Birmingham

Researchers are conducting a non-interventional, open-label, observational study across multiple sites to collect real-world data on the use of an autologous hair follicle derived secretome topical cosmetic product. This product is studied as an addition to various medical aesthetic procedures, focusing on its application for conditions such as post-procedural erythema. The study includes adults aged 18 to 60 of any skin type who are planning to undergo these aesthetic treatments. Participants will use the Acorn Autologous Hair Follicle Secretome cosmetic product following their medical aesthetic procedures. The procedures involved include laser resurfacing of the face (ablative or non-ablative), Tixel treatment of the face, and treatments for acne and surgery scars combined with ablative or non-ablative laser or microneedling. Some hair-related treatments and procedures are closed to enrollment. The study observes real-world usage without intervening in treatment decisions. During the study, participants will be monitored for symptoms and downtime related to their procedures over a period of 1 to 7 days. Researchers will collect data on post-procedure symptoms and downtime using questionnaires to understand the product's impact as an adjunct to aesthetic procedures. The study ensures safety by excluding participants with conditions that may interfere with participation and by tracking any relevant health status changes throughout the observation period.

Researchers are evaluating the safety of the IC-8 Apthera intraocular lens (IOL) after treatment for posterior capsular opacification (PCO), a common complication following IC-8 Apthera IOL implantation. This post-approval study is prospective, multi-center, and non-randomized, focusing on subjects who have previously received the IC-8 Apthera IOL and later developed PCO requiring Nd:YAG laser capsulotomy treatment. The study aims to monitor safety outcomes following this laser treatment using a standardized technique after sufficient surgeon training. Participants will receive the Nd:YAG laser capsulotomy treatment to address PCO in the eye with the IC-8 Apthera IOL. The study involves a single group of subjects, all having undergone prior IC-8 Apthera IOL implantation, with the other eye implanted with a monofocal or monofocal toric IOL. The study includes about six visits over a 24-month period following the IC-8 Apthera IOL implantation, during which safety and treatment outcomes will be assessed. During the study, subjects will be monitored for several outcomes including rates of additional Nd:YAG laser treatments, treatment complications, intraocular lens related assessments, secondary surgical interventions, serious adverse events, ocular adverse events, and subjective visual disturbances using specific questionnaires. Safety and effectiveness assessments will be conducted across the 24 months post-implantation, ensuring comprehensive evaluation of the IC-8 Apthera IOL after PCO treatment.

Researchers are evaluating the safety and effectiveness of a new smaller incision implantable miniature telescope (SING-IMT) in patients aged 65 and older with moderate to severe central vision loss due to late-stage age-related macular degeneration (AMD). This study focuses on individuals who have bilateral central scotomas caused by end-stage AMD and aims to improve their visual function through this innovative implant. Participants will undergo outpatient surgery to implant the SING-IMT device during routine cataract surgery. The implant consists of two micro lenses within a flexible silicone carrier designed to be placed inside the eye. After implantation, patients will attend five follow-up visits over approximately 12 months and may participate in up to twelve rehabilitation or training sessions with a low vision specialist to help adjust to and maximize the use of the device. Throughout the study, patients will be assessed for visual acuity with and without the implant, as well as their ability to benefit from the device using an external telescope simulator. Researchers will monitor safety and effectiveness outcomes about 12 months after surgery. Visual training, clinical exams, and imaging will support evaluating the implant's impact, with continuous safety monitoring during the follow-up period.

Researchers are studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.