Melikgazi

Researchers are evaluating the safety and effects of marstacimab, a study medicine, for potential treatment of hemophilia in boys and male children aged 1 to 17 years. The trial focuses on those with severe Hemophilia A or moderately severe to severe Hemophilia B, including participants with or without inhibitors. The study aims to compare participants experiences with marstacimab to their historical bleeding episodes without the medicine. All participants will receive weekly subcutaneous injections of marstacimab. The first dose is administered at the study site by staff, and subsequent doses can be given at home or by study staff during the 12-month treatment period. Enrollment opens sequentially by age groups, starting with adolescents 12-17 years, followed by children 6-11 years, and finally children 1-5 years. The study includes about 1 month of screening, 12 months of treatment, and 1 month of follow-up. Participants will visit the study site at least 10 times during the study, with the option for two visits to occur at home if allowed. They will also receive six phone calls approximately every two months. Researchers will monitor bleeding rates, adverse events, injection site reactions, and immune responses. The overall participation lasts about 14 months, including screening, treatment, and follow-up periods.

This observational study focuses on male patients, generally older adults with benign prostatic hyperplasia, who are undergoing Holmium Laser Enucleation of the Prostate HoLEP surgery. It aims to evaluate how different anesthesia techniques affect the quality of recovery and patient satisfaction. Researchers will compare recovery outcomes for patients receiving general anesthesia, spinal anesthesia, or combined spinal-epidural anesthesia. Patients will undergo HoLEP surgery with one of the three anesthesia methods chosen based on factors like age, other health conditions, surgery duration, and patient preference. Experienced anesthesiologists will apply the anesthesia, and routine monitoring will occur during surgery. After surgery, patients will be observed in the recovery unit before transfer to the ward once stable. The study includes assessments of catheter-related bladder discomfort, postoperative pain, analgesic needs, and satisfaction levels from both patients and surgeons. Participants will complete the Quality of Recovery 40 QoR-40 questionnaire before surgery and within 24 hours afterward. Researchers will also record patient and surgeon satisfaction using a 5-point scale, pain levels, and analgesic use. These data will be analyzed based on the anesthesia method to understand differences in recovery quality. The study will follow patients through their hospital stay with close monitoring of recovery and satisfaction outcomes.

Researchers are studying the use of LSALT peptide to prevent or reduce acute kidney injury AKI in patients undergoing on-pump cardiac surgery. This trial evaluates how often AKI occurs within 7 days after such surgery, using established kidney function criteria. The study is a randomized, double-blind, placebo-controlled Phase 2 trial involving patients at risk of AKI due to their kidney function or other health factors. Participants will be randomly assigned to receive either the LSALT peptide or a placebo. The LSALT peptide is given intravenously at 10 mg over one hour twice daily for five days, starting at least one hour before anesthesia begins. The placebo group receives a matching saline solution on the same schedule. Standard care continues alongside the study treatments, and safety is closely monitored by an independent board. Throughout the study, participants will have daily physical exams, vital sign checks, and urine output monitoring during the treatment period and shortly after. Kidney function tests and biomarker assessments occur at baseline and regularly through 28 days after surgery. Adverse events are recorded daily during treatment and on follow-up days. The study tracks kidney injury severity, need for kidney replacement therapy, mortality, hospital stay length, and other health outcomes to understand the treatments effects.

Researchers are investigating a new drug called ALE.F02 to see if it can help protect and preserve kidney function in people with antineutrophil cytoplasmic antibody ANCA associated vasculitis AAV, an autoimmune disease where the immune system attacks small blood vessels, often affecting the kidneys. The study aims to determine if ALE.F02 is safe, well tolerated, and effective when added to standard therapy for kidney inflammation caused by AAV. Participants will be assigned to one of four groups standard treatment plus ALE.F02 at low, high, or maximum doses, or standard treatment plus placebo infusions. The treatment phase lasts 24 weeks, during which participants receive 13 infusions of ALE.F02 or placebo alongside their usual therapy for AAV-related kidney inflammation. The study includes monitoring of physical health, blood and urine tests, and lung CT scans to assess vasculitis involvement. Throughout the study, participants will undergo physical exams, blood and urine sample collections to monitor kidney function, detect antibodies against the study drug, and measure biomarkers indicating disease activity. Lung scans are performed at the start and at Week 24 if lung involvement is detected. Researchers will evaluate safety and tolerability of ALE.F02 and measure changes in kidney function and protein levels over time. The study may continue up to one year to monitor outcomes and safety.