Garfield Heights

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 effects of ALTO-207 on adults with treatment-resistant depression (TRD). This Phase 2 trial compares ALTO-207 against a placebo to measure changes in depressive symptoms in participants who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments. The goal is to understand how well ALTO-207 works in improving depression symptoms in this group. Participants will receive either ALTO-207 twice daily or a matching placebo. This randomized, double-blind, placebo-controlled trial involves treatment over a period of up to 8 weeks, during which symptom changes will be closely monitored. The study focuses on adults aged 18 to 75 who are already on stable doses of one or two oral antidepressants. During the study, participants will be assessed for changes in their depression severity using the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline up to 8 weeks. Researchers will monitor safety and symptom changes throughout the treatment period. Participants’ adherence to the treatment and overall health will also be observed to gather comprehensive data on the study outcomes.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are conducting a large randomized trial to evaluate the impact of supervised ambulation by mobility technicians (MTs) on older medical inpatients aged 65 years and older. The study aims to compare short and intermediate-term outcomes between patients who receive this intervention and those who receive usual care. It also seeks to identify which patients benefit most from assisted ambulation and to assess the overall costs of care including hospitalization and the first 30 days after enrollment. Participants will be randomly assigned to either receive supervised walking assistance from MTs up to three times daily throughout their hospital stay, including weekends, or to receive usual care without this support. MTs will visit patients up to four times daily to encourage and assist with ambulation based on patient ability, guided by a mobility assessment score. The intervention will continue until discharge or for a maximum of 10 days. All participants will wear wrist accelerometers to monitor their movement during hospitalization. Throughout the study, researchers will track physical performance changes using the Short Physical Performance Battery (SPPB) within up to 10 days after admission. They will also evaluate whether patients are able to return home versus needing post-acute care and if mobility improvements last through 30 days post-discharge. Cost analysis will include the expense of MTs, the initial hospital stay, and care during the first month after enrollment. This study involves 3000 patients across five hospitals in two health systems.

This research aims to assess whether combined treatment with two devices, EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF), can improve depressive symptoms and urinary incontinence in women who delivered a healthy, single baby between 2 months and 5 years ago. The study focuses on women aged 22 to under 60 years old. It is a prospective, multi-center, two-arm, single-blinded, interventional study that compares active treatment to sham treatment to answer if these devices benefit postpartum and early post-childbirth women. Participants are randomly assigned to either an active treatment group or a sham group in a 3:1 ratio. Both groups receive six treatments with each device spaced 3 to 7 days apart. The active group receives EXOMIND treatments up to 70% motor threshold intensity over the left dorsolateral prefrontal cortex and EMSELLA treatments up to 100% intensity to the pelvic floor. The sham group receives both devices at very low intensity (1%). During the approximately five-month participation, women complete multiple questionnaires assessing depression, urinary incontinence, sexual function, mental wellbeing, suicide risk, therapy comfort, and satisfaction. Questionnaires are given before treatment, after the last treatment, and at 1-month and 3-month follow-ups. The study also monitors changes in self-reported depression symptoms over 15 months. Participants must comply with study visits and therapy instructions throughout this period.

This research aims to evaluate the safety and tolerability of iloperidone in adolescents aged 12 to 17 years who have been diagnosed with schizophrenia or bipolar I disorder. The study is designed as a Phase 4 open-label trial to observe patients over a 52-week treatment period. It focuses on understanding how well adolescent patients tolerate iloperidone and monitors any treatment-emergent adverse events throughout the study. Participants will receive iloperidone oral tablets with a dosing regimen ranging from 8 to 24 mg per day for up to one year. The study is open-label, meaning both the researchers and participants know the treatment being administered. This setup allows continuous assessment of the medication's safety profile in this age group. During the study, participants and their guardians will provide consent and assent to fully engage in all study procedures. Researchers will monitor safety by tracking any adverse events that arise during treatment. The primary outcome measured is the number of participants experiencing treatment-emergent adverse events within the year-long treatment period. This thorough monitoring ensures close observation of the medication's effects over time.

Researchers are evaluating the functional recovery of patients with high-grade partial thickness rotator cuff tears, specifically those with tears greater than 50% or more than 6mm, using either the REGENETEN14 Bioinductive Implant or the standard surgical repair technique called Completion and Repair. The study aims to determine if the bioinductive implant helps patients return to their normal activities faster compared to the standard repair. This is a prospective, multicenter, randomized controlled trial focusing on safety and efficacy in treating these shoulder injuries. Participants will receive one of two treatments: either Isolated Bioinductive Repair using the REGENETEN14 Bioinductive Implant device or Completion and Repair, which is the standard surgical method. Both treatments are designed to manage the partial thickness tears of the supraspinatus tendon or supraspinatus with infraspinatus. The study monitors patients for at least three months post-intervention to compare recovery outcomes between the two methods. During the study, patients will attend scheduled visits where their recovery and function will be assessed. Researchers will measure changes in the Western Ontario Rotator Cuff (WORC) score from baseline to three months after treatment to evaluate shoulder function improvement. Participants must be able to follow study instructions and complete questionnaires. Safety and efficacy data will be collected throughout the study to understand the benefits and risks of each treatment approach.