Joliet

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the use of AlloMend Acellular Dermal Matrix allograft in women who have undergone pre-pectoral breast reconstruction surgery after a single or double mastectomy. This retrospective study aims to describe and assess the effectiveness and safety of AlloMend in this surgical context, focusing on its use in stabilizing breast implants and minimizing implant loss during reconstruction. AlloMend is a sterile, human-derived acellular dermal matrix made from donated full-thickness skin that has been processed to remove cellular layers. It is used alongside breast implants or tissue expanders in either one-stage direct-to-implant or two-stage expander-to-implant breast reconstruction procedures. The allograft supports the implant position and is designed to integrate into the surgical site, promoting blood vessel growth and reducing inflammation or rejection. Participants in this study have completed or will complete follow-up evaluations at 2 weeks, 6 weeks, 3 months, and 6 months after surgery. Researchers collect descriptive data and assess physical function and quality of life up to six months post-operation. The study involves reviewing medical records retrospectively to evaluate outcomes and monitor safety over this period.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

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.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are evaluating the effects of dry static cupping on spasticity and function in the lower limbs during rehabilitation after stroke. The study aims to explore how this ancient therapy, which creates suction on the skin, may help reduce spasticity and improve movement following stroke. While cupping has shown benefits in orthopedic conditions and some stroke rehabilitation studies, this trial focuses specifically on lower extremity spasticity, which has not been well studied before. Participants will be randomly assigned to one of two groups. One group will receive dry static cupping, using a precise pressure pump to apply 300mmHg suction for eight minutes on specific leg muscles, alongside standard physical therapy. The other group will receive placebo cupping with a much lower pressure of 50mmHg plus the same physical therapy. Physical therapy may include balance exercises, therapeutic and neuromuscular exercises, manual therapy, and gait training tailored to each patients needs. During the study, participants will be assessed at enrollment and then monthly for three months. Researchers will measure spasticity using the Modified Ashworth Scale and evaluate walking ability, balance, and mobility through tests like the Six-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale. These assessments will help determine any changes in muscle stiffness and function over the treatment period. The trial will monitor safety and treatment responses to better understand cuppings role in stroke rehabilitation.

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.