Provo

Researchers are evaluating the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adults diagnosed with moderate-to-severe Major Depressive Disorder (MDD). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants aged 18 to 74 who have experienced their first major depressive episode before age 50. The study aims to compare azetukalner with placebo in treating MDD over a 6-week period. Participants will receive either azetukalner 20 mg or placebo orally once a day with food, preferably with the evening meal, for 6 weeks. The treatment is administered as a daily oral dose, and participants are randomly assigned to one of the two groups. The study is designed to maintain blinding of treatments to both participants and researchers. During the study, participants' depression symptoms will be assessed using the Hamilton Depression Rating Scale (HAMD-17) to measure changes from baseline to Week 6. Researchers will also monitor safety and tolerability throughout the treatment period. Participants will undergo regular evaluations, and the study includes careful screening to ensure eligibility and monitor any adverse effects during the 6 weeks of treatment.

Researchers are evaluating a clinical decision support (CDS) tool called ePNa, originally designed for emergency departments, to improve pneumonia diagnosis and treatment in urgent care clinics in Utah. This study focuses on adapting ePNa for use in urgent care centers (UCCs), where pneumonia patients are frequently seen, and combining it with Stanford's CheXED artificial intelligence model to enhance chest image analysis. The goal is to implement and test this adapted tool to support clinicians in making accurate and timely pneumonia care decisions, especially as diagnostic and treatment methods evolve during the COVID-19 pandemic. The study involves adapting ePNa to fit the data limitations and workflow of urgent care clinics, incorporating AI-based chest image classification that provides results in less than one second. The adapted tool will be piloted with selected "super user" clinicians and then deployed to one of two randomly chosen UCC clusters, while the other cluster continues usual care. The implementation process will follow the CFIR framework for best practices in integrating new clinical tools, including identifying barriers and facilitators through focus groups, interviews, and workflow observation. Participants include pneumonia patients aged 12 years and older with specific diagnostic codes, and clinicians working in the selected urgent care clinics. The study will collect data on pneumonia diagnosis accuracy, patient transfers to emergency departments, and safety outcomes like unplanned hospital visits and mortality within 30 days. Physician surveys will assess user experience with ePNa. The study is planned to last up to three years, with ongoing monitoring of how ePNa impacts urgent care clinical environments.

Researchers are conducting a multicenter randomized trial to compare two methods of cervical ripening in first-time pregnant women undergoing induction of labor at term (37 weeks or more). The study focuses on women planned for cervical ripening using a Foley catheter, aiming to see if outpatient use of the Foley catheter reduces the rate of Cesarean deliveries and lowers risks to mothers and newborns compared to the usual inpatient methods. Participants will be assigned to either outpatient cervical ripening with a Foley catheter or routine inpatient cervical ripening, which may involve a Foley catheter and/or other methods. This pragmatic trial evaluates the Foley catheter as a device used outside the hospital setting versus the standard care inside the hospital. Throughout the study, investigators will track the incidence of Cesarean deliveries at delivery as the primary outcome. Participants must have reliable transportation and a safe home environment for outpatient care. The study includes monitoring for maternal and neonatal health, with safety assessments during labor induction. The trial enrolls women aged 18 to 60 years, and participation involves following the assigned cervical ripening method until delivery.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are investigating how percussive massage affects muscle, vascular, and mitochondrial health during 10 days of immobilizing one leg. The study aims to see if this massage can reduce the usual loss of muscle size, strength, endurance, blood flow, and mitochondrial function that occurs during limb immobilization. The study will compare participants receiving percussive massage to those who do not, testing the effects on muscle and vascular health using MRI, muscle strength tests, blood flow measurements, and mitochondrial analysis. Participants will first undergo pre-measurements over two days including MRI scans, blood flow and vascular function tests, muscle biopsies, and muscle strength and endurance assessments. They will then have their left leg immobilized with a knee brace and use crutches for 10 days. During this immobilization period, participants in the massage group will receive 30-minute percussive massage sessions twice daily, while the control group will rest without treatment. Blood flow will be monitored regularly during massage sessions. After the 10-day immobilization, participants will return for post-measurements similar to the initial tests. Throughout the study, participants will complete activity and food questionnaires, and researchers will track muscle strength, size, vascular function, and mitochondrial health before and after immobilization. Outcomes include muscle strength, cross-sectional muscle area, and mitochondrial function measurements. Safety and proper use of the knee brace and crutches will be ensured. The total participation involves initial assessments, 10 days of immobilization with or without massage, and a final set of evaluations one day after the last massage session.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are collecting real-world data on children aged 6 months to 17 years who are undergoing ear tube placement (tympanostomy) in a doctor's office using the Tula4 System. This system, which has FDA approval, combines a special anesthetic delivered by iontophoresis to numb the ear drum and a tube delivery device to place the ear tubes. The study focuses on conditions like otitis media with effusion, acute otitis media, and other ear infections. The treatment involves using the Tula Iontophoresis System to deliver TYMBION2 otic anesthetic locally to the ear drum followed by insertion of ear tubes with the Tula Tube Delivery System. Up to 20 centers in the US will participate, enrolling up to 200 patients. The procedure is done in-office and follows standard medical care protocols. Participants will be monitored for outcomes immediately on the day of the procedure and followed for up to six months after their tubes fall out or are removed. Data collection includes treatment success and safety evaluations based on routine care. This registry aims to gather information on both clinical and health economic results of this in-office ear tube placement approach.

Researchers are studying preterm newborns with respiratory distress syndrome (RDS) who are breathing on their own but need non-invasive nasal respiratory support. The study aims to assess the safety and effectiveness of delivering a single dose of Infasurf® surfactant using InfasurfAero™, a new delivery device designed to provide the medicine through a pacifier-like interface without needing a breathing tube or interrupting nasal support. This is a phase 3, double-blind, randomized clinical trial comparing InfasurfAero™ treatment with a sham treatment using respiratory air alone. Participants will be randomly assigned to receive either a single dose of Calfactant surfactant at 6 ml/kg inhaled via the InfasurfAero™ nebulizer or respiratory air alone through the same device. This single-dose intervention is designed to simplify surfactant administration and avoid more invasive procedures. The study is conducted at over 10 sites, with 7 currently recruiting, and focuses on newborns stable on nasal respiratory support. During the study, newborns will be carefully monitored for outcomes such as failure of continuous positive airway pressure (CPAP) treatment or death within the first week of life. Assessments include clinical evaluations of respiratory status and safety monitoring. Parents or legal representatives provide informed consent before participation. The total participation covers the initial treatment and follow-up during the critical first week to evaluate the treatment's impact on breathing support needs and survival.

Researchers are evaluating how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years who have newly diagnosed B acute lymphoblastic leukemia (ALL). This Phase III trial aims to confirm the safety and effectiveness of adding inotuzumab ozogamicin, a monoclonal antibody that targets cancer cells, to a pediatric-inspired chemotherapy regimen called CALGB 10403. The study also explores the impact of this combination on survival, minimal residual disease, genetic factors, treatment side effects, and medication adherence. Participants begin with remission induction therapy that includes oral allopurinol, intravenous and intrathecal chemotherapy drugs such as daunorubicin, vincristine, dexamethasone, pegylated L-asparaginase, and methotrexate, along with bone marrow tests. Those who respond to induction are randomized to one of two groups: one receives standard chemotherapy courses including consolidation, maintenance, and intensification phases, while the other receives inotuzumab ozogamicin infusions in addition to the same chemotherapy regimen. Treatments are given by mouth, intravenous, subcutaneous, or intrathecal routes on specific days over several courses lasting up to three years for maintenance therapy. Throughout the study, participants undergo regular bone marrow biopsies, blood tests, and biomarker analyses to monitor disease status and treatment effects. Researchers assess event-free survival, disease-free survival, overall survival, treatment toxicity, genetic markers, and medication adherence using electronic monitoring. After treatment ends, patients are followed monthly for the first year, then less frequently up to ten years to track long-term outcomes and safety.