Celje

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are observing patients who have undergone hip replacement surgery using CoCrMo LOCK bipolar femoral heads to assess the safety and performance of these devices. This study includes individuals with displaced intracapsular hip fractures treated at a single center starting from January 2023, focusing on long-term outcomes such as revision rates and dislocations. Participants receive a bipolar hemiarthroplasty with CoCrMo LOCK femoral heads and are followed over two years. Data collection occurs at six points before surgery, during surgery, at hospital discharge, and at 4, 12, and 24 months after surgery. The study evaluates outcomes including revision rates of the implant, dislocation rates, acetabular erosion, and patient-reported measures like hip function and pain. Throughout the study, patients undergo X-rays and complete questionnaires assessing hip function and pain levels. Walking ability and living situation are also tracked before surgery and at 4 months post-operation. Researchers monitor safety and performance through these repeated assessments, with the primary focus on revision rates 24 months after surgery. The total participation period for each patient is two years.

Researchers are evaluating the real-world effectiveness of a fixed triple inhaled combination therapy called Trimbow 17259 g pMDI in adults with asthma. This study focuses on patients with severe asthma who have been treated for at least three years but still have uncontrolled symptoms despite using other inhaled therapies. The research aims to assess improvements in asthma symptom scores over six months after switching to Trimbow, as well as treatment adherence and lung function. The study is a multicenter, national, prospective, non-interventional design where patients are observed after their doctors independently decide to switch their inhaled therapy to Trimbow 17259 g pMDI. The recommended dose is two inhalations twice daily. Participants will be followed for six months, with assessments at enrollment, one month, and six months. If their asthma treatment changes away from Trimbow during the study, they are excluded. Other asthma medications and reliever inhalers are allowed as usual. Participants will attend three visits during routine clinical care where researchers will collect information on demographics, medical history, asthma control test ACT scores, lung function if available, medication adherence using a questionnaire, and any changes in asthma treatment. The main measure is the change in ACT score over six months. Secondary measures include lung function improvement and adherence to treatment. Safety and treatment changes are monitored throughout the study, which is expected to run from November 2024 to June 2026.

Crohns disease is a chronic condition causing severe inflammation in the digestive tract, mainly affecting the bowels, and leading to symptoms like belly pain, diarrhea, tiredness, and weight loss. This trial is evaluating several targeted therapies for adults with moderate to severe Crohns disease. The study involves around 540 adults and aims to assess how well these treatments work and monitor any side effects over time. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These medicines are given either by injection under the skin or infusion into a vein, depending on the drug. Participants will be randomly assigned to receive one of several treatment combinations or monotherapies, with some continuing risankizumab alone for up to 72 weeks. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and endoscopies to check the effects of treatment. Researchers will also monitor side effects, collect daily diary information, and use questionnaires. Key outcomes include the percentage of participants achieving endoscopic remission by week 12 and tracking adverse events for up to about 96 weeks.