Yonsei University — Biomedical Watch V2

Traitements8programmes

Essais7liés

Publications4liées

SourceDBlocale

Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Afinitor (everolimus)This is a prospective, randomized, double-blind, placebo-controlled cross over study designed to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive therapy in patients with focal cortical dysplasia type II who already failed more than two antiepileptic drugs and surgery. This study will assess the impact of everolimus to placebo on seizure frequency in focal cortical dysplasia type II. The number of patients who experience seizure reduction of 50% or more will be counted during last 4 weeks of each core phase.	Épilepsie	Phase 2	À vérifier	South Korea	À vérifier
Anterior thalamic deep brain stimulation with a standardized amplitude schedule and acute stimulation challengesThis prospective, single-center mechanistic pilot study will investigate the electrophysiological dose-response to anterior thalamic deep brain stimulation (ANT-DBS) in 10 adults with drug-resistant focal epilepsy undergoing clinically indicated DBS implantation. Using local field potentials (LFPs) recorded from implanted sensing-enabled DBS leads, investigators will assess stimulation-induced changes in slow-gamma (20-50 Hz) power. Standardized acute stimulation challenges will be performed at DBS activation (2.0 mA), 1 month after activation (2.0 and 3.5 mA), and 3 months after activation (2.0, 3.5, and up to 5.0 mA, as tolerated). Each amplitude will be tested at least twice against a stimulation-OFF baseline. The primary objective is to characterize the amplitude-dependent electrophysiological response, with the hypothesis that higher stimulation amplitudes produce greater slow-gamma suppression. Secondary objectives include assessing response reproducibility, characterizing longitudinal LFP adaptation during the first 3 months, investigating associations with electrode location and modeled electric fields, and exploring relationships with seizure-frequency reduction during months 7-12 after stimulation activation.	Épilepsie	Non applicable	À vérifier	South Korea	À vérifier
ClopidogrelThis trial aims to compare the safety and efficacy of apixaban alone versus apixaban combined with clopidogrel in patients with acute ischemic stroke associated with non-valvular atrial fibrillation and concomitant symptomatic intracranial or extracranial atherosclerosis. Participants will be randomly assigned in a 1:1 ratio to receive apixaban monotherapy or dual therapy with clopidogrel for 30 days. The primary outcome is the incidence of new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30 (±5) days compared with baseline MRI, adjudicated by a central committee.	Accident vasculaire cérébral, Maladie coronarienne	Phase 4	Traitement symptomatique	South Korea	À vérifier
Percutaneous Coronary Intervention (PCI)This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea. The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice. The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization. No study-specific intervention will be assigned.	Maladie coronarienne	À vérifier	À vérifier	South Korea	À vérifier
Afinitor (everolimus)This is a prospective, randomized, double-blind, placebo-controlled cross over study designed to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive therapy in patients with focal cortical dysplasia type II who already failed more than two antiepileptic drugs and surgery. This study will assess the impact of everolimus to placebo on seizure frequency in focal cortical dysplasia type II. The number of patients who experience seizure reduction of 50% or more will be counted during last 4 weeks of each core phase.	Épilepsie	Phase 2	À vérifier	South Korea	À vérifier
ClopidogrelThis trial aims to compare the safety and efficacy of apixaban alone versus apixaban combined with clopidogrel in patients with acute ischemic stroke associated with non-valvular atrial fibrillation and concomitant symptomatic intracranial or extracranial atherosclerosis. Participants will be randomly assigned in a 1:1 ratio to receive apixaban monotherapy or dual therapy with clopidogrel for 30 days. The primary outcome is the incidence of new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30 (±5) days compared with baseline MRI, adjudicated by a central committee.	Maladie coronarienne	À vérifier	Traitement symptomatique	Egypt	À vérifier
Percutaneous Coronary Intervention (PCI)This prospective, multicenter registry will consecutively enroll patients of all ages undergoing percutaneous coronary intervention (PCI) at four university hospitals in Gangwon Province, Republic of Korea. The study will describe contemporary clinical, procedural, and medication treatment patterns and assess 1-year clinical outcomes in routine practice. The primary outcome is patient-oriented composite outcome (POCO), defined as all-cause death, any myocardial infarction, or any repeat revascularization. No study-specific intervention will be assigned.	Maladie coronarienne	À vérifier	À vérifier	South Korea	À vérifier
Anterior thalamic deep brain stimulation with a standardized amplitude schedule and acute stimulation challengesThis prospective, single-center mechanistic pilot study will investigate the electrophysiological dose-response to anterior thalamic deep brain stimulation (ANT-DBS) in 10 adults with drug-resistant focal epilepsy undergoing clinically indicated DBS implantation. Using local field potentials (LFPs) recorded from implanted sensing-enabled DBS leads, investigators will assess stimulation-induced changes in slow-gamma (20-50 Hz) power. Standardized acute stimulation challenges will be performed at DBS activation (2.0 mA), 1 month after activation (2.0 and 3.5 mA), and 3 months after activation (2.0, 3.5, and up to 5.0 mA, as tolerated). Each amplitude will be tested at least twice against a stimulation-OFF baseline. The primary objective is to characterize the amplitude-dependent electrophysiological response, with the hypothesis that higher stimulation amplitudes produce greater slow-gamma suppression. Secondary objectives include assessing response reproducibility, characterizing longitudinal LFP adaptation during the first 3 months, investigating associations with electrode location and modeled electric fields, and exploring relationships with seizure-frequency reduction during months 7-12 after stimulation activation.	Épilepsie	Non applicable	À vérifier	South Korea	À vérifier

Essais cliniques

7

Molécule	Indication / population	Phase	NCT	Titre	Statut
Anterior thalamic deep brain stimulation with a standardized amplitude schedule and acute stimulation challenges	Épilepsie	Non applicable	NCT07912931	ANT-DOSE — Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy	NOT_YET_RECRUITING
Percutaneous Coronary Intervention (PCI)	Maladie coronarienne	À vérifier	NCT02038127	GWPCI — Gangwon PCI Prospective Registry	RECRUITING
Clopidogrel	Maladie coronarienne	À vérifier	NCT07876336	Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI	ENROLLING_BY_INVITATION
Apixaban	Accident vasculaire cérébral	Phase 4	NCT07237308	BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis	RECRUITING
Sitagliptin	Parkinson	Phase 2	NCT07804381	ARREST-PD — Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease	NOT_YET_RECRUITING
Cannabidiol	Épilepsie	Phase 3	NCT04611438	Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome	UNKNOWN
Afinitor (everolimus)	Épilepsie	Phase 2	NCT03198949	A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)	COMPLETED

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Afinitor (everolimus)		Drug-loaded biomorphic scaffolds for tissue regeneration and targeted antitumor therapy in bone metastasis models.	Biomaterials advances
Afinitor (everolimus)		Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials.	Annals of medicine
Afinitor (everolimus)		Advances in Endovascular Therapy for Infrainguinal Peripheral Arterial Disease: Devices and Outcomes.	The International journal of angiology : official publication of the International College of Angiology, Inc
Afinitor (everolimus)		Everolimus for the treatment of neuropsychological deficits in tuberous sclerosis complex: findings from the TRON multicentre randomised controlled trial.	Journal of medical genetics