Garfield Heights

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 ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

Researchers are conducting a randomized trial to study the effects of supervised walking, led by specially trained mobility technicians MTs, on hospitalized medical patients aged 65 and older. The study aims to compare health outcomes and costs between patients receiving this assisted ambulation and those receiving usual care. It also seeks to identify which patients benefit most and assess the financial impact of the intervention over the hospital stay and 30 days afterward. Patients enrolled in the trial will be randomly assigned to either receive usual care or to have mobility technicians help them walk up to three times daily, every day including weekends, during their hospital stay for up to 10 days. The MTs will visit patients multiple times a day to encourage and assist with walking based on individual mobility scores and physical therapy recommendations, if available. All participants will wear wrist accelerometers to track their movement throughout their hospital stay. Participants will be closely monitored with various assessments including the Short Physical Performance Battery SPPB to measure mobility at discharge or after 10 days, and additional follow-ups at 30 days post enrollment to assess physical function, frailty, hospital complications, readmissions, and daily living activities. Researchers will also evaluate total costs related to the hospital stay and 30 days afterward. The study lasts up to 30 days per participant with ongoing safety and outcome monitoring.

Researchers are evaluating whether the combined use of the EXOMIND BTL-699-2 and EMSELLA HPM-6000UF devices can improve depressive symptoms and urinary incontinence in women who gave birth to a healthy, single infant between 2 and 60 months before joining the study. The study focuses on women aged 22 to under 60 years. It uses a prospective, multi-center, two-arm, single-blinded design to compare active versus sham treatments. Participants will be randomly assigned in a 31 ratio to receive either active or sham treatments with both devices. The active group will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device to the pelvic floor muscles at intensities up to 100%. The sham group will receive similar treatments at minimal intensities 1%. Treatments are spaced 3 to 7 days apart. Participants will complete a series of questionnaires and scales before treatment, during treatment visits, after the last treatment, and at follow-ups 1 and 3 months after treatment ends. These assessments include depression scales, urinary incontinence questionnaires, sexual function indexes, mental wellbeing scales, and therapy comfort and satisfaction questionnaires. The total expected participation time is about five months, during which researchers will monitor changes in depressive symptoms, urinary incontinence, sexual function, mental wellbeing, therapy comfort, satisfaction, and any treatment-related adverse events.

Researchers are evaluating lumateperone for treating bipolar depression in children and teens aged 10 to 17 years who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the effects of lumateperone compared to placebo in this pediatric population. Participants will be randomly assigned to receive either lumateperone or a matching placebo once daily for 6 weeks. The dosage for lumateperone is 42 mg for patients aged 13 to 17 years and 21 mg for those aged 10 to 12 years. The study includes three phases up to 2 weeks of screening to confirm eligibility, 6 weeks of double-blind treatment, and a 1-week safety follow-up visit after the last dose. During the study, participants will undergo assessments including the Childrens Depression Rating Scale-Revised CDRS-R at week 6 to measure depressive symptoms. Safety will be monitored throughout, with a follow-up visit approximately one week after treatment ends. The total participation duration covers screening, treatment, and safety follow-up, ensuring comprehensive evaluation of both efficacy and safety in this age group.

This research aims to evaluate the safety and tolerability of iloperidone in adolescents diagnosed with schizophrenia or bipolar I disorder. The study focuses on treatment effects over a period of up to 52 weeks and is sponsored by Vanda Pharmaceuticals. It is a phase 4 open-label trial designed to assess how well adolescent patients tolerate iloperidone treatment. Participants will receive iloperidone in oral tablet form, with doses ranging from 8 to 24 mg per day. The treatment period lasts for one year, during which patients are monitored closely. This open-label study means both participants and researchers know the treatment being administered, with no placebo group. Throughout the study, patients will be regularly assessed for treatment-emergent adverse events and other safety measures. Researchers will track any side effects or reactions to iloperidone over the treatment period. Participation involves completing study visits and assessments for up to 52 weeks, ensuring ongoing monitoring of safety and tolerability.

This research aims to evaluate the safety and tolerability of lumateperone in pediatric patients diagnosed with schizophrenia, bipolar disorder, or autism spectrum disorder. It is a global, multicenter, open-label study lasting 26 weeks. The study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. Participants will receive lumateperone capsules or orally disintegrating tablets once daily, with doses ranging from 5 mg to 42 mg, adjusted by age and condition. The study begins with up to a 2-week screening period to confirm eligibility, followed by a 26-week open-label treatment period where all patients receive lumateperone. After the treatment period, there is a 2-week safety follow-up visit to monitor participants after their last dose. During the study, participants will be monitored regularly through clinic visits, where safety and tolerability will be assessed. Researchers will track the incidence of common adverse events throughout the 6-month treatment and follow-up period. Participants must maintain outpatient status during the trial. The total participation duration spans approximately 28 weeks, including screening, treatment, and safety follow-up.

Researchers are evaluating the REGENETEN Bioinductive Implant system in patients with high-grade partial-thickness tears of the rotator cuff. The study compares this implant to the standard surgical technique called Completion and Repair to see which approach allows patients to return to their everyday activities faster. The study focuses on functional recovery at 3 months post-treatment and is designed as a randomized controlled trial. Participants receive either the Isolated Bioinductive Repair using the REGENETEN implant or the standard Completion and Repair surgical procedure. These interventions are compared in a parallel-group design. The main study period includes follow-up assessments up to 24 months after surgery, with evaluations at multiple time points that measure shoulder function, pain, tendon healing via MRI, and patient satisfaction. During the study, participants will undergo regular assessments including clinical scores such as the Western Ontario Rotator Cuff WORC index, Constant-Murley Score, and Subjective Shoulder Value SSV. Imaging with MRI will evaluate tendon repair status at 12 months. Researchers will also monitor pain levels, opioid use, physical therapy utilization, and time to return to work, driving, and sports. The primary outcome is the change in WORC score from baseline to 3 months post-intervention, with additional secondary outcomes tracked over 2 years.