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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.
Actively Recruiting
Atrial fibrillation (AF) is a common heart rhythm disorder that can lead to serious complications like stroke and bleeding. Asian patients with AF tend to have higher rates of major bleeding, including bleeding in the brain, compared to non-Asian patients. This research focuses on understanding the use of blood-thinning medications called anticoagulants, especially newer drugs known as non-vitamin K antagonist oral anticoagulants (NOACs), which are considered safer than warfarin but are less commonly used in Asian countries due to cost concerns. The study aims to track changes in how these medications are used and how they affect health outcomes over time. The study is a large, prospective observational registry conducted across 33 centers in Thailand, enrolling 3680 patients with non-valvular AF over two years. There is no intervention or treatment assigned by the study; instead, researchers observe patients' current treatments and outcomes. Participants will be followed every six months for a total of three years to monitor their use of warfarin and NOACs and record any serious events such as stroke, systemic embolism, major bleeding, heart attacks, heart failure, and overall quality of life. Throughout the study, patients will undergo regular assessments including clinical evaluations and monitoring of their medication use. The main outcomes measured over the three years include rates of using warfarin and NOACs, occurrence of ischemic stroke or transient ischemic attack, systemic embolism, intracranial hemorrhage, and major bleeding events. This long-term follow-up aims to provide valuable information on treatment patterns and safety in Asian patients with atrial fibrillation.
Actively Recruiting
Researchers are evaluating a new approach to speed up the identification of bacterial infections and detection of antibiotic resistance genes in patients with infections caused by Pseudomonas aeruginosa or carbapenemase producing Enterobacterales. This Phase 4 trial aims to improve clinical outcomes in hospitalized patients with bloodstream infections, hospital-acquired pneumonia, or ventilator-associated pneumonia caused by these resistant bacteria. The study compares rapid diagnostic testing combined with targeted antibiotic treatment to standard antibiotic susceptibility testing and care. Participants will be randomly assigned to either an intervention group or a control group. Those in the intervention group will have their blood or respiratory samples tested using the BioFire Blood Culture Identification 2 Panel and the BioFire FilmArray Pneumonia or Pneumonia plus Panel to quickly identify bacteria and resistance genes. Antibiotic guidelines will help doctors interpret these results, and the antibiotic ceftazidime-avibactam will be used early if appropriate. The control group will receive usual care with standard clinical microbiology lab testing and antibiotic treatment based on institutional practices. Participants will be followed for 60 days after infection to assess clinical outcomes and mortality. Researchers will collect bacterial isolates for genetic analysis through whole genome sequencing. The main goal is to measure a combined outcome of death from any cause or lack of improvement in organ function 14 days after infection. The study plans to enroll about 1900 patients across 20 sites. Both groups will be monitored closely to compare the effects of early targeted therapy guided by rapid diagnostics versus standard care.
Actively Recruiting
Healthy Volunteer
Researchers are studying the impact and cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. The study involves three main parts: discrete choice experiments (DCE) to understand preferences for PrEP options, analysis of routine service data, and combining these results for epidemiological and economic evaluations. The goal is to understand what drives individual decisions about PrEP use and how new long-acting treatments might influence uptake compared to oral PrEP. The study includes several phases starting with in-depth interviews (IDIs) of 20 MSM and 20 TGW who are current or past PrEP users or interested in PrEP. These interviews identify important attributes of PrEP options. Next, focus group discussions (FGDs) with selected IDI participants refine these attributes. Then pilot testing of the DCE surveys is done with 30 MSM and 30 TGW to finalize the surveys. Finally, two separate surveys for MSM and TGW collect detailed information on sociodemographics, risk behaviors, PrEP knowledge, use, and preferences for different PrEP forms, dosing schedules, provider types, costs, and side effects. Participants will provide information through interviews, surveys, and discussions conducted in person or online. Researchers will analyze this data to estimate preferences and project how long-acting PrEP might affect uptake and cost-effectiveness over 12 months. The study measures epidemiological impact and economic value of these new prevention methods to inform future HIV prevention strategies in the key populations of Thailand.