Pendik

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Cervical radiculopathy is a condition caused by irritation or compression of cervical nerve roots, often resulting in one-sided neuropathic pain and difficulty with arm movement. This study aims to evaluate how an interlaminar epidural steroid injection ILESI affects upper arm proprioception, or the sense of joint position, in patients with chronic cervical radiculopathy due to cervical disc herniation. The study also explores how changes in proprioception relate to symptoms like pain, disability, grip strength, and quality of life. Participants will receive a single standardized ILESI at the C7-T1 level using fluoroscopic guidance. The injection includes a mixture of corticosteroid, local anesthetic, and saline. Evaluations will be done at three times before the injection, three weeks after, and three months after. The study uses a validated joint position sense test called PRO-Reach to assess proprioception and measures other clinical outcomes such as neuropathic pain scores, pain intensity, disability, hand-grip strength, and quality of life. During the study, participants will undergo tests and questionnaires at each visit to assess their symptoms and function. Data will be collected by blinded assessors to reduce bias. The main outcome is the change in upper extremity proprioception error over time. Secondary outcomes include changes in neuropathic pain, pain intensity, disability, grip strength, and quality of life. The study will last for at least three months of follow-up, with careful monitoring of participants progress and safety.

Lumbar spinal stenosis is a condition where the spinal canal narrows due to degenerative changes in the joints, discs, and ligamentum flavum, causing symptoms like neurogenic claudication, leg pain, low back pain, and sometimes urinary or fecal incontinence. This research aims to explore if the presence of spinal dural pulsation, a rhythmic movement of the dura mater seen in imaging, is linked to clinical symptoms and radiological findings in people diagnosed with lumbar spinal stenosis. Participants will be assessed for the presence of dural pulsation using ultrasound while lying face down. The study groups include those positive for dural pulsation and those negative for it. Magnetic Resonance Imaging MRI will also be used to measure spinal canal features such as dural diameter and cross-sectional area at affected levels. The study correlates these findings with clinical symptoms and disability scores. During the study, participants will undergo evaluations including pain rating scales, disability indexes, quality of life questionnaires, and walking capacity tests. MRI scans will assess anatomical features related to stenosis. These assessments occur at the time of data collection to understand the relationship between dural pulsation and patient symptoms. The study excludes individuals with certain conditions like prior lumbar surgery or inflammatory diseases and plans to complete by the end of 2026.

This research aims to evaluate the effects of Seladelpar on clinical outcomes in adults with Primary Biliary Cholangitis PBC who also have compensated cirrhosis. The study is a Phase 3 randomized, double-blind, placebo-controlled trial focusing on treatment outcomes for this liver condition. It is sponsored by Gilead Sciences and seeks to understand how Seladelpar may impact disease progression and survival in this specific patient group. Participants will be randomly assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg capsules of Seladelpar, while those with CP-B cirrhosis will take 5 mg capsules. The placebo group will take one capsule daily as well. This long-term treatment period allows researchers to compare outcomes between the two groups effectively. During the study, participants will follow a schedule of assessments to monitor their health and response to the study drug. Researchers will measure outcomes such as event-free survival, overall survival, liver transplant-free survival, and time to hospitalization over 36 months. Safety and laboratory parameters will be regularly evaluated to ensure participant well-being throughout the trial.

Researchers are evaluating whether olomorasib combined with pembrolizumab or durvalumab is more effective than these immunotherapies alone in participants with KRAS G12C-mutant non-small cell lung cancer NSCLC. The study focuses on two groups those with resected NSCLC and those with unresectable NSCLC. This Phase 3 trial aims to assess disease-free survival and progression-free survival among these participants over an estimated period of up to 3 years. Participants will receive either olomorasib or a placebo orally along with pembrolizumab or durvalumab administered intravenously for up to one year. After this combination phase, participants continue with olomorasib or placebo alone for up to a total of three years of treatment. The study includes randomized, double-blind groups to compare these combinations in both resected and unresectable NSCLC. During the study, participants undergo regular assessments to monitor disease progression, overall survival, and quality of life using questionnaires and imaging. Researchers measure outcomes such as disease-free survival, progression-free survival, response rates, and symptom changes related to NSCLC. The study also tracks safety and health impacts over the treatment period, which may last up to three years for each participant.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.