Pordenone

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying repotrectinib TPX-0005 in adults and adolescents with advanced solid tumors that have specific gene rearrangements in ALK, ROS1, or NTRK1-3. The trial aims to find the safest and most effective dose in Phase 1, and then evaluate how well the drug works in Phase 2 across different patient groups with these gene changes. This includes patients with tumors that have spread and those with brain involvement, focusing on response rates and survival outcomes. The study involves oral doses of repotrectinib. Phase 1 includes dose escalation to determine dose-limiting toxicities, maximum tolerated dose, and recommended dose for Phase 2. A sub-study also examines drug interactions with midazolam. In Phase 2, participants are assigned to one of six groups based on their tumor type and prior treatments, including different lines of targeted therapy and chemotherapy. Treatments continue according to protocol with regular monitoring. Participants will have measurable tumors confirmed by imaging reviewed centrally. They undergo physical exams, lab tests, and safety assessments throughout the study. Researchers measure response rates, duration of response, progression-free survival, overall survival, and clinical benefit over several years. The study monitors drug levels in blood and evaluates safety closely. Participation may last years with follow-up to assess long-term outcomes and effects on brain metastases.

Researchers are conducting a non-interventional, retrospective observational study to better understand the diagnosis and treatment of patients with early-stage and locally advanced non-small cell lung cancer NSCLC, specifically stages I to III. The study addresses the variability in treatment approaches, as there is no clear consensus on the best timing, sequence, or combination of surgery, chemotherapy, and radiotherapy for these patients. This research aims to collect real-world data to improve knowledge on how these patients are managed across different healthcare settings. This study involves reviewing past medical records of patients diagnosed with stage I-III NSCLC who underwent curative surgery or radiotherapy between January 2018 and June 2019. The data collection covers treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs from January 2018 to January 2021. There are no interventions or treatments being given directly as part of this study since it is observational and retrospective. Participants involvement consists of allowing access to their medical charts and treatment records for data capture. Researchers will evaluate treatment timelines and approaches as they occurred in routine clinical practice. The study also tracks the extent of healthcare resources used and costs involved. Data privacy is maintained by obtaining informed consent from patients or their representatives. The study is expected to conclude in June 2025.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are investigating the use of argon gas mixed with oxygen as a treatment to reduce neurological and heart damage after cardiac arrest outside of the hospital. Preclinical studies in animals showed argon may protect cells and improve recovery following low oxygen events. The CardioPulmonary Resuscitation with Argon CPAr trial began as a phase I-II safety study and is now continuing as a phase II trial to evaluate argons effect on brain injury after cardiac arrest. In this randomized, controlled, single-blind study, patients who have been resuscitated from out-of-hospital cardiac arrest will receive ventilation with either a mixture of 70% argon and 30% oxygen or standard ventilation with 30% oxygen for four hours. Both groups will be treated according to established European resuscitation and intensive care guidelines. The study treatment lasts four hours, followed by monitoring over a six-month period to assess safety and clinical outcomes. Participants will be closely monitored during and after treatment with assessments including neurological function, heart function, brain injury markers, survival rates up to six months, and multiorgan function. Safety will be evaluated by recording any adverse events within one month. The main outcome focuses on neuronal preservation measured 48 hours after treatment. This comprehensive follow-up aims to understand argons potential impact on recovery after cardiac arrest over both the short and long term.

This research aims to study the epidemiology of invasive bacterial diseases caused by Streptococcus pneumoniae pneumococcus, Neisseria meningitidis meningococcus, and Haemophilus influenzae hemophilus. These infections can cause severe illness and serious complications. The study focuses on monitoring these infections to guide public health efforts, evaluate vaccine impacts, and plan prevention and treatment strategies by identifying circulating strains and assessing vaccine failures. The study uses molecular diagnostic testing to identify these bacteria from blood samples, even when traditional culture methods may fail due to prior antibiotic use or sample handling issues. Pediatric and adult patients diagnosed with invasive bacterial diseases caused by these pathogens are included. This approach enables more accurate detection and characterization of the bacteria. Participants diagnosed with these invasive bacterial infections will have their samples analyzed using molecular methods. Researchers will monitor the incidence rates of these infections in children, the distribution of bacterial types, and the proportion of cases preventable by vaccination. The study will also assess vaccine failure rates. The average study duration for outcome measurement is about one year, supporting improved surveillance and public health interventions.

Researchers are evaluating the medicine pelacarsen TQJ230 compared to a placebo in adults with atherosclerotic cardiovascular disease ASCVD who have high levels of lipoproteina and are already receiving inclisiran treatment to lower their LDL cholesterol. This study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with a parallel group design to assess the efficacy, safety, and tolerability of pelacarsen. Participants will be randomly assigned to receive either pelacarsen injections once a month for 12 months or placebo injections once a month for 6 months, followed by pelacarsen injections for the remaining 6 months during an open-label phase. All participants also receive background inclisiran treatment consisting of two initial loading doses three months apart, followed by doses every six months as per approved guidelines. During the study, participants will have regular visits and assessments including laboratory tests to measure lipoproteina levels and monitor safety. Researchers will track changes in lipoproteina concentration at baseline and six months, along with adverse events and treatment tolerability over up to 16 months. The trial aims to understand how pelacarsen affects lipoproteina levels and overall safety when combined with inclisiran in this patient group.

Researchers are studying acute intoxications in children to better understand how often these poisonings occur and what social and care factors contribute to them. This research focuses on children from 1 month to 16 years old who experience acute intoxication, aiming to improve future national diagnostic and treatment approaches. The study is a prospective, multicenter observational cohort conducted by AMIETOX at Poison Control Centres and paediatric emergency rooms. The study observes children who come to emergency rooms or contact Poison Control Centres due to acute intoxication, defined as exposure to harmful substances either by toxic nature or improper use. It does not involve specific treatments or interventions but records data over approximately one year to assess incidence and prevalence. This observational approach allows researchers to collect real-world information about poisoning cases in paediatric settings. Participants will be monitored through their visits or calls to study centers, with data collected on the nature and circumstances of the intoxications. Researchers will measure how often these poisonings occur and how widespread they are among children in the study. The study involves no active treatment or placebo, focusing instead on gathering information to inform better care strategies. Participation lasts about one year, during which safety and outcomes are tracked through standard care processes.