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Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease PD under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participants needs. During the study, participants will complete Parkinsons Disease diaries to track On and Off motor states, and researchers will measure changes in Good On time and Off time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.

Researchers are conducting a randomized controlled trial to compare survival outcomes between robotic-assisted laparoscopy and open hysterectomy with lymph node assessment for early-stage cervical cancer. The study aims to determine if robotic hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy in terms of disease-free survival. It includes patients with specific cervical cancer stages and tumor sizes suitable for surgery. Participants will undergo either a radical or simple hysterectomy using either traditional open surgery or a robotic-assisted technique. In the robotic group, the vagina is closed before colpotomy, and certain vaginal manipulators are not allowed. Both groups may have salpingectomy and oophorectomy with or without ovarian transposition. Surgeons will document operative details, including any complications, blood loss, and reasons for conversion to open surgery. During the trial, participants will be closely monitored with preoperative assessments like labs, EKG, and MRI to confirm eligibility. Surgical findings and complications will be recorded. The primary outcome measured is survival at 36 months. Participants must provide informed consent and undergo follow-up to assess disease status and survival over the study period, which extends until 2030.

Researchers are evaluating a community participatory hydration intervention to improve hydration practices in schools over a three-year period. The study focuses on districts that have recently installed hydration stations and are following policies aimed at promoting healthy hydration and equal access to drinking water. The trial examines its potential effects on dental health and obesity prevention among school children. The intervention lasts four months and includes providing refillable water bottles to students in schools equipped with hydration stations. Additional components involve social marketing, behavioral reinforcement, and educational outreach. Schools are randomly assigned in a stepped-wedge design, where clusters progressively receive the intervention. The study compares an assessment-only control group with an experimental group receiving the hydration intervention. Participants include students from kindergarten through fifth grade who eat lunch in the cafeteria, with specific assessments for those enrolled in third grade and followed through fifth grade. The study collects data on hydration station usage, BMI z-scores, dental caries, beverage consumption, academic outcomes, and school staff knowledge. Evaluations occur over the full three years, with surveys administered to students and staff. The trial also monitors water bottle use, beverage sales, and participation in the National School Lunch Program.

Researchers are conducting Enroll-HD, a large, ongoing observational study that combines and expands previous Huntingtons disease HD registries across multiple continents, including Europe, North America, Australasia, and Latin America. This study collects longitudinal clinical data and biological samples from individuals with manifest HD, those carrying or at risk of carrying the HD gene mutation, and control participants without the mutation. The goal is to build a rich database to support research into disease progression, prognosis, and developing clinical trial endpoints. Participants include those with diagnosed HD, pre-manifest carriers, relatives with unknown or negative genotype status, family controls, and community controls. The study involves annual assessments with no planned end date, allowing for long-term data collection. Researchers collect demographic, clinical, family history, genetic, and blood sample information systematically from over 150 sites worldwide. During the study, participants undergo motor, functional, behavioral, and cognitive assessments using standardized tools such as the Unified Huntingtons Disease Rating Scale and Problem Behaviors Assessment-Short. Data are updated at each visit, including clinical signs and genotyping results. The study database is periodically made available to researchers globally, and participants may contribute for many years, helping to advance understanding and support future interventional studies in HD.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the safety and effectiveness of gotistobart ONC-392BNT316, a next-generation anti-CTLA-4 antibody, in patients with metastatic non-small cell lung cancer NSCLC whose disease has progressed after treatment with anti-PD-1 or PD-L1 antibody-based therapies. This Phase 3 clinical trial aims to compare gotistobart with the chemotherapy drug docetaxel to see if it can help prolong life in these patients. Approximately 630 patients will participate, and the study is divided into two stages to confirm dosing and assess outcomes. In Stage I, two dosing regimens of gotistobart will be tested against docetaxel, which is given at 75 mgm2 every 21 days. Gotistobart will be administered by intravenous infusion over 60 minutes every 21 days, either at 3 mgkg or 6 mgkg with two loading doses of 10 mgkg. After selecting the most appropriate dosing regimen, Stage II will compare that gotistobart dose with docetaxel in patients with squamous cell NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will receive regular infusions and be monitored for overall survival over 36 months, along with secondary outcomes like tumor response, progression-free survival, and treatment-related adverse events. Patients must have measurable tumors and meet specific health criteria before joining. The study includes safety monitoring and ongoing assessments to evaluate how well the treatments are tolerated and their effects on cancer progression.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System CMCS in treating patients with heart failure who also have functional mitral regurgitation FMR. This prospective, randomized, double-blinded, sham-controlled trial aims to better understand how this device may impact heart function and symptoms in people with this condition. Participants will be randomly assigned to one of two groups one group will receive the Carillon implant along with guideline-directed heart failure medications, while the other group will receive only the heart failure medications and a sham procedure to preserve blinding. Before randomization, patients will undergo specific heart imaging tests and evaluations to determine eligibility and suitability for the device placement. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety and heart function. After 24 months, all participants will be informed of their group assignment and followed annually for an additional three years. During the study, researchers will assess various health outcomes including freedom from major adverse events at 12 months and clinical improvement at 24 months. Additional measures will include changes in heart valve function, heart size, walking ability, heart failure symptoms, hospitalizations, and quality of life. Participants will have regular heart imaging, clinical evaluations, and questionnaires to track these outcomes. The total participation time may extend up to five years with long-term monitoring to better understand the devices impact over time.