Woburn

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of Phentolamine Ophthalmic Solution in adults who have previously undergone keratorefractive surgery and experience reduced visual acuity in low light conditions. This phase 3 trial compares the effects of Phentolamine Ophthalmic Solution to a placebo to determine if the drug improves night vision. The study focuses on participants who report symptoms like glare, halos, or starbursts that began within two months after their surgery. Participants will be randomly assigned to receive either 0.75% Phentolamine Ophthalmic Solution or a placebo, both administered once daily for two weeks. During this period, participants will visit the clinic weekly for checkups and testing. They will also keep a daily diary to record when they apply the study medication each evening. Throughout the study, participants will undergo vision tests to measure changes in visual acuity under mesopic (low light) conditions. The main outcome is the percentage of participants who gain at least 15 letters (equivalent to 3 lines) improvement in vision at day 15 compared to the start. Researchers will monitor safety and collect data on any side effects. Participation involves regular clinic visits, vision assessments, and adherence tracking over the two-week treatment period.

Researchers are conducting the Shwachman-Diamond Syndrome Global Patient Survey and Collaboration Program (SDS-GPS) to better understand Shwachman-Diamond Syndrome (SDS) and related conditions. This online program invites patients and their families worldwide to share their experiences living with SDS, aiming to improve quality of life and accelerate the development of new treatments and cures. The program was developed with input from patients, families, caregivers, researchers, and clinicians to create a supportive global community focused on advancing research. Participants join the SDS-GPS by creating a free account and answering surveys on topics such as demographics, medical history, treatment, disease progression, care management, and quality of life. The surveys are designed to be simple and convenient, allowing participants to complete them at their own pace without the need for clinic visits. The platform, available in multiple languages, also helps participants keep track of medical appointments, medications, and symptoms, and they can share information with their care team if they choose. Throughout the study, participants or their caregivers provide information on symptoms, quality of life using PROMIS surveys, and disease burden at baseline and every twelve months. Genetics reports can be uploaded when available. The data collected is de-identified and used to better understand the community's unmet needs, guide research priorities, and connect participants to clinical trials and educational resources. The program supports ongoing engagement without requiring in-person visits and protects participant privacy and security.