Hakodate

Researchers are comparing the length of time participants survive without signs of cancer returning after treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). This Phase 3 study focuses on patients who have received Bacillus Calmette-Guérin (BCG) treatment and have specific FGFR mutations or fusions. The study aims to evaluate and compare disease-free survival between those treated with TAR-210 and those receiving intravesical chemotherapy chosen by the investigator. Participants will receive either TAR-210, a drug administered directly into the bladder, or one of two chemotherapy drugs, Mitomycin C or Gemcitabine, also given intravesically. All visible tumors must be fully removed before randomization. The study includes patients who are either unresponsive to BCG, experienced with BCG, or intolerant to BCG treatment. Participants must not be eligible for or must refuse radical cystectomy surgery. During the study, participants will be monitored for disease-free survival for up to five years. Researchers will perform assessments including urine testing, tumor tissue analysis, and biopsies as needed to confirm eligibility and monitor disease status. Safety, treatment adherence, and patient health status will be regularly evaluated to ensure ongoing suitability for the study.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating the effectiveness and safety of a Double-effect kissing balloon technique (W-KBT) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) who have left circumflex artery (LCx) ostium stenosis. This is a prospective, observational, multi-center study focusing on patients with stable angina, non-ST-elevation acute coronary syndrome, or unstable angina who are undergoing percutaneous coronary intervention (PCI). Patients who meet selection criteria will be enrolled and treated under usual care. The PCI procedure involves W-KBT following crossover stenting for the left main trunk to left anterior descending artery direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) as the optimal treatment. Operators will obtain consent before performing PCI and will register cases continuously to assess the technique's efficacy and safety. Participants will undergo PCI with W-KBT, and data will be collected during the procedure to measure procedure success rates. Researchers will monitor major adverse cardiovascular events (MACE) within 12 months after PCI. The study will gather real-world data from multiple centers to evaluate the outcomes and safety of this treatment approach over time.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.