El Centro

Researchers are evaluating the combined use of finerenone and empagliflozin (a sodium-glucose co-transporter 2 inhibitor) compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label Phase 3 trial aims to determine the effectiveness and safety of this early, intensive management strategy in improving outcomes for these patients. Participants will receive oral finerenone and empagliflozin as part of the combination therapy. The study compares this combination treatment to usual care practices during and after hospitalization for heart failure. The trial focuses on patients currently hospitalized or recently discharged with heart failure symptoms and elevated heart failure biomarkers. During the study, researchers will monitor participants for clinical benefit over six months, including the number of serious adverse events and adverse events leading to discontinuation of the study drug. Participants will undergo regular assessments and safety monitoring throughout the six-month period to evaluate treatment effects and tolerability.

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 studying a telehealth oncofertility care intervention aimed at young cancer survivors to improve their engagement in fertility preservation and related care that matches their personal goals. This Phase 3 trial focuses on adolescents and young adults diagnosed with cancer or cancer relapse, hypothesizing that the intervention will increase participation in goal-concordant oncofertility care. The study also observes how well the intervention is implemented in real-world clinical settings. The intervention includes three main parts: a smart electronic health record tool that screens for oncofertility needs and guides referrals, telehealth counseling about fertility options when needed, and telehealth financial navigation to assist with costs if indicated. Participants receive this multi-component approach alongside their usual oncology care. The study uses a stepped wedge cluster randomized controlled design, enrolling patients at multiple clinical sites. Participants are monitored for their use of goal-concordant oncofertility care and for decisional conflict related to fertility choices, measured 12 weeks after their oncology visit. The study collects information on how the intervention is delivered and its effects on patient engagement. Eligible participants include males and females within specified age ranges who are new or relapsed cancer patients receiving care at participating centers. The total study duration and additional assessments beyond 12 weeks are not detailed.

Researchers are evaluating whether training healthcare professionals (HCPs) can increase the number of continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes (T2D) at a Federally Qualified Health Center serving mainly Hispanic/Latino patients. The study also investigates whether receiving a CGM prescription improves diabetes control measured by Hemoglobin A1c levels and explores barriers patients face when prescribed and using CGMs. This project aims to improve CGM use and diabetes outcomes through focused provider education and patient experience evaluation. The intervention includes a CGM prescription toolkit and training for HCPs and staff at three clinics, covering eligibility criteria, insurance documentation, communication scripts, and patient education materials about CGM benefits and costs. The initial 20-minute training is followed by a 10-minute booster session one month later to reinforce learning and address challenges. The study will compare CGM prescription rates before and after training using electronic health records, and evaluate changes in provider knowledge and attitudes through surveys and interviews. Patients with T2D will be recruited for surveys at baseline, 3 months, and 6 months to collect information on diabetes management, distress, and CGM discussions with providers. A subset of patients prescribed CGMs will share their experiences and barriers in interviews. Researchers will measure CGM prescription rates, changes in A1c values, diabetes distress levels, and factors influencing CGM uptake among providers and patients. The study focuses on improving diabetes care equity in an underserved, ethnically diverse population over a three-year period.

This research aims to assess a multi-part program designed to help young female cancer survivors living in rural areas engage more effectively in reproductive health care that matches their personal goals. The study focuses on women with cancer who may face fertility and contraception challenges after treatment, hoping to improve their participation in care tailored to their reproductive desires and needs. The program includes three main parts: first, young cancer patients complete a reproductive health needs screening during oncology visits to identify their desire for future children and contraception needs. Second, they receive a patient navigation session, either by telehealth or in person, with a social worker who provides personalized education and counseling about infertility risks and reproductive health management. Third, patients have a telehealth consultation with a reproductive specialist lasting about one hour. Participants will be monitored for their involvement in reproductive health care that aligns with their goals, measured 12 weeks after their oncology visit. The study focuses on female cancer survivors aged 15 to 50 who receive care at rural oncology clinics in Imperial County, California. The research evaluates how well the intervention supports patient engagement in appropriate reproductive health services.

Researchers are investigating long-term treatment outcomes for patients with opioid use disorder (OUD) who begin buprenorphine treatment in emergency departments. This study compares outpatient buprenorphine treatment delivered via telehealth versus in-person clinic visits. The goal is to see which approach leads to better treatment engagement, longer retention on buprenorphine, and improved patient experiences. The study involves patients recruited from three hospital emergency departments who start buprenorphine for OUD but do not have an outpatient clinic arranged for follow-up. Participants will be randomly assigned in a two-step process: first to either a group that chooses their treatment type or a group randomized to telehealth or in-person outpatient treatment. Those in the telehealth group will receive outpatient care through video or phone visits, while those in the in-person group will attend outpatient clinics or opioid treatment programs. Researchers will track buprenorphine prescribing using state prescription monitoring data and follow participants at 1, 3, 6, and 9 months after their emergency department visit. Participants will complete questionnaires about their care experience and treatment adherence. Researchers will measure how many patients begin outpatient treatment and how long they continue buprenorphine over six months. Other outcomes include overdose deaths, hospital visits, and how patient-reported stigma affects treatment outcomes. This study aims to guide clinicians and patients on the best outpatient referral options after emergency department buprenorphine treatment and to reduce disparities in OUD care.

This research aims to compare the number of catheter-free days and the rate and severity of infections related to dialysis access between two treatment groups, ATEV and AVF, in female patients with end-stage renal disease (ESRD) who need hemodialysis. The study is a Phase 3, prospective, multicenter, randomized trial focusing on females currently receiving hemodialysis through a central venous catheter. Participants will be grouped based on the location of their vascular access and the type of AVF procedure planned by their surgeon. Approximately 150 female patients will be randomly assigned to receive either the Acellular Tissue Engineered Vessel (ATEV) implantation or the standard autogenous arteriovenous fistula (AVF) creation procedure. These treatments involve surgical creation of an access point in the forearm or upper arm to facilitate hemodialysis. Patients will be monitored for 12 months, with follow-up continuing for another 12 months for those who maintain a patent access. During the study, participants will undergo regular assessments including physical exams, ultrasound or vessel imaging, and laboratory tests. Researchers will track catheter-free days and infection rates related to dialysis access over 12 months. Safety and effectiveness will be evaluated throughout the study, with additional long-term follow-up for some patients. Total participation may last up to 24 months for those entering the extension phase.