Campobasso

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

Researchers are studying patients with early to locally advanced stages (I-III) of non-small cell lung cancer (NSCLC) to better understand how diagnosis and treatments are managed in real-world settings. Because patients with these stages of NSCLC can vary widely, there is no single standard treatment plan, and practices differ by country and medical center. This study looks closely at how surgery, chemotherapy, and radiotherapy are timed and combined for these patients without interfering with their treatment. This is a non-interventional, retrospective observational study analyzing medical records of patients with stage I-III NSCLC who received curative surgery or radiotherapy between January 2018 and June 2019. Researchers will examine diagnostic and treatment paths, focusing on the use and timing of therapies. The study does not involve new treatments or interventions but reviews past patient data to gather insights. Participants' medical records from January 2018 to January 2021 will be reviewed to assess treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs related to NSCLC care. The study involves collecting data from available charts and follow-up information to understand treatment patterns and outcomes better. No active treatment or patient visits are required as this study relies on existing data.

Psoriatic arthritis (PsA) is a type of arthritis that causes joint swelling and stiffness and is often seen in people with the skin condition psoriasis. It results from an overactive immune system attacking healthy tissue. This research aims to describe the long-term use and effectiveness of risankizumab (RZB) compared to other advanced treatments for managing PsA in everyday clinical care. The study is not conducted in the United States but will take place in about 15 countries and include between 900 and 1200 adult participants. Participants will be assigned in a 2 to 1 ratio to receive either risankizumab or other advanced therapeutic agents. The treatments will be given following usual medical guidelines, including approved dosing and indications, as determined by local regulations and professional standards. All study visits will occur during routine clinical care with no extra burden on participants. Participants will be followed and monitored for 24 months to observe treatment persistence. During the study, participants will continue their regular clinical visits without additional procedures or tests required by the study. Researchers will measure how many participants continue their prescribed treatment over the 24-month period. The study focuses on real-world treatment patterns and outcomes in patients with active PsA who have previously shown an inadequate response or intolerance to certain medications. Safety monitoring will align with routine clinical practice throughout the study duration.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or combined, to improve heart-related outcomes in high-risk patients with type 2 diabetes. This Phase 3 trial focuses on adults aged 55 to 80 years who have type 2 diabetes and no prior coronary artery disease events but have additional risk factors like long diabetes duration, high blood sugar levels, smoking, or other markers of cardiovascular risk. The study aims to reduce serious cardiovascular events such as heart attacks, strokes, or urgent hospitalizations. Participants are randomly assigned to receive either colchicine 0.5 mg once daily, aspirin 40 mg twice daily, both medications together, or matching placebos. The aspirin is given as a non-enteric-coated tablet twice daily. Those who cannot take aspirin or have certain conditions may still receive colchicine or its placebo. The treatment and follow-up period lasts up to 60 months, during which the occurrence of serious cardiovascular events is closely monitored. During the study, participants will undergo regular assessments including monitoring for cardiovascular events like heart attacks and strokes. Safety labs and clinical evaluations will be conducted to track any side effects or adverse events. The main outcome measured is the time until the first major cardiovascular event occurs. Researchers will also ensure participants adhere to the medication schedule and will follow all patients for up to five years to evaluate long-term safety and effectiveness.

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 evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Researchers are studying financial toxicity in patients undergoing radiotherapy for cancer in Italy. They use a validated questionnaire called PROFFIT, which measures financial burden and its possible causes in cancer patients receiving radiotherapy. The study aims to compare financial toxicity among different patient groups based on their cancer type, treatment, age, and sex. Participants complete the PROFFIT questionnaire at three times: before starting radiotherapy, at the end of radiotherapy treatment, and 1 to 2 months after treatment during the first follow-up visit. Along with financial toxicity, researchers also explore how changes in financial burden relate to quality of life, side effects, and overall survival using additional questionnaires such as the EORTC QLQ-C30 and PRO-CTCAE. During the study, patients provide information through questionnaires that assess financial distress and quality of life. These assessments occur at baseline, end of treatment, and follow-up up to 12 months. The main outcome measured is the financial toxicity score over this period. This observational study is conducted in multiple centers in Italy and monitors patients' experiences related to financial strain during and after radiotherapy.

Researchers are conducting an open-label, multicenter, randomized phase III trial to compare two treatment approaches in elderly patients aged 65 and older with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma. The study evaluates the addition of vitamin D supplementation to a standard prephase treatment with oral prednisone, followed by six cycles of immunochemotherapy with either R-CHOP or R-miniCHOP. The study aims to explore the effects of vitamin D supplementation during immunochemotherapy in this patient population, with a focus on progression-free survival over 54 months. Participants are randomly assigned in a 1 to 1 ratio to either the standard arm (Arm A) or the experimental arm (Arm B). Both arms receive a prephase of oral prednisone for 7 days followed by six 21-day cycles of immunochemotherapy with R-CHOP or R-miniCHOP. Patients in Arm B also receive vitamin D3 (cholecalciferol) supplementation starting with a loading dose based on baseline vitamin D levels, followed by weekly maintenance doses throughout immunochemotherapy and the option to continue monthly supplementation for up to two years. Adjustments to vincristine dosing during prephase and immunochemotherapy are allowed based on clinical judgement. Throughout the study, participants undergo baseline assessments and regular monitoring including vitamin D levels, treatment toxicity, and response evaluations. Patients experiencing treatment-related delays longer than four weeks discontinue study treatment but continue survival follow-up. The primary outcome measure is progression-free survival assessed at the end of treatment and up to 54 months. The study also includes safety monitoring and long-term follow-up to assess sustained outcomes and adverse events.

Oligometastatic breast cancer occurs when breast cancer has spread to only a few other parts of the body. Patients with this limited spread may live longer than those with more widespread disease. Researchers are exploring whether adding local treatments like stereotactic body radiotherapy (SBRT), which delivers high doses of radiation in a few sessions without surgery, can improve disease control and survival compared to standard whole-body treatments such as chemotherapy or hormonal therapy. This study is a multicenter retrospective analysis aimed at better understanding the benefits of SBRT in this patient group. The study focuses on patients who have received SBRT to extracranial sites of oligometastatic breast cancer, with treatments delivering a minimum dose of 50 Gy EQD2 in up to 12 sessions. As a retrospective database study, it collects data from multiple institutions on patients treated with SBRT following the Oligocare definition. The study reviews treatment details and outcomes from patients aged 18 years and older with confirmed breast cancer and limited metastatic spread. Participants will have their medical records reviewed to assess progression-free survival, which is the primary outcome measure tracked from January 2010 to December 2023. Researchers will analyze disease control and survival outcomes following SBRT treatment. Since this is a retrospective study, there is no direct patient involvement, but the study relies on comprehensive data collection and evaluation from existing patient records across multiple centers.