Febrile Seizure

Researchers are evaluating RAP-219, an investigational drug, for adults with refractory focal epilepsy, a condition involving difficult-to-control focal seizures. This open-label, multi-center study aims to assess the long-term safety, tolerability, how the drug behaves in the body, and its antiseizure activity in adults who have not responded well to previous treatments. Participants will receive RAP-219 starting with one 0.125 mg capsule daily for 3 days, then one 0.25 mg tablet daily for 28 days, followed by one 0.75 mg tablet daily for the rest of the treatment period. The study is open-label, meaning all participants know they are receiving RAP-219, and the treatment period may last up to 112 weeks with ongoing monitoring. During the study, participants will be regularly assessed for treatment-related side effects and seizure frequency compared to their baseline before treatment. Researchers will monitor seizure-free days, longest seizure-free intervals, and other seizure-related measures using clinical assessments and RNS system data. Safety will be tracked through adverse event reporting up to 8 weeks after the last dose. The total participation duration can be up to about 2 years, with ongoing evaluations throughout.

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.

Researchers are evaluating the safety, tolerability, and initial effectiveness of low-intensity focused ultrasound (LIFU) neuromodulation using the NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). This pilot study involves adults with epilepsy that has not responded to standard medications, aiming to reduce abnormal brain activity and seizures. Participants will undergo six LIFU treatment sessions over three consecutive weeks. Each treatment uses specific ultrasound exposure settings delivered by the NaviFUS System. Before treatment, patients will be observed and asked to keep a seizure diary for 8 weeks. After completing treatments, there is a 12-week follow-up period to monitor outcomes. Patients may continue their anti-seizure medications throughout the study. Participants will keep a seizure diary throughout the study to track seizure frequency and severity. Researchers will also assess safety by monitoring adverse events for up to 23 weeks. Additional evaluations include EEG scans to observe changes in brain activity, and questionnaires that measure anxiety, depression, and the personal impact of epilepsy. The total study duration includes a 2-month baseline, 3 weeks of treatment, and 12 weeks of follow-up.

Researchers are investigating treatments for children aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.

This research aims to evaluate the potential benefits of acupuncture as a treatment for children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). It compares acupuncture combined with traditional Chinese herbal treatment to herbal treatment alone, using a mixed-methods approach that includes data mining, treatment outcome assessments, and patient perspectives. The study seeks to provide a detailed understanding of acupuncture's role in managing ADHD symptoms, executive function, quality of life, and sleep quality. Participants will be assigned to either an experimental group receiving acupuncture alongside herbal medicine or a control group receiving only the herbal treatment based on Chinese Medicine clinical guidelines. Acupuncture treatments involve specific needles and techniques informed by prior data analysis of effective acupoints for ADHD. Herbal treatments follow established clinical guidelines for pediatric ADHD. The study includes three phases: acupoint data mining, clinical intervention with repeated assessments, and qualitative interviews with children, caregivers, and clinicians. During the 12-month study, children will undergo quantitative assessments such as the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL 4.0, PSQI, and CGI at baseline, post-treatment, and follow-up points to measure ADHD symptoms and related impacts. Qualitative interviews will explore treatment experiences and satisfaction. Researchers will analyze changes in symptoms, executive function, quality of life, and sleep, combining statistical methods with thematic analysis. The study starts in October 2024 and is expected to complete by May 2026.

Researchers are evaluating the use of Pulsed Low-Intensity Focused Ultrasound (PLIFU) to reduce or suppress seizure activity in adults experiencing non-convulsive or focal motor status epilepticus (SE) who have not responded to standard treatments. The study focuses on brain regions that generate or control seizures, aiming to assess the effects of this non-invasive brain stimulation in a hospital setting. Participants will receive up to two sessions of PLIFU treatment in the Intensive Care Unit. Each session lasts 10 minutes and uses a custom device that delivers ultrasound to specific brain areas without damaging tissue. Treatments will be given after anti-seizure medications have been administered, and the ultrasound is applied using safe, non-thermal settings. During the study, participants will be monitored continuously with surface EEG to measure epileptic brain activity before, during, and after PLIFU treatment. Researchers will observe changes in seizure activity and follow participants throughout their hospital stay. The main outcome is the change in epileptiform activity measured by EEG at baseline and 10 minutes after treatment. The study aims to gather preliminary data to support future research.

Researchers are evaluating the effectiveness of an AI-personalized mobile app called Medilepsy in improving medication adherence and transition readiness among underserved adolescents and young adults with epilepsy, ages 14 to 24, in Florida. This study compares the AI-enhanced version of the app with a standard version that does not include AI personalization. The research focuses on key outcomes including medical adherence, usability, and language experience. Participants are randomly assigned to one of two groups: the intervention group uses the AI-personalized Medilepsy app with an interactive Smart Chatbot that provides tailored prompts, adaptive education, and personalized support for epilepsy self-management. The comparison group receives a standard version of the Medilepsy app, which offers static prompts and general educational content without personalized feedback. The study lasts 3 to 6 months, during which participants use their assigned app version. During the study, participants will be monitored for medication adherence and transition readiness skills through app usage and assessments. Researchers will evaluate the usability of the app at the end of the 3 to 6 month period. The study collects data on how well the AI features support epilepsy management compared to the standard app version. Safety and participant engagement are also observed throughout the trial duration.

Researchers are evaluating a new algorithm-assisted subjective refraction software designed specifically for children aged 6 to 12 years. This study aims to compare the accuracy of two versions of this software, each used with Vision-S™ and Vision-R™ phoropters, against the conventional subjective refraction method performed manually with the Vision-R™ phoropter. The research focuses on improving the standardization and accuracy of refraction assessments in children. The study has two phases: Phase A will validate the first version of the Kids refraction software (vA) and Phase B will evaluate the second version (vB), which includes additional steps to help manage the child's attention and cooperation. Participants will undergo subjective refraction tests using both software versions with Vision-R™ or Vision-S™ devices, as well as conventional subjective refraction with Vision-R™. Measurements will be taken under non-cycloplegic conditions, with some assessments also performed under cycloplegic conditions. Participants will have their visual acuity and refraction results assessed multiple times, including Sphere, Cylinder, and Axis measurements, starting from Day 1 and continuing up to 7.5 months. The study includes comparisons between non-cycloplegic and cycloplegic refraction results using various devices. Researchers will monitor visual acuity throughout the study to evaluate the software's performance. The total duration of participation for each child will be approximately 7.5 months.

Researchers are evaluating the need for antibiotic prevention in patients with chronic liver disease who have gastric varices and are treated with elective endoscopic injection of cyanoacrylate (GVO). Gastric varices can cause serious bleeding with a high chance of rebleeding and mortality. While endoscopic injection of tissue glue is effective in stopping acute bleeding, it still carries risks of rebleeding and infection, which are important concerns for patients with weakened immune systems due to liver conditions. The study compares two groups: one receiving an antibiotic called ertapenem injected intravenously before the endoscopic cyanoacrylate injection, and the other not receiving this antibiotic before the procedure. The trial is randomized and aims to clarify whether giving this antibiotic can help prevent infections and complications after GVO treatment. The treatment is delivered during an elective endoscopic procedure to manage gastric varices. Participants will be monitored for three years to evaluate key outcomes such as the prevention of sepsis, rebleeding rates, refractory bacterial infections, and mortality. Assessments will include tracking infections and bleeding events over time. The study is designed to provide long-term data on the benefits and risks of using antibiotic prophylaxis in this patient group, with ongoing safety monitoring throughout the follow-up period.

This research aims to evaluate the use of high-flow nasal cannula (HFNC) oxygen therapy to prevent low oxygen levels (hypoxemia) during anesthesia-induced tracheal intubation in children aged 2 to 10 years. Children have higher metabolic needs and are more likely to experience airway collapse and low oxygen during intubation compared to adults. Because spontaneous breathing stops at anesthesia induction, oxygen is rapidly used up, increasing the risk of serious complications. Ultrasound is also used to help diagnose stomach swelling during the procedure. Participants are randomly assigned to one of two groups. In the HFNC group, after the child stops breathing spontaneously, mask ventilation is done until oxygen levels reach 90%, then the mask is removed and HFNC oxygen is provided through nasal tubes to maintain oxygen during apnea. Intubation or laryngeal mask placement is performed afterward while HFNC continues. The control group receives no intervention. The study uses the AIRVO2 device for HFNC and monitors apnea time between 2 to 10 minutes. During the study, researchers will assess how long children can safely hold their breath without oxygen drops and monitor oxygen levels throughout the procedure. Children are evaluated for lung and heart health, cooperation, and anesthesia risk level before participation. The study includes triple masking to reduce bias and will run until November 2025. Safety and oxygenation effectiveness during intubation are the main focuses, with follow-up occurring during the perioperative period.