Usti Nad Labem

Researchers are evaluating two methods of planning spine stabilization surgeries for patients with traumatic injuries to the lower thoracic or lumbar spine. The study compares conventional preoperative planning using CT scans with planning based on patient-specific 3D-printed spine models. This trial intends to assess how these approaches affect surgical outcomes such as blood loss during surgery. Participants undergo standard bisegmental posterior spine stabilization surgery through a midline approach. One group receives surgery planned with conventional CT scans and fluoroscopy guidance, while the other group has surgery planned with the aid of 3D-printed spine models along with the same fluoroscopy guidance. Both groups undergo the same surgical technique with different preoperative planning tools. During the study, researchers will monitor surgery-related factors including blood loss during the operation, surgical duration, accuracy of pedicle screw placement, and the length of the surgical incision. Assessments occur during surgery and postoperatively, with screw placement accuracy evaluated on the first day after surgery and incision length checked around the time of suture removal approximately 10 to 14 days post-surgery. The study is randomized and single-blinded, involving follow-up to measure these outcomes.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

This clinical trial investigates the efficacy and safety of bimekizumab compared with placebo in adults with palmoplantar pustulosis PPP, a skin condition causing pustules on the palms and soles. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension, aiming to evaluate treatment responses and safety outcomes in participants diagnosed with PPP for at least 24 weeks and who are candidates for systemic therapy or phototherapy. Participants are randomly assigned to one of two groups one group receives bimekizumab for the entire study duration, while the other receives placebo initially before switching to bimekizumab in the maintenance phase. Treatments are given at specified time points throughout the study, which includes an initial treatment period followed by a maintenance period under open-label conditions. During the study, participants undergo assessments including the Palmoplantar pustulosis-Investigator Global Assessment PPP-IGA response at Week 16, Palmoplantar Pustulosis Area Severity Index PPPASI responses at Weeks 8 and 16, and quality of life evaluations via the Dermatology Life Quality Index DLQI. Researchers monitor pain scores, adverse events, and serious side effects from baseline through safety follow-up up to Week 117. Participants will be closely observed through regular visits and evaluations during these periods.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the use of BIOTRONIK dual-chamber pacemakers that combine left bundle branch area pacing LBBAP with Closed Loop Stimulation CLS in patients who have sinus node dysfunction SND and atrioventricular AV conduction disorders. This observational study aims to understand how this combined pacing method works in everyday clinical practice and whether it can help reduce atrial fibrillation detected by the device over 24 months. The goal is to gather real-world evidence to optimize pacemaker programming and improve patient outcomes. Participants receive permanent dual-chamber pacemakers with a ventricular lead placed in the left bundle branch area, activating the CLS rate-responsive algorithm. The study focuses on patients implanted with these devices who have no prior history of atrial fibrillation. The study follows about 150 patients for 24 months after implantation, collecting data on device-detected atrial fibrillation episodes, heart rate patterns, and pacing behavior. This is a prospective observational submodule of the BIOSTREAM.CSP registry without a control group. During the study, researchers monitor device-recorded atrial fibrillation incidence and burden from CLS activation up to 24 months. They also analyze heart rate histograms at one and two years after implantation. Patients are enrolled in the BIOSTREAM.CSP registry and are followed through routine clinical care with data collected on pacing rates and arrhythmia episodes. The study aims to provide insights into the clinical performance of CLS combined with LBBAP to inform decisions on pacemaker programming and reduce atrial arrhythmias.

This trial evaluates primary coxarthrosis patients receiving cementless total hip arthroplasty THA. It compares modular dual mobility inserts with ceramic multilayer coating against standard polyethylene inserts with metal heads. The study aims to assess if cobalt and chromium serum metal ion levels with the dual mobility system are similar to those with standard metal-on-polyethylene implants, as metal ion release is a concern and previous studies lacked a proper control group. Participants will be randomly assigned to receive either the Dual Mobility Cup device or the Standard Acetabular component device that includes polyethylene with vitamin E inlay and a metal head. Both interventions are established options in THA for conditions like coxarthrosis, rheumatic arthritis, hip fractures, and femoral head necrosis. The trial involves the use of cementless acetabular cups and will follow patients over several years. During the study, participants will undergo blood tests to measure serum cobalt and chromium levels at 12 months post-surgery. Functional outcomes will be assessed using the Harris Hip Score at 3 months, 12 months, and 3 years after surgery. Gait analysis and patient satisfaction evaluations will be performed before surgery and during follow-up visits. Radiologic assessments of cup positioning, radiolucencies, and heterotopic ossification will be done immediately post-op and at multiple intervals up to 3 years. Participants will be monitored for adherence and safety throughout the study duration, which extends to at least 3 years after surgery.

This research aims to evaluate the software Lipidica 1.0, designed to process lipidomic data from an in-house diagnostic device, for screening pancreatic cancer PaC in people at high risk due to family history, gene mutations, or hereditary pancreatic diseases. Pancreatic cancer often has a poor prognosis due to late detection and rapid progression. Early screening in high-risk groups may improve outcomes, and this study builds on previous findings showing distinct lipid profiles in pancreatic cancer patients. Participants are divided into two groups those with confirmed resectable pancreatic cancer, who will have one baseline visit for blood sampling to analyze lipid profiles and tumor markers and those at high risk without cancer, who will have two or three visits over up to 12 months. The high-risk group undergoes blood tests and medical imaging such as endoscopic ultrasonography, magnetic resonance, or computed tomography. The softwares ability to distinguish between cancer patients and high-risk individuals without cancer is the main focus. Participants will attend visits for blood collection and imaging at the start and end of the study, with some having an additional visit based on initial results. Blood tests include lipidomic analysis, tumor markers CA 19-9 and CEA, HbA1c, and hCG for women of childbearing potential. Imaging assessments occur up to three times per participant. Researchers will analyze these data to verify the softwares performance in differentiating disease presence. The study is expected to continue for about three years, with interim analysis after one year.