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Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

This registry collects real-world safety and performance data on AtriCure devices used to treat Inappropriate Sinus Tachycardia IST and Postural Tachycardia Syndrome POTS. It is both retrospective and prospective, involving multiple centers in the US and internationally. The goal is to understand how these devices are used and their outcomes in typical clinical settings. Participants have undergone or are scheduled to undergo a hybrid epicardial and endocardial ablation procedure using commercially available AtriCure devices. The registry observes these treatments as delivered in routine care without altering clinical decisions. Data collection includes outcomes over a 12-month period following device use for IST or POTS treatment. During participation, researchers collect information on treatment details, safety, and effectiveness from medical records and follow-up visits. The main measurement is device performance and patient outcomes over one year. Participants provide informed consent, and data is gathered both retrospectively and prospectively. The study runs until January 2027, capturing ongoing real-world clinical experiences.

Acute sinus infections, also called acute rhinosinusitis ARS, affect about 15% of adults annually and are a common reason for antibiotic prescriptions despite most cases being caused by viruses. This research aims to understand which patients with ARS truly benefit from antibiotics and other treatments, improving care by identifying subgroups that respond best to specific therapies. The study is a large, pragmatic, randomized controlled trial enrolling adults aged 18 to 75 with symptoms consistent with ARS. Participants enter two phases Phase 1 is a waiting period of up to 9 days with options for supportive care, during which symptom progress is monitored. Those who do not improve or who meet certain criteria move to Phase 2, where they are randomly assigned to one of four groups receiving either amoxicillinclavulanate, placebo antibiotic, amoxicillinclavulanate plus budesonide nasal spray, or placebo antibiotic plus budesonide. Treatments are given over 7 to 14 days, with dosing schedules including oral antibiotics twice daily and budesonide nasal spray once daily. Throughout both phases, participants complete daily diaries and periodic follow-ups to track symptom changes, supportive care use, and side effects. Researchers measure symptom improvement from day 1 to day 3 in Phase 2 as the primary outcome, along with additional assessments of quality of life, work productivity, adherence, and adverse events. The total study period includes up to 9 days of observation and 14 days of randomized treatment with ongoing monitoring to better target effective management for ARS.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

Researchers are evaluating a medical procedure that uses a commercially available catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate injection, locally around deep veins after removing blood clots DVT recanalization. This study focuses on patients who had deep vein thrombosis symptoms for up to 14 days before the initial clot removal. The goal is to determine if reducing local inflammation can help prevent new clots from forming and improve symptoms for up to 24 months after treatment. Participants receive either the anti-inflammatory drug dexamethasone delivered around the target vein segment or a saline solution as a comparison, both using the same device. This is a randomized, quadruple-masked trial where neither the participants, care providers, investigators, nor outcomes assessors know which treatment is given. The study includes treatment of acute femoropopliteal DVT located in major veins of the leg, with successful clot removal prior to treatment. The study treatment is combined with prescribed anticoagulant and antiplatelet medications for up to 12 months post-procedure. During the study, participants will complete questionnaires and attend follow-up visits to monitor their condition and treatment effects. Researchers will assess outcomes including the rate of keeping the vein open primary patency at 6 months, prevention of post-thrombotic syndrome progression at 6 months, and freedom from major adverse events at 30 days. Participants will be followed for up to 24 months to evaluate long-term benefits and safety of the treatment.

Researchers are studying adults hospitalized with presumed pneumonia caused by COVID-19 or other respiratory infections who require supplemental oxygen therapy. This Phase 2a, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, and efficacy of AV-001 Injection, a synthetic Angiopoietin-1 mimetic that targets vascular function to reduce harmful inflammation in the lungs. The study is sponsored by Vasomune Therapeutics, Inc. and includes up to 120 patients across different dose levels. Participants will be randomly assigned to receive either AV-001 Injection or a placebo injection alongside standard care, which may include treatments such as remdesivir or dexamethasone. AV-001 is given as a quick intravenous injection once daily, with doses starting at 12.5 micrograms per kilogram per day and increasing through several cohorts based on safety and efficacy data. The treatment period lasts up to 28 days or until the day before hospital discharge. There is potential for an additional cohort to explore intermediate dosing or effects in different patient groups. During the study, patients will be monitored closely with radiologic imaging and clinical assessments to evaluate lung involvement and response to treatment. Researchers will track safety and tolerability outcomes up to 60 days and measure efficacy outcomes up to 28 days. The study includes detailed observation of respiratory signs, symptoms, and laboratory markers, with ongoing safety reviews by an independent board. Participation duration varies depending on hospitalization and recovery.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.