Hoffman Estates

Researchers are evaluating patients with advanced or metastatic non-small cell lung cancer (NSCLC) to create control arms using current and future treatment information. This prospective study aims to generate precise external controls for patients receiving therapies recommended by the National Comprehensive Cancer Network (NCCN). The focus is on patients treated in second or third line with NCCN-approved systemic therapies. Participants must have pathologically confirmed NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status greater than 1, indicating they are fit for further systemic therapy. Eligible patients are those starting or within 14 days of starting second line therapy according to NCCN guidelines. The study monitors patients over time to assess treatment responses and outcomes. During the study, researchers assess the objective response rate (ORR) by patient cohort from September 2025 to April 2029. Participants are followed closely with imaging and clinical evaluations to ensure compliance with study protocols. Safety and life expectancy of more than three months are considered to support ongoing participation and data collection.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

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 studying the safety and performance of Motiva Implants®, silicone gel-filled breast implants used for breast augmentation and revision procedures. This prospective, non-randomized, multicenter study collects data before surgery, during the operation, and annually for up to 10 years. The study also compares the incidence of connective tissue disease signs and symptoms in participants with Motiva implants to a control group undergoing other aesthetic surgeries. Participants receive either Motiva Implants® during breast augmentation or revision surgeries or undergo other aesthetic procedures like liposuction, rhinoplasty, or face-lifts in the control group. The study includes monitoring of implant performance and safety, with some participants possibly undergoing CT, ultrasound, or MRI evaluations if recommended. Participants agree to return explanted devices to the sponsor, and they must follow all study requirements throughout the study period. During the 10 years of follow-up, participants have yearly assessments to gather operative and postoperative data. Researchers evaluate safety and effectiveness, tracking any signs of connective tissue diseases and other outcomes related to the implants or aesthetic procedures. The study monitors participant health and implant status through imaging and clinical evaluations to provide long-term safety information.

Migraine is a common neurological disorder causing moderate to severe headaches, often with nausea, vomiting, and sensitivity to light and sound. It is especially disabling in children and adolescents. This trial evaluates the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Participants aged 6 to 11 years in a pharmacokinetic (PK) cohort will receive one of two doses of ubrogepant to determine the best dose for the main study. In the main study, children and adolescents will be randomized to receive either a low or high dose of ubrogepant or a placebo, with a one in three chance of receiving placebo. The study treatment is given as oral tablets during qualifying migraine attacks, with an option for a second dose or rescue medication at least 2 hours after the initial dose if the headache remains moderate or severe. Approximately 1059 participants will be enrolled across about 120 sites in the United States. Participants will attend regular hospital or clinic visits throughout the study, which lasts up to 6 months. Researchers will monitor the effects of the treatment through medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome is the percentage of participants aged 6 to 17 years who experience freedom from pain 2 hours after the initial dose. The study includes safety monitoring and evaluates tolerability and pharmacokinetics of ubrogepant in this age group.