Clinical trials

The present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dualt ask gait training in sub-acute (at least 2 weeks after stroke onset) to chronic stroke (within 5 years post-stroke) to investigate changes in brain hemodynamics (oxy-hemoglobin and deoxy-hemoglobin concentration) as measured by functional near infrared spectroscopy (fNIRS). The findings may provides insights changes in combining tES with rehabilitation on improvements in brain hemodynamics in sub-acute to chronic stroke.

This study will evaluate the effects and preliminary cost-effectiveness of the Healthy Beat Acupunch (HBA) exercise program among community-dwelling older adults in Thailand. HBA is a 40-minute exercise program that combines gentle body movements with rhythmic tapping along traditional Chinese medicine meridian points. Older adults in the intervention group will participate in HBA exercise three times per week for 6 months. During months 1-3, the sessions will be led by trained exercise leaders. During months 4-6, participants will exercise using a prerecorded HBA video, with personnel present to monitor safety. Participants in the control group will continue their usual daily activities and usual health services without receiving the HBA program during the study period. Physical fitness, sleep quality, and health-related quality of life will be assessed at baseline, 3 months, and 6 months. The study will also compare the direct and indirect costs of the leader-led and video-led phases and conduct a preliminary cost-effectiveness analysis to examine whether the HBA program may be a practical and sustainable health-promotion approach for older adults living in the community.

This study aims to determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients aged ≥7 years with confirmed allergy to edible insects, including silkworm, bamboo worm, and palm weevil. Participants undergo skin prick testing, specific IgE testing, ALEX2, immunoblot analysis, and risk-based oral food challenges to assess clinical cross-reactivity between edible insects and white shrimp and to help avoid unnecessary shrimp restriction.

This project aims to develop and test a new questionnaire to measure how well children recover in the post-anaesthesia care unit (PACU). Currently, children in PACU are mainly assessed using discharge readiness criteria, but these do not fully capture the child's recovery experience or overall wellbeing. Participants will be children aged 2-17 years having elective procedures requiring anaesthesia or sedation, and their parents/caregivers where proxy reporting is needed for younger children. The study will be conducted in stages, including interviews to identify important aspects of recovery, expert review of draft questions, testing of question clarity and acceptability, and field testing of the questionnaire in PACU at planned time points during recovery. Clinical information routinely collected as part of care, such as pain scores, nausea vomiting, airway or oxygen events, and length of stay in PACU, will also be examined to assess how well the questionnaire performs. The expected outcome is a child-centred, practical, and reliable PACU recovery measure that can be used in clinical care, quality improvement, and future research.

Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.

Sleep disturbance is very common among critically ill patients in the intensive care unit (ICU), particularly in older adults after surgery. Poor sleep in the ICU is associated with important complications, including delirium, longer duration of mechanical ventilation, prolonged hospital stay, and increased mortality. Current non-drug approaches to improve sleep, such as reducing noise and light and clustering nursing care, may provide limited benefit and are often difficult to implement consistently. Safe and effective drug treatments for sleep in critically ill older patients remain limited. Lemborexant is a dual orexin receptor antagonist that promotes sleep by blocking wake-promoting pathways in the brain. Unlike many traditional sleep medications, lemborexant has minimal effects on breathing and has been shown to be well tolerated in older adults with insomnia. However, its effects on sleep and delirium have not been studied in critically ill patients. This study is a single-center, randomized, double-blind, placebo-controlled feasibility and pilot trial conducted in the surgical intensive care unit of Siriraj Hospital, Bangkok, Thailand. The study will enroll 100 critically ill postoperative patients aged 65 years or older who are expected to remain in the ICU for at least 48 hours. Participants will be randomly assigned to receive either low-dose lemborexant (2.5 mg) or a matching placebo once nightly for three consecutive nights. All participants will also receive standard non-pharmacologic sleep-promoting care used in the ICU. The main goals of this pilot study are to evaluate the feasibility and safety of administering lemborexant in elderly ICU patients and to explore its potential effects on sleep and delirium. Sleep will be assessed using both subjective questionnaires completed each morning and objective wrist-worn actigraphy to measure sleep duration and sleep stages. Delirium will be assessed twice daily using a standardized delirium screening tool for up to seven days or until ICU discharge. Additional outcomes include medication adherence, adverse events, duration of mechanical ventilation, length of ICU and hospital stay, and in-hospital mortality. The results of this study will provide important preliminary data on the feasibility, safety, and potential benefits of lemborexant in critically ill older adults and will help inform the design of future larger clinical trials aimed at improving sleep and reducing delirium in the ICU.

The goal of this clinical trial is to learn whether a brief suction of the airway going to the surgical lung (bronchus) can help the lung collapse faster and more completely during uniportal video-assisted thoracoscopic surgery (UVATS). This type of surgery is performed through a small incision in the chest, and good lung collapse helps the surgeon see and work safely. The main questions it aims to answer are 1. Does brief bronchial suction improve the quality of lung collapse 1 minute after chest cavity is opened? 2. Does brief bronchial suction help reach satisfactory lung collapse faster? Researchers will compare patients who receive brief bronchial suction and those who do not. This is to see if suction improves and fastens lung collapse, reduce the need for additional steps if lung is not adequately collapsed, affect inflammation, oxygenation, postoperative pulmonary complications, operative time, and the duration of one-lung ventilation. Participants will 1. Undergo UVATS under general anesthesia 2. Have a double-lumen breathing tube placed as part of the standard anesthetic care 3. Be randomly assigned to either receive bronchial suction for one minute or receive no bronchial suction 4. Have the surgical team assess the quality of lung collapse at different time points 5. Have information collected from the routine anesthesia and surgical records such as oxygen levels during surgery, length of surgery and lung-related complications within 7 days after surgery

Firstly, to study the treatment outcomes of hematopoietic stem cell transplantation (HSCT) in patients with hematologic diseases, cancers, and other conditions treated at the Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital. Secondly, to evaluate factors that may influence treatment outcomes in patients with hematologic diseases, cancers, and other conditions undergoing hematopoietic stem cell transplantation. Lastly, to study complications occurring after hematopoietic stem cell transplantation in patients with hematologic diseases, cancers, and other conditions, in order to identify opportunities to further improve treatment outcomes.

Obese people typically have chronic low-grade inflammation. Based on short-term studies, this inflammation could affect the absorption, utilization, storage, and mobilization of iron, and individuals with inflammation might develop iron deficiency (ID) and anemia when inadequacy of iron intake is presented. The double burden of malnutrition is nowadays emerging as a major public health concern in many countries, including Thailand. Understanding the association of chronic inflammation among people with overweight or obesity (OW/OB) with long-term iron absorption and loss is important for developing appropriate policies and programs to promote iron balance and, consequently, optimal iron status and health outcomes. Since previous reports among Thai women showed a high prevalence of OW/OB and anemia, this study will be conducted to determine the long-term iron absorption and loss among OW/OB free-living women using the iron isotope dilution method.

The goal of this clinical trial is to learn whether an intravenous lidocaine infusion (IVLI) works as well as a thoracic paravertebral block (TPVB) - the current standard nerve-block technique - for improving recovery after breast cancer surgery. It will also learn about the safety of both approaches. The main questions it aims to answer are: Does IVLI provide a similar quality of recovery (measured by the QoR-15 score at 24 hours) as TPVB? Does IVLI control pain during the first 24 hours after surgery (measured at rest and with arm movement) as well as TPVB? Participants will: Undergo their planned breast cancer surgery (mastectomy or breast-conserving surgery with sentinel lymph node biopsy) under general anaesthesia, along with either the TPVB injection or the IVLI infusion, assigned at random Attend a preoperative visit the day before surgery to learn how to use the pain and self-quality-of-recovery questionnaire (QoR-15) Fill out a QoR-15 once a day for the first 48 hours after surgery Participants' pain score in hospital recorded during the first 48 hours after surgery, with rescue pain medication available if needed

Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth. Standard treatment with cooling therapy (therapeutic hypothermia) lowers the risk of death or disability, but many infants still suffer long-term problems. This study will test whether adding stem cell therapy after cooling can further improve outcomes. The stem cells are taken from donated human placentas (Wharton's jelly-derived mesenchymal stem cells, MSCs). The cells are prepared under strict laboratory standards and checked for safety. Infants with moderate to severe HIE who have completed cooling will be randomly assigned to receive either three intravenous infusions of MSCs or placebo within the first 10 days of life. Each infusion is given over about 30 minutes while the infant is closely monitored. Researchers will follow participants for up to 2 years. The main outcome is whether MSC treatment can reduce the combined risk of death or serious developmental delay at 1 year of age. The study will also track brain MRI findings, safety events, and developmental progress at 2 years.

This study aims to determine the optimal parameters of lumbar sensory stimulation in office workers with chronic nonspecific low back pain. Participants will attend two laboratory sessions. The first session will characterize baseline clinical and sensorimotor function using clinical assessments, transcranial magnetic stimulation, functional near-infrared spectroscopy during unstable sitting, inertial measurement units, decomposition electromyography, and rehabilitative ultrasound imaging. The second session will use a randomized within-participant crossover design in which participants receive eight combinations of lumbar vibration frequency, amplitude, and direction while bilateral primary somatosensory cortex hemodynamic responses are continuously measured using functional near-infrared spectroscopy. The primary objective is to identify vibration parameters that produce a favorable and consistent cortical response while meeting predefined comfort, safety, and technical criteria.

This randomized, double-blind, sham-controlled trial will evaluate the effectiveness of a sensory stimulation belt in office workers with chronic nonspecific low back pain. Participants will first complete baseline clinical and sensorimotor assessments and will then be randomly assigned in a 1:1 ratio to receive either an active sensory stimulation belt or a sham belt. Participants will wear the assigned belt during their usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Daily belt use, pain intensity, adherence, skin reactions, and device-related problems will be recorded in a study logbook, with weekly follow-up by the research team. Clinical outcomes will include pain intensity, frequency and intensity of low back pain or discomfort episodes, low back pain-related disability, work-related musculoskeletal discomfort, tactile acuity, and pressure pain threshold. Mechanistic outcomes will include corticospinal excitability, somatosensory cortical responses during unstable sitting, postural control, lumbar multifidus motor-unit behavior, and lumbar multifidus contractile response. The primary objective is to determine whether 4 weeks of active lumbar sensory stimulation produces greater improvements in clinical outcomes than a sham intervention and whether clinical changes are accompanied by changes in sensorimotor and neuromuscular outcomes.

The goal of this clinical trial is to evaluate whether hypofractionated whole pelvic or extended-field concurrent chemoradiotherapy can improve treatment access and efficiency while potentially providing superior oncologic efficacy and safety compared to conventional chemoradiotherapy in patients with early-stage node-positive and locally advanced cervical cancer. Building on encouraging safety and efficacy outcomes from our Phase II HYPOCx-iRex trial (TCTR20210812003), this study will provide data for a critical evidence gap regarding the safety, feasibility, and oncologic efficacy of hypofractionated radiotherapy, including extended-field para-aortic treatment, delivered with concurrent chemotherapy. The main questions it aims to answer are: * Does hypofractionated chemoradiotherapy achieve superior nodal control compared to conventional chemoradiotherapy? * Does hypofractionated chemoradiotherapy achieve superior overall survival compared to conventional chemoradiotherapy? Researchers will compare patients receiving hypofractionated external beam radiotherapy to those receiving conventional fractionation to evaluate if the shortened hypofractionated schedule provides comparable disease control, acceptable toxicity, improved quality of life, and cost-effectiveness. Participants will: * Be randomized to receive either hypofractionated external beam radiotherapy or conventional fractionation radiotherapy, both delivered using modern IMRT/VMAT techniques targeting either the whole pelvis or extended fields (including para-aortic lymph nodes). * Receive concurrent platinum-based chemotherapy during external beam radiation. * Complete image-guided adaptive brachytherapy following external beam radiotherapy. * Attend scheduled follow-up visits to evaluate tumor response, disease control, treatment-related toxicities, quality of life, and survival outcomes.

The purpose of this nationwide cross-sectional survey is to determine the prevalence, multidimensional impacts, and associated factors of chronic occupational pain among anesthesiologists and nurse anesthetists in Thailand. Due to the physically demanding nature of anesthesia practice-such as prolonged standing, awkward postures during airway management, and high-stress environments-work-related musculoskeletal disorders are highly prevalent but often underreported. This study aims to collect self-reported data via an anonymous online questionnaire to assess pain severity, specific anatomical locations, economic burdens (including absenteeism and presenteeism), and the overall impact on the health-related quality of life. Ultimately, the findings from this study will help establish a national evidence-based database to improve workplace safety, inform occupational health policies, and enhance the overall well-being of anesthesia providers in Thailand.

A double-blind randomized controlled trial comparing beta-lactam plus levofloxacin versus beta-lactam monotherapy for the treatment of Streptococcal bacteremia

The goal of this Randomised controlled trial is to investigate the effect of exercise on changes in quality of life in in patients with clinical quiescent Inflammatory bowel Disease. The main question it aims to answer * The Relationship Between Moderate-Intensity Exercise and Quality of Life in Patients with clinical quiescent nflammatory Bowel Disease Over a Six-Month Period * To examine the association between the recurrence of clinical symptoms(defined as a Harvey-Bradshaw Index \> 5 for Crohn's disease and a Mayo Ulcerative Colitis Subscore \> 2 for Ulcerative Colitis) and changes in inflammatory markers in blood and stool, comparing patients with clinical quiescent inflammatory bowel disease (IBD) who engage in regular exercise versus those who do not. * To evaluate the relationship between higher levels of physical activity and quality of life, sleep quality, and stress levels in patients with clinical quiescent IBD. * To assess changes in body composition including body mass index (BMI), fat mass, total muscle mass, skeletal muscle mass, and skeletal muscle index between patients who exercise regularly and those who do not. Intervened participants will be encoraged in moderate-intensity exercise for at least 30 minutes per session, three times per week or more, under the supervision and guidance of a sports scientist compared participants who do not receive exercise training or supervision from a sports scientist.

This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.

The goal of this clinical trial is to learn whether a new endoscopic device called the Speedboat works as well or better than the standard needle knife for removing large colonic nonpedunculated polyps. The study will also evaluate the safety of the Speedboat device. The main aims of the study are: * To compare the resection speed of colorectal endoscopic submucosal dissection (ESD) using the Speedboat device versus the standard needle knife. * To compare the en bloc resection rate and curative (R0) resection rate between the two techniques. * To evaluate the safety of using the Speedboat device compared with the needle knife in colorectal ESD. What will happen in this study Adults aged 18 years or older who have a large, flat colorectal polyp (greater than 20 mm) that cannot be safely removed with standard snare polypectomy may take part. Participants will be randomly assigned (like flipping a coin) to one of two groups: * Speedboat group: The lesion will be removed using the Speedboat device, which combines injection, cutting, and bleeding control in one tool. * Needle knife group: The lesion will be removed using the standard needle knife and other separate tools for injection and hemostasis. What participants will do Stay one night in the hospital before the colonoscopy for bowel preparation. Undergo colonoscopy and lesion removal under anesthesia. Have blood tests and monitoring for one day after the procedure. Be followed for two weeks to check for any complications. Have a follow-up colonoscopy 6-12 months later, depending on pathology results. Where and how the study will be done The study will take place at five hospitals in Thailand: Faculty of Medicine Siriraj Hospital, Mahidol University King Chulalongkorn Memorial Hospital Rajavithi Hospital National Cancer Institute of Thailand Phra Nakhon Si Ayutthaya Hospital About 80 participants will join the study. All procedures will be performed by experienced endoscopists who have performed at least 50 colorectal ESD cases.

Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.

This study will evaluate the effects of policosanol supplementation, concurrent exercise training, and their combination on physical fitness, muscle recovery, inflammatory markers, and blood lipid profiles in adults with elevated blood lipids who are not currently indicated for lipid-lowering medication. Participants will be randomly assigned to one of four groups for 12 weeks: policosanol plus exercise training, policosanol alone, placebo plus exercise training, or placebo without structured exercise training. Participants assigned to the supplementation groups will take policosanol 5 mg per day, while those assigned to the placebo groups will take a matching placebo. Participants assigned to the exercise groups will complete a standardized concurrent exercise training program combining aerobic and resistance exercise. The study will compare changes in physical fitness, lipid profiles, and selected blood biomarkers before and after the intervention. The findings may help determine whether low-dose policosanol, alone or combined with exercise training, can support cardiometabolic health and physical fitness in adults with dyslipidemia.

A phase II study evaluating dexamethasone sparing regimen with olanzapine and palonosetron for patients receiving high dose cisplatin to prevent chemotherapy induced nausea and vomiting

The goal of this observational study is to evaluate skin temperature patterns measured by infrared thermography in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Are skin temperature patterns associated with CTS as determined by 6-item CTS scale? Participants diagnosed with CTS as part of their routine clinical care will undergo infrared thermal imaging and electrodiagnostic evaluation according to the study protocol. The relationship between thermographic findings and electrodiagnostic severity will be analyzed.

The global rise in physical inactivity represents an escalating public health crisis, with the proportion of insufficiently active adults projected to reach 35% by 2030. Office workers are at the highest risk due to prolonged occupational sitting; a lifestyle factor heavily linked to various musculoskeletal disorders. While maintaining an upright posture relies on the synergistic coordination of deep core muscles, extended sitting disrupts this muscular balance, leading to chronic postural decay. Although Pilates is proven to improve core muscle thickness, enhance physical fitness, and alleviate low back pain, existing literature shows high variability in training durations (ranging from 6 to 16 weeks) and lacks definitive conclusions regarding its long-term, residual effects post-intervention. Consequently, it remains unclear whether the benefits of Pilates can be sustained once the structured training stops. Therefore, this study aimed to investigate the efficacy of Pilates on core stability and physical fitness among sedentary individuals, providing insights into sustainable exercise interventions.

Due to advancements in technology, Posture-Analyzing and Virtual Reconstructing (PAViR) systems were developed. They used Red-Green-Blue-Depth camera sensors and artificial intelligence to evaluate human posture alignment, muscle balance, and movement without the use of radiation or physical markers. This technology served as a portable, X-ray-like device that was safe and user-friendly, providing detailed views of bone and muscle models alongside easy-to-understand 3D visualizations. However, how to utilize the data obtained from PAViR to support traditional treatment remained unclear. To fill this gap, this study aimed to investigate the effects of AI-based postural feedback on posture correction in patients with idiopathic scoliosis.