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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.
Actively Recruiting
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.
Actively Recruiting
This research aims to develop, test, and implement a standardized process for early detection of Chronic Thromboembolic Pulmonary Hypertension CTEPH in patients who have had an acute pulmonary embolism APE. It is a national, prospective, multicenter observational pilot project conducted in the Czech Republic. The goal is to improve patient outcomes by enabling timely treatment and to ensure the process is cost-effective and beneficial to the population. Patients who have experienced APE within the past 3 to 12 months and meet specific criteria will undergo a standardized screening protocol to identify early signs of CTEPH. Those found to be at risk will be quickly referred to specialized centers for further evaluation and management. The project plans to involve about 500 patients across approximately 10 selected centers. Participants will be monitored for up to six months from enrollment, during which researchers will assess the accuracy of the screening protocol, the rate of CTEPH detection, and the proportion of patients who follow up at specialized treatment centers. The study includes patient evaluations, data collection on symptoms and risk factors, and referral pathways to ensure rapid access to specialized care. The study is supported by the European Social Fund and the Czech Republics state budget.
Actively Recruiting
Researchers are conducting a national, prospective, multicenter pilot project focused on the follow-up of children who were born prematurely and are now 5 years old. The goal is to develop and test a national method for caring for these children to reduce negative effects on their overall development and support their families. This project aims to create a validated screening process to monitor developmental abnormalities in these children at age 5. The evaluation includes a comprehensive pediatric check-up covering vision screening, speech and language tests, psychological assessments, motor skill evaluations, and lung function tests. Children showing any concerns during these assessments are referred to appropriate specialists such as rehabilitation physicians, speech therapists, psychiatrists, or ophthalmologists. The study involves about 210 children from several perinatal and intermediate centers. During the study, participants will undergo assessments over a period of up to 3 days, including pediatric exams and various developmental tests. Researchers will measure how many children have identified developmental pathologies and how many require specialist referral. This follow-up aims to detect and address health complications early, benefiting both the children and their families. The project is supported by national and European funding and has ethical approval at multiple levels.
Actively Recruiting
This trial compares two types of intraocular lenses IOLs for patients with cataracts an extended depth of focus EDF IOL and a monofocal IOL. The study aims to assess the safety and effectiveness of the EDF AT LARA 829MP lens in correcting aphakia and improving vision for adults with age-related cataracts. The study is prospective, randomized, controlled, and observer-masked, involving multiple centers. Participants are randomly assigned to receive either the EDF IOL or a monofocal IOL during cataract surgery. The trial focuses on measuring visual acuity outcomes at different distances six months after implantation. Both types of lenses are implanted in the posterior chamber of the eye during phacoemulsification cataract extraction. During the study, participants will undergo evaluations of their vision, including distance-corrected intermediate and distance visual acuity, as well as photopic visual acuity. Patient-reported outcomes will also be collected. The study includes regular follow-up visits for assessments and safety monitoring. Total participation lasts at least six months after lens implantation to gather comprehensive results.