ID
28016
Beschreibung
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
Stichworte
Versionen (1)
- 10.12.17 10.12.17 -
Rechteinhaber
Priv.-Doz. Dr. med. Johannes Levin
Hochgeladen am
10. Dezember 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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PROMESA NCT02008721
Screening Visit (V0)
- StudyEvent: ODM
Beschreibung
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
Informed consent
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Informed consent
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Date of informed consent
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Name MD
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710470
- UMLS CUI [1,2]
- C0600091
Beschreibung
SIgnature investigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date informed consent
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Demographic Data
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Medical history
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Medical History
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Body system
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0460002
Beschreibung
Diagnosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Start of disease or surgery
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2]
- C1628561
Beschreibung
Start Date not known
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0439673
Beschreibung
End of disease or surgery
Datentyp
date
Alias
- UMLS CUI [1]
- C4019088
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0444930
Beschreibung
End date unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0439673
Beschreibung
Disease persistent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205322
Beschreibung
MSA History
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0262926
Beschreibung
Onset of first symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
Beschreibung
Onset of first symptoms not known
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0277793
- UMLS CUI [1,3]
- C0439673
Beschreibung
MSA diagnosis date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
Beschreibung
MSA Diagnosis date not known
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2316983
- UMLS CUI [1,3]
- C0439673
Beschreibung
MSA Type of first symptoms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C1457887
Beschreibung
MSA syncope
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0039070
Beschreibung
MSA Orthostatic hypotension
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0020651
Beschreibung
MSA Urinary Incontinence
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0042024
Beschreibung
MSA Erectile Dysfuntion
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2733447
Beschreibung
MSA Other autonomic symptoms
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C2674101
- UMLS CUI [1,3]
- C1521902
Beschreibung
MSA Bradykinesia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C3176307
Beschreibung
MSA Rigidity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0858572
Beschreibung
MSA Tremor
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0040822
Beschreibung
Only answer, if answer to previous question was 'yes'.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0234379
Beschreibung
Only answer, if answer to previous question was 'yes'.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0234378
Beschreibung
MSA Other parkinsonism symptoms
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1521902
Beschreibung
Onset of falls
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0085639
- UMLS CUI [1,2]
- C0574845
Beschreibung
frequency of falls
Datentyp
integer
Alias
- UMLS CUI [1]
- C1285588
Beschreibung
Psychiatric history
Alias
- UMLS CUI-1
- C0748059
Beschreibung
Psychiatric history
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0748059
Beschreibung
delusion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011253
Beschreibung
Delsuions specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011253
- UMLS CUI [1,2]
- C1521902
Beschreibung
Hallucinations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018524
Beschreibung
Hallucinations specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018524
- UMLS CUI [1,2]
- C1521902
Beschreibung
Affective disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0525045
Beschreibung
Affective disorder specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0525045
- UMLS CUI [1,2]
- C1521902
Beschreibung
psychiatric history other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other psychiatric history specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0748059
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschreibung
Parkinson's Disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beschreibung
Parkinson's disease medication
Alias
- UMLS CUI-1
- C0030567
- UMLS CUI-2
- C0013227
Beschreibung
Parkinson's disease medication
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0805701
Beschreibung
Parkinson's medication brand name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0030567
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0592503
Beschreibung
Dosage of Parkinson's medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0178602
Beschreibung
Parkinson's medication regimen
Datentyp
text
Alias
- UMLS CUI [1]
- C0237125
Beschreibung
Start date Parkinson's medication
Datentyp
partialDate
Maßeinheiten
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beschreibung
Medication against autonomic dysfunction
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C3277919
Beschreibung
Pharmaceutical preparation autonomic dysfunction Brand name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3277919
- UMLS CUI [1,3]
- C0592503
Beschreibung
Dosage of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Regimen
Datentyp
text
Alias
- UMLS CUI [1]
- C0237125
Beschreibung
Medication Start date
Datentyp
partialDate
Maßeinheiten
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-3
- C0013227
- UMLS CUI-4
- C0497327
Beschreibung
Antidepressant and antidementive medication
Alias
- UMLS CUI-1
- C0003289
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0497327
Beschreibung
Brand name
Datentyp
text
Alias
- UMLS CUI [1]
- C0592503
Beschreibung
Dosage of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Regimen
Datentyp
text
Alias
- UMLS CUI [1]
- C0237125
Beschreibung
Medication Start date
Datentyp
partialDate
Maßeinheiten
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Other medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0205394
Beschreibung
Generic name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beschreibung
Pharmaceutical preparation indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Beschreibung
Dosage of medication
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Regimen
Datentyp
text
Alias
- UMLS CUI [1]
- C0237125
Beschreibung
Medication Start date
Datentyp
partialDate
Maßeinheiten
- mm/yyyy
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Date of physical examination
Datentyp
date
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Body Temperature
Datentyp
integer
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Weight
Datentyp
integer
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
pHysical examination code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0805701
Beschreibung
physical examination finding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschreibung
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurologic examination cranial nerves
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
Beschreibung
cranial nerves examination specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0558819
- UMLS CUI [1,3]
- C1521902
Beschreibung
Neurologic examination Motor function
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
Beschreibung
Motor function specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0234130
- UMLS CUI [1,3]
- C1521902
Beschreibung
Neurologic examination Reflexes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
Beschreibung
Reflexes specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0436145
- UMLS CUI [1,3]
- C1521902
Beschreibung
Neurologic examination coordination
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
Beschreibung
Coordination specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0242414
- UMLS CUI [1,3]
- C1521902
Beschreibung
Neurologic examination sensation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
Beschreibung
Sensation specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0036658
- UMLS CUI [1,3]
- C1521902
Beschreibung
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Laboratory test
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Type of laboratory procedure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Laboratory procedure value
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0587081
Beschreibung
Laboratory result normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0459422
Beschreibung
Laboratory finding significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0750502
Beschreibung
Laboratory finding not significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C2985739
Beschreibung
Laboratory test not done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
Beschreibung
Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332148
Beschreibung
sporadic, progressive, adult-onset disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beschreibung
Required criteria for probable MSA
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C0042024
- UMLS CUI [2]
- C0020651
Beschreibung
in addition, one of the following criteria must apply.
Datentyp
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
Beschreibung
criteria for clinical probable MSA
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beschreibung
criteria for clinical probable MSA
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332148
Beschreibung
Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C2362652
Beschreibung
sporadic, progressive, adult-onset disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2733447
- UMLS CUI [1,2]
- C1335499
- UMLS CUI [1,3]
- C1853562
Beschreibung
MSA autonomic dysfunction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C3277919
Beschreibung
MSA additional features
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0034935
- UMLS CUI [1,2]
- C0151889
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038450
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030569
- UMLS CUI [1,2]
- C1335499
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0023570
- UMLS CUI [1,2]
- C1704632
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1843921
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0231691
- UMLS CUI [1,2]
- C0454599
- UMLS CUI [1,3]
- C1411869
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011168
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0235946
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030569
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0235946
- UMLS CUI [1,2]
- C0436540
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0347938
- UMLS CUI [1,2]
- C3641247
Beschreibung
Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011307
- UMLS CUI [1,2]
- C0206129
- UMLS CUI [1,3]
- C0183126
Beschreibung
Diagnostic criteria for clinical possible MSA apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0679228
Beschreibung
Features supporting (red flags) a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beschreibung
orofacial dystonia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1395979
Beschreibung
disproportionate antecollis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1698476
Beschreibung
Camptocormia and/or Pisa syndrome
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264162
Beschreibung
Contractors of hands or feet
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1140999
- UMLS CUI [1,2]
- C0018563
- UMLS CUI [1,3]
- C0016504
Beschreibung
inspiratory sighs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0425481
Beschreibung
severe dysphonia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1527344
- UMLS CUI [1,2]
- C0205082
Beschreibung
severe dysarthria
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013362
- UMLS CUI [1,2]
- C0205082
Beschreibung
new or increased snoring
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0037384
Beschreibung
Cold hands and feet
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0857073
Beschreibung
Pathologic laughter or crying
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0424304
- UMLS CUI [1,2]
- C0860609
Beschreibung
Jerky, myoclonic postural/action tremor
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0234379
- UMLS CUI [1,2]
- C0234376
Beschreibung
Features not supporting a diagnosis of MSA
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C1457887
Beschreibung
Classical pill-rolling rest tremor
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0751564
Beschreibung
Clinically significant neuropathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0442874
Beschreibung
Hallucinations not induced by drugs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018524
Beschreibung
Onset after age 75y
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0206132
Beschreibung
family history of ataxia or parkinsonism
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2939151
- UMLS CUI [1,2]
- C0004134
- UMLS CUI [1,3]
- C0241889
Beschreibung
Dementia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0497327
Beschreibung
White matter lesions
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2752009
Beschreibung
Suspected diagnosis
Alias
- UMLS CUI-1
- C0393571
- UMLS CUI-2
- C0332147
Beschreibung
Modified Hoehn & Yahr Staging
Alias
- UMLS CUI-1
- C3639878
Beschreibung
Modified Hoehn and Yahr Staging
Datentyp
text
Alias
- UMLS CUI [1]
- C3639878
Beschreibung
Hoehn & Yahr Stage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3639878
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
MSA possible or probable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0033204
Beschreibung
Hoehn and Yahr Stage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3639483
Beschreibung
If no, later revision possible.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0393571
- UMLS CUI [1,2]
- C0237125
- UMLS CUI [1,3]
- C0205360
Beschreibung
consumption of ECGC
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009830
- UMLS CUI [1,2]
- C1384640
Beschreibung
Written informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Contraception
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
liver disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023895
Beschreibung
Inclusion criteria
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Hoehn & Yahr stage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0451215
Beschreibung
Neurodegenerative disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0524851
Beschreibung
severe liver disease or regular intake of hepatotoxic drugs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023895
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0235378
Beschreibung
hypersensitivity to EGCG
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0059438
- UMLS CUI [1,2]
- C0020517
Beschreibung
Participation in other clinical trial
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Comorbidity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
abuse of medication, drugs or alcohol
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
Grapefruit juice consumption
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0452456
- UMLS CUI [1,2]
- C0009830
Beschreibung
Pregnancy or breast feeding
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschreibung
Contraceptive method
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
COMT-inhibitors
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3536821
Beschreibung
Bortezomib history of plasmocytoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032131
Beschreibung
Anemia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002871
Beschreibung
Other severe medical conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3843040
- UMLS CUI [1,2]
- C0205082
Beschreibung
Exclusion criteria
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
Signature of investigator
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Investigator Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
I confirm the correctness of the data documented above.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Ähnliche Modelle
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])