ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33865 results sorted by trial registration date.
  • A pilot study evaluating the effects of deep brain stimulation (DBS) on sleep and pulmonary function in Parkinson's Disease (PEDS-PD study)

    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.

  • Multidisciplinary telehealth early intervention for patients with a recent diagnosis of functional neurological disorder (FND), with functional motor symptoms and/or functional dissociative seizures: the Epworth RESET-FND study

    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.

  • A pilot study of rice bran arabinoxylan compound (RBAC) supplementation on the nutritional status of participants with colorectal cancer.

    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.

  • The impact of short-term dairy intake on the pathophysiological pathway of heatstroke in endurance trained individuals.

    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.

  • Does reinforced tension line closure of abdominal incision reduce incisional hernias after liver transplantation? A randomised controlled trial

    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.

  • Adaptive Phase I clinical study to evaluate the safety, tolerability and performance of VXM-305-00-P, an intradermal high-density microarray patch (HD-MAP) delivery system, in healthy children and adult parent/guardians

    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.

  • Continuous monitoring using skin bioimpedance in newborn babies to assess skin safety and signal quality

    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.

  • Non-invasive continuous temperature monitoring in major burns patients in the Alfred Emergency Department

    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.

  • NAVIGATE: Transition Coaching to build health literacy, self-advocacy and healthy lifestyle behaviours for Queensland Adolescents with Aacquired Brain Injury and their caregivers.

    This project will develop and test a Queensland Transition Coaching Program to support young people aged 15–19 years with acquired brain injury (ABI) as they move from child to adult health and support services. The program will be co-designed with young people, families, clinicians and community services to ensure it reflects lived experience and meets the needs of Queenslanders. A pilot involving 60 participants from metropolitan and regional Queensland will focus on building confidence, independence and practical skills, including understanding ABI, self-advocacy, managing supports, navigating adult services and maintaining healthy lifestyles. Psychology support will be available to help young people engage with the program. Feedback from participants, families and clinicians will be used to assess whether the program is useful, accessible and appropriate, and to inform the development of a statewide ABI transition protocol, toolkit and training resources.

  • Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants- AUSTRALIA (BALLOON-AU)

    Preterm infants born <30 weeks’ gestation are at increased risk from additional damage to their already impaired lungs through Lower Respiratory Tract Infections over their first year of life. Data supports the use of trained immunity vaccines to reduce rates of Lower Respiratory Tract Infections and wheeze/asthma in the at risk populations, which include small numbers of preterm infants, not currently separately analyzed. This study aims to apply this potentially effective treatment specifically to a very preterm population. It is hypothesized that treatment with Bactek in the first year of life will reduce Lower Respiratory Tract Infections and Lower Respiratory Tract Infection associated healthcare utilization in infants born very preterm.

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