Merrillville

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are evaluating the changes in symptoms and functional limitations in adults with symptomatic hypertrophic cardiomyopathy (HCM), including both obstructive and non-obstructive types. This Phase 3 trial aims to compare the effects of sotagliflozin, an oral medication, to a placebo in these participants. The study focuses on how these treatments affect heart-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) over 26 weeks. Participants will be randomly assigned to receive either sotagliflozin tablets or matching placebo tablets once daily. The study includes participants with specific heart function criteria, including left ventricular outflow tract gradients for obstructive or non-obstructive HCM and stable background therapy. The treatment period lasts 26 weeks, during which participants take the assigned tablets daily. Throughout the study, participants will undergo assessments including symptom evaluations and functional status measurements. Researchers will monitor changes from the start of the study to week 26 using the KCCQ CSS to evaluate treatment effects on heart symptoms and quality of life. Safety and adherence to medication will also be observed during this time.

Researchers are evaluating the effects and safety of the study medicine PF-07275315 for treating moderate to severe chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult and lowers quality of life. This clinical trial includes adults aged 35 to 80 years who have had COPD for at least 12 months and a history of at least two moderate or severe COPD flare-ups in the past year. The study has two phases: Phase 2 and Phase 3, each designed to assess different outcomes related to lung function and lung flare-ups over time. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections (shots under the skin) at the clinic. The Phase 2 part lasts 24 weeks with 11 clinic visits and focuses on the change in lung function measured by forced expiratory volume in 1 second (FEV1). The Phase 3 part lasts 52 weeks with 18 clinic visits and evaluates the annual rate of moderate or severe COPD flare-ups. Both study phases compare the effects of PF-07275315 to the placebo to assess safety and effectiveness. During the study, participants will visit the clinic regularly for assessments including lung function tests and health evaluations. They will continue their usual COPD maintenance treatments throughout the trial. Researchers will monitor lung function changes and the frequency of COPD exacerbations as primary outcome measures. Participants remain in the study for about 40 weeks in Phase 2 or about 68 weeks in Phase 3, including follow-up visits to ensure safety and collect health information.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

This research aims to collect ongoing safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis used by patients with lower extremity pareses. The study follows patients who have been casted for a C-Brace fitting and consent to participate, focusing on documenting their progress and experiences over time with this device. The C-Brace device includes custom thigh, calf, and foot components connected by an ankle joint and sensor system that continuously monitors knee joint movement. This allows the device to adjust resistance and control knee flexion and extension during walking. Participants will receive standard care including baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after final fitting. Participants will undergo assessments such as walking speed tests, mobility and balance evaluations, and balance confidence questionnaires to measure changes from baseline. The study also tracks device-related adverse events, especially falls, to monitor safety over 12 months and beyond. The total follow-up period extends up to 36 months to provide comprehensive data on long-term use.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are studying immune response changes in men with metastatic castrate-resistant prostate cancer (mCRPC) who have been treated with PROVENGE® immunotherapy. This Phase 2, open-label, multicenter trial evaluates the effects of a single booster infusion of sipuleucel-T following the initial PROVENGE® treatment course. The study aims to measure the humoral immune response to specific prostate cancer antigens after this booster infusion. Participants will have previously completed three infusions of PROVENGE® before being randomized to receive one additional sipuleucel-T booster infusion. The intervention involves a single infusion of sipuleucel-T, which is designed to enhance the immune system's response against prostate cancer. This booster phase follows the initial PROVENGE® treatment. During the study, participants will be monitored through a five-year overall survival period, with assessments focused on the immune response to the treatment. Researchers will evaluate blood samples to measure antibody responses to PAP and PA2024 antigens after the booster infusion. The study involves ongoing safety and immune monitoring to understand the long-term effects of the booster treatment on this patient population.

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.