Owosso

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are evaluating the effectiveness of satralizumab compared to a placebo in treating Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This Phase III study focuses on the time from randomization to the first confirmed MOGAD relapse during the double-blind treatment period. Participants who experience a relapse or complete the double-blind phase may continue into an open-label extension period, with additional adolescents possibly joining the extension after the primary clinical cutoff. The study involves administering satralizumab or placebo by subcutaneous injection in the abdominal or femoral area during site visits after completing other study procedures. Treatment is given as either monotherapy or alongside baseline therapy. Participants remain in the double-blind phase until relapse or study completion, after which they may enter the open-label extension to continue receiving satralizumab. During the study, participants undergo regular assessments to monitor for relapses, including evaluations by an adjudication committee. Researchers measure the time to first MOGAD relapse while also monitoring safety, pharmacokinetics, and pharmacodynamics. The study includes ongoing follow-up and safety monitoring for up to approximately 44 months from randomization, ensuring comprehensive evaluation of the treatment's impact.

Researchers are evaluating how well proton beam radiation therapy compares with intensity modulated photon radiotherapy in treating patients with stage I to IVA esophageal cancer. This phase III trial aims to determine if proton beam therapy can improve overall survival and reduce serious heart and lung side effects compared to photon therapy. The study also looks at symptom impact, quality of life, treatment costs, response rates, and hospitalization length between the two treatments. Participants are randomly assigned to receive either proton beam therapy or intensity modulated photon therapy, both given in 28 sessions over 5.5 weeks alongside chemotherapy. Chemotherapy options include carboplatin/paclitaxel, FOLFOX/CAPOX, or docetaxel/fluorouracil regimens, selected by the patient and physician. After completing chemoradiation, patients may have surgery to remove the tumor if it is safe and feasible. During the study, blood samples and imaging scans such as PET/CT or CT are collected to monitor progress. Patients are followed every 3 to 6 months for three years and then yearly to track survival, side effects, and disease status. Researchers also assess patient-reported symptoms and quality of life. The main outcomes measured are overall survival and the occurrence of serious heart and lung side effects related to treatment over up to eight years. Additional assessments include immune cell levels, disease recurrence, and treatment toxicity.

Researchers are evaluating the efficacy, safety, and tolerability of remibrutinib in people living with relapsing multiple sclerosis (RMS). This Phase 3b study compares remibrutinib after switching from ocrelizumab to continuous ocrelizumab treatment. It aims to provide important data on how well remibrutinib works and how safe and tolerable it is for patients with RMS. Participants are randomly assigned to receive either remibrutinib tablets taken daily or ongoing ocrelizumab infusions or injections at standard doses (600mg infusion or 920mg injection). The study includes an initial Core Part lasting up to 24 months, followed by an Extension Part lasting up to 24 months where eligible participants continue open-label treatment with remibrutinib. The study is conducted at multiple centers, including locations in the USA and worldwide. During the study, participants will be monitored regularly with assessments that include brain MRI scans to measure the annualized rate of new or enlarging T2 lesions. Researchers will also evaluate safety and tolerability throughout both study parts. Those completing the Core Part may join the Extension Part to continue receiving remibrutinib for long-term observation. The total study duration for participants can be up to 48 months.

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.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.

Researchers are evaluating whether adding the drug apalutamide to the usual hormone therapy and radiation therapy after surgery improves outcomes in men with lymph node positive prostate cancer. This phase III trial focuses on patients who have had radical prostatectomy and have detectable prostate-specific antigen (PSA) indicating possible cancer recurrence. The study aims to compare metastasis-free survival between standard treatment and treatment that includes apalutamide, as well as assessing quality of life, overall survival, and treatment-related side effects. Participants are randomly assigned to one of two groups. The first group receives standard hormone therapy for 24 months along with pelvis and prostate bed radiation therapy administered 5 days a week for 5 to 8 weeks. The second group receives the same hormone and radiation therapy plus apalutamide taken orally once daily in 90-day cycles for up to eight cycles. Imaging tests like CT, MRI, bone scans, and PET scans may be done as needed. Blood samples are also collected during the study to support additional research. Throughout the study, participants undergo regular health assessments including questionnaires on quality of life and pain, as well as monitoring for any side effects. After treatment, follow-up visits occur every 6 months for 3 years and then annually to track disease progression and overall health. The primary outcome measured is the length of time participants remain free from metastatic disease or death, assessed for up to 7.5 years.

Researchers are evaluating a virtual reality (VR) platform designed to support dementia caregivers who provide in-home care. The VR-CARES project aims to reduce work-related stress and social isolation by creating a virtual community where caregivers can connect, share experiences, access support, and build resilience. This user-informed study involves caregivers employed by Right at Home caring for clients with mild cognitive impairment or dementia. Participants will first be trained to use the Rendever social engagement VR platform, which they will use independently and with clients for about 4 to 8 weeks. After this period, they will receive an update with the VR-CARES platform, developed with caregiver input to provide additional features for caregiver-specific social support. Caregivers will then use this enhanced VR community platform for 8 weeks, joining virtual activities, support groups, and training sessions focused on self-care and dementia care. During the study, caregivers complete surveys at baseline, midpoint (8 weeks), and study end (16 weeks) to assess usability, job satisfaction, and empowerment. Researchers will conduct focus groups and interviews before and after platform use to gather feedback. The study monitors social connection, health, job satisfaction, and VR platform usability, with ongoing support and training provided remotely throughout the 16-week participation period.