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Found 5 Actively Recruiting clinical trials
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 the best dose of dolutegravir (DTG) for treating people who have both HIV and tuberculosis (TB) infections while taking rifampin (RIF) based anti-TB therapy. This Phase 2 study focuses on Thai patients newly diagnosed with pulmonary, pleural, or lymph node TB who have never received antiretroviral therapy (ART) before. The goal is to understand how DTG works in combination with RIF and find the optimal dose that will later be tested in a larger study for safety and effectiveness. The study has two stages. In the first stage, 40 HIV/TB patients will be randomly assigned to take either DTG 50 mg once daily with food or DTG 50 mg twice daily, both along with two other antiretroviral drugs. Researchers will closely monitor drug levels at week 4 and assess safety and tolerability. If results are promising, the study will proceed to stage two, enrolling 160 more patients randomized to the same two dosing groups. Drug concentrations will be checked at weeks 4 and 48, with ongoing safety and efficacy evaluations. Participants will be followed for at least 24 weeks, during which researchers will measure the amount of HIV in the blood to see how well the treatment suppresses the virus. Other assessments include laboratory tests for liver and kidney function, blood counts, and monitoring for side effects. The study also involves collecting data on how the drugs interact and the patients' overall health while on combination therapy for HIV and TB. Safety follow-up and interim analyses will guide the study's progress and ensure participant well-being.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not need hospitalization. This Phase 3, double-blind, randomized trial aims to assess participants' clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also examines outcomes in two groups: those receiving other approved antiviral treatments and those who are not. Participants receive either a single 3.5-gram infusion of hIVIG or a 35-milliliter infusion of saline placebo, with equal chance of assignment to each group. The randomization is stratified by study site and whether participants are receiving standard antiviral care. The infusion occurs once, and participants are monitored thereafter to compare the effects of hIVIG plus standard care versus placebo plus standard care. During the study, participants provide written consent and agree to follow study procedures through 28 days. Researchers assess clinical status seven days after infusion and track safety and disease progression. The study excludes those with prior immune therapies or certain medical conditions and requires participants to avoid other COVID-19 treatment trials through Day 7 unless hospitalized or experiencing significant disease worsening. Clinical assessments and monitoring continue to ensure participant safety and capture outcomes related to COVID-19 illness severity.
Actively Recruiting
The HYIMPACT study is a large, observational research project across seven Asian countries designed to understand how Nebilet (nebivolol) works in people with high blood pressure, also called hypertension. It focuses on how Nebilet affects blood pressure control over time, treatment adherence, quality of life, prescription habits, and heart-related outcomes. The study includes about 5,000 adults with newly diagnosed or uncontrolled hypertension, some of whom may have other heart-related conditions. Participants will either start Nebilet treatment or have been on it for no more than two weeks before joining. They will be observed regularly for up to three years, with blood pressure measurements taken at baseline, 12, 24, and 36 months. The study also compares Nebilet used alone versus in combination with other treatments, and examines the relationship between blood pressure readings taken at home and in the clinic. Throughout the study, patients will have their blood pressure monitored, complete questionnaires about medication adherence and quality of life, and provide health information including cardiovascular risk factors and lab test results when available. Researchers will track major heart events like heart attacks and strokes, and record any side effects. Data will be collected electronically to ensure quality and consistency, helping to provide real-world insights about Nebilet 's role in managing hypertension over time.
Actively Recruiting
Chronic Obstructive Pulmonary Disease (COPD) is a major global health issue causing significant illness and death, especially in low- and middle-income countries. It involves a progressive decline in lung function with frequent worsening events called exacerbations, which accelerate disease progression and increase mortality risk. Current guidelines recommend assessing lung function, exacerbation history, and patient symptoms to guide treatment, including triple therapy with inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta-agonists for patients with persistent symptoms and frequent exacerbations. This study focuses on evaluating the use of Breztri/Trixeo (BGF), a fixed-dose triple combination inhaler, in real-world settings across various global regions to better understand its impact on clinical and patient-reported outcomes over 12 months. The study is an international, multicenter, observational cohort design enrolling adults with moderate to severe COPD who have been prescribed BGF but have not yet started treatment. Patients will be followed for up to 52 weeks with visits at baseline, 12, 26, and 52 weeks. All treatments and assessments are conducted according to routine care by the patients' physicians without study intervention. The aim is to observe changes in COPD health status, measured by the COPD Assessment Test (CAT) and other patient-reported outcomes, as well as clinical outcomes such as exacerbation rates and lung function. The study includes diverse populations from Latin America, Asia, and the Middle East and Africa to gather broadly applicable real-world evidence. Participants will complete questionnaires and undergo routine clinical evaluations during scheduled visits. Researchers will collect data on demographics, medical history, lung function tests, exacerbations, medication use, and patient satisfaction with inhaler devices. The primary outcome is the change in CAT score after 12 weeks of BGF treatment, with secondary assessments at later time points and evaluation of exacerbation frequency and lung function parameters. The study will also monitor safety and treatment discontinuation, providing valuable insights into the effectiveness and patient experience with BGF in everyday clinical practice.