Mueang Phitsanulok District

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.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

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.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.

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.