ANZCTR search results

Many children start school with health or developmental needs that are not identified early, particularly in families who experience barriers to accessing services. This study evaluates the Healthy Beginnings model, delivered in early childhood education and care centres, which includes screening, nurse-led care coordination and triage, follow-up support by health professionals, and education for parents and educators. The program will be compared with enhanced usual care, which provides screening, information, and guidance on accessing existing services. The main aim of this pilot study is to determine whether the program is feasible, acceptable, and practical to implement, and to inform a future larger trial. It is expected that the Healthy Beginnings model will improve early identification of children’s needs and help families access appropriate support more quickly compared with usual care.

This study aims to investigate the effects of fat content in a mixed-nutrient meal on muscle and adipose tissue microvascular blood flow (MBF) in healthy humans. We will compare the effects of low-fat vs high-fat content in a mixed-nutrient meal ( a liquid milkshake) on post-meal skeletal muscle and adipose tissue MBF healthy humans in a randomised crossover design.We will also measure gut-derived hormones and perform a correlation analysis with the MBF response. Hypothesis: We hypothesise that the low-fat mixed-nutrient meal will increase muscle and adipose MBF after the meal in healthy individuals, while the high-fat meal mixed-nutrient will not show this increase in MBF responses. We also hypothesise that levels of gut-derived hormones in the plasma will be correlated to MBF responses. Expected outcomes and significance: We aim to show that fat content within a mixed-nutrient meal is an important factor determining tissue MBF response and can affect the risk of cardiometabolic disease.

Psilocin facilitates profound psychological experiences that can interrupt rigid, maladaptive thought patterns commonly underlying chronic and treatment-resistant mental illnesses. This open-label study will evaluate the safety and preliminary effects of a novel intravenous (IV, i.e. into the vein) formulation of the psychedelic psilocin (TRP-8803) in Anorexia Nervosa, Fibromyalgia, Generalized Anxiety Disorder, Irritable Bowel Syndrome, Major Depressive Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder. Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 8 weeks, and followed up until 12 weeks post second dose.

This study is examining whether an artificial intelligence (AI) mental health smartphone app called Cara Plus can help reduce symptoms of anxiety and depression in adults. We are recruiting adults aged 18 and over from Australia and the United States who are currently experiencing mild to moderate symptoms of anxiety and/or depression. The study is advertised as a digital mental health intervention. Participants will be randomly allocated to one of two groups: one group will use the Cara Plus app for 8 weeks, and the other group will be directed to publicly available mental health information websites. We hypothesise that participants who use the Cara Plus app will experience greater reductions in anxiety and depression symptoms compared to those who receive the static information resources. Symptoms will be measured using the Generalised Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9) at the start of the study and at Weeks 2, 4, and 8. All study procedures are completed entirely online.

This randomized controlled trial aims to evaluate whether a digitally delivered patient education platform improves health information comprehension compared to standard physical education for patients undergoing surgical prehabilitation. The study will recruit approximately 56 patients scheduled for surgery at Nepean Hospital. Participants will be randomly assigned to either a physical group receiving a standard printed booklet and videos on a USB stick, or a digital group receiving short, easy-to-read educational modules on a tablet or smartphone. The study will measure participants' understanding of their surgical preparation, anxiety levels, and overall feedback on the educational materials using targeted surveys before and after the intervention.

Brief description of the study purpose This study is being conducted to determine whether adding a targeted internal radiation treatment called OncoSil™ (Phosphorus-32 microparticles) to standard chemotherapy improves outcomes for patients with locally advanced pancreatic cancer. Who is it for? You may be eligible for this study if you are male or female aged 18 or older, with unresectable locally advanced pancreatic adenocarcinoma as per National Comprehensive Cancer Network (NCCN) guidelines, fit to commence first-line standard FOLFIRINOX therapy and have a life expectancy greater than 3 months. Study details Those who are eligible will be randomly allocated to either receive standard FOLFIRINOX chemotherapy alone or chemotherapy plus a single endoscopic ultrasound-guided OncoSil™ implantation into the tumour. Participants will be followed over time with regular scans, blood tests, and health assessments to monitor tumour response, side effects, and quality of life. It is hoped that the results from this study will help determine whether this combined treatment approach is more effective and safe than chemotherapy alone.

Is the ‘Fit for Purpose’ intervention clinically and cost-effective for improving pain and physical function in older adults with knee OA who have had TKR surgery? This research project will test the effectiveness of a new physiotherapy intervention called ‘Fit for Purpose’ Training provided in early post-surgical care (~3 months) after TKR surgery. This new intervention was co-designed with patients and clinicians and aims to improve long-term pain and function outcomes after TKR surgery. The goal of this research is to better understand long-term (1 year) outcomes after TKR surgery and if we can improve these long-term outcomes. Specifically, we aim to test whether our new Fit for Purpose physiotherapy intervention is more effective than an educational intervention.

The study aims to effectiveness the impact of light therapy, known as photobiomodulation (PBM), on recipients of allogeneic haematopoietic stem cell transplant (alloHSCT) in the prevention of oral mucositis. This work is important because oral mucositis is common, painful, costly, and a major cause of suffering during transplant care. PBM is a simple, quick, non invasive therapy with international guideline support but limited local use. Who is it for? You may be eligible for this study if you are an adult who is receiving allogeneic haematopoietic stem cell transplant at the Royal Adelaide Hospital. Study details Participants in this study will either receive current standard practice in the prevention and treatment of oral mucositis, or, they will receive current practice plus light therapy. Light therapy sessions will occur daily from the day of first chemotherapy session until 2 days after receiving the allogeneic haematopoietic stem cell transplant. Treatment sessions will take approximately 5 minutes and occur while the participant is an inpatient at the Royal Adelaide Hospital. Participants will then be followed up to determine if they are experiencing oral mucositis and data will be collected from medical records. The primary outcome of the study will be the incidence and duration of severe oral mucositis. It will also measure patient wellbeing, pain, nutrition, bacteraemia rates, hospital stay length, and how easily staff can adopt the treatment. It is hoped that this study will help provide clearer evidence on PBM’s real world effectiveness, data on costs and quality of life benefits, and practical information related to its implementation.

The purpose of this study is to test if a medical device called a SpiroNose® can be used to diagnose health conditions that cause respiratory symptoms, lung imaging abnormalities and sleep disorders. Who is it for? You may be eligible for this study if you are an adult who is either: 1. attending clinic for assessment of your respiratory symptoms or sleep or lung conditions, or 2. in the community and do not currently experience any respiratory symptoms or have lung abnormalities or any sleep conditions Study details Participants will be asked to perform a breath test on a device called a SpiroNose® . This breath test involves gentle breathing into the mouthpiece of the SpiroNose® and takes about 1 minute. Participants will also be asked to complete a few questionnaires immediately after the breath test. One questionnaire asks the participant what they thought about the SpiroNose® breath test; other questionnaires are used to collect clinical information such as the diagnosis of their current condition, if their condition has been diagnosed, and other health issues they may have. All participants will be followed up with a telephone call 2 months later to check if health status has changed, if medications have changed or if they have had more medical tests. The study coordinator will check their medical records for the final diagnosis up to 24 months after the breath test. Participants attending the respiratory clinic for assessment or management of lung cancer may be invited by their treating physician to perform a second SpiroNose® breath test after surgery or treatment as part of their clinical care. It is hoped that this research study will help determine if the SpiroNose® device can be used to identify participants with medical conditions such as asthma, chronic obstructive pulmonary disease, lung cancer, bronchiectasis, interstitial lung abnormalities, cardiac failure, obstructive sleep apnoea and narcolepsy.

To evaluate if a doctor-pharmacist collaborative prescribing model of care (intervention) produces fewer medication prescribing errors compared to usual care (medical prescribing - control) with regards to the prescribing for patients’ admission medication orders, and the appropriateness of surgical antibiotic prophylaxis orders, in a perioperative setting within a non-tertiary hospital. Consented patients were randomised into an intervention or control group. Based on the elective surgery determined by the physician, the intervention group had their admission medication chart prescribed by the prescribing pharmacist. This included intentional withholding, or medication amendments to the patients usual home medications during the perioperative period, as well as prescribing any applicable surgical antibiotic prophylaxis.