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Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the efficacy and safety of BGB-16673 compared with the investigators choice of treatments in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with both Bruton Tyrosine Kinase inhibitors BTKi and B-cell leukemialymphoma 2 protein inhibitors BCL2i. This study addresses the urgent need for new treatments to extend life and control symptoms such as enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever in these patients. Participants will be randomly assigned to receive either BGB-16673 once daily or the investigators choice of treatment, which includes idelalisib plus rituximab for CLL only, bendamustine plus rituximab, or venetoclax plus rituximab retreatment. Treatments will continue until criteria for stopping treatment are met. This is a Phase 3, open-label, randomized study conducted globally with about 250 participants. During the study, participants will undergo regular assessments to monitor disease progression and response to treatment. Researchers will evaluate progression-free survival, overall survival, response rates, duration of response, and quality of life measures over approximately 24 to 36 months. Safety will be closely monitored by tracking treatment-emergent adverse events. Participants involvement includes receiving study medication, regular visits, and various evaluations to assess treatment effects and side effects.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Kidney failure is a serious health problem that requires treatment with dialysis or transplantation to survive. Haemodialysis, the most common treatment, can cause symptoms like fatigue, pain, cramps, and poor quality of life, with less than 60% of full health reported by patients. Early mortality rates are high, especially in the first 3 to 6 months after starting haemodialysis at the usual three sessions per week. This trial investigates whether starting haemodialysis incrementally at two sessions per week preserves quality of life and kidney function better than conventional treatment. The study compares two approaches incremental haemodialysis, where participants begin with two sessions per week and increase to three sessions only if needed, and conventional haemodialysis, where participants start with three sessions per week from the beginning. This randomized, open-label trial will recruit 372 participants across centers in Australia and Canada. The goal is to assess if the incremental method is a safe, practical, and cost-effective alternative that reduces the physical and financial burdens of dialysis. Participants will be followed for up to 18 months, with quality of life assessed at 6 months using the Kidney Disease Quality of Life Short Form questionnaire as the primary measure. Additional assessments include kidney function, healthcare use and costs, mortality, hospital admissions, symptoms, fatigue, nutritional status, and vascular access, collected at regular intervals. The study will monitor safety and side effects throughout the trial period to provide comprehensive data on the impacts of both dialysis approaches.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.

Researchers are conducting a prospective observational study to understand the natural progression of coronary plaque buildup in people with melanoma who are treated with immune checkpoint inhibitors ICIs. The study focuses on assessing coronary atherosclerosis and cardiovascular risk factors in this population. It is sponsored by Monash University and takes place across several sites in Australia. Participants are observed without any experimental treatments being administered by the study. The study evaluates how statin use relates to the amount and progression of coronary artery disease in patients treated with ICIs. The study also looks at the effects of using CT coronary angiography CTCA to guide preventive statin therapy. Various outcomes are assessed over an 18-month period. During the study, participants undergo imaging tests such as CTCA and assessments of their cardiovascular risk factors and quality of life. Researchers will track major cardiovascular events, melanoma progression-free survival, and overall survival. The study requires follow-up visits and imaging, and participants are monitored for up to 18 months to gather these data.