Clinical trials

This is a pilot, single-site clinical trial that will follow a randomized, double-blinded, parallel-group, placebo-controlled design. A total of 60 participants aged 18-65 will be recruited for a 12-week intervention, followed by a 4-week observational phase and a post-intervention visit at week 16. Participants will attend five scheduled visits at 4-week intervals (baseline, weeks 4, 8, 12, and 16) at the Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, the University of Hong Kong (HKUSCM). At each visit, assessments will include psychological attributes and sleep quality. Participants will be randomly allocated to one of 2 groups (n=30 per group): the intervention group, which will receive VCMBF and VCDSF, and the control group, which will receive a placebo matched for appearance, smell, and taste. Written informed consent will be obtained from each participant prior to the commencement of the study. The primary outcome will be overall mental health, accessed by the Depression, Anxiety and Stress Scale - 21 items (DASS-21). Secondary outcomes will include anxiety status, measured by the Chinese version of the Beck Anxiety Inventory (BAI-C); depression status, measured by the Chinese version of the Beck Depression Inventory-II (C-BDI-II); stress levels, measured by the Perceived Stress Scale (PSS); psychological well-being, measured by the General Health Questionnaire-28 (GHQ-28); quality of life, assessed using the WHOQOL-BREF (Hong Kong version); and sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), the Mi wristband as an objective measure, and the Consensus Sleep Diary (CSD) for cross-validation. Tongue and pulse characteristics will also be recorded for qualitative analysis. Safety profiles of VCMBF and VCDSF will be evaluated throughout the study. Assessments will occur every four weeks until week 16, with tongue and pulse characteristics recorded at baseline, week 12, and week 16. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.

Diabetes is a systemic condition characterized by elevated blood glucose levels and is associated with multiple long-term complications. This systemic disease is mutually linked to inflammatory gum diseases through circulating inflammatory mediators. Controlling inflammatory gum diseases by maintaining oral hygiene improves blood glucose levels and reduces long-term complications. However, close supervision of good oral hygiene through home care is labor-intensive and expensive. Artificial Intelligence (AI) has been used to provide personalized advice on the adequacy of patients' home care (oral hygiene). The investigators hypothesize that the use of AI can improve home care, thereby enhancing both gum health and systemic health, similar to human dental professionals and standardised oral health instructions.

The goal of this study is to learn whether the timing of weekly chatbot reminders affects user engagement with the chatbot cessation service. Participants enrolled in the routine chatbot cessation service will be included in a micro-randomized trial. The delivery timing of weekly reminders will be randomly assigned across different day types and times of day during the 12-week chatbot cessation service period. The study will use routine chatbot system records to evaluate engagement after reminder delivery, including whether participants respond to the chatbot and how quickly they re-engage with the service.

This study is a feasibility study about a test on adjuvant therapy for patients in hepatocellular carcinoma (HCC) with a higher risk of tumour recurrence after liver resection or ablation. By collecting individual patient's liver and tumour tissue during surgical operation, 3D bioprinting technology will be adopted to construct patient-specific biomimetic liver models -'Liver-in-Cube', to test and identify the most effective adjuvant therapy for individual patients, thereby personalising treatment and improving treatment outcomes, and hence reducing the recurrence rate of HCC. This is a phase II, non-randomised, open-label, single-centre, prospective feasibility study designed to evaluate the use of biomimetic 3D bioprinting technology in guiding the selection of adjuvant treatment regimens to prevent hepatocellular carcinoma (HCC) recurrence after curative liver resection. The study will be conducted at Queen Mary Hospital as a 5 years project. A total of 20 HCC patients who are going to receive liver resection or ablation with a higher risk of tumour recurrence will be recruited. Patients will be identified from clinic and asked if willing to participate in the study. Consent will be signed before operation. Biological samples such as tissue and blood samples will be collected during operation for Liver-in-Cube construction. Patients will receive standard post operative care upon discharge, follow-up in clinic regularly as usual, and be referred to collaborated oncologists for adjuvant therapy. A 1-month post operative scan will also be arranged as standard procedure to confirm the post operative disease status. Result from Liver-in-Cube will be treated as an additional information about adjuvant therapy in preventing HCC recurrence. Patients will discuss with oncologists and decide if to adopt adjuvant therapy or not for HCC recurrence prevention. During the follow-up period, blood samples will also be collected for laboratory analysis outside the routine blood assessment.

Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to current knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.

This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training. Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.

The goal of this feasibility study is to learn if a brief meaning-making wellness intervention based on Viktor Frankl's Existential Psychology works to improve fatigue levels in Young Adult Cancer Survivors (YACS) who have completed primary treatment. The main questions it aims to answer are: * What would be the recruitment and retention rates? * What might the feedback from participants be? * Could there be any effects on fatigue and other related symptoms? Researchers will compare meaning-making to usual care (no intervention) to see if meaning-making works to improve fatigue and other symptoms in YACS. Participants will: * Complete questionnaires (self-reported outcome measures) at baseline, 1-week post-intervention, and at 1-month follow-up. * Attend an in-person, two-session brief meaning-making program

Over 80% of caregivers for individuals with neurodegenerative diseases (ND) engage in significant risk behaviors, particularly physical inactivity, which increases the risk of cardiometabolic diseases (CMD) by 30% and reduces life expectancy by 4-8 years. Despite the health benefits of maintaining healthy behaviors, awareness of behavioral risk management among healthcare professionals and the public is low, and research on this topic for ND caregivers is limited. Given that physical activity (PA) is the most prevalent modifiable risk factor, timely intervention is essential. International guidelines prioritize PA as a key strategy for caregiver health. However, existing PA interventions often struggle with low compliance due to the physical and emotional challenges caregivers face. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA by improving attentional regulation and psychological flexibility. The World Health Organization advocates for non-communicable disease (NCD) prevention through brief lifestyle interventions, such as ecological momentary interventions (EMI), which use mobile messaging (e.g., WhatsApp) to deliver personalized health content. This method is particularly valuable for caregivers who find it difficult to access traditional services due to their responsibilities. A pilot RCT was conducted to compare B-Mindful-Life to brief lifestyle education program in Chinese neurodegenerative disease caregivers, demonstrating promising acceptability, engagement, and effect for increasing PA (NCT06583018). Therefore, this full-power randomized clinical trial aims to rigorously examine its effectiveness and broader impact on this underserved population with several advancement: (i) broaden the population into all neurological disorder caregivers to test for the generalizability of the B-Mindful-Life program; (ii) conduct a 12-month follow-up to assess long-term effects of B-Mindful-Life intervention in real-life settings; (iii) modify outcome measures for targeted assessment. The primary outcome will measure the change in accelerometer-determined, 10-minute bout moderate-to-vigorous physical activity (MVPA) over a 7-day period from baseline to post-intervention.

This pilot feasibility randomized controlled trial will evaluate the feasibility, acceptability, safety, and preliminary effects of Dyadic STEP-SexPCare, a culturally tailored, nurse-led psychosexual programme for Hong Kong Chinese prostate cancer survivors and their female partners after primary treatment. Approximately 72 couples (144 participants) will be randomized 1:1 at the couple level to Dyadic STEP-SexPCare plus standard prostate cancer survivorship care or standard survivorship care alone. Dyadic STEP-SexPCare contains six core components delivered over a planned 6 weeks, with an allowable 6-8-week completion window: four live nurse-led dyadic sessions and two self-paced modules. The programme addresses sexual recovery, couple communication, intimacy, mutuality, dyadic coping, emotional adjustment, sexual adaptation, and shared intimacy planning through a Screen-Tailor-Escalate-Plan approach. Outcomes will be assessed at baseline before randomization, post-intervention at approximately Week 8, and 3 months after the intervention. The primary aim is to assess the feasibility, acceptability, safety, and implementation of the intervention and trial procedures. Secondary analyses will estimate preliminary between-group effects on sexual functioning, mutuality, dyadic coping, psychological distress, and quality of life to inform a future definitive randomized controlled trial.

The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.

The transition from theoretical knowledge to clinical practice is a critical and challenging phase for nursing students. Limited opportunities for scenario-based learning before an clinical practicum impacts students' preparedness for practice and clinical competence. Consequently, this lack of preparation directly fuels stress, creating a a negative feedback loop where this stress inhibits cognitive processing and effective learning. Generative artificial intelligence (GenAI) has emerged as a novel educational technology capable of providing interactive, flexible, and learner-centred simulation experiences. This waitlist randomised controlled trial aims to examine the effectiveness of incorporating the GenAI patient simulation in preparing the undergraduate nursing students for clinical practicum and enhancing the clinical competence compared to the current practice. Hypotheses of this study include: 1. Participants using the GenAI patient simulation will report higher preparedness for the first acute clinical practicum (CP) and higher clinical competence scores compared to the usual practice group at all time points. 2. The frequency of using the GenAI patient simulation will be positively correlated with preparedness for the CP and clinical competence. 3. Participants using the GenAI patient simulation will report lower perceived stress before and during the CP compared to the usual practice group. 4. The frequency of using of the GenAI patient simulation will negatively correlate with the levels of perceived stress before and during the CP.

The goal of this clinical trial is to determine whether strontium-doped bioactive glass-ceramic (SBGC)-filled dentine adhesive is effective in relieving dentine hypersensitivity. The main question it aims to answer is: Is SBGC-filled dentine adhesive more effective in reducing dentine hypersensitivity than non-SBGC-filled dentine adhesive? Researchers will compare SBGC-filled dentine adhesive to a dentine adhesive to see if SBGC-filled dentine adhesive is more effective at relieving dentine hypersensitivity. Participants will receive a single application of either SBGC-filled dentine adhesive (intervention group) or dentine adhesive (control group) on the root surfaces of teeth presenting with pain subject to an air-blast test. The degree of pain will be assessed using a Sensitivity Score at baseline, immediately after application of either the intervention dentine adhesive or control dentine adhesive. The participants will visit the clinic at 1 month, 3 months and 6 months for re-assessment of the severity of dentine hypersensitivity.

The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are: Does the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation? The investigators will compare people taking the Lingzhi supplement to those who do not receive any treatment (waitlist group) to see if it works. Participants will: * Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group) * Visit the clinic 2 times for blood tests (before and after taking the supplement) * Complete questionnaires 3 times about their fatigue and quality of life (4 times participants in the waitlist group)

The purpose of this study is to investigate the effects of the frailty-specific prehabilitation program on functional capacity, frailty, cardiac-specific functional status, serum albumin level, high-sensitivity C-reactive protein (hs-CRP) level, HRQoL, psychological outcomes, major adverse cardiovascular and cerebral events (MACCEs), and hospital readmission rates in cardiac patients. This study tests a home-based prehabilitation program for frail older adults waiting 5+ weeks for heart surgery. Participants, aged 65+ with mild-to-moderate frailty, receive structured preoperative education, protein-rich nutrition advice, relaxation techniques for stress, and exercise training 3 times weekly via home visits, video calls, and self-practice. A control group gets sham light stretching plus usual care.

This study examines how a smartphone conversational application affects feelings of loneliness in Cantonese-speaking older adults living in Hong Kong. Seventy-two adults aged 60 or above who report at least moderate loneliness will be randomly assigned to one of two versions of the same application. Both versions look and work the same way, offer the same three conversational companions, and provide the same set of in-app tools. The two versions differ only in how the companions' replies are produced: in one version replies are generated by a large language model, and in the other they are assembled from pre-written templates selected by keyword and conversation state. Participants use the application for four weeks and are then followed for a further four weeks with continued access. The main question is whether any difference between the two versions in emotional loneliness operates through how understood, validated and cared for participants feel during individual conversations. Participants are not told which version they are using, and the researcher who carries out the assessments is also unaware of the assignment.

This randomized controlled trial aims to evaluate the effectiveness of an online emotion regulation and parenting program for parents of children aged 2-6 years. The program is designed to help parents better manage their emotions and respond more adaptively to their children's emotional and behavioral needs. Participants will be randomly assigned to either the intervention group or the control group. The study will examine whether the intervention reduces parents' emotion regulation difficulties, improves their acceptance of children's negative emotions and their perceived ability to respond adaptively, and improves children's socio-emotional and behavioral outcomes.

The goal of this clinical trial is to assess the efficacy and safety of linear piezoelectric Li-SWT for erectile dysfunction patients who have poor treatment respond from PDE5i oral treatment. Participants will be randomised to either receive 4 cycles, once per week, of Li-SWT treatment on the penis or the Sham group, where the treatment appears to be identical but the shockwave machine is deactivated. Investigators will compare the before and after treatment erectile function using the IIEF questionnaire of the two groups 1 month after treatment to assess the treatment outcome. After that, the Sham group patient would be offered to receive compensatory Li-SWT treatment and their post treatment response will be assessed. All the patients completing the Li-SWT treatment will be followed up at 6 and 12 months to assess the efficacy and adverse events.

The goal of this clinical trial is to learn if improv comedy helps reduce anxiety symptoms and improve mental well-being in Chinese young adults in Hong Kong. The main questions it aims to answer are: 1. Does improv comedy reduce anxiety symptoms? 2. Does improv comedy improve mental well-being? Researchers will compare participants who join the improv comedy workshops to participants who are placed on a waiting list to receive the workshops later, to see if improv comedy reduces anxiety and improves mental well-being. Participants will: 1. Attend weekly three-hour improv comedy workshops for 4 consecutive weeks 2. Complete four assessments and brief reflections during or around the workshop sessions 3. Take part in up to two individual interviews (optional)

The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. A previous randomized controlled trial demonstrated that it reduced pain scores and OBAS compared to plain bupivacaine alone, especially on postoperative day (POD) 1. Adding adjuncts to non-liposomal local anaesthetics can also enhance and prolong postoperative pain relief. The effectiveness of liposomal bupivacaine compared to adjuncts like dexamethasone and dexmedetomidine remains unclear. Since liposomal bupivacaine is more expensive, it is crucial to compare its analgesic efficacy with these alternatives. A randomized controlled trial comparing liposomal bupivacaine versus dexamethasone in the interscalene BPB for shoulder surgery found that liposomal bupivacaine resulted in statistically significantly lower pain scores and less pain interference in the Brief Pain Inventory, although the reduction was not considered clinically relevant. Its high cost may therefore limit its routine use unless specific clinical contexts where its efficacy is maximized are identified. Notably, patients with risk factors like psychological factors, preoperative pain, and prior analgesic use may benefit most from its application. A randomized controlled trial to compare the analgesic efficacy of liposomal bupivacaine plus plain bupivacaine versus dexamethasone plus plain bupivacaine in supraclavicular BPB for patients at higher risk of poor acute pain control post distal radial fracture surgery will be conducted. Patients with severe preoperative pain, opioid use, depressive symptoms, anxiety symptoms, and/or higher energy and high-grade fracture cases will be selected. The primary outcome measured is the intensity of acute postoperative pain with movement in the first 48 hours after surgery. Important secondary outcomes include pain intensity at rest, opioid consumption, OBAS scores, chronic pain, and upper limb functionality.

Research evidence is emerging on the co-existence of a positive caregiving experience in the physically and psychosocially taxing dementia care context, but little attention has been paid to promoting the positive aspects of caregiving (PAC) among family carers. We adopt the paradigm of existential positive psychology, integrating cognitive behavioural theory, construal level theory, and Antonovsky's theory of salutogenesis to develop an existential-cognitive intervention to enhance positive aspects of caregiving (EXCITE-PAC), and thereby improve the health outcomes of family carers of people living with dementia (PLwD). A pilot mixed-method study comprising a randomised controlled trial and a post-trial qualitative interview is proposed to evaluate the effects of EXCITE-PAC on carers' health and to examine whether any such effects are mediated through changes in PAC. Post-trial interviews with carers will further elucidate their experiences of the intervention and their perceptions of its impact. Overall aim \& objectives This sequential mixed-method study aims to: i) evaluate the effects of the 12-week EXCITE-PAC programme on PAC (primary outcome), Health-related quality of life (HRQoL), depression, caregiving self-efficacy and meaning-making among the family carers of PLwD; ii) explore whether the health benefits of EXCITE-PAC, if any, are mediated through improved PAC at the 36-week (i.e., about 6 months) follow-up endpoints; and iii) explore carers' perceptions of the benefits, limitations and acceptability of the EXCITE-PAC programme.

Sarcopenia prevention and management are highly prioritised goals in the Healthy Ageing agenda. The study aims to: 1) evaluate the effects of the digital-enhanced, volunteer-engaged collaborative care pathway to improve sarcopenia, reduce fall risk, and increase health-related quality of life (HRQL) among community-dwelling older adults with risk of, or diagnosed with, sarcopenia; 2) evaluate whether the volunteers who received health coach capacity training and supported the intervention experienced health benefits across time; 3) explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; 4) evaluate the intervention implementation process and effects from the perspectives of social care workers.

The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to 1. reduce caregivers' Expressed Emotion (EE), 2. reduce caregivers' depressive symptoms, 3. reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and 4. improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD). Researchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is. Participants will take part in: Pretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion

To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's goal-based SDM model. The investigators hypothesize that compared with patients in the usual care group, patients in the 'CKD Jumpstart- Tips' intervention group will have: 1. increased level of shared decision-making (observer-based and patient-reported), 2. improved quality of communication, 3. increased patient involvement in decision-making, 4. lower decisional conflict, 5. lower decision regret, 6. decreased time to decision, 7. improved adherence to treatment choice, and 8. improved health-related quality-of-life.

Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). \[1-3\] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules. Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized \[4-9\], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.

The goal of this clinical trial is to conduct a study randomizing glaucoma patients to home intra-ocular pressure (IOP) telemonitoring combined with Smart phone-based intervention (Management Paradigm I) or Smart phone-based intervention alone (Management Paradigm II), with the objectives to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal nerve fiber layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. We hypothesize that glaucoma patients randomized to Management Paradigm I will (1) attain lower levels of intra-ocular pressure (IOP), and (2) a slower rate of Retinal nerve fiber layer (RNFL) and ganglion cell inner plexiform layer (GCIPL) thinning compared with those randomized to Management Paradigm II because of having a more precise assessment of intra-ocular pressure (IOP) to guide intra-ocular pressure (IOP)- lowering therapy would be feasible in Management Paradigm I. It aims to: to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal Nerve Fiber Layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. Participants will asked to do, * Management Paradigm I: will be provided with an iCare Home and instructed to measure and upload 6 intra-ocular pressure (IOP) measurements weekly (2 days a week, 1 measurement in the early morning (5 am to 9 am), 1 during the mid-day (12 pm to 4 pm) and 1 in the evening (7 pm to 11pm)) to a secure server via iCare CLINIC (the number of weekly intra-ocular pressure (IOP) measurements follows the number of weekly blood pressure measurements in the HyperLink study). The morning measurement will include two readings with the first obtained in the supine position before getting out of the bed and the second obtained in the upright position right after. Patients may take additional intra-ocular pressure (IOP) measurements in supine position if they wake up in bed from sleep, as well as other times of the day, but this is not mandatory. These additional intra-ocular pressure (IOP) measurements will not be included for treatment decisions during the study period. * Management paradigm II: Patients will be treated with a topical prostaglandin analogue after baseline intra-ocular pressure (IOP) measurements.