Toyoake

Researchers are evaluating the safety and performance of the AMJ-401 Everolimus Eluting Resorbable Scaffold System for treating patients with ischemic heart disease who have one or two new coronary artery lesions. This clinical investigation focuses on patients undergoing percutaneous coronary intervention (PCI) in separate epicardial coronary vessels. The study aims to gather evidence on this device's use in native coronary artery lesions. Patients will receive the AMJ-401 device during PCI to treat their coronary artery blockages. This device is designed to be a resorbable scaffold that elutes everolimus. The study includes patients who require treatment for one or two de novo lesions in separate vessels. There is no mention of comparator groups or additional interventions. The trial is conducted in Japan and assesses outcomes at 6 months. Participants will be monitored for outcomes including acute strut fracture and strut coverage at 6 months after the procedure. The study involves follow-up evaluations and assessments to measure these outcomes. Participants must consent to the study and meet eligibility criteria before enrollment. The study monitors safety and device performance during and after the intervention.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating the safety of taking combined febuxostat and inosine tablets twice daily for 12 weeks in adults with early-stage Parkinson's disease who are on stable medications. This Phase Ib trial involves 24 participants and aims to gather safety data that could guide future Parkinson's treatments. Participants must meet specific Parkinson's disease diagnostic criteria and have stable symptoms within defined ranges. Participants will be assigned to one of four dosing regimens, taking febuxostat and inosine tablets twice a day, once in the morning and once in the evening, for 12 weeks. They will attend clinic visits at the start and at weeks 4, 8, and 12 to undergo blood tests measuring plasma hypoxanthine levels, clinical exams, and complete questionnaires. During the study, participants will keep a simple diary to record any side effects or changes in daily activities. Throughout the 12-week period, researchers will monitor safety and measure changes in blood hypoxanthine from baseline. Assessments include clinical evaluations and questionnaires to track symptoms and side effects. The study excludes individuals with certain medical conditions, recent medication changes, or inability to take oral drugs as prescribed. Safety and adherence will be carefully observed to understand the treatments' impact in this population.

Researchers are conducting a non-interventional, observational, retrospective study to describe the characteristics, clinical outcomes, and event rates of participants diagnosed with propionic acidemia (PA). This global, multicenter study focuses on gathering medical record data from participants who meet specific inclusion criteria related to PA diagnosis and clinical history. Medical data will be collected through review of records from medical clinics, hospitals, and academic medical centers. The study includes participants with confirmed PA diagnosis based on molecular genetic testing of specific enzyme subunits. Data must support clinical event adjudication and cover participants' history from birth or January 1, 2015, onward. The study records metabolic decompensation events (MDEs) experienced by participants over up to 10 years. Participant involvement consists of medical record abstraction without intervention or direct treatment. Researchers will evaluate the number of MDEs adjudicated by a clinical event committee. Eligibility requires informed consent and sufficient data availability. Participants with certain prior treatments or conditions, such as gene therapy, organ transplantation, or participation in specific clinical trials, will be excluded. The observation period includes retrospective data spanning multiple years to assess long-term clinical events and outcomes.

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.