Boadilla Del Monte

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating the effectiveness of remote monitoring for cancer patients who are receiving outpatient oral cancer treatment. This study aims to determine if using a self-management software platform called Caaring® can empower patients during their illness and reduce the number of in-person and telephone visits with specialized medical and nursing staff. The study is designed as a randomized trial with two groups to compare the outcomes. Participants are divided into two groups: one group will use the Caaring® software for remote monitoring, where they will confidentially enter data and complete questionnaires on their smartphones. This group will also receive educational and prevention recommendations related to cancer. The second group will be followed through their routine medical visits without remote monitoring for 12 weeks after enrollment. Participants will be involved for 12 weeks during which adherence to their prescribed cancer treatment will be measured. Researchers will collect data through the software and routine visits, assessing treatment adherence rates, and monitoring patient progress. The study also involves evaluating participants' technological skills to use the smartphone application and ensuring safety and routine follow-up throughout the study period.

Researchers are evaluating the effectiveness of drug-coated balloon (DCB) therapy in patients with small native vessel coronary artery disease in a post-market, prospective, multicenter, observational study. The study also aims to assess the safety of a short 7-day dual antiplatelet therapy (DAPT) in high-bleeding risk patients treated with DCB therapy. Patients undergo percutaneous coronary intervention (PCI) with DCB based on the treating physician's decision, and the study includes those with acute coronary syndrome, chronic coronary syndrome, or silent angina requiring PCI. Participants receive PCI with DCB, followed by standard or short-duration DAPT. The study includes a high-bleeding risk subgroup defined by a PRECISE-DAPT score of 25 or higher or the need for oral anticoagulation. The angiographic results are analyzed by a core lab blinded to patient outcomes. Treatment decisions, including antiplatelet therapy regimens, are made by local investigators and medical teams. Participants will have clinical follow-ups at 30 days, 6 months, and 12 months after the procedure to assess outcomes and safety. The main outcome measured is the effectiveness of DCB therapy at one year. The study involves monitoring the patients' clinical status, with data collected on antiplatelet therapy use and bleeding risk. The total participation duration includes one year of follow-up after the PCI procedure.

Researchers are evaluating a multimodal intervention aimed at reducing the incidence of ventilator-associated pneumonia (VAP) in newborns admitted to Neonatal Intensive Care Units (NICUs) who require invasive mechanical ventilation. The study focuses on developing and implementing standardized definitions, diagnostic criteria, and prevention protocols based on good clinical practices for managing neonates on ventilatory support. The goal is to improve and unify care practices across Spanish NICUs to decrease VAP frequency and its impact. The intervention involves training healthcare teams on evidence-based recommendations covering hand hygiene, intubation techniques, suctioning practices, patient positioning, feeding adjustments, and oral care. The study includes phases: an initial period with usual diagnostic criteria, a training phase for NICU teams, and a final phase where teams apply the preventive measures and diagnostic standards learned. Additionally, a diagnostic technique using a blind-protected catheter is assessed to improve VAP diagnosis accuracy while reducing contamination risk. Participants are newborns admitted to participating NICUs on invasive mechanical ventilation for at least 48 hours. Data collected include general patient information, medications used, and clinical, radiological, and sometimes microbiological data if pneumonia develops. Researchers will monitor adherence to the intervention protocols, track behavioral changes, and evaluate outcomes from the start of ventilation until extubation plus two days. The study aims to provide evidence on the intervention's effect on VAP incidence and improve neonatal care practices.

This research investigates a combination treatment of 177Lu-DOTATATE (Lutathera®) and the PARP inhibitor olaparib in children and adolescents with recurrent or relapsed solid tumors that express somatostatin receptors (SSTR). These tumors include various types such as neuroblastoma, medulloblastoma, gliomas, meningioma, and others. The study aims to evaluate the safety and preliminary effectiveness of this combination therapy, building on prior evidence of 177Lu-DOTATATE’s use in adults and early pediatric studies, with the hope of improving outcomes in these difficult-to-treat tumors. The treatment involves administering 177Lu-DOTATATE intravenously every 8 weeks, with dosing adjusted by age and weight: a fixed dose for those 12 years and older, and a weight-based dose for younger children, accompanied by renal protective infusions. Patients receive four such infusions over approximately 32 weeks. Olaparib is taken by mouth twice daily starting the day after 177Lu-DOTATATE administration and continuing for 28 days in each 8-week cycle. The combination schedule is designed based on previous findings to optimize tumor targeting and minimize normal tissue damage. Participants will undergo evaluations including imaging for somatostatin receptor expression, blood tests, and performance status assessments before and during treatment. Safety is monitored closely, particularly during the first 8 weeks, while treatment response is followed for up to 24 months. The study requires participants to be at least 3 years old and able to swallow tablets, with ongoing assessment of organ function and overall health. Consent procedures and follow-up support are also integral parts of the study experience.