Loos

This research aims to evaluate the long-term safety and tolerability of brivaracetam in children and adolescents with epilepsy. It includes pediatric participants who previously took part in neonatal or long-term follow-up studies, as well as new participants from Japan with partial-onset seizures. The study also includes evaluation of pharmacokinetics in Japanese participants. It is a Phase 3, open-label, single-arm, multicenter study focusing on pediatric epilepsy patients treated with brivaracetam as an additional therapy. Participants will receive brivaracetam orally twice daily, either as tablets available in 10 mg, 25 mg, or 50 mg strengths, or as an oral solution with a concentration of 10 mg/ml. The treatment is administered in two equal doses each day. The study includes those previously enrolled in related studies and new enrollees from Japan, with treatment and monitoring continuing over an extended period to assess long-term safety. During the study, researchers will monitor participants from the initial evaluation visit through safety visits that may last up to five years. They will track any adverse events related to treatment, including serious events and those causing discontinuation of the drug. Assessments include clinical evaluations, laboratory tests, and electroencephalogram readings, with ongoing safety monitoring to understand how well participants tolerate the medication over time.

Researchers are investigating how the brain's motor cortex changes during the process of learning a new motor skill from scratch, known as de novo motor learning. The study focuses on measuring changes in corticospinal excitability and intracortical reorganization in healthy individuals across three sessions separated by different time intervals. The goal is to better understand the brain's plasticity mechanisms related to motor learning and how motor performance correlates with these neural changes. Participants will take part in three de novo motor learning sessions on days 1, 2, and 8. During these sessions, they will practice new motor tasks designed to stimulate changes in the motor cortex. The study does not involve medication or devices but relies on behavioral interventions centered on motor skill practice. Throughout the study, researchers will assess changes in motor evoked potentials and intracortical inhibition and facilitation using transcranial magnetic stimulation at multiple time points: before and immediately after each session on days 1, 2, and 9. These measurements will help track brain excitability and reorganization. Participants will be monitored for motor learning progress and safety, with total participation spanning these sessions and corresponding assessments.

Researchers are studying how the body's natural daily rhythm affects blood sugar control during different types of exercise in adolescents with type 1 diabetes. This study focuses on comparing the effects of exercise timing, either in the morning or afternoon, and exercise type, continuous moderate or intense intermittent exercise, on blood glucose levels during and after physical activity. The study is conducted at a single center and aims to better understand glycemic variation related to these factors in this young population. Participants will perform physical tests involving continuous and intermittent exercise on a cycloergometer. The study compares four different conditions combining exercise timing and type, assessing blood sugar regulation during and after exercise sessions. This approach helps evaluate how different exercise schedules might influence glucose control in adolescents with type 1 diabetes. During the study, participants will be monitored for changes in blood glucose levels to compare glycemic variation across the tested conditions. Researchers will collect data over a period lasting until September 2026. Participants are expected to comply with all study procedures and duration. Safety and adherence will be ensured through careful observation and regular assessments throughout the trial.

This research aims to explore how genetic differences affect muscle damage caused by exercise in healthy young adults aged 18 to 35 years. By studying variations in DNA sequences, the researchers hope to understand why some athletes may be more prone to muscle injury during intense training designed to improve physical performance. The focus is on elite athletes who experience repeated muscle strain and the risk of injury that comes with it. Participants will perform a specific type of exercise that causes muscle damage through eccentric movements. The study examines changes in blood creatine kinase (CPK) levels, a marker of muscle damage, before the exercise and at three time points after exercising. The researchers will analyze these biological responses in relation to the participants' genetic polymorphisms to identify potential links. During the study, 300 participants affiliated with Olympic sports clubs will be monitored with blood tests to track CPK levels from the day of exercise through three days afterward. Participants will undergo assessments to gather genetic and physiological data. The main outcome is to observe how CPK changes over time relate to genetic differences, helping to better understand individual responses to muscle damage and improve training safety and effectiveness.

Researchers are investigating how a single session of moderate aerobic exercise affects motor cortex neuroplasticity in older adults, both alone and combined with transcranial direct current stimulation (tDCS), and comparing these effects with those in young adults. Aging leads to changes in the central nervous system that can reduce the brain's ability to adapt and learn new motor skills. Physical exercise is studied as a potential way to counter these age-related declines in brain plasticity. The study involves three experimental sessions per participant. Two sessions follow a randomized crossover design where participants either perform 20 minutes of moderate aerobic cycling followed by 20 minutes of tDCS, or 20 minutes of seated rest followed by tDCS. The third session assesses the effect of aerobic exercise alone. Aerobic exercise is performed on a cycle ergometer at moderate intensity, while tDCS is applied over the primary motor cortex at 2 mA for 20 minutes. Corticospinal excitability and sensorimotor circuit function are evaluated using transcranial magnetic stimulation (TMS) before and after each intervention. Participants undergo baseline assessments, including questionnaires and motor threshold determination, and have electromyography electrodes placed on a hand muscle. Researchers measure motor evoked potentials and various intracortical inhibitory and facilitatory mechanisms. The primary outcome is corticospinal excitability changes immediately after interventions. The study duration for each session ranges from about one to two hours, with sessions spaced at least one week apart. These measures aim to better understand how exercise and brain stimulation interact to support motor function and independence in aging.

Researchers are investigating whether adding venetoclax to a chemotherapy combination of fludarabine, cytarabine, and gemtuzumab ozogamicin (GO) can improve survival in children, adolescents, and young adults with relapsed acute myeloid leukemia (AML) who cannot receive more anthracyclines or who are in their second relapse. The study focuses on AML cases resistant to chemotherapy due to overexpression of the BCL-2 protein, which venetoclax targets to restore cancer cell death. This is a phase 3 randomized trial designed to evaluate venetoclax's effectiveness alongside intensive chemotherapy in this high-risk population. Participants receive up to two 42-day cycles of induction chemotherapy combining fludarabine, cytarabine, and gemtuzumab ozogamicin. In the experimental arm, venetoclax is added during these cycles and may continue with azacitidine maintenance treatment for up to 24 cycles if clinical benefit is seen. The control arm receives azacitidine alone for maintenance. Those who cannot immediately proceed to stem cell transplantation after induction may receive maintenance therapy based on investigator discretion. Throughout the study, participants undergo evaluations to monitor survival over up to five years. Assessments include clinical response, treatment tolerance, and toxicity. Researchers track overall survival as the primary outcome, with close monitoring before and after hematopoietic stem cell transplantation. The study includes comprehensive follow-up during treatment and maintenance to assess long-term effects and safety.