ID

21015

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. 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 (2)
  1. 22.02.17 22.02.17 -
  2. 03.04.17 03.04.17 -
Hochgeladen am

3. April 2017

DOI

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Creative Commons BY 4.0
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Hospitalization Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Englisch

Hospitalization Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare  
Hospitalization Report Form
Beschreibung

Hospitalization Report Form

1. Date of admission (dd mon yy)
Beschreibung

Date of admission

Datentyp

date

Alias
UMLS CUI [1]
C1302393
2. Date of discharge (dd mon yy)
Beschreibung

Date of Discharge

Datentyp

date

Alias
UMLS CUI [1]
C2361123
3. Did the patient spend any days at the Intensive Care Unit (ICU) during the hospitalization?
Beschreibung

intensive care unit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021708
UMLS CUI [1,2]
C0030673
If yes, number of days.
Beschreibung

Number of days

Datentyp

float

Alias
UMLS CUI [1,1]
C0809949
UMLS CUI [1,2]
C0021708
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
4. Was the reason for admission an outcome event?
Beschreibung

Reason for admission

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0809949
If yes, please indicate which outcome event and complete the respective outcome event form. NOTE: there is no outcome event form for TTP or neutropenia
Beschreibung

Outcome Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0441471
If NO, please indicate reason for admission and complete the Serious Adverse event form.
Beschreibung

Reason for admission

Datentyp

integer

Alias
UMLS CUI [1]
C0681841
Specify "Other"
Beschreibung

Specification

Datentyp

text

Alias
UMLS CUI [1]
C2348235
5. Did the patients experience outcome events during hospitalization? If yes, please complete respective Outcome Event Forms.
Beschreibung

Outcome events during hospitalization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0019993
6. Were any of the following procedures performed?
Beschreibung

Performed Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
If yes, please indicate which:
Beschreibung

Indication

Datentyp

integer

Alias
UMLS CUI [1]
C3146298
Specify "Other"
Beschreibung

Specification

Datentyp

text

Alias
UMLS CUI [1]
C2348235
7. What was the patients discharge destination?
Beschreibung

Discharge of Destination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0079220
UMLS CUI [1,2]
C0586514
Specify "Other destination"
Beschreibung

Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0079220
UMLS CUI [1,2]
C2348235
Invenstigator´s Declaration
Beschreibung

Invenstigator´s Declaration

8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
Beschreibung

Invenstigator´s Declaration

Datentyp

text

Investigator´s signature
Beschreibung

Investigator´s signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316
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Ähnliche Modelle

Hospitalization Report Form PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Hospitalization Report Form
Date of admission
Item
1. Date of admission (dd mon yy)
date
C1302393 (UMLS CUI [1])
Date of Discharge
Item
2. Date of discharge (dd mon yy)
date
C2361123 (UMLS CUI [1])
intensive care unit
Item
3. Did the patient spend any days at the Intensive Care Unit (ICU) during the hospitalization?
boolean
C0021708 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])
Number of days
Item
If yes, number of days.
float
C0809949 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Reason for admission
Item
4. Was the reason for admission an outcome event?
boolean
C0392360 (UMLS CUI [1,1])
C0809949 (UMLS CUI [1,2])
Item
If yes, please indicate which outcome event and complete the respective outcome event form. NOTE: there is no outcome event form for TTP or neutropenia
integer
C1547647 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
Outcome Event
Code List
If yes, please indicate which outcome event and complete the respective outcome event form. NOTE: there is no outcome event form for TTP or neutropenia
CL Item
Stroke (1)
CL Item
Myocardial infarction (2)
CL Item
Congestive Heart Failure (3)
CL Item
ODVE (4)
CL Item
Hemorrhagic event (5)
CL Item
TTP (6)
CL Item
Neutropenia (7)
CL Item
Severe Neutropenia (8)
CL Item
Diabetes (9)
Item
If NO, please indicate reason for admission and complete the Serious Adverse event form.
integer
C0681841 (UMLS CUI [1])
Reason for admission
Code List
If NO, please indicate reason for admission and complete the Serious Adverse event form.
CL Item
Cancer (1)
CL Item
Fracture (2)
CL Item
Unstable Angina (3)
CL Item
Genito-urinary (4)
CL Item
Pulmonary (5)
CL Item
Injury (6)
CL Item
Psychiatric (7)
CL Item
Gastrointestinal (8)
CL Item
Other (9)
Specification
Item
Specify "Other"
text
C2348235 (UMLS CUI [1])
Outcome events during hospitalization
Item
5. Did the patients experience outcome events during hospitalization? If yes, please complete respective Outcome Event Forms.
boolean
C1705586 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Performed Procedures
Item
6. Were any of the following procedures performed?
boolean
C0087111 (UMLS CUI [1])
Item
If yes, please indicate which:
integer
C3146298 (UMLS CUI [1])
Indication
Code List
If yes, please indicate which:
CL Item
Coronary angiography (1)
CL Item
PTCA (2)
CL Item
Temporary Pacemaker (3)
CL Item
Carotid stenting (4)
CL Item
CABG (5)
CL Item
Carotid endarterectomy (6)
CL Item
Permanent Pacemaker insertion (7)
CL Item
Other procedures (8)
Specification
Item
Specify "Other"
text
C2348235 (UMLS CUI [1])
Item
7. What was the patients discharge destination?
integer
C0079220 (UMLS CUI [1,1])
C0586514 (UMLS CUI [1,2])
Discharge of Destination
Code List
7. What was the patients discharge destination?
CL Item
Home (1)
CL Item
Assisted living (2)
CL Item
Not applicable (3)
CL Item
Rehabilitation Centre (4)
CL Item
Nursing Home (5)
CL Item
Other destination (6)
Specification
Item
Specify "Other destination"
text
C0079220 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Invenstigator´s Declaration
Invenstigator´s Declaration
Item
8. Invenstigator´s Declaration By signing and dating this page, I declare that I have reviewed for accuracy all case report form pages for this patient; the information contained on these pages accurately reflects the medical record including the results of tests and evaluations performed in the dates specified.
text
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
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