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ID
28147
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)
- 21.12.17 21.12.17 -
Rechteinhaber
Priv.-Doz. Dr. med. Johannes Levin
Hochgeladen am
21. Dezember 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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PROMESA NCT02008721
30 Week control visit (V5)
- StudyEvent: ODM
Ähnliche Modelle
30 Week control visit (V5)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
CL Item
Yes (please specify below) (1)
CL Item
No (2)
Changes in MSA History
Item
Changes in MSA History since last visit (V4)
boolean
C0393571 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
MSA syncope
Item
Syncope
boolean
C0393571 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,2])
MSA Orthostatic hypotension
Item
Orthostatic hypotension
boolean
C0393571 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,2])
MSA Urinary Incontinence
Item
Urinary Incontinence
boolean
C0393571 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
C0042024 (UMLS CUI [1,2])
MSA Erectile Dysfuntion
Item
Erectile Dysfuntion
boolean
C0393571 (UMLS CUI [1,1])
C2733447 (UMLS CUI [1,2])
C2733447 (UMLS CUI [1,2])
MSA Other autonomic symptoms
Item
Other (please specify)
text
C0393571 (UMLS CUI [1,1])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Bradykinesia
Item
Bradykinesia
boolean
C2733447 (UMLS CUI [1,1])
C3176307 (UMLS CUI [1,2])
C3176307 (UMLS CUI [1,2])
MSA Rigidity
Item
Rigidity
boolean
C2733447 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0858572 (UMLS CUI [1,2])
MSA Tremor
Item
Tremor
boolean
C2733447 (UMLS CUI [1,1])
C0040822 (UMLS CUI [1,2])
C0040822 (UMLS CUI [1,2])
Resting tremor
Item
Resting tremor
boolean
C0234379 (UMLS CUI [1])
Postural tremor
Item
Postural tremor
boolean
C0234378 (UMLS CUI [1])
MSA Other parkinsonism symptoms
Item
other (please specify)
text
C2733447 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Gait ataxia
Item
Gait ataxia
boolean
C2732311 (UMLS CUI [1,1])
C0751837 (UMLS CUI [1,2])
C0751837 (UMLS CUI [1,2])
MSA limb ataxia
Item
Limb ataxia
boolean
C2732311 (UMLS CUI [1,1])
C4015302 (UMLS CUI [1,2])
C4015302 (UMLS CUI [1,2])
MSA Other cerebellar symptoms
Item
Other (please specify)
text
C2732311 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0037088 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
several times per day (1)
CL Item
several times per week (2)
CL Item
several times per month (3)
CL Item
several times per year (4)
CL Item
Cardiovascular (01)
CL Item
Pulmonary (02)
CL Item
Abdominal (03)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Surgery/Hospital Admission (06)
CL Item
Other (07)
Diagnosis
Item
Disease/Diagnosis
text
C0011900 (UMLS CUI [1])
Start of disease or surgery
Item
Start of disease or surgery
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1628561 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C1628561 (UMLS CUI [2])
Start Date not known
Item
Not known
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
End of disease or surgery
Item
End of disease or surgery
date
C4019088 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
End date unknown
Item
Not known
boolean
C0806020 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
Disease persistent
Item
Persistent
boolean
C0012634 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
Concomitant Medication
Item
Are there any changes in concomitant medication?
boolean
C2347852 (UMLS CUI [1])
Parkinson drugs
Item
Has the patient a stable regimen for drugs acting against Parkinsonism.
boolean
C0003405 (UMLS CUI [1])
pharmaceutical preparation autonomic dysfunction
Item
Has the patient a stable regimen for drugs acting against autonomic dysfunction.
boolean
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
C3277919 (UMLS CUI [1,2])
antidepressant and antidementive drugs
Item
Has the patient a stable regimen for antidepressant and antidementive drugs.
boolean
C0013227 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,3])
C0003289 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,3])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (please specify below) (2)
CL Item
Cardiovascular (01)
CL Item
Pulmonary (02)
CL Item
Abdominal (03)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Psychiatric (06)
CL Item
other (07)
physical examination finding
Item
Finding
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Item
Cranial nerves
integer
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C0558819 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
cranial nerves examination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Motor function
integer
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
Motor function specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Reflexes
integer
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C0436145 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
Reflexes specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Coordination
integer
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
Coordination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Sensation
integer
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal (2)
Sensation specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
CL Item
done (1)
CL Item
not done (2)
CL Item
Erythrocytes T/L (1)
CL Item
Leukocytes G/L (2)
CL Item
Thrombocytes G/L (3)
CL Item
Hemoglobin g/dL (4)
CL Item
PTT sec (5)
CL Item
PchE kU/L (6)
CL Item
GOT (AST) U/L (7)
CL Item
GPT (ALT) U/L (8)
CL Item
Bilirubin mg/dL (9)
CL Item
Creatinine mg/dL (10)
CL Item
Creatine Kinase U/L (11)
CL Item
Potassium mmol/L (12)
CL Item
Sodium mmol/L (13)
CL Item
GFR mL/min (14)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,2])
Item Group
Unified MSA Rating scale - Part 1: Historical review
C0393571 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
C0681889 (UMLS CUI-2)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Cutting food and handling utensils
integer
C3639844 (UMLS CUI [1])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Unified MSA rating scale - Part 2: Motor examination scale
C0393571 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
C0681889 (UMLS CUI-2)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Rapid alternating movements of hands
integer
C3166247 (UMLS CUI [1,1])
C3166248 (UMLS CUI [1,2])
C3166248 (UMLS CUI [1,2])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Arising from chair
integer
C1290946 (UMLS CUI [1,1])
C3639721 (UMLS CUI [1,2])
C3639721 (UMLS CUI [1,2])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item Group
Unified MSA rating scale - Part 3: Autonomic examination
C0393571 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
C0681889 (UMLS CUI-2)
CL Item
Supine (1)
CL Item
Standing (2min) (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
vital signs Unable to record
Item
Unable to record
boolean
C0518766 (UMLS CUI [1])
Item Group
Unified MSA rating scale - Part 4: Global disability scale
C0393571 (UMLS CUI-1)
C0681889 (UMLS CUI-2)
C0681889 (UMLS CUI-2)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
Therapeutic effect marked; Side effects none (1)
CL Item
Therapeutic effect marked; Side effects do not significantly interfere with patient's functioning (2)
CL Item
Therapeutic effect marked; Side effects significantly interfere with patient's functioning (3)
CL Item
Therapeutic effect marked; Side effects outweighs therapeutic effect (4)
CL Item
Therapeutic effect moderate; Side effects none (5)
CL Item
Therapeutic effect moderate; Side effects do not significantly interfere with patient's functioning (6)
CL Item
Therapeutic effect moderate; Side effects significantly interfere with patient's functioning (7)
CL Item
Therapeutic effect moderate; Side effects outweighs therapeutic effect (8)
CL Item
Therapeutic effect minimal; Side effects none (9)
CL Item
Therapeutic effect minimal; Side effects do not significantly interfere with patient's functioning (10)
CL Item
Therapeutic effect minimal; Side effects significantly interfere with patient's functioning (11)
CL Item
Therapeutic effect minimal; Side effects outweighs therapeutic effect (12)
CL Item
Therapeutic effect unchanged or worse; Side effects none (13)
CL Item
Therapeutic effect unchanged or worse; Side effects do not significantly interfere with patient's functioning (14)
CL Item
Therapeutic effect unchanged or worse; Side effects significantly interfere with patient's functioning (15)
CL Item
Therapeutic effect unchanged or worse; Side effects outweighs therapeutic effect (16)
side effects study drug
Item
Did any study-drug side effects occur?
boolean
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
regular intake of study medication
Item
Did the patient regularly take the study-drug?
boolean
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study medication intake
Item
If no, please explain:
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Number of capsules returned
Item
Number of capsules returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Missing capsules
Item
Comment (in case of missing capsules)
text
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Item
Trial medication exchange
integer
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
CL Item
done (1)
CL Item
not done (2)
Date of study drug exchange
Item
Date
date
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study medication regimen
Item
Regimen
text
C0008976 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0237125 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C0237125 (UMLS CUI [1,3])
Number of Capsules dispensed
Item
Number of Capsules dispensed
integer
C0013227 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,2])
Planned medication start
Item
Planned new dosis start
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Total dose
Item
Total dose according to protocol (1200 mg/d)?
boolean
C3174092 (UMLS CUI [1])
Dosage different than according to protocol
Item
If no, please explain
text
C3174092 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])