ID

31347

Beskrivning

Transcranial Magnetic Stimulation to Treat Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00753519

Länk

https://clinicaltrials.gov/show/NCT00753519

Nyckelord

Versioner (1)
  1. 2018-08-17 2018-08-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00753519

Engelsk

Eligibility Parkinson Disease NCT00753519

1 Formulär  
Criteria
Beskrivning

Criteria

men and women aged 40 to 80 years with dopa-responsive pd
Beskrivning

Age | Parkinson Disease Levodopa-responsive

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C1853846
hoehn and yahr grade of 2 to 4 while off
Beskrivning

Hoehn and Yahr grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0451215
must be on a regimen including levodopa.
Beskrivning

Therapeutic procedure Including Levodopa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0023570
total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
Beskrivning

Levodopa | Dopamine Agonists | Dopamine Equivalent | Total Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
UMLS CUI [3,1]
C0013030
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C2986497
UMLS CUI [4,2]
C0456683
problems with walking, including freezing gait time for a 10-meter distance greater than six seconds or more
Beskrivning

Difficulty walking | Freezing of gait Time Distance

Datatyp

boolean

Alias
UMLS CUI [1]
C0311394
UMLS CUI [2,1]
C0860515
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0012751
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any active psychiatric disease or evidence of dementia
Beskrivning

Mental disorder | Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0497327
history of seizures and epilepsy
Beskrivning

Seizures | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for ssri
Beskrivning

Tricyclic Antidepressive Agents | Antipsychotic Agents | Pharmaceutical Preparations Lowered convulsive threshold | Exception Antiparkinson Agents | Exception SSRI

Datatyp

boolean

Alias
UMLS CUI [1]
C0003290
UMLS CUI [2]
C0040615
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0234976
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003405
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0360105
pallidotomy, implanted electrodes and generator for deep brain stimulation
Beskrivning

Pallidotomy | Electrodes, Implanted | Deep brain stimulator

Datatyp

boolean

Alias
UMLS CUI [1]
C0195893
UMLS CUI [2]
C0013814
UMLS CUI [3]
C4069029
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tep.
Beskrivning

Implants | Artificial cardiac pacemaker | Pump Implanted | Hearing Aids Implanted | Plates, Cranioplasty | Metallic implant Skull | Metallic implant Eye

Datatyp

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0182537
UMLS CUI [3,2]
C0021102
UMLS CUI [4,1]
C0018768
UMLS CUI [4,2]
C0021102
UMLS CUI [5]
C0182313
UMLS CUI [6,1]
C3693688
UMLS CUI [6,2]
C2951888
UMLS CUI [7,1]
C3693688
UMLS CUI [7,2]
C0015392
study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
Beskrivning

Study Subject Participation Status At risk | Tendency to fall | Fatigue Excessive | Frailty General | Apprehensiveness Excessive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1444641
UMLS CUI [2]
C2830327
UMLS CUI [3,1]
C0015672
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0424594
UMLS CUI [4,2]
C0205246
UMLS CUI [5,1]
C0233485
UMLS CUI [5,2]
C0442802
dementia as assessed by the folstein's mini-mental test examination (mmse less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying updrs will evaluate patient's mental capacity using conventional clinical interview)
Beskrivning

Dementia Mini-mental state examination | Mental impairment | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
UMLS CUI [2]
C0683322
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
unable to walk a 10-meter distance.
Beskrivning

Lacking Able to walk Meter Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C0475209
UMLS CUI [1,4]
C1265611
more than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in updrs item 13), history of fall(s) with significant injuries, absence of postural response in the on condition and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in updrs item 30)
Beskrivning

Falls Daily UPDRS | History of fall | Injuries | Absence of postural response | Impairment of balance UPDRS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0000921
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C3639721
UMLS CUI [2]
C1561668
UMLS CUI [3]
C3263723
UMLS CUI [4]
C4036289
UMLS CUI [5,1]
C0241981
UMLS CUI [5,2]
C3639721
pregnancy is unusual in patients with pd, grade 2-4. urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to the itbs start, at the day of the initial interview and signing the consent form. women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.
Beskrivning

Childbearing Potential Urine pregnancy test | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430056
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
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Similar models

Eligibility Parkinson Disease NCT00753519

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age | Parkinson Disease Levodopa-responsive
Item
men and women aged 40 to 80 years with dopa-responsive pd
boolean
C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C1853846 (UMLS CUI [2,2])
Hoehn and Yahr grades
Item
hoehn and yahr grade of 2 to 4 while off
boolean
C0451215 (UMLS CUI [1])
Therapeutic procedure Including Levodopa
Item
must be on a regimen including levodopa.
boolean
C0087111 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
Levodopa | Dopamine Agonists | Dopamine Equivalent | Total Dose U/day
Item
total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
C0013030 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C2986497 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Difficulty walking | Freezing of gait Time Distance
Item
problems with walking, including freezing gait time for a 10-meter distance greater than six seconds or more
boolean
C0311394 (UMLS CUI [1])
C0860515 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0012751 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Mental disorder | Dementia
Item
any active psychiatric disease or evidence of dementia
boolean
C0004936 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
Seizures | Epilepsy
Item
history of seizures and epilepsy
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Tricyclic Antidepressive Agents | Antipsychotic Agents | Pharmaceutical Preparations Lowered convulsive threshold | Exception Antiparkinson Agents | Exception SSRI
Item
concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for ssri
boolean
C0003290 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0234976 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0003405 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0360105 (UMLS CUI [5,2])
Pallidotomy | Electrodes, Implanted | Deep brain stimulator
Item
pallidotomy, implanted electrodes and generator for deep brain stimulation
boolean
C0195893 (UMLS CUI [1])
C0013814 (UMLS CUI [2])
C4069029 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Implants | Artificial cardiac pacemaker | Pump Implanted | Hearing Aids Implanted | Plates, Cranioplasty | Metallic implant Skull | Metallic implant Eye
Item
surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during tep.
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0182537 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C0018768 (UMLS CUI [4,1])
C0021102 (UMLS CUI [4,2])
C0182313 (UMLS CUI [5])
C3693688 (UMLS CUI [6,1])
C2951888 (UMLS CUI [6,2])
C3693688 (UMLS CUI [7,1])
C0015392 (UMLS CUI [7,2])
Study Subject Participation Status At risk | Tendency to fall | Fatigue Excessive | Frailty General | Apprehensiveness Excessive
Item
study would cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general frailty, or excessive apprehensiveness.
boolean
C2348568 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2830327 (UMLS CUI [2])
C0015672 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0424594 (UMLS CUI [4,1])
C0205246 (UMLS CUI [4,2])
C0233485 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
Dementia Mini-mental state examination | Mental impairment | Informed Consent Unable
Item
dementia as assessed by the folstein's mini-mental test examination (mmse less than or equal to 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying updrs will evaluate patient's mental capacity using conventional clinical interview)
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C0683322 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Lacking Able to walk Meter Quantity
Item
unable to walk a 10-meter distance.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C0475209 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Falls Daily UPDRS | History of fall | Injuries | Absence of postural response | Impairment of balance UPDRS
Item
more than occasional falls, i.e. daily falls (corresponding to a score greater than or equal to 3 and more in updrs item 13), history of fall(s) with significant injuries, absence of postural response in the on condition and/or spontaneous loss of balance in the off condition (corresponding to a score of greater than or equal to 2 and greater than or equal to 3 in on/off condition, respectively, in updrs item 30)
boolean
C0000921 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,3])
C1561668 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C4036289 (UMLS CUI [4])
C0241981 (UMLS CUI [5,1])
C3639721 (UMLS CUI [5,2])
Childbearing Potential Urine pregnancy test | Childbearing Potential Contraceptive methods
Item
pregnancy is unusual in patients with pd, grade 2-4. urine sample for the pregnancy test will be obtained in patients of childbearing potential prior to the itbs start, at the day of the initial interview and signing the consent form. women of childbearing potential will be asked to take appropriate measures to prevent a pregnancy during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
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