Vineland

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis CAVS in adults aged 50 and older. This study is conducted in two parts Part A focuses on whether ataciguat reduces calcium buildup in the aortic valve over 24 weeks, while Part B examines if the drug slows narrowing of the valve area and improves peak oxygen consumption over 48 weeks. Safety, tolerability, and how the body processes ataciguat are also assessed. Participants receive either ataciguat or a placebo daily for up to 156 weeks. Part A enrolls about 132 participants, and Part B will begin after Part A completes, enrolling around 1144 participants. Part B includes additional evaluation of heart function and ability to exercise. The study uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants undergo imaging tests like CT scans and echocardiograms to measure valve calcium and valve area. Cardiopulmonary exercise testing CPET is used to assess peak oxygen consumption. Researchers also monitor heart function, symptoms, and quality of life using questionnaires. Assessments occur mainly at baseline, Week 24, and Week 48, with long-term follow-up to 156 weeks for safety and efficacy. The studys total duration extends to 2030.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

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 a text-based program designed to help rural cancer survivors who smoke to quit smoking. This phase III trial compares an eight-week scheduled gradual reduction SGR intervention delivered via personalized text messages combined with the National Cancer Institutes Smokefree.TXT service to a control group receiving a smoking cessation booklet. The study aims to assess how effective these approaches are in achieving biochemically validated smoking cessation six months after quitting, as well as their impact on quality of life. Participants are randomly assigned to one of two groups. The first group follows a personalized eight-week gradual reduction schedule, supported by cessation messages sent by text for 12 weeks. The second group receives the NCI Clearing the Air booklet to assist in planning gradual smoking cessation. After completing the interventions, participants are followed for a total of six months post-quit date to evaluate outcomes. During the study, participants will provide urine samples and complete questionnaires to measure smoking status and quality of life at baseline, 30 days, and six months after quitting. The research team uses biochemical validation to confirm smoking cessation. Participants must have texting capability on a cell phone or smartphone and be able to read and speak English. The total participation includes the intervention period plus follow-up to monitor smoking cessation and quality of life changes.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Chemotherapy-induced peripheral neuropathy CIPN is a side effect caused by chemotherapy drugs that affect the nerves in the hands and feet. This trial evaluates the use of the Lilac Glove and Boot devices, which apply gentle pressure to the hands and feet to reduce chemotherapy exposure to peripheral nerves. The study aims to assess the safety and potential prevention of moderate to severe neuropathy symptoms during cancer treatment. Participants are randomly assigned to either use the Lilac Device or a sham device that looks similar but applies less compression. The devices are fitted and turned on before chemotherapy infusion, worn continuously during infusion, and for up to two hours afterwards. The study focuses on patients receiving specific chemotherapy regimens based on Oxaliplatin or Paclitaxel, with or without additional targeted therapies. During the trial, participants wear the devices during chemotherapy cycles planned for up to 12 months and complete questionnaires related to neuropathy symptoms. Researchers monitor the occurrence of neuropathy symptoms at 12 weeks post-treatment, focusing on overall symptoms and those in the hands. The study also tracks safety and tolerability, with the total participation lasting through the chemotherapy period and follow-up assessments.

Researchers are evaluating the Lily Device to see if it can reduce hair loss caused by chemotherapy in adults with breast cancer stages 1 to 3. The study also aims to assess the safety of the device by monitoring any adverse events related to its use. The main questions focus on whether patients preserve their hair after four chemotherapy cycles and the occurrence of any device-related side effects. Participants will use the Lily Device during each chemotherapy session. The device must be worn during the chemotherapy infusion and for at least two hours, up to four hours, after the infusion ends. The study includes at least four cycles of chemotherapy, with various chemotherapy regimens allowed. The devices use is monitored throughout the chemotherapy treatment period. Study participants will be assessed after four chemotherapy cycles for hair preservation by both healthcare professionals and patients themselves. Researchers will collect photographs of the scalp, ask participants to complete quality of life questionnaires, and track how well participants follow the device wear schedule. Safety is closely monitored from enrollment until 30 days after the last treatment, looking for any adverse device events or serious side effects.

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in leg arteries caused by peripheral artery disease PAD. The study aims to determine whether the Thor system is safe and effective for treating these lesions. Patients experience leg pain due to poor blood flow, and the study will observe how the Thor system works in this setting. All participants will receive treatment using the Thor laser atherectomy system, which targets calcified lesions to improve blood flow. During the procedure, doctors may also use additional devices such as angioplasty balloons, drug-coated balloons, stents, and clot-collecting filters if needed. The procedure includes x-ray imaging, and patients will be monitored closely until discharge or for up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. These visits include medical history reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure comparisons, ultrasound imaging, and questionnaires about walking ability and quality of life. The study will measure outcomes such as freedom from major adverse events, procedural success, lesion openness, and improvements in walking and health surveys over one year.