment of pd.
Descripción

Study Subject Participation Status | Therapeutic procedure Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0030567
patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (icd's).
Descripción

Artificial cardiac pacemaker Demand | Implantable defibrillator Demand

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0441516
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0441516
patients who have medical conditions that require repeat mri scans or diathermy treatments.
Descripción

Medical condition Requirement MRI Scans Repeat | Medical condition Requirement Diathermy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0917711
UMLS CUI [1,4]
C0205341
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0012002
evidence of existing dyskinesias or motor fluctuations.
Descripción

Dyskinetic syndrome Evidence of | Motor fluctuations Evidence of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013384
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1868976
UMLS CUI [2,2]
C0332120
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Similar models

Eligibility Parkinson's Disease NCT00282152

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Probable
Item
patients must have a clinical diagnosis of probable idiopathic pd.
boolean
C0030567 (UMLS CUI [1,1])
C0332148 (UMLS CUI [1,2])
Dopaminergic drug therapy Disease Response | Parkinsonian features motor Improvement UPDRS - Motor Examination Sub-total
Item
demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the updrs motor examination subscore, following the administration of their da drug(s) during the screening neurological examination.
boolean
C3267134 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0582422 (UMLS CUI [2,1])
C1513492 (UMLS CUI [2,2])
C2986411 (UMLS CUI [2,3])
C3827704 (UMLS CUI [2,4])
Hoehn and Yahr Stage | Pharmaceutical Preparations Off
Item
hoehn and yahr (h&y) stage ii when off medication.
boolean
C3639483 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1518543 (UMLS CUI [2,2])
Operative Surgical Procedures Medical contraindication Absent
Item
no contraindications to surgery.
boolean
C0543467 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
age between 50 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
Clinical Study Follow-up Patient Available
Item
available for follow-up for four years.
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Informed Consent
Item
informed consent: the subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
boolean
C0021430 (UMLS CUI [1])
MRI normal Age Related
Item
mri within normal range for age.
boolean
C0436481 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Levodopa | Dopamine Agonists
Item
levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diagnosis Alternative Evidence of | Secondary Parkinson Disease Evidence of | Parkinsonian features Early Unusual | Postural instability Prominent | Freezing phenomenon | Hallucinations Post Symptoms Onset | Motor symptoms Before Dementia | Supranuclear gaze palsy | Upward gaze Restricted | Slowing of vertical saccades | Dysautonomia Symptomatic Severe | Condition Causing Parkinsonian Disorders | Lesion of brain Focal | Antipsychotic Agents Use of
Item
evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
boolean
C0011900 (UMLS CUI [1,1])
C1523987 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0030569 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0582422 (UMLS CUI [3,1])
C1279919 (UMLS CUI [3,2])
C2700116 (UMLS CUI [3,3])
C1843921 (UMLS CUI [4,1])
C0205402 (UMLS CUI [4,2])
C1262022 (UMLS CUI [5])
C0018524 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C1457887 (UMLS CUI [6,3])
C0332162 (UMLS CUI [6,4])
C0426980 (UMLS CUI [7,1])
C0332152 (UMLS CUI [7,2])
C0497327 (UMLS CUI [7,3])
C1720037 (UMLS CUI [8])
C0439774 (UMLS CUI [9,1])
C0443288 (UMLS CUI [9,2])
C4011795 (UMLS CUI [10])
C0013363 (UMLS CUI [11,1])
C0231220 (UMLS CUI [11,2])
C0205082 (UMLS CUI [11,3])
C0348080 (UMLS CUI [12,1])
C0678227 (UMLS CUI [12,2])
C0242422 (UMLS CUI [12,3])
C0221505 (UMLS CUI [13,1])
C0205234 (UMLS CUI [13,2])
C0040615 (UMLS CUI [14,1])
C1524063 (UMLS CUI [14,2])
Medical condition Uncontrolled | Disease Clinical Significance | Risk Increase Complication Preoperative | Risk Increase Postoperative Complications | Heart Disease | Lung disease | Uncontrolled hypertension
Item
uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0035647 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
C0009566 (UMLS CUI [3,3])
C0445204 (UMLS CUI [3,4])
C0035647 (UMLS CUI [4,1])
C0442805 (UMLS CUI [4,2])
C0032787 (UMLS CUI [4,3])
C0018799 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
Dementia Evidence of
Item
evidence of dementia
boolean
C0497327 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Mental disorder Major
Item
major psychiatric disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Operation on brain | Brain Injury
Item
previous brain operation or injury.
boolean
C0195775 (UMLS CUI [1])
C0270611 (UMLS CUI [2])
Study Subject Participation Status | Therapeutic procedure Parkinson Disease
Item
active participation in another clinical trial for the treatment of pd.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Artificial cardiac pacemaker Demand | Implantable defibrillator Demand
Item
patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (icd's).
boolean
C0030163 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0441516 (UMLS CUI [2,2])
Medical condition Requirement MRI Scans Repeat | Medical condition Requirement Diathermy
Item
patients who have medical conditions that require repeat mri scans or diathermy treatments.
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0917711 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0012002 (UMLS CUI [2,3])
Dyskinetic syndrome Evidence of | Motor fluctuations Evidence of
Item
evidence of existing dyskinesias or motor fluctuations.
boolean
C0013384 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1868976 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
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