Kenner

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 evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine (20vPnC) protects adults aged 65 and older who are hospitalized with radiologically-confirmed community-acquired pneumonia (RAD+CAP). The study focuses on pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria included in the 20vPnC vaccine. This observational study uses a test-negative design to compare the presence of these specific bacterial types in vaccinated and non-vaccinated participants. Participants provide a urine sample that is tested with BinaxNOW4 S. pneumoniae and serotype-specific urinary antigen detection (UAD) assays to detect the bacteria and its strains. Cases are defined as participants with pneumonia caused by the seven additional serotypes in 20vPnC beyond those in the 13-valent vaccine, plus serotype 15C. Controls include participants without these vaccine serotypes or with pneumonia caused by other agents. The main diagnostic procedure is the non-invasive urine test, and all participants are hospitalized adults aged 65 or older with pneumonia confirmed by chest imaging. Participants share demographic and medical history information and undergo urine testing during their hospital stay, which typically lasts 1 to 2 days for study procedures. Researchers collect data on illness and hospitalization for up to 30 days through medical chart reviews. The primary outcome measures how effective 20vPnC is against pneumonia caused by the additional serotypes over a 55-month period, helping to understand the vaccine's real-world performance in this older population.

Researchers are evaluating pain levels in patients undergoing arthroscopic rotator cuff repair, focusing on those with high-grade partial or full thickness rotator cuff tears. The study compares pain scores using the Patient-Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale (NRS) between patients receiving standard care and those receiving a combination of cold therapy and compression. This randomized controlled trial aims to assess pain from before surgery through six months after the procedure. Participants are assigned to one of two groups: the standard care group, which receives hydrocodone/APAP pain medication as needed along with traditional cold therapy such as ice bags or gel packs; and the cold and compression group, which uses a device providing continuous circulating cold flow combined with dynamic compression. Treatment is monitored from before surgery, daily for 14 days after surgery, weekly for three months, and finally at six months post-surgery. Throughout the study, participants are assessed regularly for pain using the PROMIS Pain NRS subscale during the entire six-month period. Researchers track pain changes starting at enrollment and continuing through the follow-up visits. Monitoring includes evaluating adherence to treatments and any side effects or complications. The goal is to understand differences in pain relief and recovery between the two approaches over time.

This research aims to evaluate the effectiveness of a multi-level, evidence-based weight loss program called LA-CEAL CONNECT for adults living with obesity in low-income and underserved communities in Louisiana. The study seeks to determine if LA-CEAL CONNECT leads to greater weight loss at 6 months compared to enhanced usual care, and whether weight loss is sustained at 12 months. The trial also examines improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, while assessing the feasibility of implementing the program in these communities. Participants in both study groups receive health literacy-tailored educational materials and resources for weight loss and attend clinic visits at baseline, 6 months, and 12 months for clinical and survey assessments. Those in the LA-CEAL CONNECT intervention group additionally receive virtual health coaching from trained community health workers over 6 months, use digital tools like cellular-connected scales and wrist fitness trackers for daily self-monitoring of weight and activity, and attend group meetings to enhance use of community health and wellness resources identified through community asset mapping. The program also includes provider training and an obesity management toolkit for primary care providers at participating clinics. Throughout the study, participants are monitored through clinical visits collecting physical measurements and surveys at three timepoints over one year. Coaches remotely track weight and physical activity data to provide personalized support. The primary outcome is the difference in percentage weight change between groups at 6 months. The study also evaluates other health and behavioral measures, program feasibility, and sustainability over 12 months.

Researchers are evaluating the effectiveness and safety of ravulizumab compared to a placebo in adult patients at high risk of delayed graft function (DGF) following a deceased donor kidney transplant. This Phase 3, double-blind, randomized, placebo-controlled study aims to reduce the severity of DGF by measuring the time it takes for participants to become free from dialysis within 90 days after transplant. The study focuses on patients with dialysis-dependent end-stage kidney disease (ESKD) receiving kidneys from specific donor types. Participants will be randomly assigned in a 1:1 ratio to receive either ravulizumab or a placebo through intravenous infusions. The treatment is administered intravenously during the study. No additional treatment groups are mentioned, and the study is conducted across multiple centers. The purpose is to compare the impact of ravulizumab versus placebo on the recovery of kidney function post-transplant. During the study, participants will be monitored for their time to freedom from dialysis up to 90 days after the transplant procedure. Safety and efficacy assessments will be conducted throughout the study period. The researchers will evaluate how quickly the transplanted kidney starts functioning without the need for dialysis. The total duration of participant involvement and follow-up details beyond the 90-day period are not specified in the provided information.

Researchers are collecting real-world data on the use of commercially available Boston Scientific drug-eluting devices for treating lesions in the peripheral blood vessels. This study aims to include patient populations not previously well represented in peripheral vascular disease trials and to gather health economic information to support the safe use of these devices. Participants will be treated with any eligible Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. These devices are used to treat lesions located in the peripheral vasculature. The study is global, prospective, open-label, non-randomized, and involves multiple centers. During the study, researchers will monitor major adverse events and lesion patency over 12 months. Participants will be followed to assess the safety and effectiveness of the devices in real-world settings. Health economic data will also be collected to better understand the broader impact of these treatments.

Researchers are evaluating the effectiveness and safety of an oral drug called KAI-7535 in adults living with obesity or overweight who have at least one weight-related health condition. The study focuses on how well KAI-7535 helps reduce body weight compared to a placebo, especially in participants without diabetes. The study also includes participants with type 2 diabetes to assess the drug's effects and safety in this group. Participants will receive either KAI-7535 or a placebo in oral tablet form once daily. The study is designed as a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial. Those enrolled must meet specific body mass index (BMI) criteria and have certain weight-related health conditions or, if they have type 2 diabetes, be on stable diabetes treatment. The treatment period and specific dosing schedules are not detailed beyond the once-daily oral administration. During the study, participants' body weight changes will be measured, especially the percent change from baseline at week 44 for those without diabetes. Researchers will also monitor safety, tolerability, and other weight-related outcomes. Additional assessments may include medical history and medication use, with attention to any weight changes or health status during the trial. The study includes adults aged 18 to 75 years of all genders.

Researchers are evaluating the Galleri4 multi-cancer early detection (MCED) test in a multi-center prospective cohort study involving the Medicare population aged 50 years and older. This study aims to understand the real-world clinical impact of the test, including its safety and how well it detects cancers early. The study seeks to enroll participants who represent the Medicare population, including those with Traditional Medicare or Medicare Advantage coverage. Participants in the study are divided into two groups: one group receives the Galleri test through blood collection and multi-cancer early detection testing with return of results, while the other group receives usual care without the Galleri test. The study excludes individuals who have previously had an MCED test, are undergoing clinical evaluation for suspected cancer, have certain recent or untreated cancer histories, are pregnant, or are currently inpatient at a participating site. The study is designed to monitor participants over time without specifying a maximum age limit. During the study, researchers will track the incidence rates of stage IV cancers over a period of up to 3 years. Participants will be monitored for safety and test performance outcomes. The study involves informed consent from participants who are capable of providing it directly, and it excludes those who cannot comply with study procedures or who are not registered patients at participating centers. This research aims to provide data on the effectiveness and safety of the Galleri test in a real-world Medicare population setting.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.