ID

20364

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.02.17 21.02.17 -
Hochgeladen am

21. Februar 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Month 15 Phone Check Of Patient
Beschreibung

Month 15 Phone Check Of Patient

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

Telephone check

Datentyp

boolean

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

if Yes

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Visit
Beschreibung

Visit

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

Visit done

Datentyp

boolean

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

If No,reason

Datentyp

integer

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

If Yes date of visit 3

Datentyp

date

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

Type of visit

Datentyp

integer

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

If not patient, indicate source

Datentyp

integer

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

Vital Signs

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

Systolic blood pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
8. Diastolic Blood Pressure after 5 minutes sitting/supine
Beschreibung

Diastolic Blood Pressure

Datentyp

float

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
9. Blood Pressure Position
Beschreibung

Blood Pressure Position

Datentyp

integer

Alias
UMLS CUI [1]
C1828063
Neurological Status
Beschreibung

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
Beschreibung

Clinical Neurological Status is different

Datentyp

integer

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

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)
Beschreibung

Outcome Events or Serious Adverse Events

Datentyp

boolean

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

If Yes

Datentyp

integer

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

New Or Worsening Disease States

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

PAOD

Datentyp

boolean

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

PAOD Worsening

Datentyp

boolean

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

Foot ulcers/foot infection

Datentyp

boolean

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

Renal Dialysis

Datentyp

boolean

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

diabetic nephropathy

Datentyp

boolean

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

Other Nephropathy

Datentyp

boolean

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

Laser therapy for retinopathy

Datentyp

boolean

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

Cataract extraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0185115
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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