ANZCTR search results

This study aims to assess whether non-invasive methods (imaging and mouth swabs) can detect early signs of oral cancer in people with changes in the soft tissues of their mouth. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an oral soft tissue disease, this may include oral cancer, periodontitis (gum disease), pre-cancerous tissue changes and other oral lesions; and you are undergoing treatment with a doctor or dentist for your condition. Study details All participants who choose to enrol in this study will be asked to attend an appointment at your usual treatment location . During the appointment, the dentist will use two types of camera to take regular and heat-sensitive images of the inside and outside of your mouth and will ask you to provide a saliva sample and cheek/tongue swabs for assessment. The appointment should take no more than 20 minutes. Individual image captures will not be provided to participants. Your care will continue as usual. It is hoped this research will determine whether these non-invasive methods can help doctors and dentists spot oral cancer earlier, which may reduce the need for unnecessary surgeries, and ideally would make the process easier and less stressful for patients. signs of oral cancer in people with changes in the soft tissues of their mouth. Instead of relying only on traditional biopsies, the study will test new tools—such as special cameras that take regular and heat-sensitive photos, and simple mouth rinse or gentle brush samples—to see if they can accurately identify which mouth changes are at risk of becoming cancer. The main idea is that these new, non-invasive methods can help doctors and dentists spot cancer earlier, reduce the need for unnecessary surgeries, and make the process easier and less stressful for patients. The study's hypothesis is that these non-invasive tools will be just as good, or better, than current methods at telling the difference between harmless and risky mouth changes, leading to earlier and more accurate treatment for those who need it.

This study investigated reductions in metacognitive beliefs as a mechanisms by which mindfulness training reduces anxiety and depression symptoms. It investigates whether increases in trait mindfulness through training reduces metacognitive beliefs, with a flow-on effect to reductions in mind-wandering, rumination and worry, which in turn reduce anxiety and depression symptoms. It does this through an 8-week intervention that combines mindfulness training and psychoeducation on emotions aimed at reducing maladaptive cognitive processes as a mechanism of symptom-reduction effects..

Deep brain stimulation (DBS) is a treatment for Parkinson's disease that uses a small implanted device to send electrical signals to specific areas of the brain, helping to control movement symptoms. While DBS is known to improve movement, less is known about how it affects sleep quality and breathing (pulmonary function) in people with Parkinson's disease. This pilot study aims to find out what types of sleep and breathing problems occur in people with Parkinson's disease who have a DBS device. There are three common brain locations where the DBS device can be placed, and this study will compare how each of these affects sleep and breathing. Participants who already have a DBS device will attend the hospital for an overnight sleep study, and separately for breathing tests, both with their DBS switched on and again with it switched off, so researchers can see the difference stimulation makes. A comparison group of people with Parkinson's disease who don't have DBS (managed with medication only) will also complete the breathing tests, to help researchers understand whether any breathing changes are related to the DBS device itself, to Parkinson's disease more broadly, or to something else. By better understanding how DBS affects sleep and breathing, this research aims to help doctors make more informed decisions about DBS placement and management, and ultimately improve quality of life for people living with Parkinson's disease.

Functional Neurological Disorder (FND) is a condition in which people experience neurological symptoms, such as movement difficulties or seizures, that are related to changes in brain functioning rather than structural neurological disease. FND can significantly affect physical functioning, emotional wellbeing, quality of life, and day-to-day activities. The purpose of this research project is to evaluate a new multidisciplinary telehealth treatment program called RESET-FND. RESET-FND combines neuropsychological therapy and physiotherapy delivered by telehealth by clinicians experienced in the management of FND. This study aims to determine whether the RESET-FND program improves symptoms, physical functioning, psychosocial wellbeing, and quality of life compared with a supportive therapy control intervention. As a randomised study, patients are randomly allocated to one of two study groups: The RESET-FND intervention group, or a supportive therapy control group. to assess the potential benefits of this REST-FND intervention as assessed over 12 months.

Brief description of the study purpose This research aims to investigate the potential of rice bran arabinoxylan compound (RBAC) as an immunonutrition supplement to improve the nutritional status and quality of life (QoL) of colorectal cancer (CRC) patients, with the goal of preventing malnutrition and complementing primary oncological treatments of surgery, chemotherapy and radiotherapy. Who is it for? You may be eligible for this study if you are male or female age 18 years or older, with histologically confirmed diagnosis of colorectal adenocarcinoma at stage II or above and currently undergoing chemotherapy. Study details Participants who meet the eligibility criteria will be prospectively randomised to receive either RBAC or a placebo. Participants will be instructed to take their allocated intervention once daily in sachet form for 24 weeks. During and at the completion of the intervention period, participants will undergo blood testing to assess nutritional status, metabolic parameters, and inflammatory markers. Stool samples will also be collected to evaluate the gut microbiome. Participants will be asked to complete both self-reported and clinician-administered assessments relating to malnutrition, cachexia, quality of life, and fatigue throughout the study.

As a result of climate change, the incidence of heat illnesses has increased in the general population, with fatalities evident in those exposed to exertional-heat stress (e.g., mining, agriculture, military, and sport). The pathophysiology of heat illnesses (i.e., high body temperature), stems from metabolic heat production, ambient conditions, gut and immune responses. Thus, the aim of the current study is to assess if the consumption of a dairy product may provide support in adapting the human body to cope with the increased daily ambient temperature associated with the present global warming crisis. It is hypothesized that a one-week increased consumption of dairy beverages, rich in fermentable lactose and ß-GOS, and protein availability, will suppress gastrointestinal and immune perturbations linked with the pathophysiological pathway of heatstroke.

The main aim of this study is to determine if the reinforced tension line (RTL) closure suture technique to close the abdominal incision during liver transplantation will reduce the rate of incisional hernia when compared to the standard suture closure technique. The study will provide the liver transplant surgeons with information about which technique is better to close the abdominal muscle (fascia). Currently, there is no prior study comparing these two surgical techniques in the liver transplantation group. The RTL technique has shown to be safe and effective in reducing hernias in other abdominal surgery (such as for bowel surgery operations). This is a prospective single centre randomised controlled clinical trial.

Vaxxas Pty Ltd is developing a novel needle-free high-density microarray patch (HD MAP) delivery system for the intradermal administration of vaccines. This technology may offer potential advantages over conventional needle and syringe delivery of vaccines. This Phase I clinical study is a critical step in the development of the HD-MAP delivery system to verify its safety and suitability for use in children. The study will help confirm the safety and consistency in performance of the HD-MAP delivery system in children at different anatomical administration sites and using different hold times. The paediatric population represents a significant segment of the population requiring vaccination; therefore, evaluating the safety and suitability of the HD-MAP delivery system in children is essential. The findings could support the future development of a needle-free approach to routine childhood vaccinations and facilitate vaccine delivery in low- and middle-income countries, including during outbreak scenarios.

Babies in neonatal intensive care often need peripheral intravenous (IV) lines, but fluid can leak from the vein into surrounding tissue and cause infiltration or extravasation injury. This study will assess whether the Vedette device can safely and continuously measure transcutaneous bioelectrical impedance near an IV site and collect signals of sufficient quality for future early-detection development. Up to 55 babies will have up to four neonatal ECG-style adhesive electrodes placed on the skin and connected to Vedette for 5 to 24 hours per day, without changing their usual treatment or replacing routine IV-site checks. The main outcomes are the frequency of electrode-related skin injury and the proportion of babies who provide at least one usable recording lasting five continuous hours. The study will also explore whether changes in the bioimpedance signal correspond with clinical events such as IV infiltration, swelling or IV-site changes.

This study will test whether a non-invasive ear sensor can help track body temperature more closely in adults with major burns who come to the Alfred Emergency and Trauma Centre. Currently, temperature is checked at set points using a forehead thermometer, or continuously through invasive probes inserted into the food pipe or bladder. The researchers expect that using this wearable, easy-to-apply ear sensor for continuous monitoring will pick up more episodes of temperature outside the recommended range, including hypothermia (low body temperature). Hypothermia is common in patients with large burns and has been associated with poorer outcomes. The aim of this interventional study is to measure these temperature episodes and to look at whether detecting them affects how patients are treated and how they recover, including their time in intensive care and hospital.