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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting an Italian multicenter, observational, prospective study to gather information on patients with bone metastases. The study aims to establish a National Bone Metastasis Database by collecting detailed data from all patients with bone metastases referred to participating centers. This effort helps track and understand the condition better over a long period. Patients with bone metastases from solid tumors will be registered in a specially designed online database created for this study. Each enrolled patient will be entered into this database and followed over time until death or until follow-up is stopped for any other reason. This approach allows researchers to monitor the disease progression and treatment outcomes using a centralized digital system. Participants will provide informed consent to be part of the study. Their medical data, including diagnosis information, will be collected and stored in the database. This process includes ongoing monitoring and follow-up assessments as available during the study, which may last up to 15 years. The main outcome is the creation and maintenance of the comprehensive National Bone Metastasis Database to support research and patient care.
Actively Recruiting
Researchers are evaluating whether brain MRI surveillance alone is as effective as prophylactic cranial irradiation (PCI) combined with brain MRI surveillance for treating patients with small cell lung cancer (SCLC). This phase III study aims to determine if MRI surveillance alone is not worse in terms of overall survival. It also looks at secondary goals like cognitive failure free survival, quality of life, treatment toxicities, and other outcomes related to brain metastases and disease progression. Participants will be assigned to either brain MRI surveillance alone or PCI plus brain MRI surveillance. PCI is a radiation treatment targeting the brain to reduce metastasis risk. The study includes patients with limited or extensive stage SCLC who have completed standard therapies including chemotherapy and possibly radiotherapy or surgery. Treatments and assessments are done under a structured protocol with careful monitoring of side effects and cognitive function. During the study, participants will undergo regular brain MRI scans and other imaging to monitor disease status. Researchers will collect information on survival, cognitive health, quality of life through questionnaires, and treatment side effects. Blood samples will also be taken for biobanking. Follow-up evaluations will help assess the benefits and risks of each approach over time, with overall survival at 12 months as the main outcome measure.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the clinical performance and long-term safety of bioabsorbable scaffold implantation for treating coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers in the Emilia-Romagna region and the MAGIC retrospective study participants, working together under a unified protocol. The study aims to address limitations of current permanent metallic stents, such as thrombosis and restenosis, by investigating newer scaffold devices. Participants will receive scaffold implantation, including devices like Magmaris or Desolve, following specific strategies agreed upon by investigators. These include mandatory predilatation, 1:1 sizing, avoiding vessels with diameters outside 2.8 to 3.8 mm or severe calcifications, and mandatory postdilation with a non-compliant balloon at least 0.5 mm larger than the scaffold diameter. The study focuses on patients under 65 years, complete revascularization, long lesions especially in the left anterior descending artery, and spontaneous coronary dissection. During the study, all adverse events will be monitored continuously by a Data Safety Monitoring Board. Coronary angiographies and interventions will be independently reviewed by a core laboratory to assess implantation techniques and outcomes. The primary outcome is the occurrence of device-oriented cardiac events over one year. Participants must provide informed consent and agree to at least one year of follow-up and compliance with dual antiplatelet therapy. The study duration includes enrollment and a one-year follow-up period.
Actively Recruiting
Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the disease's natural history in real-world settings. This study aims to define and validate models that predict disease progression and response to treatment at any stage. The registry will also promote collaboration among amyloidosis experts and physicians across Italy involved in diagnosing and managing systemic amyloidosis. The study involves collecting data from patients diagnosed or suspected to have systemic or localized amyloidosis. An online registry tool will be established to share this data with healthcare providers, facilitating diagnosis and treatment decisions. This network will enable physicians to access diagnostic resources through the ARTC and support ongoing patient management. Participants will provide informed consent and have planned or ongoing follow-up at participating centers. Data collected includes information at diagnosis and during follow-up visits. The primary outcome is to establish an online data-sharing tool accessible to healthcare providers over a five-year period. This approach aims to improve understanding, collaboration, and care for patients with ATTR amyloidosis.