Macerata

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

The ARON-2 study is a multicentric international retrospective research focused on patients with metastatic urothelial carcinoma (UC). It aims to analyze outcomes in patients treated with pembrolizumab either as first-line therapy for those unable to receive platinum or as second-line therapy after progression following platinum-based chemotherapy. The study was amended to also include patients treated with enfortumab vedotin after progression on prior platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor therapy. Participants include those with histologically confirmed UC of the upper or lower urinary tract and confirmed metastatic disease. The study examines two groups: patients who received pembrolizumab with at least one treatment cycle between January 1, 2018, and November 30, 2021, and patients who received enfortumab vedotin with at least one cycle between June 1, 2022, and July 31, 2023. This retrospective approach involves reviewing existing treatment records within these time frames. Researchers will assess overall survival, progression-free survival, and overall response rate for patients treated with either pembrolizumab or enfortumab vedotin. The study collects data retrospectively from medical records to evaluate these outcomes in patients who met the treatment criteria. There are no prospective treatment or monitoring procedures, as the study analyzes past clinical data from patients with metastatic UC.

This research aims to collect and analyze real-world data on treatments for metastatic prostate cancer in three specific settings. It focuses on patients with hormone/castration-sensitive metastatic prostate cancer receiving hormone therapy combined with androgen receptor signaling inhibitors (ARSI) or ARSI plus docetaxel, patients with castration-resistant metastatic prostate cancer treated with Lutetium-177-PSMA therapy, and patients with castration-resistant prostate cancer receiving PARP inhibitors alone or in combination. The study is international and retrospective, gathering global experiences to better understand these therapies. The study evaluates various treatment regimens including ADT combined with Apalutamide, Enzalutamide, Abiraterone, or Darolutamide with or without Docetaxel for hormone-sensitive patients. For castration-resistant patients, it includes Lutetium-177-PSMA therapy and PARP inhibitors such as olaparib, niraparib, and talazoparib, sometimes combined with other agents like abiraterone or enzalutamide. Treatments are assessed in their respective groups: ARON-3S for hormone-sensitive, ARON-3Lu for Lutetium therapy, and ARON-3GEN for PARP inhibitors. Participants are involved through retrospective data collection of their treatment outcomes, including overall survival, progression-free survival, and overall response rates, measured between January 31 and May 31, 2024. The study observes patients with confirmed metastatic prostate cancer and specific treatment histories, including the presence or absence of homologous recombination deficiency (HRD) status for PARP therapy. Safety and effectiveness data from real-world clinical practice will be analyzed to inform future treatment strategies.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating the impact of a mobile health (m-health) solution on improving the self-management skills of adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the personalized m-health solution, integrated with patients' Electronic Patient Records (EPR), to usual care. The main goal is to assess changes in glycated haemoglobin (HbA1c) levels from the start of the intervention through 18 months, along with other health-related factors like medication adherence, lifestyle habits, self-efficacy, and quality of life. Participants in the treated group will receive training and personalized setup of the m-health solution, which includes mobile applications for tracking health data, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers at Diabetes Centres (CADs) will monitor patient data via a dedicated EPR interface and maintain communication as needed. The intervention begins at the CADs and continues at participants' homes, with follow-up evaluations at 6, 12, and 18 months. Throughout the study, participants will complete self-administered questionnaires and clinical assessments during routine physician visits. Data will be collected from the m-health solution, clinical evaluations, and focus groups to evaluate usability, patient experience, and cost-effectiveness. Importantly, no extra visits or laboratory tests beyond usual care are required. The total observation period spans 18 months from baseline to final follow-up.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

This research focuses on invasive bacterial diseases caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae, which lead to severe health problems and frequent serious complications. The study aims to understand the epidemiology of these infections, including the distribution of bacterial strains, to better plan prevention and treatment strategies. It highlights the importance of monitoring these infections to guide public health actions, detect vaccine failures, and assess the impact of vaccination programs. The study uses molecular diagnostic testing on blood samples to identify the pathogens, even when traditional culture methods fail due to prior antibiotic use or sample handling issues. Molecular diagnosis allows for more accurate detection of these bacteria regardless of their viability in samples. This testing is conducted on patients from hospitals within and outside the Tuscany region as part of ongoing surveillance. Participants include both pediatric and adult patients diagnosed with invasive bacterial diseases caused by these bacteria. Researchers will track the incidence rates of infections caused by each pathogen over about one year. The study involves collecting biological samples for molecular testing and monitoring the presence and types of bacteria. This will help improve understanding of infection trends and support the development of better prevention and treatment approaches.

Researchers are monitoring the long-term safety and effectiveness of Increlex4, a treatment for children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). This global registry study is observational and non-interventional, designed to collect safety data during treatment and for at least five years after treatment ends. The study includes participants who have already started Increlex4 therapy as well as those beginning treatment, across various countries including the USA and several European nations. Participants receive Increlex4, a mecasermin injection given twice daily at doses ranging from 40 to 120 mcg/kg or 0.04 to 0.12 mg/kg, as prescribed by their physician. The study does not assign treatments but records data from patients undergoing routine care. This registry captures real-world use of Increlex4 according to local approved guidelines for managing SPIGFD. Throughout the study, researchers collect information on serious adverse events, any adverse events, deaths, and withdrawals related to treatment. Data collection continues during the treatment period and up to 30 days after the last dose. Safety monitoring is the primary focus, with long-term follow-up planned for at least five years post-treatment to assess ongoing health outcomes in children and adolescents receiving Increlex4 therapy.