Latina

Researchers are evaluating the effects of a medicine called rimegepant in adolescents aged 12 to less than 18 years who have frequent migraine attacks. Participants must have a history of migraine for at least 6 months, experience 15 or more headache days per month including 8 or more migraine days, and untreated migraine attacks lasting 4 to 72 hours. This Phase 3 study aims to assess the safety and effectiveness of rimegepant for migraine prevention in this age group. In the first part of the study, about half of the participants will receive a rimegepant tablet every other day, and the other half will receive a matching placebo tablet every other day. This phase will last for 3 months and is double-blind and placebo-controlled. In the second part, all participants who continue will receive rimegepant every other day for 1 year to evaluate long-term safety. Tablets are orally disintegrating and taken on or under the tongue. Participants will have up to 19 visits at the study clinic, approximately every 4 weeks, with some visits possibly occurring every 2 to 8 weeks. Home health visits may also take place. Each visit includes a health check and blood sample collection. Participants will complete a daily diary to record their migraine attacks. The main outcome measured is the number of migraine days per month over 12 weeks.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

This research aims to improve understanding of rare autoinflammatory diseases (AID), which cause repeated inflammatory episodes without infection or cancer. The study focuses on hereditary periodic syndromes (monogenic AID) caused by gene mutations, as well as related polygenic or multifactorial AID like Behcet's disease, Still disease, Schnitzler's disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, spondyloarthritis, and Castleman disease. The goal is to gather detailed clinical and therapeutic data to expand knowledge of these rare conditions, which are often difficult to diagnose outside specialized centers. Participants will be enrolled in the AIDA international registry, which uses a secure online platform to collect retrospective and prospective information. Data collected include demographics, genetics, clinical features, laboratory and radiologic results, treatments, and socioeconomic impact. The registry covers multiple specific AID types and will track patients over at least 10 years through routine clinical visits usually every 3-6 months. The platform supports data sharing and analysis to identify disease patterns, treatment responses, and long-term outcomes. During the study, patients' medical records will be regularly updated with clinical and laboratory data. Researchers will analyze changes in patient numbers and disease characteristics over time. The registry also aims to foster international collaboration, improve early diagnosis, assess quality of life and socioeconomic effects, and support future research and clinical trials. Patient data privacy is maintained by using pseudonyms and complying with data protection laws throughout the study.

Researchers are studying women who carry mutations in the BRCA1 or BRCA2 genes, which increase the risk of developing breast and ovarian cancers. Despite many studies over the past two decades, the best ways to manage these mutation carriers are still not fully established. In Italy, about 140,000 to 150,000 individuals carry these mutations, and it is estimated that 87% of women with these mutations will develop a genetically linked tumor during their lifetime. Approximately 20% of ovarian cancer cases in Italy each year have a genetic origin and could benefit from preventive approaches. Currently, there is no national prospective data collection specifically for women with BRCA mutations in Italy.

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.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

Researchers are evaluating the effectiveness and safety of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraine. This Phase 3 study focuses on participants who have had migraines for at least six months with a limited number of headache and migraine days per month. The study aims to understand how well rimegepant works to reduce the number of migraine days over a 12-week period. Participants will receive either rimegepant in doses of 75mg or 50mg (two 25mg orally disintegrating tablets) or a matching placebo. The treatment is administered over a double-blind 12-week phase where neither the participants nor the researchers know which treatment is given. This setup helps ensure unbiased results when comparing the preventive effects of rimegepant against placebo. Throughout the study, participants will be monitored for changes in their migraine frequency, specifically the average number of migraine days per month from the start to the end of the 12 weeks. Evaluations include headache and migraine tracking, as well as assessments of daily activity disruption. Safety and side effects will also be closely observed to understand the medication's impact on young patients.

Researchers are conducting an open-label, randomized, multicenter phase III study to evaluate the feasibility of allogeneic stem cell transplantation (HSCT) in patients with higher-risk myelodysplastic syndromes (HR-MDS). The study compares two approaches: hypomethylating therapy (HMT) followed by HSCT versus HSCT upfront in patients with less than 10% bone marrow blasts, and conventional chemotherapy (CHT) versus HMT followed by HSCT in patients with more than 10% bone marrow blasts. This non-inferiority trial aims to assess which treatment strategy is more feasible based on the proportion of patients who successfully receive HSCT over four years. Participants receive treatments based on their bone marrow blast counts. Those with under 10% blasts receive azacitidine, administered as 75 mg/m2 subcutaneously daily for 7 days every 28 days, followed by HSCT or HSCT upfront. Patients with more than 10% blasts are treated with standard chemotherapy consisting of two cycles of intravenous induction and consolidation therapy using cytarabine and daunorubicin before HSCT. The study compares these treatment regimens to determine the best sequence for transplantation. During the study, participants are closely monitored for treatment feasibility, including assessments of successful HSCT receipt. Researchers evaluate outcomes over a four-year period, focusing on the proportion of patients completing the transplantation process. Patients must meet specific health criteria and provide informed consent. Safety and treatment adherence are observed throughout the trial, ensuring comprehensive data on the transplantation strategies in HR-MDS patients aged 18 to 70 years.

Researchers are evaluating the addition of gemtuzumab ozogamicin to standard chemotherapy to reduce minimal residual disease (MRD) levels in adults aged 18 to 60 with favorable or intermediate-risk acute myeloid leukemia (AML) who have not been previously treated. This phase 3 study focuses on patients with de novo AML, excluding certain subtypes and mutations, to see if MRD-driven post-remission therapy, such as autologous or allogeneic stem cell transplant, improves anti-leukemic outcomes. Participants will receive induction and consolidation chemotherapy combining gemtuzumab ozogamicin with daunorubicin and cytarabine. The treatment aims to lower MRD before transplant and guide risk assignment for subsequent therapy intensity. The study is conducted at multiple centers and targets patients with specific AML risk profiles, excluding those with prior chemotherapy (except limited hydroxyurea use) or radiotherapy. During the study, patients will be closely monitored for MRD levels, along with assessments of organ function and overall health status. Primary outcomes include achieving MRD negativity within two months. Safety evaluations and follow-up will track treatment effects, adherence, and patient response. The study duration and detailed follow-up schedules are determined by the protocol to ensure comprehensive evaluation of treatment impact.

Researchers are investigating whether blocking the late sodium current can help protect the small blood vessels in the heart in patients who have had a specific type of heart attack called ST-Elevation Myocardial Infarction (STEMI) and have disease in multiple heart vessels. This Phase IIb, multicenter, randomized, open-label study aims to compare the effects of the drug ranolazine to standard care in preserving coronary microcirculation after such heart attacks. The study will measure how well the small vessels function using the Index of Microcirculatory Resistance (IMR) or its angiography-derived version (angioIMR) at baseline and during follow-up. Participants who have had a successful primary percutaneous coronary intervention (pPCI) for STEMI and have at least one other significant blocked artery will be randomly assigned to receive either ranolazine or standard therapy. Ranolazine will be given orally, starting with 500 mg twice daily and increasing to 750 mg twice daily from one week after pPCI until about six weeks later. The study involves assessments at the time of the initial revascularization and during staged procedures on other blocked vessels occurring within six weeks. During the study, participants will undergo evaluations of coronary microcirculation at baseline and follow-up, cardiac magnetic resonance imaging to assess infarct size, and tests of endothelial function. Researchers will also monitor major cardiovascular events, angina symptoms, and quality of life using questionnaires. The main outcome is preservation of coronary microcirculation up to eight weeks, with additional measures including procedural complications, infarct size, and symptom improvement. Participants will be followed closely during this period to assess the safety and effects of ranolazine compared to standard care.