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Brain Diseases clinical trials

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NCT ID: NCT06245473 Recruiting - Cirrhosis Clinical Trials

Metobolomics in the Characterisation of HE

METABO-EH
Start date: April 23, 2024
Phase:
Study type: Observational

Hepatic encephalopathy is (HE) defined by the neurological and/or neuropsychological symptoms caused by an acute or chronic liver disease and/or a portosystemic shunt. Its pathophysiology is still debated, although the synergic role of hyperammonemia and inflammation is now admitted for years. Several additional mechanisms have been suspected, one of them being an altered permeability of the brain blood barrier (BBB). Nevertheless, many aspects remain poorly understood. The rise of "-omics" techniques, and especially metabolomics, allowed to identify more precisely the different metabolic pathways that are involved in the pathophysiology of HE. Using a high flow chemistry technique and multivariate data analysis, metabolomics is an accurate way to understand the pathophysiology and pathogenesis of multifactorial diseases such as HE. Several studies have been published in cirrhosis. It has been suggested that serum metabolites at admission, as well as thyroxine, can predict advanced HE in patients without brain failure. In a cohort including more than 600 patients, a higher microbially-derived metabolites, together with a lower thyroxine level, were associated with further development of brain failure. In another study from the same team, serum and urinary metabolites were significantly different in hospitalised patients who had developed poor outcome or not. Another study conducted in the CANONIC cohort as also found changes in metabolites of patients with cirrhosis and acute-on-chronic liver failure (ACLF), revealing mitochondrial dysfunction in peripheral organs that may contribute to organ failures. Last, our team previously analysed plasma and cerebrospinal fluid (CSF) samples of patients with cirrhosis and HE hospitalised in intensive care unit (ICU), showing alteration in ammonia and amino-acids metabolism, and also in energy metabolism. However, in the latest study, ALCF grading was not available. As many of these patients were in a severe condition, one could hypothesize that the metabolomic changes observed in these patients may have been confounded by an ACLF profile. Therefore, the objective of this study is to characterize the metabolomic fingerprints of HE in patients with cirrhosis, using 4 different groups of patients: patients with or without HE, with or without ALCF.

NCT ID: NCT06244823 Recruiting - Migraine Disorders Clinical Trials

The FreMRI Study: Advanced MRI on Migraine Patients Treated With Fremanezumab

FreMRI
Start date: March 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this open-label, single-blind, controlled-trial is to evaluate brain changes evaluated with diffusion Magnetic Resonance Imaging (MRI) and functional MRI in patients with high-frequency episodic migraine and chronic migraine that will be treated with Fremanezumab, 12 weeks after the treatment onset, compared with the baseline. Type of study: Phase IV clinical trial Participant population: high-frequency episodic migraine and chronic migraine. Participants will be treated with Fremanezumab.

NCT ID: NCT06201988 Not yet recruiting - Clinical trials for Hepatic Encephalopathy

Revealing Engagement Patterns Among Hepatic Encephalopathy Patients

Start date: January 2025
Phase:
Study type: Observational

This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors. In essence, this trial aims to deepen understanding of the factors influencing participation in hepatic encephalopathy clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.

NCT ID: NCT06200519 Not yet recruiting - Clinical trials for Gestational Diabetes

Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

DiFuSE
Start date: January 2024
Phase:
Study type: Observational

The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. The main question it aims to answer are: - What are the normal reference ranges for parameters of diastolic cardiac function in neonates? - How are these influenced by maternal, intrapartum and neonatal factors? - Do the diastolic changes noted during the first two days of life persist into infancy? Participants will have four echocardiographic assessments in total: - Two during the first 48 hours of life (prior to discharge home) - Two during infancy (as an outpatient)

NCT ID: NCT06195345 Recruiting - Clinical trials for Hemodynamic Instability

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

ICHOR 1
Start date: November 1, 2018
Phase:
Study type: Observational

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

NCT ID: NCT06193252 Recruiting - Parkinson Disease Clinical Trials

Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands

Slow-SPEED-NL
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months). Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups

NCT ID: NCT06189950 Recruiting - Clinical trials for Intracranial Aneurysm

Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.

NCT ID: NCT06186024 Recruiting - Brain Diseases Clinical Trials

A PROSPECTIVE, MULTICENTER, SINGLE-ARM TRIAL FOR THE NEW SIZES OF BRIDGE STENTS FOR VERTEBRAL ARTERY STENOSIS: Bridge-MAX

Start date: September 27, 2023
Phase: N/A
Study type: Interventional

Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .

NCT ID: NCT06179368 Recruiting - Hepatic Impairment Clinical Trials

Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase.

NCT ID: NCT06172491 Recruiting - Delirium Clinical Trials

Automating Delirium Severity in the ICU

ADS-ICU
Start date: January 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients >50 years of age. The main questions it aims to answer are: - Is the trained convolutional neural network able to reliably measure delirium severity. - Is the Passive Digital Marker able to accurately measure delirium severity - Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers). Participants will: - Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU). - Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.