Miamisburg

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, including granulomatosis with polyangiitis or microscopic polyangiitis. This phase 4 randomized, double-blind, placebo-controlled trial focuses on participants newly diagnosed or experiencing a relapse who require induction treatment with cyclophosphamide or rituximab and have specific antibody positivity and disease activity criteria. Participants will receive oral avacopan or placebo alongside standard of care immunosuppressive therapy for induction and maintenance, tailored by the investigator according to guidelines and patient needs. The study monitors treatment effects and safety over an extended period, up to 60 months, assessing adverse events and clinical changes. Throughout the study, participants will undergo regular evaluations including vital signs, blood tests, and urinalysis to detect any significant changes from baseline. The main outcomes measured include the percentage of participants experiencing various types of adverse events, serious adverse events, and events leading to withdrawal or death, all tracked up to 60 months to ensure comprehensive long-term safety data.

Screening and Patient Selection Subjects will be selected from the pool patients of routine care who meet all the inclusion criteria for this study and none of the exclusion criteria, as described in Section 9.3. Candidates will be given a patient information sheet (or Informed Consent) either in clinic or sent via post. Each approached candidate will be logged, assigned a screening number, and evaluated by the site research team. Subjects who sign the Informed Consent for participation and meet the Inclusion and Exclusion criteria will be enrolled and listed with an enrollment number. Recruitment will continue competitively until at least 84 subjects have evaluable data for evaluation of the primary endpoint. Average pain levels will be captured at screening/baseline. Diagnostic Injection A diagnostic injection of the IPS under ultrasound, fluoroscopy or landmark guided in the clinic will be performed administering no more than 2cc of anesthetic. No steroids are allowed for the diagnostic injection. Only those subjects with significant temporary pain relief (\> 75%) compared to the average pain level captured at baseline, and after at least 2 hours of the injection, will be allowed to continue with the study. Trial Implant All subjects will be brought to the procedure room or operating room (OR) for the trial implant procedure under local anesthetic. An introducer will be placed under ultrasound or fluoroscopic guidance at the target nerve and the electrodes percutaneously advanced towards the IPS. After insertion of the receiver and then confirmation of stimulation, the trial stimulator will be secured to the skin. The stimulator tail will be outside the body and attached to the skin. All subjects will undergo an active 7-day provisional test period. Only those subjects reporting \> 50% pain relief at the end of the 7-day provisional test period as compared to the average pain level captured at baseline will be allowed to continue with the study. The trial leads will be removed at the end of 7 days. Permanent Implant All subjects responding to therapy with \> 50% pain relief at 7 days will, at a later date, be brought to the operating room (OR) and given a sedative and local anesthetic for implantation of a permanent electrode. An introducer will be placed under ultrasound or fluoroscopic guidance onto the target nerve and the electrode array advanced towards the nerve. The receiver will be mated with the electrode array, and, after confirmation of stimulation, the permanent stimulator will be tunneled and secured. The device will remain inactive for 10 days to allow for satisfactory healing. If no localized infection or other complication, subjects can be brought back to the office for randomization. Randomization/Blinding Subjects will be randomized to either active sub-threshold (high frequency) stimulation or no stimulation (sham) by Curonix's Clinical Support. All subjects, the investigator and the research team will be blinded to the group assignment for up to 30 days from the moment of randomization. Office Study Visits After randomization follow-up visits will be conducted at 1 week, 1 month, 3 months, and 6 months. Initial and follow-up evaluations will consist of physical exams, pain scale (m-MPS), Knee Injury \& Osteoarthritis Outcome Score Junior (KOOS Jr), range of motion (flexion and extension measured by goniometer, work status and medication intake evaluation. At 1-month post-randomization, all subjects will be unblinded. Active devices can be adjusted for optimal pain relief. Sham devices will be reprogrammed to receive active treatment. Available stimulation programs include tonic (on table testing), 500 Hz, 1000 Hz 1499 Hz frequency stimulation, all of which may be utilized on the same subject. Remote Study Visits Follow up phone calls at 12 months, 18 months, and 24 months post-implantation will be performed to confirm durability of pain relief with the m-MPS and the global perceived effects scale (GPES). Any adverse events will be assessed and captured as part of the study.

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 effectiveness and visual symptoms of the MiSight 1 Day contact lens in children aged 8 to 12 years with myopia. The study aims to confirm the lens's ability to slow the progression of myopia in clinical practice in the US and assess how stable the reduction in myopia remains after one year without treatment. This is a multicenter, randomized, double-masked clinical trial lasting four years, divided into two parts. In Part 1, participants are randomly assigned to wear either MiSight 1 Day lenses or Proclear 1 Day lenses for three years to compare their effects on myopia progression. In Part 2, all participants wear Proclear 1 Day lenses for one additional year to study the stability of the myopia control after stopping the MiSight lenses. Both participants and investigators remain masked to the treatment assignments from Part 1. Participants will attend scheduled visits for eye examinations including measurements of spherical equivalent refractive error and axial length. Researchers will monitor visual acuity, eye health, and myopia progression over the four-year period. The main outcomes measured are the changes in refractive error and axial length after three years and the rate of change during the one-year post-treatment period. Participants are expected to wear the lenses about 10 hours daily, six days per week, and maintain follow-up visits throughout the study.

Researchers are evaluating a stepped care approach called STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) to reduce suicide risk among youth aged 12 to 17 years who receive pediatric primary care. Suicide is a leading cause of death in this age group, and many at-risk youth are not identified or treated. This five-year study tests the effectiveness of STARRS-PC compared to usual care (treatment as usual, TAU) across 14 pediatric primary care clinics. The study also examines factors affecting the implementation and sustainability of this suicide prevention approach using the Practical, Robust Implementation, and Sustainability Model (PRISM).