Eligibility NCT00175903 Epilepsy

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

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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