Buffalo Junction

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of CREXONT, a combination of Carbidopa and Levodopa in extended-release capsules, in people with Parkinson's disease (PD) under real-world conditions. This Phase 4 study focuses on participants who have PD diagnosed according to specific criteria and experience motor fluctuations and "Off" periods despite stable treatment with oral Carbidopa-Levodopa. Participants will receive CREXONT ER capsules during the study. The study includes a treatment period lasting 42 days, during which participants continue their PD medication regimen while taking CREXONT. The study assesses changes in the amount of time participants spend in the "Good On" state, where motor symptoms are well controlled. Throughout the study, participants will complete Parkinson's Disease diaries, questionnaires, and attend study visits and phone calls. Researchers will monitor motor function using standardized rating scales and diary entries to evaluate changes in motor states from the start of the study to Day 42. Safety and adherence to treatment will also be assessed during this period.

Researchers are conducting a multi-center, open-label, randomized clinical trial to compare survival outcomes between robotic-assisted laparoscopy and open surgery for patients with early stage cervical cancer. The study tests whether robotically assisted hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy regarding disease-free survival. Patients must have specific cancer types and stages without evidence of metastases to participate. Participants will be randomly assigned to either the robotic surgery group or the open surgery group. In the robotic arm, hysterectomy is performed using a minimally invasive robotic device with specific surgical protocols to close the vagina prior to colpotomy. In the standard arm, an open radical or simple hysterectomy is performed with vaginal closure over the tumor before colpotomy. Both groups may have ovary removal or preservation, and detailed surgical records are maintained. During the study, patients undergo preoperative assessments including imaging and lab tests, and pregnancy tests for pre-menopausal women. Surgeons document operative details and complications. The primary outcome is survival measured over 36 months. Follow-up includes monitoring for disease-free survival and safety. Participants must be able to attend follow-up visits and provide consent to share health information.

This research aims to evaluate a community-participatory hydration intervention over three years in a district with newly installed hydration stations. It focuses on promoting healthy hydration, improving equitable access to drinking water, and preventing dental caries and obesity among school children. The study measures the effectiveness and sustainability of the intervention through hydration station usage, body mass index scores, and dental health outcomes. The intervention involves a 4-month community-driven program implemented sequentially in groups of schools. It includes providing refillable water bottles in schools with hydration stations, along with social marketing, behavioral reinforcement, and education and outreach. Schools are introduced to the program in a stepped-wedge design to assess the impact over time. Participants include students from kindergarten to fifth grade who eat lunch in the cafeteria, with specific assessments for third graders followed through fifth grade. The study includes observations, surveys for students and staff, and assessments of body mass index and dental caries. Researchers will monitor hydration station use, beverage choices, water bottle use, academic outcomes, and health measures for up to three years to evaluate the intervention's long-term effects.

Researchers are conducting Enroll-HD, a large, long-term observational study involving individuals affected by Huntington's Disease (HD), those at risk, and control participants. This study combines data from previous registries in Europe, North America, Australasia, and now includes Latin America. It aims to build a comprehensive database of clinical information and biological samples to support research on disease progression, prognosis, and clinical characteristics, as well as to establish clear endpoints for future interventional studies. Enroll-HD collects detailed clinical and genetic information along with blood samples from participants categorized as carriers of the HD gene mutation, controls without the mutation, and family or community controls. The study enrolls participants from over 150 sites in 23 countries and conducts annual assessments without a set end date. Participant groups include those with manifest HD symptoms, pre-manifest carriers, relatives with unknown genotype, and genotype-negative relatives. Participants undergo yearly evaluations including motor, functional, behavioral, and cognitive assessments using standardized scales such as the Unified Huntington's Disease Rating Scale and the Problem Behaviors Assessment-Short. Researchers track changes over an average of one year or longer through this ongoing registry. Data collected supports multiple research efforts and is accessible to qualified researchers worldwide.

The HEALEY ALS Platform Trial is an ongoing, multi-center study designed to evaluate the safety and effectiveness of various investigational treatments for Amyotrophic Lateral Sclerosis (ALS). This perpetual platform trial uses a single Master Protocol to test multiple treatments either simultaneously or one after another, allowing efficient study of different therapies under one trial structure. Participants diagnosed with ALS are randomly assigned to receive one of the active investigational drugs or a matching placebo in a controlled setting. The study includes several treatment regimens, each testing a different investigational product. These treatments include subcutaneous injections and oral medications given daily or twice daily, such as Zilucoplan, Verdiperstat, CNM-Au8, Pridopidine, and others. Each regimen is placebo-controlled and has its own specific study details summarized in separate appendices. New investigational products and regimens are continuously added to the trial, allowing enrollment of additional participants over time. Participants will be involved in regular assessments over a minimum 36-week period to monitor disease progression and treatment effects. Evaluations include clinical exams, consent and compliance checks, and respiratory function measurements. Safety is closely monitored throughout the trial. The study aims to gather detailed information on how these investigational products impact ALS progression, with participants having equal chances of being assigned to any active regimen at screening.

Researchers are evaluating the effects of Lenrispodun as an additional treatment for patients with Parkinson's Disease who experience motor fluctuations and levodopa-induced dyskinesia. This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. Participants must have a diagnosis consistent with the UK Parkinson's Disease Society Brain Bank criteria and show wearing-off symptoms alongside levodopa-induced dyskinesia. The study consists of three main periods: an initial screening period lasting up to 4 weeks to assess eligibility, followed by a 4-week double-blind treatment period where patients are randomly assigned to receive either 30 mg of Lenrispodun orally once daily or a matching placebo. After this, there is a 1-week safety follow-up period during which participants return to the clinic for safety evaluations approximately one week after finishing the study medication. During the study, participants will complete a self-reported home diary called the Hauser Diary to track motor function status. Researchers will monitor the effects of treatment on motor symptoms and safety outcomes. Study visits include assessments to confirm eligibility, monitor response to treatment, and ensure participant safety throughout the study period.

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 evaluating the safety and effectiveness of a new antibody drug called gotistobart (ONC-392/BNT316) compared to the chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has worsened after treatment with PD-1 or PD-L1 inhibitors. This Phase 3 clinical trial aims to see if gotistobart can help patients live longer than with standard chemotherapy. The study will enroll about 630 patients who have squamous cell NSCLC and have shown disease progression on prior immunotherapy. The trial has two stages. In Stage I, two different dosing regimens of gotistobart will be tested against docetaxel to confirm the best dose. Gotistobart is given through a 60-minute intravenous infusion every 21 days at either 3 mg/kg or 6 mg/kg (with two initial loading doses of 10 mg/kg). Docetaxel is given by IV infusion every 21 days at 75 mg/m2. Stage II will compare the chosen gotistobart dose to docetaxel in patients with squamous NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will undergo tumor measurements to confirm disease progression and meet health criteria such as organ function and performance status. Researchers will monitor overall survival over 36 months as the main outcome. Safety and side effects will be closely followed. The study requires patients to have recovered from prior treatment effects and have no active infections or serious heart or lung disease. Through this trial, researchers hope to determine whether gotistobart is a beneficial treatment option for this group of lung cancer patients.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System (CMCS) in treating patients with heart failure who have functional mitral regurgitation (FMR). This is a prospective, randomized, double-blinded, sham-controlled clinical trial involving 300 participants across sites in the United States, Canada, and Europe. The study aims to compare the CMCS implant procedure with a control group receiving a sham procedure to assess improvements in heart function and safety over time. Participants will be randomly assigned to one of two groups: an intervention group receiving the Carillon implant, which is placed in the coronary vein to reshape the mitral valve and reduce leakage, or a control group undergoing a similar procedure without implant placement. Both groups will continue receiving guideline-directed heart failure medications. Before randomization, participants undergo echocardiographic, coronary angiogram, and venogram evaluations to confirm eligibility and anatomical suitability for the implant. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety, heart function, and clinical status. After 24 months, the study will be unblinded, and participants will continue with annual contacts and echocardiograms for an additional 3 years, totaling 5 years of monitoring. Primary outcomes include freedom from major adverse events at 12 months and a clinical composite measure of efficacy at 24 months.