Loos

This research aims to evaluate the long-term safety and tolerability of brivaracetam in children and adolescents with epilepsy, including those who participated in earlier studies or are newly enrolled in Japan with partial-onset seizures. The study also seeks to assess pharmacokinetic data in Japanese participants. The study is an open-label, single-arm, multicenter trial focusing on pediatric epilepsy treatment with brivaracetam. Participants will receive brivaracetam tablets or oral solution administered twice daily in two equal doses. Dosage varies based on weight up to 5 mgkgday for those weighing 11 to less than 20 kg, up to 4 mgkgday for those weighing 20 to less than 50 kg, and no more than 200 mgday. Directly enrolled participants in Japan will receive 1 to 4 mgkgday, not exceeding 200 mgday. The study includes long-term follow-up for up to 5 years. During the study, participants will be monitored for treatment-emergent adverse events, serious adverse events, and adverse events leading to discontinuation of the drug. Evaluations occur from Day 1 through safety visits over the 5-year period. Researchers will assess safety, tolerability, and pharmacokinetics. The total participation duration extends up to 5 years, with ongoing safety evaluations throughout this time.

Researchers are studying how new motor skills are learned from scratch by examining changes in the brains motor system excitability during motor learning sessions. This research focuses on understanding the brain plasticity mechanisms involved in learning new movements, particularly exploring increased corticospinal excitability and motor cortex reorganization. The study aims to measure these changes across three separate motor learning sessions spaced over time. Participants will engage in three de novo motor learning sessions on days 1, 2, and 9. During these sessions, they will perform specific motor tasks designed to evaluate learning progress and brain excitability changes. The study uses single-pulse and paired-pulse transcranial magnetic stimulation TMS to assess motor evoked potentials and intracortical inhibition and facilitation at various time points before and after each session. Throughout the study, participants will be assessed on motor evoked potential amplitude input-output curves and short-interval and long-interval intracortical inhibition as well as intracortical facilitation at baseline and immediately before and after each motor learning session. Motor learning performance will be measured using movement path length during a 3D finger-cursor task. The total involvement includes multiple assessments to track brain activity and motor skill acquisition over nine days.

Researchers are studying how the timing of exercise and the type of exercise affect blood sugar control in adolescents aged 10 to 16 who have type 1 diabetes. This study evaluates the impact of exercising in the morning versus the afternoon and compares continuous moderate exercise with intense intermittent exercise. The goal is to better understand how these factors influence blood glucose levels during and after physical activity. Participants will perform four types of exercise tests using a cycloergometer continuous moderate exercise in the morning, continuous moderate exercise in the afternoon, intermittent intense exercise in the morning, and intermittent intense exercise in the afternoon. The study is randomized and controlled, with no masking. Each participant will experience these different exercise conditions to allow comparison of glycemic responses. Throughout the study, researchers will monitor blood glucose changes during and after each exercise session. They will compare glycemic variations between the four exercise conditions over a period extending to September 2026. Participants must comply with study procedures and attend all sessions, providing consent along with their legal guardians. The study includes assessments to ensure safety and proper adherence, aiming to gather detailed information on how exercise timing and type affect glycemic regulation in young people with type 1 diabetes.

Researchers are studying how genetic differences affect muscle damage caused by exercise in healthy adults aged 18 to 35 who are members of sports clubs affiliated with Olympic federations. The study aims to understand how variations in DNA relate to changes in plasma creatine phosphokinase CPK levels before and after muscle-damaging exercise. This research could help identify athletes more prone to muscle injury and optimize training loads. Participants will perform muscle-damaging eccentric exercise designed to induce muscle damage while researchers observe their biological responses. The study focuses on assessing genetic polymorphisms and their impact on exercise-induced muscle damage by measuring blood CPK levels at multiple time points from the day of exercise up to three days afterward. During the study, participants blood samples will be collected before exercise and at three post-exercise times to analyze CPK levels and genetic markers. Researchers will monitor the association between specific gene variations and changes in muscle damage markers. The study involves a single exercise group and includes a total of 300 participants, with all assessments conducted under medical supervision throughout the study duration.

Researchers are investigating how a single session of moderate aerobic exercise affects motor cortex neuroplasticity in older adults and comparing these effects with those in young adults. The study focuses on understanding how exercise, alone and combined with transcranial direct current stimulation tDCS, influences brain changes related to motor function and sensorimotor integration, which may decline with age. This research aims to improve knowledge about strategies to preserve motor function and independence in aging populations. Participants will take part in three experimental sessions involving different conditions aerobic exercise followed by tDCS, physical inactivity followed by tDCS, and aerobic exercise alone. The aerobic exercise consists of 20 minutes of cycling on an ergometer at moderate intensity, while tDCS involves 20 minutes of anodal stimulation over the primary motor cortex. Sessions are spaced at least one week apart, with randomized order for the first two conditions. During each session, participants will undergo assessments using transcranial magnetic stimulation TMS to measure corticospinal excitability and intracortical and sensorimotor circuit functions before and after interventions. Researchers will record motor evoked potentials from a hand muscle to evaluate neuroplasticity changes. Additional evaluations include questionnaires on physical activity and pain. Each session lasts between about 1 to 2 hours, with careful monitoring of exercise intensity and brain responses to the interventions.

Researchers are evaluating whether adding venetoclax to a chemotherapy combination of fludarabine, cytarabine, and gemtuzumab ozogamicin improves survival in children, adolescents, and young adults with acute myeloid leukemia AML who have relapsed once or twice. This phase 3 randomized trial focuses on patients in first relapse who cannot receive more anthracyclines or those in second relapse. The study investigates if targeting the BCL-2 protein with venetoclax can overcome chemotherapy resistance and improve outcomes for this population with poor prognosis. Participants are randomly assigned to two treatment groups. One group receives the chemotherapy combination alone during two 42-day cycles, while the other group receives venetoclax plus the same chemotherapy. Venetoclax is given orally, with dosing schedules varying during the cycles. After the two cycles, participants may undergo stem cell transplantation or receive maintenance therapy with azacitidine alone or combined with venetoclax for up to 24 cycles, depending on the group and clinical benefit. During the trial, participants undergo assessments including survival tracking for up to five years, response rates, relapse incidence, and adverse events. Blood tests measure venetoclax levels at specific time points to understand how the drug behaves in the body. The study also monitors organ function and overall health status. Participants are followed closely to evaluate the effectiveness and safety of the treatments over time.