Loma Linda

Researchers are evaluating the safety and performance of Teleflex's vascular access devices in real-world medical settings through a clinical registry. The study aims to collect high-quality Level 3 or better data on how well these devices work and their clinical benefits when used according to their instructions. The devices include various types such as central venous access devices, midline catheters, peripheral catheters, hemodialysis catheters, and arterial catheters with navigation or tip confirmation features, some with antimicrobial and antithrombogenic properties. Participants will undergo procedures involving the placement of Teleflex vascular access devices to gain access to the bloodstream for treatments such as administering fluids, medications, blood products, or hemodialysis. The registry covers the use of these index devices and their accessories routinely used for placement and maintenance. Data will be collected prospectively to assess device performance and safety. During the study, participants will be monitored for successful use of the catheter devices without removal due to device-related adverse events within 7 days after device removal. Additionally, the accuracy of catheter tip positioning will be verified immediately after device removal. The study collects informed consent and health information, with follow-up assessments focusing on device safety and effectiveness in clinical practice.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

This research involves both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood and immune system. It focuses on using unlicensed cryopreserved cord blood units (CBUs) for transplantation, aiming to study how well these unlicensed CBUs support recovery after transplant. The study also looks at important outcomes such as infection transmission, infusion reactions, survival rates, and graft-versus-host disease. Participants will receive transplants using these unlicensed cord blood units as part of a multicenter access and distribution protocol. The study is conducted at multiple U.S. transplant centers under the care of transplant physicians. The transplantation process involves administering these CBUs to patients with hematologic malignancies and other relevant conditions. Patients will be monitored for neutrophil recovery at 60 and 100 days post-transplant to assess engraftment success. Researchers will also evaluate infection rates, serious infusion reactions, survival one year after transplant, and incidences of acute and chronic graft-versus-host disease. Platelet recovery will be tracked as well. The study involves regular assessments to follow patients’ health and transplant outcomes over time.

This research aims to evaluate the clinical benefit and safety of tabelecleucel for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT) and have failed prior rituximab or rituximab plus chemotherapy treatments. The study focuses on participants with EBV+ PTLD after failure of rituximab alone or with chemotherapy, including subgroups based on chemotherapy eligibility and transplant type. Tabelecleucel, an off-the-shelf allogeneic T-cell immunotherapy, is given intravenously in 5-week cycles, with doses administered on Days 1, 8, and 15, followed by observation through Day 35. Treatment continues until maximal response, unacceptable side effects, new non-protocol therapy starts, or treatment failure. The study includes cohorts for solid organ transplant recipients (with or without chemotherapy) and hematopoietic cell transplant recipients, with up to 2 or 4 different HLA restrictions allowed, respectively. Participants undergo disease assessments including PET-CT or MRI scans to measure response, and safety is monitored throughout treatment. Follow-up lasts up to 5 years for some participants, with more frequent monitoring every 3 months for others, depending on enrollment timing and response. The primary outcome measured is the objective response rate over 2 years in different participant groups receiving commercial or comparable tabelecleucel products.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Diabetic peripheral neuropathy, a common and costly complication of diabetes affecting over half of patients, is the focus of this study. Researchers aim to understand the physiological effects behind two treatments for Type 2 Diabetic Peripheral Neuropathy (T2DPN): Intraneural Facilitation Therapy (INF4 Therapy) and standard physical therapy. The study will evaluate how these approaches impact factors like balance and pain, using non-invasive methods to gather detailed information about the treatments' mechanisms. Participants will be randomly assigned to either the INF4 Therapy group or the standard physical therapy group, with 40 patients divided evenly. The INF4 Therapy involves three specific manual holds designed to improve blood flow through nerves, while the standard physical therapy includes muscle stretching, balance, and strengthening exercises aimed at reducing neuropathy symptoms. Patients will attend 11 sessions over 6 weeks, receiving 60-minute treatment sessions during most visits, with various physiological measurements taken before and after treatments. Throughout the study, participants will undergo multiple assessments including pain scales, neuropathy severity tests, vascular analysis using ultrasound, and Neuropad4 testing. Heart rate variability will be monitored using the Welltory App at several points around treatment sessions. Blood tests to measure inflammation and blood sugar control will be performed at specific visits. Data will be analyzed to compare how each therapy affects heart rate variability and other physiological markers, providing insight into improving treatment methods for T2DPN.

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.