ID
121
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00165828
Länk
http://clinicaltrials.gov/show/NCT00165828
Nyckelord
Versioner (4)
- 2011-12-02 2011-12-02 -
- 2014-03-25 2014-03-25 - Martin Dugas
- 2014-04-13 2014-04-13 - Julian Varghese
- 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den
2 december 2011
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00165828 Epilepsy
Eligibility
- StudyEvent: Eligibility
Beskrivning
Inclusion criteria for randomisation
Beskrivning
Exclusion criteria at screening
Beskrivning
Epileptic state during the past year
Datatyp
boolean
Beskrivning
Non-epileptic fits
Datatyp
boolean
Beskrivning
Generalized epilepsy
Datatyp
boolean
Beskrivning
More than 4 weeks of seizure freedom during baseline phase
Datatyp
boolean
Beskrivning
Concomitant progressive CNS disease including progressive myoclonus epilepsy
Datatyp
boolean
Beskrivning
Concomitant treatment with vigabatrine and / or topiramate
Datatyp
boolean
Beskrivning
Hepatic and/or renal insufficiency
Datatyp
boolean
Beskrivning
Body weight <= 40 kg
Datatyp
boolean
Beskrivning
Kidney stones
Datatyp
boolean
Beskrivning
drug or alcohol dependence
Datatyp
boolean
Beskrivning
Active psychosis
Datatyp
boolean
Beskrivning
Suicide attempt during the past 3 years
Datatyp
boolean
Beskrivning
Pre-treatment with zonisamide
Datatyp
boolean
Beskrivning
Known hypersensitivity to sulfonamides
Datatyp
boolean
Beskrivning
concomitant treatment with neuroleptic drugs
Datatyp
boolean
Beskrivning
pregnant or breast feeding woman
Datatyp
boolean
Beskrivning
other study
Datatyp
boolean
Beskrivning
blood donation
Datatyp
boolean
Beskrivning
elective surgery planned
Datatyp
boolean
Beskrivning
patient is not willing or not capable to meet the study demands
Datatyp
boolean
Beskrivning
patient does not agree to the forwarding of his/her pseudonymous data
Datatyp
boolean
Beskrivning
patient without legal competence
Datatyp
boolean
Beskrivning
Exclusion criteria for randomisation
Beskrivning
Medical concepts
Beskrivning
Age
Datatyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beskrivning
Epilepsy
Datatyp
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
Beskrivning
Epilepsies, Partial
Datatyp
string
Alias
- UMLS CUI
- C0014547
- SNOMED CT 2010_0731
- 230381009
- MedDRA 13.1
- 10065337
Beskrivning
Pharmaceutical Preparations
Datatyp
string
Alias
- UMLS CUI
- C0013227
Beskrivning
Antiepileptic Agents
Datatyp
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Beskrivning
pregnant
Datatyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beskrivning
Contraception
Datatyp
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Beskrivning
Informed Consent
Datatyp
string
Alias
- UMLS CUI
- C0021430
Beskrivning
Seizures
Datatyp
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Beskrivning
Status Epilepticus
Datatyp
string
Alias
- UMLS CUI
- C0038220
- SNOMED CT 2010_0731
- 230456007
- MedDRA 13.1
- 10041962
- ICD-10-CM Version 2010
- G41
Beskrivning
Epilepsy, Generalized
Datatyp
string
Alias
- UMLS CUI
- C0014548
- SNOMED CT 2010_0731
- 19598007
Beskrivning
Creatinine
Datatyp
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- MedDRA 13.1
- 10011358
- LOINC Version 232
- 38483-4
Beskrivning
ALT
Datatyp
string
Alias
- UMLS CUI
- C0001899
- SNOMED CT 2010_0731
- 56935002
- MedDRA 13.1
- 10001844
Beskrivning
Weight
Datatyp
string
Alias
- UMLS CUI
- C1305866
- SNOMED CT 2010_0731
- 107647005
- MedDRA 13.1
- 10047890
- LOINC Version 232
- LP18015-5
Beskrivning
Kidney Calculi
Datatyp
string
Alias
- UMLS CUI
- C0022650
- SNOMED CT 2010_0731
- 95570007
- MedDRA 13.1
- 10023436
- ICD-10-CM Version 2010
- N20.0
- ICD-9-CM Version 2011
- 592.0
- CTCAE Version 4.03
- E13018
Beskrivning
Alcohol abuse
Datatyp
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
Beskrivning
Drug abuse
Datatyp
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
Beskrivning
Psychotic Disorders
Datatyp
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
Beskrivning
Suicide attempt
Datatyp
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
Beskrivning
Allergy
Datatyp
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 257550005
- ICD-10-CM Version 2010
- T78.40
Beskrivning
Sulfonamides
Datatyp
string
Alias
- UMLS CUI
- C0038760
- SNOMED CT 2010_0731
- 387406002
- LOINC Version 232
- MTHU007722
Beskrivning
Antipsychotic Agent
Datatyp
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 10784006
- LOINC Version 232
- MTHU003337
Beskrivning
pregnant
Datatyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beskrivning
Lactation
Datatyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beskrivning
Enrollment
Datatyp
string
Alias
- UMLS CUI
- C1516879
Beskrivning
Elective Surgical Procedure
Datatyp
string
Alias
- UMLS CUI
- C0206058
- SNOMED CT 2010_0731
- 274075007
- MedDRA 13.1
- 10058829
Beskrivning
Compliance
Datatyp
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Similar models
Eligibility
- StudyEvent: Eligibility
102518004 (SNOMED CT 2010_0731)
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)
230381009 (SNOMED CT 2010_0731)
10065337 (MedDRA 13.1)
10036586 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
230456007 (SNOMED CT 2010_0731)
10041962 (MedDRA 13.1)
G41 (ICD-10-CM Version 2010)
19598007 (SNOMED CT 2010_0731)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
107647005 (SNOMED CT 2010_0731)
10047890 (MedDRA 13.1)
LP18015-5 (LOINC Version 232)
95570007 (SNOMED CT 2010_0731)
10023436 (MedDRA 13.1)
N20.0 (ICD-10-CM Version 2010)
592.0 (ICD-9-CM Version 2011)
E13018 (CTCAE Version 4.03)
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)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
82313006 (SNOMED CT 2010_0731)
10042464 (MedDRA 13.1)
T14.91 (ICD-10-CM Version 2010)
E12969 (CTCAE Version 4.03)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
10036586 (MedDRA 13.1)
10006247 (MedDRA 13.1)
274075007 (SNOMED CT 2010_0731)
10058829 (MedDRA 13.1)
405078008 (SNOMED CT 2010_0731)