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Brain Diseases clinical trials

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NCT ID: NCT05778188 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

STAR
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

NCT ID: NCT05772416 Recruiting - Clinical trials for Neonatal Encephalopathy

Neonatal Neurological Examination to Detect Infants at Risk

Start date: September 1, 2021
Phase:
Study type: Observational

The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

NCT ID: NCT05767476 Recruiting - Clinical trials for Encephalopathy, Hypoxic Ischemic

Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

Start date: April 28, 2021
Phase:
Study type: Observational

The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: - Identify patients at risk of neuromotor, cognitive and epileptic sequelae - Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: - Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment - Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. - Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. - Brain magnetic resonance imaging between 7 and 14 days. - Electroencephalogram (EEG) within 7 days. After discharge study population will perform: - EEG between 3 and 6 months. - Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. - General Movement Assessment at 3 months. - Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. - Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. - Motor performance assessment using Movement ABC between 42 and 48 months.

NCT ID: NCT05754996 Recruiting - Clinical trials for Hepatic Encephalopathy

Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy

Start date: March 12, 2023
Phase: Phase 3
Study type: Interventional

Evaluating the efficacy and safety of the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy

NCT ID: NCT05754476 Recruiting - Brain Diseases Clinical Trials

Multi-center Study of Artificial Intelligence Model for Gadolinium-based Contrast Agent Reduction in Brain MRI (MAGNET)

MAGNET
Start date: March 29, 2019
Phase:
Study type: Observational

MAGNET is a multi-center and prospective study to minimize Gadolinium-based Contrast Agent (GBCA) combining novel artificial intelligence (AI) methods with pre-contrast images and/or low-dose images to synthesize virtual contrast-enhanced T1 (vir-T1c) images, based on a large clinical and MRI database and subsequently validated for its clinical value. MRI examinations for patients included T1-weighted images (T1WI) before and after contrast agent administration and at two dose levels: low-dose (10% or 25%) and full-dose (100%), T2-weighted images (T2WI), fluid-attenuated inversion recovery (FLAIR), and diffusion-weighted imaging sequences (DWI) and the computed apparent diffusion coefficient (ADC), all either acquired three dimensional [3D] or two dimensional [2D]). The standard dose of intravenous gadolinium contrast agent was 0.1mmol/kg(body weight) by manual injection or automatic injection with a high-pressure syringe at a flow rate of 4mL/s.The sequence parameters used for the 3DT1WI scans must be consistent, and the standard for intravenous injection of gadolinium contrast agent is 0.1mmol/kg (body weight), administered either manually or automatically with a high-pressure syringe at a rate of 4mL/s. Additionally, arterial spin labeling (ASL), amide-proton transfer chemical exchange saturation transfer (APT-CEST), susceptibility-weighted imaging (SWI), or quantitative susceptibility mapping (QSM) can be acquired at the same time if the conditions permit.

NCT ID: NCT05754372 Recruiting - Clinical trials for Hyperammonemic Encephalopathy

Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

Start date: January 15, 2023
Phase:
Study type: Observational

Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB[(Cinlet - Coutlet)/Cinlet]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia. The aim of this study is to validate these formula with a prospective study.

NCT ID: NCT05746624 Recruiting - Ischemic Stroke Clinical Trials

Procedural Motor Memory in Long COVID-19

Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Background: Most people who get COVID-19 seem to recover with no long-term effects. However, some people who recover from acute COVID-19 infections report lingering symptoms. This is called long COVID. Many people with long COVID report symptoms related to the nervous system; these can include problems with fatigue, speech, and memory. Objective: To test motor memory in people with long COVID, compared to healthy volunteers. Eligibility: People aged 18 to 90 years who are also enrolled in study protocol 000089. Healthy adults are also needed. Design: Participants will be screened by telephone. They will confirm they are able to type without discomfort using their nondominant hand. They will confirm they have access to a computer connected to the internet. All study tasks will be done online. Participants will complete 2 tasks in 2 days. Participants will be sent a link to a website. The website will give them instructions. They will place the fingers of their nondominant hand over 4 numbers on the keyboard and type a sequence (eg, 4-1-3-2-4). They will type this sequence as often as they can in 10 seconds. Then they will rest for 10 seconds before repeating the task. They will repeat this pattern for 15 minutes. After they finish the typing task, participants will take a 10-minute questionnaire. They will answer questions about their experiences with COVID-19 and memory issues; they will say which hand they use for tasks such as brushing their teeth or throwing a ball. Participants will get a notice to repeat the typing task 22 hours after they finish the first one. They should complete the second task within 28 hours....

NCT ID: NCT05738486 Recruiting - Dementia Clinical Trials

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Start date: February 28, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

NCT ID: NCT05722990 Recruiting - Clinical trials for Epileptic Encephalopathy

Genetic Investigations in Children With Developmental and Epileptic Encephalopathies in Ho Chi Minh City, Vietnam

Start date: March 16, 2022
Phase:
Study type: Observational [Patient Registry]

Early childhood is one of the periods of life in which the risk to develop epilepsy is highest. Besides, genetic causes are much more common in the young. Recently, an ever-increasing amount of genes has been found to be involved in numerous early-onset epilepsies. Thanks to next-generation sequencing (NGS), a diagnosis can now be reached in close to 50% of children with epilepsy and developmental delay. This, in turn, has led to the successful application of the concept of individualized treatment in a growing number of children with epilepsy. Genetic investigations have thus been progressively included in the routine work-up of children with early-onset epilepsies throughout the world, mostly in high-income countries up to now. As a result of a scientific collaboration between pediatric neurology divisions at University Hospitals Geneva (HUG), Switzerland, and Children's Hospital 2 in Ho Chi Minh City (HCMC), Viet Nam, genetic testing of children with early-onset epilepsies followed at the pediatric neurology division, Children's Hospital 2 started at the genetics laboratory of the Vietnam National University in 2017. Aims: Our project aims at establishing the proportion of patients in whom a causal genetic finding can be identified, in a prospective cohort of children with Developmental and Epileptic Encephalopathies (DEE) followed at Children's Hospital 2 (ND2). The investigators also aim at identifying the percentage of these children in whom this approach would change current management. Methods: A series of children diagnosed with DEE and followed at ND2 Hospital, enrolled consecutively. Exome sequencing was applied to all, with biostatistical analyses of a panel of 671 genes involved in epilepsies and developmental disorders performed in parallel at Ho Chi Minh City Vietnam National University and Geneva Genetic Medicine Division. Sanger sequencing confirmation of potentially causal variants in patients, and in parents for familial segregation. Comparison of Vietnamese and Swiss genetic findings, and multidisciplinary discussions in formal Genome Boards. Additional genetic investigations, if deemed necessary in Genome Board sessions. Clinical management adapted to genetic findings wherever applicable, and follow-up according to standard practice. One-hundred-and-fifty patients are expected to participate during the 3-year study period.

NCT ID: NCT05700695 Recruiting - Clinical trials for Hepatic Encephalopathy

Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

Start date: January 17, 2023
Phase: Phase 1
Study type: Interventional

This multi-centric study analyses the effect of intravenous branched-chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators aim to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone, ammonia measures, endotoxin, metabolomics, and cerebral edema in the medical management of overt HE in patients with ACLF. The study will also access the impact on overall survival and improvement in the grade of HE.