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Brain Diseases clinical trials

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NCT ID: NCT05395195 Recruiting - Encephalopathy Clinical Trials

Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

EMBRACE
Start date: December 31, 2022
Phase: Phase 3
Study type: Interventional

One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment when used as a mono therapy in pre-clinical models (i.e without adjunct hypothermia). The preclinical data on combined use of Eythropoeitin and hypothermia is less convincing as the mechanisms overlap. Thus, the HEAL (High dose erythropoietin for asphyxia and encephalopathy) trial, a large phase III clinical trial involving 500 babies with with encephalopathy reported that that Erythropoietin along with hypothermia is not beneficial. In contrast, the pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98). Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of Epo monotherapy in LMIC is now warranted.

NCT ID: NCT05386108 Recruiting - Neoplasms Clinical Trials

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer

ELECTRA
Start date: August 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER-positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.

NCT ID: NCT05378035 Recruiting - Stroke Clinical Trials

DOAC in Chinese Patients With Atrial Fibrillation

DOAC-REAL
Start date: September 28, 2022
Phase:
Study type: Observational

Direct oral anticoagulants (DOACs) have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation (NVAF). All four DOACs - apixaban, dabigatran, edoxaban, and rivaroxaban - were shown to reduce the risk of major bleeding compared to warfarin. The predictable pharmacokinetic profiles of DOACs also favour their use over warfarin. Together with increasing AF incidence due to population ageing, increased AF detection, and territory-wide reimbursement schemes, DOAC prescriptions have been surging worldwide. In Hong Kong, more than 78,354 patients received DOAC from January 2009 through April 2021 according to the Hospital Authority registry. The more liberal use of DOACs has led to new issues that require a thorough understanding of ethnic-specific DOAC pharmacokinetic profiles. For instance, 12- 15% of anticoagulated patients annually required interventional procedures that involve temporary discontinuation of DOAC for 48 hours or more. Although guideline-based periprocedural DOAC interruption resulted in a low 30-day thromboembolism rate of 0.16% - 0.6% in a Caucasian cohort, same measures for elective colonoscopies in a local population-based study resulted in a 30-day periprocedural thromboembolism rate of up to 2.2%. Although these studies cannot be compared directly, the remarkable interethnic discrepancy between the two cohorts warrants further pharmacokinetic and pharmacogenomic studies. More importantly, quantifying residual DOAC levels during the interruption periods may imply on duration of periprocedural DOAC interruption, length of hospital-stay, and the risk of thromboembolic and bleeding complications. Mapping inter- and intra-individual variations in DOAC levels may also impact on the management of ischemic stroke among DOAC recipients. Epidemiological studies have shown alarmingly up to 13% of acute ischemic stroke patients were on anticoagulation prior to stroke onset with increasing number of DOAC. These patients received low rates of recanalization therapy due to apprehension of bleeding complications, thus compromised survival and neurological recovery. A prospective study that reveals Asian-specific DOAC pharmacokinetic profiles may inform cross-disciplinary, territory-wide periprocedural care and acute stroke intervention strategy for the rapidly expanding DOAC population.

NCT ID: NCT05368922 Recruiting - Cerebral Palsy Clinical Trials

Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy (RV-REEDUC)

RV-REEDUC
Start date: March 4, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of a virtual reality rehabilitation protocol on visuo-motor coordination and upper limb functional abilities in children with unilateral or bilateral cerebral palsy.

NCT ID: NCT05361070 Recruiting - Stroke Clinical Trials

Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy

NSR-GENE
Start date: August 9, 2022
Phase:
Study type: Observational [Patient Registry]

The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.

NCT ID: NCT05346029 Recruiting - Sarcopenia Clinical Trials

Role of Sarcopenia and Nutritional/Physical Therapy Intervention in Post-TIPS Hepatic Encephalopathy

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The placement of TIPS (transjugular intrahepatic portosystemic shunt) is the most effective strategy to treat complications of portal hypertension. However, the threat of developing post-TIPS complications diminishes its use and applicability. Hepatic encephalopathy (HE) is the most feared and frequent post-TIPS complication, affecting between 25-54% of patients. Available treatments against HE are only partially effective. Therefore, the best existing strategy is to accurately select patients for TIPS excluding those presenting known high risk factors associated to post-TIPS HE. Despite applying this approach, the incidence of post-TIPS HE still remains very high. The investigators hypothesize that a better identification of risk factors for post-TIPS HE, together with the introduction of therapeutic interventions modulating pathophysiological mechanisms involved in post-TIPS HE development - among which sarcopenia stands out- would lead to a reduction in the incidence of HE and, eventually, to an increase in the number of patients benefiting from TIPS. Thus, our project is aimed at 1. Demonstrate that a 12 weeks lifestyle intervention based on resistance training and nutritional counseling can reduce sarcopenia and, ultimately, post-TIPS HE. 2. To study predictive factors of post-TIPS HE, focusing on the role of factors that have never been evaluated in the setting of TIPS: gut microbiome and cognitive function

NCT ID: NCT05322343 Recruiting - Depression Clinical Trials

Biobank and Brain Health in Bordeaux.

B-cube
Start date: March 22, 2022
Phase:
Study type: Observational [Patient Registry]

B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

NCT ID: NCT05318976 Recruiting - Alzheimer Disease Clinical Trials

A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

MINDFuL
Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.

NCT ID: NCT05287750 Recruiting - Brain Tumor Clinical Trials

Brain Diseases on 7.0T Magnetic Resonance Imaging

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

NCT ID: NCT05275296 Recruiting - Clinical trials for Cardiovascular Diseases

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

PROMISE
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms