Maribor

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

This trial investigates the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. It compares the effects of empasiprubart and intravenous immunoglobulin IVIg to evaluate which treatment may better reduce symptoms and improve function in people with CIDP. The study is a Phase 3, randomized, double-blind trial designed to assess both efficacy and safety of these treatments over an extended period. Participants are randomly assigned in Part A to receive either empasiprubart with a placebo resembling IVIg or IVIg with a placebo resembling empasiprubart for 24 weeks 6 months. After Part A, all participants enter Part B, where they receive empasiprubart for an additional 96 weeks 24 months. During Part B, those previously receiving empasiprubart continue with it, and those initially on IVIg switch to empasiprubart. Treatments are administered by intravenous infusion using a double-dummy design to maintain blinding. Throughout the study, participants undergo regular assessments of their disability, strength, grip, and quality of life using various scales such as aINCAT, I-RODS, MRC-SS, and others. Safety is monitored by tracking adverse events and antibody formation against empasiprubart. The primary outcome is the reduction of at least one point in the aINCAT score at week 24. Total participation lasts up to 120 weeks, including both treatment periods, with ongoing evaluations to understand the long-term effects of empasiprubart.

Researchers are evaluating BHV-7000 as a treatment for adults with refractory focal onset epilepsy, a form of epilepsy that does not respond to standard anti-seizure medications. The study aims to determine if BHV-7000 can reduce seizure frequency and assess its safety and tolerability. This Phase 23 clinical trial is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 75 years with a diagnosis of focal epilepsy lasting at least one year and resistant to previous treatments. The trial consists of two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000 once daily or a matching placebo. After completing Part A, participants may enter Part B, which involves randomization to either 75 mg of BHV-7000 once daily or placebo. Both parts are blinded, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment periods. Participants will keep accurate seizure diaries throughout the study to track seizure frequency. Researchers will monitor safety by recording adverse events and laboratory abnormalities from Week 8 to Week 20 in both parts. The main outcome measured in Part B is the change in average seizure frequency over 28 days compared to baseline. Secondary outcomes include the percentage of participants with significant seizure reduction and seizure freedom during the study. The total participation duration includes treatment and follow-up assessments over several weeks.

Researchers are evaluating the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients admitted to intensive internal care. With nearly 150,000 people in Slovenia living with diabetes, monitoring blood sugar levels closely is essential to prevent complications. This study involves patients in the intensive care unit who require blood sugar monitoring during their stay. Participants will have two small sensors placed on each upper arm to continuously measure blood sugar levels using the Syai Tag system, though these readings will not be visible to medical staff. At the same time, healthcare professionals will carry out routine blood sugar measurements. The study compares the accuracy of the continuous glucose monitoring system to standard blood sugar tests over the duration of the ICU stay, up to 14 days. During the study, researchers will monitor sensor uptime and compare glucose readings from the Syai Tag system to arterial blood gas measurements. They will also evaluate the impact of noradrenaline on measurement accuracy and the lifespan of the sensors in ICU conditions. The procedure is safe and painless, and patients will continue to receive the usual high-quality care throughout their participation.

Shock is a serious condition that can cause multiple organs to fail and can be life-threatening. This research focuses on patients with distributive shock who have low blood pressure despite receiving common vasopressor drugs like noradrenaline and vasopressin. The study evaluates the relationship between renin levels, an enzyme involved in blood pressure regulation, and the use of synthetic angiotensin II, a drug given when standard vasopressors are not enough. Researchers aim to understand which patients might benefit most from angiotensin II treatment based on renin concentration changes. Participants who are adults with distributive shock not responding adequately to noradrenaline and vasopressin will receive an infusion of angiotensin II starting at 20 ngkgmin, adjustable up to 40 ngkgmin as needed. Blood samples will be taken before the infusion and six hours afterwards to measure renin levels. This observational study will track how renin changes during treatment and how it relates to clinical outcomes. During the study, researchers will monitor the number of days patients remain free from organ failure and days spent outside the intensive care unit over 30 days. They will also assess the duration of vasopressor need, the requirement for mechanical ventilation or dialysis, and trends in renin levels within the first six hours. The study participation will last up to 30 days, with close observation of patient responses to angiotensin II and their overall clinical progress.

This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the models ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patients B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.

Researchers are evaluating the effect of a multistrain probiotic called OMNi-BiOTiC4 Hetox on healing, pain management, and postsurgical complications following neurosurgery. This randomized controlled trial aims to determine if the probiotic improves patient-reported disability after neurosurgery by comparing it to a placebo. The study is led by University Maribor and focuses on adults who have undergone neurosurgery for conditions like disc herniation, stenosis, or spinal instability. Participants will be randomly assigned to receive either the OMNi-BiOTiC4 Hetox probiotic or a placebo. The probiotic contains several bacterial strains including Lacticaseibacillus casei W56, Lactobacillus acidophilus W37, and others, along with various supportive substances. The study involves a supplementation period lasting 4 weeks during which participants take the assigned dietary supplement. During the study, researchers will measure changes in disability using the Oswestry Disability Index ODI at 3 months after starting supplementation. Participants will undergo assessments and follow-up visits to monitor healing progress and any postsurgical complications. The trial includes safety monitoring to ensure no adverse reactions to the probiotic and has a total participation period covering at least 3 months after supplementation begins.

Researchers are evaluating epoetin alfa, a medication related to erythropoiesis stimulating agents, in critically ill trauma patients who require mechanical ventilation in intensive care units ICUs. This phase III, randomized, double-blind trial aims to see if epoetin alfa can reduce death rates and severe disability six months after injury. The study involves 2500 patients admitted to ICUs with primary trauma diagnoses from centers in Australia, New Zealand, Europe, and Saudi Arabia. Participants will receive either epoetin alfa 40,000 IU or a placebo sodium chloride 0.9% by subcutaneous injection on Study Days 1 and 8 while in the ICU. Treatment is administered during their ICU stay, and patients are randomly assigned to one of these two groups. The study is designed to compare the effects of epoetin alfa against placebo in this critically ill population. During the study, patients will be monitored for survival and disability outcomes using tools like the World Health Organization Disability Assessment Schedule WHODAS 2.0 at six months. Other outcomes include mortality at different time points and thrombotic vascular events. Data on clinical status, adverse events, and safety will also be collected. The total participation length includes ICU stay and follow-up assessments up to six months after injury.

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.