ID
28016
Beschrijving
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
Trefwoorden
Versies (1)
- 10-12-17 10-12-17 -
Houder van rechten
Priv.-Doz. Dr. med. Johannes Levin
Geüploaded op
10 december 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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PROMESA NCT02008721
Screening Visit (V0)
- StudyEvent: ODM
Beschrijving
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Informed consent
Datatype
integer
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Informed consent
Datatype
integer
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Date of informed consent
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
Name MD
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710470
- UMLS CUI [1,2]
- C0600091
Beschrijving
SIgnature investigator
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date informed consent
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
Demographic Data
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Medical history
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Medical History
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Body system
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0460002
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Start of disease or surgery
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1628561
Beschrijving
Start Date not known
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beschrijving
End of disease or surgery
Datatype
date
Alias
- UMLS CUI [1]
- C4019088
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0444930
Beschrijving
End date unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0439673
Beschrijving
Disease persistent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205322
Beschrijving
MSA History
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0262926
Beschrijving
Onset of first symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
Beschrijving
Onset of first symptoms not known
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
- UMLS CUI [1,3]
- C0439673
Beschrijving
MSA diagnosis date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
Beschrijving
MSA Diagnosis date not known
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
- UMLS CUI [1,3]
- C0439673
Beschrijving
MSA Type of first symptoms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C1457887
Beschrijving
MSA syncope
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0039070
Beschrijving
MSA Orthostatic hypotension
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0020651
Beschrijving
MSA Urinary Incontinence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0042024
Beschrijving
MSA Erectile Dysfuntion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2733447
Beschrijving
MSA Other autonomic symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2674101
- UMLS CUI [1,3]
- C1521902
Beschrijving
MSA Bradykinesia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C3176307
Beschrijving
MSA Rigidity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0858572
Beschrijving
MSA Tremor
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0040822
Beschrijving
Only answer, if answer to previous question was 'yes'.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0234379
Beschrijving
Only answer, if answer to previous question was 'yes'.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0234378
Beschrijving
MSA Other parkinsonism symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1521902
Beschrijving
Onset of falls
Datatype
date
Alias
- UMLS CUI [1,1]
- C0085639
- UMLS CUI [1,2]
- C0574845
Beschrijving
frequency of falls
Datatype
integer
Alias
- UMLS CUI [1]
- C1285588
Beschrijving
Psychiatric history
Alias
- UMLS CUI-1
- C0748059
Beschrijving
Psychiatric history
Datatype
boolean
Alias
- UMLS CUI [1]
- C0748059
Beschrijving
delusion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011253
Beschrijving
Delsuions specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011253
- UMLS CUI [1,2]
- C1521902
Beschrijving
Hallucinations
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018524
Beschrijving
Hallucinations specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018524
- UMLS CUI [1,2]
- C1521902
Beschrijving
Affective disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0525045
Beschrijving
Affective disorder specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0525045
- UMLS CUI [1,2]
- C1521902
Beschrijving
psychiatric history other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other psychiatric history specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschrijving
Parkinson's Disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beschrijving
Parkinson's disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beschrijving
Parkinson's disease medication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0805701
Beschrijving
Parkinson's medication brand name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0592503
Beschrijving
Dosage of Parkinson's medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
Beschrijving
Parkinson's medication regimen
Datatype
text
Alias
- UMLS CUI [1]
- C0237125
Beschrijving
Start date Parkinson's medication
Datatype
partialDate
Maateenheden
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beschrijving
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beschrijving
Pharmaceutical preparation autonomic dysfunction Brand name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3277919
- UMLS CUI [1,3]
- C0592503
Beschrijving
Dosage of medication
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Regimen
Datatype
text
Alias
- UMLS CUI [1]
- C0237125
Beschrijving
Medication Start date
Datatype
partialDate
Maateenheden
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-3
- C0013227
- UMLS CUI-4
- C0497327
Beschrijving
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0497327
Beschrijving
Brand name
Datatype
text
Alias
- UMLS CUI [1]
- C0592503
Beschrijving
Dosage of medication
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Regimen
Datatype
text
Alias
- UMLS CUI [1]
- C0237125
Beschrijving
Medication Start date
Datatype
partialDate
Maateenheden
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Other medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0205394
Beschrijving
Generic name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beschrijving
Pharmaceutical preparation indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beschrijving
Dosage of medication
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Regimen
Datatype
text
Alias
- UMLS CUI [1]
- C0237125
Beschrijving
Medication Start date
Datatype
partialDate
Maateenheden
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of physical examination
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Body Temperature
Datatype
integer
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Weight
Datatype
integer
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
pHysical examination code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0805701
Beschrijving
physical examination finding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschrijving
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Neurologic examination cranial nerves
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
Beschrijving
cranial nerves examination specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
- UMLS CUI [1,3]
- C1521902
Beschrijving
Neurologic examination Motor function
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
Beschrijving
Motor function specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
- UMLS CUI [1,3]
- C1521902
Beschrijving
Neurologic examination Reflexes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
Beschrijving
Reflexes specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
- UMLS CUI [1,3]
- C1521902
Beschrijving
Neurologic examination coordination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
Beschrijving
Coordination specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
- UMLS CUI [1,3]
- C1521902
Beschrijving
Neurologic examination sensation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
Beschrijving
Sensation specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
- UMLS CUI [1,3]
- C1521902
Beschrijving
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beschrijving
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Type of laboratory procedure
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Laboratory procedure value
Datatype
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0587081
Beschrijving
Laboratory result normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0459422
Beschrijving
Laboratory finding significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Beschrijving
Laboratory finding not significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C2985739
Beschrijving
Laboratory test not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
Beschrijving
Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332148
Beschrijving
sporadic, progressive, adult-onset disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beschrijving
Required criteria for probable MSA
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0042024
- UMLS CUI [2]
- C0020651
Beschrijving
in addition, one of the following criteria must apply.
Datatype
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
Beschrijving
criteria for clinical probable MSA
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beschrijving
criteria for clinical probable MSA
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332148
Beschrijving
Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C2362652
Beschrijving
sporadic, progressive, adult-onset disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beschrijving
MSA autonomic dysfunction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C3277919
Beschrijving
MSA additional features
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0034935
- UMLS CUI [1,2]
- C0151889
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038450
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030569
- UMLS CUI [1,2]
- C1335499
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0023570
- UMLS CUI [1,2]
- C1704632
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1]
- C1843921
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0231691
- UMLS CUI [1,2]
- C0454599
- UMLS CUI [1,3]
- C1411869
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011168
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1]
- C0235946
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030569
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0235946
- UMLS CUI [1,2]
- C0436540
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beschrijving
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011307
- UMLS CUI [1,2]
- C0206129
- UMLS CUI [1,3]
- C0183126
Beschrijving
Diagnostic criteria for clinical possible MSA apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0679228
Beschrijving
Features supporting (red flags) a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beschrijving
orofacial dystonia
Datatype
boolean
Alias
- UMLS CUI [1]
- C1395979
Beschrijving
disproportionate antecollis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1698476
Beschrijving
Camptocormia and/or Pisa syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264162
Beschrijving
Contractors of hands or feet
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1140999
- UMLS CUI [1,2]
- C0018563
- UMLS CUI [1,3]
- C0016504
Beschrijving
inspiratory sighs
Datatype
boolean
Alias
- UMLS CUI [1]
- C0425481
Beschrijving
severe dysphonia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1527344
- UMLS CUI [1,2]
- C0205082
Beschrijving
severe dysarthria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013362
- UMLS CUI [1,2]
- C0205082
Beschrijving
new or increased snoring
Datatype
boolean
Alias
- UMLS CUI [1]
- C0037384
Beschrijving
Cold hands and feet
Datatype
boolean
Alias
- UMLS CUI [1]
- C0857073
Beschrijving
Pathologic laughter or crying
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0424304
- UMLS CUI [1,2]
- C0860609
Beschrijving
Jerky, myoclonic postural/action tremor
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0234379
- UMLS CUI [1,2]
- C0234376
Beschrijving
Features not supporting a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beschrijving
Classical pill-rolling rest tremor
Datatype
boolean
Alias
- UMLS CUI [1]
- C0751564
Beschrijving
Clinically significant neuropathy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0442874
Beschrijving
Hallucinations not induced by drugs
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018524
Beschrijving
Onset after age 75y
Datatype
boolean
Alias
- UMLS CUI [1]
- C0206132
Beschrijving
family history of ataxia or parkinsonism
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2939151
- UMLS CUI [1,2]
- C0004134
- UMLS CUI [1,3]
- C0241889
Beschrijving
Dementia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0497327
Beschrijving
White matter lesions
Datatype
boolean
Alias
- UMLS CUI [1]
- C2752009
Beschrijving
Suspected diagnosis
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332147
Beschrijving
Modified Hoehn & Yahr Staging
Alias
- UMLS CUI-1
- C3639878
Beschrijving
Modified Hoehn and Yahr Staging
Datatype
text
Alias
- UMLS CUI [1]
- C3639878
Beschrijving
Hoehn & Yahr Stage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3639878
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
MSA possible or probable
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beschrijving
Hoehn and Yahr Stage
Datatype
boolean
Alias
- UMLS CUI [1]
- C3639483
Beschrijving
If no, later revision possible.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Beschrijving
consumption of ECGC
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009830
- UMLS CUI [1,2]
- C1384640
Beschrijving
Written informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Contraception
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
liver disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023895
Beschrijving
Inclusion criteria
Datatype
boolean
Alias
- UMLS CUI [1]
- C1512693
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Hoehn & Yahr stage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0451215
Beschrijving
Neurodegenerative disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0524851
Beschrijving
severe liver disease or regular intake of hepatotoxic drugs
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023895
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0235378
Beschrijving
hypersensitivity to EGCG
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0059438
- UMLS CUI [1,2]
- C0020517
Beschrijving
Participation in other clinical trial
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
Comorbidity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
abuse of medication, drugs or alcohol
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
Grapefruit juice consumption
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0452456
- UMLS CUI [1,2]
- C0009830
Beschrijving
Pregnancy or breast feeding
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
Contraceptive method
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
COMT-inhibitors
Datatype
boolean
Alias
- UMLS CUI [1]
- C3536821
Beschrijving
Bortezomib history of plasmocytoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032131
Beschrijving
Anemia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002871
Beschrijving
Other severe medical conditions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3843040
- UMLS CUI [1,2]
- C0205082
Beschrijving
Exclusion criteria
Datatype
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Signature of investigator
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
I confirm the correctness of the data documented above.
Datatype
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])