28 results for "Brain, Back and Nerves (Neurosciences)"

Multiple Sclerosis and documentation of the drug utilization of Tecfidera (Dimethyl Fumarate)

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF).

ALS and the effects of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA)

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.

Migraine attacks and the effects of lasmiditan

This study will assess the efficacy, consistency of response, and safety of lasmiditan in acute treatment of 4 migraine attacks with or without aura.

Plegridy Real World Effectiveness and Safety Observational Program

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice.

Multiple Sclerosis and the effects of Ocrelizumab

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.

Multiple Sclerosis and the effects of MD1003

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry

The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulants in community practice.

Open Posterior Spinal Fusion Procedures and the effects of the SA4AG Vaccine

The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

Exploratory Digital Assessment of Cognition and Function with Alzheimer's Disease

Exploratory Digital Assessment of Cognition and Function in Healthy Controls and Subjects with Alzheimer's Disease

Supranuclear Palsy and the effects of Intravenously Administered BMS-986168

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.

Neuromuscular Blockade and the effects of Sugammadex

This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adult ASA Physical Status Class 3 and 4 participants. The first primary objective of this study is to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex.

Brain tumors and the effects of EVICEL® Fibrin Sealant (Human) vs a Hydrogel Sealant

Patients undergoing brain surgery (craiectomy or craniotomy) will be enrolled in the trial. Upon completion of the sutured dural repair, the closure will be evaluated for intraoperative cerebrospinal fluid (CSF) leakage. Subjects who have a CSF leak will be stratified by surgical procedure, posterior fossa or supratentorial approach and then randomized to either EVICEL Fibrin Sealant or DuraSeal™ Dural Sealant System in a 1:1 allocation ratio. Subjects will be followed post-operatively through discharge and again at 30 (-/+7) days and 60 (-/+14) days post-surgery.

Embolic Stroke and the effects of dabigatran etexilate vs acetylsalicylic acid

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

Ischemic Stroke and the effects of HT-3951 on Upper Extremity Motor Function

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

Ischemic Stroke and the Rate of Atrial Fibrillation Through 12 Months

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Systemic Embolism/Stroke and the effects of Rivaroxaban with Aspirin

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

GlIadeL WAfer ImplaNT (VIGILANT) Registry

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.

Non-Small Cell Lung Cancer (NSCLC) and the effects of Tumor Treating Fields (TTFields) - METIS

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Cancer and the effects of intravenous 4-demethyl-4-cholesteryloxycarbonylpenclomedine (dm-choc-pen)

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary (astrocytomas, GBM) and metastatic lung cancers.

Optune Prescription

Optune Prescription

Migraine Treatment and management Electronic Diary (M-TED)

A non-interventional, prospective, study assessing the burden of migraine using a smartphone-based tracker app

Pediatric Seizures and the effects of Perampanel Oral Suspension

This is an open-label, multicenter study with an extension phase to evaluate the safety and tolerability of an perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic seizures (PGTC).

Epilepsy and the effects of NRL-1

This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will be based on the subject's body weight.

Parkinson's disease and the effects of urate-elevating inosine treatment

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD.

ALS and the effects of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA)

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.

Migraines and the effects of the nVNS as prophylactic treatment

This study collects clinical data related to the safety and efficacy of the nVNS for the prophylactic treatment of migraine.

Epilepsy and the effects of SAGE-547 (Allopregnanolone with Captisol)

Medication trial for patients suffering from super-refractory status epilepticus (life-threatening, continuous seizures) that has failed traditional treatment.

Epilepsy and the effects of Vimpat, Lacosamide

This study is exploring a medication (currently on the market) for its effectiveness in controlling “grand-mal” seizures in patients with a specific type of epilepsy.