0 Avaliações
ID

20364

Descrição

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Visit 6 (Month 18) Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

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Versões (1)
  1. 21/02/2017 21/02/2017 -
Transferido a

21 de fevereiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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    Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    Inglês

    Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    1 Formulários  
    Month 15 Phone Check Of Patient
    Descrição

    Month 15 Phone Check Of Patient

    Alias
    UMLS CUI-1
    C0039457
    UMLS CUI-2
    C1283174
    1. Was telephone check done?
    Descrição

    Telephone check

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0039457
    UMLS CUI [1,2]
    C1283174
    2. If Yes, date of phone call (dd-mon-yy)
    Descrição

    if Yes

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Visit
    Descrição

    Visit

    Alias
    UMLS CUI-1
    C0545082
    3. Was visit 6 done?
    Descrição

    Visit done

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0545082
    4. If No, indicate reason:
    Descrição

    If No,reason

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0681841
    5. If Yes date of visit 6 (dd-mon-yy)
    Descrição

    If Yes date of visit 3

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    6. Type of visit
    Descrição

    Type of visit

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C3641100
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    Descrição

    If not patient, indicate source

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0449416
    UMLS CUI [1,2]
    C3146298
    Vital Signs
    Descrição

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    8. Systolic blood pressure after 5 minutes sitting/supine
    Descrição

    Systolic blood pressure

    Tipo de dados

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    8. Diastolic Blood Pressure after 5 minutes sitting/supine
    Descrição

    Diastolic Blood Pressure

    Tipo de dados

    float

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    9. Blood Pressure Position
    Descrição

    Blood Pressure Position

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1828063
    Neurological Status
    Descrição

    Neurological Status

    Alias
    UMLS CUI-1
    C0746866
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    Descrição

    Clinical Neurological Status is different

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C2047944
    Events
    Descrição

    Events

    Alias
    UMLS CUI-1
    C0877248
    11. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)
    Descrição

    Outcome Events or Serious Adverse Events

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1705586
    UMLS CUI [2]
    C0877248
    12. If "YES" please indicate all that apply:
    Descrição

    If Yes

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1521902
    New Or Worsening Disease States
    Descrição

    New Or Worsening Disease States

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C1442792
    1. New peripheral arterial occlusive disease (PAOD)
    Descrição

    PAOD

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1306889
    UMLS CUI [1,2]
    C0205314
    2. Worsening peripheral arterial occlusive disease (PAOD)
    Descrição

    PAOD Worsening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1306889
    UMLS CUI [1,2]
    C0332271
    3. Foot ulcers/foot infection requiring antibiotics
    Descrição

    Foot ulcers/foot infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085119
    UMLS CUI [2,1]
    C0016504
    UMLS CUI [2,2]
    C3714514
    UMLS CUI [3]
    C0003232
    4. Renal Dialysis
    Descrição

    Renal Dialysis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011946
    5. Diabetic Nephropathy
    Descrição

    diabetic nephropathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011881
    6. Other Nephropathy
    Descrição

    Other Nephropathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    7. Laser therapy for retinopathy
    Descrição

    Laser therapy for retinopathy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0035309
    UMLS CUI [1,2]
    C1955835
    8. Cataract extraction
    Descrição

    Cataract extraction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0086543
    UMLS CUI [1,2]
    C0185115
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    Similar models

    Visit 6 Phone Check Vital Signs Neurological Status Events Disease Status PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Month 15 Phone Check Of Patient
    C0039457 (UMLS CUI-1)
    C1283174 (UMLS CUI-2)
    Telephone check
    Item
    1. Was telephone check done?
    boolean
    C0039457 (UMLS CUI [1,1])
    C1283174 (UMLS CUI [1,2])
    if Yes
    Item
    2. If Yes, date of phone call (dd-mon-yy)
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Visit
    C0545082 (UMLS CUI-1)
    Visit done
    Item
    3. Was visit 6 done?
    boolean
    C0545082 (UMLS CUI [1])
    Item
    4. If No, indicate reason:
    integer
    C0681841 (UMLS CUI [1])
    If No,reason
    Code List
    4. If No, indicate reason:
    CL Item
    Died (complete respective outcome event form and End of Trial visit) (1)
    CL Item
    Patients refuses further participation (2)
    CL Item
    Unable to contact patient or other source (3)
    If Yes date of visit 3
    Item
    5. If Yes date of visit 6 (dd-mon-yy)
    date
    C1320303 (UMLS CUI [1])
    Item
    6. Type of visit
    integer
    C3641100 (UMLS CUI [1])
    Type of visit
    Code List
    6. Type of visit
    CL Item
    Clinic (in-person) (1)
    CL Item
    Telephone (2)
    CL Item
    Information obtained from source other than patient (3)
    Item
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    integer
    C0449416 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    If not patient, indicate source
    Code List
    7. If not patient, indicate source (try to re-establish direct contact with patient)
    CL Item
    Physician (1)
    CL Item
    Relative or friend (2)
    CL Item
    Other (3)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic blood pressure
    Item
    8. Systolic blood pressure after 5 minutes sitting/supine
    float
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    8. Diastolic Blood Pressure after 5 minutes sitting/supine
    float
    C0428883 (UMLS CUI [1])
    Item
    9. Blood Pressure Position
    integer
    C1828063 (UMLS CUI [1])
    Blood Pressure Position
    Code List
    9. Blood Pressure Position
    CL Item
    Sitting (1 )
    CL Item
    Supine (2 )
    Item Group
    Neurological Status
    C0746866 (UMLS CUI-1)
    Item
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    integer
    C0038454 (UMLS CUI [1,1])
    C2047944 (UMLS CUI [1,2])
    Clinical Neurological Status is different
    Code List
    10. Please check careful whether the present clinical neurological status is different from baseline to determine if the patient may have experienced a stroke since the last visit
    CL Item
    Unchanged (1)
    CL Item
    Improved (2)
    CL Item
    Worsened (3)
    Item Group
    Events
    C0877248 (UMLS CUI-1)
    Outcome Events or Serious Adverse Events
    Item
    11. Have any Outcome Events or Serious Adverse Events been experienced, or has patient been hospitalised? (See instructions on facing page)
    boolean
    C1705586 (UMLS CUI [1])
    C0877248 (UMLS CUI [2])
    Item
    12. If "YES" please indicate all that apply:
    integer
    C1521902 (UMLS CUI [1])
    If Yes
    Code List
    12. If "YES" please indicate all that apply:
    CL Item
    Stroke (1)
    CL Item
    Myocardial Infarction (2)
    CL Item
    Death (3)
    CL Item
    New or worsening congestive heart failure (CHF) (4)
    CL Item
    Other designated vascular event (5)
    CL Item
    Hemorrhagic Event (6)
    CL Item
    Thrombotic Thrombocytopenic purpura (7)
    CL Item
    Neutropenia (8)
    CL Item
    Other Hospitalization (9)
    CL Item
    Newly diagnosed diabetes (10)
    Item Group
    New Or Worsening Disease States
    C0012634 (UMLS CUI-1)
    C1442792 (UMLS CUI-2)
    PAOD
    Item
    1. New peripheral arterial occlusive disease (PAOD)
    boolean
    C1306889 (UMLS CUI [1,1])
    C0205314 (UMLS CUI [1,2])
    PAOD Worsening
    Item
    2. Worsening peripheral arterial occlusive disease (PAOD)
    boolean
    C1306889 (UMLS CUI [1,1])
    C0332271 (UMLS CUI [1,2])
    Foot ulcers/foot infection
    Item
    3. Foot ulcers/foot infection requiring antibiotics
    boolean
    C0085119 (UMLS CUI [1])
    C0016504 (UMLS CUI [2,1])
    C3714514 (UMLS CUI [2,2])
    C0003232 (UMLS CUI [3])
    Renal Dialysis
    Item
    4. Renal Dialysis
    boolean
    C0011946 (UMLS CUI [1])
    diabetic nephropathy
    Item
    5. Diabetic Nephropathy
    boolean
    C0011881 (UMLS CUI [1])
    Other Nephropathy
    Item
    6. Other Nephropathy
    boolean
    C0022658 (UMLS CUI [1])
    Laser therapy for retinopathy
    Item
    7. Laser therapy for retinopathy
    boolean
    C0035309 (UMLS CUI [1,1])
    C1955835 (UMLS CUI [1,2])
    Cataract extraction
    Item
    8. Cataract extraction
    boolean
    C0086543 (UMLS CUI [1,1])
    C0185115 (UMLS CUI [1,2])
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