Rijeka

Researchers are studying children aged 10 to 14 years who have a retrognathic mandible, a condition where the lower jaw is positioned backward. The trial aims to evaluate how functional appliance therapy using the Twin Block device affects 3D craniodentofacial features and reported sleep-related breathing disorders. This research also includes assessing the impact of the therapy on upper airway dimensions and sleep problems, which are important for overall child growth and development. Participants will receive the Twin Block functional appliance proposed after diagnostics, which they will wear for about one year. Three-dimensional facial scans will be taken before treatment, including at rest and with the mandible moved forward using the Fraenkel maneuver, as well as after the treatment ends. Caregivers will complete the Pediatric Sleep Questionnaire PSQ before and after treatment to evaluate perceived changes in sleep-related breathing issues. Additionally, lateral cephalogram X-rays will be taken from enrollment to the end of treatment to support the assessment. During the study, children will undergo detailed facial scans and X-rays to monitor changes in their facial structure and airway. Caregivers will provide input through questionnaires to assess sleep breathing problems. Researchers will compare initial scans and predicted treatment outcomes with actual results to evaluate therapy effectiveness. The total participation period is approximately one year, during which the team will closely observe facial growth, airway changes, and sleep-related symptoms to understand the therapys influence.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Many premature newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure NCPAP. When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the babys mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.

Researchers are evaluating the clinical efficacy, safety, and tolerability of XEN1101 as an additional treatment for people with focal-onset seizures in a Phase 3 randomized, double-blind, placebo-controlled study. This trial aims to compare two doses of XEN1101 with a placebo to see how well the medication can reduce seizure frequency in patients who continue their current antiseizure medications. The study involves adults diagnosed with focal epilepsy who have tried at least two antiseizure medicines without achieving seizure freedom. About 360 participants will be randomly assigned to receive either 25 mg or 15 mg of XEN1101 or a placebo once daily with an evening meal. The study includes up to 9.5 weeks of baseline monitoring to track seizure frequency followed by 12 weeks of blinded treatment. Participants maintaining the study drug can then join an open-label extension to continue treatment or enter an 8-week follow-up after treatment ends. Throughout the study, participants will keep accurate seizure diaries and continue their stable antiseizure medications. Researchers will measure the median percentage change in seizure frequency from baseline through the 12-week treatment period, along with secondary outcomes like the proportion of participants with at least a 50% reduction in seizures and patient-reported improvement. Safety will be monitored from screening until 56 days after the last dose. Overall, participants are involved for the baseline, treatment, and follow-up phases lasting several months.

This research aims to evaluate how well two new drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. The study includes participants aged 8 to under 18 years who have overweight or obesity. It is a Phase 3 trial that compares these new drugs with semaglutide, a drug already prescribed for weight management, and a placebo to understand their effects on weight loss. Participants in the main study are randomly assigned to receive one of four treatments CagriSema, cagrilintide, semaglutide, or placebo. All treatments are given once weekly as subcutaneous injections, starting with a dose escalation phase lasting up to 16 weeks, followed by a maintenance phase for 52 weeks. Those who receive semaglutide do not join the extension study. Participants in the extension study continue treatment with either CagriSema or cagrilintide for up to 156 weeks, while placebo participants follow a specific dosing regimen before continuing in the extension. During the study, participants will be monitored for changes in body mass index BMI and weight over time, with assessments at baseline, week 68, and for some measures, week 224. Researchers will also track body composition, metabolic markers, quality of life, and safety events. The entire duration for participants can be up to nearly five years if they take part in both the main and extension studies, involving regular visits and evaluations to understand the treatments effects and safety.

Many newborn babies experience breathing difficulties that require intubation, a procedure where a tube is inserted into the windpipe to help with breathing support. This trial compares two methods used by doctors to perform intubation the traditional direct laryngoscopy DL, where doctors look directly into the babys mouth with a standard laryngoscope, and video laryngoscopy VL, which uses a camera and screen to view the windpipe. The study aims to determine if VL leads to more successful first attempts without causing drops in oxygen levels or heart rate compared to DL. The trial uses a stepped-wedge cluster randomized design across multiple hospitals. Initially, each hospital uses the standard DL method for intubation. At randomly assigned intervals, hospitals switch to using the VL device, the C-MAC video laryngoscope, which includes a monitor and special blades. Doctors receive training and practice with this device before switching. Other intubation practices, such as drug use and supplemental oxygen, remain the same throughout the study. Participants in the trial are newborn infants undergoing intubation. Researchers will collect information about intubation attempts, including success rates, oxygen levels, heart rates, and any complications like oral trauma or need for chest compressions. The main outcome is whether babies are successfully intubated on the first try without physiological instability within five minutes. Additional measures include procedure time, number of attempts, and adverse events. Data will be compared between the periods using DL and VL to assess effectiveness and safety over the course of the study, which lasts until August 2026.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating whether combining vedolizumab and upadacitinib, called dual targeted therapy DTT, reduces bowel inflammation and ulcers more effectively than vedolizumab alone in adults with moderately to severely active Crohns Disease CD. The study also compares the safety and effectiveness of these treatments. This Phase 3b trial is conducted worldwide and sponsored by Takeda, enrolling about 396 participants. Participants are randomly assigned to receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks during the Induction Phase. Vedolizumab is given as a 300 mg intravenous infusion at Weeks 0, 2, 6, and 10 upadacitinib or placebo is taken daily by mouth. Those who respond to treatment at Week 12 will continue with vedolizumab alone every 8 weeks for 40 weeks in the Maintenance Phase. Vedolizumab dosing frequency may increase to every 4 weeks if needed. During the approximately 70-week study, participants visit the clinic 15 times for assessments including clinical evaluations, endoscopic exams, and patient-reported outcomes. Researchers measure clinical remission, endoscopic response, and safety outcomes at Week 12 and Week 52. There is also an 18-week safety follow-up after the maintenance period to monitor participants health.