ANZCTR search results

Exercise is known to support mental well-being during and after pregnancy as well as in times of grief. However, there is very little research on how exercise may support individuals after pregnancy loss. This study will explore the safety and feasibility of a 10-week, group-based exercise program for individuals following pregnancy loss. It compares a supervised, instructor led progressive exercise program with individualised prescription, to a standardised, in-person stretching program with no individualisation or progression. Thirty-two individuals who have recently experienced pregnancy loss will be invited to take part in a 10-week program run by an accredited exercise professional, combining physical activity with education and peer support. The aim of this research is to better understand how exercise and connection with others can help to improve emotional well-being and reduce isolation after pregnancy loss, and to address critical gaps in current research and practice.

Before some patients have a CT scan of the heart's arteries (called a CT coronary angiogram), they are given medication to slow their heart rate down. A slower, steadier heart rate produces clearer pictures and helps the scan work well. The medication used is a type called a beta-blocker. At present, this medication is usually given as a tablet taken by mouth. Tablets take time to work, and some patients' heart rates do not slow down enough, which can delay the scan or mean it has to be postponed. Another option is to give the same type of medication through a drip into a vein, which may work more quickly. This study aims to find out whether giving the heart-rate medication through a drip, rather than by tablet, gets patients ready for their scan sooner. We will compare the two approaches in patients coming in for a CT scan of the heart's arteries. Everyone taking part will be randomly placed into one of two groups: one group will receive the tablet approach currently used, and the other will receive the medication through a drip. We will mainly measure the time it takes each patient to be ready for their scan, and we will also look at how well each approach controls the heart rate, the quality of the scan pictures, the dose of medication needed, and whether any side effects occur. We think that giving the medication through a drip will prepare patients for their scan more quickly than tablets, without affecting their safety or the quality of the scan. If this is correct, it could mean shorter waits, fewer cancelled scans, and a smoother experience for patients.

This study is investigating the safety and skin effects of a new hyaluronic acid-based treatment called Functional Ligand–Hyaluronic Acid Cross-Linked (Fli-HAXL) in healthy adults with facial wrinkles and signs of skin aging. The treatment is applied to the skin and delivered into the superficial layers of the skin using a microneedling device. Each participant will receive the investigational treatment on one cheek and a comparator vehicle treatment on the other cheek. The study aims to determine whether the investigational treatment is safe and well tolerated, with particular focus on skin reactions, vascular occlusion events, and visual symptoms. The study will also assess whether the treatment improves the appearance of facial wrinkles and participant satisfaction with their skin appearance. The hypothesis is that treatment with Functional Ligand–Hyaluronic Acid Cross-Linked delivered by microneedling will have a safety profile comparable to the comparator treatment while improving the appearance of facial wrinkles in adults with signs of skin aging.

Brief description of the study purpose: This study is investigating a personalised mRNA vaccine for children and young people with high risk central nervous system tumours. The vaccine is made individually for each participant using information from their tumour and is designed, based on laboratory and preclinical research, to help the immune system recognise proteins associated with the tumour. Who is it for? You may be eligible if you are male or female 6 months to 25 years old, have a high-risk central nervous system tumour, and are enrolled in the ZERO Childhood Cancer molecular profiling program, you have measurable disease (with some exceptions for newly diagnosed cases), a Karnofsky/Lansky score equal to or above 50, a life expectancy of at least 12 weeks, have recovered from prior therapy according to required washout periods, and have adequate blood counts, kidney function, liver function, and coagulation. You must not have a known hypersensitivity to mRNA vaccines, not be pregnant or breastfeeding and have no underlying congenital immunodeficiency. You must not be taking corticosteroids other than physiologic replacement doses and have no live vaccines within 3 months of starting protocol therapy. What is involved for participants? Study participants will be required to have periodic physical examinations, sample collections (blood and urine tests), completion of quality of life questionnaires, a heart function check and brain imaging to check the tumour. Study details Participants will receive the recommended Phase II dose (RP2D) of the personalised mRNA vaccine for eight doses, followed by a booster dose at six months. Phase II participants will be enrolled into two strata. Phase II Stratum A will include participants with newly diagnosed DMG and Phase II Stratum B will include participants with other high-risk brain tumours.

A randomised cross-over feeding study conducted in free-living adults (aged 18 years and older) with high blood pressure and type 2 diabetes or pre-diabetes living in the local Hunter region. Participants will be enrolled in an 8-week dietary intervention consisting of a 2-week run-in period (habitual/usual diet) followed by 2 x 2-week dietary intervention periods that include a 2-week washout between them. The 2-week diet periods will consist of a ‘Healthy Australian Diet’ (HAD) and the “Healthy Australian Dietary pattern + bioactive foods” (HAD+). The HAD+ will have foods from the 5 core food groups from the current Australian Dietary Guidelines for adults with the addition of high bioactive foods that have been associated with reducing BP. The key foods in the HAD+ diet will include oats, beetroot, leafy green vegetables, flaxseeds, citrus fruit, and mixed nuts. These two diets will be allocated in a randomised order. During the 2-week washout period the participant returns to their / usual diet). The entirety of the diet (i.e., 3 main meals and snacks per day) will be provided to participants during dietary period 1 and 2. Participants will supply their own meals and foods during the run-in and washout periods. Study participation involves completing self-administered questionnaires (e.g., food frequency, health, demographic, physical activity questionnaire); collection of biosamples (fasted blood sample, urine and faecal sample) and physical measurements such as blood pressure, arterial stiffness, anthropometry and body composition.

The ZenZone Trial will test whether an eight-week dairy study is practical, safe, and acceptable for 14-year-old girls experiencing elevated depressive symptoms. Participants will be randomly assigned to consume either a yoghurt containing added BB-12, conventional yoghurt, or flavoured milk each day. The main aim is to assess recruitment, retention, adherence, completion of study activities, protocol compliance, and safety. The study will also explore changes in mood, sleep, thinking, gastrointestinal symptoms, diet, the gut microbiome, saliva biomarkers, and, for some participants, brain imaging measures. We expect the study procedures to be workable and acceptable, and will examine whether probiotic yoghurt shows more promising changes than conventional yoghurt or milk to inform a larger future trial.

This pilot study aims to compare a new wound closure technique — called boot-lace assisted tissue expansion — against standard reconstructive surgery (skin grafts or flaps) for closing skin wounds on the arms, legs, and trunk in adults following skin cancer removal or trauma. Who is it for? You may be eligible for this study if you are an adult presenting for elective excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) or post-traumatic event. Study details Participants will be randomly allocated to either boot-lace assisted wound tissue expansion, or conventional techniques including local or regional flap, full-thickness skin graft or split-thickness skin graft. Participants assigned to the boot-lace technique group may be further randomly allocated to undergo the Khouri technique, which involves small needle perforations made in the surrounding skin to further improve its elasticity. Outcomes assessed will include scar quality, wound healing time, pain, complications, cost effectiveness, and patient satisfaction. It is hoped that findings from this study inform future surgical practice for skin cancer removal and post-trauma events.

This pilot study aims to assess the feasibility and acceptability of a structured breathwork exercise program delivered through the Physitrack mobile application for patients preparing to undergo Deep Inspiration Breath Hold (DIBH) radiation therapy. The study will investigate whether the program may help improve breathing control and breath-hold performance in patients who have difficulty performing DIBH because of respiratory limitations. Who is it for? You may be eligible for this study if you are male or female with a cancer diagnosis who have been offered DIBH radiation therapy but are unable to achieve or maintain adequate breath holds during initial assessment due to respiratory-related limitations. Participants must be able to provide informed consent and commence the program at least one week before their radiation therapy planning appointment. Study details Those who are eligible will be randomly assigned to one of two groups. One group will receive a structured breathwork exercise program delivered through the Physitrack mobile application, while the other group will receive the standard breath-hold exercises currently provided as part of routine departmental education. Participants in both groups will complete breathing exercises twice daily for approximately two weeks before their CT simulation/planning appointment, with each session taking less than 10 minutes. The intervention group will receive video-guided exercises, reminders, and adherence tracking through the Physitrack app, while the control group will receive written instructions and record exercise completion in a paper diary. Participants will undergo assessments of inspiratory capacity, breath-hold stability, and DIBH capability. Exercise adherence will also be monitored through app-recorded data or participant diaries, depending on group allocation. It is hoped that this research will determine whether a digital breathwork program is practical and acceptable for patients and provide information to support a larger trial aimed at improving access to and effectiveness of DIBH radiation therapy.

People with traumatic brain injury can experience mental health and behavioural difficulties, but access to specialist psychiatric care is often limited, particularly for people living in rural and regional areas. This study will evaluate a telepsychiatry service that provides specialist psychiatric advice and support through videoconferencing to people with acquired brain injury and the clinicians involved in their care. The purpose of this study is to understand whether this model of care is practical, acceptable, and helpful for improving access to specialist mental health support. We expect to learn about changes in participants’ mental health, wellbeing, and everyday functioning after receiving telepsychiatry support, as well as the experiences of patients, clinicians, and psychiatry trainees involved in the service. The study will also identify the benefits, challenges, and opportunities for improving the delivery of telepsychiatry for people with brain injury.

Brief description of the study purpose This study aims to investigate whether adding a targeted internal radiation treatment called OncoSil™ to standard chemotherapy, with or without immunotherapy, can improve outcomes for people with metastatic pancreatic cancer. Who is it for? You may be eligible for this study if you are male or female aged 18 or older, have confirmed pancreatic ductal adenocarcinoma that has spread to a limited number of sites (oligo-metastatic disease), who are well enough to receive standard chemotherapy and meet the study's health and laboratory requirements. Study details All those who are eligible will be randomly allocated to one of three treatment groups: (1) OncoSil™ plus chemotherapy, (2) OncoSil™ plus chemotherapy and immunotherapy (nivolumab), or (3) chemotherapy standard care. Participants receiving OncoSil™ will undergo a single endoscopic ultrasound (EUS)-guided implantation of phosphorus-32 microparticles into the primary pancreatic tumour approximately four weeks after starting chemotherapy. All participants will attend regular follow-up visits, which include clinical reviews, imaging scans, blood sample collection, and completion of quality of life and pain questionnaires. Researchers will also analyse blood and, where available, tumour samples to better understand how OncoSil™ affects the immune system and response to treatment. The findings may help determine whether this treatment approach could improve future care for people with metastatic pancreatic cancer.