Clinical trials

This study will examine whether student-centred simulation-based skills training helps undergraduate nursing students in the United Arab Emirates feel more confident in coping with difficult situations and experience less stress and anxiety. Simulation-based training allows students to practice skills through realistic scenarios. The study will compare a group receiving this training with a comparison group, using questionnaires before and after the training to assess changes in confidence in coping, perceived stress, and current anxiety.

The goal of this clinical trial is to learn if adding an oxygen-releasing gel to a deep dental cleaning treatment can improve gum health more than deep cleaning alone, in adults with severe gum disease. The main questions it aims to answer are: 1. Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone? 2. Does adding oxygen-releasing gel to deep cleaning lead to greater improvement in gum attachment, less gum recession, less plaque, and less bleeding, compared to deep cleaning alone? 3. Do any improvements last for up to 6 months? Researchers will compare one side of each participant's mouth, treated with deep cleaning plus oxygen-releasing gel, to the other side, treated with deep cleaning alone, to see if adding the gel produces a bigger and longer-lasting improvement in gum health. Participants will: * Attend 5 visits over 6 months * Receive deep cleaning (scaling and root debridement) on both sides of the mouth at visits where it is needed * Have one side of the mouth randomly chosen, using a method similar to drawing lots, to also receive the oxygen-releasing gel * Receive the gel twice: once at the first visit, and again one week later * Have their gum measurements checked at each visit

This is a multicentre, prospective, observational study of the medicine tirzepatide as it is used in routine clinical care in Pakistan. Tirzepatide is already approved for type 2 diabetes and for obesity, but there is very little information on how it works for people in South Asia, and none from Pakistan specifically. This study aims to fill that gap. The study will follow 330 adults who are starting tirzepatide as part of their normal treatment, across ten diabetes and endocrinology centres in Pakistan. Everyone taking part has obesity, and they are grouped into three cohorts based on their blood sugar status at the start: obesity without diabetes, prediabetes with obesity, and type 2 diabetes with obesity. The study does not change anyone's treatment. The treating doctor decides whether to prescribe tirzepatide, at what dose, and for how long. The study simply observes and records what happens over 24 weeks, with assessments at the start, at Weeks 12 to 14, and at Weeks 24 to 26. The main things measured are the change in blood sugar control (HbA1c) in the diabetes cohort, and the change in body weight in the obesity and prediabetes cohorts. The study also looks at changes in blood pressure, cholesterol, and other measures, how well people stay on treatment, any side effects, and how participants feel about their treatment and quality of life. The findings will help doctors understand how tirzepatide performs in real-world care in Pakistan and inform its use in similar populations.

This parallel three-arm, single-blind (assessor-blinded), randomized controlled trial (RCT) aims to compare the effects of ACT, CBT, and treatment-as-usual (TAU) on the severity of depressive symptoms (primary outcome), the severity of comorbid anxiety symptoms, marital satisfaction, intimacy with spouse, quality of life, and experiential avoidance (secondary outcomes) among people diagnosed with major depressive disorder (MDD) with marital crisis across four time points (T0 = baseline (pre-intervention), T1 = post-intervention (immediately after completion of the intervention, 8 weeks after its commencement), T2 = follow-up at 12 weeks after completion of the intervention, T3 = follow-up at 24 weeks after completion of the intervention). A total of 120 MDD patients with marital crisis will be recruited from two study sites and randomized by stratified block randomization into three groups (ACT, CBT and TAU) in a 1:1:1 ratio. ACT group therapy will be conducted once a week for 8 weeks in the ACT group, while CBT group therapy once a week for 8 weeks will be carried out in the CBT group. During baseline assessment (T0), the demographic and clinical characteristics, the Chinese versions of the Beck Depression Inventory-II (BDI-II), the Generalized Anxiety Disorder 7-item scale (GAD-7), the Personal Assessment of Intimacy in Relationships (PAIR), the Dyadic Adjustment Scale (DAS), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and the Acceptance and Action Questionnaire-II (AAQ-II) will be administered to all participants. The re-administration of the BDI-II, GAD-7, PAIR, DAS, WHOQOL-BREF and AAQ-II will be carried out at T1, T2, and T3.

The goal of this observational study is to learn whether community pharmacy-based risk assessment and point-of-care HbA1c testing can help detect undiagnosed type 2 diabetes and prediabetes among adults in Irbid Governorate, Jordan, who have no previous diabetes diagnosis. The main questions it aims to answer are: What proportion of participants fall into each Finnish Diabetes Risk Score category? What proportion of participants at high or very high risk have HbA1c results within the prediabetes or diabetes range? Participants will: Complete the Finnish Diabetes Risk Score questionnaire at a community pharmacy. Receive a finger-prick HbA1c test at the pharmacy if their risk score is 15 or higher. Visit a general practitioner or primary care facility for diagnostic confirmation if their HbA1c result is abnormal. Attend follow-up assessments at three and six months if a general practitioner confirms type 2 diabetes.

The goal of this interventional study is to test the effectiveness of reading rehabilitation module towards reading speed and error, and quality of life in glaucoma patients.The main questions it aims to answer are: 1. Is there a significant difference in reading speed over a 6-month period between glaucoma patients who undergo a reading rehabilitation module and those who receive standard care? 2. To what extent does the implementation of a reading rehabilitation module reduce the frequency of reading errors in glaucoma patients compared to a control group across baseline, 3-month, and 6-month follow-ups? 3. How does a structured reading rehabilitation module influence the self-reported quality of life in glaucoma patients from baseline to 6 months when compared to those receiving standard care? Participants will: Patients in interventional group will be instructed to practice the reading module for 20-30 minutes daily, minimum 3 days/week, for 6 months. Visit the clinic once every 3 months for checkups and tests A logbook will be provided to record their practice sessions. While participants in control group will receive standard care, visit the clinic once every 3 months for checkups and tests.

The goal of this randomised control trial is to learn about the effect of home based circuit training on patients with primary glaucoma. The main questions to answer are: 1. Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training? 2. Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training? 3. Is there any difference of choroidal thickness layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training? Researchers will compare patients with primary glaucoma who are performing home-based circuit training and not performing home-based circuit training to see if any affect to intraocular pressure, retina nerve fibre layer and choroidal thickness.

This study aims to evaluate the effectiveness of a single HA injection in improving pain, function, and quality of life in patients with knee OA over a 12-month period. By focusing on a single-arm open-label design, this study will provide practical insights into the real-world application of this treatment approach.

The goal of this three arm, double-blind, randomized controlled trial is to learn if an exergame-acceptance and commitment therapy (e-ACT) program can treat depression and anxiety in breast cancer patients, compared to acceptance and commitment therapy (ACT) alone and treatment-as-usual. The main question it aims to answer is: Is there a difference in the effectiveness of the e-ACT program in reducing depressive and anxiety symptoms, cancer-related fatigue, experiential avoidance, and serum IL-6 levels, while increasing BDNF and improving posttraumatic growth and quality of life among breast cancer patients, compared to ACT alone and treatment-as-usual, measured at baseline, 8 weeks (post-intervention), and 12 weeks after the intervention (follow-up)? Researchers will compare the e-ACT group, the ACT-alone group, and the treatment-as-usual group to see if the e-ACT program yields superior outcomes in reducing psychological distress and improving well-being. Participants will: Be randomly assigned to one of three groups: (1) e-ACT (exergame + ACT), (2) ACT alone, or (3) treatment-as-usual (general patient education). Attend an 8-week program (one session per week) if in the e-ACT or ACT group; the control group continues their usual care. Complete questionnaires at three time points (baseline, 8 weeks, and 20 weeks) to assess depression, anxiety, quality of life, posttraumatic growth, valued living, experiential avoidance, and cancer-related fatigue. Provide blood samples at pre-intervention and post-intervention (week 8) for analysis of interleukin-6 (IL-6) and brain-derived neurotrophic factor (BDNF) biomarkers.

This randomized controlled trial aims to compare the effectiveness of motor control exercise, aerobic walking exercise, and muscle strengthening exercise in overweight male adults with non-specific chronic low back pain and central sensitization. A total of 156 participants will be randomly assigned to one of four groups: motor control exercise plus patient education, aerobic walking exercise plus patient education, muscle strengthening exercise plus patient education, or patient education only. The interventions will be delivered over 12 weeks. The primary outcome is conditioned pain modulation (CPM), which reflects endogenous pain inhibitory function. Secondary outcomes include pain intensity, disability, health-related quality of life, executive function, and isometric trunk muscle strength. Body weight and body mass index will also be assessed as exploratory variables. Outcomes will be evaluated at baseline, immediately after the 12-week intervention, and at 6-month follow-up.

The goal of this clinical trial is to learn if the Mobithron Advance drug works to treat and slow the progression of osteoarthritis (OA) in patients. It will also learn about the safety and long-term effects of this drug. The main questions it aims to answer are: * Does long-term administration of Mobithron Advance can modify the progression of knee osteoarthritis with Kellgren-Lawrence grade 1 to 3 in HUSM patients? * Does long term usage of Mobithron Advance has safety profile? Researchers will compare the Mobithron Advance drug to a placebo (a look-alike substance that contains no drug) to see if said drug works to treat OA. Participants will: * Undergo pre-study assessment (baseline assessments) during first visit * Take oral Mobithron Advance daily for 1 year * Visit the clinic once at 3 months, 6 months and 12 months intervals from the initial visit for follow up assessments

This investigational research aims to understand the mechanism of delaying the progression of dementia through different types of exercise. Exercise plays a protective role by attenuating the progression of cognitive impairments in mild cognitive impairment (MCI), an early and reversible stage of dementia. However, how different types of exercise induce changes in physical frailty and cognitive function is understudied. The participants will be randomized to receive an exercise intervention program (cycling or strength training) for 12 weeks or a control group. The participants will be asked to perform certain cognitive and physical assessments at the start of the study, at the end of 12 weeks of exercise intervention, and 4 weeks after the end of the intervention. Below is the list of the assessments: * Patient Health Questionnaire-9 (PHQ-9) * World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0-12) * Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls * body height, weight and fat percentage, heart rate, blood pressure, Dual-Energy X-Ray Absorptiometry (DEXA) scan: measurements to evaluate overall physical characteristics * handgrip strength: to evaluate musculoskeletal function * Stroop test: to evaluate information processing speed and executive cognitive control * n-back task: to evaluate working memory and executive function * Timed Up and Go (TUG) test: to measure balance * single-task gait: to measure walking ability * double-task gait: to measure walking stability and attention During Stroop test, n-back task, Timed Up and Go (TUG) test, single-task gait and double-task gait, the participants will be equipped with a mobile functional near-infrared spectroscopy (fNIRS) device over their forehead. This device is used to detect changes in blood flow in the front area of the brain. Their participation will last approximately 18 weeks (2 weeks of familiarization and assessment, 12 weeks of exercise intervention, and 4 weeks of follow-up).

Office workers often suffer from chronic low back pain due to long hours of sitting and poor posture. This study will test whether Baduanjin-a gentle, traditional Chinese exercise-can help reduce pain and improve physical function in office staff with long-standing back pain. Thirty participants will be randomly assigned to either practice Baduanjin for eight weeks or receive no special intervention. Researchers will measure changes in pain levels, movement ability, balance, posture, and daily functioning before and after the program. Baduanjin is a safe, low-cost, and easy-to-learn exercise that could be widely used in community health settings as a non-drug therapy for back pain.

This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.

Computer vision syndrome (CVS), also referred to as Digital eye strain (DES), is a group of eye and vision problems caused by prolonged use of electronic devices. The American Optometric Association (APA) defines DES as a group of eye and vision-related problems caused by prolonged computer, tablet, e-reader, and cell phone use. Currently, for more than 20 years, DES has been recognised as a public health issue, and the terms DES are also used to describe the condition, attributed to the wide range of digital devices associated with potential problems.

This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics. A two-arm, parallel cluster-randomized controlled trial (1:1 allocation) will be implemented, where the study group receives Anticipatory Guidance (AG) through Motivational Interviewing (MI), and the control group receives conventional MOH AG. Mothers aged ≥18 years who can understand Bahasa Malaysia and their healthy 6-month-old infants (full-term, without congenital conditions) are eligible. Mothers with postpartum depression and infants requiring special oral healthcare are excluded. A total of 228 mother-infant pairs will be recruited using multistage sampling. Three MCHCs from Setiu and three randomly selected MCHCs from Hulu Terengganu will participate. Systematic sampling will be applied within each clinic. Data collection occurs at infant ages 6, 9, and 12 months during routine immunization visits. At each visit, infants undergo oral examination using ICDAS and a caries risk assessment. Mothers complete age-specific validated questionnaires on knowledge and practices. The study group receives two MI sessions (at 6 and 9 months) with follow-up phone calls, while the control group receives routine AG by MOH staff. The MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers and dental officers/therapists in MOH MCHC and MOH dental clinic in Besut district. While fidelity assessment of MI sessions conducted will be done using MITI 4.2.1 guidelines. All MI sessions will be delivered by the trained principal investigator. Approximately 8 minutes are required for infant oral examination, 7 minutes for questionnaire completion, and 30 minutes for MI. Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p \< 0.05. Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ Human Research Ethics Committee USM (HREC) and Medical Research and Ethics Committee (MREC) MOH. Participation is voluntary, with confidentiality ensured. No major risks are expected.

The purpose of this study is to better understand how physical characteristics, walking patterns, and a blood-based brain health marker differ between older adults with dementia and healthy older adults. Dementia is often associated with changes in physical health and movement, but these changes are not fully understood. This study asks whether people with dementia show differences in body composition, walking ability, and levels of brain-derived neurotrophic factor (BDNF), a protein involved in brain function, compared with individuals without dementia. To answer this question, participants will complete a single assessment session that includes basic physical measurements, an assessment of walking while moving at a comfortable pace, and a small blood sample collection. The information collected will be used to compare the two groups and explore possible relationships between physical function, walking patterns, and BDNF levels.

This observational study will evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. The study will compare questionnaire-based results with clinical examination findings to assess diagnostic accuracy and agreement.

The goal of this clinical trial is to evaluate the effects of stingless bee honey (Kelulut honey) in juvenile open-angle glaucoma patients. The study evaluates the effects on serum Interleukin 6 level(IL-6), retinal nerve fiber layer(RNFL) thickness and dry eye-related symptoms. A total of 60 participants who meet the study criteria will be randomly assigned to one of two groups. One group will consume 30 grams of Kelulut honey daily for a period of three months, while the control group will not receive honey or a placebo. Serum IL-6 level, RNFL thickness, Tear break up time (TBUT) and Schirmer Test 1 will be done before and after 90 days. Adherence to honey consumption will be monitored using a daily diary. This study aims to provide better understanding of the potential role of Kelulut honey as a supplementary therapy in patients with juvenile open-angle glaucoma.

Basketball players often injure the anterior cruciate ligament (ACL), a key structure that stabilizes the knee. Even after surgery and standard rehabilitation, many athletes continue to have problems with knee stability, movement control, and performance during jumping and landing. These issues increase the risk of re-injury and can limit their ability to return to competition. Neuromuscular training (NMT) is a type of exercise program that focuses on improving balance, muscle coordination, and movement patterns. It uses activities such as jump-landing drills, balance tasks, agility exercises, and core training. Previous research shows that NMT can help athletes land more safely, reduce harmful knee movements, and improve sport performance. However, little is known about its long-term benefits in college basketball players who are more than one year post-ACL surgery. This study aims to evaluate whether a 12-week NMT program, added to standard basketball training, can improve knee biomechanics, stability, and performance in college basketball players with a history of ACL reconstruction. Thirty participants will be randomly assigned to either an NMT group or a control group. Both groups will complete basketball training, but only the NMT group will receive the additional neuromuscular exercises. Knee movement will be measured using 3D motion capture and force plates, and performance will be tested through vertical jumps and other sport-specific tasks. The main outcomes will include knee angles during landing, ground reaction forces, dynamic stability, and jump height. The expected outcome is that athletes who undergo NMT will demonstrate safer landing strategies, better knee control, and improved performance compared to those who only receive standard basketball training. These findings may help coaches and healthcare providers design safer, more effective rehabilitation programs for athletes after ACL surgery.

The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars? Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies. Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to: * apply the topical application on their scar twice a day for 8 weeks * attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs * immediately inform the researcher if they experience any side effects

Anterior cruciate ligament reconstruction (ACLR) is commonly performed to restore knee stability after injury, but many patients continue to experience gait abnormalities and reduced knee function during rehabilitation. Proprioceptive training is frequently included in rehabilitation programs to improve joint position sense, neuromuscular control, and movement coordination, yet its specific effects on gait performance and knee function after ACLR are not fully understood. This study aims to investigate the effects of a 12-week proprioceptive training program on gait performance and knee function in patients who have undergone ACLR. Patients who meet the inclusion criteria will undergo baseline assessments, including gait analysis and knee function tests. They will then participate in a structured 12-week proprioceptive training program as part of their rehabilitation, followed by post-intervention assessments using the same measures. The primary outcomes include changes in gait performance, such as walking speed, step length, cadence, support time, knee motion, and knee joint angles and moments during walking. Secondary outcomes include changes in knee function, including isokinetic muscle strength, joint position sense, and patient-reported outcomes measured by the Lysholm score and the International Knee Documentation Committee (IKDC) questionnaire. The findings from this study may help to clarify the functional benefits of proprioceptive training and support the development of more targeted and effective rehabilitation strategies for patients recovering from Anterior cruciate ligament (ACL) injuries.

Journeying along the historic Silk Road exposes travelers to dramatic dietary shifts, unfamiliar microbial environments, and the physical stresses of long-distance travel-all known to disrupt gut health and cause gastrointestinal complaints, including traveler's diarrhea and sleep disturbances. Such disruptions may also elevate the risk of acquiring antibiotic-resistant organisms. This randomized, double-blind, placebo-controlled trial evaluated whether probiotic supplementation can help maintain gut microbial balance and support traveler well-being during trips to Silk Road regions. In addition to monitoring changes in gut microbiota composition, the study assessed gastrointestinal symptoms, sleep quality, anxiety levels, overall well-being, gut immune markers, functional profiles of the microbiome, and the presence of antibiotic resistance genes.

The goal of this clinical trial is to learn whether Kelulut honey eyedrops are safe and helpful in treating dry eye disease in adults. It will also learn about any side effects that may occur with the use of Kelulut honey eyedrops. This Kelulut honey eyedrops are sterile ophthalmic solutions formulated with honey derived from stingless bees (Trigona spp.) at concentrations of 12.5% 25% and 50%. The eyedrop formulations are prepared according to a standardized laboratory protocol to ensure sterility, stability, and suitability for ocular use. Full formulation details are proprietary but can be provided to the ethics committee or regulatory authorities upon request. The main questions this clinical trial aims to answer are: 1. Does Kelulut honey improve tear film stability and dry eye symptoms? 2. Are Kelulut honey eyedrops safe and well tolerated on the ocular surface? Researchers will compare different concentrations of Kelulut honey eyedrops to determine which concentration provides the best balance of safety and clinical benefit. Participants will: 1. Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments. 2. Attend scheduled follow-up visits (on week 2 and week 4) for eye examinations and dry eye assessments (e.g., TBUT, ocular surface staining, Schirmer test, and OSDI). 3. Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.

The goal of this clinical trial is to learn if oral Kelulut honey works to improve eye symptoms in adults with allergic conjunctivitis. It will also look at how safe Kelulut honey is when taken as a daily supplement. The main questions it aims to answer are: 1. Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis? 2. Does oral Kelulut honey improve tear film stability and the health of conjunctival goblet cells (special cells on the eye surface that help keep the eye moist)? 3. What side effects or medical problems do participants have when taking Kelulut honey? Researchers will compare oral Kelulut honey to a honey-flavoured placebo syrup (a look-alike drink that does not contain Kelulut honey) to see if Kelulut honey is more effective than placebo for treating eye symptoms in allergic conjunctivitis. Participants will: 1. Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month 2. Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor 3. Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health 4. Answer questionnaires about their eye symptoms and how these affect their daily activities and vision-related quality of life Participation is voluntary, and participants may stop taking part in the study at any time. Data collected up to the time they withdraw may still be used for research, but their routine medical care will not be affected