Joliet

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of the Port Delivery System (PDS) with ranibizumab compared to standard intravitreal ranibizumab injections in adults with diabetic macular edema (DME). This Phase III, multicenter, randomized study aims to compare PDS treatment every 24 weeks with injections every 4 weeks. A substudy will assess the safety of re-implanting the updated PDS and performing refill-exchange procedures in participants previously enrolled in the main study. Participants will receive either the PDS implant pre-filled with ranibizumab or intravitreal ranibizumab injections according to their assigned group. Treatments will be administered on a set schedule specific to each arm. The substudy involves re-implantation of the updated PDS and monitoring post-procedure. The PDS refill exchange is also part of the treatment plan for some participants. Throughout the study, participants will undergo assessments including vision tests using the ETDRS chart to measure changes in best-corrected visual acuity (BCVA). Safety will be monitored by tracking ocular and systemic adverse events, device-related effects, and any serious complications up to 72 weeks after treatment or re-implantation. The study evaluates both short-term and long-term safety and efficacy outcomes over the full duration of participation.

Researchers are evaluating the use of AlloMend4 Acellular Dermal Matrix, a human-derived tissue graft, in women undergoing pre-pectoral breast reconstruction after single or double mastectomy. This retrospective, single-center study aims to describe and assess the safety and effectiveness of AlloMend4 in stabilizing breast implants and minimizing implant loss during reconstruction. The study includes women aged 18 and older who have had this procedure. AlloMend4 is made from donated human full-thickness skin that has been processed to remove certain layers, creating a sterile graft that integrates with the patient's tissue. It is used alongside breast implants or tissue expanders in either one-stage or two-stage reconstruction procedures. The graft is intended to support implant position and reduce complications after mastectomy. Participants will be followed for up to six months after surgery, with clinical evaluations scheduled at 2 weeks, 6 weeks, 3 months, and 6 months post-operation. Researchers will collect descriptive data during this period to monitor the graft's incorporation and overall outcomes. The study focuses on safety and effectiveness measures during the post-operative follow-up visits.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) at 100 mg/mL in people with neovascular age-related macular degeneration (nAMD). This study includes participants who have completed previous Phase II or Phase III studies or reached Week 24 in a related study but were not randomized. The study also explores two sub-studies: one assessing a laser treatment to reduce eye bleeding related to the PDS implant procedure, and another assessing the safety of re-implanting an updated PDS device. Participants receive the PDS implant with ranibizumab according to specific schedules in their study arms. The first sub-study uses transscleral photocoagulation with an Iridex laser system to reduce vitreous hemorrhages after implantation, enrolling about 55 participants. The second sub-study involves up to 100 participants in the United States who undergo re-implantation of the updated device and are followed for up to 72 weeks. Treatments and procedures are carefully monitored throughout. Participants undergo regular visits for up to 240 weeks to monitor for adverse events, including eye-related and systemic effects, severity, duration, and any device-related issues. The sub-studies also track specific complications like vitreous hemorrhages and adverse device effects during postoperative and follow-up periods. Safety assessments include eye exams, imaging, and evaluation of systemic health to ensure ongoing monitoring of participant well-being throughout the study.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

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 whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. 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 after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are studying the effects of dry static cupping on spasticity and lower extremity function in patients undergoing rehabilitation after a stroke. While cupping has been used for various orthopedic conditions and some studies suggest benefits for stroke rehabilitation, there is limited high-quality evidence for its effects on spasticity, especially in the lower limbs. This study aims to explore how dry static cupping might reduce spasticity and improve function in stroke patients with hemiparesis. Participants will receive dry static cupping treatment using a myofascial decompression cup set with a precision pressure pump applied to the affected leg's adductor and hamstring muscles. The treatment involves applying a negative pressure of 300mmHg for eight minutes. A placebo group will receive a similar treatment with lower pressure (50mmHg). All patients will also undergo standard physical therapy focused on balance, therapeutic exercises, neuromuscular coordination, manual therapy, and gait training. Individualized therapy will be tailored by physical therapists based on each patient's condition. Throughout the study, researchers will assess spasticity using the Modified Ashworth Scale at the start and then at 1, 2, and 3 months after treatment begins. Participants will attend rehabilitation sessions at Ascension Rehabilitation of Joliet and will be evaluated for improvements in spasticity and lower limb function. The study includes patients aged 30 to 80 years who have had a stroke within the past 6 months and experience spasticity and hemiparesis. Safety and treatment effects will be monitored throughout the study period.

This research focuses on parents who have lost a child unexpectedly or traumatically, such as through suicide or overdose, and who often face serious mental and physical health challenges along with family disruptions. The trial examines two different ways to support these grieving parents, addressing the gap where medical examiners or coroners (MEs) typically have limited training and no standard guidelines for helping families during this difficult time. The goal is to identify which approach better connects parents to the care and resources they need after their child's death. The study compares two interventions delivered through a community organization called Missing Pieces. One intervention, CommunityRx-Bereavement (CRx-B), involves a Grief Navigator who contacts parents, provides personalized grief and social support resources, and maintains ongoing communication up to 12 months after the child's death. The other, General Bereavement Support Information (GBSI), sends parents text messages with links to general grief resources and information at multiple intervals up to 12 months post-loss. Parents will be asked to complete surveys about their experiences approximately 6.5 months after their child's death. Researchers will measure outcomes like how confident parents feel in finding support resources and levels of complicated grief. The study includes multiple sites and is designed as a randomized controlled trial to evaluate which method more effectively supports bereaved parents over time.