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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 safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the safety and effectiveness of the AlphaReturn Blood Management System used together with the AlphaVac Multipurpose Mechanical Aspiration MMA System for treating acute pulmonary embolism. This prospective, multicenter, single-arm study focuses on patients with acute intermediate-risk pulmonary embolism confirmed by computed tomography angiography CTA and specific clinical signs. The study aims to assess device-related adverse events and the technical success of the procedure. Participants will undergo mechanical thrombectomy using the AlphaVac MMA System. After the procedure, the aspirated blood will be filtered through the AlphaReturn Blood Management System and reinfused back into the patient. This investigational device study involves a single treatment group using these combined systems to manage blood during the intervention. During the study, participants will be closely monitored for device-related adverse events up to 30 days after the procedure. Additional assessments include tracking major adverse events, complications, symptomatic pulmonary embolism recurrence, reduction in right ventricle to left ventricle RVLV ratio, use of thrombolytics, and length of stay in intensive care and hospital. Safety and effectiveness outcomes will be collected throughout the follow-up period to evaluate the procedures impact and participant health.

Researchers are evaluating the safety and effectiveness of the Edwards SAPIEN X4 and X4S Transcatheter Heart Valves THV in people with symptomatic, severe, calcific aortic stenosis. This is a prospective, single group, multicenter study that also includes a separate registry for participants with bicuspid aortic valve morphology. Participants will undergo transcatheter aortic valve replacement TAVR using the SAPIEN X4 or X4S valves. Those with bicuspid aortic valves will be enrolled in a distinct registry but will also undergo TAVR. The study focuses on implantation of these balloon-expandable heart valves as the main intervention. During the study, participants will be monitored for safety and outcomes like death and stroke over one year. Researchers will assess heart function through the Kansas City Cardiomyopathy Questionnaire and check for complications such as paravalvular leak and the need for a permanent pacemaker within 30 days. The total participation time includes follow-up assessments up to one year after valve implantation.

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating the effectiveness of intravenous clevidipine compared to other intravenous antihypertensive treatments in patients with acute intracerebral hemorrhage ICH who also have high blood pressure. The study focuses on how quickly and effectively these treatments help patients reach a stable systolic blood pressure SBP target within 60 minutes of enrollment. This research aims to improve blood pressure management strategies in stroke patients experiencing ICH, sponsored by the Zeenat Qureshi Stroke Institute. Participants receive either clevidipine injection or an alternate intravenous antihypertensive regimen, typically nicardipine at hospitals not using clevidipine. Clevidipine is started at 1-2 mghour and adjusted every few minutes, with doses generally ranging from 4-6 mghour and not exceeding recommended limits to avoid lipid load issues. The alternate treatment follows institutional standards, starting at 5 mghour and titrating to effect. Treatments are initiated within 12 hours of symptom onset. During the study, participants undergo blood pressure monitoring every 15 minutes to assess the primary outcome of reaching and maintaining the target SBP. The study includes follow-up visits at 90 and 180 days after enrollment to collect additional data. Patients neurological status, stroke severity, and brain imaging are considered for eligibility and monitoring. The total duration of participation extends through these follow-up periods to evaluate longer-term outcomes.

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.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.