ID

125

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00175903

Link

http://clinicaltrials.gov/show/NCT00175903

Stichworte

Versionen (2)
  1. 06.12.11 06.12.11 -
  2. 13.04.14 13.04.14 - Julian Varghese
Hochgeladen am

6. Dezember 2011

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00175903 Epilepsy

Englisch

Eligibility

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

Inclusion Criteria

16 Years and older
Beschreibung

Age

Datentyp

boolean

Diagnosis of epilepsy (all types of seizures) was made during the past year
Beschreibung

Diagnosis of epilepsy

Datentyp

boolean

Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
Beschreibung

number of seizures

Datentyp

boolean

Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method.
Beschreibung

not pregnant, contraception

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
Beschreibung

previously trial treatment

Datentyp

boolean

Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
Beschreibung

other trial

Datentyp

boolean

Pregnant or lactating women
Beschreibung

Pregnant or lactating women

Datentyp

boolean

Presence of known pseudoseizures within the last year
Beschreibung

Pseudoseizures

Datentyp

boolean

Uncountable seizures (clusters) or history of convulsive status epilepticus
Beschreibung

Uncountable seizures

Datentyp

boolean

Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
Beschreibung

Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs

Datentyp

boolean

History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
Beschreibung

suicide attempt, serious psychiatric disorders

Datentyp

boolean

Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
Beschreibung

progressive cerebral or neurological disease

Datentyp

boolean

Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
Beschreibung

Terminal illness

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
Epilepsia
Beschreibung

Epilepsy

Datentyp

string

Alias
UMLS CUI
C0014544
SNOMED CT 2010_0731
84757009
MedDRA 13.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Convulsion
Beschreibung

Seizures

Datentyp

string

Alias
UMLS CUI
C0036572
SNOMED CT 2010_0731
91175000
MedDRA 13.1
10039910
ICD-9-CM Version 2011
780.39
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
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C1516879
Pseudoseizure (Hysterical fits, factitious seizures)
Beschreibung

Dissociative convulsions

Datentyp

string

Alias
UMLS CUI
C0349245
SNOMED CT 2010_0731
191714002
MedDRA 13.1
10037148
ICD-10-CM Version 2010
F44.5
Epileptic state
Beschreibung

Status Epilepticus

Datentyp

string

Alias
UMLS CUI
C0038220
SNOMED CT 2010_0731
230456007
MedDRA 13.1
10041962
ICD-10-CM Version 2010
G41
Malabsorption
Beschreibung

Malabsorption

Datentyp

string

Alias
UMLS CUI
C0024523
SNOMED CT 2010_0731
155841000
ICD-10-CM Version 2010
K90.4
Renal Insufficiency
Beschreibung

Kidney Insufficiency

Datentyp

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10038474
Hepatic Insufficiency
Beschreibung

Liver Insufficiency

Datentyp

string

Alias
UMLS CUI
C1306571
SNOMED CT 2010_0731
59927004
MedDRA 13.1
10056542
Attempted Suicide
Beschreibung

Suicide attempt

Datentyp

string

Alias
UMLS CUI
C0038663
SNOMED CT 2010_0731
82313006
MedDRA 13.1
10042464
ICD-10-CM Version 2010
T14.91
CTCAE Version 4.03
E12969
Psychosis (Psychotic disorder)
Beschreibung

Psychotic Disorders

Datentyp

string

Alias
UMLS CUI
C0033975
SNOMED CT 2010_0731
69322001
MedDRA 13.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE Version 4.03
E12954
Brain Neoplasms
Beschreibung

Brain tumor

Datentyp

string

Alias
UMLS CUI
C0006118
SNOMED CT 2010_0731
126952004
MedDRA 13.1
10061019
ICD-9-CM Version 2011
239.6
CNS disorder, Central Nervous System Disease
Beschreibung

CNS disease

Datentyp

string

Alias
UMLS CUI
C0007682
SNOMED CT 2010_0731
23853001
MedDRA 13.1
10007943
ICD-10-CM Version 2010
G96.9
Degenerative Neurologic Disease
Beschreibung

Neurodegenerative Disorder

Datentyp

string

Alias
UMLS CUI
C0524851
MedDRA 13.1
10053643
ICD-10-CM Version 2010
G31.9
end stage disease
Beschreibung

Terminal illness

Datentyp

string

Alias
UMLS CUI
C0679247
SNOMED CT 2010_0731
300936002
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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
16 Years and older
boolean
Diagnosis of epilepsy
Item
Diagnosis of epilepsy (all types of seizures) was made during the past year
boolean
number of seizures
Item
Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
boolean
not pregnant, contraception
Item
Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method.
boolean
Item Group
Exclusion Criteria
previously trial treatment
Item
Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
boolean
other trial
Item
Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
boolean
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
Pseudoseizures
Item
Presence of known pseudoseizures within the last year
boolean
Uncountable seizures
Item
Uncountable seizures (clusters) or history of convulsive status epilepticus
boolean
Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
Item
Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
boolean
suicide attempt, serious psychiatric disorders
Item
History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
boolean
progressive cerebral or neurological disease
Item
Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
boolean
Terminal illness
Item
Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
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)
Epilepsy
Item
Epilepsia
string
C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Seizures
Item
Convulsion
string
C0036572 (UMLS CUI)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
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)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Dissociative convulsions
Item
Pseudoseizure (Hysterical fits, factitious seizures)
string
C0349245 (UMLS CUI)
191714002 (SNOMED CT 2010_0731)
10037148 (MedDRA 13.1)
F44.5 (ICD-10-CM Version 2010)
Status Epilepticus
Item
Epileptic state
string
C0038220 (UMLS CUI)
230456007 (SNOMED CT 2010_0731)
10041962 (MedDRA 13.1)
G41 (ICD-10-CM Version 2010)
Malabsorption
Item
Malabsorption
string
C0024523 (UMLS CUI)
155841000 (SNOMED CT 2010_0731)
K90.4 (ICD-10-CM Version 2010)
Kidney Insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10038474 (MedDRA 13.1)
Liver Insufficiency
Item
Hepatic Insufficiency
string
C1306571 (UMLS CUI)
59927004 (SNOMED CT 2010_0731)
10056542 (MedDRA 13.1)
Suicide attempt
Item
Attempted Suicide
string
C0038663 (UMLS CUI)
82313006 (SNOMED CT 2010_0731)
10042464 (MedDRA 13.1)
T14.91 (ICD-10-CM Version 2010)
E12969 (CTCAE Version 4.03)
Psychotic Disorders
Item
Psychosis (Psychotic disorder)
string
C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
Brain tumor
Item
Brain Neoplasms
string
C0006118 (UMLS CUI)
126952004 (SNOMED CT 2010_0731)
10061019 (MedDRA 13.1)
239.6 (ICD-9-CM Version 2011)
CNS disease
Item
CNS disorder, Central Nervous System Disease
string
C0007682 (UMLS CUI)
23853001 (SNOMED CT 2010_0731)
10007943 (MedDRA 13.1)
G96.9 (ICD-10-CM Version 2010)
Neurodegenerative Disorder
Item
Degenerative Neurologic Disease
string
C0524851 (UMLS CUI)
10053643 (MedDRA 13.1)
G31.9 (ICD-10-CM Version 2010)
Terminal illness
Item
end stage disease
string
C0679247 (UMLS CUI)
300936002 (SNOMED CT 2010_0731)
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