Hyattsville

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are collecting real-world data on the safety and performance of AtriCure devices used to treat Inappropriate Sinus Tachycardia (IST) and Postural Tachycardia Syndrome (POTS). This study is a multicenter, observational registry conducted in the US and internationally, including both retrospective and prospective data collection. The goal is to better understand outcomes of using these devices in actual clinical practice. The study involves the use of AtriCure commercially available devices to perform epicardial and endocardial hybrid ablation procedures aimed at treating IST or POTS. These procedures use the AtriCure devices to ablate cardiac tissue and are evaluated within this registry setting. Participants who have undergone or are scheduled to undergo treatment with these devices will be included. Researchers will collect and analyze data on the use of these devices over a 12-month period to assess treatment outcomes. The study focuses on tracking safety and performance information from real-world patient experiences.

Sinus infections, also called acute rhinosinusitis (ARS), affect about 15% of adults each year and often lead to antibiotic prescriptions despite most infections being viral and resolving without antibiotics. This research aims to better understand which patients truly benefit from antibiotics and explore other treatment options to improve outcomes for people with sinus infections. The study focuses on adults aged 18 to 75 who have symptoms consistent with ARS and evaluates different treatment approaches in a large, pragmatic, randomized controlled trial. Participants enter the study through two phases. Phase 1 is a waiting period of up to 9 days during which supportive care is provided, and symptoms are monitored. Those who do not improve by day 9, have had symptoms longer than 9 days at enrollment, or experience worsening after initial improvement move to Phase 2. In Phase 2, lasting 14 days, participants are randomly assigned to one of four groups receiving either oral amoxicillin/clavulanate potassium, placebo, intranasal budesonide nasal spray, or combinations thereof. Treatment involves oral medication twice daily for 7 days or nasal spray once daily. Throughout both phases, participants complete a brief daily diary about their symptoms and have periodic follow-ups. Researchers track symptom improvement from day 1 to day 3 in Phase 2 and monitor changes over time across treatment groups. The study also includes safety monitoring and aims to identify which treatments best help subgroups of patients, with total participation lasting up to approximately 23 days from initial evaluation through treatment and follow-up.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are studying a medical procedure that uses the Bullfrog® Micro-Infusion Device to deliver the anti-inflammatory drug dexamethasone sodium phosphate injection around deep veins after treating deep vein thrombosis (DVT). This study focuses on patients with DVT symptoms lasting up to 14 days before the recanalization procedure. The goal is to find out if reducing local inflammation helps prevent blood vessel re-blockage and improves symptoms for up to 24 months after the initial procedure. Participants will be assigned to receive either perivascular dexamethasone or a saline sham treatment delivered around the affected vein segments. The study involves acute femoropopliteal DVT patients who have undergone successful thrombus removal from the major femoropopliteal veins, possibly extending into the iliac veins. The treatments are given as part of a phase 2 clinical trial evaluating these two approaches. During the study, participants will be monitored for clinically relevant vein openness (primary patency) and prevention of post-thrombotic syndrome (PTS) over 6 months, along with tracking major adverse events within 30 days. Follow-up assessments will include questionnaires and visits over a 24-month period to evaluate symptom improvement and treatment safety.

Researchers are evaluating a medical procedure using a catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate, around deep veins after removing blood clots in patients with iliofemoral deep vein thrombosis (DVT). The study focuses on people who have had DVT symptoms for at least 14 days but no more than 60 days before the clot removal. The goal is to determine if local anti-inflammatory treatment helps prevent the reformation of clots and improves symptoms for up to 24 months after the initial procedure. Participants receive either perivascular dexamethasone or a saline solution delivered around the affected vein segment using the catheter. This is a phase 2 study comparing these two treatments after successful recanalization of the target vein and includes patients who require stenting of the iliofemoral segment. The treatment is given locally at the time of vein recanalization. During the study, participants will be monitored for clot openness (primary patency) at 6 months and for any major adverse events within 30 days. They will undergo follow-up visits, complete questionnaires, and have ongoing evaluations to track symptoms and safety for up to 24 months. The study requires adherence to prescribed anticoagulant and antiplatelet medications as part of post-procedure care.

Researchers are conducting a Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AV-001 Injection in adults hospitalized with pneumonia due to COVID-19 or other respiratory infections. Pneumonia, caused by various microorganisms including viruses and bacteria, can lead to acute respiratory distress syndrome (ARDS), a serious condition with high mortality. The study focuses on patients requiring supplemental oxygen therapy and aims to address lung vascular dysfunction that contributes to ARDS and its complications. Participants will be randomly assigned in a 1:1 ratio to receive either AV-001 Injection or a placebo injection, alongside standard care which may include remdesivir and dexamethasone. AV-001, a synthetic Angiopoietin-1 mimetic, is administered by intravenous bolus injection once daily up to day 28 or until the day before hospital discharge. Four cohorts will receive ascending doses starting at 12.5 mcg/kg/day, increasing through higher doses in cohorts 2 and 3, with the fourth cohort dose determined by safety and efficacy data. A possible fifth cohort may be added to explore intermediate doses or different patient characteristics. Participants will be closely monitored throughout the study and up to 60 days for safety and tolerability of multiple doses. Assessments include clinical evaluations, radiologic imaging, respiratory signs and symptoms, and laboratory tests. The primary outcome is to assess the safety of AV-001 in hospitalized patients with pneumonia. The study will collect data on adverse events and overall patient response, providing important information on the potential role of AV-001 in treating pneumonia-related lung injury.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.