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Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
Rochester, MN
The purpose of this study is to determine if a mobile application used to label stools according to the Bristol Stool Scale can safely assist subjects with lactulose titration and lead to decreased rates of hepatic encephalopathy. Additionally, to assess patient willingness to interact with mobile application in taking pictures of bowel movements.
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Development of a Novel Vocal Biomarker in the Diagnosis and Management of Hepatic Encephalopathy
Jacksonville, FL
Hepatic encephalopathy (HE) is a serious complication of cirrhotic stage liver disease. It is reported that 30-70% of all patients with cirrhosis have HE. The current diagnostic methodology for HE includes a blood lab monitoring of ammonia and neuropsychometric testing, which can define the diagnosis but cannot assess the vitally important daily variability of this complication.
There are, however, distinct cognitive neurologic findings in HE that could be mapped and exploited for quick and accurate daily assessment. Vocal changes and speech analysis may provide guidance in the diagnosis and management of HE. The computer algorithm calculating vocal changes in HE would be ...
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A Study of the Imaging, Genetics, Clinical Presentation, Diagnostics, and Progression of Chronic Traumatic Encephalopathy
Scottsdale/Phoenix, AZ
The purpose of this study is to collect and analyze neuroimaging, genetic markers, and clinical presentations and progressions of chronic traumatic encephalopathy to develop methods of diagnosing the disease during life.
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Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
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A Study to Evaluate Voice-enabled Artificial Intelligence to Diagnosis Hepatic Encephalopathy
Rochester, MN
early detection of hepatic encephalopathy
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Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Rochester, MN
The purposes of this research are to assess the effect of NBI-827104, compared with placebo (no active drug), on the overnight epileptiform electroencephalogram (EEG) activity in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS), to evaluate the safety and tolerability of multiple doses of NBI-827104 in pediatric participants with EECSWS, and to evaluate the effect of NBI-827104 on sleep and on cognition in pediatric participants with EECSWS.
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Extension Study to Evaluate NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (Steamboat 2)
Rochester, MN
The primary objective of this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric subjects with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS) when administered for up to 106 weeks.
Its secondary objectives are to investigate the effect of NBI-827104 on the overnight epileptiform video-electroeItephalogram (video-EEG) activity in pediatric subjects with EECSWS, and to investigate the long-term effect of NBI-827104 on the symptoms of EECSWS, including sleep and cognition, in pediatric subjects.
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Rochester, MN
This is a single patient IND using Ampyra. The purpose of using Ampyra in this patient with epileptic encephalopathy is to control her epileptic seizures and prolong seizure free intervals.
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A Study to Detect Non-convulsive Seizures with Single-channel Electroencephalogram (EEG)
Rochester, MN
The purpose of this study is to assess how accurately a portable single-channel EEG device (Epilog™ by Epitel) detects generalized non-convulsive seizures, and to determine the feasibility of use of this device in an acute setting such as the Emergency Department (ED).
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Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effectiveness and safety of rifaximin SSD-40IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites. Participants who have cirrhosis determined by histopathological evidence, transient elastography or presence of esophageal varices, and who have not previously experienced OHE, spontaneous bacterial peritonitis (SBP), esophageal variceal bleeding (EVB), or acute kidney injury-hepatorenal syndrome (AKI-HRS) will be enrolled in the study.
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A Study to Evaluate Real-time Bedside Video Recognition and Reasoning
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to enable the recognition ability of a camera by providing its training in advance to detect breathing tubes and oxygen masks on any person’s face and reliably recognize signature features of acute brain failure displayed by the patient.
The specific aim for this study is to develop a Computer Vision model using a camera to automatically detect the presence of an endotracheal tube (ETT), an oxygen mask, or a noninvasive ventilation device on patients in the ICU.Digital Video Recordings (DVRs) have played an important role in patient care as preventive and remote monitoring. ...
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A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
Rochester, MN
The purpose of this study is to evaluate the long-term safety of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.
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Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies (PACIFIC)
Rochester, MN
The primary objective of this study is to investigate the safety, tolerability, and effectiveness of multiple doses of LP352 in adult subjects with developmental and epileptic encephalopathies.
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North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
Rochester, MN
The North American Mitochondrial Disease Consortium (NAMDC)maintains a patient contact registry and tissue biorepository for patients with mitochondrial disorders.
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Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
Rochester, MN
The objectives of this study are to assess the effectiveness of NBI-921352 as adjunctive therapy on the frequency of countable motor seizures (defined as generalized tonic-clonic seizure [GTCS], tonic, atonic or focal onset seizures [FOS] with noticeable motor component), to evaluate the effectiveness of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change scales and the Clinical and Parent/Caregiver Global Impression of Severity scales, to explore the effect of NBI-921352 on symptoms and seizure activity, physical activity, quality of life, as well as seizure freedom. to characterize the pharmacokinetics (PK) of NBI-921352 and determine the effect of NBI-921352 on plasma levels of concomitant antiseizure ...
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Study of the Incidence of Electrographic Status Epilepticus and Seizures of PICU Patients at National Children’s Hospital in Hanoi, Vietnam.
Rochester, MN
The purpose of the study is:
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To determine the incidence of subclinical electrographic seizures and electrographic status epilepticus in children admitted to the PICU for head trauma, traumatic brain injury (TBI), and/or child abuse at National Children’s Hospital in Hanoi, Vietnam.
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To determine whether a correlation exists between length of stay, morbidity, and mortality with incidence of subclinical SE and seizures.
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A Biorepository for the Center for Multiple Sclerosis and Autoimmune Neurology
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), urine, stool, DNA and tissue specimens collected from patients who have central nervous system (CNS) inflammatory diseases.