Boadilla Del Monte

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating the effectiveness of a remote monitoring software called Caaring in cancer patients undergoing outpatient oral cancer treatment. The study aims to see if using this self-management platform helps patients manage their illness better and reduces the number of in-person and telephone visits with specialized medical and nursing staff. This is a randomized, multicenter clinical trial comparing two groups of patients over 12 weeks. One group will use the Caaring app on their smartphones to report data and complete questionnaires related to their treatment and health. This group will also receive educational and prevention recommendations about cancer. The other group will receive routine medical follow-up visits without the remote monitoring app. Both groups will be observed for 12 weeks following their inclusion in the study. Participants will be monitored through the app or routine visits, with researchers collecting information on treatment adherence, completion of data, use of health resources, and patient satisfaction with the software. The main outcome is the percentage of adherence to prescribed treatment over 12 weeks. Secondary outcomes include data completion rates, changes in health resource use, and patient satisfaction. The study involves regular assessments and questionnaires, with a total participation duration of 12 weeks.

Researchers aim to develop clear, universal definitions and standardized practices to diagnose and prevent ventilator-associated pneumonia VAP in newborns in neonatal intensive care units NICUs. This project involves creating evidence-based recommendations and best practice protocols for healthcare teams to improve and unify care and diagnosis across participating units. The study is observational and seeks to understand how these interventions reduce the frequency and impact of VAP in neonates undergoing invasive mechanical ventilation. The study involves several phases initially, researchers provide access to data collection forms and instructions to follow usual diagnostic criteria. Next, all NICU teams receive training on the evidence-based preventive measures and diagnostic criteria. Finally, these trained practices are incorporated into daily care routines. A surveillance registry collects data such as patient demographics, antibiotic use, clinical signs, and diagnostic tests related to VAP throughout invasive ventilation and a short monitoring period after extubation. Participants are newborns admitted to NICUs who require mechanical ventilation for at least 48 hours. Data collected includes clinical evaluations, radiological and microbiological tests, and antibiotic treatments. Researchers monitor how well preventive measures are implemented and track changes in VAP diagnosis and prevention. The main outcome measured is the impact of this multimodal intervention on VAP incidence from the start of ventilation until extubation plus two extra days in some cases. The study runs through multiple phases including training, data collection, and analysis over several years.

Researchers are evaluating the combination of 177Lu-DOTATATE Lutathera4 and the PARP inhibitor olaparib for treating children and adolescents with recurrent or relapsed solid tumors that express somatostatin receptors SSTR. These tumors typically have a poor prognosis, and while 177Lu-DOTATATE has been approved for certain adult neuroendocrine tumors, its use in children is still being explored. Combining 177Lu-DOTATATE with olaparib aims to enhance the treatment effect by preventing DNA repair in cancer cells, potentially leading to increased tumor cell death. The study is a single-arm, open-label Phase III trial administering up to four cycles of treatment. 177Lu-DOTATATE is given intravenously every 8 weeks at doses adjusted by age and body weight, along with intravenous fluids and amino acid infusions to protect the kidneys. Olaparib is taken orally twice daily from day 3 to day 28 of each 8-week cycle, with doses gradually increased according to a standard design. Treatment continues unless unacceptable side effects, disease progression, withdrawal, or death occur. Participants will undergo regular assessments including imaging to monitor tumor response, safety evaluations, and tests of organ function. Researchers will measure safety mainly through observations during the first 8 weeks and evaluate preliminary treatment activity up to 24 months. The study includes follow-up to assess longer-term safety, tolerability, and effectiveness of the drug combination in this young population.