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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.
Actively Recruiting
This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.
Actively Recruiting
This research evaluates the use of drug-coated balloons DCB compared to drug-eluting stents DES in patients with stable coronary artery disease CAD or acute coronary syndrome ACS who are at high risk of bleeding. The study aims to test whether using DCB with a shorter dual antiplatelet therapy DAPT regimen is not worse than using DES with a longer DAPT duration. If the DCB strategy is found not inferior, its superiority over DES will be further assessed. Participants will receive either a DCB or a DES during percutaneous coronary intervention PCI. The DCB group uses the SeQuent Please device combined with a tailored antithrombotic regimen based on patient stability and oral anticoagulation use. The DES group involves implantation of various CE-marked drug-eluting stents alongside individualized antithrombotic treatment. Treatment regimens vary between stable patients and those with ACS, with differences in DAPT duration and lifelong therapies. Throughout the study, participants are monitored for major adverse cardiac events MACE and bleeding episodes using the BARC classification over 12 months as the primary outcome. Additional outcomes include mortality, revascularization events, myocardial infarction, stroke, and bleeding tracked up to 36 months. The study uses a randomized, triple-blind design to compare these treatments with ongoing safety and efficacy assessments.
Actively Recruiting
Healthy Volunteer
Endometriosis is a long-lasting condition where tissue similar to the lining inside the uterus grows outside it, causing pain and fertility problems for many women of reproductive age. This research aims to find specific RNA and protein markers in endometriosis tissue and normal uterine lining to help develop new treatments and diagnostic tools. The study also seeks to identify markers that predict disease progression and infertility through a detailed 10-year follow-up. Participants include women aged 19 to 48 years either with surgically confirmed endometriosis or healthy women without endometriosis confirmed by laparoscopy during sterilization. The study involves collecting tissue samples during surgery by laparoscopy or laparotomy for analysis of hormone metabolism and gene expression. Healthy volunteers are also included to provide comparison samples. During the study, researchers will collect samples during surgery and follow participants annually for up to 10 years using questionnaires about pain symptoms, fertility, and treatments. The study measures hormone levels and gene expression in tissues and blood, and tracks pain recurrence after surgery. This long-term follow-up aims to better understand disease behavior and support development of personalized treatment options.
Actively Recruiting
The trial investigates two different ways to stop high flow nasal cannula treatment in infants with acute bronchiolitis, a common cause of hospitalization in young children. Researchers want to find out if stopping the therapy immediately is safe and helps to reduce hospital stay, compared to slowly reducing the flow rate. Acute bronchiolitis mainly affects infants under one year and currently has no effective medication treatment in Finland. Participants will receive one of two approaches either the high flow nasal cannula is stopped immediately or the flow rate is gradually decreased until it ends. Typical high flow rates used are about 2 liters per kilogram per minute. The study compares these two strategies to see which method is more effective and safe for infants. During the study, infants will be monitored for treatment success, hospital stay length, and any readmissions within a week after discharge. Oxygen levels and suitability for ending therapy will be assessed by doctors. Researchers will measure hospitalization time starting from when they are assigned to a treatment method. The trial lasts for one week after randomization, with safety and treatment failure closely observed.
Actively Recruiting
Healthy Volunteer
This research aims to understand how the loop electrosurgical excision procedure LEEP affects sexual function and quality of life in women with HPV-related cervical lesions. The study compares women undergoing LEEP to those who only have colposcopy visits, focusing on any changes in sexual function and health-related quality of life over time. The research is conducted across multiple centers and includes women referred for colposcopy due to cytological abnormalities or repeated HPV positivity. Participants are divided into two groups one receiving the LEEP treatment, which removes the affected cervical area using a small electric loop under local anesthesia, and a control group undergoing only colposcopy without LEEP. The study follows women over several years, with assessments planned at the first visit, then at 6 months, 24 months, 3 years, and 5 years after the initial procedure or colposcopy. During the study, participants complete web-based questionnaires about their sexual function using the Female Sexual Function Index FSFI and health-related quality of life using the 15D questionnaire. Researchers also collect background information from patient files and questionnaires. No additional visits or sample collections are required. The main outcomes measured are self-reported sexual function and quality of life scores over the follow-up period, with data securely managed and stored for analysis.
Actively Recruiting
Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.