ID
28016
Beskrivning
Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München
Nyckelord
Versioner (1)
- 2017-12-10 2017-12-10 -
Rättsinnehavare
Priv.-Doz. Dr. med. Johannes Levin
Uppladdad den
10 december 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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PROMESA NCT02008721
Screening Visit (V0)
- StudyEvent: ODM
Beskrivning
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beskrivning
Informed consent
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Informed consent
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Date of informed consent
Datatyp
date
Alias
- UMLS CUI [1]
- C2985782
Beskrivning
Name MD
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710470
- UMLS CUI [1,2]
- C0600091
Beskrivning
SIgnature investigator
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date informed consent
Datatyp
date
Alias
- UMLS CUI [1]
- C2985782
Beskrivning
Demographic Data
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Medical history
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Medical History
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Body system
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0460002
Beskrivning
Diagnosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
Start of disease or surgery
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1628561
Beskrivning
Start Date not known
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beskrivning
End of disease or surgery
Datatyp
date
Alias
- UMLS CUI [1]
- C4019088
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0444930
Beskrivning
End date unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0439673
Beskrivning
Disease persistent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205322
Beskrivning
MSA History
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0262926
Beskrivning
Onset of first symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
Beskrivning
Onset of first symptoms not known
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
- UMLS CUI [1,3]
- C0439673
Beskrivning
MSA diagnosis date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
Beskrivning
MSA Diagnosis date not known
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
- UMLS CUI [1,3]
- C0439673
Beskrivning
MSA Type of first symptoms
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C1457887
Beskrivning
MSA syncope
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0039070
Beskrivning
MSA Orthostatic hypotension
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0020651
Beskrivning
MSA Urinary Incontinence
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0042024
Beskrivning
MSA Erectile Dysfuntion
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2733447
Beskrivning
MSA Other autonomic symptoms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2674101
- UMLS CUI [1,3]
- C1521902
Beskrivning
MSA Bradykinesia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C3176307
Beskrivning
MSA Rigidity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0858572
Beskrivning
MSA Tremor
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0040822
Beskrivning
Only answer, if answer to previous question was 'yes'.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0234379
Beskrivning
Only answer, if answer to previous question was 'yes'.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0234378
Beskrivning
MSA Other parkinsonism symptoms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1521902
Beskrivning
Onset of falls
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0085639
- UMLS CUI [1,2]
- C0574845
Beskrivning
frequency of falls
Datatyp
integer
Alias
- UMLS CUI [1]
- C1285588
Beskrivning
Psychiatric history
Alias
- UMLS CUI-1
- C0748059
Beskrivning
Psychiatric history
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0748059
Beskrivning
delusion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011253
Beskrivning
Delsuions specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011253
- UMLS CUI [1,2]
- C1521902
Beskrivning
Hallucinations
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018524
Beskrivning
Hallucinations specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018524
- UMLS CUI [1,2]
- C1521902
Beskrivning
Affective disorder
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0525045
Beskrivning
Affective disorder specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0525045
- UMLS CUI [1,2]
- C1521902
Beskrivning
psychiatric history other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other psychiatric history specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beskrivning
Parkinson's Disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beskrivning
Parkinson's disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beskrivning
Parkinson's disease medication
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0805701
Beskrivning
Parkinson's medication brand name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0592503
Beskrivning
Dosage of Parkinson's medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
Beskrivning
Parkinson's medication regimen
Datatyp
text
Alias
- UMLS CUI [1]
- C0237125
Beskrivning
Start date Parkinson's medication
Datatyp
partialDate
Måttenheter
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beskrivning
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beskrivning
Pharmaceutical preparation autonomic dysfunction Brand name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3277919
- UMLS CUI [1,3]
- C0592503
Beskrivning
Dosage of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Regimen
Datatyp
text
Alias
- UMLS CUI [1]
- C0237125
Beskrivning
Medication Start date
Datatyp
partialDate
Måttenheter
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-3
- C0013227
- UMLS CUI-4
- C0497327
Beskrivning
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0497327
Beskrivning
Brand name
Datatyp
text
Alias
- UMLS CUI [1]
- C0592503
Beskrivning
Dosage of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Regimen
Datatyp
text
Alias
- UMLS CUI [1]
- C0237125
Beskrivning
Medication Start date
Datatyp
partialDate
Måttenheter
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Other medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0205394
Beskrivning
Generic name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beskrivning
Pharmaceutical preparation indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beskrivning
Dosage of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Regimen
Datatyp
text
Alias
- UMLS CUI [1]
- C0237125
Beskrivning
Medication Start date
Datatyp
partialDate
Måttenheter
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Vital signs
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Date of physical examination
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Body Temperature
Datatyp
integer
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Weight
Datatyp
integer
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
pHysical examination code
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0805701
Beskrivning
physical examination finding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beskrivning
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Neurologic examination cranial nerves
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
Beskrivning
cranial nerves examination specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
- UMLS CUI [1,3]
- C1521902
Beskrivning
Neurologic examination Motor function
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
Beskrivning
Motor function specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
- UMLS CUI [1,3]
- C1521902
Beskrivning
Neurologic examination Reflexes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
Beskrivning
Reflexes specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
- UMLS CUI [1,3]
- C1521902
Beskrivning
Neurologic examination coordination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
Beskrivning
Coordination specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
- UMLS CUI [1,3]
- C1521902
Beskrivning
Neurologic examination sensation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
Beskrivning
Sensation specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
- UMLS CUI [1,3]
- C1521902
Beskrivning
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Type of laboratory procedure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Laboratory procedure value
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0587081
Beskrivning
Laboratory result normal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0459422
Beskrivning
Laboratory finding significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Beskrivning
Laboratory finding not significant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C2985739
Beskrivning
Laboratory test not done
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
Beskrivning
Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332148
Beskrivning
sporadic, progressive, adult-onset disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beskrivning
Required criteria for probable MSA
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0042024
- UMLS CUI [2]
- C0020651
Beskrivning
in addition, one of the following criteria must apply.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C1853846
- UMLS CUI [2,1]
- C0231691
- UMLS CUI [2,2]
- C0454599
- UMLS CUI [2,3]
- C1411869
Beskrivning
criteria for clinical probable MSA
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beskrivning
criteria for clinical probable MSA
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332148
Beskrivning
Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C2362652
Beskrivning
sporadic, progressive, adult-onset disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beskrivning
MSA autonomic dysfunction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C3277919
Beskrivning
MSA additional features
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0034935
- UMLS CUI [1,2]
- C0151889
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038450
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030569
- UMLS CUI [1,2]
- C1335499
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0023570
- UMLS CUI [1,2]
- C1704632
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1843921
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0231691
- UMLS CUI [1,2]
- C0454599
- UMLS CUI [1,3]
- C1411869
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011168
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0235946
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030569
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0235946
- UMLS CUI [1,2]
- C0436540
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beskrivning
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011307
- UMLS CUI [1,2]
- C0206129
- UMLS CUI [1,3]
- C0183126
Beskrivning
Diagnostic criteria for clinical possible MSA apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0679228
Beskrivning
Features supporting (red flags) a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beskrivning
orofacial dystonia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1395979
Beskrivning
disproportionate antecollis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1698476
Beskrivning
Camptocormia and/or Pisa syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264162
Beskrivning
Contractors of hands or feet
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1140999
- UMLS CUI [1,2]
- C0018563
- UMLS CUI [1,3]
- C0016504
Beskrivning
inspiratory sighs
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0425481
Beskrivning
severe dysphonia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1527344
- UMLS CUI [1,2]
- C0205082
Beskrivning
severe dysarthria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013362
- UMLS CUI [1,2]
- C0205082
Beskrivning
new or increased snoring
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0037384
Beskrivning
Cold hands and feet
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0857073
Beskrivning
Pathologic laughter or crying
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0424304
- UMLS CUI [1,2]
- C0860609
Beskrivning
Jerky, myoclonic postural/action tremor
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0234379
- UMLS CUI [1,2]
- C0234376
Beskrivning
Features not supporting a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beskrivning
Classical pill-rolling rest tremor
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0751564
Beskrivning
Clinically significant neuropathy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0442874
Beskrivning
Hallucinations not induced by drugs
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018524
Beskrivning
Onset after age 75y
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0206132
Beskrivning
family history of ataxia or parkinsonism
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2939151
- UMLS CUI [1,2]
- C0004134
- UMLS CUI [1,3]
- C0241889
Beskrivning
Dementia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0497327
Beskrivning
White matter lesions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2752009
Beskrivning
Suspected diagnosis
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332147
Beskrivning
Modified Hoehn & Yahr Staging
Alias
- UMLS CUI-1
- C3639878
Beskrivning
Modified Hoehn and Yahr Staging
Datatyp
text
Alias
- UMLS CUI [1]
- C3639878
Beskrivning
Hoehn & Yahr Stage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3639878
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
MSA possible or probable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beskrivning
Hoehn and Yahr Stage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3639483
Beskrivning
If no, later revision possible.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Beskrivning
consumption of ECGC
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009830
- UMLS CUI [1,2]
- C1384640
Beskrivning
Written informed consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Compliance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beskrivning
Contraception
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
liver disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023895
Beskrivning
Inclusion criteria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1512693
Beskrivning
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Hoehn & Yahr stage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0451215
Beskrivning
Neurodegenerative disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0524851
Beskrivning
severe liver disease or regular intake of hepatotoxic drugs
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023895
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0235378
Beskrivning
hypersensitivity to EGCG
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0059438
- UMLS CUI [1,2]
- C0020517
Beskrivning
Participation in other clinical trial
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
Comorbidity
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beskrivning
abuse of medication, drugs or alcohol
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beskrivning
Grapefruit juice consumption
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0452456
- UMLS CUI [1,2]
- C0009830
Beskrivning
Pregnancy or breast feeding
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beskrivning
Contraceptive method
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beskrivning
COMT-inhibitors
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3536821
Beskrivning
Bortezomib history of plasmocytoma
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032131
Beskrivning
Anemia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002871
Beskrivning
Other severe medical conditions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3843040
- UMLS CUI [1,2]
- C0205082
Beskrivning
Exclusion criteria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beskrivning
Signature of investigator
Alias
- UMLS CUI-1
- C2346576
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
I confirm the correctness of the data documented above.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Screening Visit (V0)
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1628561 (UMLS CUI [2])
C0439673 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
C0439673 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
C0277793 (UMLS CUI [1,2])
C0277793 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,2])
C0042024 (UMLS CUI [1,2])
C2733447 (UMLS CUI [1,2])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3176307 (UMLS CUI [1,2])
C0858572 (UMLS CUI [1,2])
C0040822 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0592503 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C3277919 (UMLS CUI-2)
C3277919 (UMLS CUI [1,2])
C3277919 (UMLS CUI-2)
C3277919 (UMLS CUI [1,2])
C0592503 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0013227 (UMLS CUI-3)
C0497327 (UMLS CUI-4)
C0013227 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0013227 (UMLS CUI-2)
C0497327 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0592502 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0558819 (UMLS CUI [1,2])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0234130 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0436145 (UMLS CUI [1,2])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0242414 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0036658 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0459422 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,2])
C0332148 (UMLS CUI-2)
C1335499 (UMLS CUI [1,2])
C1853562 (UMLS CUI [1,3])
C0042024 (UMLS CUI [1,2])
C0020651 (UMLS CUI [2])
C1853846 (UMLS CUI [1,2])
C0231691 (UMLS CUI [2,1])
C0454599 (UMLS CUI [2,2])
C1411869 (UMLS CUI [2,3])
C0033204 (UMLS CUI [1,2])
C0332148 (UMLS CUI [1,2])
C2362652 (UMLS CUI-2)
C1335499 (UMLS CUI [1,2])
C1853562 (UMLS CUI [1,3])
C3277919 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,2])
C0151889 (UMLS CUI [1,2])
C1335499 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,2])
C0454599 (UMLS CUI [1,2])
C1411869 (UMLS CUI [1,3])
C3641247 (UMLS CUI [1,2])
C0436540 (UMLS CUI [1,2])
C3641247 (UMLS CUI [1,2])
C0206129 (UMLS CUI [1,2])
C0183126 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C0679228 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0018563 (UMLS CUI [1,2])
C0016504 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
C0860609 (UMLS CUI [1,2])
C0234376 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0004134 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0332147 (UMLS CUI [1,2])
C0033204 (UMLS CUI [1,2])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1384640 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
C0020517 (UMLS CUI [1,2])
C0009830 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])