ID
121
Description
ODM derived from http://clinicaltrials.gov/show/NCT00165828
Lien
http://clinicaltrials.gov/show/NCT00165828
Mots-clés
Versions (4)
- 02/12/2011 02/12/2011 -
- 25/03/2014 25/03/2014 - Martin Dugas
- 13/04/2014 13/04/2014 - Julian Varghese
- 13/04/2014 13/04/2014 - Julian Varghese
Téléchargé le
2 décembre 2011
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0 Legacy
Modèle Commentaires :
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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
Type de données
boolean
Description
Non-epileptic fits
Type de données
boolean
Description
Generalized epilepsy
Type de données
boolean
Description
More than 4 weeks of seizure freedom during baseline phase
Type de données
boolean
Description
Concomitant progressive CNS disease including progressive myoclonus epilepsy
Type de données
boolean
Description
Concomitant treatment with vigabatrine and / or topiramate
Type de données
boolean
Description
Hepatic and/or renal insufficiency
Type de données
boolean
Description
Body weight <= 40 kg
Type de données
boolean
Description
Kidney stones
Type de données
boolean
Description
drug or alcohol dependence
Type de données
boolean
Description
Active psychosis
Type de données
boolean
Description
Suicide attempt during the past 3 years
Type de données
boolean
Description
Pre-treatment with zonisamide
Type de données
boolean
Description
Known hypersensitivity to sulfonamides
Type de données
boolean
Description
concomitant treatment with neuroleptic drugs
Type de données
boolean
Description
pregnant or breast feeding woman
Type de données
boolean
Description
other study
Type de données
boolean
Description
blood donation
Type de données
boolean
Description
elective surgery planned
Type de données
boolean
Description
patient is not willing or not capable to meet the study demands
Type de données
boolean
Description
patient does not agree to the forwarding of his/her pseudonymous data
Type de données
boolean
Description
patient without legal competence
Type de données
boolean
Description
Exclusion criteria for randomisation
Description
Medical concepts
Description
Age
Type de données
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Description
Epilepsy
Type de données
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
Type de données
string
Alias
- UMLS CUI
- C0014547
- SNOMED CT 2010_0731
- 230381009
- MedDRA 13.1
- 10065337
Description
Pharmaceutical Preparations
Type de données
string
Alias
- UMLS CUI
- C0013227
Description
Antiepileptic Agents
Type de données
string
Alias
- UMLS CUI
- C0003299
- SNOMED CT 2010_0731
- 255632006
- LOINC Version 232
- MTHU006781
Description
pregnant
Type de données
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Contraception
Type de données
string
Alias
- UMLS CUI
- C0700589
- SNOMED CT 2010_0731
- 146680009
- MedDRA 13.1
- 10010808
Description
Informed Consent
Type de données
string
Alias
- UMLS CUI
- C0021430
Description
Seizures
Type de données
string
Alias
- UMLS CUI
- C0036572
- SNOMED CT 2010_0731
- 91175000
- MedDRA 13.1
- 10039910
- ICD-9-CM Version 2011
- 780.39
Description
Status Epilepticus
Type de données
string
Alias
- UMLS CUI
- C0038220
- SNOMED CT 2010_0731
- 230456007
- MedDRA 13.1
- 10041962
- ICD-10-CM Version 2010
- G41
Description
Epilepsy, Generalized
Type de données
string
Alias
- UMLS CUI
- C0014548
- SNOMED CT 2010_0731
- 19598007
Description
Creatinine
Type de données
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- MedDRA 13.1
- 10011358
- LOINC Version 232
- 38483-4
Description
ALT
Type de données
string
Alias
- UMLS CUI
- C0001899
- SNOMED CT 2010_0731
- 56935002
- MedDRA 13.1
- 10001844
Description
Weight
Type de données
string
Alias
- UMLS CUI
- C1305866
- SNOMED CT 2010_0731
- 107647005
- MedDRA 13.1
- 10047890
- LOINC Version 232
- LP18015-5
Description
Kidney Calculi
Type de données
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
Type de données
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
Type de données
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
Type de données
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
Type de données
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
Type de données
string
Alias
- UMLS CUI
- C0020517
- SNOMED CT 2010_0731
- 257550005
- ICD-10-CM Version 2010
- T78.40
Description
Sulfonamides
Type de données
string
Alias
- UMLS CUI
- C0038760
- SNOMED CT 2010_0731
- 387406002
- LOINC Version 232
- MTHU007722
Description
Antipsychotic Agent
Type de données
string
Alias
- UMLS CUI
- C0040615
- SNOMED CT 2010_0731
- 10784006
- LOINC Version 232
- MTHU003337
Description
pregnant
Type de données
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Description
Lactation
Type de données
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Description
Enrollment
Type de données
string
Alias
- UMLS CUI
- C1516879
Description
Elective Surgical Procedure
Type de données
string
Alias
- UMLS CUI
- C0206058
- SNOMED CT 2010_0731
- 274075007
- MedDRA 13.1
- 10058829
Description
Compliance
Type de données
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)