Langhorne

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease (CKD) and high blood pressure (hypertension). This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

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 medicine PF-08046054 compared to the standard treatment docetaxel for adults with non-small cell lung cancer (NSCLC) that has PD-L1 expression of 1% or higher. This study focuses on participants whose cancer has spread or cannot be removed by surgery or treated with radiation, and who have progressed after treatment with PD-L1 or PD-1 inhibitors, platinum chemotherapy, and targeted therapies when applicable. The study is a randomized, phase 3 trial sponsored by Pfizer. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will have an intravenous infusion twice every 21 days, while those in the docetaxel group will receive one infusion every 21 days. Treatment may continue for up to five years if the cancer responds well. The treatments are given in cycles with close monitoring. During the study, participants will visit the clinic regularly for evaluations to monitor their health and response to the study treatments. Researchers will assess overall survival over about five years and track disease progression, response rates, duration of response, and quality of life measures. Safety will be monitored through adverse event reporting for up to 90 days after treatment ends. Additional blood tests will measure drug levels and antibody responses during the first year of treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy in people aged 18 and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study focuses on participants who have not previously received treatment for advanced disease and have good overall health, including healthy organs. This study includes two phases: the first assesses safety and response to the new medicine with chemotherapy, and the second compares this combination to an existing treatment of nivolumab plus chemotherapy. In the first phase, participants receive PF-08634404 intravenously with chemotherapy to evaluate safety and how well they respond. In the second phase, participants are randomly assigned to receive either PF-08634404 plus chemotherapy or nivolumab plus chemotherapy, both given intravenously. Treatments are given in repeated cycles. The study uses a double-blind design to compare outcomes between these groups over approximately four years. Participants will undergo regular assessments including scans to measure tumor response using RECIST 1.1 criteria, monitoring for side effects and laboratory abnormalities, and blood tests to measure drug levels and immune response. Researchers will also track progression-free survival, overall survival, and quality of life using specific questionnaires for gastric cancer. Safety monitoring continues through 90 days after the last treatment, with overall participation lasting about four years.

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 evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

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 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.