Radom

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the effectiveness of combining autogene cevumeran with nivolumab compared to nivolumab alone as adjuvant treatment for participants with high-risk muscle-invasive urothelial carcinoma (MIUC). The study is a Phase II, randomized, double-blind, multicenter trial aiming to assess disease-free survival and safety in this patient group. This study includes participants who have undergone surgical removal of MIUC and may have received prior treatments such as neoadjuvant chemotherapy or checkpoint inhibitors. The study begins with a safety run-in phase where participants receive both autogene cevumeran and nivolumab to monitor safety. After this phase, additional participants will be randomized to receive either autogene cevumeran plus nivolumab or saline plus nivolumab. All treatments are administered via intravenous infusion according to the specified schedules. The study compares the two treatment approaches to evaluate their impact on preventing cancer recurrence. Participants will be closely monitored throughout the study, with assessments including imaging scans to confirm absence of disease, biomarker analyses from tumor tissue, and regular safety evaluations. The primary outcome measure is investigator-assessed disease-free survival, tracked from randomization until recurrence or death, over approximately six years. Participants' recovery status and overall health will be evaluated throughout the study to ensure safety and treatment adherence.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

This research evaluates the safety and effectiveness of cardioneuroablation (CNA) compared to permanent pacemaker therapy in patients with symptomatic bradycardia due to sinus node dysfunction (SND) or atrioventricular block (AVB). The study aims to determine if CNA can allow patients to stop or optimize their pacemaker therapy and develop a diagnostic approach to identify those suitable for CNA. Blood samples will also be collected for future analysis and biobanking. Participants will be randomly assigned to one of three groups: Group 1 will receive invasive electrophysiology study (EPS), extracardiac vagal stimulation (ECVS), CNA, and implantable loop recorder (ILR) implantation with continued pacemaker therapy; Group 2 will have EPS, ECVS, ILR implantation, and continued pacemaker therapy without initial CNA; Group 3 will be observed without intervention. CNA is performed under general anesthesia and may be repeated if full parasympathetic denervation is not achieved. The pacemaker settings will be adjusted throughout the study based on individual assessments. Over 18 months, participants will undergo multiple visits for evaluations including medical history, pacemaker and ILR checks, ECG, 24-hour Holter monitoring, and non-invasive electrophysiological studies. Symptoms of bradycardia, syncope, and procedure complications will be assessed regularly. Patients whose pacemaker usage drops to zero may have pacing turned off, with follow-up to monitor safety. The study includes long-term monitoring with ILR until battery depletion or patient request for removal. Primary outcomes focus on composite measures of efficacy and safety at 18 months.

Researchers are collecting real-world data from cancer patients who are treated with radiotherapy. This study aims to support radiotherapy research and provide evidence on how radiation oncology fits into a multidisciplinary cancer treatment approach. It is a prospective, open-ended, non-interventional, and non-therapeutic multi-cohort study. Participants included in this study are those planned to receive radiotherapy as part of their cancer treatment. The study involves observing and collecting data without introducing any new treatments or interventions. It includes patients aged 12 years and older with pathologically confirmed cancer who have consented to participate. During the study, researchers will monitor and record the number of patients treated with radiotherapy over a five-year period. There are no additional interventions or treatments given; the focus is on gathering information to better understand radiotherapy's role in cancer care. Participation duration varies as the study is open-ended and ongoing.

This research aims to evaluate the safety, effectiveness, and clinical results of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in routine clinical practice in Poland. It focuses on rates of procedural success, complications, different PCI strategies and techniques, and the impact of artificial intelligence-based analysis on predicting outcomes and quality of life. The study includes a variety of patient subgroups, including those at higher risk due to conditions like low ejection fraction or diabetes. Patients receiving CTO PCI as part of their usual medical care will be enrolled in a national, multicenter registry. The study will observe different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It will also assess the use of intravascular imaging and mechanical circulatory support during PCI, examining how these factors relate to clinical outcomes. Participants will have clinical, procedural, and follow-up data collected to assess real-world results. Researchers will monitor procedural success within one day and track complications and cardiac injury markers after treatment. The study will analyze quality-of-life improvements and outcomes in high-risk groups over time, providing a comprehensive view of CTO PCI in contemporary practice.

Researchers are evaluating the effectiveness of saruparib (AZD5305) combined with camizestrant compared to physician's choice of CDK4/6 inhibitor plus endocrine therapy or plus camizestrant in patients with advanced breast cancer. Participants must have hormone receptor-positive, HER2-negative breast cancer with specific genetic mutations in BRCA1, BRCA2, or PALB2. This is a phase III randomized, open-label study focused on first-line treatment for this patient group. Participants will be randomly assigned in a 2:2:1 ratio to one of three treatment groups: saruparib plus camizestrant; physician's choice of CDK4/6 inhibitor plus physician's choice of endocrine therapy; or physician's choice of CDK4/6 inhibitor plus camizestrant. Treatment continues until disease progression confirmed by blinded independent central review, unacceptable side effects occur, or the participant decides to stop. During the study, about 500 participants will be monitored for progression-free survival for up to approximately 59 months. Researchers will collect tissue samples and assess organ function, performance status, and treatment safety. Participants will be evaluated regularly for disease progression, treatment tolerability, and overall health throughout the study duration.