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ID

28167

Description

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

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Versions (1)
  1. 22/12/17 22/12/17 -
Détendeur de droits

Priv.-Doz. Dr. med. Johannes Levin

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22 de diciembre de 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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    PROMESA NCT02008721

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    Telephone visit 2 (T2)

    1 Formulaires  
    1. StudyEvent: ODM
      1. Telephone visit 2 (T2)
    Date of Telephone contact
    Description

    Date of Telephone contact

    Alias
    UMLS CUI-1
    C0302186
    UMLS CUI-2
    C0011008
    Date of telephone contact
    Description

    Date of telephone contact

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0302186
    UMLS CUI [1,2]
    C0011008
    Adverse event
    Description

    Adverse event

    Alias
    UMLS CUI-1
    C0877248
    Adverse event occurred?
    Description

    If yes, please fill in AE report form.

    Type de données

    boolean

    Concomitant medication
    Description

    Concomitant medication

    Alias
    UMLS CUI-1
    C2347852
    Are there any changes in the concomitant medication?
    Description

    If Yes, please fill in Concomitant Medication Record.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Study medication
    Description

    Study medication

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0304229
    Did any study-drug side effects occur?
    Description

    If yes, please fill out AE form!

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0041755
    Did the patient regularly take the study-drug?
    Description

    regular intake of study medication

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0205272
    If no, please explain:
    Description

    Study medication intake

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0205272
    Regimen
    Description

    e.g. 1-0-0

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0237125
    UMLS CUI [1,2]
    C0304229
    Total dose (mg/d)
    Description

    Total dose

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2986497
    UMLS CUI [1,2]
    C1521826
    Laboratory test
    Description

    Laboratory test

    Alias
    UMLS CUI-1
    C0022885
    Date
    Description

    Please fill in the raised values and assess whether they´re normal or not. If abnormal, evaluate if it is clinically significant or not. If the value is abnormal and clinically significant, please document as concomitant disease under medical history.

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0022885
    Laboratory test performed?
    Description

    laboratory procedures

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0022885
    Laboratory test
    Description

    Laboratory test

    Alias
    UMLS CUI-1
    C0022885
    Type of laboratory procedure
    Description

    Type of laboratory procedure

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0022885
    Value
    Description

    Laboratory procedure value

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0587081
    Normal
    Description

    Laboratory result normal

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C0459422
    Clinical significant
    Description

    Laboratory finding significant

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0750502
    Clinically not significant
    Description

    Laboratory finding not significant

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C2985739
    Not done
    Description

    Laboratory test not done

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0445106
    Signature of investigator
    Description

    Signature of investigator

    Alias
    UMLS CUI-1
    C2346576
    Date of Investigator Signature
    Description

    Investigator Signature Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Name of investigator
    Description

    Investigator name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826892
    Investigator signature
    Description

    I confirm the correctness of the data documented above.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2346576
    Retour au début de la page

    Similar models

    Telephone visit 2 (T2)

    1 Formulaires
    1. StudyEvent: ODM
      1. Telephone visit 2 (T2)
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Date of Telephone contact
    C0302186 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Date of telephone contact
    Item
    Date of telephone contact
    date
    C0302186 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Adverse event
    C0877248 (UMLS CUI-1)
    adverse event
    Item
    Adverse event occurred?
    boolean
    Item Group
    Concomitant medication
    C2347852 (UMLS CUI-1)
    Concomitant Medication
    Item
    Are there any changes in the concomitant medication?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Study medication
    C0013227 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    side effects study drug
    Item
    Did any study-drug side effects occur?
    boolean
    C0304229 (UMLS CUI [1,1])
    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])
    Study medication intake
    Item
    If no, please explain:
    text
    C0013227 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0205272 (UMLS CUI [1,3])
    Study drug regimen
    Item
    Regimen
    text
    C0237125 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item
    Total dose (mg/d)
    integer
    C2986497 (UMLS CUI [1,1])
    C1521826 (UMLS CUI [1,2])
    Total dose
    Code List
    Total dose (mg/d)
    CL Item
    800 (1)
    CL Item
    1200 (2)
    Item Group
    Laboratory test
    C0022885 (UMLS CUI-1)
    Date laboratory
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Item
    Laboratory test performed?
    text
    C0022885 (UMLS CUI [1])
    laboratory procedures
    Code List
    Laboratory test performed?
    CL Item
    done (1)
    CL Item
    not done (2)
    Item Group
    Laboratory test
    C0022885 (UMLS CUI-1)
    Item
    Type of laboratory procedure
    integer
    C0022885 (UMLS CUI [1])
    Type of laboratory procedure
    Code List
    Type of laboratory procedure
    CL Item
    GOT (AST) U/L (1)
    CL Item
    GPT (ALT) U/L (2)
    CL Item
    Bilirubin mg/dL (3)
    Laboratory procedure value
    Item
    Value
    float
    C0587081 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Laboratory result normal
    Item
    Normal
    boolean
    C0587081 (UMLS CUI [1,1])
    C0459422 (UMLS CUI [1,2])
    Laboratory finding significant
    Item
    Clinical significant
    boolean
    C0456984 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Laboratory finding not significant
    Item
    Clinically not significant
    boolean
    C0587081 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Laboratory test not done
    Item
    Not done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0445106 (UMLS CUI [1,2])
    Item Group
    Signature of investigator
    C2346576 (UMLS CUI-1)
    Investigator Signature Date
    Item
    Date of Investigator Signature
    date
    C2346576 (UMLS CUI [1,1])
    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])
    Retour au début de la page 

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