Hall In Tirol

Researchers are evaluating the efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics SmPC. The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response within 7 days, end of treatment up to 6 months, test of cure, and follow-up up to one year for osteomyelitis. Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.

This research aims to evaluate the effects of Seladelpar on clinical outcomes in adults with Primary Biliary Cholangitis PBC who also have compensated cirrhosis. The study is a Phase 3 randomized, double-blind, placebo-controlled trial focusing on treatment outcomes for this liver condition. It is sponsored by Gilead Sciences and seeks to understand how Seladelpar may impact disease progression and survival in this specific patient group. Participants will be randomly assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg capsules of Seladelpar, while those with CP-B cirrhosis will take 5 mg capsules. The placebo group will take one capsule daily as well. This long-term treatment period allows researchers to compare outcomes between the two groups effectively. During the study, participants will follow a schedule of assessments to monitor their health and response to the study drug. Researchers will measure outcomes such as event-free survival, overall survival, liver transplant-free survival, and time to hospitalization over 36 months. Safety and laboratory parameters will be regularly evaluated to ensure participant well-being throughout the trial.

Researchers are conducting a phase III trial to evaluate the safety and effectiveness of autologous skeletal muscle-derived cells for patients with urge fecal incontinence caused by dysfunction or damage to the external anal sphincter. This study aims to assess clinical outcomes in patients who have not sufficiently improved with conservative treatments. The condition involves uncontrolled leakage due to sphincter weakness or disruption. Participants receive either injections of their own skeletal muscle-derived cells into the external anal sphincter or a placebo solution. The study is randomized with two groups one receiving the investigational cell therapy and the other receiving the placebo vehicle. Both treatments are administered under medical supervision, and the study follows participants over a 12-month period to assess changes in incontinence episodes. During the trial, participants will be monitored for safety and efficacy through regular evaluations. The main outcome measured is the change in the frequency of incontinence episodes over 12 months. The study includes thorough assessments such as anal manometry and ultrasound imaging of the anal canal. Participants adherence, symptoms, and safety are carefully tracked through scheduled visits throughout the trial duration.