Clinical trials

This single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Forty adults with T2DM will undergo a pre-durian phase, a durian consumption phase, and a post-durian phase, each lasting 10 to 14 days. Participants will attend five visits at Singapore General Hospital for clinical assessments, continuous glucose monitoring, fasting blood collection, stool sample collection, and dietary and stool record submission. The study aims to determine whether durian consumption alters microbiome and metabolomic profiles and whether it affects glycemic measures in adults with T2DM.

As people grow older, their immune system - the body's natural defence against diseases - becomes weaker, making them more vulnerable to infections and less responsive to vaccines. This was clearly seen during the COVID-19 pandemic, where older adults were more likely to develop severe illness. Researchers have made an interesting discovery about AS01, an ingredient already used in successful vaccines like the shingles vaccine. They found clues that AS01 might work like a general fitness trainer for the immune system, potentially making it stronger and better at fighting off various types of infections, not just specific ones. To confirm this possibility, we are conducting this research study with adults aged 21-59 to test whether AS01 by itself can boost and train the immune system, how long this boost lasts, and if it actually helps you fight off other infections more effectively.

The goal of this clinical trial is to evaluate the feasibility and acceptability of using silver-impregnated dressings, compared to standard daily topical antibiotic exit-site dressings, for the management of catheter exit-site infection or tunnel infection in adult patients undergoing peritoneal dialysis. The study also aims to explore infection resolution, safety, and clinical outcomes associated with this alternative exit-site care approach. The main questions it aims to answer are: Is the use of silver-impregnated dressings feasible and acceptable for peritoneal dialysis patients with exit-site or tunnel infection? Does the use of silver-impregnated dressings result in faster resolution of catheter exit-site or tunnel infection? Does replacing daily topical antibiotic dressings with silver-impregnated dressings reduce the frequency of dressing changes and the time spent on exit-site care? Are there any adverse events associated with the use of silver-impregnated dressings? What infection-related clinical outcomes occur, including recurrence of infection, need for catheter removal, or infection-related hospitalisation? Standard management of catheter exit-site or tunnel infection typically includes daily exit-site cleansing, application of topical antibiotics, sterile dressing coverage, and systemic antibiotic therapy. Despite these treatments, some patients continue to experience persistent or recurrent infections and adverse outcomes such as peritonitis, catheter loss, or transfer to haemodialysis. Participants will: Be randomly assigned to receive either silver-impregnated dressings or standard exit-site care with daily topical antibiotic dressings as alternative approaches to local exit-site management Continue to receive systemic antibiotics according to current clinical guidelines Attend regular clinic visits for exit-site assessment and monitoring Be followed for up to twelve weeks to evaluate feasibility, safety, patient experience, and infection-related outcomes The results of this pilot study will help evaluate whether silver-impregnated dressings are a feasible and acceptable alternative to standard topical antibiotic exit-site dressings for managing catheter-related infections in peritoneal dialysis patients and will inform the design of future larger clinical studies.

Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.

Natural orifice specimen extraction (NOSE) is a minimally invasive colorectal surgical technique in which the surgical specimen is removed through a natural orifice, including transanal or transvaginal routes, thereby avoiding an abdominal extraction incision. Observational studies suggest that NOSE may reduce wound-related morbidity and improve postoperative recovery, but prospective multicenter data evaluating long-term outcomes remain limited. AP-NOSES is a prospective, multicenter observational registry evaluating clinical, patient-reported, and long-term wound outcomes following minimally invasive colorectal surgery with NOSE or transabdominal specimen extraction. The primary objective is to compare time to incisional hernia within 24 months between NOSE-eligible patients undergoing planned NOSE extraction and NOSE-eligible patients undergoing planned transabdominal extraction. Secondary objectives include evaluation of postoperative complications, extraction-related morbidity, bowel function, urinary and sexual function, oncologic outcomes, and long-term patient-reported and clinical outcomes across participating centers. This study does not alter routine clinical care. Surgical technique, perioperative management, and follow-up are performed according to local institutional practice.

Background: The current legal standard of advice in Singapore has three components: distinction of advice from the other parts of clinical consultation (i.e. diagnosis and treatment) for the purpose of standard setting, categories of information that need to be disclosed to patients and how the adequacy of this information is judged in court. A review of empirical data shows that information deficit is not the only or most pressing concern in decision-making from the patients' perspective. The data also reflects the value that is placed on relationships that patients have with their treating doctors. Features of a good doctor-patient relationship can be found in partnerships, which are based on therapeutic alliance and mutuality. Objective: To develop a contextual understanding of the role of clinical partnerships in Singapore, empirical data is needed from both patients and healthcare workers on their understanding and interpretation of doctor-patient partnerships and how medical decisions are made using this relationship. Design: A qualitative study using interpretive analysis of semi-structured interviews conducted via in-person, telephone and videoconferencing interviews.

Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles. Traditional verbal consent may not consistently ensure comprehension or reduce preoperative anxiety. PEAR (Patient Education of Anesthesia Risks) is a multilingual, AI-driven chatbot developed to enhance patient education and improve the quality of anaesthesia risk counselling. Study Objective: To compare PEAR's performance in delivering anaesthesia risk consent against the standard face-to-face verbal method.

The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.

This study aims to find out whether listening to music before, during, and after pain procedures can help reduce anxiety, pain catastrophising, and acute pain in patients with chronic pain. Music therapy may provide a simple, safe, and non-drug way to help patients relax and feel more comfortable. In this study, adult patients with chronic pain who are scheduled for interventional pain procedures at Singapore General Hospital will be randomly assigned to one of two groups. One group will listen to self-selected music through headphones and speakers before, during, and after the procedure. The other group will receive standard care without music. Researchers will measure anxiety, pain catastrophising, and pain levels before and after the procedure using validated questionnaires. The main outcome will be the level of anxiety after the procedure. Other outcomes include pain catastrophising scores, pain scores during local anaesthetic injection, and overall patient satisfaction. This study will help determine if music therapy can be routinely used to improve comfort and emotional well-being for patients undergoing interventional pain procedures.

The goal of this clinical trial is to learn the feasibility of equipping the volunteer community responders (VCR) with the mobile external automated defibrillators (mAEDs) for the management of adults experiencing out-of-hospital cardiac arrest (OHCA) patients. It will also provide early signals if this enhanced system can help increase the frequency of defibrillation and doing it earlier. The main questions it aims to answer are: * Can equipped VCRs apply mAEDs more frequently and earlier to potentially get more patients successfully resuscitated? * Is this system enhancement is feasible in the long run. Participants, the VCRs, will: * Carry a 450 gm mAED with them all the time for up to an year and use it on an OHCA patient if and when alerted to help. * They will hand over this single-use battery-operated device to the EMS crew for data retrieval and potential replacement * They will be interviewed for their experience of being equipped and use of the mAED.

Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers. The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context. The main questions it aims to answer are: 1. Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)? 2. Can the care bundle prevent the development of new pressure injuries? 3. How well do caregivers learn and apply PI care knowledge after receiving the educational intervention? 4. How practical and acceptable is this care bundle for use in home settings? The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement. Participants and their caregivers will: Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care. Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them. The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.

The goal of this study is to learn if a behavioral change intervention can improve physical activity in stroke survivors living in the community. The main question it aims to answer is, if a behaviour change intervention and personalised physical activity prescription, are effective in improving the time spent in moderate to vigorous physical activity amongst chronic stroke survivors. Researchers will compare the intervention group to a control group, to see if physical activity counselling and a personalized physical activity prescription is more effective in improving moderate to vigorous physical activity, than usual care alone. The study period for each participant is 6 months. Assessments are conducted at month 1 (baseline), 3 and 6. The control group will receive only usual care, which consists of an information sheet on physical activity with the following content: (1) Why be active and (2) How to be active (with URL links to resources and videos). The usual care is delivered at 3-time points during month 1, 3 and 6. The intervention group will receive usual care and a behavioral change intervention. The behavioral change intervention consists of up to 6 individual physical activity counselling sessions and a personalized physical activity prescription. The 6 sessions will take place only during months 1 to 3 and there will be no intervention during months 4 to 6. Of the 6 sessions, 3 are conducted face-to-face and another 3 sessions will take place using telehealth methods such as phone, text messaging and videoconference. Participants can meet the study physiotherapist at their preferred exercise space during the 3 face-to-face sessions. The physical activity counselling sessions consist of goal setting and action planning, and problem-solving barriers around participation in physical activity. The overall aim is to increase time spent in moderate-vigorous physical activity.

Sarcopenia, a condition where individuals lose muscle mass and strength, is associated with poorer health and function. While aging is a well-known cause of sarcopenia, obesity is increasingly recognised as a significant factor. When sarcopenia and obesity occur together, it can result in more severe health problems. This is especially concerning because weight loss, the treatment for obesity, can further reduce muscle mass and potentially worsen the situation. Despite this, it is unknown how common sarcopenia is among people with obesity, as only a few studies have looked into this using the most accurate diagnostic criteria, showing a prevalence of 4-13%. In this study, the investigators will examine the prevalence of sarcopenia in 300 adults with obesity at a specialized Obesity Center. The investigators expect to find a higher prevalence among Asian participants due to differences in body composition compared to other ethnic groups. The investigators will also explore various factors that might be linked to sarcopenia in these individuals, such as age, gender, race, body mass index, smoking and alcohol use, medical conditions, medications, physical activity, aerobic capacity, and dietary protein intake. Some of these factors could help in identifying those at risk of sarcopenia and could be targeted for future treatments. Currently, screening for sarcopenia is not a standard part of routine obesity care as it requires specialized equipment and trained staff. By determining how common sarcopenia is in people with obesity, this study will help healthcare providers better understand the problem and allocate resources effectively. Identifying factors associated with sarcopenia will also help streamline diagnosis and monitoring for those at risk.

This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.

The rise in out-of-hospital cardiac arrest (OHCA) cases in Singapore highlights the need for effective bystander cardiopulmonary resuscitation (BCPR). Despite many lay responders performing CPR, survival rates with good neurological outcomes have not significantly improved, prompting research into the quality of CPR as a critical factor. The study by Gallagher EJ et al. showed a significant survival improvement with high-quality CPR. To address this, the Unit of Pre-hospital and Emergency Research (UPEC) trained thousands of community first responders (CFRs) in simplified CPR techniques using hands-only and DA-CPR methods. A significant innovation is the CPRcard®, developed by Laerdal in Norway, which offers real-time feedback on the quality of chest compressions. However, only 36% of CFRs using the CPRcard® achieved the desired compression standards, indicating room for improvement. The study proposes enhancing CFR support with information communication technology (ICT), enabling two-way audio and one-way video communication between CFRs and dispatchers. This aims to reduce stress among responders, increase their willingness to engage with OHCA alerts, and improve CPR quality. The clinical trial in Singapore will compare the current system against the enhanced CFR support system (eCSS), focusing on the real-time relay of CPR performance data, communication ease, and implementation factors. The high-quality CFR and OHCA registries in Singapore provide a robust setting for this research, aiming to enhance CPR delivery and improve OHCA outcomes through technology and real-time support.

This clinical trial aims to determine whether Natural Killer (NK) cell therapy administered in combination with concurrent chemoradiotherapy (CRT) can reduce recurrence in patients with advanced nasopharyngeal cancer (NPC), and to identify the highest safe and tolerable dose of allogeneic NK cells. Allogeneic NK cells, derived from healthy donors, have demonstrated good tolerability in cancer patients. The primary research questions are: 1. What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients? 2. Can the addition of allogeneic NK cells to standard CRT reduce the proportion of NPC patients with detectable plasma EBV-DNA from 30% to 10%? Phase 1: Participants will receive one of five escalating doses of allogeneic NK cells with CRT to determine the MTD. Phase 2: Participants will receive the established MTD NK dose together with CRT. Participants will undergo regular safety monitoring, side-effect assessment, measurement of plasma EBV-DNA levels, and surveillance for disease recurrence.

Spinal cord injury (SCI) often results in persistent motor deficits that are inadequately addressed by conventional rehabilitation. Transcutaneous spinal cord stimulation (tSCS) is a promising non-invasive neuromodulatory approach that can enhance motor activation and gait performance; however, current tSCS systems rely on static, pre-programmed stimulation parameters that do not adapt to real-time motor output or task demands. This limitation may reduce muscle selectivity and disrupt the spatiotemporal dynamics of spinal network activation required for functional movement. This study aims to develop and evaluate an AI-powered closed-loop multielectrode tSCS system that dynamically adjusts stimulation parameters in real time based on kinematic and surface electromyography (EMG) feedback during walking in individuals with incomplete SCI. The study will compare immediate muscle recruitment and motor performance between conventional static tSCS and dynamic, targeted tSCS guided by real-time physiological signals. The investigators hypothesize that AI-driven closed-loop tSCS will be safe and feasible, and will result in superior muscle activation patterns and improved gait performance compared with static stimulation. Findings from this study will provide foundational evidence for adaptive neuromodulation strategies and support the advancement of next-generation, data-driven spinal cord stimulation technologies for neurorehabilitation in SCI.

This observational study aims to develop novel contemporary risk factor tools for detecting young onset diabetes (under 40y) in young Asians in Singapore. The investigators aim to recruit 3000 people not currently known to have diabetes, selected across age and Body Mass Index categories, and perform formal diagnostic tests for diabetes (oral glucose tolerance test and HbA1c). The participants will also undergo continuous glucose monitoring sensor, keep a food diary, and undergo body composition analysis using bioimpedance analysis, handgrip measurements for muscle strength, and sociobehavioural profiling through download of a curated list of social media interactions. The participants will also have a blood sample retrieved and stored for subsequent comparison between people with normal glucose versus abnormal glucose levels. The whole group will also have another blood sample stored for whole gene analysis.

The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications. This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.

Individuals with chronic cervical spinal cord injury (SCI) and tetraplegia commonly experience persistent impairment in upper limb function, leading to reduced independence and quality of life. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that has demonstrated potential to improve upper limb strength and function when combined with rehabilitation. However, access to tSCS is limited in Singapore due to cost, regulatory barriers, and the need for frequent outpatient therapy. This study evaluates the safety, efficacy, and feasibility of a home-based digital rehabilitation program incorporating tSCS delivered using a commercially available neuromuscular electrical stimulation (NMES) device. Using a prospective, open-label single-case experimental design with multiple baselines across participants, individuals with chronic, non-progressive cervical SCI will receive daily home-based tSCS combined with an mobile application-guided upper limb exercise program. Upper limb function, quality of life, feasibility, and safety outcomes will be assessed longitudinally over a 22-week study period.

The purpose of this research study is to investigate how body weight and weight-loss surgery affect the natural chemicals found in scalp hair over time. We will also find out how common and severe hair thinning/hair loss and muscle loss are in the first 6 months after bariatric surgery.

Advanced cancer is a life-limiting condition that can negatively impact quality of life and function. Patients often suffer from physical, emotional, social, spiritual, and decision-making issues. As such, most would benefit from basic palliative care (PC) which includes establishing goals of care through serious illness conversations (SIC), managing basic pain and other symptoms and addressing psychosocial needs, among others. Patients with advanced cancer are also at higher risk of functional decline due to receiving multiple concurrent treatments. Yet, among patients with advanced cancer undergoing major surgery, there has been little consideration of PC and functional needs. The palliative surgical care model is a care model in which PC educated surgical oncology teams deliver basic PC, allowing sustainable PC provision to an increasing number of patients living with advanced cancer. In a local pilot palliative surgical care model, it was found that a care coach-led palliative surgical oncology (PSO) care model significantly increased palliative care delivery, ensuring more consistent and comprehensive support for patients. In addition, cancer rehabilitation delivered by rehabilitation professionals addresses functional impairments during the cancer journey, restoring and/or maintaining function and improving quality of life. It also plays a preventive role before surgery, a restorative role during treatment, and a supportive role during cancer progression. Therefore, to address longitudinal PC and functional needs, an integrated care coach-led palliative surgical oncology rehabilitation (PSO+R) care model involving PC-trained care coaches, surgical oncology teams, rehabilitation professionals, supported by specialist palliative care (SPC) physicians who will provide PC and cancer rehabilitation throughout the patient's advanced cancer journey, is proposed.

Focal therapy (FT) is a new approach to treating localized prostate cancer. Instead of treating the entire prostate, it targets only the cancerous areas while preserving healthy tissue. This helps reduce side effects like urinary, sexual, and bowel problems. In a prospective observational expansion of a phase II clinical trial (ProAMFocal), 80% of patients with small, localized prostate cancers treated with FT had no cancer recurrence at one year, and 70% at 3 years after treatment. The investigators studied the genetic makeup of each cancer, and found that certain genetic markers and cancer subtypes were better at predicting recurrence than standard clinical measures. Based on this, the investigators are launching the FLAME-PC trial. In this study, all patients who qualify for FT will first undergo genetic profiling of their cancer. Patients with favorable profiles (low risk based on genetic markers) will receive FT, while those with high-risk profiles will be advised to undergo standard treatments like prostate removal or radiation. The investigators current main goal is to test if genetic profiling can help us better select patients for FT. They believe that patients chosen using this method will have low recurrence rates (\<10%) compared to those in their previous study (20-30%). FLAME-PC aims to show that personalized treatment based on genetic profiling can improve outcomes for prostate cancer patients, offering effective cancer control with fewer side effects.

The purpose of this research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.

To explore the usefulness of SFDI in the assessment of revascularization pre and post intervention