ID

13741

Beschreibung

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Stichworte

Versionen (1)
  1. 02.03.16 02.03.16 -
Hochgeladen am

2. März 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

Englisch

CABACS Case Report Form [neurological examination:day 30]

1 Formulare  
Modified Rankin Scale,structured interview
Beschreibung

Modified Rankin Scale,structured interview

Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Do you (your family member) need constant nursing care?
Beschreibung

Constant nursing care

Datentyp

integer

Alias
UMLS CUI [1]
C0204650
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
Beschreibung

Assistance ADL needed

Datentyp

integer

Alias
UMLS CUI [1]
C2599638
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
Beschreibung

Home maintenance assistance

Datentyp

text

Alias
UMLS CUI [1]
C0150250
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
Beschreibung

Change in social life

Datentyp

text

Alias
UMLS CUI [1,1]
C0815198
UMLS CUI [1,2]
C0392747
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
Beschreibung

Neurologic Symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0497297
No disability at all
Beschreibung

Disability

Datentyp

boolean

Alias
UMLS CUI [1]
C0231170
DemTect B
Beschreibung

DemTect B

Date of visit
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient age
Beschreibung

Age

Datentyp

integer

Alias
UMLS CUI [1]
C0001779
Did you perform the DemTect test with the patient?
Beschreibung

Psychometric testing for dementia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Count of correctly repeated words of wordlist:grass,butter,stone,child,shack,whistle,plank,horse,earth,nail
Beschreibung

See instruction for DemTect testing and converting table in your investigator file Please read the list to the patient, let him/her repeat and count correctly repeated words. Then read it to the patient a second time and let him/her repeat again. Add the count of correctly repeated to the first count

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Converting numbers: Count of correctly converted numbers 308= ;6032= ; fourhundredtwentythree= ; eightthousandfiftyseven=
Beschreibung

I.e 4=four or two=2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please count the number of animals your patient can think of within one minute
Beschreibung

Psychometric testing for dementia

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
Beschreibung

First attempt:5-3 ; 2-7-9; 4-1-9-8; 3-6-4-2-8; 3-1-7-9-4-2 Second attempt: 7-4; 5-4-8; 8-9-6-1; 5-7-8-2-9; 6-1-4-8-5-2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
Beschreibung

Psychometric testing for dementia

Datentyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
Beschreibung

Psychometric testing for dementia

Datentyp

text

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Date of completion of this form
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beschreibung

Signature

Datentyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beschreibung

Name of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C0008961
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Ähnliche Modelle

CABACS Case Report Form [neurological examination:day 30]

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Modified Rankin Scale,structured interview
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Do you (your family member) need constant nursing care?
integer
C0204650 (UMLS CUI [1])
Constant nursing care
Code List
Do you (your family member) need constant nursing care?
CL Item
yes (severe disability,bedridden,incontinence,constant nursing care in almost every aspect of daily life)  (1)
CL Item
No (2)
Item
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
integer
C2599638 (UMLS CUI [1])
Assistance ADL needed
Code List
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
CL Item
Yes (moderately severe disability, walking without help impossible,assistance with ADL´s needed)  (1)
CL Item
No (2)
Item
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
text
C0150250 (UMLS CUI [1])
Home maintenance assistance
Code List
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
CL Item
Yes (Moderate disability, assistance needed but can walk with or without walking aid)  (1)
CL Item
No (2)
Item
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
text
C0815198 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Change in social life
Code List
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
CL Item
Yes (mild disability, not all former activities can be performed but independend life without help is still possible)  (1)
CL Item
No (2)
Item
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
text
C0235031 (UMLS CUI [1,1])
C0497297 (UMLS CUI [1,2])
Neurologic Symptoms
Code List
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
CL Item
Yes (no significant disability, despite symptoms all daily activities can be performed independently)  (1)
CL Item
No (2)
Disability
Item
No disability at all
boolean
C0231170 (UMLS CUI [1])
Item Group
DemTect B
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
Psychometric testing for dementia
Item
Did you perform the DemTect test with the patient?
boolean
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Count of correctly repeated words of wordlist:grass,butter,stone,child,shack,whistle,plank,horse,earth,nail
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Converting numbers: Count of correctly converted numbers 308= ;6032= ; fourhundredtwentythree= ; eightthousandfiftyseven=
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please count the number of animals your patient can think of within one minute
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
text
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
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