Hurst

Researchers are evaluating the effect of providing access to two types of heated tobacco products HTP on smoking reduction and abstinence among healthy adult smokers aged 21 to 65 years in the United States. This multi-site, open-label study aims to assess how using HTP devices with different flavored stick variants influences smokers ability to stop or reduce combustible cigarette use over a 3-month period. The primary goal is to measure the rate of complete cigarette abstinence in the final seven days of the study. Participants are randomly assigned to one of two study groups one using a one-piece HTP device and the other using a two-piece HTP device. Each device group includes access to four stick variantstwo menthol and two tobacco flavorsunder the brand name virto. The study includes a 90-day actual use period where participants try all four stick variants during a 1-week product trial and then continue use as they choose. The interventions are designed to explore the impact of these devices and flavors on cigarette smoking habits. Throughout the study, participants complete questionnaires via a smartphone app and undergo assessments related to cigarette use and product preferences. Researchers track cigarette reduction, switching to HTP use, time to abstinence, and adverse events over the 3-month period. The primary outcome is self-reported abstinence from combustible cigarettes in the last 7 days of the study. Secondary measures include reduction in cigarette use by at least 50%, complete switching to HTP, and safety monitoring. The total study duration spans up to 3 months with ongoing data collection and follow-up.

Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.

Researchers are evaluating the efficacy of dotinurad compared with allopurinol in lowering serum uric acid sUA levels in adults with tophaceous gout. This Phase 3 trial focuses on adult participants aged 18 to 75 years who have measurable tophi and a diagnosis of gout for at least one year. The study aims to assess how well dotinurad reduces sUA levels at Week 24 compared to allopurinol, an established treatment for this condition. Participants are randomly assigned to one of two treatment groups. One group will stop their current allopurinol and continue with study-supplied allopurinol once daily through Week 76. The other group will discontinue allopurinol and start dotinurad at 1 mg daily for the first 4 weeks, then increase to 2 mg daily for the next 8 weeks, and finally 4 mg daily thereafter until Week 76. Both treatments are given as oral tablets, and participants are closely monitored throughout the study. During the study, participants will undergo various assessments including blood tests to measure serum uric acid levels at multiple time points, evaluation of tophi response, and tracking of gout flare frequency and severity. Safety monitoring will include recording any adverse events and serious side effects up to Week 80. The main outcome measures focus on the percentage of participants achieving target sUA levels at Week 24 and clinical responses in tophi at Week 76, with ongoing evaluations up to Week 80 to assess longer-term effects and safety.

This research aims to evaluate the rate of malposition and related clinical outcomes of the Hydrus Microstent within 24 months after implantation. The study focuses on adults aged 45 and older who have primary open angle glaucoma and an operable cataract. Participants will undergo cataract surgery combined with the placement of a monofocal intraocular lens IOL followed by Hydrus Microstent implantation. Participants will have the Hydrus Microstent implanted immediately after cataract surgery and IOL placement. The cataract surgery uses standard anesthesia and phacoemulsification techniques. After surgery, participants will attend follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 to monitor outcomes. Throughout the study, participants will be evaluated for device positioning and any associated clinical consequences. Researchers will assess the occurrence of device malposition, intraoperative ocular adverse events, and sight-threatening or other postoperative ocular events up to 24 months after surgery. This schedule of visits and evaluations aims to gather comprehensive safety and performance data over a two-year period.