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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): 18.0-65.0, Epilepsy Epilepsies, Partial Seizures History of simple or complex partial epilepsy that has been documented or witnessed during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks good physical health Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG females who are capable of having children | 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 Epilepsies, Partial Seizures History of simple or complex partial epilepsy that has been documented or witnessed an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and no seizure-free interval longer than 3 weeks good physical health Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG females who are pregnant, nursing, or those not using adequate birth control if capable of having children | 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 Epilepsies, Partial Seizures History of simple or complex partial epilepsy that has been documented or witnessed an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and no seizure-free interval longer than 3 weeks good physical health Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG females who are capable of having children | 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 Epilepsies, Partial Seizures History of simple or complex partial epilepsy that has been documented or witnessed an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy during an 8-week baseline phase, patient must have at least 8 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs) and have no more than one seizure-free interval of up to 3 weeks and no seizure-free interval longer than 3 weeks good physical health Patients having solely generalized seizures or lacking documentation of partial epilepsy patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy generalized seizures, which are defined by the EEG wave pattern seizures that lack an abnormal pulsation pattern on EEG female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children | 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, Neurodegenerative Diseases Mild Cognitive Impairment years or older Healthy person without memory complaints OR person diagnosed with a neurodegenerative disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis) MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.) Pregnant Claustrophobic anxieties | 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, Heart Failure, Congestive New York Heart Association (NYHA) Class II Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end diastolic dimension ≥ 60 mm (by echocardiogram) within 6 months prior to randomization Intrinsic QRS complex width ≥ 120 ms OR paced QRS measurement ≥ 200 ms ICD indication for primary or secondary prevention Optimal heart failure pharmacological therapy Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate ≤ 60 beats per minute (bpm) and 6 minute hall walk ventricular heart rate of ≤ 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate > 60 bpm and 6 minute hall walk ventricular heart rate of > 90 bpm and booked for atrioventricular junction ablation Intravenous inotropic agent in the last 4 days Patients with a life expectancy of less than one year from non-cardiac cause Expected to undergo cardiac transplantation within one year (status I) In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care Uncorrected or uncorrectable primary valvular disease Restrictive, hypertrophic, or reversible form of cardiomyopathy Severe primary pulmonary disease such as cor pulmonale Tricuspid prosthetic valve Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfy all other inclusion/ Coronary revascularization (coronary artery bypass graft surgery [CABG] or percutaneous coronary intervention [PCI]) < 1 month if previously determined LVEF > 30%. Patients with a more recent revascularization can be included if a previously determined LVEF was ≤ 30% | 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 for enrollment: 1. Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries or significantly impair functional ability. 2. Subject's seizures are distinct, stereotypical events that can be reliably counted. 3. Subject failed treatment with a minimum of 2 anti-seizure medications. 4. Subject has remained on the same antiepileptic medication(s) over the 3 most recent consecutive months (other than acute, intermittent use of benzodiazepines). Subjects on the ketogenic diet are permitted if the diet has been stable for the preceding 3 months. 5. Subject reports having an average of 3 or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures per month over the 3 most recent consecutive months, with no month with less than 2 seizures. 6. Subject is between the ages of 18 and 70 years. 7. Subject has undergone diagnostic testing that has identified no more than 2 epileptogenic regions. 8. Subject is male or a female of childbearing potential using a reliable method of contraception or is at least two years post-menopause. 9. Subject or legal guardian is able to provide appropriate consent to participate. 10. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual. 11. Subject is able to complete regular office and telephone appointments per the protocol requirements. 12. Subject is willing to be implanted with the RNS® System as a treatment for his/her seizures. 13. Subject is able to tolerate a neurosurgical procedure. 14. Subject is considered a good candidate to be implanted with the RNS® System. Note: A subject is still eligible to participate if antiepileptic medication(s) were temporarily discontinued for the purposes of diagnostic or medical procedures during the preceding 3 months for enrollment: 1. Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year 2. Subject has been diagnosed with primarily generalized seizures. 3. Subject has experienced unprovoked status epilepticus in the preceding year. 4. Subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease. 5. Subject is taking chronic anticoagulants. 6. Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded. 7. Subject is pregnant or planning on becoming pregnant in the next 2 years. 8. Subject is enrolled in a therapeutic investigational drug or device trial. 9. Subject has an implanted Vagus Nerve Stimulator (VNS) or is unwilling to have the VNS explanted. (VNS therapy must have been discontinued for at least 3 months prior to enrollment.) 10. Subject has had therapeutic surgery to treat epilepsy in the preceding 6 months. 11. Subject has had a cranial neurosurgical procedure (including endovascular procedures) other than an epilepsy surgery involving the skull or brain in the previous month. 12. Subject is implanted with an electronic medical device that delivers electrical energy to the head. 13. Subject is an unsuitable candidate for neurosurgery. 14. Subject requires repeat MRIs in which the head is exposed to the radio frequency field. 15. Subject's epileptogenic region(s) is/are located caudal to the level of the thalamus. 16. Implantation of the RNS® Neurostimulator and Lead(s) would present unacceptable risk | 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): 10.0-999.0, Epilepsy Seizures Epilepsies, Partial Epilepsy, Generalized Seizures, Tonic-Clonic Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures having at least 1 seizure within the 3 months prior to entry who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks weighing at least 25 kilograms (approximately 55 pounds) if female of childbearing potential, must be using an acceptable method of birth control Patients who have previously taken topiramate for the treatment of epilepsy who are currently taking topiramate for any reason having active liver disease having a clinically significant medical condition or disease women who are 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): 13.0-85.0, Epilepsy Patients with a recent diagnosis epilepsy Able to describe their symptoms by themselves Have had at least 2 episodes of seizures during the previous year Have had at least 1 headache during the previous year Well-controlled epileptic patients taking anti-epileptic medications | 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, Heart Failure age greater than 18 years old, 2. CHF diagnosis for more than 6 months regardless of etiology, 3. echocardiography-based left ventricular ejection fraction equal or less than 40%, and 4. prior CHF admission within three months from randomization thoracic deformity or severe chronic lung disease imposing technical limitation to perform high-quality echocardiography, 2. acute coronary syndrome in the last three months, 3. congenital heart disease, 4. moderate to severe stenotic heart valve disease or 5. end-stage renal failure | 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): 3.0-999.0, Epilepsy typical history of focal seizures EEG centrotemporal sharp waves age of onset 3-12 years no previous epilepsy type (febrile seizures OK) normal development normal neurological examination normal MRI/CT (if done) only history of secondary generalized seizures atypical history/semiology history and EEG inconsistent | 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): 2.0-999.0, Seizures Epilepsy Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor History of the type of seizure during the period prior to in the study and sufficient medical records to document this. Prior treatment until in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months Patients with progressive brain tumor or other progressive or degenerative disorders Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout 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): 18.0-65.0, Schizophrenia Heavy Smoking Age 18-65 male or female. 2. DSM -IV for chronic schizophrenia or schizoaffective disorder. 3. Ability and willingness to sign informed consent for participation in the study. 4. Patients' expressed interest in participating in a smoking-reduction program 5. Smoking a minimum of 20 cigarettes daily, for 6 months prior to the study period, as per patient report. 6. Patients treated with antipsychotic agents Significant physical illness. 2. Evidence of organic brain damage , mental retardation , alcohol or drug abuse. 3. Pregnant or nursing female patients | 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 Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months Symptomatic epilepsy due to malignant brain tumour or progressive brain disease Confirmed diagnosis of a concomitant chronic 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): 40.0-999.0, Osteoarthritis clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/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): 6.0-65.0, Severe Hemophilia A Male At least 6 years of age and not more than 65 years of age Signed and dated Informed Consent Form and Patient Authorization for Release of Information approved by the appropriate Institutional Review Board (IRB) prior to screening and enrollment. If the subject is a minor (i.e., less than 18 years of age) both he and his parent or legal guardian must sign and date the informed consent Diagnosis of severe hemophilia A Levels of Factor VIII less than 0.01 IU/mL Treatment with cryoprecipitate, Factor VIII concentrates, and/or whole blood, for at least 150 cumulative exposure days (CEDs) prior to enrollment No treatment with cryoprecipitate, Factor VIII concentrate, or any other blood product, for at least 72 hours prior to screening No previous diagnosis with inhibitors to Factor VIII at any detectable titer Subjects must never have been diagnosed with nonspecific inhibitors of coagulation Negative test for the presence of Factor VIII inhibitors at screening and enrollment Any immunosuppressive medications including intravenous immunoglobulins at the time of enrollment Clinical signs or symptoms of an infection, such as fever, chills or nausea during screening or enrollment History of frequent reactions to Factor VIII concentrates (e.g., chills or headaches) Prior treatment with Alphanate® (Solvent-Detergent/ Heat-Treated) Immunocompromised (including HIV+ status or has an impaired immune system due to disease or treatment) | 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, Severe Sepsis Age >= 18 years Confirmed early-onset severe sepsis, defined as: o---Objective evidence of infection likely to be caused by a bacterial or fungal pathogen o---Presence of at least 3 of 4 systemic inflammatory response syndrome (SIRS) o---Sepsis-associated organ dysfunction Baseline Acute Physiology and Chronic Health Evaluation II (Apache II) Score of 21 to 37 < 12 hours between onset of the first qualifying organ dysfunction and expected administration of study drug A commitment to full patient support Pregnancy or breastfeeding Extensive (>20% Body Surface Area) third-degree burns Weight > 150 kg at admission Patients whose death from sepsis is considered imminent Patients not expected to survive for at least 2 months due to a pre-existing and uncorrectable medical condition, or those in a chronic vegetative state Patients with severe congestive heart failure Patients currently receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer chemotherapy Patients with granulocyte counts < 1000/mm^3 unless the decreased count is believed to be due to sepsis Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment Human immunodeficiency virus (HIV)-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes | 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, Temporal Lobe Epilepsy Patients will be included under the following circumstances: 1. Age between 18 to 80 years. 2. Written informed consent is given by the patient. 3. Epileptogenic focus in the temporal lobe or in the frontal lobe (unilateral or bilateral with dominant focus). 4. Seizures are not completely responsive to medical treatment (8 or more seizures per month for at least 3 months) and patients have failed at least two anticonvulsant regimens in the past. The implantation of a vagus nerve stimulator will also be counted as anticonvulsant regimen. 5. A stable anticonvulsant regimen (not more than three anticonvulsants) defined as unchanged dose or dose modifications lower than 20% in the last month (Blood levels of anticonvulsants will be measured at the beginning of the study, prior and after intervention, and after the study to assure that the type and dose of medication remains constant). For the vagus nerve stimulator, the stimulation parameters will have to be unchanged for at least one month. 6. One antidepressant on a stable dose regimen for at least 1 month will be allowed. 7. Mini-Mental-Status examination greater than or equal to 23 points. 8. Commitment to participate in the long-term follow-up (up to 5 months) We will patients if one of the following conditions applies: 1. A history of any neurological illness other than the epilepsy. 2. Acute symptomatic seizures (caused by brain tumor, acute stroke, intracranial hemorrhage, encephalitis) or psychogenic seizures. 3. Generalized epilepsy or focal epilepsy with the epileptogenic zone outside the temporal lobe. 4. A history of severe alcohol or drug abuse; psychiatric illness such as severe, clinically significant depression (as evaluated by BDI); poor motivational capacity; or severe language disturbances, particularly of receptive nature or with serious cognitive deficits. 5. More than moderate uncontrolled medical problems (e.g., cardiovascular disease, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, hypo/hyperthyroidism, severe diabetes, peripheral arteriopathy, or a deteriorated condition due to age, or other medical conditions as determined by the study physician, that would interfere with participation in this study). 6. Increased intracranial pressure as evaluated by clinical means (presence of papilledema in eye ground exam, compressed sulci/ventricle on MRI scan). 7. Previous implantation of metallic material (e.g., vascular clips, cochlear implant) in the cranium (except in the mouth), pacemaker, implanted medication pumps, neural stimulators. This does not apply for implantation of a vagus nerve stimulator (Cyberonics ® (Registered Trademark) [Registered Trademark] 100, 102 or 102R). 8. Drug treatment acting primarily on the central nervous system (other than the regular anticonvulsant treatment and one antidepressant) that lowers the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants. 9. Diseased or damaged skin over the face or scalp. 10. 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, Epilepsy patients currently taking divalproex direct release for any seizure and/or behavior disorder patients with intellectual disability other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected patients with a recent history of status epilepticus in the past 6 months seizures in the past 3 months patients with acute illness requiring changes in concurrent drugs patients unwilling to change from their present direct release divalproex to divalproex extended release patients that do not have a reliable caregiver patients with lack of verbal expressive speech | 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): 16.0-65.0, Epilepsies Partial Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615] Female patients during pregnancy, delivery and lactation, or suspected of pregnancy | 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 Drug Resistant Age from 18 to 65 Drug resistant epilepsy, partial seizure Epilepsy diagnosed for more than 2 years Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment Onset of cluster seizure in the 24 hours before enrolment For women : effective contraception Affiliation to the French social security Inability to tolerate levetiracetam, likely poor compliance Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00 Patient taking 1g/day of levetiracetam with Creatinin clearance < 50ml/min Patient taking 2g/day of levetiracetam with Creatinin clearance < 80ml/min Patient taking more than 2g/day of levetiracetam Hepatic or cardiovascular pathology Progressive psychiatric pathology Degenerative neurologic disease Cluster seizure due to an acute symptomatic reason Disorder of consciousness | 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): 2.0-65.0, Epilepsy Epilepsy with partial seizures Tonic clonic seizures Generalized seizures of Lennox-Gastaut Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug Concurrent AEDs: Subjects taking concurrent VPA Previous participation in a study of Lamictal Known hypersensitivity to any drugs Pregnant women nursing mothers women who may be pregnant women contemplating pregnancy during the study period | 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 Epilepsy MRI incompatible Pregnancy | 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, Partial Seizures Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder | 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, Brain and Central Nervous System Tumors Seizure Unspecified Adult Solid Tumor, Protocol Specific Histologically confirmed solid tumor Pathological confirmation of brain metastasis is not required provided the clinical and neuroradiographic picture is typical Has had at least one prior seizure due to brain metastasis Life expectancy ≥ 12 weeks Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ 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): 18.0-75.0, Metastatic Breast Cancer Patients diagnosed with metastatic breast cancer 2. Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease). 3. The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2). 4. Patient presents, at least one lesion measurable according to (see Appendix 3) 5. Patients with a life expectancy of at least 3 months. 6. Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile. 2. Patients previously treated with capecitabine. 3. Patients with organ transplants. 4. Other diseases or severe affections: 1. Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance. 2. Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression. 3. Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months. 4. Severe renal impairment (baseline creatinine clearance < 30 ml/min) 5. Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded. 6. Patients with an active infection. 7. Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured. 8. Patients showing the following laboratory values: 1. Neutrophil count < 555 x 109/l 2. Platelet count< 100 x 109/l 3. Serum creatinine > 1,5 x upper normality limit 4. seric bilirubin > 2,0 x upper normality limit 5. ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases 6. Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases. 9. Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy. 10. Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery. 11. Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome. 12. Patients who have received more than two cycles of chemotherapy for the metastatic disease. 13. Patients Her2 + per FISH ó +++ Immunohistochemistry | 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): 12.0-75.0, Epilepsy Male or female subjects 12 to 75 years of age Subjects must have inadequately controlled partial onset epilepsy Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s) A history of status epilepticus in the 6 months preceding randomization Significant medical, psychiatric or neurological illness Intake of benzodiazepines on more than an occasional basis History of previous treatment with levetiracetam or sensitivity to levetiracetam | 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): 16.0-75.0, Traumatic Brain Injury Cerebral Infarction Cerebral Hemorrhage One week following Traumatic Brain Injury Cerebro Vascular Accident Subsequent brain CT showed cerebral cortex injury A known ailment of the central nervous system Use of medications or illicit drugs that significantly affect the central nervous system tourist or temporary residents not available for follow-up For MRI examinations: heart pacemaker, metal implants, or metal shrapnel | 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): 21.0-999.0, Osteoarthritis Chronic Pain Subject is 21 years of age or older Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential Negative pregnancy test if female of childbearing potential Subject is in general good health Subject required treatment of joint pain within the last 90 days Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee Subject has a documented history of allergic reaction or intolerance to morphine or other opioids Subject is pregnant or breast-feeding Subject is receiving systemic chemotherapy Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence Subject has history of major depressive disorder not controlled with medication Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD) Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis | 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 Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy Age above 18 years TIQ > 80 Able to give informed consent Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries Able to adequately report seizure frequencies 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 Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy MR 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 are 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 | 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, Depressive Disorder 18 years of age or older. 2. Diagnosis of Major Depressive Disorder validated by SCID. Subjects may meet for both melancholic and atypical depression per this protocol. 3. Have failed three or more antidepressant regimens during the current depressive episode with minimum daily dose(s) as defined in the Medication History for Depression Case Report Form and for a minimum duration of treatment of at least 4 weeks. For purposes of the Study, augmentation will be considered a separate regimen. 4. Able to stop all medications for 5 half-lives of the medication(s), with the exception of hormones, thyroid, hydrochlorthiazide and Ambien. See Appendix II for a list of the half-lives of medications History of: closed head injury with unconsciousness, craniotomy, cerebral metastases, cerebrovascular accident; no current diagnosis of seizure disorder, bipolar disorder, schizophrenia, dementia, mental retardation, substance abuse, or major depression with psychotic features; or use of depot neuroleptics in last 12 months. 2. Participation in any other therapeutic drug study evaluating a treatment for depression within 60 days preceding unless drug(s) half-life is known. 3. Known pregnancy and/or lactation, or intent to become pregnant during this study. 4. Doesn't qualify via rEEG analysis due to Potential physiologic abnormality Low abnormality in comparison to current rEEG database No strong prediction by rEEG analysis for any particular medication class | 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 Seizures Patients must have seizures documented by appropriate clinical and laboratory studies . This criterion will be established by studies performed by the referring physicians, preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic, or if necessary, inpatient video-EEG monitoring Male and Female subjects aged between 18 and 60 years Healthy control subjects will also be recruited Subjects must be able to give written informed consent prior to participation in this study Patients younger than 18 or older than 60 years old. There is evidence for reduced 5HT1A receptor binding in patients over 60 Patients with a known treatable seizure etiology such as neoplastic or infectious disease Patients with MRI findings consistent with brain tumors, trauma or AVMs Patients with progressive neurologic disorders Patients with a history of significant medical disorders, or requiring treatment with drugs that can not be stopped, and would interfere with the study, except for antidepressants Patients with cancer Patients not capable of giving an informed consent Patients who had seizure activity 24 hours prior to the study Women who are pregnant or nursing Subjects who are current smokers, and cannot stop for at least two weeks before the PET scan, as smoking may affect serotonergic neurotransmission | 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, Primary Central Nervous System Lymphoma Patients must fulfill all the following to be eligible for admission for the study: 1. Histologically proven central nervous system lymphoma of brain parenchyma with or without leptomeningeal involvement. 2. No evidence of systemic lymphoma. 3. Age between 18 years and 75 years. 4. With at least one measurable lesion, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 10 mm. See Section 10.2.1 for the evaluation of measurable disease. 5. Laboratory requirements Hematology: Neutrophils≧ 1500/mm3, Hemoglobin≧ 10 g/dL, and Platelet count≧ 100000/mm3 Hepatic function: Total bilirubin level≦ 1.5x upper normal limit (UNL), ALT (SGPT) and AST (SGOT)≦ 2.5 x UNL Renal function: Creatinine≦ 1.5 mg/dL. 6. No prior malignancy (excluding in situ carcinoma of the cervix or non melanomatous skin cancer) unless disease free for at least 5 years. 7. Signed informed consent. 8. Patients must be accessible for treatment and follow-up Patient meets any of the following will be excluded form the study. 1. Patients who are seropositive for HIV, AIDS, use of immunosuppressant or who are post organ transplant are not eligible. 2. Previously treated with chemotherapy, radiotherapy or other investigational agents. Patients with corticosteroid use are considered eligible. 3. With ocular involvement or with any lesion beyond brain parenchyma except leptomeningeal. 4. Pregnant, or lactating patients; patients of childbearing potential must implement adequate contractive measures during study participation. 5. Other serious illness or medical conditions Congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias Uncontrolled infection (active serous infections that are not controlled by antibiotics. 6. Concurrent treatment with any other experimental drugs. - | 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, Depression Epilepsy Home address within 30 miles of Seattle Diagnosis of epilepsy (ICD-9 code 345.XX) Appointment in the UW REC or Neurology clinic in the past 2 years and currently enrolled in this clinic Current age older than 18 years Diagnosis of major depression, minor depression or dysthymia Ability to speak/read English Alcohol and/or substance abuse/dependence based on a score greater than 1 on 4-item validated CAGE-AID Cognitive impairment based on a score less than 3 on a 6-item validated cognitive screen Diagnosis of bipolar disorder, schizophrenia/schizoaffective disorder or other psychotic disorder Women who are pregnant or nursing Terminal medical illness Those currently seeing or planning to see a psychiatrist Those with suicidal ideation nearly every day | 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): 18.0-69.0, Partial Epilepsy Catamenial Epilepsy Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy During the 8 week baseline period preceding randomization visit (Visit 4), subjects should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average Subjects should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Subjects with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.] Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening Maintenance of current AEDs without a change in dosing for the duration of study Concomitant vigabatrin not permitted Felbamate is allowed if the subject has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. [Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.] Subjects receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs Male or female, 18 to 69 years of age (inclusive). [Note: Subjects who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.] A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities Presence of non-motor simple partial seizures only History of pseudoseizures in the last 5 years History of a primary generalized seizure in the last 5 years Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed) Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease Status epilepticus within the last year prior to randomization Clinically unstable psychiatric disorder within the last 2 years Suicidal attempt within the last 5 years or current significant suicidal ideation History of psychosis within the last 5 years. [Note: Subjects who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.] Current use of neuroleptics for psychosis | 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 Referred to neurological institute at University Hospitals Case Medical Center for care of seizures/epilepsy Referred to neuropsychology laboratory for evaluation Participants must complete the routine check-in of all patients and sign consent and HIPAA forms Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable Be aged 18-64 years old Be able to provide documented informed consent Have a confirmed diagnosis of right or left temporal lobe epilepsy (TLE), which is made independent of their pre-surgical neuropsychological evaluation. Neurological disease must be confirmed by one (or more) of the following: (a) MRI study of the head, (b) CT study of the head, (c) EEG study, (d) Video-EEG study, (e) PET study of the head, (f) Neurological and Psychiatric exam by a physician Referred from an attorney or their evaluation is part of a personal injury claim Be intoxicated from alcohol or other illicit substance Received Electroconvulsive (ECT) treatment within the last 21 days Have an MMSE score of 25 or less Have undergone Deep Brain Stimulator (DBS) surgery | 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, Blepharospasm Healthy volunteers (aged 18 or older) who are willing to participate Patients (aged 18 and older) with benign essential blepharospasm FOR Subjects with a history of neurological or psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy Subjects receiving drugs acting primarily on the central nervous system FOR Subjects with a history of neurological disorders other than blepharospasm Subjects with a history of a psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy Subjects receiving drugs acting primarily on the central nervous system Subjects who have been treated with botulinum toxin injections within 3 months prior to their participation in the study Subjects who are taking any medication for dystonia at the time of the study Subjects with severe forceful closure of eyelids, subjects scoring more than 20 on the Blepharospasm Disability scale (Lindeboom et al., 1995) | 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): 18.0-90.0, Movement Disorders General for FMD patients Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist Able to give informed consent Age 18 or older General for Caregivers Age 18 or older Able to give informed consent Takes care of a patient with FMD patient enrolled in protocol 07-N-0190 for 10 or more weekly hours. General for PNES patients Diagnosis of PNES based on recording of patient s typical episode during 24 h video-EEG without concomitant EEG changes. The diagnosis must be made by a neurologist Able to give informed consent Age 18 or older General for Healthy Volunteers General for FMD patients Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy Inflammatory disorders or autoimmune disorders active within the last 6 months Patients with psychotic disorders or manic depression or active substance abuse within the last 6 months Current suicidal ideation Disease severity requiring inpatient treatment Additional for FMD patients for MRI Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations | 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, Tonic-clonic Seizure age 18 or older patient presenting to Grady Memorial Hospital's Emergency Department after having a tonic-clonic seizure (primary or secondarily generalized) within the last 4 hours Cause of seizure for reason for seizure is often undetermined at time of presentation to the Emergency Department. The most likely expected causes of a seizure are noncompliance to existing antiepileptic drug regimen, refractory epilepsy with breakthrough seizure, metabolic aberration, alcohol withdrawal, or unknown non-English speaking first time seizure seizures other than tonic-clonic seizure (primary or secondarily generalized) more than 3 seizures in 24 hours or status epilepticus, pregnant patients by history or by urine pregnancy testing, serious neurologic insult resulting in seizure but where seizure is not the primary reason for admission (e.g. traumatic brain injury with seizure or hemorrhagic stoke would be excluded) contraindication to IV levetiracetam received IV phenytoin within 24 hours known allergy to phenytoin previously enrolled in the study | 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): 16.0-70.0, Epilepsy diagnosis of Epilepsy completion of double blind trial taking other investigational drug than Lacosamide meeting withdrawal from double blind 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): 16.0-70.0, Epilepsy Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization) Must be experiencing 2 to 40 seizures per 28-day period Stable dose of 1 or 2 marketed antiepileptic drugs Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening Subject has a history of primary generalized or unclassified seizures Seizure disorder primarily characterized by isolated auras History of status epilepticus Seizures that are uncountable due to clustering Has greater than 5 seizures/day Subjects taking Benzodiazepines, Phenobarbital or Primidone Subject has Vagus Nerve Stimulation (VNS) Significant medical or psychiatric condition History of alcohol or drug abuse History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997 | 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): 10.0-75.0, Epilepsy probable or definite localization-related, primary generalized or symptomatic generalized epilepsy that is medically-refractory, as defined by treatment failure of at least 2 anti-epilepsy drugs at standard doses, despite medication compliance as determined by the treating neurologist at least 3 seizures/month in the 3-month period prior to randomization. Seizures that will be considered generalized tonic clonic, complex partial, myoclonic and absence seizures. Simple partial seizures must have an observable motor component or have been otherwise been documented by videoEEG to be a definite seizure Patients with prior epilepsy brain surgery or vagal nerve stimulator implantation will be allowed if medication and seizure frequency has been stable for the prior 3 months Ages between 10 and 75 years will be eligible for inclusion. Elderly patients without a history or symptoms of cardiovascular disease may be eligible on a case-by-case basis. No patients older than 75 will be included due to the possible cardiovascular side-effects Pre-menopausal women must be utilizing two reliable forms of birth control or abstinence ability of the patient to understand the concept of a clinical trial by answering the following questions appropriately: o will your seizures get better, worse or stay the same? Response in the spirit of: Any of the 3 could happen pregnancy or breast-feeding systolic blood pressure <100mmHg resting heart rate < 55 bpm concurrent calcium channel, beta-blocker or digoxin therapy Known hypersensitivity to carvedilol or any component of the formulation Decompensated cardiac failure requiring intravenous inotropic therapy Coronary artery disease with history of angina or Any cause of unstable angina Second or third-degree AV block or sick sinus syndrome Bronchial asthma or related bronchospastic conditions | 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, Epilepsy Partial Seizure Disorder Epilepsies, Partial Complex Partial Seizure Disorder Subjects (male or female) must be > 18 years or ≤ 80 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures; partial seizures may be simple or complex, with or without secondary tonic-clonic generalization Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs They must have had a 12 lead electrocardiogram (ECG) without clinically significant abnormal findings prior to randomization Subjects must have had magnetic resonance imaging or contrast enhance computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy Women of childbearing potential must be established on an effective method of contraception during the study. Women should also have a negative pregnancy test prior to study entry During the 6-week baseline period, subjects must have had a minimum of four partial seizures, with no 28 day period free of partial seizures with or without secondary generalization. A caregiver or witness must be with the subject for a sufficient duration to accurately chronicle the occurrence of seizures. These seizures must have been documented in the subject's diary Subjects with electroencephalograph (EEG) testing done within 2 years of randomization. EEG abnormalities should be consistent with a diagnosis of focal-onset epilepsy Signed and dated informed consent will be obtained from each subject (only those able to consent) in accordance with the local regulatory and legal requirements Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Subjects who are willing, but need assistance for self administered questionnaires may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any to any screening tests or procedures for the study Females who are pregnant, breastfeeding, or intending to become pregnant during the course of the trial Subjects with other neurologic illness that could impair endpoint assessment, or patients with Lennox-Gastaut syndrome, absence seizures, status epilepticus within the 12 months prior to study entry, or with seizures due to an underlying medical illness or metabolic syndrome Subjects with clinically significant liver disease or with a calculated creatinine clearance of <60mL/min Subjects with a history of lack of response, hypersensitivity or poor tolerability to gabapentin or pregabalin Previous use of gabapentin or pregabalin within 2 weeks prior to screening or likelihood of engaging in these treatments during the study period Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial Subjects who are not suitable to be treated with pregabalin or gabapentin according to the respective local labeling Subjects with a history of retinal abnormalities or treatment with retinotoxic agents | 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): 0.0-60.0, Epilepsy Localization-related Epilepsy Infantile Spasms Lennox-Gastaut Syndrome Polymicrogyria Periventricular Heterotopias Current age from 4 weeks to 60 years Clear diagnosis of epilepsy, i.e., a lifetime history of two or more unprovoked seizures Age at first unprovoked seizure younger than 40 years High quality clinical and laboratory data (i.e., neuroimaging, EEG) must be available throughout the patient's history All patients with localization-related epilepsy (LRE) or idiopathic generalized epilepsy (IGE) must have a first-degree relative (parent, child, or sibling) with non-symptomatic (idiopathic or cryptogenic) epilepsy who is willing and available to participate All patients with infantile spasms (IS), Lennox-Gastaut syndrome (LGS), or malformations of cortical development (MCD) must have both biological parents available and willing to participate Clinical and laboratory data do not allow a clear determination of whether the patient has epilepsy, or whether the diagnosis is LRE, IGE, IS, LGS, or MCD Exclusively febrile seizures or other acute symptomatic seizures Identified antecedent cause of epilepsy (i.e., a structural or metabolic insult to the CNS prior to the first unprovoked seizure, such as stroke, brain tumor, severe head trauma, etc., or a progressive neurodegenerative disorder) Recognized genetic syndrome (e.g., tuberous sclerosis, neurofibromatosis, Rett's or Angelman's syndromes) or chromosomal abnormality. (e.g., aneuploidies, unbalanced translocations, or chromosomal deletions and duplications detectable by conventional medical karyotyping) | 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, Schizophrenia Patients will fulfill DSM-IV-TR diagnostic for schizophrenia Patients reporting auditory hallucinations on average at least 5 times per day based on prospective assessment using a diary or handheld counter Patients are maintained on their psychotropic medication at steady dosages for at least 4 weeks before study entry and for the duration of the trial Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort History of current hypertension History of seizure or heat convulsion History of epilepsy or seizure in first degree relatives History of head injury History of any metal in the head (outside the mouth) Known history of any metallic particles in the eye Implanted cardiac pacemaker or any intra-cardiac lines Implanted neuro-stimulators Surgical clips or any medical pumps | 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, Post-Traumatic Age >= 18 years old 2. Patient with severe brain injury defined as follow Initial Glasgow Coma score (assessed on the scene of the accident) <= 8 related to the brain injury Stage 2 to 4 on the TDM US TCDB classification 3. Initial brain CT scan performed within 48 hours after hospital admission 4. Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline) 5. Written informed consent from the patient's next-of-kin. If no relative is present as the time of the patients will be included according to the emergency procedure Isolated extradural hematoma 2. Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.) 3. Current participation in an other protocol or within one month before study entry 4. Previous treatment with Levetiracetam 5. Patient's follow-up judged to be difficult by the investigator 6. Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients 7. Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol) | 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, Focal Dystonia Peripheral Nervous System Disease WITH FOCAL (ONLY) Age 18 years or older Presence of FD and no CRPS WITH CRPS (ONLY) Age 18 years or older Presence of CRPS and no FD WITH AND CRPS (CRPS + Age 18 years or older Presence of FD and CRPS in the same limb Concurrent significant medical, surgical, neurologic or psychiatric condition Taking the following medications: anxiolytics, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines Taking antidepressants or anticonvulsants needs to be discussed specifically in each patient Received botulinum toxin injection within 3 months of starting the protocol For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye History of seizure disorder No known history of hearing loss For MRI: Presence of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware Pregnancy | 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, Traumatic Brain Injury Epilepsy Moderate to severe traumatic brain injury, defined as one or more of the following: penetrating head wound seizure within the first hour after injury intracerebral hematoma or cortical contusion subdural or epidural hematoma Glasgow Coma Score <= 12 or motor score 1-5 (if intubated). Patients who have been pharmacologically paralyzed will be evaluated after the paralytic has worn off or been pharmacologically reversed depressed skull fracture requirement for emergent neurosurgical procedure 2. Time since TBI less than 24 hours 3. Age greater than or equal to 18 years 4. Subject capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. - Known prior history of epilepsy or unprovoked seizures. Patients with a history of acute symptomatic seizures (e.g. febrile seizure, alcohol withdrawal seizure) will not be excluded 2. Administration of an antiepileptic drug before enrollment 3. History of allergy to topiramate or phenytoin 4. Pregnancy or breast-feeding. Women of childbearing potential must have a negative pregnancy test (urine pregnancy test or serum beta-HCG) before randomization 5. Compromised renal function with serum creatinine > 2 6. Severe concurrent illness with life expectancy <6 months 7. Treatment with another investigational agent for TBI 8. Unable to take medications orally and contraindication to placement of nasogastric tube. 9. Irreversibly fatal TBI 1. All four findings: Glasgow Coma Score = 3, no pupillary reaction, age > 45 years, and severe coagulopathy OR 2. Severe brainstem lesion on neuroimaging studies 10. Patients with a history of kidney stones or glaucoma. 11. Inability to maintain adequate fluid intake while taking topiramate. 12. Patients whose TBI is a result of self inflicted injury 13. Patient's who are currently using illicit drugs - | 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 Controls (20 Subjects) Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below) History of seizures, faints, or any unexplained blackouts Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs They should not have a clear family history of epilepsy (first degree relatives) History of any substance abuse within the past 5 years History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded History of stroke without complete recovery of neurologic function Pregnancy With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material Inability to understand the consent. (standard form attached) Inability to speak fluent English. Note: the neuropsychological tests are standardized for English speakers. They are not all available in multiple languages. Since the scoring and norms are established for English speakers, simply translating them would still not make the testing norms and scoring applicable. Juvenile Myoclonic Epilepsy (JME; 20 Subjects) | 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): 0.0-24.0, Infant, Newborn Hypoxia, Brain Hypoxia-Ischemia, Brain Encephalopathy, Hypoxic-Ischemic Hypoxic-Ischemic Encephalopathy Ischemic-Hypoxic Encephalopathy Infants born at 36 0/7ths weeks gestational age or greater (by best obstetrical estimate) Postnatal age between 6 and 24 hours following birth Infants with a high probability of acute hemodynamic compromise, such as those with An acute perinatal event (abruptio placenta, cord prolapse, severe FHR abnormality) An Apgar score ≤ 5 at 10 minutes Continued need for ventilation initiated at birth for at least 10 minutes Cord pH or first postnatal blood gas pH at ≤ 1 hour of ≤ 7.0 Base deficit on cord gas or first postnatal blood gas at ≤ 1 hour of ≥ 16 mEq/L Infants matching the above who also have an abnormal neurological exam showing the presence of moderate or severe encephalopathy Infants whose parents/legal guardians have provided consent for enrollment. NOTE: These are identical to the NICHD Neonatal Research Network's 2005 Hypothermia study (see links below), except for the time of entry (6-24 hours vs. < 6 hours of age) Any infant with a core body temperature (axilla, rectal) less than 34.0°C for greater than 1 hour Presence of a known anomaly or chromosomal aberration Birth weight < 1,800 grams Infant in extremis Infants whose parents/legal guardians or attending physician refuse 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, Severe Sepsis Clinical evidence of infection requiring treatment with parenteral antibiotics Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) Patients must meet for cardiovascular and/or respiratory dysfunction Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction Moribund and death is considered imminent, or patient not expected to survive 90 days because of underlying medical condition, or classified as Do Not Resuscitate or Do Not Treat Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a Systolic Blood Pressure (SBP) >80 mmHg in the presence of vasopressors and iv fluids for a period of ≥2 hours Receiving immunosuppressants, or high dose steroids within 2 months of provision of informed consent Any history of hypersensitivity reaction to sheep products, latex, papain or papaya, or chymopapain or previously administered antivenom manufactured using ovine serum, digoxin immune fab (DigiFab™ , ), crotalidae polyvalent immune fab (ovine) (CroFab™ ), or other sheep derived product Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before provision of written 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, Severe Trauma age 18 years or older, blunt or penetrating trauma and one or more of the following: systolic blood pressure less than 90 mmHg at the scene or within one hour of arrival to the Emergency Department, 2) base deficit ≥ -6 within one hour of admission, 3) ISS greater than 25, or 4) more than 6 units of blood transfused in the first 12 hours.- | 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 from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included Those who do not fulfill the requirements | 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, Epilepsy Subjects from 16 to 75 years, both inclusive Well-characterized focal epilepsy or epileptic syndrome Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose Seizure type IA non-motor as only seizure type History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline Other serious uncontrolled 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): 16.0-75.0, Epilepsy Subjects from 16 to 75 years, both inclusive Well-characterized focal epilepsy or epileptic syndrome Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose Seizure type IA non-motor as only seizure type History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline Other serious uncontrolled 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): 7.0-55.0, Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy FOR 1. Age 7-55 2. Documentation of localization-related epilepsy based on clinical, neuropsychological and imaging 3. Failure of seizures to respond to adequate therapy with at least two standard antiepileptic drugs 4. Willingness to be considered for surgery 5. Fluency in English. Non-native speakers may be included if their fluency is equivalent to that of a native speaker. FOR 1. Age 7-55 2. Willingness to participate in and complete the study 3. Right-handedness assessed by the Edinburg handedness inventory 4. Fluency in English FOR 1. Contra-indications to MRI studies (such as pacemakers, cochlear devices, surgical clips etc. metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator) 2. Claustrophobia or anxiety disorders exacerbated by the MRI scanner 3. People with neurological or psychiatric disease or taking medications that would affect fMRI and MEG language studies 4. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning 5. Patients on phenobarbital or chronic benzodiazepines FOR 1. Contra-indications MRI studies (metallic implants, recent orthopedic pins, cochlear implants, surgical clips, cardiac pacemakers and defibrillation devices, shrapnel, permanent eyeliner, vagus nerve stimulator) 2. Any medical condition or chronic medication that might affect fMRI or MEG language activation by affecting cerebral structure or function, such as diabetes, hypertension, antihypertensive medications, psychotropic agents. 3. Pregnancy. All females of child bearing potential must have a negative test prior to MRI scanning | 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, Temporal Lobe Epilepsy Unilateral or Bilateral Mesial Temporal lobe Epilepsy Age ≥ 18 years Global IQ ≥70 Failure of ≥ 2 AEDs approved for treatment of partial seizures, used alone or in combination at recommended dosages Average ≥ 3 seizure-days per month in prior 6 months during which disabling seizures occurred. Disabling seizures are defined as complex partial seizures with or without secondary generalization, or as simple partial seizures that are noticeable by others or interfere with function Ability to complete self-administered questionnaires Availability of reliable collateral historian or witness Patient preference for non-resective surgery, or not a candidate for mesial temporal resection Give written informed consent Extratemporal or multifocal epilepsy MRI evidence of potentially epileptogenic lesions outside the mesial temporal region Lesions precluding electrode implantation (eg, vascular malformations, vascular tumors) Severe hippocampal sclerosis that in the surgeon's opinion precludes accurate electrode placement Brain lesions that demand prompt surgical therapy (eg, malignant tumors, vascular malformations) Progressive neurological disorders (eg, malignant tumor, dementia, degenerative disorders) Medical or psychiatric conditions precluding surgery or interfering with adherence to treatment and follow-up Planned pregnancy during the study. Women of child-bearing age will require a negative pregnancy test and adequate contraception methods Ongoing or planned participation in other studies of new epilepsy therapies Contraindication for stereotactic surgery, e.g. bleeding diathesis, anticoagulants, treatment with valproate at the time of surgery (risk of bleeding) | 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, Motor Epilepsy, Complex Partial Epilepsy, Simple Partial Focal Motor Epilepsy Must have completed the 14-week double-blind treatment phase of study must be willing/able to follow the restrictions and prohibitions of the protocol must be able to complete the patient diaries correctly (patients or legally acceptable representatives) must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives) adolescents capable of understanding the nature of the study must provide assent to participate in the study Patients who have not completed the 14-week double-blind treatment phase of 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): 18.0-75.0, Treatment Resistant Depression Have a DSM-IV diagnosis of a major depressive episode 2. Are referred for or an outpatient course of ECT at the Alfred Hospital 3. Age 18-75 4. Have a Montgomery-Asberg Depression Rating Scale (MADRS) score of > 25 (moderate - severe depression) 5. Demonstration of capacity to give informed consent: this will be assessed by the study psychiatrist as well as the patient's primary treating psychiatrist Have an unstable medical condition, or neurological disorder or are currently pregnant or lactating. 2. Patients not considered sufficiently well to undergo general anaesthesia for any reason 3. Patients with cardiac pacemakers, cochlear implants or other implanted electronic devices. Patients with non-electric metallic implants will also be excluded. 4. Significant concurrent axis 1 or 11 psychiatric comorbidity | 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): 4.0-999.0, Epilepsy iodiopathic focal epilepsy with cognitif deficit medical history of status epilepticus | 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): 5.0-999.0, Epilepsy Subjects are selected on the basis of intractability of their seizures to medical intervention by antiepileptic drugs and following a noninvasive workup that indicates the patient would be an excellent candidate for resective surgery Patient is under the age of 5 | 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 and Adults (18 years and older) of either gender who would otherwise be eligible for temporal lobe resection will be offered enrollment for randomization to RS or ATL. 1. Seizure type: Patients must have simple and/or complex partial seizures with or without secondary generalization. 2. Seizure Frequency: Patients must have at least 3 complex partial seizures during the 3 month (12 week) baseline seizure diary period with at least 1 of 3 seizures occurring within the last 2 months (8 weeks). 3. Patients with electrographic evidence of seizures arising from one temporal lobe, with radiographic evidence of mesial temporal sclerosis in the same temporal lobe will be included. Patients with normal MRIs, bilateral hippocampal damage, or cortical lesion will be excluded. 4. Subjects should be on stable doses of antiepileptic medications for at least 3 months prior to treatment. 5. All female patients of childbearing age will have documented that they are using a safe and effective means of birth control and will have a negative urine pregnancy test completed within 1 week prior to their treatment. 6. Patients should be able to understand the potential benefits and risks of this therapy and be able to understand the protocol and sign their own consent forms. For these reasons, only patients 18 years and older and with I.Q. greater than or equal to 70 will be included. 7. Patients with any focal neurologic deficit that would make it difficult to detect a new radiation-associated injury will be excluded. All patients will receive formal visual field testing (Humphrey) and patients with visual field deficits will be excluded. 8. Patients with radiographic evidence of other pathologies such as vascular malformations or tumors will be excluded. 9. Patients with diabetes mellitus or hypertension will be excluded from this study because radiation injury to the brain is more common in these patients. 10. Subjects should not have significant psychiatric conditions that would make accurate assessment of seizure frequency difficult, as judged by the principal investigator. Such conditions a history of non-epileptic seizures, psychosis (other than post-ictal psychosis) and severe mood disorders including suicide attempt within past 12 months or noncompliance with psychotropic medications. 11. Patients with a history of significant past or present medical disorders determined severe enough to prevent participation in a surgical trial by the principal investigator are excluded. 12. Patients with any progressive neurological disorder (such as multiple sclerosis or systemic lupus erythematosis) are excluded. 13. Patients with a history of poor compliance with past antiepileptic drug therapy as judged by the principal investigator are excluded. 14. Patients with a recent history of abusing drugs or alcohol with significance as judged by the principal investigator are excluded. 15. Patients who are receiving any investigational drugs at the time of enrollment are excluded. 16. Patients with current use of vigabatrin are excluded. Past use does not a patient pending a normal formal visual field test. 17. Patients with currently functioning vagal nerve stimulators (VNS) are excluded. Past use does not a patient as long as the device is explanted. Indwelling VNS electrodes are permitted in agreement with each center's policies on brain MRI imaging. 18. Patients who can not be anticipated to participate for the full 36 months of the trial will be excluded. 19. Native English speakers from the U.S. or other English speaking countries or patients who learned English before age 5 and were educated in English. Spanish speaking patients can be included as long as the study site can provide an officially translated (IRB approved) consent form in Spanish. Non-Spanish speaking patients with English as a second language (ESL) and/or non-English and non-Spanish speaking patients can be included only under the following conditions: 1) the study site must be able to have the consent form translated into the patient's native language using an official translator, and 2) the study site's neuropsychologist must be willing and able to assess the patient at baseline and post-treatment at 12, 24, and 36 months in that patient's native language to ensure the patient's safety | 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, Epilepsy Male or female, age 18 History of intractable localization related/partial onset seizures and generalized tonic/clonic or tonic seizures defined according to International League Against Epilepsy (ILAE) classification as A history compatible with localization related partial epilepsy A history of generalized tonic clonic or tonic seizures with loss of consciousness Three or more simple partial, complex partial or tonic-clonic seizures per month An EEG and/or an MRI consistent with a localization related epilepsy Evidence of at least three seizures per month for at least two months prior to the study Exposure to at least one antiepileptic drug at adequate dose Significant or progressive medical, cardiac, or other illness Allergy to fish products or fish oil History of a coagulation disorder History of non-epileptic seizures Consumption of Fish Oil at any time 30 days or less prior to enrollment Any change in antiepileptic drugs for 30 days or less prior to enrollment Treatment with Warfarin for 30 days or less prior to enrollment Previous poor compliance with therapy Drug or alcohol abuse Uncountable seizures as a result of seizure clustering, or inadequate supervision if the patient cannot count their own seizures | 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, Depression Mood Disorders Depressive Disorder Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV for a diagnosis of major depression and be free of antidepressant or other psychotropic medication for a minimum of two weeks before enrollment. If a subject is talking psychiatric medication he/she may be weaned off of the medication by their treating physician prior to study enrollment. Such a course of action would only be advised if the current medication was not considered to be of any benefit to the subject. In particular, if a patient is on antidepressant medication which is of benefit, we would not advise tapering off medication - and subsequent risk of relapse - in order to participate in the study. The same line of thinking applies to all psychiatric diagnoses and associated medications candidate subjects may be taking Significant head trauma with loss of consciousness. 2. Active abuse of alcohol or illegal substances. 3. Excluded psychiatric diagnoses Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder 4. Pregnant or nursing women. 5. Any contraindication to being scanned in the 3T scanner at the Lucas Center such as having a pacemaker or any implanted device that has not been cleared for scanning at 3 Tesla. 6. Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis). 7. Use of psychotropic medications within 2 weeks of enrollment | 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, Epilepsy Epilepsy, Temporal Lobe Depression Depressive Disorder, Major Male and female subjects aged between 18 and 55 years Epileptic patients must have clinically documented partial seizures, in either the left or right temporal lobe, or generalized seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard antiepileptic treatment for at least one year. This criterion will be established by preliminary screening in the NINDS CES outpatient clinic, and, where previous studies are not adequate, by inpatient video-EEG monitoring All subjects with epilepsy must exhibit seizures not adequately controlled by medication alone, despite adequate trials of multiple agents. Subjects with epilepsy must currently be taking an AED which exerts its primary method of action on a system other than GABA. Examples sodium or calcium channel blockers (phenytoin, carbamazepine, oxcarbazepine, lamotrigine, zonisamide, and ethosuximide), drugs that bind to SV2A sites (levetiracetam), or drugs which bind to the alpha2delta subunit of calcium channels (gabapentin and pregbalin). Patients on AEDs that have direct effects on GABA and glutamate (vigabatrin, phenobarbital, benzodiazepines, tiagabine) will be excluded. No subject s medication will be changed for the purpose of in this study Patients with TLE and depression must currently meet DSM-IV for the category "Mood disorder due to epilepsy" (293.83), and the subtype "with Major Depressive-Like Episode", 296.2 Major Depressive Disorder, Single Episode, or 296.3 Major Depressive Disorder, Recurrent, indicating that subjects meet diagnostic for a major depressive episode Patients with MDD alone must currently meet DSM-IV for Major Depressive Disorder, and also have either a family history of mood disorders, or a history of multiple major depressive episodes Healthy control subjects who do not meet for any DSM-IV axis I psychiatric disorder, and have no family history (in first degree relatives) of a mood or anxiety disorder will also be recruited Subjects must be able to give written informed consent prior to participation in this study Subjects with major medical or neurological disorders (besides TLE or generalized epileptiform disorder) expected to influence cerebral blood flow or morphology Subjects with epilepsy taking any medications (other than antiepileptic drugs) that may affect cerebral blood flow, GABA or glutamate neurotransmission, or metabolism Subjects with epilepsy taking AED s known to exert direct effects on GABA or glutamate Subjects with epilepsy with depression who have taken anti-depressant drugs within 2 weeks of the study (4 weeks for fluoxetine) Medically healthy depressed subjects who have taken any drugs, including anti-depressants, expected to influence cerebral blood flow, metabolism, or morphology within 2 weeks of the study (4 weeks for fluoxetine) Healthy subjects who are taking any medications expected to influence cerebral blood flow, metabolism, or morphology Healthy subjects must be free from a personal history of seizure disorders In order to subjects at-risk for the development of a mood disorder, healthy control subjects must be free from either a personal or family history (first-degree relatives) of Axis I psychiatric disorders Subjects with a history of drug or alcohol abuse within one year, or a lifetime history of alcohol or drug dependence (DSM-IV criteria). Subjects who consume an excessive amount of alcohol (more than 7 drinks per week for women, more than 14 drinks per week for men) will also be excluded Subjects with structural lesions visible on MRI, excluding mesial temporal sclerosis | 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, Partial Epilepsy Age 18-70 years old Reliable history of seizure semiology, EEG or EEG video telemetry confirming the diagnosis of partial epilepsy Seizure frequency of at least 6 complex partial seizures over the 9 weeks prior to enrollment, with no 3 week period with less than one seizure, in spite of adequate treatment with a stable anticonvulsant dosage with one or two anticonvulsants for at least one month. Every seizure in a cluster will count as a separate seizure Willing to maintain current anticonvulsant dosage for 32 weeks. Tapering off a third anticonvulsant up to one month prior to enrollment to allow study participation is permitted. Consent will be obtained prior to tapering of a third anticonvulsant. Habitual use of an additional rescue medication such as lorazepam for excess seizure activity is permitted but not more frequently than once every three weeks Women of childbearing potential need to have a negative urine pregnancy test and practice two simultaneous methods of birth control, which may not oral contraceptives. Due to drug interactions, oral contraceptives are not considered a safe method of birth control in patients using anticonvulsant medications. Women who are at least two years post-menopausal will be exempt from the pregnancy test or birth control requirements Unreliable history of seizure semiology Seizure frequency less than six complex partial seizures over 9 weeks or no seizure in any 3-week period in the 9 weeks prior to enrollment Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded Patients with a widely fluctuating seizure frequency (good months and bad months) or a history of status epilepsy will be excluded Women who are currently pregnant or lactating Patients with other serious medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders such as schizophrenia or major depression will be excluded Patients with progressive epilepsy syndromes, neurodegenerative disorders or dementia will be excluded Patients with impaired renal or hepatic function as detected by abnormal BUN or AST/ALT/alk phos on initial screening will be excluded Patients at increased risk for ventricular arrhythmias (history of heart failure, prolonged QTc > 450 ms, family history of prolonged QT syndrome, hypokalemia, or those using any diuretics or drugs which prolong the QT, see http://www.azcert.org) will be excluded Patients with a high likelihood of psychogenic or non-epileptic seizures will be excluded by the following method previously developed at the Oregon Health and Science University (OHSU) epilepsy program | 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): 20.0-90.0, Hemiplegia hemiplegia; unilateral weakness of sudden onset secondary to strokes or other brain lesions compatible with brain lesions confirmed by imaging studies bilateral weakness any history of intensive trauma of the shoulder, reported preexisting musculoskeletal disorder of the shoulder | 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, UPDRS PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank with Hoehn & Yahr stages II IV while "off" Participants on antidepressants should be at least 2 months on stable therapy Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative Patients on neuroleptics Patients with dementia or any unstable medical disorder History or current unstable hypertension History of head injury or neurosurgical interventions History of any metal in the head (outside the mouth) | 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, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also 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): 18.0-65.0, Epilepsy Adult Medically intractable epilepsy Min 4 complex partial seizures/ month Ability to give informed consent Underlying progressive neurological condition | 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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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, Dermatologic Disease of Inpatients in Internal Medicine Patients will be eligible for enrolment if they fulfil the following 1. Male or female patients, age ? 18 years of age and 2. Hospitalised at the Division of Internal Medicine, University Hospital Zurich 3. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2) Patients will be excluded from the study if they fulfill any of the following 1. Ability to communicate orally severely impaired due to any reason, namely illness or inability to speak German. 2. Terminal patients or other patients where participation in a visit with oral and physical examination would represent an unreasonable exertion. 3. Pregnant 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): 20.0-65.0, Opioids Use Age between 20-65 years old, all genders. 2. Psychiatry doctor diagnosed who met DSMIV-TR opioid addiction or opioid abusing. 3. Participants need to understand procedures and assays of this experiment. 4. Participants are willing to accept methadone substitutive abstaining program. 5. Participants are willing to provide small amount of blood for testing. 6. Participants are voluntarily to join interview(s), approximately 30-45min Participants have respiratory distress or other respiratory system illnesses. 2. Participants have serious illness and possible die within 1 year or intensive care needed within 6 month. 3. Participants have been diagnosed cardio-vascular disease recently. 4. Participants have allergy to N-acetylcysteine | 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 65 years of age Normal IQ as estimated by the Wechsler Test of Adult Reading (WTAR) Able to give consent Able to live independently and complete activities of daily living Stable frequency of seizures. There is no minimum/maximum for the frequency of partial seizures. Those with infrequent secondary generalized seizures may participate, with infrequent seizures defined as two or fewer per year The subject's treating physician does not believe a change in anticonvulsant regimen to be warranted. The anticonvulsant drugs must remain unchanged during the 26 week trial Partial-onset seizures. Seizure type will be determined by clinical history, MRI, SPECT and/or PET imaging, and interictal and/or ictal EEG Either symptomatic or idiopathic seizures Non-epileptic seizures Prior surgical resection for treatment of seizures Progressive neurologic illness (i.e. tumor evident on MRI) Current alcohol or drug abuse, as this may affect memory by other mechanisms. This information may be obtained by self-report, from the referring physician or by medical record Diagnosis of Alzheimer's disease, nutritional deficiency, infection or metabolic/electrolyte disorder causing memory loss Non-native English speaking and/or multilingual Seizure(s) must not have occurred within 3 days of testing Subjects who are pregnant will not be eligible to take part in the study, as memantine is classified as a Pregnancy Category B drug and may pose risk to the fetus Women who are breastfeeding may not participate in this study Those with renal tubular acidosis or infections of the urinary tract will not be eligible for participation, as memantine is renally cleared and conditions that alkalinize the urine may reduce clearance of the drug | 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): 15.0-999.0, Partial Epilepsy medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure full informed consent of the patient (or of his/ her legal representative) year or older patient contraindication to cortectomy contraindication to depth-EEG indication of epilepsy surgery without depth-EEG monitoring high grade glioma, arterio-veinous malformations pregnancy history of severe cardio-vascular event (coronaropathy, 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): 16.0-999.0, Epilepsies, Partial The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat® The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to the patient in the study The Vimpat® treatment should have been started not longer than 2 weeks before study of the patient The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat® In accordance with the Summary of Product Characteristics (SmPC) | 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 Depression Subjects for this study will meet the following 1. Age greater than or equal to 18 years. 2. Must be in accordance with the diagnostic of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. The duration to the latest seizure must be longer than 24 hours. 3. Score of a 17 item Hamilton Depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks. 4. Haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks. 5. Must sign the informed consent form Now accepting or have accepted other drugs clinical trial in the last month. 2. History of serious psychiatric illness other than depression. 3. Having suicide ideas or suicide behaviors. 4. Progressive illness of central nervous system, such as degenerative disease or tumor. 5. History of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors. 6. The value of ALT or AST is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul. 7. During pregnant or lactation period. 8. The person who is disabled or mentally disabled | 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 Seizures patients in whom seizures are not controlled by their antiseizure medication must have at least 2 seizures per month patients with cardiovascular problems that could be adversely affected by verapamil | 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, Acute Heart Failure A diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) Prior clinical diagnosis of heart failure Must be identified within 24 hours of hospital admission (24 hour clock begins when the admission orders are placed) Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation Male or female patient ≥18 years old Willingness to provide informed consent Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started Anticipated hospitalization of at least 72 hours Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization Systolic BP <90 mmHg Hemoglobin (Hgb) < 9 g/dl Renal replacement therapy History of renal artery stenosis > 50% Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent) Active myocarditis Hypertrophic obstructive cardiomyopathy | 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 Epilepsy patient over 15 years old who agrees with Informed Consent Form 2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures. 3. Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s). 4. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time. 5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain. 2. Patient who experiences pseudoseizures and/or who has uncountable clusters. 3. Patient who has serious systemic or drug metabolism affecting disorder . 4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels. 5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3. 6. Patient who has medical history of renal stones. 7. Patient who is allergic to sulfonamide. 8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder. 9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception. 10. A terminal patient and/or a scheduled surgical patient. 11. Patient who has medication history of zonisamide. 12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this 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): 18.0-65.0, Pathological Gambling Pathological gambling according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) History of a primary major psychiatric or cognitive disorder according to DSM IV apart from Pathological gambling Current alcohol or other substance abuse or dependence Alcohol or other substance abuse or dependence during the last 12 months before recruitment History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery Significant neurological co-morbidity psychiatric co-morbidity psychotropic medications Severe somatic co morbidity Cardiac pace makers, other electronic implants, intracranial metallic particles History of seizures or epileptiform activity | 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 Seizure Disorders Ages 18 No serious or progressive medical illness A history of intractable partial seizures At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months MRI or EEG consistent with localization-related or partial epilepsy Exposure to at least two antiepileptic drugs at adequate doses Concurrent use of at least one antiepileptic drug at adequate doses No change in antiepileptic dose for at least 30 days before study enrollment History of non-epileptic seizures Inability to maintain accurate seizure calendars (self or caregiver) Frequent use of benzodiazepines for clusters defined as greater than four times a month History of facial pain or trigeminal neuralgia Concurrent vagus nerve stimulation 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, Alcohol Withdrawal Need for admission to hospital for acute alcohol withdrawal allergy to phenobarbital, lorazepam, age<18 or >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): 18.0-40.0, Traumatic Brain Injury Stroke Headache PTSD Age 18 to 40 2. Able to give consent 3. Normal clinical examination for healthy subjects 4. Must be able to follow instructions and perform required tasks, and TBI patients must have the Mini-mental state examination (MMSE) score of 25 or above. 5. Clearly right dominant handedness as assessed by Handedness scales MILD TBI: Traumatically induced physiological disruption of brain function, as manifested by at least on the following: 1. Any loss of consciousness 2. Any loss of memory for events immediately before or after the accident (except for short-lasting benzodiazepines for sleep. 3. Focal neurological deficit(s) that may or may not be transient 4. Any alteration in metal state at the time of the accident (e.g. feeling dazed, disoriented or confused) and focal neurological deficit (s) that may or may not be transient, but where the severity of the injury does not exceed the following Loss of consciousness (LOC) of approximately 30 min After 30 min, an initial Glasgow Coma Scale (GCS) sore of 13 (or clinically diagnosed concussion) and Post-traumatic amnesia (PTA) not greater than 24 hour Moderate TBI: Those meeting the same as mild TBI plus any one of the following: 1. GCS of 9-12 (if available) or results of a clinical evaluation as moderate TBI 2. Mental status change or LOC 30 min to 24 hour 3. PTA 1-7 days Being diagnosed as an alcoholic or with drug addiction. 2. Chronic use of medications acting primarily on the central nervous system such as those for seizures (e.g., carbamazepine, phenytoin) except for short-lasting benzodiazepines for sleep and antidepressants (e.g., SSRIs and SNRIs). 3. Pregnancy 4. Medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., dental braces, pacemakers, implanted medication pumps, cochlear devices, neural stimulators, certain metals in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia) 5. History of epilepsy (to avoid brain abnormalities other than mild to moderate TBI) 6. Less than three months post-TBI and with severe post traumatic stress disorder (PTSD) or PTSD Check List (PCL) score > 60 7. Penetrating head wound 8. For healthy volunteer, history of brain injury and/or structural MRI abnormality. 9. Staff from our section | 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 Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU). 2. Patient likely requires an EMU evaluation for a period of at least 3 days. 3. In the opinion of the Principal Investigator, the Patient is likely to have 3 seizures during the EMU stay. 4. Patient is currently taking at least one antiepileptic medication. 5. Patients must be 18 years or older and may be of either sex and of any race. 6. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements. 7. Patient must be willing and able to complete informed consent and HIPAA authorization. 8. Patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study. 2. Patients experiencing status epileptic within the last 6 months. 3. Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk. 4. Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed. 5. Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation. 6. Patients currently dependent on alcohol or narcotic drugs as defined by DSM IV-R. 7. Patients with a history of only psychogenic seizures or pseudo seizures. 8. Women who are pregnant. Women of childbearing age must take a pregnancy test | 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, Major Depression Epilepsy Patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by DSM-IV and assessed on the MINI, of at least 4 weeks duration. 2. All subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist. 3. Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months. 4. If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months. 5. Patients must be ages 18 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20. 6. Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior). 2. History of psychosis, mania or hypomania. 3. Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures. 4. Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately . 5. Unstable medical or neurological disorder (other than epilepsy). 6. Epilepsies related to a progressive neurologic disease such as a brain tumor. 7. Substance abuse including ETOH within the past 6 months. 8. Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep. 9. Concurrent or recent (within 3 months) entry into a new psychotherapy. 10. Actively or acutely suicidal. 11. Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year. 12. Pregnancy or lactation. 13. Females of child bearing potential who do not practice adequate contraception. - | 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): 16.0-80.0, Epilepsy Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years Subjects having at least 8 Type I seizures [POS; focal seizures (according to the 1981 ILAE classification)] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1 Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED Subject previously randomized within this study or any other prior study with BRV as a dosing arm Seizure type IA (1981 ILAE classification) nonmotor as only seizure type Subject is currently treated with LEV or has taken LEV within 90 days prior to V1 Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries) Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline Subject has history or presence of known psychogenic nonepileptic seizures Subject on felbamate with less than 18 months exposure before V1 Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period | 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 Epilepsy, Temporal Lobe Partial Epilepsy To be eligible for entry into the study, candidates must meet all the following 1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy. 2. Have focal onset seizures. 3. Seizures must persist despite medical therapy (drug resistant epilepsy) or seizures must be associated with the presence of a brain tumor. 4. Able to give informed consent, or have a parent able to provide informed consent if a child. 5. Agree to undergo brain surgery if indicated to treat drug resistant epilepsy Candidates will be excluded if they: 1. Are pregnant (subjects of childbearing age will be tested with a urine pregnancy test and will have agreed to avoid being pregnant by practicing a reliable form of contraception or by abstinence from sexual intercourse while undergoing evaluation for epilepsy surgery and for 1 month after epilepsy surgery). 2. Cannot have an MRI scan. 3. Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions which would make testing or surgery unsafe, such as lung or cardiac disease which would increase the risk of general anesthesia or severe immunodeficiency or systemic cancer not related to a brain lesion | 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 Epilepsy, Temporal Lobe Partial Epilepsy Enrolled in protocol 01-N-0139 2. Age 18 to 65 3. Localization-related epilepsy diagnosed by standard clinical that has not responded to treatment with up to two standard antiepileptic drugs either sequentially or in combination. 4. Patients must be able to provide informed consent. 5. Patients must be able to remain on their baseline AED drugs and doses for the duration of the study 6. Patients must be able to use seizure calendars to record seizures throughout the trial. 7. Experiences 4 seizures within a 6-week period Pregnancy or lactation 2. Women of child-bearing potential and men who are unable or unwilling to take adequate contraceptive precautions, including one of the following hormonal contraception (birth control pills, injected hormones or vaginal ring) intrauterine device barrier methods (condom or diaphragm) combined with spermicide surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner 3. Current treatment for another significant medical disorder, such as diabetes, or heart disease, or an untreated disorder, that is discovered during the screening examination and might interfere with the study and is determined by the PI to warrant of the participant. 4. An abnormality on clinical laboratory tests, physical examination, EEG or ECG that might increase the risk associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal, or hematocrit lower than 30. 5. A level 4 or 5 on the Columbia Suicide Severity Rating Scale rating for symptoms during the last month 6. Concomitant treatment with more than 2 AEDs 7. Evidence for a potentially progressive neurologic disorder, such as an astrocytoma 8. Use of sublingual lorazepam for seizure clusters more than once per wee 9. Use of any of the following prohibited medications/classes with less than required interval period Any other Investigational drugs; required interval period (weeks prior to baseline) is 4 benzodiazepines; required interval period (weeks prior to baseline) is 4 MAO Inhibitors anti depressant; required interval period (weeks prior to baseline) is 4 Buspirone; required interval period (weeks prior to baseline) is 2 other psychotropic medicines; required interval period (weeks prior to baseline) is 2 | 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): 17.0-70.0, Epilepsy participants from 17 to 70 years old history of Type I partial onset seizures (complex or simple with motor symptoms only) participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures participants having at least eight Type I partial onset seizures during 8-week baseline period participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS) participant has been on a stable dose of their current anti-epileptic treatment regime currently taking phenobarbital or primidone currently taking felbamate or vigabatrin history of prior allergic reaction to phenobarbital history of psychogenic seizures history or presence of status epilepticus history or presence of seizures occurring only in clusters participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1 history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) presence of any sign suggesting rapidly progressing brain disorder or brain tumor presence of unstable arteriovenous malformations, meningiomas or other benign tumors | 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 Focal Epilepsy Generalized Epilepsy Focal or generalized epilepsy diagnosis More than 3 recordable seizures per month BMI > 18,5 Not responded to at least three 3 AEDs years or older Motivated to complete the diet after thorough information Capable of recording seizures Capable of preparing the diet Hypercholesterolemia, cardiovascular disease or kidney disease Been on modified Atkins diet for more than one week during the last year Status epilepticus last six months epilepsy surgery or VNS implant last year weeks continuous seizure freedom last 2 months PNES seizures other disease where dietary treatment is contraindicated usage of drugs or supplements that may interfere with diet or AED being pregnant or planning 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, Severe Sepsis Clinical diagnosis of Sepsis Mechanical ventilation due to acute pulmonary dysfunction One additional (second) acute sepsis-related organ dysfunction Pregnant women and nursing mothers Conditions or medications associated with an increased risk of bleeding/complications from anticoagulation Previous episode of sepsis during this hospitalization PaO2/FiO2 ratio < 300 Severe granulocytopenia (leukocytes <500 / μl) Acute hepatic diseases or severe liver failure or cirrhosis Chronic cardiovascular disease precluding extracorporeal treatment Human immunodeficiency virus complicated by AIDS defining illness Evidence of active bleeding uncontrolled hemorrhage | 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, Arthroplasty, Replacement, Knee Patients having total knee arthroplasty AsA 1-3 patients with a history of significant medical or psychiatric problems, BMI > 40, allergy to local anesthetic drugs, prior surgery in the inguinal region, neurological disease with sensory or motor deficit, and diabetic neuropathy | 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): 40.0-999.0, Alzheimer's Disease Mild Cognitive Impairment Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment must be able to swallow pills known or suspected bipolar disorder | 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): 17.0-999.0, Epilepsy Seizures Age 17 years Newly diagnosed epilepsy or history of first unprovoked, witnessed seizure Lack of consent provoked seizure due to obvious Acute lesion on CT (e.g. stroke, hemorrhage Provoked seizure due to obvious, chronic lesion on CT (e.g. vascular malformation, tumour) Progressive brain disease (e.g. neoplastic, infectious, demyelinating diseases) History of epilepsy longer than 1 year at presentation to FSC History of AED treatment for more than 4 weeks Contraindication to MRI | 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 and above diagnosed by a neurologist as suffering from drug-resistant epilepsy (all types of seizures) outpatient in Neurology service of the investigation centres inhabitant in the Limousin region having signed the informed consent affiliated or profiting of a social security system patients that are deprived of their freedom patients with disabilities patients suffering from a chronic or an acute delusional disorder patients suffering from others handicaps | 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): 4.0-65.0, Epilepsy Partial Seizures Patients of both sexes, aged between 04 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol Patient´s weight ≥ 20kg Consistent diagnosis of refractory focal epilepsy, with or without secondary generalization Patient with onset of seizures for at least 02 years preceding the screening visit Presence at least 12 partial seizures during the 03 months preceding the screening visit (04 seizures per month) Only seizures that generate motor manifestation will be recorded in this study Absence of brain injury progressive or expansive, previously documented by CT scan, MRI or other imaging test applicable (in the last 05 years Patient with electroencephalogram performed up to 02 years before this visit Subject with stable regimen (minimum of 01 month) from one to three antiepileptic drugs Vagus nerve stimulation for 04 weeks prior to V1, or use of benzodiazepines for more than 07 consecutive days will be considered as concomitant epileptic drugs) Patients with Seizures of non epileptic origin Pseudoseizures Seizures occurring in clustered patterns (03 or more seizures in 30 minutes), in the 03 months preceding the screening visit (V1) History of status epilepticus while taking antiepileptic drugs during the 03 months that preceding the screening visit (V1) Epileptic syndromes that occurs with cognitive deficits or secondary epilepsy evolving from some brain disease History of schizophrenia or suicide attempt Patients with psychiatric ill ongoing Presence of severe mental retardation of any etiology Previous exposure to levetiracetam | 1 |
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