Mueang Phitsanulok District

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Atrial fibrillation AF is a major cause of heart-related illness and death, especially among Asian patients who face higher risks of serious bleeding such as brain hemorrhage compared to non-Asians. This research, called the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation COOL-AF Phase 2, aims to study how antithrombotic medication use changes over time and how these changes affect health outcomes in people with AF. The study is observational and conducted across multiple centers in Thailand. Participants in this study have known or newly diagnosed non-valvular AF and are followed without any intervention or treatment assigned by the study. The study plans to enroll about 3680 patients over two years from 33 centers. Participants will be monitored every 6 months for up to 3 years to observe patterns of medication use, particularly warfarin and non-vitamin K antagonist oral anticoagulants NOACs, and clinical events including stroke, systemic embolism, bleeding, heart attacks, and heart failure. Throughout the study, patients will have regular check-ins every six months to track their medication usage and health status. Researchers will collect data on important outcomes such as rates of stroke, bleeding events, and quality of life. The studys primary focus is on long-term safety and effectiveness of antithrombotic treatments in this population. The total participation duration can be up to 3 years, ensuring thorough observation of clinical outcomes and treatment patterns.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the best dose of dolutegravir DTG for treating people co-infected with HIV and tuberculosis TB who are also receiving rifampin RIF based TB therapy. This Stage II trial aims to understand how DTG behaves in the body when combined with RIF and to compare two dosing schedules of DTG in Thai patients newly diagnosed with pulmonary, pleural, or lymph node TB confirmed to be sensitive to RIF. The study will provide important information before moving on to a larger Stage III trial focused on safety and effectiveness.

Researchers are evaluating the epidemiological impact and cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai men who have sex with men MSM and transgender women TGW. The study includes discrete choice experiments DCEs to understand preferences for different pre-exposure prophylaxis PrEP options, as well as analysis of routine service data. The findings will guide mathematical modeling of long-acting PrEP uptake and its impact on HIV prevention. The study has three phases. Phase I involves in-depth interviews IDIs and focus group discussions FGDs with current, previous, or interested PrEP users to identify important attributes for PrEP choices. Phase II pilots the DCEs with convenience samples to refine the survey. Phase III launches two final surveys for MSM and TGW, collecting data on demographics, risk behavior, HIV and STI testing, PrEP knowledge, use, and preferences across attributes like product form, dosing frequency, provider type, and cost. Participants will take part in interviews, group discussions, and surveys conducted either in person or online. Data collected includes sociodemographic information, risk behaviors, PrEP attitudes, and preferences. Researchers will measure the projected uptake of long-acting PrEP, epidemiological impact, and cost-effectiveness over 12 to 18 months. The study includes ongoing monitoring of participant responses to optimize understanding of factors influencing PrEP use.