Valparaiso

Researchers are evaluating a new treatment option for children with certain types of cancer, specifically hepatoblastoma and rhabdomyosarcoma RMS that have either come back after treatment or did not respond to prior therapies. Hepatoblastoma is a common liver cancer in very young children, while RMS begins in muscle cells and often appears in areas such as the head, neck, bladder, arms, or legs. This study is a phase 12 trial aiming to assess the safety and effectiveness of a drug called patritumab deruxtecan HER3-DXd in these pediatric patients. Participants will receive patritumab deruxtecan through an intravenous infusion on the first day of each three-week cycle. The study includes two parts first, a safety lead-in phase to determine a tolerable dose and assess safety, followed by a phase to evaluate how well the treatment works in shrinking or eliminating cancer. Participants will continue treatment until disease progression or other reasons for stopping occur. Throughout the study, children will be closely monitored for side effects and how the drug behaves in their bodies over time, with various blood tests and assessments conducted at designated times up to approximately five years. Researchers will measure outcomes such as the percentage of patients experiencing toxicities or adverse events, treatment response rates, and survival metrics. This long-term follow-up aims to gather comprehensive data on safety and effect.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

This clinical trial investigates the best way to use prone position placing patients on their stomachs for adults with moderate to severe Acute Respiratory Distress Syndrome ARDS who need mechanical ventilation. Researchers want to find out if longer prone sessions lasting more than 48 hours improve survival compared to daily sessions lasting 16 to 24 hours. The study also evaluates the safety of prolonged prone positioning and its impact on medical problems related to this intervention. Participants are randomly assigned to one of two groups one receiving prolonged prone position sessions lasting at least 48 hours and up to 120 hours until their oxygenation improves, and the other receiving intermittent daily prone sessions lasting between 16 and 24 hours. Both groups may have repeated prone sessions during the first 7 days if their oxygen levels fall below a certain threshold after returning to the supine position. This design allows comparison of continuous versus intermittent prone positioning in managing ARDS. During the study, participants will be followed for up to 90 days to monitor their clinical progress. Researchers will assess outcomes including mortality at 28 and 90 days, ventilator-free days, and hospital-free days at 28 days. Safety and adverse events related to prone positioning will also be recorded. The total participation involves receiving the assigned prone sessions during the first week and ongoing clinical follow-up to evaluate the effectiveness and safety of each approach.

Researchers are evaluating the DIAGEN-IA diagnostic support platform, designed to help identify pediatric neurological diseases with a genetic basis. The study aims to see if the platform reduces inappropriate referrals to clinical geneticists, improves the completeness of initial diagnostic evaluations, enhances referral quality, and increases user satisfaction. Conducted at Carlos Van Buren Hospital in Chile, the trial uses a prospective before-and-after design to compare outcomes between baseline and intervention phases. The study includes two 6-month phases. In the first phase, baseline data on referral appropriateness and evaluation completeness are collected without the platform. In the second phase, pediatric neurologists trained to use DIAGEN-IA will use the platform during consultations to guide referrals and recommend diagnostic tests. The platform uses a Bayesian network model integrating medical ontologies to suggest diagnoses and tests based on clinical data. Usage of the platform, including login frequency and evaluations performed, will be monitored. Participants include healthcare professionals providing care to children under 18 years old and responsible for referring suspected rare disease cases to clinical geneticists. The study collects demographic data and monitors referral appropriateness using a 5-point Likert scale, referral quality based on standard criteria, and user satisfaction via questionnaires at one and six months. Data will be anonymized, and the results aim to improve referral processes and diagnosis in pediatric neurological care.

This research aims to assess the feasibility and early effectiveness of a mental health literacy MHL program designed for teachers and parents to support the mental health of children aged 8 to 11 years in primary schools located in vulnerable communities in Chile and Ecuador. It addresses the high prevalence of child mental health problems and the gap in treatment access in Latin America by improving knowledge and confidence in recognizing and managing mental health issues within schools and families. The study builds on a previous project that showed benefits from teacher-focused MHL training and expands it by including parents and evaluating child outcomes across two countries. The intervention includes a teacher program consisting of six 2-hour participatory workshops covering topics like self-care, child development, anxiety, depression, suicide prevention, behavioral disorders, autism, and child maltreatment. Parents participate in three 90-minute educational sessions focusing on stigma, social support, healthy development, and emotional containment. The study involves seven primary schools randomly assigned to either the intervention or control group, with approximately 230 children, their parents, and teachers participating. Data collection occurs before and after the intervention using validated tools. Participants will be involved in assessments including surveys and biological measures such as cortisol levels in fingernails to evaluate stress. Researchers will measure changes in mental health literacy among parents and teachers, emotional wellbeing of adults, child mental health problems, and intervention feasibility indicators like retention and satisfaction. The study combines quantitative and qualitative methods, including focus groups, to understand the programs acceptability and cultural fit, with follow-up lasting up to 16 weeks post-intervention.

Researchers are studying the safety and effectiveness of zilovertamab vedotin in children and young adults aged 6 to 25 years with certain blood cancers and solid tumors, including relapsed or refractory B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphomaBurkitt lymphoma, neuroblastoma, and Ewing sarcoma. This phase 12 study aims to assess how well this treatment works and to monitor any side effects in these young participants. Participants receive escalating doses of zilovertamab vedotin through an intravenous infusion once every 21 days in repeated cycles. The study includes both dose-finding and efficacy evaluation stages to determine the best dose and treatment impact over time. Treatment continues with cycles every three weeks, with ongoing monitoring throughout the study period. During the trial, participants will have regular assessments including monitoring for adverse events, dose modifications, and treatment discontinuations. Blood samples will be collected to study how the drug moves through the body and its effects. The main outcomes measured include the number of participants experiencing dose-limiting toxicities, response rates for different cancers, and duration of response. This study may last up to approximately 54 months to fully evaluate safety and effectiveness.