Higashiosaka

Researchers are evaluating the effectiveness and safety of a combination of follitropin alfa and lutropin alfa in Japanese women with luteinizing hormone LH and follicle stimulating hormone FSH deficiency who are undergoing assisted reproductive technology ART. This Phase 3 study focuses on women who have had at most one previous ART stimulation without pregnancy and aims to compare this combination product with human menopausal gonadotropin hMG. Participants will receive either a fixed combination of recombinant follitropin alfa and lutropin alfa in a 21 ratio or hMG during ovarian stimulation. The follitropin alfalutropin alfa combination is administered subcutaneously once daily starting with 150 IU of follitropin alfa and 75 IU of lutropin alfa for up to 18 days. Additional medications such as cetrorelix acetate, corio gonadotropin alfa, and progesterone gel are used during ovarian stimulation, final follicular maturation, and luteal phase support. During the study, participants will be monitored through vaginal ultrasound scans, semen analysis, and cytologic tests. Researchers will measure the total number of oocytes retrieved, hormone levels, number of follicles, fertilization rates, blastocyst freezing, and pregnancy outcomes. Safety will be assessed by tracking adverse events, ovarian hyperstimulation syndrome occurrences, laboratory changes, and local reactions over approximately 5.5 months for nonpregnant participants and up to 13 months for those with confirmed pregnancy.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating the effectiveness and safety of a new investigational device compared to the standard autologous iliac bone graft ICBG for patients needing bone fusion through spinal fixation at two levels in the lower spine L2-S1. This study focuses on individuals with disc degeneration or spinal deformity requiring intervertebral support and spine stabilization. It is a prospective, multi-center, open-label, randomized clinical trial aiming to assess treatment outcomes in this patient group. Participants will be randomly assigned to receive either the investigational device MDT-0123, which includes a spine cage and a kit, or the standard treatment using the MDT-0123 spine cage combined with ICBG. The goal is to compare these two approaches for lumbar vertebral fusion over a treatment period. The study is conducted before the market release of the device and follows a parallel group design. During the trial, participants will undergo assessments over 12 months to measure success and safety, including changes in disc height, general health condition, disability index, and pain levels in the lower back and legs. Researchers will also track the time required for bone fusion. Participants will have regular follow-ups to monitor outcomes and safety. The total study period extends up to 12 months after the procedure, with detailed evaluations to understand the effectiveness of the treatments.