ID
121
Description
ODM derived from http://clinicaltrials.gov/show/NCT00165828
Link
http://clinicaltrials.gov/show/NCT00165828
Keywords
Versions (4)
- 12/2/11 12/2/11 -
- 3/25/14 3/25/14 - Martin Dugas
- 4/13/14 4/13/14 - Julian Varghese
- 4/13/14 4/13/14 - Julian Varghese
Uploaded on
December 2, 2011
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00165828 Epilepsy
Eligibility
- StudyEvent: Eligibility
Description
Inclusion criteria for randomisation
Description
Exclusion criteria at screening
Description
Epileptic state during the past year
Data type
boolean
Description
Non-epileptic fits
Data type
boolean
Description
Generalized epilepsy
Data type
boolean
Description
More than 4 weeks of seizure freedom during baseline phase
Data type
boolean
Description
Concomitant progressive CNS disease including progressive myoclonus epilepsy
Data type
boolean
Description
Concomitant treatment with vigabatrine and / or topiramate
Data type
boolean
Description
Hepatic and/or renal insufficiency
Data type
boolean
Description
Body weight <= 40 kg
Data type
boolean
Description
Kidney stones
Data type
boolean
Description
drug or alcohol dependence
Data type
boolean
Description
Active psychosis
Data type
boolean
Description
Suicide attempt during the past 3 years
Data type
boolean
Description
Pre-treatment with zonisamide
Data type
boolean
Description
Known hypersensitivity to sulfonamides
Data type
boolean
Description
concomitant treatment with neuroleptic drugs
Data type
boolean
Description
pregnant or breast feeding woman
Data type
boolean
Description
other study
Data type
boolean
Description
blood donation
Data type
boolean
Description
elective surgery planned
Data type
boolean
Description
patient is not willing or not capable to meet the study demands
Data type
boolean
Description
patient does not agree to the forwarding of his/her pseudonymous data
Data type
boolean
Description
patient without legal competence
Data type
boolean
Description
Exclusion criteria for randomisation
Description
Medical concepts
Description
Age
Data type
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Description
Epilepsy
Data type
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
Description
Epilepsies, Partial
Data type
string
Alias
- UMLS CUI
- C0014547
- SNOMED CT 2010_0731
- 230381009
- MedDRA 13.1
- 10065337
Description
Pharmaceutical Preparations
Data type
string
Alias
- UMLS CUI
- C0013227
Description
Antiepileptic Agents
Data type
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Description
pregnant
Data type
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Contraception
Data type
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Description
Informed Consent
Data type
string
Alias
- UMLS CUI
- C0021430
Description
Seizures
Data type
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
Status Epilepticus
Data type
string
Alias
- UMLS CUI
- C0038220
- SNOMED CT 2010_0731
- 230456007
- MedDRA 13.1
- 10041962
- ICD-10-CM Version 2010
- G41
Description
Epilepsy, Generalized
Data type
string
Alias
- UMLS CUI
- C0014548
- SNOMED CT 2010_0731
- 19598007
Description
Creatinine
Data type
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- MedDRA 13.1
- 10011358
- LOINC Version 232
- 38483-4
Description
ALT
Data type
string
Alias
- UMLS CUI
- C0001899
- SNOMED CT 2010_0731
- 56935002
- MedDRA 13.1
- 10001844
Description
Weight
Data type
string
Alias
- UMLS CUI
- C1305866
- SNOMED CT 2010_0731
- 107647005
- MedDRA 13.1
- 10047890
- LOINC Version 232
- LP18015-5
Description
Kidney Calculi
Data type
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
Description
Alcohol abuse
Data type
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
Description
Drug abuse
Data type
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
Description
Psychotic Disorders
Data type
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
Description
Suicide attempt
Data type
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
Description
Allergy
Data type
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 257550005
- ICD-10-CM Version 2010
- T78.40
Description
Sulfonamides
Data type
string
Alias
- UMLS CUI
- C0038760
- SNOMED CT 2010_0731
- 387406002
- LOINC Version 232
- MTHU007722
Description
Antipsychotic Agent
Data type
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 10784006
- LOINC Version 232
- MTHU003337
Description
pregnant
Data type
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Lactation
Data type
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Description
Enrollment
Data type
string
Alias
- UMLS CUI
- C1516879
Description
Elective Surgical Procedure
Data type
string
Alias
- UMLS CUI
- C0206058
- SNOMED CT 2010_0731
- 274075007
- MedDRA 13.1
- 10058829
Description
Compliance
Data type
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)