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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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NINDS CDE Surgeries and Other Procedures Epilepsy - Surgeries and Other Procedures

- 9/20/21 - 1 form, 3 itemgroups, 168 items, 1 language
Itemgroups: Surgery and Pathology,Additional surgical details,Postoperative complications
NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Devices Epilepsy - Devices

- 9/20/21 - 1 form, 3 itemgroups, 61 items, 1 language
Itemgroups: Device Revision/Replacement Log,Devices Log,Implanted Devices Log
NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE Classification of Etiology,Seizures and syndromes by age of onset Epilepsy - Classification of Etiology,Seizures and syndromes by age of onset

- 9/20/21 - 1 form, 4 itemgroups, 121 items, 1 language
Itemgroups: Classification of Etiology,Specific Etiology,Classification of Seizures,Syndromes by Age of Onset
NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Eligibility NCT00699283 Epilepsy - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 8 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00699283

Eligibility NCT01243177 Epilepsy - Eligibility

- 9/20/21 - 1 form, 2 itemgroups, 18 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01243177

Eligibility Epilepsy NCT01941706

- 12/7/19 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT; ODM derived from: https://clinicaltrials.gov/show/NCT01941706

Eligibility Epilepsy NCT01125241

- 12/7/19 - 1 form, 2 itemgroups, 14 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01125241

Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123) - Study Termination Record

- 9/23/19 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative,Study Termination,Investigator's Statement
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123) - Comment Log; Investigator's Statement

- 9/23/19 - 1 form, 3 itemgroups, 8 items, 1 language
Itemgroups: Administrative,Comment Log,Investigator's Statement
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123) - Visit 7 / Final Assessment - Vital Signs; Physical Examination; Compliance; Quality of Life; Global Evaluation

- 9/23/19 - 1 form, 12 itemgroups, 67 items, 1 language
Itemgroups: Administrative,Vital Signs,Physical Examination,Physical Examination - Changes,Neurological Examination,Neurological Examination,Haematology ,Clinical Chemistry ,Plasma Concentrations of AEDs ,Compliance Record,Quality of Life,Global Evaluation
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Lamotrigine as add-on therapy in patients with a clinical diagnosis of a Lennox-Gastaut syndrome (105-123) - Visit 2; 3; 4; 5; 6 - Dispensing Record; Adverse Experiences; Concomitant Medication; Seizure Counts

- 9/23/19 - 1 form, 18 itemgroups, 67 items, 1 language
Itemgroups: Administrative ,Haematology ,Clinical Chemistry ,Plasma Concentrations of AEDs ,Adverse Experiences and Concomitant Medication,Admission Criteria,Randomisation,Compliance Record,Adverse Experiences,Adverse Experiences,Concomitant AED Medication,Concomitant AED Medication ,Emergency AED Therapy used irregularly as required,Emergency AED Therapy used irregularly as required,Concomitant Medication other than AEDs,Concomitant Medication other than AEDs ,Seizure Record,Atypical Absence Seizures (1 Hour Count)
Study ID: 105-123 Clinical Study ID: 105-123 Study Title: Lamotrigine as add-on therapy in patients with clinical diagnosis of a Lennox-Gastaut syndrome (severe generalised epilepsy of childhood onset.) A multicentre, double-blind, placebo controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Seizures

Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377) - Pharmacogenetics - Research Consent; Research Withdrawal of Consent

- 8/16/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Pharmacogenetic Research Consent,Pharmacogenetic Research Withdrawal of Consent
Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

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