Usti Nad Labem

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the changes in symptoms and functional limitations in adults with symptomatic hypertrophic cardiomyopathy (HCM), including both obstructive and non-obstructive types. This Phase 3 trial aims to compare the effects of sotagliflozin, an oral medication, to a placebo in these participants. The study focuses on how these treatments affect heart-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) over 26 weeks. Participants will be randomly assigned to receive either sotagliflozin tablets or matching placebo tablets once daily. The study includes participants with specific heart function criteria, including left ventricular outflow tract gradients for obstructive or non-obstructive HCM and stable background therapy. The treatment period lasts 26 weeks, during which participants take the assigned tablets daily. Throughout the study, participants will undergo assessments including symptom evaluations and functional status measurements. Researchers will monitor changes from the start of the study to week 26 using the KCCQ CSS to evaluate treatment effects on heart symptoms and quality of life. Safety and adherence to medication will also be observed during this time.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating modular dual mobility inserts with ceramic multilayer coating compared to standard polyethylene inserts in primary total hip arthroplasty (THA) using a cementless acetabular cup. The study aims to compare cobalt and chromium metal ion levels in the blood after surgery between these two types of hip implants. This research addresses the lack of control group data in previous studies on metal ion release from modular dual mobility systems, with the standard metal on polyethylene articulation being the most commonly used combination in the Czech Republic for decades. Participants will receive either a Dual Mobility cup or a standard acetabular component with polyethylene and a vitamin E inlay plus a metal head during their hip replacement surgery. Both devices are established treatments for conditions like coxarthrosis, rheumatic arthritis, hip fractures, and femoral head necrosis. The study follows patients for at least 12 months after surgery to assess outcomes. During this time, researchers will monitor serum levels of cobalt and chromium metal ions at 12 months post-surgery to compare the two implant types. Participants will be assessed through blood tests to measure these metal ions. The study includes follow-up visits to ensure adherence and to monitor safety and effectiveness over the study period.

Pancreatic cancer is a disease with a poor prognosis due to its late detection and rapid progression. This research evaluates the performance of the medical software "Lipidica" designed to analyze lipid profiles from blood samples to screen for pancreatic cancer in people at high risk due to family history, genetic mutations, or hereditary pancreatic diseases. The goal is to confirm that this software can distinguish between patients with pancreatic cancer and those at increased risk without cancer. Participants will provide blood samples and undergo medical imaging, including endoscopic ultrasonography, magnetic resonance, and computed tomography, with each imaging method performed up to three times during the study. The software processes lipidomic data alongside laboratory tests measuring markers like CA 19-9, CEA, HbA1c, and hCG (for women of childbearing potential). The study includes a baseline visit and an end-of-study visit, with some participants having an additional visit depending on initial results. Throughout the average three-year participation, researchers will monitor participants using blood tests and imaging to assess the software's ability to differentiate pancreatic cancer cases from high-risk individuals. The main outcome is an interim analysis one year after the first participant enrolment and continuing through study completion. This includes safety monitoring and medical evaluations with the aim of improving early detection methods for pancreatic cancer in high-risk groups.

Researchers are evaluating depemokimab for adults with uncontrolled Hypereosinophilic Syndrome (HES) who are already receiving standard care treatment. This Phase 3 study is a 52-week, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants must have a confirmed HES diagnosis, be on stable therapy for at least 4 weeks before randomization, have experienced at least two disease flares in the past year, and have a blood eosinophil count of at least 1,000 cells/µL during screening. Historical flares are defined by worsening symptoms or increased eosinophils that require treatment changes. Eligible participants will be randomly assigned in a 2:1 ratio to receive either depemokimab or a matching placebo, while continuing their usual HES therapy. The study medication will be administered alongside standard care to assess the drug’s effect on reducing HES flares over the course of one year. During the study, participants will be monitored regularly for flare frequency, safety, and treatment effects. Researchers will collect data on the number of HES flares up to 52 weeks. Safety assessments and clinical evaluations will be conducted throughout the study to understand how participants respond to the treatment and to monitor any adverse events.

Researchers are evaluating whether adding duroplasty, a surgical procedure that expands the dura (the tough membrane around the spinal cord), to standard spinal surgery improves muscle strength and outcomes after severe traumatic spinal cord injury in the neck. This condition often causes permanent disabilities like paralysis and loss of bladder and bowel control, and currently, no treatments have proven to improve recovery. The study focuses on adults with severe cervical spinal cord injury who need surgery within 72 hours of injury. Participants will be randomly assigned to receive either standard spinal surgery, which includes laminectomy (removal of part of the vertebra), or spinal surgery plus duroplasty. The duroplasty involves opening the dura and stitching a patch to relieve pressure on the swollen cord. A subgroup of patients will also take part in a smaller mechanistic study using probes at the injury site to monitor pressure, blood flow, metabolism, and inflammation. The study will recruit 222 adults over 4 years from major trauma centers in the UK. During the study, patients will be assessed at baseline, 3, 6, and 12 months after surgery for muscle strength, hand function, walking ability, bladder and bowel control, quality of life, complications, and survival. Some patients will have additional monitoring at the injury site. The main outcome measured is the change in motor function at 6 months compared to baseline. Participants will be followed for one year to evaluate recovery and safety.

This research aims to improve early detection of Hepatitis C virus (HCV) infection among people who inject drugs (PWID) in the Czech Republic. It is a national, prospective, multicenter, non-interventional pilot project conducted in 18 clinical centers. The goal is to prepare, implement, and evaluate a screening process for early HCV detection and to develop new methods to integrate this screening into social healthcare systems. The project also seeks to reduce further transmission of HCV by identifying gaps in ongoing care for this population. Participants will undergo testing for hepatitis C antibodies to determine past exposure to the virus. Those who test positive for antibodies will receive further testing for HCV RNA and genotype to confirm active infection. Approximately 3,000 PWID will be enrolled to test the screening procedure and assess its effectiveness in real-world clinical settings. Participants will be screened and monitored until December 31, 2025, with researchers tracking the incidence of HCV in the screened cohort. The study will help create a methodology for continuous care from early diagnosis through treatment and propose system changes to make screening more efficient. The project is supported by European and Czech funding and registered by national authorities.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.