Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age >18 Years
Item
Alter älter als 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients must be treated within 24 hours of their initial stroke symptoms onset.
Item
Patients must be treated within 24 hours of their initial stroke symptoms onset.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
Item
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
boolean
C1513040 (UMLS CUI 2011AA)
C0205234 (UMLS CUI 2011AA)
87017008 (SNOMED CT 2011_0131)
C0521654 (UMLS CUI 2011AA)
264552009 (SNOMED CT 2011_0131)
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
Item
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
boolean
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
Item
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0948008 (UMLS CUI 2011AA)
422504002 (SNOMED CT 2011_0131)
10055221 (MedDRA 14.1)
C1269012 (UMLS CUI 2011AA)
181312002 (SNOMED CT 2011_0131)
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
Item
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
boolean
CL425202 (UMLS CUI 2011AA)
C1697238 (UMLS CUI 2011AA)
10065527 (MedDRA 14.1)
C1697239 (UMLS CUI 2011AA)
10065528 (MedDRA 14.1)
C0260026 (UMLS CUI 2011AA)
C1140618 (UMLS CUI 2011AA)
53120007 (SNOMED CT 2011_0131)
MTHU011974 (LOINC Version 232)
C0023216 (UMLS CUI 2011AA)
61685007 (SNOMED CT 2011_0131)
MTHU011970 (LOINC Version 232)
Immediately (i.e. minutes) pre-stroke, MRS < 2
Item
Immediately (i.e. minutes) pre-stroke, MRS < 2
boolean
C0205253 (UMLS CUI 2011AA)
88694003 (SNOMED CT 2011_0131)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
CL423500 (UMLS CUI 2011AA)
Women of childbearing potential must have a negative pregnancy test prior to enrolment
Item
Women of childbearing potential must have a negative pregnancy test prior to enrolment
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Signed informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
Item
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
boolean
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
C1697239 (UMLS CUI 2011AA)
10065528 (MedDRA 14.1)
CL414978 (UMLS CUI 2011AA)
C0234425 (UMLS CUI 2011AA)
6942003 (SNOMED CT 2011_0131)
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
Item
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
boolean
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0006118 (UMLS CUI 2011AA)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0006114 (UMLS CUI 2011AA)
2032001 (SNOMED CT 2011_0131)
10008107 (MedDRA 14.1)
G93.6 (ICD-10-CM Version 2010)
348.5 (ICD-9-CM Version 2011)
E12650 (CTCAE 1105E)
C0576481 (UMLS CUI 2011AA)
299728009 (SNOMED CT 2011_0131)
10069551 (MedDRA 14.1)
C0577559 (UMLS CUI 2011AA)
4147007 (SNOMED CT 2011_0131)
10026865 (MedDRA 14.1)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0332459 (UMLS CUI 2011AA)
71173004 (SNOMED CT 2011_0131)
C0007799 (UMLS CUI 2011AA)
35764002 (SNOMED CT 2011_0131)
MTHU024384 (LOINC Version 232)
C0521542 (UMLS CUI 2011AA)
95457000 (SNOMED CT 2011_0131)
10006147 (MedDRA 14.1)
C0236073 (UMLS CUI 2011AA)
95460007 (SNOMED CT 2011_0131)
10008034 (MedDRA 14.1)
C0038525 (UMLS CUI 2011AA)
21454007 (SNOMED CT 2011_0131)
10042316 (MedDRA 14.1)
430 (ICD-9-CM Version 2011)
C2937358 (UMLS CUI 2011AA)
274100004 (SNOMED CT 2011_0131)
10008111 (MedDRA 14.1)
431 (ICD-9-CM Version 2011)
C0240059 (UMLS CUI 2011AA)
23276006 (SNOMED CT 2011_0131)
10022840 (MedDRA 14.1)
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
Item
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0205434 (UMLS CUI 2011AA)
5650002 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0443318 (UMLS CUI 2011AA)
263892007 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Previous disorders that may confound the interpretation of the neurological scales
Item
Previous disorders that may confound the interpretation of the neurological scales
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0205494 (UMLS CUI 2011AA)
1199008 (SNOMED CT 2011_0131)
MTHU031871 (LOINC Version 232)
C0349674 (UMLS CUI 2011AA)
278111002 (SNOMED CT 2011_0131)
Drug addiction-related disorders
Item
Drug addiction-related disorders
boolean
C1510472 (UMLS CUI 2011AA)
191816009 (SNOMED CT 2011_0131)
10013663 (MedDRA 14.1)
304 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
Item
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
boolean
C2347662 (UMLS CUI 2011AA)
C0497327 (UMLS CUI 2011AA)
52448006 (SNOMED CT 2011_0131)
10012267 (MedDRA 14.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
C0231170 (UMLS CUI 2011AA)
21134002 (SNOMED CT 2011_0131)
10013050 (MedDRA 14.1)
DIS (HL7 V3 2006_05)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL423500 (UMLS CUI 2011AA)
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
Item
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
Item
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
boolean
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Patients under current treatment with citicoline
Item
Patients under current treatment with citicoline
boolean
C2827774 (UMLS CUI 2011AA)
C0010725 (UMLS CUI 2011AA)
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