Birmingham

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 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 prospective, multi-center, non-randomized study focuses on patients who have already received the IC-8 Apthera IOL and now require NdYAG laser capsulotomy for PCO. The study aims to verify post-market safety following training in a standardized laser treatment technique. Participants previously implanted with the IC-8 Apthera IOL and experiencing PCO will be treated with NdYAG laser capsulotomy using a sponsor-recommended method. There is one study group, and subjects will be followed for 24 months after their IC-8 Apthera IOL implantation. The study includes about six visits over this two-year period to monitor safety and treatment outcomes. During the study, participants will undergo assessments of laser treatment outcomes, any complications, and IOL-related evaluations. Researchers will track additional laser treatments, secondary surgical interventions, ocular and serious adverse events, and subjective visual disturbances using specific questionnaires. The study lasts for two years post-implantation, with regular visits to ensure thorough monitoring of participant eye health and treatment effects.

This research aims to evaluate the safety and effectiveness of the smaller incision, new generation implantable miniature telescope SING-IMT in patients aged 65 and older who have moderate to severe central vision loss caused by late-stage age-related macular degeneration AMD. The study focuses on individuals with vision impairment due to geographic atrophy or disciform scars affecting the central retina, conditions related to advanced AMD. Participants who qualify will undergo implantation of the SING-IMT device during routine cataract surgery. The device consists of two micro lenses within a glass tube mounted on a flexible silicone carrier and is inserted through an approximately 6.5 mm incision using a proprietary delivery system. After implantation, patients will attend five follow-up visits over about 12 months and may receive up to 12 rehabilitation or training sessions with a low vision specialist to help adapt to the device. Throughout the study, participants will have their best-corrected distance and near visual acuity checked, including tests with and without refraction and with an external telescope simulator to assess potential benefit. Researchers will monitor safety and effectiveness outcomes approximately 12 months post-surgery, including measurements of visual acuity, anterior chamber depth, device positioning, adverse events, and posterior capsule opacification. The total study involvement lasts about one year following surgery, with ongoing assessments and rehabilitation support.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.