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 medicine's 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. The study is conducted in two parts: Part A focuses on whether ataciguat reduces the buildup of calcium in the aortic valve, while Part B assesses if it slows the loss of aortic valve area and improves peak oxygen consumption. The safety, tolerability, and how the body processes ataciguat are also being studied. Participants will receive either ataciguat or a placebo daily for up to 156 weeks. Part A will enroll about 132 participants to study calcium changes over 24 weeks, and Part B will enroll approximately 1144 participants to observe valve area and exercise capacity over 48 weeks. The study uses random assignment and participants and researchers will not know who receives ataciguat or placebo. Throughout the study, participants will undergo imaging scans like non-contrast CT and echocardiograms, exercise tests to measure peak oxygen consumption, and questionnaires about heart-related quality of life. Researchers will monitor heart function, valve calcium, and symptoms at baseline and follow-up visits up to about three years. Safety and any side effects will be carefully tracked during this time.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating a phase III trial that compares a text-based smoking cessation program to a manual booklet in rural cancer survivors who smoke. The study aims to see if a personalized eight-week gradual reduction schedule combined with supportive text messages can help reduce cigarette use to zero and improve quitting success. The trial also looks at quality of life changes after quitting smoking. Participants are randomly assigned to one of two groups. The first group follows an eight-week scheduled gradual reduction program with text message support for 12 weeks. The second group receives the National Cancer Institute's Clearing the Air booklet to help plan quitting. After completing the interventions, participants are followed up for six months. During the study, participants provide urine samples and complete questionnaires on quality of life at the start, 30 days, and six months after the quit date. Researchers measure smoking cessation using biochemical validation up to six months post-quit. Quality of life scores are also tracked at these times. The trial includes assessments throughout and monitors participant progress over a total of about six months post-quit date.

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.

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 device's 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 the arteries of their legs caused by peripheral artery disease (PAD). The study seeks to find out if the Thor system is safe and effective for treating these leg artery lesions. Patients experiencing leg pain due to poor blood flow and meeting specific artery blockage criteria may be eligible to participate. All participants will receive treatment using the Thor laser atherectomy system, which involves removing calcified lesions and modifying calcium deposits in their leg arteries. During the procedure, doctors will take x-ray images of the arteries and may also use additional treatments like angioplasty balloons, drug-coated balloons, stents, or clot-collecting filters if necessary. Patients will be monitored until discharge or up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. Each of these visits includes medical history updates, medication reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure measurements, ultrasounds of the treated leg, and assessments of walking difficulty and quality of life. The main outcomes measured include freedom from major adverse events within 30 days, procedural success, and changes in blood flow and walking ability over time. The study will last about 12 months for each participant, with enrollment over approximately 24 months.