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ID

30543

Beschreibung

This ODM file contains Holter and Telemetry Results. Holter part to be filled at Screening, Session 1 and 2 (Day -1 and Day 1), Telemetry part to be filled at Sessions 1 and 2 (Day 1 only). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Stichworte

Versionen (1)
  1. 13.06.18 13.06.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. Juni 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    Englisch

    Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Type of Visit
    Beschreibung

    Visit

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Holter
    Beschreibung

    Holter

    Alias
    UMLS CUI-1
    C0013801 (Holter Electrocardiography)
    Planned relative Time on Day 1 of Sessions.
    Beschreibung

    Not to be filled at Screening or Day -1 of Sessions.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0013801 (Holter Electrocardiography)
    Start Date of Holter
    Beschreibung

    Record the dates and times recorded by the Holter monitoring equipment.

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Start Time of Holter
    Beschreibung

    Record the dates and times recorded by the Holter monitoring equipment.

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Stop Date of Holter
    Beschreibung

    Record the dates and times recorded by the Holter monitoring equipment.

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Stop Time of Holter
    Beschreibung

    Record the dates and times recorded by the Holter monitoring equipment.

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Holter monitoring method
    Beschreibung

    Holter monitoring method

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C0871511 (Test Method)
    Interpretation of Holter
    Beschreibung

    Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional Holter abnormalities page if clinically significant abnormalities are present.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0013801 (Holter Electrocardiography)
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Telemetry
    Beschreibung

    Telemetry

    Alias
    UMLS CUI-1
    C0039451 (Telemetry)
    Planned relative Time on Day 1 of Sessions
    Beschreibung

    Telemetry only mandatory on day 1 of Sessions. Not to be done at screening or Day -1 of Sessions.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0039451 (Telemetry)
    Start date of Telemetry
    Beschreibung

    Start date of Telemetry

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Start time of Telemetry
    Beschreibung

    Start time of Telemetry

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    End date of Telemetry
    Beschreibung

    End date of Telemetry

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    End time of Telemetry
    Beschreibung

    End time of Telemetry

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Result of Telemetry
    Beschreibung

    Result of Telemetry

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0039451 (Telemetry)
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Holter (Screening, Session 1+2), Telemetry (Session 1 + 2)

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    (Comment:en)
    CL Item
    Session 1 (Day 1) (Session 1 (Day 1))
    (Comment:en)
    CL Item
    Session 2 (Day 1) (Session 2 (Day 1))
    (Comment:en)
    CL Item
    Unscheduled (Unscheduled)
    (Comment:en)
    CL Item
    Session 1 (Day -1) (Session 1 (Day -1))
    (Comment:en)
    CL Item
    Session 2 (Day -1) (Session 2 (Day -1))
    (Comment:en)
    Item Group
    Holter
    C0013801 (UMLS CUI-1)
    Item
    Planned relative Time on Day 1 of Sessions.
    text
    C0439564 (UMLS CUI [1,1])
    C0013801 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned relative Time on Day 1 of Sessions.
    CL Item
    Pre-Scan (Pre-Scan)
    CL Item
    Post-Scan (Post-Scan)
    Start Date of Holter
    Item
    Start Date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time of Holter
    Item
    Start Time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date of Holter
    Item
    Stop Date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time of Holter
    Item
    Stop Time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Holter monitoring method
    text
    C0013801 (UMLS CUI [1,1])
    C0871511 (UMLS CUI [1,2])
    Holter monitoring method
    Code List
    Holter monitoring method
    CL Item
    12 Lead 1000Hz (1)
    CL Item
    12 lead 180Hz (2)
    CL Item
    3 Lead 180 Hz (3)
    CL Item
    Telemetry (4)
    CL Item
    5 Lead 512Hz (5)
    CL Item
    4 Lead 0.05-40 Hz (6)
    CL Item
    6 Lead 0.05-40 Hz (7)
    CL Item
    7 Lead 0.05-100 Hz-3dB (8)
    CL Item
    7 Lead 3 channel 133 Hz (9)
    CL Item
    2 Lead 200 Hz (10)
    CL Item
    Other (OT)
    Item
    Interpretation of Holter
    integer
    C0013801 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of ECG
    Code List
    Interpretation of Holter
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal - clinically significant (3)
    CL Item
    no result (4)
    CL Item
    unable to evaluate (8)
    Item Group
    Telemetry
    C0039451 (UMLS CUI-1)
    Item
    Planned relative Time on Day 1 of Sessions
    text
    C0439564 (UMLS CUI [1,1])
    C0039451 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned relative Time on Day 1 of Sessions
    CL Item
    Pre-Scan (Pre-Scan)
    CL Item
    Post-Scan (Post-Scan)
    Start date of Telemetry
    Item
    Start date of Telemetry
    date
    C0039451 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start time of Telemetry
    Item
    Start time of Telemetry
    time
    C0039451 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    End date of Telemetry
    Item
    End date of Telemetry
    date
    C0039451 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    End time of Telemetry
    Item
    End time of Telemetry
    time
    C0039451 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Result of Telemetry
    integer
    C0039451 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of ECG
    Code List
    Result of Telemetry
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal - clinically significant (3)
    CL Item
    no result (4)
    CL Item
    unable to evaluate (8)
    Zum Seitenanfang zurückkehren 

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