Bang Pla Soi

Researchers are studying the effectiveness of a tetravalent dengue vaccine TDV in reducing hospital stays due to dengue in children and adolescents aged 6 to 12 years living in Southeast Asian countries with high dengue transmission, including Thailand, Indonesia, and Malaysia. This observational study focuses on participants in a community-based cohort who may or may not receive the vaccine as part of a pilot public vaccination program where TDV is already approved. The study particularly aims to assess the vaccines effectiveness against less common dengue virus types DENV-3 and DENV-4. The study includes a nested case-control design with two groups cases who are hospitalized children or adolescents with confirmed dengue infection, and matched controls who live in the same neighborhood but have not been hospitalized with dengue. Participants are followed individually for up to 3 years within the cohort. The study is non-interventional, observing outcomes based on vaccination status within the existing vaccination program. Participants will be monitored through active hospital surveillance to identify dengue hospitalizations confirmed by laboratory testing. Data collected includes blood samples for RT-PCR testing, clinical diagnosis, and hospitalization records. Researchers will measure the rate of hospitalization due to dengue virus infections by serotype and baseline dengue immune status. The primary outcome is dengue-related hospitalization up to 36 months. Parents or legal representatives provide consent and assent for participants, including agreement for blood sample collection and follow-up over the study period.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Researchers are evaluating two surgical methods for treating acute acromioclavicular joint injury ACJI, a common shoulder injury often caused by direct force to the shoulder. The study compares functional and radiologic outcomes between arthroscopic assisted coracoclavicular CC stabilization alone and the same procedure with additional K-wire fixation. The goal is to see if adding K-wire fixation changes recovery outcomes such as joint stability and shoulder function. Participants will be randomly assigned to one of two groups one receiving arthroscopic assisted CC stabilization with an extra K-wire device inserted from the acromion process to the distal clavicle, and the other receiving only the arthroscopic assisted CC stabilization without K-wire. This device is used as an additional fixation tool. The study will assess outcomes over a year to compare effectiveness. During the study, participants will have their shoulder function measured using scores like ACJI, Constant, DASH, and pain levels VAS at multiple time points including 3, 6, and 12 months after surgery. Radiologic outcomes such as coracoclavicular distance and gleno-acromio-clavicular angle will be monitored at specific intervals from day 1 post-surgery up to one year. These assessments help track the joint stability and recovery progress throughout the follow-up period.

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 comparing two methods of minimal invasive surgery to treat severe Hallux Valgus, a condition affecting the big toe causing pain and deformity. This randomized controlled trial evaluates the outcomes of using either one or two Kirshner wires for fixation during distal linear metatarsal osteotomy. The study aims to understand if adding a second wire improves stability, reduces complications like recurrence and infections, and enhances pain relief and function. Participants are divided into two groups of 25 each. One group receives the standard fixation with one Kirshner wire placed through the first metatarsal bone, while the other group has an additional wire inserted across the metatarsophalangeal joint for extra stability. This second-generation minimal invasive surgery is chosen for its cost-effectiveness, less pain, smaller scars, shorter surgery time, and reduced blood loss. Over a follow-up period of one year, participants will attend regular visits to complete questionnaires and undergo radiographic exams to measure the Hallux Valgus Angle at baseline and multiple time points up to 12 months. Researchers will analyze pain, function, and complications to compare the two fixation methods. The study involves detailed monitoring to assess the effectiveness and safety of the surgical techniques.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

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.

Researchers are investigating whether peripheral magnetic stimulation PMS combined with balance training can reduce the risk of falls and decrease disease severity in patients with diabetic polyneuropathy. This proof-of-concept study uses the Magnetic and Balance Training Activator MAGBATA, which delivers electromagnetic pulses to the feet while standing, aiming to improve sensory input, brain plasticity, and nerve regeneration. The trial is designed as a phase 2 randomized controlled study involving 40 patients with diabetic polyneuropathy aged 50 to 75 years. Participants will be randomly assigned to either an active intervention group receiving repetitive peripheral magnetic stimulation rPMS or a control group receiving sham stimulation. The active group will perform warm-up exercises involving ankle muscle contractions with 10 Hz rPMS, followed by one-leg stance exercises with 20 Hz rPMS applied to the foot. The control group will perform the same exercises but with sham stimulation that mimics the procedure without therapeutic intensity. The intervention consists of eight sessions over four weeks, with two sessions per week. During the study, assessments including the one-leg stance test OLST, timed up and go test TUGT, and short physical performance battery SPPB will be conducted before and after the 4-week intervention. Additionally, nerve conduction studies will be performed at baseline and after 8 weeks to evaluate disease severity. The study includes safety measures such as the use of a safety belt and walker assistance during balance exercises, and all tests are supervised by a physiotherapist and a blinded rehabilitation physician.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.