Syosset

This research aims to evaluate the safety and effectiveness of the FloStent, a medical device used for treating men experiencing symptoms of Benign Prostatic Hyperplasia BPH. The study compares the FloStent implant procedure to a sham procedure without deploying the device. It involves men aged 45 and older with symptomatic BPH to better understand how this device may impact urinary symptoms. Participants will undergo a flexible cystoscopy procedure. Those randomized to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant deployment, serving as a sham treatment. The study is randomized, double-blind, and includes parallel groups to compare outcomes over time. Throughout the study, participants will be assessed on changes in their International Prostate Symptom Score IPSS over 12 months. Researchers will monitor symptom improvements at 3, 6, and 12 months to evaluate response rates. Participants will complete study visits and follow the protocol to help researchers gather data on the devices safety and impact on urinary symptoms.

This research evaluates the PureWick Urine Collection System as a non-invasive way to manage nocturia in women aged 50 and older. Nocturia, which involves waking at night to urinate, is common in older adults and increases the risk of falls and fractures. The study aims to assess whether using PureWick can reduce nighttime bathroom trips and improve sleep quality and overall life quality. Participants use the PureWick System, which includes an external catheter, tubing, and a collection canister. The device allows urine collection while remaining in bed, potentially lowering fall risk. The study is a single-group pilot conducted at one center, with follow-up lasting up to 3 months to observe urinary and sleep outcomes, as well as any related adverse events. During the study, participants are monitored for changes in the number of nocturia episodes, sleep quality via questionnaires, and other health factors such as urinary tract infections and skin condition. Data is collected at the start and after 3 months of device use. Researchers will measure how many patients achieve a 50% or greater reduction in nighttime urination, along with quality-of-life improvements and safety outcomes.

Researchers are evaluating the effects of Tradipitant on treating nausea and vomiting caused by GLP-1 receptor agonist use in adults who are overweight or have class I or II obesity. This phase 3, randomized, placebo-controlled study includes healthy volunteers without serious medical issues or diabetes. The goal is to better understand how Tradipitant impacts these symptoms compared to a placebo. Participants will be randomly assigned to receive either Tradipitant or a placebo, both given as oral capsules twice daily for about two weeks. The study has two treatment arms one receiving Tradipitant and the other receiving a placebo. The study uses quadruple masking to ensure unbiased results. During the study, participants will record nausea and vomiting symptoms daily in a symptom diary. Researchers will measure the proportion of participants experiencing vomiting episodes and assess nausea severity over one week. The study will monitor safety and side effects throughout, with the total participation duration around two weeks of treatment.

Researchers are conducting a non-interventional, observational study to collect real-world data on the use of an autologous hair follicle derived secretome topical cosmetic product as an adjunct following various medical aesthetic procedures. The study focuses on adults aged 18 to 60 undergoing these procedures and aims to better understand post-procedural symptoms and recovery. Participants plan to use the Acorn Autologous Hair Follicle Secretome cosmetic product after medical aesthetic treatments such as laser resurfacing, microneedling, and other related procedures. The study includes individuals with different Fitzpatrick skin types and those receiving hair procedures with stable hair loss medication use. Some specific hair and scalp treatments are closed to enrollment. During the study, participants will be observed for post-procedure symptoms and will complete downtime questionnaires for 1 to 7 days following their procedures. Researchers will gather data on recovery and any side effects experienced. The study is open-label, multi-site, and will follow participants over time to monitor outcomes related to the product use and aesthetic treatments.

Researchers are evaluating the effects of two types of amnion graftsa tri-layer and a single-layer membrane wrapon hard-to-heal diabetic foot ulcers DFUs and venous leg ulcers VLUs. This multicenter hybrid platform trial compares these interventions to a matched retrospective control group receiving standard care. The study aims to gather real-world evidence to better understand how these treatments perform in everyday clinical settings across a diverse patient population. Participants are randomly assigned to receive either the BioLab Membrane Wrap Lite, a single-layer human amnion graft, or the BioLab Tri-Membrane Wrap, a triple-layer graft containing amnion and chorion layers. Both grafts are used alongside standard care, which includes debridement, moisture balance maintenance, bacterial reduction, offloading, and compression. The control group consists of matched patients from a large wound registry receiving standard care alone. During the study, participants will be monitored for wound healing progress, with the primary outcome being wound closure at 12 weeks. Secondary outcomes include wound area reduction at 4, 8, and 12 weeks. The study involves regular visits to assess wound size and healing status. This research helps evaluate the potential benefits of adding amnion grafts to standard wound care over a 12-week period.

Researchers are observing the long-term outcomes of people with Stage 2 Type 1 Diabetes T1D who have received teplizumab treatment. The study aims to understand how teplizumab may delay the progression to Stage 3 T1D and assess its impact on quality of life, including emotional and social aspects. This observational study collects data from patients treated as part of routine care across multiple sites. Participants will be followed for up to 10 years after starting teplizumab treatment. The study does not provide the treatment but monitors patients who have received at least one infusion in real-world settings. Data collected includes clinical outcomes, patient-reported quality of life measures, and adverse events over time. Throughout the study, researchers will track the time from treatment start to the onset of Stage 3 T1D as the primary outcome. Secondary outcomes include treatment completion rates, adverse events, glycemic control measures like HbA1c and glucose monitoring, use of insulin and other therapies, and mental health assessments. Hospitalizations and emergency visits related to T1D complications will also be recorded. Participants may be involved in regular assessments and questionnaires for up to 10 years.

This research aims to compare the safety and effectiveness of two minimally invasive treatments for relieving lower urinary tract symptoms caused by benign prostatic hyperplasia BPH in men aged 50 and older. The study evaluates the temporary iTind device against the permanent UroLift system to determine which approach better manages symptoms related to an enlarged prostate. The iTind device is a self-expanding implant placed temporarily for 5 to 7 days to reshape the prostatic urethra by applying localized pressure. In contrast, the UroLift system involves permanently placed implants that retract the enlarged prostate lobes to widen the urethra. Participants are randomly assigned to receive either the iTind or the UroLift treatment, allowing direct comparison of both devices. Participants will undergo assessments including symptom scoring using the International Prostate Symptom Score IPSS at baseline and multiple follow-up points up to 36 months. Researchers will monitor adverse events, quality of life, and rates of additional interventions. The study will track changes in urinary symptoms and safety outcomes through regular visits over several years, ensuring thorough evaluation of both devices impact.

Researchers are evaluating whether TR987 0.1% gel combined with Standard of Care is more effective than Standard of Care alone for treating Venous Leg Ulcers VLUs. This Phase 3, outpatient, randomized, double-blind study focuses on participants with non-healing VLUs to assess the drugs efficacy and safety over 16 weeks. Participants are assigned to one of two groups one receiving TR987 0.1% gel plus Standard of Care, and the other receiving Standard of Care alone. The gel is applied topically twice weekly for the first four weeks, then weekly for the remaining 12 weeks. Standard of Care includes wound cleansing, dressings, and compression bandaging throughout the treatment period. During the study, participants will be regularly assessed for ulcer closure, pain levels, and changes in ulcer size at 12 and 16 weeks. The primary measure is the proportion of participants with complete ulcer closure by Week 16. Secondary outcomes include sustained closure at 3 months, pain reduction, and significant ulcer size reduction. Safety and tolerability are also monitored throughout the study period.