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41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-999.0, Seizure Disorder Generalized Tonic Clonic Clinical diagnosis of PGTC seizures (with or without other subtypes of primary generalized seizures) and experiencing greater than or equal to 3 PGTC seizures during the 8-week period prior to randomization 2. Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period with electroencephalographic features consistent with primary generalized epilepsy; other concomitant anomaly should be explained by adequate past medical history 3. On a fixed dose of one to a maximum of three concomitant antiepileptic drugs (AEDs) for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine, oxcarbazepine, or phenytoin) out of the maximum of two AEDs will be allowed 4. A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted greater than or equal to 5 months prior to Baseline (stimulator parameters cannot be changed for 30 days prior to Baseline and for the duration of the study). 5. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive cause of epilepsy 6. A ketogenic diet will be allowed as long as the participant has been on this diet for 5 weeks prior to randomization 1. A history of status epilepticus that required hospitalization within 12 months prior to Baseline 2. Seizure clusters where individual seizures cannot be counted 3. A history of psychogenic seizures 4. Concomitant diagnosis of Partial Onset Seizures (POS) 5. Progressive neurological disease 6. Clinical diagnosis of Lennox-Gastaut syndrome 7. If felbamate is used as a concomitant AED, participants must be on felbamate for at least 2 years, with a stable dose for 60 days prior to Baseline. They must not have a history of white blood cell (WBC) count below less than or equal to 2500/microL (2.50 1E+09/L), platelets less than 100,000/microL, liver function tests (LFTs) greater than 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. 8. Concomitant use of vigabatrin: Participants who took vigabatrin in the past must be discontinued for approximately 5 months prior to Baseline, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test 9. Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline 10. Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour period considered one-time rescue) two or more times within the 30 days prior to Baseline | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Epilepsy Target disease: Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having the following seizure types as classified by the International Classification of Seizures Partial seizures (with or without secondarily generalisation) Generalized tonic-clonic seizures without focal onset, with or without myoclonus but without other generalized seizure type(s). 2. Subjects have a confident diagnosis of epilepsy uncomplicated by pseudoseizures (psychogenic nonepileptic seizures). 3. Subjects have had at least 2 seizures in the previous 6 months with at least 1 seizure in the previous 3 months. 4. Age: ≥16 years (at the time of obtaining consent) 5. Outpatients 6. Subjects are able to write a seizure diary. 7. Subjects understand and sign written informed consent. If a subject is under 20 years at the time of obtaining consent, a subject and a legally acceptable representative (e.g., a parent or a custodian) sign written consent to participate in this study. 8. Gender: Male or female If female, and of childbearing potential, be using an acceptable form of birth control. 9. QTc<450 millisecond (msec) or <480msec for subjects with Bundle Branch Block values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period. 10. Subjects are able to comply with dosing of investigational products and all study procedures Subjects having seizure types other than partial seizure or generalized tonic clonic seizures with or without myoclonus. Subjects having status epilepticus within the 6 months prior to the start of study treatment. 2. Subjects with a history of treatment with AEDs (≥2 weeks) during 6 months before the start of treatment with the investigational product. 3. Subjects with a history of treatment with lamotrigine. 4. Subjects with a history of rash associated with other AED treatment. 5. Subjects with a history of substance (including alcohol and drugs) dependence within 12 months before the start of investigational product or abuse within 1 month before the start of investigational product according to DSM-IV-TR. 6. Subjects with an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or with any unstable physical symptoms likely to require hospitalization during participation in the study. 7. Subjects with a severe psychiatric disorder which affects the procedure of study or drug assessment. 8. Subjects with an acute or progressive neurological disorder or an organic disease. 9. Subjects with any clinically significant chronic cardiac, renal, or hepatic medical condition. Any patient with these conditions are excluded from the study even if these conditions are being controlled with chronic therapy. 10. Subjects with an unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 11. Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study. 12. Subjects taking inducers of lamotrigine glucuronidation (i.e., rifampicin, lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or hormone drug which includes estrogen. 13. Subjects having participated in other clinical study within 3 months before the start of investigational product. 14. Subjects who have active suicidal plan/intent or have had active suicidal thoughts in the past 3 months before the start of investigational product or who have history of suicide attempt in the last 1 year before the start of investigational product or more than 1 lifetime suicide attempt. 15. Subjects whom the investigator or subinvestigator considers ineligible for the study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-40.0, Idiopathic Generalized Epilepsy For patients Men and women aged between 18 and 40 Person affiliated to social security or beneficiary of such a regime idiopathic generalized epilepsy treated with lamotrigine, an association of lamotrigine, topiramate, levetiracetam, lamotrigine or levetiracetam alone (group patients) for at least 14 days without changing doses The idiopathic generalized epilepsy is defined by generalized seizures: generalized tonic-clonic seizures, absences or myoclonic seizures, excluding any other type of seizure, and electroencephalographic appearance following: presence of interictal EEG discharge generalized to type of spikes, spike-wave or wave polyspikes generalized, sporadic or rhythmic> or = 3 Hz background activity is normal. For healthy volunteers Men and women aged between 18 and 40 Person affiliated to social security or beneficiary of such a regime Topic wrongly included Deflecting protocol that can skew the primary endpoint Primary endpoint missing If the investigator considers the health of the subject is incompatible with the continuation of the study. for non-inclusion For patients The presence of interictal focal discharges on EEG previous The emergence of partial seizures Restless Leg Syndrome All non-antiepileptic treatment may affect levels of dopamine Current use of illicit drugs | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-45.0, Acne Vulgaris Male or female subjects 12 to 45 years (inclusive) of age in good general health Subjects must have both on the face: A) A minimum of 17 but not more than 60 inflammatory lesions (papules/pustules), including nasal lesions. And B) A minimum of 20 but not more than 150 non-inflammatory lesions (open/closed comedones), including nasal lesions An ISGA score of 2 or greater at baseline Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the contraception The ability and willingness to follow all study procedures and attend all scheduled visits The ability to understand and sign a written informed consent form (Written informed consent must be obtained also from the parent or guardian in case of subject under 20 years of age at the time of given consent) Have any nodule-cystic lesions at baseline Are pregnant or breast-feeding Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea or antibiotic-associated colitis) or similar symptoms Used any of the following agents on the face within the previous 2 weeks:Topical antibiotics (or systemic antibiotics);Topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates);Abradants, facials, or peels containing glycolic or other acids;Masks, washes or soaps containing BPO, sulfacetamide sodium, or salicylic acid;Non-mild facial cleansers (e.g., facial scrub, cleansers containing agents with anti-inflammatory action); Moisturizers that contain retinol, salicylic acid, or α or β-hydroxy acids;Astringents and toner (Subjects are allowed to enroll in this study, if the subject has been on treatment for more than 2 consecutive weeks prior to start of investigational product use) Used the following agents on the face or performed the following procedure within the previous 4 weeks:Topical corticosteroids (Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable);Facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc.) Used systemic retinoids within the previous 6 months or topical retinoids on the face within the previous 6 weeks Received treatment with estrogens, androgens, or anti-androgenic agents within the previous 12 weeks (Subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug, or discontinue use during the study) Used any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day], corticosteroids*, androgens, haloperidol, halogens [e.g., iodide and bromide], lithium, hydantoin, and phenobarbital). *: except the using of topical corticosteroids (e.g., inhaled, intra-articular, or intra-lesional steroids) other than for facial acne | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Acute Myelogenous Leukemia (AML) For Arm A Part 1 (monotherapy/dose escalation): refractory or recurrent AML, not an appropriate candidate for standard therapy For Arm A Part 2 (monotherapy/dose confirmation/cohort expansion): refractory or recurrent AML, not an appropriate candidate for standard therapy, and have wild type p53 gene mutation analysis For Arm B Part 1 (combination therapy/dose escalation): recurrent AML having achieved an initial CR or CRi of 6-12 months duration and age ≥18 years old and <70 years old For Arm B Part 2 (combination therapy/dose confirmation/cohort expansion): recurrent AML having achieved an initial CR or CRi of 6-12 months duration, age ≥18 years old and <70 years old, and have wild type P53 gene mutation analysis Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for all Arm A, or 0 or 1 for all Arm B Negative pregnancy test within 72 hours of the first dose of study medication Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study therapy Adequate organ function Recovered from the effects of any prior surgery, radiotherapy or anti-neoplastic treatment, with the exception of alopecia Must be able to swallow, retain, and absorb oral medications and oral nutrition Active malignancy other than AML Leptomeningeal leukemia requiring intrathecal therapy For Arm A and B, Part 1 only: history of myelodysplastic syndrome (MDS) For Arm A and B, Part 2: AML in the background of MDS may be included Isolated extramedullary leukemia without also meeting bone marrow for acute leukemia AML blast crisis of chronic myelogenous leukemia (CML) Bone marrow transplant with active graft-versus host disease (GVHD) or who receives immunosuppressive therapy Uncontrolled active infection that requires systemic treatment Clinically significant hepatitis at Screening, or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive Persistent, unresolved, drug-related toxicity | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Anxiety Disorder Seizures Epilepsy Partial Epilepsy Depression Patients may be male or female Patients will be aged 18 65 Patients must have at least 3 seizures during the one-month baseline Localization-related epilepsy diagnosed by standard clinical that has not responded to treatment with two standard antiepileptic drugs either sequentially or in combination Patients must be able to provide informed consent Patients must be able to remain on their baseline AED drugs and doses throughout the study Patients must be able to use seizure calendars to record seizures throughout the trial Pregnant patients will not participate in the study During the study, women of child-bearing potential must use a reliable method of birth control and will have pregnancy testing throughout the protocol Use of any alcohol or recreational drugs starting two weeks before entering baseline and for the duration of the study Patients on medications with potential for a clinically significant interaction with buspirone, including MAO inhibitors, clozapine, zolpidem, hypnotics, hydromorphone derivatives, oxycodone, and diltiazem Current treatment for psychiatric disorder other than depression, anxiety or bipolar disorder Patients with a diagnosis of schizophrenia Current treatment for another significant medical disorder, such as diabetes, or heart disease, or an untreated disorder, that might interfere with the study Calculated Creatinine clearance of less than 80 ml/min calculated with the Cockcroft-Gault formula Clcr = [(140-age) times ideal body weight in Kg] times (0.85 if female) divided by (72 times serum Cr in mg/dL) Evidence of impaired liver function based on serum chemistries | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Intraventricular Hemorrhage Intracerebral Hemorrhage Hospitalization for an admitting diagnosis of hemorrhagic stroke admitted to the neurosurgical intensive care unit Age greater than 18 years No evidence of ischemic cerebrovascular injury Concomitant traumatic brain injury Antibiotics on admission to the NICU Immunocompromised by chemotherapy or HIV positive or patient with neutropenia (ANC <1000) Women who are pregnant and/or of childbearing age where a pregnancy test has not already occurred | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Refractory Epilepsy Fulfilling the of labeling indications of Medtronic® DBS™ Therapy for Epilepsy Patient with diagnosis of refractory epilepsy as defined by 1981 ILAE (International League Against Epilepsy) classification, who have been implanted or will be implanted with Medtronic® DBS™ Therapy for Epilepsy For both cohorts, completed at least two full consecutive months diary information on seizure type and frequency prior to DBS implant (seizure type should be classified at least as simple partial, complex partial, partial evolving to secondarily generalized seizures, and generalized). In regard to the prospective cohort, the patient will be conditionally enrolled at the enrolment visit, and the criterion will be reassessed at the baseline visit Patient or patient's legally authorized representative able to understand and to provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC or local law and regulations Incomplete and/or unreliable patient seizure diary based on the physician's judgment Patient is currently enrolled in or plans to enroll in any concurrent drug, surgery and/or device study that may confound the results of this registry | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Stress Anxiety Depression Documented HIV-1 infection Ages 18 to 65 Experiencing some level of stress, anxiety, or depression No current use of other meditation practices or holistic modalities Non-English readers or speakers Hearing-impaired Low literacy below 5th grade reading and comprehension level | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-40.0, Medically Intractable Epilepsy Age 18-40 years old Fluency in English, including reading and writing Confirmed diagnosis of epilepsy as indicated by review of medical records (video-EEG, routine EEG and imaging) Drug-refractoriness as indicated by at least two failures to achieve seizure freedom per adequate drug trials in the patient's history to be subjected to a surgical intervention aiming at seizure reduction A baseline seizure frequency of at least two complex partial seizures per month Willingness not to begin another non-pharmaceutical treatment while enrolled in the study Readiness to attempt not to change pharmaceutical treatment while enrolled in the study Motivation to comply with the intervention protocols A history of a relapsing remission course of epilepsy Presumed psychogenic events Scheduled or likely change of treatment within 8 months after enrollment in the trial Negative compliance history Noncompliance with baseline measurement A seizure frequency of less than two seizures per month during baseline measurement Serious other medical problems, such cancer, stroke, significant heart disease, psychiatric disorders Brain tumors, vascular malformations, progressive epilepsy syndromes, neurodegenerative disorders or significant developmental delay (IQ<80) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-50.0, Epilepsy, Cryptogenic Epilepsy, Partial Seizure Disorder Autoimmune Diseases, Nervous System Limbic Encephalitis Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months Age 18 to 50 Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy Refractory to an adequate trial of two or more main-line anti-epileptic drugs Ability to keep a seizure diary Normal brain magnetic resonance imaging (MRI) Tesla, seizure protocol; with the exception of hippocampal sclerosis History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects Evidence of psychogenic epilepsy History of convulsive status epilepticus History of primary generalized epilepsy in a first degree relative Known serious medical illness | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-75.0, Epilepsy Patient with temporal lobe epilepsy (TLE) Patient with epilepsy for at least two years. Arm 1: Patient with drug-resistant TLE proved potentially a candidate for surgery. Arm 2: Patient with TLE seizure-free for 12 months or more Patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. Patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Diagnosed with Epilepsy Age (under 18, over 65) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-55.0, Major Depressive Disorder For Patients with Major Depressive Disorder • Male and female outpatients, aged 18-55 years Subjects meeting full for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician HAM-D17 score of 14 or higher Able to provide informed consent Right handed, normal (corrected) vision and normal hearing • Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD) Substance use disorder (abuse or dependence with active use within the last 6 months) Significant sensory deficits such as deafness or blindness Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods) Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls Males and females, aged 18-55 years Subjects who do not meet full for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician Right handed, normal (corrected) vision and normal hearing Any current primary psychiatric, or medical condition determined to be clinically significant | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Osteoarthritis of the Knee Willing and able to give written informed consent Willing and able to understand the study procedures, and comply with all study procedures Females or males, age ≥ 18 years old Body mass index 18-39, inclusive In good general health Clinical diagnosis of OA in one or both knees Have been on a stable regimen of pain medication for the management of OA knee pain Not experiencing adequate pain relief with their current dosing regimen Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control. Male subjects must agree to use contraception Females who are pregnant or lactating Known history of hypersensitivity, intolerance, or allergy to opioids Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA Presence of any medical condition that would preclude study participation in the opinion of the investigator Clinically significant abnormalities of vital signs or clinical laboratory results Clinically significant electrocardiographic abnormalities Received systemic corticosteroids within 30 days prior to signing the consent form Subjects who are known or suspected to be currently abusing alcohol or drugs Positive urine drug screen, or alcohol breath test during Screening Period testing Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C (anti-HCV) during Screening Period testing | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 10.0-999.0, Minor Head Injury Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Intellectual Disabilities Intellectual disability Visual impairments Auditory impairments Currently receiving cognitive behaviour therapy Acute psychosis | 2 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, SUDEP Sudep Group Subjects diagnosed with epilepsy whose cause of death was sudden and unexplained, and whose families are willing to participate, will be included in the study. Control Group For the control group, we will any patient diagnosed with epilepsy currently in the care of the NYU Comprehensive Epilepsy Center, willing and able to participate in the study | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Epilepsies, Partial For patients Age 18-60 Able to give written informed consent Drug resistant participants will be defined as having clinically documented partial seizures with consistent EEG evidence as defined by the 2010 Revised terminology and concepts for organization of seizures and epilepsies and refractory to standard antiepileptic treatment for at least one year prior to enrolling in this study. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies Drug-responsive participants will be defined as having clinically documented partial seizures with consistent EEG evidence as defined by the 2010 Revised terminology and concepts for organization of seizures and epilepsies, seizure-free on standard antiepileptic treatment for at least three months prior to enrolling in this study. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies No prior diagnosis of drug or alcohol abuse or dependence. For healthy volunteers Age 18-60 Able to give written informed consent No prior diagnosis of drug or alcohol abuse or dependence For patients Previous research radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed the NIH RSC 5 rad per year research limit Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine History of brain disease other than epilepsy Cannot lie on their back for at least two hours Serious medical illness, other than epilepsy Clinically significant laboratory abnormalities Brain abnormality such as a brain tumor, infection, stroke, brain damage from head trauma or blood vessel abnormalities, on an MRI scan Pregnancy or breast feeding Able to get pregnant but does not use birth control | 2 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Focal Epilepsy With and Without Secondary Generalization The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS) The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician) Patient must be at least 18 years of age The patient must have had at least one seizure within the last 3 months prior to enrolment | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-75.0, Hemifacial Spasm patients referred to the neurosurgical service for microvascular decompression surgery for HFS males and females 18 to 75 years of age otherwise normal neurological exam signed informed consent Botox treatment within the last three months | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Partial Epilepsy Patient with drug-resistant focal epilepsy Candidates for pre-surgical evaluation including FDG PET, MRI, MEG and SEEG recordings Age 18-65 years EEG-confirmed focal epilepsy for >2 years Signed informed consent form Age <18 years and >65 years Contraindication to the MRI Pregnant woman Head size incompatible with MEG recordings Adult subject to legal protection measure | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-75.0, Epilepsies, Partial fully characterized refractory unifocal neocortical epilepsy (i.e. the epileptogenic zone is well defined) on a stable drug regimen for at least one month able to complete a seizure dairy either by the patient or by a significant other Metal in the head including deep brain stimulators, aneurysmal clips, ventricular shunts, cochlear implants, ossicular reconstruction of the middle ear… pacemaker, implantable cardioverter-defibrillator (ICD) psychogenic non-epileptic seizures and other non-epileptic spells | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 5.0-18.0, Migraine Children with migraine without aura (MoA) diagnosed according to the for pediatric age of the International Classification of Headache Disorders (IHS-2) aged from 5 to 18 years at least four attacks /month mental retardation (IQ <70) genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome) hypothyroidism psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD) neuromuscular disorders epilepsy obesity (BMI>95 percentiles) liver or renal diseases gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn hypersensitivity to medication studies | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Seizure Disorder US Veteran Epilepsy (Seizure Disorder) >18 years | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy (Treatment Refractory) Male or female, aged 18 years or older Female subjects must be using a form of contraception >1 seizures per month EEG confirmation of seizure activity (no non-epileptic seizures) Agrees to comply with study procedures, and keep seizure diary Agrees not to make any major deviations from current diet (especially fish intake) or medications (type, dosage) Agrees to having portions of blood samples stored for assays Has given voluntary, written, informed consent to participate in the study Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial Use of significant amounts of fish oil or flax oil (omega-3) supplements within 8 weeks of the study Allergy or sensitivity to fish, fish oil, coconut oil, olive oil, hemp oil, safflower oil, flax seed oil, or soybean oil Cognitive impairment (I.Q. below 70) and/or inability to give informed consent Failure to understand English Subjects taking regular warfarin or aspirin | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy years of age or older Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study Male or non-pregnant female English speaking Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings Have a movement disorder that may affect GT3X+ recordings | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-70.0, Seizures Sleep Epilepsy epilepsy non-epileptic | 2 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Intellectual Disability for the patients: Clinical diagnosis of intellectual disbility for the unaffected sibs: to be aged at least 3 years informed consent absence of informed consent | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Phantom Limb Pain Men and women 18 years or older Amputation at any level of one lower limb by anti-personnel land mines Symptoms compatible with PLP, defined as painful sensation, sensation of shooting, stabbing, boring, boring, sqeezing, throbbing and burning or paresthesia or any other pain sensation in a limb that doesn't exist anymore Willingness to participate in the study and to sign the informed consent form Diagnosis of complex regional pain syndrome Any pathology that based on the judgment of the researcher that could alter the course of PLP (neoplasias, immunological disorders, etc.) Previous diagnosis of cancer Renal insufficiency requiring dialysis treatment Pregnancy History of epilepsy Cardiac arrhythmias Metallic prostheses in the skull History of severe head trauma Use of tricyclic antidepressants (amitriptyline, imipramine, clomipramine) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 5.0-16.0, Epilepsy, Partial Epilepsy, Localization Related Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry Child has diagnosed epilepsy as defined by one of the following definitions At least two unprovoked seizures occurring more than 24-hours apart, or One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures (approximately 75% or more), or At least two seizures in a setting of reflex epilepsy Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) and which may Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell) Participants must either be antiepileptic drug (AED) therapy naïve or on an AED (excluding benzodiazepines) for 1-week or less. Children may be on a stable dose of psychostimulants at the time of enrollment, but no change in medication, dose, or schedule in 3 months prior to study enrollment, with no anticipated dosing changes during the 6 months of the study. If participants are taking psychostimulants at the time of study entry, they should plan on continuing them for the 6 month duration of the study protocol including the 3-month and 6-month cognitive and behavioral testing time points Females of child bearing potential must agree to acceptable forms of birth control, which may abstinence Children with history of primary generalized seizures (absence, myoclonic, drop) Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome) Children with sensory seizures only (i.e., auras) Children with 6+ seizures in the previous week Children with a history of status epilepticus Children with a history of neonatal seizures Children with diagnoses of pervasive developmental disorders (e.g., autism/autism spectrum disorders) Children with progressive neurological disease (e.g., degenerative, progressive neoplasm) Children with major medical disease (e.g., Insulin-Dependent Diabetes Mellitus (IDDM), cancer, renal failure) Children with diseases with cognitive impact (e.g., inborn errors of metabolism, sickle cell disease with history of stroke) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Seizure The patient is diagnosed with epilepsy with; primary generalized tonic-clonic or partial complex or simple complex or focal onset seizures, with or without secondary generalization. 2. The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable 3. The patient is receiving a stable dose of up to 2 oral AED medication(s) and is not expected to have any change in his/her baseline AED treatment during the treatment period. 4. The patient is having more than 2 recordable seizures a month The patient has had status epilepticus within the last six months. 2. The patient has had epilepsy surgery or a VNS implant. 3. The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted). 4. The patient has had 4 weeks continuous seizure freedom last 2 months. 5. The patient has psychogenic non-epileptic seizures (PNES) seizures. 6. The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy. 7. The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study. 8. The patient has had an episode of status epilepticus within 4 weeks of Screening. 10. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site. 11. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction. 12. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction). 13. Has had a previous bilateral, right, or left cervical vagotomy. 14. Has uncontrolled high blood pressure. 15. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. 16. Has a history of carotid endarterectomy or vascular neck surgery on the right side. 17. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site. 18. Has a recent or repeated history of syncope. 19. Has a known history or suspicion of substance abuse or addiction. 20. In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures. 21. Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Intellectual Disability Participants were can write and read to ask scales Participant were able to use an Smartphone Physical illness that prevent physical activity | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Epilepsy Partial Seizures Subject is of Chinese origin and ≥ 16 years of age Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS) Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS) Subject has only experienced type IA nonmotor seizures Subject has a history or presence of seizures occurring only in clustered patterns Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures Subject has a history of Status Epilepticus | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Seizure Disorder Age 18-65 Partial onset seizures (complex partial or secondary generalized tonic-clonic) At least one seizure every three months No serious or progressive medical or psychiatric illness At least one complex partial or generalized tonic-clonic seizure in the last three months MRI or EEG consistent with localization-related or partial epilepsy Exposure to at least two anti-epileptic drugs at adequate doses Concurrent use of at least one anti-epileptic drug at adequate doses No change in anti-epileptic drug dose for at least 30 days prior to study enrollment Vagus nerve stimulation (VNS) History of non-epileptic seizures Inability to maintain accurate seizure calendars (self or caregiver) Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month History of facial pain or trigeminal neuralgia Pregnancy | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 4.0-999.0, Lennox-Gastaut Syndrome Patients will be four years and older Patients will have an established diagnosis of Lennox-Gastaut syndrome, and Documented history or current presence of multiple seizure types associated with LGS (including tonic or atonic seizures (drop attacks) and atypical absences) Documented history or current presence of typical EEG abnormalities (e.g., bursts of slow spike and wave activity) Presence of intellectual / learning disability (a variable degree is permitted) Patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. This includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy Female patients who are pregnant, lactating, or whom are planning to become pregnant Female patients, of child bearing potential, who are not willing to use appropriate contraception (This is at the discretion of the investigator) Those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current Summary of Product Characteristics (SPC) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 13.0-70.0, Acute Injury of Anterior Cruciate Ligament Skeletally mature subjects with age 13 years Sustain an acute full ACL rupture in one knee < 28 day May or may not undergo ACL reconstruction Low grade injury to the collateral ligaments not resulting in instability and not requiring reconstruction will be included Radiographic evidence of early osteoarthritis, defined as Grade 1 joint space narrowing or Grade 1 osteophyte formation Injuries to other ligaments requiring surgical intervention Have cartilage resurfacing procedures performed at the time of injury Inability to undergo the standard pre and post-injury/operative rehabilitation Varus or valgus instability requiring ligament repair or reconstruction (from clinical exam at time of injury) History of osteoarthritis and inflammatory arthritis Women who are pregnant are excluded Previous injury and/or surgery on either knee | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 40.0-80.0, Amnesia Patient group Clinical of definition of transient global amnesia: Acute disorder of anterograde memory observed by a witness. Respect of the other cognitive functions. No for this diagnosis (see section). Hippocampal lesion in DWI MRI performed at 72h Clinical resolution of memory disorder within 24 hours Control group No cognitive complaint No history of transient amnesia Both groups Age between 40 and 80 years old Patient group Disturbance of consciousness or loss of identity Argument in favor of seizure disorders Presence of a neurological deficit focused Both groups Recent head trauma Acute intoxication ethyl Taking drugs influencing memory processing Severe hypoglycemia Psychiatric disorder altering capacity for judgment Progressive neurological disorder with cognitive alteration Indication against MRI French language level insufficient to be appropriately involved in neuropsychological assessment, Administrative issues: unable to give informed about information, not covered by a social security system, refusal to sign the consent, patient under curators. Pregnant Woman | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Respiratory Complication Morbid Obesity All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Peritoneal Carcinomatosis Colorectal Cancer Appendiceal Cancer Peritoneal Mesothelioma Pseudomyxoma Peritonei Gastric Cancer Age ≥ 18 years Capable of providing informed consent The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer of colorectal, appendiceal, peritoneal mesothelioma, pseudomyxoma or gastric origin with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction indicated by Disease confined to the peritoneal surfaces No parenchymal liver metastases No evidence of clinical, biochemical or radiological biliary obstruction Small volume of disease in the gastro-hepatic ligament defined by a < 5cm mass in the epigastric region on cross-sectional imaging No clinical or radiological evidence of hematogenous or distant nodal metastasis Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete cytoreduction as indicated by Evidence of distant hematogenous metastatic disease or distant nodal metastases Evidence of parenchymal hepatic metastases Evidence of clinical, biochemical or radiological biliary obstruction Evidence of gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity which limits ability to obtain complete cytoreduction Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-999.0, Severe Hemophilia A Key Have severe hemophilia A Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not subjects No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening Platelet count ≥100,000 platelets/μL at screening CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening Viral load of <400 copies/mL if known HIV antibody positive at screening. Key Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion Previous treatment with rFVIIIFc as study drug or commercial product Other coagulation disorder(s) in addition to hemophilia A History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted) Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids. NOTE: Other protocol-defined inclusion/ May Apply | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-60.0, Epilepsy Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of medically refractory medial temporal lobe epilepsy Age above 12 years, below 60 years Average of 2 partial seizures per month during a baseline of 2 months Recording of seizures must have been done in a prospective manner using standard seizure diaries Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI Women of child-bearing age will be required to use a reliable method of contraception during the study duration Patient must be able to provide reliable seizure counts using seizure diaries and to complete the evaluations specified in the study procedures flow chart Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial medically refractory medial temporal lobe epilepsy MRI evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas Prior resective intracranial surgery Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording Patients who previously underwent any other type of neurostimulation for treating epilepsy Patients who unable to fill in questionnaires and comply with protocol requirements Progressive neurological or medical conditions Medical or psychiatric conditions precluding surgery or compliance Patients taking antidepressant medication Pregnancy at study onset | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-0.333, TSC Tuberous Sclerosis Complex Epilepsy for TSC patients male or female infants with a definite diagnosis of TSC (Roach criteria; Roach 1998 or DNA confirmed) age up to 4 months at the moment of enrolment no clinical seizures seen by caregivers or on baseline videoEEG recording written informed consent of caregivers. It is possible to give consent for the observational part of the study only. In this case, the child will not enter the randomized part of the study. for the control group male or female infants who have undergone routine MRI for reasons other than epilepsy and brain tumor or cortical defects age up to 24 months at the moment of study entry written informed consent of caregivers for TSC patients any type of seizures observed till baseline visit antiepileptic treatment at or prior to study entry contraindications to MRI any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the analyses or procedures for the control group any sign or symptom suggesting TSC diagnosis any type of seizures observed at study entry antiepileptic treatment at study entry history of seizures, with the exception of febrile seizures | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Intellectual Disability uses AAC with client client has congenital intellectual disability supports client for at least 6 months client has dementia symptoms client has severe, non-corrected visual impairment client has diagnosed autism | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy aged 18-65 years Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid poor compliance subjects whose dose of antiepileptic drug are changed during the study subjects whose seizure is not well-controlled judged by neurologist history of any kind of drug allergy pregnancy or nursing existing or recent significant disease (cardiac, hepatic, or renal disease, severe diabetes mellitus, sepsis, etc.) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-45.0, Healthy Volunteer between 18 and 45 years old 2. right-handed. 3. Fluent in English. 4. able to provide written informed consent. 1. Has a dermatological condition such as scars, burns, callouses, or tattoos that might influence cutaneous sensibility on the hands 2. Has had recent or permanent injury of upper limbs or amputation or use of prosthetic arm or leg 3. Used recreational drugs within the past month 4. Is pregnant or breastfeeding. 5. Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months). 6. Has a major medical condition, such as kidney, liver, cardiovascular, autonomic, pulmonary, or neurological problems (including blindness or deafness) or a chronic systemic disease (e.g. diabetes). 7. Has a medical condition potentially affecting somatosensation (e.g. Raynaud s Disease, peripheral neuropathy, or circulatory disorder). 8. Participant has or had psychiatric disorders such as major depression, major anxiety-related problems, substance or alcohol dependence or abuse, post-traumatic stress syndrome, bipolar disorder, psychosis, or suicide attempts or persistent suicide ideation. 9. Has metal implants or fragments in the body as this would make having an MRI scan unsafe. This includes pacemakers, medication pumps, aneurysm clips, metallic prostheses (such as metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have. 10. Is uncomfortable in closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine, or a condition that prevents him/her from lying flat for up to 1 hour or rotating palm up for 15 minutes while lying flat. 11. Weight of 275 pounds or higher. 12. History of head trauma that was diagnosed as a concussion or was associated with loss of consciousness or was associated with loss of consciousness. 13. Personal history of a seizure or first degree relative with a seizure disorder 14. Participation in brain stimulation within one week of any TMS session in this study 15. Use of neuro-active drugs including opioids, antidepressants, anticonvulsants/antiepileptics, antipsychotics, dopamine agonists, sleep or anxiety medications, stimulants like methylphenidate (Ritalin), antihistamines, certain viral medications, or any other medication affecting the central nervous system 16. History of hearing loss 17. Obtained less than 6 hours of sleep the night before either TMS session (will be asked at each TMS session) 18. Consumed more than 16oz of coffee or an energy drink (anything with 500mg caffeine or more) on the day of the TMS session. (Caffeine > 500mg and sleep deprivation can increase seizure risk (Engel J, 2008). 19. Consumed alcohol on the day of the TMS session or shows signs of alcohol intoxication or alcohol withdrawal syndrome 20. Motor threshold over 82% of Magstim output | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-60.0, Focal Epilepsy Clinical seizure(s) and history consistent with focal epilepsy At least two confirmed spontaneous seizures, at least 24 hours apart, in the 12 months prior to enrollment Complete AED history prior to enrollment (with approximate dates and doses) is available (exception can be made for AEDs taken for <1 week) Age ≥12 years and ≤60 years at time of seizure onset Age ≥12 years and ≤60 years at time of enrollment Treatment instituted not more than 4 months prior to enrollment One of the following: 1. Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing) 2. Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG 3. Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG 4. Focal lesion (non-progressive) on MRI with normal EEG (acceptable focal lesions MTS, FCD, single cavernoma, and AVMs that are not of large size and lack significant amounts of hemosiderin) Idiopathic or symptomatic generalized epilepsy Any epilepsy etiology that could produce significant gliosis or brain injury and would be likely to alter biomarkers. These 1. Epilepsy with an etiology occurring in the previous two years that would produce significant CNS injury (e.g., traumatic brain injury that involves direct disruption of brain tissue, stroke, encephalitis) 2. History of intracranial bleeding (e.g., subarachnoid, intraparenchymal) Identified genetic epilepsy syndrome Presence of moderate or greater developmental or cognitive delay prior to seizure onset (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be > 70) History of chronic drug or alcohol abuse within the last 2 years IGE/focal epilepsy mixed syndromes Progressive neurological disorder (brain tumor, AD, PME, etc.) Major medical co-morbidities such as renal failure requiring dialysis, metastatic cancer, HIV, or significant liver or renal disease Autism Spectrum Disorder Seizures only during pregnancy | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Cervical Dystonia • 18-65 year old male and female patients with primary cervical dystonia Subject may be untreated with botulinum toxin; treated with botulinum toxin but who are at least 8 weeks (+ 1 week) from a previous injection; or who have experienced an insufficient response to botulinum toxin in the opinion of the enrolling investigator. Note: We will aim to subjects who have a stable response that lasts 12 weeks or longer Subjects may be on stable anti-dystonia treatment (for at least one month) including anticholinergics, baclofen, and anxiolytics including benzodiazepines Secondary cervical dystonia Significant dystonia in body areas other than cervical region Cognitive impairment (e.g., Montreal Cognitive assessment (MOCA) < 26) Active psychosis History of aggression Active depression (Hamilton Depression Rating Scale (HDRS) score ≥ 12) Current abuse of alcohol or subjects who do not agree to avoid alcohol during treatment Substance abuse (current or prior) Active infection Hypersensitivity to perampanel | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Patients are diagnosed with medically intractable epilepsy patients have frequent interictal spikes on clinical EEG monitorings patients without large morphological abnormalities Patients with skull bony defects, intracerebral mass lesions, major brain malformations, large cystic regions will be excluded Any indwelling metal objects or implantable devices such as pace makers, cochlear implants, or implanted intracranial electrodes Patients with claustrophobia Patients with more than 2 grand mal seizures per month Patients will not be excluded on the basis of location of seizure onset zone, type or number of medications, or cognitive status (assuming the minimum has been met), or race | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Severe Intellectual Disability Patients with severe intellectual disability (IQ <35 ) or moderate (IQ <50) isolated or syndromic presentation but undiagnosed . The diagnosis is established during genetic counseling of a 6 CHU interregion Lack of family history ( parents). We are interested in this project to patients who do not have family history in order to increase the probability of identifying a de novo mutation . We do not however the hypothesis for some patients a mechanism recessive autosomal or X-linked Recruitment in 6 CHU HUGO . Patients are required to have been seen in genetics in a 6 CHU interregion . Molecular analyzes of the Fragile X syndrome and the CGH technique must be negative Indication sequencing exomique adopted by the Scientific Committee. The Scientific Committee project role to select patients whose DNA will be studied in order to optimize the chances of success for sequencing . This selection must take into account clinical parameters , but also genetic parameters ( potential inbreeding ) . The files will be selected by videoconferencing at the end of the monthly meeting of CLAD . The methodologist of the study will be invited to videoconferencing specific consent obtained for the study Parents patient with moderate or severe intellectual disability disagree with the preferred hypothesis of de novo mutation or recessive transmission mechanism Form with known syndromic diagnosis can be targeted molecular studies (clinical signs) Cause molecular DI identified by targeted molecular analysis or CGH Explicit refusal to participate in the study of the patient, parents, or one of the two parents Any other indication that intellectual disability The parents of the patient or the patient may be removed | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.333-0.833, Gross Motor Development Delay Cerebral Palsy will be based on delayed psychomotor development, as assessed by Alberta Motor Infants Scale, using -2SD as a cut-off point. Neurological signs will be investigated by Hammersmith Infant Neurological examination (HINE) together with a clinical neurological examinations. Magnetic resonance imaging (MR) will be used if available to support the risk of development of CP, only MR done for clinical purpose will be used. The risk factors suggested for in the intervention program will be confirmed by a child neurologist is unstable health, uncontrolled epilepsy, progressive disorder, diagnosis with a specific syndrome. Parent's communication language should be Swedish or English with satisfactory skills in either language for simple conversation. If the children show a catch-up in development at the second assessment (after 12 weeks) and show no sign of neurodevelopmental disorder the program will be terminated | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Male and female patients aged 18-65 years Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit At least 4 seizures per month within the last 2 months prior to randomisation Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy) Written informed consent Patient with nervus vagus stimulation Patient with primarily generalized seizures Known progressive neurological disturbance A history of status epilepticus within the past 3 months Seizure of non-epileptic origin Restricted legal competence and incapability to follow trial instructions Major psychiatric disorders Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers Need of excluded concomitant medication (see section 9.4.6.2) Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 9.0-999.0, Acne Vulgaris The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.) The Subject has more than 1 nodule on the face at Screening and at Baseline visits The Subject has any acne cyst on the face at Screening and at Baseline visits | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-55.0, Cognition Disorder Attention Deficit Disorder Traumatic Brain Injury To be included in the protocol, study participants must meet the following 1. Age 18 years, inclusive 2. A history of having sustained a moderate or severe TBI >= 6 months prior to enrollment. Evidence will be any one of the following 3 1. GCS 3 (GCS obtained in Emergency Room and noted in medical record) 2. Post-traumatic amnesia > 24 hours 3. TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e., documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history indicates that the patient suffered a TBI and meets the criteria) 3. Persistent post-concussive symptoms, according to the DSM-IV Research for Post-Concussional Disorder, including: a) Difficulty in attention or memory. b) One or more of the following symptoms, which started shortly after the trauma and persist for at least three months: i) Fatigability ii) Disordered sleep iii) Changes in personality iv) Apathy or lack of spontaneity c) Symptoms in (a) and (b) must have their onset after trauma, or there was a significant worsening of pre-existing symptoms after trauma. d) Disturbance from these symptoms causes significant impairment of social or occupational functioning and represents a significant decline from previous level of functioning. 4. Ability to read, write, and speak English 5. Ability to give informed consent. 1. Evidence of penetrating brain injury. 2. Contraindication to methylphenidate therapy: 1. Known glaucoma (consistently raised intraocular pressure with or without associated optic nerve damage) 2. Motor tics or a family history of Tourette's syndrome (diagnosed by presence of both multiple motor and one or more vocal tics over the period of a year, with no more than three consecutive tic-free months) 3. Known hypersensitivity to methylphenidate (hives, difficulty breathing, and swelling of face, lips, tongue, or throat). 4. Known severe anxiety or restlessness which prevents from doing day to day activities. 5. Known preexisting hypertension, heart failure, myocardial infarction, or ventricular arrhythmia. 6. Known preexisting psychosis, bipolar illness. 7. History of seizures, or interictal epileptiform discharges (IEDs) on EEG in absence of seizures. 8. Known peripheral vasculopathy, including Raynaud s phenomenon. 9. History of drug dependence or alcoholism. 10. Concomitant treatment with coumadin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine,clomipramine, desipramine). 11. Concomitant therapy with monoamine oxidase inhibitors (such as Marplan (isocarboxazid), Nardil (phenelzine), Emsam (selegiline), and Parnate (tranylcypromine) 12. Concomitant treatment with blood pressure medication (both for high and low blood pressure). 13. Pregnancy 14. Breastfeeding 3. History or evidence of disabling pre-existing or co-existing disabling neurologic or psychiatric disorders not related to TBI, such as: 1. Multiple sclerosis, pre or co-existing 2. Stroke (other than stroke at the time of TBI) 3. Pre-existing disabling developmental disorder 4. Pre-existing epilepsy 5. Pre-existing major depressive disorder, aggressive behavior, hostility 6. Pre-existing schizophrenia 4. Contraindication to MRI scanning 1. Ferromagnetic metal in the cranial cavity or eye, e.g., aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body 2. Implanted cardiac pacemaker or auto-defibrillator or pump 3. Non-removable body piercing 4. Claustrophobia 5. Inability to lie supine for two hours 5. Contraindication to TMS, such as metal in the cranial cavity or implanted electronic hardware. 6. Current participation in other interventional clinical trial 7. Non-adherence to use of effective method of contraception for females of able to become pregnant for time from enrollment to the study until 2 weeks after completion of the study drug. 8. Present history of alcohol and substance abuse disorder determined (by DSM-IV). 9. Body mass index (BMI) > 40 | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 3.0-15.0, Cortical Dysplasia Children aged 3 years; 2. MRI changes consistent with a diagnosis of FCD type II a or b; 3. History of at least two epileptic seizures in the past 6 months before randomisation; 4. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable; 5. Parent/ legal representative willing to give consent Previous use of the KD; 2. Not a surgical candidate for FCD resection; 3. Administration of the KD is medically contraindicated | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Epilepsy age between 18-70 years 2. diagnosis of temporal lobe epilepsy, with seizure focus defined by seizure semiology, EEG, MRI Brain, PET and/or ictal and interictal SPECT. 3. Must have a stable seizure frequency in the two (2) months prior to enrollment, as verified by the patient's seizure log and/or clinic notes and without recent antiepileptic medication changes. 4. Must score above 22/30 on the Montreal Cognitive Assessment (MoCA). 5. Must be able to provide informed consent Patient has a progressive or unstable neurological or systemic disease 2. Patient has an ictal focus over the F3 or F4 (DLPFC) field 3. Patient has a history of severe depression, as determined by a screen inventory test such as the Beck Depression Inventory or a psychiatrist 4. Patient has a history of severe traumatic brain injury or prior brain surgery with skull defect 5. Contraindictations to tDCS, including metal in the head or implanted brain medical devices 6. Pregnancy 7. Any implanted electrical medical device, including pacers and implanted cardiac defibrillators 8. History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year 9. History of dementia | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Brain Tumor Related Epilepsy (BTRE) Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider of the patient in the NIS A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative Patient is a male or female ≥ 16 years of age Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment) Patient has a retrospective Baseline seizure frequency of at least 1 partial-onset seizure in the 8 weeks prior to Visit 1 (enrollment/ Baseline visit) Patient does not have a previous diagnosis of epilepsy before tumor onset Patient does not have brain metastases Patient has a Karnofsky performance status scale index ≥ 60 % Patient is currently taking only 1-2 Baseline anti-epileptic drugs (AEDs) for epilepsy, other than LCM N/A | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.167-2.0, Infantile Spasms Age 2-24 months 2. Clinical spasms 3. Initial EEG with hypsarrhythmia or modified hypsarrhythmia The do not quantify the initial severity or frequency of infantile spasms. Infantile spasms is a unique epileptic disorder characterized by clusters of brief infantile spasms, where each one lasts a few seconds and cluster may last minutes. The diagnosis of infantile spasms and response to medication depends on the presence or absence of these events and the frequency of infantile spasms has not been used to determine medication efficacy in previous studies. A seizure diary will be used to quantify the seizure burden, however efficacy will depend on complete resolution of clinical spasms and resolution of hypsarrhythmia on EEG - Age <2months or older than 24 months 2. Tuberous sclerosis (if known at the time of enrolment) 3. Previous treatment (within 28 days) with VGB or hormonal treatments 4. Contraindications to hormonal therapy: This includes untreated systemic fungal infections, known hypersensitivity to prednisolone or other corticosteroids, or to any of the non-medicinal ingredients present in the solution. Active or latent tuberculosis, ocular herpes simplex, hypothyroidism, hepatic cirrhosis, nonspecific ulcerative colitis, abscess or other pyogenic infection, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, cardiac disease, thromboembolic disorders and diabetes mellitus. All patients with cardiac risk factors will receive an electrocardiogram (ECG), chest xray (CXR) and cardiology referral if indicated. Patients diagnosed with cardiac disorders will be excluded from the study since high dose steroids may exacerbate arrhythmias. 5. Inability of parents or guardians to give consent 6. Enrolment in a concurrent treatment trial that might affect outcome measures of this trial - | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Psychogenic Non Epileptic Seizure Patient above 18 years old Affiliation to social security Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination Standardized announcement of the disease made by a neurologist participant / PHRC training Good understanding of the French language Patient consented to participate in the study Acute psychiatric pathology at the time of warranting urgent hospitalization (acute suicidal risk, Table delusional ...) Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...) A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...) Simultaneous participation to another therapeutic intervention study during the first 12 months | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy For Adult patient (≥ 18 years) suffering from drug-resistant partial epilepsy Patient undergoing long-term video-EEG monitoring in one of the participating centre to record and characterize its seizure Patient who gave its written informed consent to participate to the study For randomization Patient who suffers a secondary generalized tonic-clonic seizure during the long-term video-EEG monitoring while being supervised by a nurse or a physician Age < 18 years Patient that has already been randomized in this study Pregnant or breastfeeding women Hypersensitivity to naloxone History of severe heart disease (myocardial infarction, heart failure disorder, arrhythmia severe hypertension) Ongoing opioïd treatment, including both pure agonists and partial agonists Addiction to opioïds, heroin, or any similar substance Patient participating in another drug trial for less than 2 months | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-64.0, Epilepsy, Temporal Lobe Diagnosis of mesial temporal lobe epilepsy based on the combination of clinical semiology, neuroimaging findings, and electroencephalogram results At least 1 seizure with loss of awareness per 4-week period, on average, despite the use of antiepileptic drugs Prior brain surgery or exposure to transcranial magnetic stimulation Rapidly progressive brain lesions Inability to tolerate MRI or TMS Specific MRI or TMS contraindication as set forth in standard protocols of our institution | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Focal Seizures For in Part B of the study patients must fulfil ALL of the following Male or female aged between 18 and 65 years, inclusive Well-documented history of focal epilepsy, compatible electroencephalogram and clinical history Documented computerized tomography / magnetic resonance imaging that shows no progressive neurologic abnormality Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination) Currently treated with one to three AEDs All medications or interventions for epilepsy (including ketogenic diet) must have been stable for one month prior to screening and the subject is willing to maintain a stable regimen throughout the study Subject is willing to keep any factors expected to affect seizures stable (such as the level of alcohol consumption and smoking). The patient may not enter Part B of the study if ANY of the following apply Time of onset of focal epilepsy treatment is less than two years prior to enrolment Patient has seizures that are not of focal onset | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Focal Seizures For in Part A of the study patients must fulfil ALL of the following Male or female aged between 18 and 65 years, inclusive Well-documented history of focal epilepsy, with focal seizures as the primary seizure type, compatible electroencephalogram and clinical history Documented computerized tomography / magnetic resonance imaging that shows no progressive neurologic abnormality Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination) Currently treated with one to three AEDs as follows Group 1 subjects on inducer AEDs (and not on inhibitor AEDs) Group 2 subjects on inhibitor AEDs (and no on inducer AEDs) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-99.0, Epilepsy Generalized Tonic-Clonic Seizures Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or female between the ages of 2-99. 4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm). 5. If female and of childbearing potential, has a negative pregnancy test. 6. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments. 7. Subject and/or Primary Caregiver must be competent to follow all study procedures. 8. Is able to read, speak, and understand English Does not have a documented history of generalized seizures. 2. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission. 3. Intracranial EEG electrodes are being used 4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm). 5. Pregnant female. 6. Subject/Caregiver is unable to provide consent | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com). This post-approval study also has the following additional study related Subject or legal guardian is able to provide appropriate consent to participate Subject is able to maintain a seizure diary alone or with the assistance of a competent individual Subject is able to attend clinic appointments in accordance with the study schedule Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com). This post-approval study has the following additional study related Subject is participating in a therapeutic investigational drug or device study Subject was treated with a VNS within the last three months (90 days) Subject is pregnant | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 4.0-999.0, Epilepsy Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981) Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline) If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS) Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) Subject meets the withdrawal for SP0982 or is experiencing an ongoing serious adverse event (SAE) Subject has an active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS) Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%) For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic case report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the limit may be repeated once for confirmation. This includes re-screening | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-80.0, Epilepsy Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Epilepsy adults with no contraindications to MRI scanning. Initial screening for MR compatibility will be performed at recruitment. 2. epilepsy with interictal epileptic discharges evident on scalp EEG. 3. rarity or lack of seizures. This is an important point to minimise the risk of the patient having a seizure during scanning. 4. expected rate of interictal epileptic discharges sufficient to allow at least 10 but less than 200 events to be recorded per hour. Both too few and too many events make interpretation of the EEG-fMRI results difficult. 5. willingness to remain in the scanner for a minimum of 40 minutes. This ensures that a reasonable amount of fMRI data is collected. It is important that motivated subjects are recruited, preferably those who have previously undergone MRI scanning and so have some idea of the environment contraindications to MRI scanning. 2. epilepsy with rare or absent interictal discharges, or frequent seizures. 3. patient is unable to give informed consent or understand the nature of the study. 4. neurological or psychiatric diagnosis other than epilepsy | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-59.0, Epilepsy Seizures, Epileptic The patient has been correctly informed The patient must have given his informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is at least (≥) 18 years old and less than (<) 60 years old The patient has experienced a first generalized, epileptic seizure (patients with partial onset and secondary generalization can also be included) The seizure has occurred less than 24 hours ago The patient is participating in another study that may interfere with the results or conclusions of this study Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study The patient is in an period determined by a previous study The patient is under judicial protection The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant or breast-feeding (MRI contraindicated) Patient has a previous abnormal brain imaging (MRI) Patient has abnormal biological tests for toxicology (alcohol, cocaine and cannabis tests), blood ionogram (hyponatremia <130mM), liver enzymes (>5N), inflammatory syndrome (elevated C-reactive protein) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 20.0-80.0, Bladder Cancer all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 15.0-999.0, Epilepsy Age greater than or equal to 15 years Patients with drug-partial resistant epilepsy with the following characteristics Disabling epilepsy despite an optimized pharmacological treatment An average of one seizure a day or more during the week preceding the Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data Existence of measurable EEG markers of epilepsy Anti-epileptic drug treatment unmodified during the 2 weeks preceding the no change to treatment planned during the study Signed informed consent Patients under 15 years Patients in which a standard quality EEG recording is not possible Patients with ictal bradycardia or ictal syncope Patients with heart disease which may result in heart arrhythmia Incapacitated patients (curatorship, guardianship), patients deprived of liberty Pregnant or lactating women Vagus nervus stimulation is not an | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Hemispatial Neglect Written informed consent Healthy participants Age 18-80 years Neurologically healthy, i.e., with no documented or present neurological disease or brain injury normal or corrected-to-normal visual acuity Patients Age 18-80 years Showing signs of left hemispatial neglect after a right-hemispheric brain lesion, as assessed by previous neuropsychological testing and clinical judgment Normal or corrected-to-normal visual acuity Healthy participants Any instable medical condition, in particular epilepsy (past or present, including seizures or febrile convulsions) Any surgical intervention to the brain Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers) Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces) Drug or alcohol abuse Intake of any medication that is likely to lower seizure threshold For female participants: pregnancy or breast feeding or intention to become pregnant during the course of the experiment. All participants of childbearing potential will be asked to take a pregnancy test Patients Any instable medical condition, in particular epilepsy (past or present, including seizures or febrile convulsions) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Heart Rate Nocturnal Seizures Autonomic Nervous System Epilepsy Clinically firm diagnosis of epilepsy. 2. 18 years of age 3. Having the capacity to consent to this project Patients who are on medication for cardiac conditions like beta blockers, anti arrhythmic agents, calcium channel blockers. 2. Patients who have other neurological disorders which may be associated with an autonomic neuropathy 3. Patients who have diabetes, renal failure or another general medical disorder associated with autonomic neuropathy. 4. Patients unable to complete self-report measures unaided | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.083-3.917, Epilepsy With Partial-onset Seizures Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks gestational age]) to <4 years of age Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1 prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be consistent with this diagnosis Subject weighs >=4 kg to <30 kg at Visit 1 Subject has experienced >=2 partial-onset seizures with or without secondary generalization during each consecutive 7-day period during the 2 weeks prior to Visit 1 Subject has >=2 partial-onset seizures with or without secondary generalization during the End-of-Baseline video-EEG. Electrographic seizures are defined as recognizable ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge lasting a total of >10 seconds Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs. The dosage regimen of concomitant AED therapy must be kept constant for a period of >=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant benzodiazepine (BZD) will be considered as a concomitant AED Vagus nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must have been implanted for >=6 months prior to Visit 1; device settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed Subject is an acceptable candidate for venipuncture Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to partial-onset seizures is not exclusionary Subject is on a ketogenic diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study Subject has creatinine clearance <30 mL/minute Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450 ms) Subject has a hemodynamically significant congenital heart disease Subject has an arrhythmic heart condition requiring medical therapy Subject has a known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias Subject has nonepileptic events that could be confused with seizures. Subjects may be included if epileptic events can be clearly distinguished and the frequency meets the study Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis continua, primary generalized epilepsy, Dravet Syndorme, or seizures that are not of partial-onset origin Subject has a history of generalized convulsive status epilepticus <=2 months prior to Screening (Visit 1) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 10.0-18.0, Intellectual Disability Intellectual disabilities (ID) group children with mild to moderate intellectual disabilities able to walk independently can follow simple commands 2. Typical developed children age-matched TD children fracture or receive orthopedic surgery within six months. 2. Participate in regular soccer training | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Highly Drug-resistant Focal Epilepsy Subject is an adult (18 years of age or more) Subject is able to understand the study and the ICF as assessed by the Investigator. Subjects with known mental retardation (defined as IQ below 70) are not eligible to participate. Subject and/or caregiver is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and the medication intake scheme as instructed according to the judgment of the Investigator Subject fulfills ILAE (1989) for focal epilepsy; clinical semiology should be described and fulfill for focal seizures; there will have been an electroencephalogram (EEG) reading compatible with focal epilepsy in the last 5 years; the subject has no seizures that are not focal by the new ILAE criteria; a brain MRI (magnetic resonance imaging) or head CT (computed tomography) to be performed before randomization, if no such scan was performed in the last 5 years, and a report is available. If a scan was performed within the last 5 years but the epilepsy has not been stable since the last scan, a new scan should be obtained Subject has failed to achieve seizure control with ≥4 appropriately chosen Antiepileptic Drug (AED) regimens of adequate dose and duration, including the current treatment, as documented in medical records and per Investigator assessment of patient report Subject is currently treated with a stable dose of at least 1 AED for the 4 weeks prior to the Screening Visit (Visit 1) and throughout the duration of the Treatment Period with or without additional concurrent vagus nerve stimulation (VNS) or other neurostimulation treatments. The VNS must have been in place for at least 12 months with constant settings for at least 3 months and the battery life of unit anticipated to extend for the duration of study prior to the Screening Visit and throughout the duration of the study During the 4 weeks prior to Screening (Historical Baseline Period), subject must report to have had an average of at least 4 spontaneous and observable focal seizures per week ("focal seizures" refers to partial-onset seizures of type IA1, IB, and IC, but does not type IA2, IA3, or IA4 seizures), and cannot have had any seizure-free period longer than 3 days (based on Investigator assessment of subject report and seizure diaries if available). The cut-off seizure frequency (4 seizures per week) and maximum seizure-free interval (3 days) must be maintained during the 2-week Prospective Outpatient Baseline Period Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods. Oral or depot contraceptive treatment with at least ethinylestradiol 30 μg per intake used with an additional barrier contraception method, monogamous relationship with vasectomized or female partner, or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status. Abstinence will be considered as an acceptable method of contraception if the Investigator can document that the subject agrees to be compliant when it is in line with the preferred and usual lifestyle of the subject Male subjects confirm that during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) and that the respective partner will use an additional contraceptive method Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device) Subject has a known hypersensitivity to any components of UCB0942 formulation or to similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy that, in the opinion of the Investigator or UCB Study Physician, contraindicates her/his participation Subject has a current or past psychiatric condition that, in the opinion of the Investigator, could compromise his/her safety or ability to participate in this study including a history of schizophrenia, schizoaffective disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric will be determined based on screening with the BPRS plus the Mini International Neuropsychiatric Interview (MINI) Subject has taken other (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital or any other drug known to induce CYP3A4 liver enzymes; Subject is taking tiagabine, felbamate, or vigabatrin; Subject is taking benzodiazepines, zolpidem, zaleplon, or zopiclone >3 times per week for any indication Subject has a clinically significant abnormality on echocardiography at Screening or a history of rheumatic heart disease or other known valvular abnormalities Subjects with a history of hypersensitivity reactions or autoimmune disease Female subject who is pregnant or breastfeeding | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Epilepsy Clinical diagnosis of symptomatic epilepsy Disease progression for the last 1-3 years Resistance of epilepsy to therapy with carbamazepine, valproic acid, topiramate, lamotrigine, and phenobarbital (anti-epileptic drugs/AEDs) as monotherapies or combination therapies Signed informed consent Central nervous system inflammatory disorders (meningoencephalitis of viral or parasite origin) Chronic decompensated psychoses ,dementia, social disadaptation Central nervous system tumours Blood positivity for hepatitis B or C or HIV infection According to the judgment of the researchers, subjects who were unable to complete the study or may not have been able to comply with the requirements of this study (due to administrative or other reasons) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-90.0, Cortical Spreading Depolarization Cortical Spreading Depression Subarachoid Hemorrhage Traumatic Brain Injury GCS <8 SAH or severe traumatic brain injury requiring craniotomy Consent obtainable (via legal representative) Ictus (bleed or injury) within 48 hours of enrollment Clinically appropriate for multimodality monitoring Anticipated survival <48 hours No craniotomy Infratentorial craniotomy only•Unable to obtain consent Absence of clinically used multimodality monitoring Prisoners Pregnant | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Epilepsy Refractory unifocal epilepsy Early ictal SPECT with intravenous injection did not localize the ictal onset zone Several seizure per day, or clusters of several seizures per day Seizures are of short duration (i.e. less than 10-15 seconds) Patient asks for epilepsy surgery Renal failure Allergy to contrast agents Fever Anemia Usage of anticoagulants Pregnancy | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, COPD The established were: having a COPD (COPD was confirmed if the post-bronchodilator forced expiratory volume in one second (FEV1) divided by the forced vital capacity was less than 0.7 (FEV1/FVC<70%) and having been admitted at least twice in the previous year or three times in the two previous years for a COPD exacerbation (eCOPD) were another significant respiratory disease, an active neoplasm, a terminal clinical situation, inability to carry out any of the measurements of the project, or unwillingness to take part in the study | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Partial Epilepsy Male or female and greater than or equal to 18 years of age at the time of signing the informed consent. The upper age limit is 70 years inclusive. 2. Weight at least 30 kg 3. Written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. In Germany, only the subject may sign the informed consent form in accordance with ICH guidelines. 4. A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history). 5. Have uncontrolled partial seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years. 6. Currently on stable antiepileptic treatment regimen: 1. Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2 2. Vagal nerve stimulator (VNS) will not be counted as an AED; however, the parameters must remain stable for at least 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1. 3. Benzodiazepines taken at least once per week during the 1 month prior to Visit 1 for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED and must be continued unchanged throughout the study. Therefore only a maximum of 2 additional approved AEDs will be allowed. 7. Computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within the past 10 years that ruled out a progressive cause of epilepsy. If a CT or MRI has not been performed within the past 10 years, one must be performed prior to randomization. 8. Ability to reach subject by telephone. 9. Use of an acceptable form of birth control by female subjects of childbearing potential History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization. 2. History of any drug-induced rash or hypersensitivity reaction. 3. History of a first degree relative with a serious cutaneous drug-induced adverse reaction. 4. History of serious systemic disease, including hepatic insufficiency, renal insufficiency, a malignant neoplasm, any disorder in which prognosis for survival is less than 3 months, or any disorder which in the judgment of the investigator will place the subject at excessive risk by participation in a controlled trial 5. Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone 6. Subjects taking concomitant AEDs other than phenytoin or phenobarbital, must not be taking phenytoin or phenobarbital or primidone 7. Subjects with clinical evidence of phenytoin or phenobarbital toxicity 8. A history of nonepileptic or psychogenic seizures 9. Presence of only nonmotor simple partial seizures or primary generalized epilepsies 10. Presence of Lennox-Gastaut syndrome 11. Scheduled epilepsy surgery within 8 months after Visit 1 12. Subjects implanted with or planning to have implantation of deep brain stimulator 13. Pregnancy or lactation 14. Any clinically significant laboratory abnormality that in the opinion of the investigator would the subject from the study 15. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal (ULN) 16. An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results 17. Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study 18. Presence of psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recent history (within 6 months) of major depressive episode 19. History of alcoholism, drug abuse, or drug addiction within the past 2 years 20. Current use of felbamate with less than 18 months of continuous exposure 21. Current or recent (within the past year) use of vigabatrin or ezogabine. Subjects with a prior history of treatment with vigabatrin must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies. 22. History of status epilepticus within 3 months of Visit 1 23. Screening laboratory investigation demonstrates abnormal renal function 24. Absolute neutrophil count less than 1500/µL 25. Clinical or ECG evidence of serious cardiac disease, including ischemic heart disease, uncontrolled heart failure, and major arrhythmias, or relevant replicated changes in QT intervals (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females) 26. Platelet counts lower than 80,000/µL in subjects treated with VPA 27. A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years. 28. More than 1 lifetime suicide attempt 29. Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations) 30. Current use of any of the following medications: clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, fosphenytoin, ethotoin, mephenytoin, or natural progesterone (within 1 month of Visit 1) 31. History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV 32. Presence of congenital short QT syndrome 33. A history of previous exposure to YKP3089 | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.083-21.0, Train-of-Four-Monitoring general anesthesia participation in another trial refusal of participation state after burns diabetes mellitus reflux disease difficult airway pregnancy Medications volatile anesthetics antibiotics (Aminoglykoside, Polymyxin, Clindamycin, Lincomycin, Tetrazykline) local anesthetics | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Key Participant must have had epilepsy, as determined by the investigator, and must have been taking CLB Participant must have had a documented magnetic resonance imaging/computerized tomography of the brain ruling out a progressive neurologic condition Participant must have experienced at least 1 seizure of any type (that is, convulsive: tonic-clonic, tonic, clonic, atonic; focal: focal seizures with retained consciousness and a motor component, focal seizures with impaired consciousness, focal seizures evolving to bilateral secondary generalization) within the 2 months prior to randomization Participant must have been taking CLB and no more than 2 other antiepileptic drugs (AEDs) during the course of the study. However, any participants who were taking these medications after screening were not withdrawn from the study unless there were safety concerns AED(s), including CLB, must have been stable for 4 weeks prior to screening and regimen must have remained stable throughout the duration of the double-blind phase of the study Intervention with vagus nerve stimulation and/or ketogenic diet must have been stable for 4 weeks prior to Baseline and participant/caregiver must have been willing to maintain a stable regimen throughout the double-blind phase of the study. Key Participant had clinically significant unstable medical conditions other than epilepsy Participants were on CLB at doses above 20 mg per day Participants taking CLB intermittently as rescue medication Participant had a history of symptoms related to a drop in blood pressure due to postural changes (for example, dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) Participant had any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale in the last month or at screening Participant had clinically relevant symptoms or a clinically significant illness, other than epilepsy in the 4 weeks prior to screening or enrollment, other than epilepsy Participant had consumed alcohol during the 7 days prior to enrollment and was unwilling to abstain during the double-blind phase of the study Participant was currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry Participant had any known or suspected history of any drug abuse or addiction Participant was unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex) for the duration for the study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Ictal/Post-ictal Hypoxemia Patient suffering from drug-resistant focal epilepsy Age ≥ 18 years Patient for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment For women of childbearing age, a method of contraception considered effective by the investigator Patient who have given their written informed consent Patient accepting an interview with a psychologist and to be refered to a psychiatrist in the event that mood disorders were detected on mood scores and considered severe by the investigator and / or psychologist, leading to require psychiatric care or immediate antidepressant treatment Patient with a social security number Age < 18 years Patient under legal protection Pregnant or breastfeeding women Hypersensitivity to fluoxetine or its excipients History of other serious side effects related to an earlier prescription of fluoxetine Current suicidal ideation or history of suicide attempt Manic episode Disruption of liver enzymes considered material by the investigator using the following transaminases (ALT and AST)> 2N alkaline phosphatase (ALP)> 2N gamma glutamyl transpeptidase (GGT)> 5N (performed as part of routine monitoring of epileptic patients on antiepileptic treatment. Patients often exhibit changed deemed clinically insignificant due to the enzyme-inducing effect of these drugs) Renal failure with creatinine clearance <30 ml / min Acute heart disease | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Patients over 18 years patients definitively diagnosed Focal Epilepsy based on clinical and additional tests patients with stable and identifiable antiepileptic treatment during the last two years patients according to the investigator are able to provide clinical data necessary for the development of the study Patients who signed informed consent Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach and / or attachment to one of the study groups | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Severe Sepsis Prior written informed consent of the patient. If this is not possible, it will be necessary for the investigator to obtain initial informed consent according to the requirements. The legally authorized representative has to provide the written informed consent or in his absence a declaration for in an emergency situation is to be signed by a consultant physician who is not involved in the study and who is independent of the investigational team. If the patient dies following the in the clinical trial based on the consulting physician´s vote and no legally authorized representative is available / able to give informed consent, no additional informed consent will be needed and the consultant physician´s vote will be considered sufficient. 2. Male or female patient aged 18 years or older 3. Presence of severe sepsis defined as Sepsis due to a known or suspected infection with two or more of the modified systemic inflammatory response syndrome (SIRS) (46) Temperature (> 38°C or < 36°C) Heart rate (> 90 beats / minute) Respiratory rate (>20 breaths / minute) or arterial carbon dioxide (PaCO2) < 32 mmHg (< 4.3 kPa) White blood cells (WBC) > 12.000 cells/mm3, < 4000 cells/mm3, or > 10% immature (band) forms Severe sepsis for less than 24 hours with at least one of the following characteristics Ratio of partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) < 250 Arterial pH < 7.3 or serum lactate level > 1.5 × ULN (upper limit of normal) Hypotension: Inadequately fluid resuscitated patients with a systolic blood pressure ≤ 90 mmHg or MAP ≤ 70 mmHg, or adequately fluid resuscitated patients requiring vasopressors to maintain blood pressure within normal ranges Volume expansion with a dosage of HES administered prior to randomization rendering a patient unsuitable for based on the treating physician´s discretion in consideration of the suggested maximal dose/day. 2. Known volume expansion with any dosage of HES 200.000 prior to during the actual hospital admission. 3. Participation in another clinical study with an investigational drug or an investigational medical device within 30 days before screening or planned during the study period. 4. Known hypersensitivity to any components of the investigated solutions. 5. Known pregnancy; female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum or urine dipstick pregnancy test (if a test result is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive). 6. Known serum creatinine > 300 μmol/L, corresponding to 3.4 mg/dL (if a serum creatinine value is not available at the time of randomization or an available value is older than 24 hours, a patient may be randomized and treated. If a creatinine value of > 300 μmol/L becomes available later, treatment with the study drug may be continued if the risk/benefit ratio for the individual patient is regarded as positive by the investigator.) 7. Known history of chronic renal failure (hemodialysis) 8. Anuria lasting more than 8 hours (<50ml urine output / 8 hours) despite fluid resuscitation prior to randomization. 9. Requirement for renal support (either continuous or discontinuous techniques, including intermittent hemodialysis, hemofiltration and hemodiafiltration) 10. History of known hemostatic disorders with clinical bleeding (hemophilia and known or suspected Willebrand disease) 11. Burns >20% of body surface 12. State of brain death 13. Known co-morbidities: Hematologic malignant disorders, neutropenia (polymorphonuclear leukocytes [PMN] < 500/mm3), proven liver cirrhosis, Aquired immunodeficiency syndrome (AIDS) Expected requirement for concomitant cancer therapy (e.g. chemotherapradiotherapy or surgery) from randomization until Day 4 Requirement for concomitant cancer therapy (e.g. chemotherapy, radiotherapy or surgery) from randomization until Day 4 14. Known fluid overload (EVLWI > 10 ml/kg BW) 15. Need for fluid restriction 16. Refractory septic shock defined as severe sepsis with hypotension unresponsive to adequate fluid resuscitation, along with the presence of hypoperfusion abnormalities or organ dysfunction as defined by Bone et al., 1992. Patients receiving inotropic or vasopressor agents may no longer be hypotensive by the time they manifest hypoperfusion abnormalities or organ dysfunction, yet they would still be considered to have septic shock. Patients treated with low dose vasopressors are not excluded provided they are responsive to fluid resuscitation as demonstrated by an individual fluid challenge. Patients receiving norepinephrine (noradrenaline) or epinephrine (adrenaline) at a dose > 0.5 μg/kg/min or dopamine at a dose > 15 μg/kg/min at the timepoint of Screening are not eligible for the study. 17. Intracranial bleeding 18. Any condition rendering a patient unsuitable for based on the treating physician´s discretion | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Epilepsy patients with planned intracerebral exploration (SEEG) informed patient patient affiliated to French social security Patients under 18 Pregnant or breastfeeding women Patients deprived of liberty by legal decision Patients not covered by social security Patients who did not sign informed consent patients who cannot undertake MRI exam | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, IgG4-related Sclerosing Cholangitis IgG4-related Disease The presence of a biliary stricture years and older Consented to IRB 707-03 Younger than 18 years of age Unable to collect a bile sample Abnormal postsurgical anatomy preventing collection of a bile sample | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Highly Drug-resistant Focal Epilepsy A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study Subject must have completed Visit 13 (V13) of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073 In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half lives whichever is longer) prior to study entry Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded: 1. Prolonged QTc (Bazett's, machine-read) interval defined as > 450 ms for males and > 470 ms for females 2. Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms) 3. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats 4. In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration Subject has a clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073 Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome) at the EV (V2) of EP0073 (V15 of EP0069). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For enrolled subjects with a baseline result ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). If subject has >ULN ALT, AST, or ALP that does not meet the limit at screening (ie, the value is ULN but <=2xULN at the EV [V2] of EP0073), repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, of the subject must be discussed with the Medical Monitor | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 8.0-999.0, Epilepsy Cancer Brain Neoplasm To be eligible for entry into the study, a candidate must meet all the following Be 8 years of age or older Have solitary primary or recurrent brain tumor with associated seizures. Brain tumor may be diagnosed radiologically. Associated seizures are defined as those with activity starting within three months of radiologic diagnosis of the primary or recurrent tumor. In cases when the timing of seizure activity is unclear with respect to the timing of diagnosis, seizures will be considered associated with the tumor if seizure semiology is consistent with that location. Ongoing seizures are not required. Patients can be included if they have had a single previous seizure. Patients who have not experienced seizures after institution of anti-convulsant therapy are not excluded Agree to undergo brain surgery Willing and able to appoint a durable power of attorney Candidates will be excluded if they Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions that would make surgery unsafe, such as lung or cardiac disease that would render them unable to tolerate the risk of general anesthesia, or severe immunodeficiency or systemic cancer not related to a brain lesion Cannot have an MRI scan Have multiple brain tumors, evidence of carcinomatous meningitis, gliomatosis cerebri, or primary CNS lymphoma. Patients with multiple metastatic lesions that for which surgery is not indicated will be exluded. Patients with peripheral neurological or systemic metabolic disorders that cause seizures will be excluded Have an underlying seizure disorder that is unrelated to the brain tumor, or underlying neurological disorder that is unrelated to the brain tumor and that may contribute to seizure activity At the time of enrollment, lack consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Patients with mental disorders or those patients who are cognitively impaired yet still retain consent capacity will not be excluded. Children may be enrolled if there is a parent or guardian able to consent on their behalf | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Traumatic Brain Injury (TBI) 60 years of age Fluent in English Documented history of TBI or blast exposure since 2001 Inability to have MRI Pregnancy History of TIA within last 6 months Presently involved in open litigation | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 1.0-60.0, Epilepsy Ages 1-60 years of age. 2. Patient must have at least 4 clinically countable seizures per month. They must also have prior concomitant video-EEG with evidence documenting a diagnosis of epilepsy. Seizure history to a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization. 3. Drug resistant epilepsy defined as a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial and documented evidence of drug and other therapeutic failures. 4. Between 1-4 baseline anti-epileptic drugs at time of enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit and are not contraindicated for inclusion. 5. Subject and family sign assent (if capable)/consent/research authorization and are able to meet the study expectations for appointments for the duration of the study 6. VNS, if in use must be on stable settings for a minimum of 1 month. 7. If on ketogenic diet, must be on stable ratio for a minimum of 3 months. 8. Patients or their caregivers must be able to consistently maintain a seizure diary for at least 2 months prior to enrollment and during the course of the study period. 9. Must be Nebraska state resident Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by: values above upper limits of normal for BUN/creatinine, or values twice the upper limit of normal for serum transaminases (ALT/SGPT, AST/SGOT), values twice the upper limit of normal for serum lipase and amylase, platelets <80,000 /mcL, WBC<3.0 103 /mcL 2. Less than 4 countable (non-countable seizures includes absence and myoclonic) seizures per month 3. Use of cannabis-related product within last 30 days 4. Active substance abuse/addiction. 5. CBD is contraindicated in pregnancy and breastfeeding. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a urine pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while taking cannabidiol, and must agree to an acceptable method of barrier contraception use during the study which should abstinence or a double barrier method for the duration of treatment. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study. If pregnancy occurs, CBD will be stopped in the most clinically appropriate manner. 6. Allergy to CBD or any cannabinoid. 7. Unable to provide consent (and no LAR available) 8. Unable to comply with study visits/requirements. 9. Use of alcohol | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Epilepsy With POS With or Without Secondary Generalization Patient has never been treated with brivaracetam (BRV) prior to enrollment in this Non-Interventional Study (NIS) The decision by the treating physician to prescribe BRV is made independently of the participation in the NIS Patient is a male or female ≥16 years of age Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or without secondary generalization Patient uses an epilepsy/seizure diary No specific | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-999.0, Rett Syndrome Diagnosis of Classic Rett syndrome as defined by the clinical consensus Presence of a MECP2 mutation Post-regression stage of development, defined as greater than 6 months since the last loss of hand use or verbal language Average of at least 4 observable seizures (generalized or partial-onset [Generalized Tonic-Clonic, Generalized Tonic, Generalized Clonic, Generalized Atonic, Partial/Focal with Secondary Generalization, Myoclonic, Myoclonic Atonic, Myoclonic Tonic, Complex Partial/Focal, and Simple Partial/Focal Motor) in one month prior to the study by caregiver report or presence of dystonia on average at least four times in one month prior to the study in at least one body region rated as at least "mild" by caregiver report Use of at least one anti-seizure medication at screening visit At screening visit, managed on four or fewer concomitant anti-seizure medications that must have been stable in dose at least one month prior to the beginning of screening and anticipated to remain stable in dose through the end of the 8.5 month trial period Legally authorized caregiver must be willing to give written informed consent after the nature of the study has been explained, and prior to any research-related procedures Caregiver and participant must, in the opinion of the investigator, be willing and able to complete all aspects of the study, comply with accurate completion of the seizure and dystonia diaries, and be likely to complete the four month treatment period Markedly abnormal metabolic screening laboratory testing (e.g., serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2X the upper limit of normal) Any known hypersensitivity to triheptanoin that, in the judgment of the investigator, places the subject at increased risk for adverse effects Prior use of triheptanoin within 1 month prior to screening Participants or caregivers who are unwilling or unable to discontinue use of a prohibited medication or other substance that may confound study objectives Use of any other investigational product, including drugs or supplements within 1 month prior to Screening, or at any time during the study Has a condition of such severity and acuity, in the opinion of the investigator, that it warrants immediate surgical intervention or other treatment Has a concurrent disease or condition, or laboratory abnormality that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or introduces additional safety concerns (e.g., diabetes mellitus) Pregnant or nursing women | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-45.0, Seizures, Focal All patients with the clinical diagnosis of localization related epilepsy/focal seizure (International League Against Epilepsy 2010) with a history of an episode of seizure within 48 hours of presentation Treatment naïve patients or patients who had not taken any treatment for at least 3 weeks before inclusion History of any recent traumatic brain injury, cerebral ischemia/transient ischemic attack/stroke Patients with neuroendocrinal tumours History of any invasive neurosurgical /non-invasive neuropsychiatric procedure Patients who are already under treatment for the presenting conditions Medication history of psychoactive or central nervous system depressant drugs Pregnant and nursing women | 1 |
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