Ventura

This research focuses on pediatric participants aged 6 to 17 years with obesity or overweight conditions. Its aim is to establish a framework to evaluate the safety and effectiveness of drug treatments for managing chronic weight issues in this population. The study is part of a Phase 3 Master Protocol that includes multiple interventions and will report results when all intervention-specific arms finish. Participants may receive either Orforglipron, a drug given orally, or a placebo, also taken by mouth. Different intervention-specific arms may begin independently as new treatments become available for testing. The study sets clear entry criteria for newly enrolled participants across these intervention arms. During the study, researchers will monitor participants from baseline up to 72 weeks, focusing on the number of participants allocated to each intervention arm. They will also track safety and treatment effectiveness. Participation involves regular assessments of weight, health status, and any side effects, ensuring a thorough evaluation of the chronic weight management interventions over time.

Researchers are evaluating the long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system in treating people who have symptomatic paroxysmal atrial fibrillation (PAF). This condition involves irregular heart rhythms that start and stop suddenly. The study focuses on how well this treatment manages atrial fibrillation over time using a specialized catheter system. The treatment involves pulsed field ablation using the VARIPULSE catheter combined with the TRUPULSE generator. This device is designed to perform pulmonary vein isolation (PVI) to help control atrial fibrillation symptoms. Participants will undergo this catheter-based procedure as the main intervention during the study. Participants will be monitored closely after the procedure, with researchers tracking early adverse events within 7 days and occurrences of atrial tachyarrhythmia episodes from day 61 up to 1095 days post-procedure. The study includes follow-up testing and assessments to measure safety and effectiveness over an extended period. Participants must comply with all study requirements during this time to help ensure accurate results.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the effects of orforglipron, an oral medication taken once daily, compared to a placebo in adolescents with obesity or those who are overweight with related health issues. This Phase 3 study aims to assess the medicine's safety, how it is processed in the body, and how well it works over a period lasting about 18 months. Participants include adolescents aged 12 to 17 years who have struggled to lose weight despite previous diet and exercise programs. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken by mouth once daily. The study will monitor changes in body mass index (BMI) from the start of the trial to week 72. Those in the study must meet specific criteria related to their BMI percentiles and presence of weight-related conditions such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, or certain liver diseases. During the study, participants will be regularly evaluated through medical assessments that include measuring BMI and monitoring overall health and safety. Researchers will track how the body responds to orforglipron and observe any side effects. The study's total length of participation is approximately 18 months, allowing close follow-up to understand long-term effects and treatment outcomes.

Researchers are evaluating the Indigo173 Aspiration System for its safety and performance in patients with lower extremity acute limb ischemia (LE ALI). This condition involves a sudden blockage in the arteries of the lower limbs, and the study aims to collect clinical evidence to support the use of this mechanical device in treating it. Participants will undergo treatment with the Indigo173 Aspiration System, which uses computer-assisted vacuum thrombectomy (CAVT) aspiration tubing to remove clots from the affected arteries. The study includes patients with acute occlusions in the lower limb arteries, specifically from the common iliac artery or below, with symptoms lasting 14 days or less. Patients may be re-enrolled if they develop a new acute occlusion in the opposite limb after 30 days. During the study, researchers will monitor participants closely, focusing on the target limb salvage rate 30 days after the procedure. Participants will provide informed consent, and their health status, including limb condition and response to treatment, will be assessed. Safety and performance data will be collected to understand the device's impact on limb salvage and overall patient outcomes.

Researchers are investigating whether the virus that causes COVID-19, called SARS-CoV-2, is present in the stools of people infected with the virus. This study aims to understand if and when the virus is shed in the stool during and after infection. The research focuses on the relationship between the gut microbiome and COVID-19 infection. The study does not involve any treatment or intervention. Instead, stool samples will be collected from patients who are being treated for COVID-19 both during their treatment and after recovery. These samples will be analyzed to detect the presence of the virus and to study the gut flora. Participants will provide stool samples at specified times during and following treatment. Researchers will analyze these samples through microbiome sequencing to measure the relative abundance of the virus and gut flora. The primary outcome is to correlate the microbiome composition with disease presence over one year. Safety monitoring and follow-up assessments will be conducted to support this observational study.

Researchers are evaluating barzolvolimab in a Phase 3, randomized, double-blind, placebo-controlled study for adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. The study aims to assess the safety and activity of barzolvolimab compared to a placebo in these participants. Participants must have a diagnosis of these conditions for at least 3 months and meet specific diagnostic criteria related to provocation testing and symptom severity. The study includes a screening period of up to 4 weeks, followed by a 24-week treatment period where participants receive either barzolvolimab or placebo by subcutaneous injection. Those on barzolvolimab receive a 450mg dose at the start and then 150mg every 4 weeks. After this, there is a 28-week treatment phase where all participants receive 300mg barzolvolimab every 8 weeks. Finally, a 16-week follow-up period observes all participants without treatment. During the study, participants will complete daily symptom electronic diaries and attend regular study visits. Researchers will monitor safety through blood counts, liver function tests, and provocation testing to measure response. The main outcome measured is the complete response to provocation testing at Week 12 from the first dose. The total study duration includes screening, treatment, and follow-up phases to evaluate long-term safety and effectiveness.

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

Researchers are evaluating a home-monitoring approach for patients with Chronic Obstructive Pulmonary Disease (COPD), focusing on those with moderate to severe, poorly controlled conditions classified as GOLD 2-3, C-D. The study aims to validate the use of patient-facing devices that collect accurate data on medication use and lung function, specifically lung impedance, to detect early signs of acute exacerbations. This pilot study includes 50 COPD patients monitored over six months to explore correlations between airway obstruction, medication quality, symptom data, and exacerbation events. Participants will receive CareCOPD devices designed to monitor airway impedance, medication use, and symptoms from home. These devices provide continuous, objective data to help identify exacerbations earlier than traditional patient-reported assessments like the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) questionnaires. The study seeks to achieve early detection of acute exacerbations by at least one day and maintain false positive rates below 20%. During the six-month monitoring period, participants will regularly use the devices and input symptom information via a smartphone or tablet. Researchers will analyze the collected data to measure the percentage of acute exacerbations detected within this timeframe. Safety and adherence to study procedures will be monitored throughout. The goal is to improve early detection of worsening COPD conditions to better manage patient care.

Researchers are collecting information in a national registry to study patients receiving fecal microbiota transplantation (FMT) or other gut-related microbiota products. The goal is to evaluate the short-term and long-term safety and effectiveness of these treatments. The registry will include up to 4,000 patients from 75 sites across North America and focus on conditions such as Clostridium difficile infection and gut microbiome health. Patients undergoing FMT will be enrolled and information about the procedure, including donor and recipient screening, preparation, and delivery methods, will be recorded. After the treatment, participants will be followed regularly for up to 10 years. Follow-up will include updates from healthcare providers at 1 month, 6 months, 1 year, and 2 years post-FMT, along with annual direct contact with patients to monitor outcomes. During the study, data will be collected on any treatment-related adverse events and disease recurrence over the 10-year period. Participants will be asked to provide information via internet or telephone. This long-term monitoring aims to provide valuable insight into the safety and effectiveness of FMT and related microbiota therapies.