St. Charles

Researchers are conducting a multinational, multicenter observational study to understand the real-world use of garadacimab in patients with hereditary angioedema HAE. The study includes patients who are newly starting garadacimab treatment as part of their regular clinical care. The main goal is to evaluate the effectiveness of garadacimab by comparing the rate of HAE attacks before and after treatment over a 24-month period, along with assessing safety and quality of life. Participants will receive garadacimab as prescribed by their doctors in routine practice, without any additional interventions from the study. There is one study group consisting of patients treated with garadacimab. Data collection includes information from patient medical records, electronic diaries, and routine clinical visits. Retrospective and prospective data on HAE attacks, prior treatments, safety, and healthcare resource use will be gathered throughout the study. Each participant will be followed for 48 months from the first garadacimab dose. During this time, researchers will collect data through electronic diaries, medical record reviews, and scheduled clinical assessments. Outcome measures include attack rates, adverse event monitoring, angioedema control, and quality-of-life questionnaires. This long-term follow-up helps capture the real-world experience and safety of garadacimab in routine care.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This trial studies parents or caregivers grieving the traumatic or unexpected death of a child under 25 years old. It compares two approaches to support these bereaved parents after their loss, addressing a gap in medical examiner or coroner ME services who often have limited training in helping grieving families. The goal is to find effective ways to connect parents to grief resources and improve their mental and physical health during this difficult time. Participants are randomly assigned to one of two interventions managed by Missing Pieces, a community-based organization helping families find grief support. The first intervention, CommunityRx-Bereavement CRx-B, offers personalized support with a Grief Navigator who contacts parents by phone or text, provides tailored grief resources, and maintains contact over 12 months. The second intervention, General Bereavement Support Information GBSI, sends parents general grief resource links via unidirectional text messages at multiple times after the childs death. Parents complete surveys about 6.5 months after their childs death to evaluate outcomes like their confidence in finding resources and experiences of complicated grief. The study monitors how well these interventions support parents over time, with the trial running from 2024 to early 2028. Participants are involved through referrals from medical examiners or coroners and ongoing communication from Missing Pieces, aiming to improve bereavement care systems.