Indaiatuba

Researchers are evaluating the Move Sapiens virtual reality VR exergame combined with a short high-intensity interval training HIIT model as a potential intervention for adolescents aged 12 to 17 with Attention-Deficit Hyperactivity Disorder ADHD. This study aims to determine if this VR exercise game can improve attention, executive function, and reduce symptoms like sleep problems and anxiety compared to a control group. The trial also explores possible brain function changes in a smaller group using neuroimaging. Participants will be randomly assigned to either the experimental group, which practices the Move Sapiens VR exergame incorporating HIIT cycles of intense effort and rest, or the control group, which uses an adapted version of the game without physical exercise, interacting through a joystick. Both groups will complete 20 sessions over 4 weeks, with the first four and last sessions conducted in the lab under supervision where heart rate is monitored. The remaining sessions occur at home with remote monitoring, and game scores will be tracked throughout. During the study, participants will visit the clinic for assessments before and after the intervention, including attention and executive function tests as well as questionnaires on sleep and anxiety. Heart rate will be measured during lab sessions. Researchers will analyze changes in inattention and inhibitory control as primary outcomes, with secondary measures including working memory, cognitive flexibility, reaction time, sleep quality, anxiety symptoms, impulsivity, and attention. The study will last about 4 weeks with close monitoring and data collection from all participants.

Researchers are evaluating tozorakimab as an additional treatment to standard care in adults hospitalized with viral lung infection who need supplemental oxygen. The study aims to determine if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation. This Phase III trial involves a large group of participants to assess the safety and effectiveness of this approach. Participants are randomly assigned to one of two groups one group receives a single intravenous dose of tozorakimab on the first day, while the other group receives a matching placebo. The study uses a double-blind design, meaning neither participants nor researchers know which treatment is given. This helps ensure unbiased results. The treatments are given once, and participants continue to receive standard care during the trial. During the study, participants are closely monitored and evaluated up to 60 days after treatment. Researchers track important outcomes such as death rates, progression to invasive ventilation, days alive outside intensive care, and oxygen use. They also assess clinical progression using a World Health Organization scale and monitor for any anti-drug antibodies. The trial lasts until November 2027, with multiple assessments throughout to understand the treatments impact and safety.

Suicide is a leading cause of early death worldwide, with rising rates especially in low- and middle-income countries like Brazil where access to specialized care is limited. This trial evaluates whether adding a single esketamine infusion or a Crisis Response Planning session to enhanced treatment as usual eTAU can better prevent future suicide-related events in adolescents and adults aged 14 and older who recently attempted suicide or have severe suicidal thoughts. The study also examines which approach provides faster or longer-lasting improvements in mental health and quality of life, and assesses feasibility and cost-effectiveness in a public health setting. Participants are randomly assigned to one of three groups a single intravenous esketamine infusion with continuous monitoring plus eTAU a 20- to 45-minute Crisis Response Planning session with a trained clinician plus eTAU or eTAU alone, which includes standard emergency care, lethal means safety counseling, connection to mental health services, and a psychiatric follow-up within 7 days. Esketamine is administered in a clinical setting with safety monitoring for up to 24 hours, while Crisis Response Planning involves creating a personalized written and digital safety plan. Participants experiencing a new suicide-related event during the study may receive an open-label combined rescue treatment. Throughout the one-year study, participants complete questionnaires at 11 time points assessing suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life. They provide a blood sample at baseline for exploratory biomarker analysis and use a smartphone app to report mood and thoughts four times daily for four weeks. Safety is monitored continuously, and assessments include a wide range of validated mental health scales. The study reflects real-world emergency care in Brazils public health system and aims to inform scalable suicide prevention strategies.