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ID

30488

Description

This ODM file contains Medical Conditions, alcohol intake and History of Tobacco use. To be filled in at screening visit (Date on Administrative Data, Demography and Child-Bearing Potential Form). 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.

Lien

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

Mots-clés

  1. 8/6/18 8/6/18 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

8 de junio de 2018

DOI

Pour une demande vous connecter.

Licence

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

    Medical Conditions, Alcohol Intake and History of Tobacco Use

    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0262926
    Diagnosis
    Description

    Only in the absence of a diagnosis, record the signs and symptoms on separate lines Use a new entry for each entity.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0011900
    Current or Past
    Description

    CURRENT MEDICAL CONDITIONS: Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS: Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1444635
    UMLS CUI [1,2]
    C0012634
    Alcohol intake
    Description

    Alcohol intake

    Alias
    UMLS CUI-1
    C0001948
    Does the subject consume alcohol?
    Description

    Alcohol consumption

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0001948
    If yes, record the average number of units of alcohol consumed per week.
    Description

    1 unit of alcohol in UK = half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.

    Type de données

    float

    Unités de mesure
    • units / week
    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    units / week
    History of Tobacco Use
    Description

    History of Tobacco Use

    Alias
    UMLS CUI-1
    C0543414
    What is the subject's history of smoking use?
    Description

    Never smoked: Never smoked Current smoker: Exclude current smokers as determined by urinary cotinine levels indicative of smoking Former smoker: Exclude subjects if there is a history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1519384
    If former smoker: When did the subject last smoke?
    Description

    Last smoking

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0425310
    UMLS CUI [1,2]
    C0806020

    Similar models

    Medical Conditions, Alcohol Intake and History of Tobacco Use

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Medical Conditions
    C0262926 (UMLS CUI-1)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Current or Past
    integer
    C1444635 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Code List
    Current or Past
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item Group
    Alcohol intake
    C0001948 (UMLS CUI-1)
    Item
    Does the subject consume alcohol?
    text
    C0001948 (UMLS CUI [1])
    Code List
    Does the subject consume alcohol?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Units of alcohol per week
    Item
    If yes, record the average number of units of alcohol consumed per week.
    float
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    History of Tobacco Use
    C0543414 (UMLS CUI-1)
    Item
    What is the subject's history of smoking use?
    integer
    C1519384 (UMLS CUI [1])
    Code List
    What is the subject's history of smoking use?
    CL Item
    Never Smoked (1)
    CL Item
    Current Smoker (2)
    CL Item
    Former Smoker (3)
    Last smoking
    Item
    If former smoker: When did the subject last smoke?
    date
    C0425310 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])

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