ID

4864

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00190047

Link

http://clinicaltrials.gov/show/NCT00190047

Stichworte

Versionen (2)
  1. 13.12.11 13.12.11 -
  2. 13.04.14 13.04.14 - Julian Varghese
Hochgeladen am

13. April 2014

DOI

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Eligibility NCT00190047 Stroke

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

18 Years to 85 Years
Beschreibung

Age

Datentyp

boolean

Patients with ischemic stroke, (that is, stroke that results from a blockage of blood flow to part of the brain), which is accompanied by language dysfunction (e.g. inability to understand speech), visual field defect or inattention to one side of the body or the space around the patient
Beschreibung

ischemic stroke with language dysfunction, visual field defect or inattention to one side of the body

Datentyp

boolean

Patients in whom the study treatment can start no less than 1 and not more than 9 hours after the stroke's onset
Beschreibung

start of study treatment between 1 and 9 hours after stroke onset

Datentyp

boolean

Patients with moderate-severe degree of neurological deficit in the 9 hours after stroke onset (defined as NIHSS score of 7 to 20)
Beschreibung

moderate-severe neurological deficit

Datentyp

boolean

Patients that can understand the requirements of the study and are willing to provide written informed consent (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative.)
Beschreibung

informed consent

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Patients with a brain (intracerebral or subarachnoid) hemorrhage per screening computed tomography scan
Beschreibung

brain hemorrhage

Datentyp

boolean

candidates for thrombolytic therapy for the current stroke
Beschreibung

candidates for thrombolytic therapy

Datentyp

boolean

patients having a mental impairment that renders them incapable to understand the study's requirements
Beschreibung

patients with mental impairment

Datentyp

boolean

patients with other diseases that in the investigator's opinion may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may confuse the evaluation of the present stroke
Beschreibung

other diseases

Datentyp

boolean

Patients likely to undergo a procedure involving cardiopulmonary bypass during the study period
Beschreibung

cardiopulmonary bypass

Datentyp

boolean

Patients with medical conditions that may not enable them to complete the study (e.g life-threatening diseases,)
Beschreibung

other medical conditions

Datentyp

boolean

Patients whose condition improves already during the screening period
Beschreibung

Patients whose condition improves already during the screening period

Datentyp

boolean

Patients who already have functional limitations before the present study (retrospective Modified Rankin Scale score of >3)
Beschreibung

Rankin Scale Score >3

Datentyp

boolean

Patients who suffered a stroke within the past 90 days that seems to have been in the same brain region as the current acute stroke
Beschreibung

stroke within the past 90 days in the same brain region

Datentyp

boolean

Patients with severe hypertension (systolic BP >210 mm Hg or diastolic BP >120 mm Hg) or hypotension (systolic BP <90 mm Hg),
Beschreibung

severe hypertension or hypotension

Datentyp

boolean

Patients with significant history of renal or liver disease(s) (serum creatinine of > 2.0 mg/dL, alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values of > threefold the upper normal limit)
Beschreibung

renal or liver disease

Datentyp

boolean

Patients with a platelet count of <100,000/mm3
Beschreibung

platelet count of <100,000/mm3

Datentyp

boolean

Female patients of childbearing potential who are not using adequate and effective birth control measures or who are pregnant or lactating (the screening evaluation of female subjects of childbearing potential will include a serum pregnancy test.)
Beschreibung

pregnancy, lactation, no contraception

Datentyp

boolean

Patients who are users of addictive agents, or alcoholics
Beschreibung

Patients who are users of addictive agents, or alcoholics

Datentyp

boolean

Patients who have received an investigational drug within the 90 days before the present stroke or such that are past recipients of DP-b99
Beschreibung

Other trials

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Ischemic stroke
Beschreibung

Ischemic stroke

Datentyp

string

Alias
UMLS CUI
C0948008
SNOMED CT 2010_0731
422504002
MedDRA 13.1
10055221
Disorder of language
Beschreibung

Language Disorders

Datentyp

string

Alias
UMLS CUI
C0023015
SNOMED CT 2010_0731
62305002
ICD-10-CM Version 2010
F80.9
Visual field defect
Beschreibung

Scotoma

Datentyp

string

Alias
UMLS CUI
C0036454
SNOMED CT 2010_0731
12184005, 23388006
MedDRA 13.1
10047555, 10039729
ICD-10-CM Version 2010
H53.4
ICD-9-CM Version 2011
368.4
Hemi-inattention
Beschreibung

Neglect of one side of body

Datentyp

string

Alias
UMLS CUI
C0422887
SNOMED CT 2010_0731
246564008
ICD-10-CM Version 2010
R41.4
Onset
Beschreibung

Onset

Datentyp

string

Alias
UMLS CUI
C0332162
SNOMED CT 2010_0731
77374008
NIH-SS
Beschreibung

NIH stroke scale

Datentyp

string

Alias
UMLS CUI
C1697238
MedDRA 13.1
10065527
Neurologic deficit
Beschreibung

Deficits, Neurologic

Datentyp

string

Alias
UMLS CUI
C0521654
SNOMED CT 2010_0731
264552009
Informed Consent
Beschreibung

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Compliance
Beschreibung

Compliance

Datentyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Brain hemorrhage
Beschreibung

Haemorrhagic stroke

Datentyp

string

Alias
UMLS CUI
C0553692
SNOMED CT 2010_0731
230706003
MedDRA 13.1
10019016
Therapeutic procedure
Beschreibung

Therapeutic procedure

Datentyp

string

Alias
UMLS CUI
C0087111
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Mental impairment disorders
Beschreibung

Mental impairment disorders

Datentyp

string

Alias
UMLS CUI
C1112722
MedDRA 13.1
10057167
Cardiopulmonary bypass operation
Beschreibung

Cardiopulmonary Bypass

Datentyp

string

Alias
UMLS CUI
C0007202
SNOMED CT 2010_0731
63697000
MedDRA 13.1
10066123
Life expectancy
Beschreibung

Life expectancy

Datentyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
Rankin score
Beschreibung

Rankin score

Datentyp

string

Alias
UMLS CUI
CL423500
Hypertensive disease
Beschreibung

Hypertension

Datentyp

string

Alias
UMLS CUI
C0020538
SNOMED CT 2010_0731
38341003
MedDRA 13.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE Version 4.03
E13785
Hypotension
Beschreibung

Low blood pressure

Datentyp

string

Alias
UMLS CUI
C0020649
SNOMED CT 2010_0731
45007003
MedDRA 13.1
10003146
ICD-10-CM Version 2010
I95
ICD-9-CM Version 2011
458
Creatinine
Beschreibung

Creatinine

Datentyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
GPT (Serum)
Beschreibung

ALT

Datentyp

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
MedDRA 13.1
10001844
GOT (Serum)
Beschreibung

AST

Datentyp

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
MedDRA 13.1
10003543
Gamma Glutamyl Transpeptidase Measurement
Beschreibung

GGT

Datentyp

string

Alias
UMLS CUI
C0202035
SNOMED CT 2010_0731
69480007
MedDRA 13.1
10017687
LOINC Version 232
2324-2
Platelet count - finding
Beschreibung

Platelet count

Datentyp

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Alcohol abuse
Beschreibung

Alcohol abuse

Datentyp

string

Alias
UMLS CUI
C0085762
SNOMED CT 2010_0731
15167005
MedDRA 13.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Drug abuse
Beschreibung

Drug abuse

Datentyp

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C2348568
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 85 Years
boolean
ischemic stroke with language dysfunction, visual field defect or inattention to one side of the body
Item
Patients with ischemic stroke, (that is, stroke that results from a blockage of blood flow to part of the brain), which is accompanied by language dysfunction (e.g. inability to understand speech), visual field defect or inattention to one side of the body or the space around the patient
boolean
start of study treatment between 1 and 9 hours after stroke onset
Item
Patients in whom the study treatment can start no less than 1 and not more than 9 hours after the stroke's onset
boolean
moderate-severe neurological deficit
Item
Patients with moderate-severe degree of neurological deficit in the 9 hours after stroke onset (defined as NIHSS score of 7 to 20)
boolean
informed consent
Item
Patients that can understand the requirements of the study and are willing to provide written informed consent (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative.)
boolean
Item Group
Exclusion Criteria
brain hemorrhage
Item
Patients with a brain (intracerebral or subarachnoid) hemorrhage per screening computed tomography scan
boolean
candidates for thrombolytic therapy
Item
candidates for thrombolytic therapy for the current stroke
boolean
patients with mental impairment
Item
patients having a mental impairment that renders them incapable to understand the study's requirements
boolean
other diseases
Item
patients with other diseases that in the investigator's opinion may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may confuse the evaluation of the present stroke
boolean
cardiopulmonary bypass
Item
Patients likely to undergo a procedure involving cardiopulmonary bypass during the study period
boolean
other medical conditions
Item
Patients with medical conditions that may not enable them to complete the study (e.g life-threatening diseases,)
boolean
Patients whose condition improves already during the screening period
Item
Patients whose condition improves already during the screening period
boolean
Rankin Scale Score >3
Item
Patients who already have functional limitations before the present study (retrospective Modified Rankin Scale score of >3)
boolean
stroke within the past 90 days in the same brain region
Item
Patients who suffered a stroke within the past 90 days that seems to have been in the same brain region as the current acute stroke
boolean
severe hypertension or hypotension
Item
Patients with severe hypertension (systolic BP >210 mm Hg or diastolic BP >120 mm Hg) or hypotension (systolic BP <90 mm Hg),
boolean
renal or liver disease
Item
Patients with significant history of renal or liver disease(s) (serum creatinine of > 2.0 mg/dL, alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values of > threefold the upper normal limit)
boolean
platelet count of <100,000/mm3
Item
Patients with a platelet count of <100,000/mm3
boolean
pregnancy, lactation, no contraception
Item
Female patients of childbearing potential who are not using adequate and effective birth control measures or who are pregnant or lactating (the screening evaluation of female subjects of childbearing potential will include a serum pregnancy test.)
boolean
Patients who are users of addictive agents, or alcoholics
Item
Patients who are users of addictive agents, or alcoholics
boolean
Other trials
Item
Patients who have received an investigational drug within the 90 days before the present stroke or such that are past recipients of DP-b99
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Ischemic stroke
Item
Ischemic stroke
string
C0948008 (UMLS CUI)
422504002 (SNOMED CT 2010_0731)
10055221 (MedDRA 13.1)
Language Disorders
Item
Disorder of language
string
C0023015 (UMLS CUI)
62305002 (SNOMED CT 2010_0731)
F80.9 (ICD-10-CM Version 2010)
Scotoma
Item
Visual field defect
string
C0036454 (UMLS CUI)
12184005, 23388006 (SNOMED CT 2010_0731)
10047555, 10039729 (MedDRA 13.1)
H53.4 (ICD-10-CM Version 2010)
368.4 (ICD-9-CM Version 2011)
Neglect of one side of body
Item
Hemi-inattention
string
C0422887 (UMLS CUI)
246564008 (SNOMED CT 2010_0731)
R41.4 (ICD-10-CM Version 2010)
Onset
Item
Onset
string
C0332162 (UMLS CUI)
77374008 (SNOMED CT 2010_0731)
NIH stroke scale
Item
NIH-SS
string
C1697238 (UMLS CUI)
10065527 (MedDRA 13.1)
Deficits, Neurologic
Item
Neurologic deficit
string
C0521654 (UMLS CUI)
264552009 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Haemorrhagic stroke
Item
Brain hemorrhage
string
C0553692 (UMLS CUI)
230706003 (SNOMED CT 2010_0731)
10019016 (MedDRA 13.1)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Mental impairment disorders
Item
Mental impairment disorders
string
C1112722 (UMLS CUI)
10057167 (MedDRA 13.1)
Cardiopulmonary Bypass
Item
Cardiopulmonary bypass operation
string
C0007202 (UMLS CUI)
63697000 (SNOMED CT 2010_0731)
10066123 (MedDRA 13.1)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Rankin score
Item
Rankin score
string
CL423500 (UMLS CUI)
Hypertension
Item
Hypertensive disease
string
C0020538 (UMLS CUI)
38341003 (SNOMED CT 2010_0731)
10020772 (MedDRA 13.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE Version 4.03)
Low blood pressure
Item
Hypotension
string
C0020649 (UMLS CUI)
45007003 (SNOMED CT 2010_0731)
10003146 (MedDRA 13.1)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
AST
Item
GOT (Serum)
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
GGT
Item
Gamma Glutamyl Transpeptidase Measurement
string
C0202035 (UMLS CUI)
69480007 (SNOMED CT 2010_0731)
10017687 (MedDRA 13.1)
2324-2 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
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