Students

Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.

This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.

Researchers are conducting a master protocol study to streamline several clinical trials testing different drugs in children and young adults with various cancers. This master protocol allows multiple cancer-specific studies to be added over time as new drugs become available. Participation depends on how long the treatment benefits last. The study is sponsored by Eli Lilly and Company and focuses on patients aged 1 to 39 years with measurable or evaluable cancer. The study evaluates multiple treatment combinations for specific cancer types. For desmoplastic small round cell tumor (DSRCT), participants may receive ramucirumab intravenously with oral cyclophosphamide and intravenous vinorelbine in 28-day cycles or cyclophosphamide and vinorelbine without ramucirumab. For synovial sarcoma (SS), treatment options include ramucirumab with gemcitabine intravenously or gemcitabine with docetaxel intravenously in 21-day cycles. For Ewing's sarcoma (ES), participants may receive abemaciclib orally with intravenous irinotecan and oral temozolomide or irinotecan with temozolomide alone, also in 21-day cycles. Treatments are given according to randomized assignment without masking. Participants are monitored from baseline through the first four weeks to track allocation to each treatment group. Eligibility requires certain performance scores and recovery from prior cancer treatments, along with adequate organ function. Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception. Throughout the study, medical history, disease assessments, and safety monitoring are conducted to evaluate treatment effects. The study is planned to continue until May 2027, allowing for long-term observation and data collection.

Researchers are evaluating the use of CD19 CAR-T cell therapy in adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This open-label, multicenter study aims to assess how effective and safe this treatment is for this specific group of leukemia patients. Additional goals include studying how the CAR-T cells grow and persist in the body, as well as their effect on B-cell levels. Participants will receive an intravenous infusion of CD19 CAR-T cells at a dose of 2 x 10^6 CAR+ T cells per kilogram of body weight. The study includes approximately 50 adult patients and is designed as a single-arm trial without a comparison group. The treatment is administered once, followed by monitoring and evaluation periods. During the study, patients will be closely monitored for treatment response and safety. Key assessments include measuring the complete molecular response rate 28 days after infusion and tracking outcomes such as leukemia-free survival, overall survival, and relapse incidence over two years. Patients will undergo blood tests, genetic testing, heart function evaluations, and be observed for any infections or other health changes. Participation involves signing informed consent and agreeing to contraception measures if of childbearing potential.

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 investigating the use of hyperbaric oxygen (HBO) therapy to improve umbilical cord blood (UCB) stem cell transplant outcomes for blood and lymph gland cancers such as AML, NHL, Hodgkin Disease, and myelodysplastic syndrome. UCB transplant has advantages like easier access and lower risk of infections and graft versus host disease, but challenges include limited stem cell doses and problems with homing, where stem cells lodge in the bone marrow. This study aims to see if HBO given before transplant can improve homing and engraftment by reducing a hormone that may impair this process. Participants in this randomized phase II trial will be assigned to either receive hyperbaric oxygen therapy or no additional intervention before their UCB transplant. HBO therapy involves breathing 100% oxygen in a pressurized chamber at 2.5 times normal atmospheric pressure. The study compares time to neutrophil recovery and other blood count and transplant success measures within 100 days after transplant between the two groups. Participants will be monitored closely with blood tests to track recovery and engraftment, including neutrophil and platelet counts and donor cell presence. Safety assessments and evaluations of transplant outcomes will occur regularly during the first 100 days post-transplant. The study runs until June 2027 and aims to provide important information on whether HBO therapy improves transplant success and immune recovery.

Researchers are evaluating a mindfulness program specifically adapted for Hispanic young adults aged 18 to 25 who engage in heavy episodic drinking. This randomized control trial aims to test the feasibility and acceptability of an 8-week Mindfulness-Based Stress Reduction (MBSR) program designed to reduce problematic drinking among this population. The study seeks to understand how well this culturally and developmentally tailored intervention works in a real-world setting. Participants will be randomly assigned to one of two groups: an intervention group receiving weekly 1.5-hour in-person mindfulness sessions over 8 weeks at Florida International University's MMC campus, or an assessment-only control group. Both groups will complete online surveys and provide fingerprick blood samples to measure alcohol biomarkers, as well as have their heart rate and blood pressure measured at four timepoints: baseline, 1 month, 2 months, and 3 months after baseline. The intervention group will also receive Contingency Management incentives to encourage attendance. Throughout the study, participants will spend up to 16 hours over approximately 14 weeks completing assessments, participating in the mindfulness sessions if assigned, and attending follow-up evaluations. Researchers will measure outcomes such as program acceptability, attendance, retention, changes in heavy drinking behavior, alcohol consumption, and perceived stress. Safety and minimal risks like discomfort from assessments or blood sampling will be monitored during the study.

The GEROS Project is designed to develop and implement a Service-Learning program that combines Comprehensive Geriatric Assessment (CGA) and health promotion for older adults aged 60 and above. It involves university students from various health-related fields and aims to foster intergenerational learning and community engagement. The study follows a non-experimental mixed-method design and focuses on evaluating frailty, intrinsic capacity, quality of life, and other health indicators in participating older adults. Participants will receive a series of three sessions at the University of Vic - Central University of Catalonia, where students supervised by health professionals conduct CGA evaluations. Following the assessment, users receive a report with their CGA results along with personalized health education and recommendations. The program integrates practical student training with real-world health promotion for older adults. During the study, researchers will assess frailty and quality of life at baseline, and measure satisfaction and self-perceived knowledge and skills of both students and older adult participants after the intervention sessions. Data will be collected through questionnaires and recorded using REDCap. The study supports active aging and aligns with global health and equality goals, with total participation spanning up to 2-4 weeks after intervention.

This research aims to study how mind and body activities, including those done with virtual reality (VR), affect brain health, thinking skills, and emotional well-being in college students aged 18 to 25 years. The study uses a detailed approach that looks at thinking, emotional health, biological markers, and brain imaging to understand how these activities might help. Researchers believe that three types of activities—Mindfulness-Based Stress Reduction (MBSR), Qigong, and High-Intensity Functional Training (HIFT)—will improve thinking and well-being after three months compared to before starting. Participants will be divided randomly into groups to try either traditional or VR versions of these three activities, each lasting 12 weeks. Study 1 involves 174 students doing online HIFT, Qigong, or MBSR sessions, while Study 2 includes 45 students doing the same activities but using VR. Each intervention includes guided group sessions and individual practice. Before and after the 12-week programs, medical, mental, and physical tests are done, with brain scans and biological samples collected in Study 1. There is also a follow-up 12 weeks after the interventions to check on physical and emotional well-being through online questionnaires. During the study, participants will complete various tests measuring memory, attention, thinking skills, psychological symptoms, self-esteem, mindfulness, sleep quality, and diet. Physical fitness and health measures like heart rate, muscle strength, balance, and brain imaging will be done before and after the interventions. The study also tracks changes in gut microbiota and emotional status. For the VR group, usability and acceptance of the VR system are evaluated. The entire study includes careful monitoring and assessments over several months to understand the effects of these interventions on brain and psychological health.

This research aims to build evidence for a youth firearm violence prevention program in Washington D.C., a city facing disparities in youth firearm violence outcomes. It focuses on how participation in the summer youth employment program called The T.R.I.G.G.E.R Project, designed to address the root causes of gun violence, relates to youth behavioral outcomes such as pro-social involvement, aggression, and attitudes toward firearms. Participants will be involved in The T.R.I.G.G.E.R Project over several years, with waves of youth participating in summer youth employment programs from 2022 through 2025. The program includes components like summer employment, social and emotional learning, future orientation, adult and peer support, critical consciousness, and civic engagement, all aimed at addressing firearm violence causes. Youth participants will complete four surveys over one year to track changes in attitudes and behaviors: a pre-test at the program start, then post-tests 2-4 weeks, 6 months, and 12 months after the program ends. Researchers will measure changes in civic efficacy, pro-social involvement, violence-related attitudes, aggressive behavior, firearm carriage frequency, firearm use, and firearm aggression throughout these time points.