Bang Pla Soi

Researchers are evaluating the effectiveness of the tetravalent dengue vaccine (TDV) in reducing hospital stays due to dengue virus infections among children and adolescents in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia. This study focuses on participants aged 6 to 12 years who are part of a community-based cohort and may or may not receive TDV as part of a pilot public vaccination program. The research aims to provide further information on TDV's effectiveness, especially against the less common dengue virus types DENV-3 and DENV-4. This is a non-interventional study where participants are observed over a period of three years. Some cohort members may receive the TDV vaccine as part of a public vaccination program, while others may not be vaccinated. Researchers will compare hospitalization rates due to dengue between vaccinated and unvaccinated participants, without administering any study-specific treatments or interventions. Participants will be followed individually for three years, with their health monitored to identify any hospital stays caused by dengue infections. Blood samples may be collected at baseline and during illness episodes to confirm dengue infection using laboratory tests like RT-PCR. The primary outcome measured is hospitalization due to virologically confirmed dengue of any serotype. The study also includes matched case-control analyses within the cohort to better understand vaccine effectiveness and safety.

Researchers are evaluating the effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.

Researchers are evaluating the differences in functional and radiologic outcomes between two surgical methods for treating acute acromioclavicular joint injury (ACJI). This randomized controlled trial compares arthroscopic assisted coracoclavicular (CC) stabilization alone with the same procedure plus additional K-wire fixation. The study focuses on patients aged 18 to 45 with Rockwood classification III, IV, or V ACJI, aiming to determine if the added K-wire fixation improves outcomes such as joint stability and function. The intervention group receives an arthroscopic assisted CC stabilization combined with K-wire No. 2.0 insertion from the acromion process to the distal clavicle. The control group undergoes arthroscopic assisted CC stabilization alone. Both procedures are designed to stabilize the shoulder joint after injury, and the study measures how these approaches affect functional scores and radiologic differences. Participants are monitored for one year after surgery, with the main outcome being the Acromioclavicular Joint Instability (ACJI) score at 12 months post-operation. Researchers will also assess pain levels, shoulder function, and radiographic measurements such as CC-distance and GACA difference. The study includes evaluations of strength, range of motion, and daily activity capability to understand the effectiveness and safety of both surgical options.

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 evaluating two different Kirshner wire fixation techniques in minimal invasive surgery to treat severe Hallux Valgus, a foot deformity affecting the big toe. This randomized controlled trial compares the use of one versus two Kirshner wires for fixing the first metatarsal bone during distal linear metatarsal osteotomy. The goal is to assess if adding a second wire improves stability, reduces complications like wire loosening or infection, and enhances pain relief and foot function. The study includes two groups of patients receiving minimal invasive surgery for Hallux Valgus. One group receives the standard fixation with a single Kirshner wire, while the other group receives an additional second wire for extra fixation across the metatarsophalangeal joint. The surgery involves making an osteotomy cut at the first metatarsal neck and placing the wires intramedullary. Both groups are monitored over time to compare radiographic and functional outcomes. Participants are followed for one year, during which they complete questionnaires and undergo radiographic exams at baseline, 2 weeks, 1 month, 2 months, 4 months, 8 months, and 12 months to measure Hallux Valgus angle changes. Researchers track pain, foot function, and possible complications. Data analysis includes statistical tests to evaluate differences between the two fixation methods. The study includes adults aged 18 to 60 with persistent pain and specific radiographic findings who have failed conservative treatment.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

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.

Researchers are evaluating whether peripheral magnetic stimulation (PMS) combined with balance training can reduce the risk of falls and lessen disease severity in older patients with diabetic polyneuropathy. This phase 2 proof-of-concept study uses the MAGBATA platform, which delivers electromagnetic pulses to the soles of the feet while patients stand. The goal is to enhance sensory input, brain plasticity, and nerve regeneration through repetitive peripheral magnetic stimulation (rPMS). The study randomly assigns 40 participants to either an active intervention group or a control group. The active group performs a warm-up with ankle dorsiflexion exercises while receiving 10 Hz rPMS on the tibialis anterior muscles, followed by one-leg stance exercises on the MAGBATA platform with 20 Hz rPMS applied to the foot's plantar surface. The control group undergoes the same exercises but with sham stimulation. The intervention includes eight sessions over four weeks, with two sessions per week. Participants are assessed through balance tests including the one-leg standing balance test (OLST), timed up and go test (TUGT), and short physical performance battery (SPPB) at the start and after four weeks. Additionally, nerve function is evaluated by a rehabilitation physician using electrophysiologic studies at baseline and eight weeks. Safety measures include supervision by a physiotherapist and use of safety belts and walkers during exercises to prevent falls.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.