ID

20226

Description

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.

Keywords

Versions (2)
  1. 2/15/17 2/15/17 -
  2. 2/20/17 2/20/17 -
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February 15, 2017

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Creative Commons BY-NC 3.0
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Screening Baseline Visit 1 Month 0 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

English

Screening Baseline Visit 1 Month 0 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms  
Patient Characteristics Prior to Qualifying Stroke
Description

Patient Characteristics Prior to Qualifying Stroke

Alias
UMLS CUI-1
C2707520
UMLS CUI-2
C0332152
UMLS CUI-3
C0038454
1. Did patient snore before the qualifying stroke?
Description

Snoring

Data type

boolean

Alias
UMLS CUI [1,1]
C2219850
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0038454
If yes, does it disturb family members?
Description

if yes

Data type

boolean

Alias
UMLS CUI [1,1]
C2219850
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0086282
2. Was the patient fatigued during the day?
Description

Was the patient fatigued

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0585022
UMLS CUI [1,3]
C2707520
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0038454
3. Did the patient fall asleep during conversation or while driving?
Description

Falling asleep

Data type

boolean

Alias
UMLS CUI [1,1]
C2037218
UMLS CUI [1,2]
C0871703
UMLS CUI [2,1]
C2037218
UMLS CUI [2,2]
C0004379
4. Had the patient ever been diagnosed or treated for obstructive sleep apnea?
Description

Obstructive sleep apnea

Data type

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C2707520
UMLS CUI [1,3]
C0332152
5. What was the patient´s usual bedtime (24 hour clocktime hh:mm)?
Description

Bedtime

Data type

time

Alias
UMLS CUI [1,1]
C0521112
UMLS CUI [1,2]
C2707520
6. What time did the patient usually wake up in the morning (24 hour clocktime hh:mm)?
Description

Wake up time

Data type

time

Alias
UMLS CUI [1,1]
C3175926
UMLS CUI [1,2]
C2707520
7. Did the patient feel well rested upon waking in the morning?
Description

Feel well rested

Data type

boolean

8. Did the patient nap during the day?
Description

Taking a nap

Data type

integer

Alias
UMLS CUI [1,1]
C0870935
UMLS CUI [1,2]
C0585022
UMLS CUI [1,3]
C2707520
If daily what is the patient´s usual nap time (hh:mm)?
Description

If daily what is the patient´s usual nap time (hh:mm)?

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0870935
UMLS CUI [1,3]
C0585022
UMLS CUI [1,4]
C2707520
9. Had the patient ever had a time when they felt sad, low in spirits or depressed for 2 weeks or more in a row?
Description

Feeling sad, low in spirits or depressed

Data type

boolean

Alias
UMLS CUI [1,1]
C3845528
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C2707520
10. If yes, please answer the following questions:
Description

10. If yes, please answer the following questions:

Did the patient lose interest in most things like hobbies, work or activities that usually gave him/her pleasure?
Description

Lost interest in most things

Data type

boolean

Alias
UMLS CUI [1,1]
C0424091
UMLS CUI [1,2]
C0014406
UMLS CUI [1,3]
C2707520
Did the patient feel tired or low on energy?
Description

Feel tired or low on energy

Data type

boolean

Alias
UMLS CUI [1,1]
C3539029
UMLS CUI [1,2]
C2707520
Did the patient gain or lose weight?
Description

Weight gain or loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1517378
UMLS CUI [1,3]
C2707520
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C1517945
UMLS CUI [2,3]
C2707520
Did the patient have more trouble falling asleep than usual?
Description

Trouble falling asleep

Data type

boolean

Did the patient have more trouble concentrating than usual?
Description

Having trouble concentrating

Data type

boolean

Alias
UMLS CUI [1]
C0424099
Did the patient think a lot about death ( either his/her own or someone else´s or death in general)?
Description

Thinking about death

Data type

boolean

When he/she felt sad did the patient feel down on him/herself, no good or worthless?
Description

Feel down on him/herself, no good or worthless

Data type

boolean

Did the patient require treatment for depression? (mark all that apply)
Description

Treatment for depression

Data type

integer

11. How many friends did the patients speak with on the phone in an ordinary week?
Description

Speak to friends on the phone

Data type

float

12. What was the patient´s average physical activity prior to the qualifying stroke?
Description

Average physical activity

Data type

integer

Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
13. Has urine sample (preferably first morning) been collected for central analysis?
Description

Urine sample

Data type

boolean

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Similar models

Screening Baseline Visit 1 Month 0 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Characteristics Prior to Qualifying Stroke
C2707520 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0038454 (UMLS CUI-3)
Snoring
Item
1. Did patient snore before the qualifying stroke?
boolean
C2219850 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
if yes
Item
If yes, does it disturb family members?
boolean
C2219850 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,3])
Was the patient fatigued
Item
2. Was the patient fatigued during the day?
boolean
C0015672 (UMLS CUI [1,1])
C0585022 (UMLS CUI [1,2])
C2707520 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0038454 (UMLS CUI [1,5])
Falling asleep
Item
3. Did the patient fall asleep during conversation or while driving?
boolean
C2037218 (UMLS CUI [1,1])
C0871703 (UMLS CUI [1,2])
C2037218 (UMLS CUI [2,1])
C0004379 (UMLS CUI [2,2])
Obstructive sleep apnea
Item
4. Had the patient ever been diagnosed or treated for obstructive sleep apnea?
boolean
C0037315 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Bedtime
Item
5. What was the patient´s usual bedtime (24 hour clocktime hh:mm)?
time
C0521112 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
Wake up time
Item
6. What time did the patient usually wake up in the morning (24 hour clocktime hh:mm)?
time
C3175926 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
Feel well rested
Item
7. Did the patient feel well rested upon waking in the morning?
boolean
Item
8. Did the patient nap during the day?
integer
C0870935 (UMLS CUI [1,1])
C0585022 (UMLS CUI [1,2])
C2707520 (UMLS CUI [1,3])
Taking a nap
Code List
8. Did the patient nap during the day?
CL Item
no (1)
CL Item
Occasionally (2)
CL Item
Once Daily (3)
CL Item
Several times/ day (4)
If daily what is the patient´s usual nap time (hh:mm)?
Item
If daily what is the patient´s usual nap time (hh:mm)?
time
C0040223 (UMLS CUI [1,1])
C0870935 (UMLS CUI [1,2])
C0585022 (UMLS CUI [1,3])
C2707520 (UMLS CUI [1,4])
Feeling sad, low in spirits or depressed
Item
9. Had the patient ever had a time when they felt sad, low in spirits or depressed for 2 weeks or more in a row?
boolean
C3845528 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2707520 (UMLS CUI [1,3])
Item Group
10. If yes, please answer the following questions:
Lost interest in most things
Item
Did the patient lose interest in most things like hobbies, work or activities that usually gave him/her pleasure?
boolean
C0424091 (UMLS CUI [1,1])
C0014406 (UMLS CUI [1,2])
C2707520 (UMLS CUI [1,3])
Feel tired or low on energy
Item
Did the patient feel tired or low on energy?
boolean
C3539029 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
Weight gain or loss
Item
Did the patient gain or lose weight?
boolean
C0005910 (UMLS CUI [1,1])
C1517378 (UMLS CUI [1,2])
C2707520 (UMLS CUI [1,3])
C0005910 (UMLS CUI [2,1])
C1517945 (UMLS CUI [2,2])
C2707520 (UMLS CUI [2,3])
Trouble falling asleep
Item
Did the patient have more trouble falling asleep than usual?
boolean
Having trouble concentrating
Item
Did the patient have more trouble concentrating than usual?
boolean
C0424099 (UMLS CUI [1])
Thinking about death
Item
Did the patient think a lot about death ( either his/her own or someone else´s or death in general)?
boolean
Feel down on him/herself, no good or worthless
Item
When he/she felt sad did the patient feel down on him/herself, no good or worthless?
boolean
Item
Did the patient require treatment for depression? (mark all that apply)
integer
Treatment for depression
Code List
Did the patient require treatment for depression? (mark all that apply)
CL Item
no (1)
CL Item
Medication (2)
CL Item
Admitted to hospital (3)
CL Item
Shock Treatment/ECT (4)
CL Item
Saw a doctor psychologist or counsellor (5)
Speak to friends on the phone
Item
11. How many friends did the patients speak with on the phone in an ordinary week?
float
Item
12. What was the patient´s average physical activity prior to the qualifying stroke?
integer
Average physical activity
Code List
12. What was the patient´s average physical activity prior to the qualifying stroke?
CL Item
Sedentary (Walking < 1mile per day) (1)
CL Item
Some physical activity (20-30 minutes, three times per week) (2)
CL Item
Intense physical activity (> 30minutes, > 3 times per week) (3)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Urine sample
Item
13. Has urine sample (preferably first morning) been collected for central analysis?
boolean
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