ID

18771

Beschreibung

Investigating the Safety of srTMS in the Treatment of Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00063284

Link

https://clinicaltrials.gov/show/NCT00063284

Stichworte

Versionen (1)
  1. 20.11.16 20.11.16 -
Hochgeladen am

20. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00063284

Englisch

Eligibility Parkinson Disease NCT00063284

1 Formulare  
Criteria
Beschreibung

Criteria

subjects will be men and women aged 40 to 80 years with dopa-responsive, akinetic-rigid pd.
Beschreibung

Age | Parkinson Disease Dopa Responsive | Parkinson Disease Akinetic Rigid

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0013023
UMLS CUI [2,3]
C0205342
UMLS CUI [3,1]
C0030567
UMLS CUI [3,2]
C0233568
UMLS CUI [3,3]
C0026837
after obtaining the informed consent, patients will be interviewed and examined by either the prinicipal investigator (pi) or a brain stimulation unit (bsu) or an hmcs physician to establish the diagnosis of pd and rule out any other neurologic condition.
Beschreibung

Informed Consent | patient interview | Physical Examination | Parkinson Disease | Condition Neurologic

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0030567
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0205494
only patients with a hoehn and yahr grade of 2 to 4 while 'off' will be accepted.
Beschreibung

Hoehn and Yahr grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0451215
patients must be on a regimen including l-dopa, and they must have a total dose of medication equal to more than 300 mg of l-dopa equivalent, including their dopamine agonist agents.
Beschreibung

Levodopa | Medication dose Levodopa Equivalent | Dopamine Agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0023570
UMLS CUI [2,3]
C0205163
UMLS CUI [3]
C0178601
any patient whose record does not contain a neurological examination from the past year will be reexamined before enrollment.
Beschreibung

Neurologic Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0027853
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant medical or psychiatric illness (other than pd), pregnancy, history of epilepsy, or concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
Beschreibung

Illness | Mental disorders | Parkinson Disease | Pregnancy | Epilepsy | Tricyclic Antidepressive Agents | Antipsychotic Agents | Pharmaceutical Preparations Lowered convulsive threshold | Illicit Drugs Lowered convulsive threshold | Antiparkinson Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0014544
UMLS CUI [6]
C0003290
UMLS CUI [7]
C0040615
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0234976
UMLS CUI [9,1]
C0086190
UMLS CUI [9,2]
C0234976
UMLS CUI [10]
C0003405
persons with surgically or traumatically implanted foreign bodies such as a pacemaker, or any implanted stimulators, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
Beschreibung

Implanted Medical Device | Artificial cardiac pacemaker | Stimulator Implant | Pharmaceutical Preparations pump Implant | skull-plate; present | Metal foreign body in eye region | Dental appliances | tooth filling | Physical hazard | Magnetic Field Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C2828363
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0175727
UMLS CUI [3,2]
C0021102
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0182537
UMLS CUI [4,3]
C0021102
UMLS CUI [5]
C1409480
UMLS CUI [6]
C0562528
UMLS CUI [7]
C0441319
UMLS CUI [8]
C0178866
UMLS CUI [9]
C0337044
UMLS CUI [10]
C2350609
most of these exclusions also come under the category of significant medical illness. patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general fatigue, general frailty, or excessive apprehensiveness will also be excluded.
Beschreibung

Illness Significant At risk Study Subject Participation Status | Tendency to fall | Fatigue Excessive | Fatigue General | Frailty General | apprehensiveness Excessive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C2348568
UMLS CUI [2]
C2830327
UMLS CUI [3,1]
C0015672
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0015672
UMLS CUI [4,2]
C0205246
UMLS CUI [5,1]
C0424594
UMLS CUI [5,2]
C0205246
UMLS CUI [6,1]
C1408583
UMLS CUI [6,2]
C0442802
a urine sample for the pregnancy test will be obtained from any women of childbearing potential prior to the start of srtms, on the day of the initial interview and signing of the consent form. pregnant women will be excluded from the study.
Beschreibung

Childbearing Potential Urine pregnancy test | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430056
UMLS CUI [2]
C0032961
mentally impaired patients who have no capacity to provide their own consent will be excluded from the study.
Beschreibung

Mentally Disabled Persons | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0079822
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Parkinson Disease NCT00063284

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Parkinson Disease Dopa Responsive | Parkinson Disease Akinetic Rigid
Item
subjects will be men and women aged 40 to 80 years with dopa-responsive, akinetic-rigid pd.
boolean
C0001779 (UMLS CUI [1])
C0030567 (UMLS CUI [2,1])
C0013023 (UMLS CUI [2,2])
C0205342 (UMLS CUI [2,3])
C0030567 (UMLS CUI [3,1])
C0233568 (UMLS CUI [3,2])
C0026837 (UMLS CUI [3,3])
Informed Consent | patient interview | Physical Examination | Parkinson Disease | Condition Neurologic
Item
after obtaining the informed consent, patients will be interviewed and examined by either the prinicipal investigator (pi) or a brain stimulation unit (bsu) or an hmcs physician to establish the diagnosis of pd and rule out any other neurologic condition.
boolean
C0021430 (UMLS CUI [1])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0030567 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0205494 (UMLS CUI [5,2])
Hoehn and Yahr grades
Item
only patients with a hoehn and yahr grade of 2 to 4 while 'off' will be accepted.
boolean
C0451215 (UMLS CUI [1])
Levodopa | Medication dose Levodopa Equivalent | Dopamine Agonists
Item
patients must be on a regimen including l-dopa, and they must have a total dose of medication equal to more than 300 mg of l-dopa equivalent, including their dopamine agonist agents.
boolean
C0023570 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0023570 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0178601 (UMLS CUI [3])
Neurologic Examination
Item
any patient whose record does not contain a neurological examination from the past year will be reexamined before enrollment.
boolean
C0027853 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness | Mental disorders | Parkinson Disease | Pregnancy | Epilepsy | Tricyclic Antidepressive Agents | Antipsychotic Agents | Pharmaceutical Preparations Lowered convulsive threshold | Illicit Drugs Lowered convulsive threshold | Antiparkinson Agents
Item
any significant medical or psychiatric illness (other than pd), pregnancy, history of epilepsy, or concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
boolean
C0221423 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0003290 (UMLS CUI [6])
C0040615 (UMLS CUI [7])
C0013227 (UMLS CUI [8,1])
C0234976 (UMLS CUI [8,2])
C0086190 (UMLS CUI [9,1])
C0234976 (UMLS CUI [9,2])
C0003405 (UMLS CUI [10])
Implanted Medical Device | Artificial cardiac pacemaker | Stimulator Implant | Pharmaceutical Preparations pump Implant | skull-plate; present | Metal foreign body in eye region | Dental appliances | tooth filling | Physical hazard | Magnetic Field Therapy
Item
persons with surgically or traumatically implanted foreign bodies such as a pacemaker, or any implanted stimulators, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation will also be excluded.
boolean
C2828363 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0175727 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C0182537 (UMLS CUI [4,2])
C0021102 (UMLS CUI [4,3])
C1409480 (UMLS CUI [5])
C0562528 (UMLS CUI [6])
C0441319 (UMLS CUI [7])
C0178866 (UMLS CUI [8])
C0337044 (UMLS CUI [9])
C2350609 (UMLS CUI [10])
Illness Significant At risk Study Subject Participation Status | Tendency to fall | Fatigue Excessive | Fatigue General | Frailty General | apprehensiveness Excessive
Item
most of these exclusions also come under the category of significant medical illness. patients for whom participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as tendency to fall, excessive fatigue, general fatigue, general frailty, or excessive apprehensiveness will also be excluded.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C2830327 (UMLS CUI [2])
C0015672 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0015672 (UMLS CUI [4,1])
C0205246 (UMLS CUI [4,2])
C0424594 (UMLS CUI [5,1])
C0205246 (UMLS CUI [5,2])
C1408583 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
Childbearing Potential Urine pregnancy test | Pregnancy
Item
a urine sample for the pregnancy test will be obtained from any women of childbearing potential prior to the start of srtms, on the day of the initial interview and signing of the consent form. pregnant women will be excluded from the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
Mentally Disabled Persons | Informed Consent Unable
Item
mentally impaired patients who have no capacity to provide their own consent will be excluded from the study.
boolean
C0079822 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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