Langhorne

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 the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating whether adding up to ten sequential 24-hour treatments using the Selective Cytopheretic Device SCD to continuous kidney replacement therapy CKRT can improve survival and reduce the need for long-term dialysis in patients with Acute Kidney Injury AKI who require CKRT. This pivotal, randomized, controlled study involves approximately 339 patients in intensive care units across multiple sites. The study aims to compare outcomes between patients receiving standard CKRT care alone and those receiving CKRT plus SCD treatments. Participants in the experimental group will receive standard CKRT plus up to ten consecutive 24-hour sessions with the SCD integrated into their existing CKRT circuit. The SCD device, which includes a synthetic hollow fiber membrane cartridge connected in series with the CKRT hemofilter, is designed to modulate inflammation by binding activated white blood cells during treatment. Regional citrate anticoagulation will be used throughout the blood circuit. The control group will receive standard CKRT therapy alone as appropriate. Treatments will be monitored over time to assess safety and efficacy. Throughout the study, patients will be closely monitored using clinical assessments and laboratory tests. The primary outcome is a combined measure of mortality or dialysis dependency at 90 days after treatment. Secondary outcomes include dialysis dependence at one year, ICU-free days within the first 28 days, and mortality at 28 days. Patient safety will be observed continuously, and the total study participation may extend over several months to evaluate long-term effects of the therapies.

Researchers are studying a new medicine called PF-08634404 combined with chemotherapy in people 18 years and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This study aims to understand how well this combination works and how safe it is compared to another approved treatment, nivolumab plus chemotherapy, in those who have not yet received treatment for advanced disease. Participants will receive intravenous PF-08634404 combined with chemotherapy in repeated treatment cycles. The study has two parts the first part focuses on safety and response to the new treatment, and the second part compares the new treatment plus chemotherapy against nivolumab plus chemotherapy. Treatments are given intravenously, and the study lasts approximately four years to monitor effects and outcomes. During the study, participants will be regularly monitored with medical tests to assess tumor response, side effects, survival, and quality of life. Researchers will collect data on tumor shrinkage using RECIST 1.1 criteria, adverse events, laboratory results, and serum levels of the study drug. Follow-up includes assessments up to 90 days after treatment ends. The total participation duration spans about four years, covering both treatment and observation periods.

Researchers are evaluating an experimental procedure of delivering verapamil directly into arteries for patients who have had an acute ischemic stroke. This study focuses on testing the safety of intra-arterial verapamil, a drug commonly used to treat blood vessel spasms, and how it affects recovery after stroke. The trial is limited to patients who have already received a mechanical thrombectomy as part of their standard care. Participants are randomly assigned to receive one of two doses of verapamil 10 mg or 20 mg administered intra-arterially following the mechanical thrombectomy procedure. This randomized, interventional study compares these two treatment groups to explore how the different doses impact patient outcomes and safety. During the study, participants will be monitored for bleeding complications and serious adverse events, including death, over a three-month period. Functional outcomes will be assessed at 30 and 90 days, and neuroimaging will be performed at 180 and 365 days. Researchers will track recovery progress and safety through these evaluations, with an overall follow-up period extending up to one year.