Jacksonville Beach

Researchers are monitoring the long-term safety of efgartigimod, a biological treatment, in patients with generalized myasthenia gravis (gMG). This study is a non-interventional, prospective, post-authorization safety study designed to observe patients who are either starting or already receiving efgartigimod, as well as those with gMG who have not been treated with it. The study aims to compare the occurrence of serious infections and other safety outcomes over a period of up to 10 years. Patients with gMG who are expected to begin efgartigimod treatment at enrollment or who are currently in their first treatment cycle will be included in the efgartigimod group. Those with gMG who are not starting efgartigimod and have never received it will be enrolled in a non-efgartigimod group. There are no assigned treatments or interventions from the researchers; the study simply observes patients as they receive routine care. Participants will be followed for up to 10 years to track safety outcomes, including serious infections. Data collection will involve routine clinical assessments and monitoring as per standard medical practice. The study observes the real-world use of efgartigimod and its safety profile in managing gMG, providing valuable long-term information without altering patients' treatment plans.

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 investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.