Kenner

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 effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile C. difficile infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine 20vPnC works against pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria. This study focuses on adults aged 65 years and older who are hospitalized with pneumonia confirmed by chest imaging. The study aims to compare the presence of pneumonia caused by these specific bacteria types in people vaccinated with 20vPnC versus those with pneumonia caused by other bacteria or strains. This observational study involves adults 65 years and older hospitalized with radiologically-confirmed community-acquired pneumonia RADCAP. Participants will provide a urine sample for testing pneumococcal bacteria using BinaxNOW and specific urinary antigen detection assays UAD-1 and UAD-2. Cases are identified by detection of the seven additional bacteria types in 20vPnC beyond the previous 13-valent vaccine, while controls include other pneumonia cases without these serotypes. No treatment is given as part of the study. Participants will be involved for about 1 to 2 days for urine sample collection and providing medical history. Researchers will collect detailed information on illness and hospital stay up to 30 days through medical record review. The main outcome measured is the effectiveness of 20vPnC against pneumonia caused by the seven additional bacterial types over approximately 55 months. Other clinical features and pneumonia types will also be reviewed during this period.

Researchers are evaluating pain levels in adults aged 35 and older who have high-grade partial or full thickness rotator cuff tears and are undergoing arthroscopic rotator cuff repair. The study compares standard post-surgical care with and without the addition of cold and compression therapy to understand how these treatments affect pain over time. The trial is randomized without masking and is sponsored by Ochsner Health System. Participants will be assigned to one of two groups. One group will receive standard therapy after surgery, including 28 hydrocodoneAPAP 7.5 mg pills with an option for a refill, plus cold therapy using ice bags or gel packs. The other group will receive the same pain medication along with a cold and compression therapy device provided by the sponsor. Treatment and monitoring will continue regularly from before surgery through six months after surgery. During the study, participants will have their pain recorded using the PROMIS Pain NRS subscale before surgery, daily for 14 days after surgery, weekly for three months, and again at six months post-surgery. Researchers will track pain scores as the primary outcome and monitor participants recovery and adherence to therapy. The study involves outpatient physical therapy for rehabilitation and requires participants to speak English and attend follow-up visits over the six-month period.

This research aims to evaluate the effectiveness of a multi-level weight loss intervention called LA-CEAL CONNECT in adults living with obesity in Louisiana. The study will compare this intervention with enhanced usual care to determine if it leads to greater weight loss at 6 months and sustained weight loss at 12 months. It also aims to assess improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, as well as the feasibility of implementing the program in community settings. Participants in the study will be randomly assigned to either the LA-CEAL CONNECT intervention or enhanced usual care. Those in the intervention group will receive culturally tailored educational materials, health coaching from community health workers over 6 months, tools for self-monitoring weight and physical activity using digital devices like a Fitbit and digital scale, and group meetings to connect with community health resources. Both groups will receive educational materials and their healthcare providers will get training and toolkits to support obesity management. During the study, participants will visit clinic sites at the start, 6 months, and 12 months to have clinical measurements and surveys collected. Researchers will monitor weight change as the main outcome at 6 months, along with changes in waist circumference, blood pressure, diet, physical activity, and quality of life. The study will last up to 12 months, with ongoing support and tracking of health behaviors through coaching and digital monitoring devices.

Researchers are evaluating the safety and effectiveness of ravulizumab compared to placebo in adult patients at high risk of delayed graft function DGF following deceased donor kidney transplantation. The study aims to show whether ravulizumab can reduce the severity of DGF, specifically by shortening the time patients need dialysis after transplant. This phase 3, randomized, double-blind trial focuses on patients with dialysis-dependent end-stage kidney disease receiving kidneys from specific donor types. Participants will be randomly assigned to one of two groups one receiving intravenous infusions of ravulizumab, and the other receiving placebo infusions. The treatment is given intravenously, and participants receive either the study drug or placebo throughout the study. The trial compares these groups to assess the impact on DGF. The study is conducted across multiple centers and follows participants through 90 days after transplantation to measure outcomes. Throughout the study, participants will undergo regular assessments to monitor their kidney function and dialysis needs. Researchers will measure the time until participants no longer require dialysis, the number of dialysis sessions needed, the incidence of DGF within 7 days post-transplant, and kidney function as measured by eGFR. Safety and efficacy data are collected during the post-transplant period, with primary outcome measurements taken through 90 days after transplant. The total participation period extends until the studys completion in 2028.

Researchers are collecting Real-World Data to better understand treatment outcomes and health economics related to lesions in the peripheral vasculature. This global, prospective, non-randomized, open-label, multi-center Registry aims to include populations not well represented in previous Peripheral Vascular Disease trials. The study supports the safe use of commercially available Boston Scientific drug-eluting devices for this condition. Participants receive treatment using any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. The study includes two cohorts a Clinical Cohort, where patients undergo standard of care assessments with follow-up for up to 2 years in multiple countries and 5 years in China, and an Outcomes Cohort at select sites with additional evaluations including Quality of Life questionnaires, six-minute walk tests, and healthcare utilization data collection. During the study, participants complete various assessments according to standard care and additional tests depending on their cohort. Researchers measure major adverse events and lesion patency at 12 months to evaluate outcomes. The study monitors participants through follow-up visits extending up to 5 years to gather safety and effectiveness data in real-world clinical practice.

Researchers are evaluating the effectiveness of oral KAI-7535 taken once daily compared to a placebo in adults living with obesity or overweight who have at least one weight-related health condition, excluding those with diabetes mellitus. The study also examines how well KAI-7535 works in participants with type 2 diabetes mellitus. Safety, tolerability, and other weight-related results will be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a placebo once a day. The study includes multiple dosing schedules of KAI-7535 to evaluate its effects. The trial follows a parallel design with a quadruple masking method to ensure unbiased results. The treatment period lasts up to 44 weeks. Throughout the study, participants will have their body weight and body mass index measured at the start and at week 44. Researchers will track the percentage change in body weight and the number of participants achieving weight loss of 5% or 10%. Safety and tolerability will also be monitored. The entire participation period can last over 44 weeks, including screening and follow-up assessments.

Researchers are evaluating the real-world clinical impact of the Galleri4, a blood-based multi-cancer early detection MCED test, in a Medicare population aged 50 years and older. This multi-center prospective cohort study aims to assess the tests safety and performance alongside usual care, enrolling participants representative of Medicare beneficiaries. The study is observational and compares outcomes between those receiving the Galleri test plus usual care and those receiving usual care alone. Participants in the Galleri-tested arm will have blood collected for the MCED test with results returned to guide further evaluation. The comparator group consists of Medicare beneficiaries receiving usual care without the Galleri test. Both groups will be observed over a period of up to 3 years to evaluate cancer incidence and diagnostic outcomes. Throughout the study, researchers will monitor the incidence of stage IV cancers, the number and types of invasive procedures following test results, adherence to recommended cancer screening, and healthcare resource use related to cancer diagnostics. Safety and test performance will be tracked in the Galleri-tested group. Participation involves routine clinical visits and data collection for up to 3 years, with no interventions withheld for either group.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.