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ID

29086

Descrição

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

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Versões (1)
  1. 23/02/2018 23/02/2018 -
Titular dos direitos

GlaxoSmithKline (GSK)

Transferido a

23 de fevereiro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

    Inglês

    Assessment Week12

    1 Formulários  
    1. StudyEvent: ODM
      1. Assessment Week12
    Administration
    Descrição

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Patient number
    Descrição

    Patient number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Visit date
    Descrição

    Visit date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Center Number
    Descrição

    Center Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    IRLS Rating Scale
    Descrição

    IRLS Rating Scale

    Alias
    UMLS CUI-1
    C0681889
    UMLS CUI-2
    C0035258
    Please complete the IRLS Rating Scale
    Descrição

    IRLS Rating Scale

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0681889
    UMLS CUI [1,2]
    C0035258
    Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
    Descrição

    Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.

    Alias
    UMLS CUI-1
    C0034394
    UMLS CUI-2
    C0035258
    UMLS CUI-3
    C0679830
    Vital signs
    Descrição

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Weight (without shoes)
    Descrição

    Weight

    Tipo de dados

    integer

    Unidades de medida
    • kg / lbs
    Alias
    UMLS CUI [1]
    C0005910
    kg / lbs
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766
    Orthostatic vital signs
    Descrição

    Orthostatic vital signs

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0518766
    Time Vitals Taken
    Descrição

    Time Vitals Taken

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Blood pressure systolic/diastolic
    Descrição

    Blood pressure

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse
    Descrição

    Pulse

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Descrição

    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.

    Alias
    UMLS CUI-1
    C0199171
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Descrição

    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.

    Alias
    UMLS CUI-1
    C2347852
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    Descrição

    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.

    Alias
    UMLS CUI-1
    C0877248
    Clinical Global Impressions
    Descrição

    Clinical Global Impressions

    Alias
    UMLS CUI-1
    C3639708
    Laboratory evaluation
    Descrição

    Laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    Date of blood sample:
    Descrição

    Date of blood sample

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Were any clinically significant abnormalities detected?
    Descrição

    If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1853129
    Is the patient a female of child-bearing potential?
    Descrição

    If ’Yes’, please perform a pregnancy dipstick test and record result below.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0430056
    Pregnancy?
    Descrição

    If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Followup.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Assessment Week12

    1 Formulários
    1. StudyEvent: ODM
      1. Assessment Week12
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient number
    integer
    C1830427 (UMLS CUI [1])
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    IRLS Rating Scale
    C0681889 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    IRLS Rating Scale
    Item
    Please complete the IRLS Rating Scale
    boolean
    C0681889 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale. • Hospital Anxiety and Depression Scale (HADS). • Patient Satisfaction Question.
    C0034394 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    C0679830 (UMLS CUI-3)
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight (without shoes)
    integer
    C0005910 (UMLS CUI [1])
    Item Group
    Orthostatic vital signs
    C0518766 (UMLS CUI-1)
    Item
    Orthostatic vital signs
    integer
    C0518766 (UMLS CUI [1])
    Orthostatic vital signs
    Code List
    Orthostatic vital signs
    CL Item
    After 10 minutes semi-supine (1)
    CL Item
    After erect for 1 minute (2)
    Time Vitals Taken
    Item
    Time Vitals Taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood pressure
    Item
    Blood pressure systolic/diastolic
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    C0199171 (UMLS CUI-1)
    Item Group
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    C2347852 (UMLS CUI-1)
    Item Group
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    C0877248 (UMLS CUI-1)
    Item Group
    Clinical Global Impressions
    C3639708 (UMLS CUI-1)
    Item Group
    Laboratory evaluation
    C0022885 (UMLS CUI-1)
    Date of blood sample
    Item
    Date of blood sample:
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory abnormalities
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C1853129 (UMLS CUI [1])
    Pregnancy dipstick
    Item
    Is the patient a female of child-bearing potential?
    boolean
    C0430056 (UMLS CUI [1])
    Pregnancy
    Item
    Pregnancy?
    boolean
    C0032961 (UMLS CUI [1])
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