ANZCTR search results

This open label, safety, acceptability and feasibility trial aims for determine whether two doses of Pomaglumetad methionil (2 X 40mg, 80mg in total) per day over a 12-week period is safe, acceptable and tolerable in young people aged 18-25 years with first-episode psychosis (i.e., the first onset of a psychotic disorder in the lifetime of an individual, FEP) or at clinical high risk for psychosis (i.e., a state in which specific predictive criteria are met which indicate that the person has an increased chance of transitioning to a psychotic illness in the future, CHR). Safety of dose and administration will be determined using safety bloods, side effects profile and treatment-emergent adverse events. Acceptability/tolerability will be assessed using recruitment and retention rates, protocol adherence (including medication adherence), stakeholder acceptability, and time to discontinuation. Secondary/exploratory aims will investigate changes from baseline after 12 weeks of treatment at full study dose in total symptomatology and dysfunction, positive and negative symptoms, quality of life and functioning. Target engagement of the investigational product will be assessed with MRI (optional component).

We propose this trial to test a modified MST and the gold standard BCTT in healthy children aged 8 –18 years . The modified protocol front-loads early increments and slows higher-intensity increments to better match BCTT exertion profiles. The perceived level of exertion and HR measured during the new Modified Shuttle Test (MST) will correlate with those measured during the Buffalo Concussion Treadmill Test (BCTT) in children without concussion.

Eph receptors are proteins found on cells that help guide how cells grow, move, connect, and survive. One of these proteins, called EphA4, is especially important in the brain and spinal cord. It helps guide nerve growth and nerve connections, and it may also affect how nerve cells respond to damage. Research suggests that EphA4 may play a role in how ALS progresses and could be a useful target for treatment. NUN-004 is an investigational medicinal product consisting of a modified EphA4 receptor. NUN-004 is taken via IV infusion. The study will include 75 people with ALS across several study sites. Participants will be randomly assigned to receive either NUN-004 or a placebo for up to 24 weeks. After the first 24 weeks, participants may continue into an open-label extension for another 24 weeks. In this extension, all participants will receive NUN-004. The main goal of the study is to see whether NUN-004 can slow the progression of ALS. This will be measured using a standard ALS rating scale. The study will also be assessing safety and tolerability of NUN-004.

People with angina and non-obstructive coronary arteries (ANOCA) often continue to experience chest pain despite standard medical treatment. This study will investigate whether a non-invasive ear stimulation device that activates the vagus nerve can improve angina symptoms in people with ANOCA. Participants will use the device at home for 60 minutes each day for four weeks while continuing their usual medical care. The study will assess changes in angina symptoms, quality of life, heart rate variability, treatment adherence, and device safety. The findings will help determine whether this treatment is feasible, safe, and potentially effective, and whether a larger randomised clinical trial should be undertaken.

Diets rich in plant foods such as whole grains, legumes, nuts, seeds, fruits, and vegetables are associated with a lower risk of type 2 diabetes and may improve blood sugar control and overall heart and metabolic health. In contrast, diets high in ultra-processed foods (manufactured products that often contain ingredients extracted from foods combined with additives, flavourings, and preservatives) such as hotdogs and deli meats may increase the risk of type 2 diabetes. Many people following a plant-based diet also consume plant-based ultra-processed foods (e.g. chips/crisps, plant-based burgers, cereals, chocolate). However, it is not yet clear how these foods affect diabetes risk and metabolic health. The purpose of this study is to examine how a vegan diet high in plant-based ultra-processed foods affects insulin sensitivity, blood sugar control, and other markers of cardiometabolic health. The findings will help improve our understanding of how different types of plant-based foods may influence risk factors for type 2 diabetes.

Brief description of study purpose: CLARITY is a research study investigating how interferon (IFN) alpha, a treatment commonly used for myeloproliferative neoplasms (MPNs), affects blood cancer cells over time. By studying blood and bone marrow samples collected before and during treatment, researchers hope to better understand why some patients respond differently to IFN alpha and identify biological markers that may help improve future treatment and monitoring of MPNs. Who is it for? This study is for adults aged 18 years and older with a confirmed diagnosis of a myeloproliferative neoplasm (MPN) who are planning to start IFN alpha treatment as part of their usual care. Participants with a JAK2V617F-positive MPN and additional high-risk clinical or genetic features may be eligible for the study's monitoring cohort. Study details: CLARITY is being conducted at hospitals across Australia. Researchers plan to screen at least 125 people, with up to 62 participants joining the monitoring cohort, which includes additional study-specific blood and bone marrow sample collection. Participants will be followed for up to two years. CLARITY does not test a new treatment. All participants will receive IFN alpha as prescribed by their treating doctor, and all treatment decisions will remain part of routine clinical care. Participants in the monitoring cohort will provide blood and bone marrow samples before starting IFN alpha treatment and again during treatment. Researchers will analyse these samples to study genetic and biological changes in MPN cells over time and compare these findings with information collected from routine medical care. The information gained from this study may help researchers develop better ways to monitor MPNs, understand which patients are most likely to benefit from IFN alpha treatment, and improve future treatment strategies for people living with MPNs.

Purpose of the study The RISE4SkinCancer study aims to improve the diagnosis and management of skin cancer for people living in the Loddon Mallee Region of Victoria. The study will compare the current approach to care with a new model of care designed to strengthen GP services and improve access to skin cancer care in rural communities. Who is it for? You may be eligible for this study if you are an adult aged 18 years or above with a primary diagnosis of skin cancer and attend an eligible GP clinic in the Loddon Mallee Region. What we expect to learn (main hypothesis) We expect that the new model of care will help GPs provide better skin cancer care, improve access to timely diagnosis and treatment, and improve the quality of life for people with skin cancer. We also want to learn whether this approach could reduce the impact of skin cancer in rural areas and be used more widely across Australia. Study design, interventions and outcomes GP clinics in the Loddon Mallee Region will be allocated to one of two groups. One group will continue providing their usual care, while the other group will introduce a new model of care. The new model is expected to include GP training, improved referral pathways, artificial intelligence tools to support care, health information for patients, and a First Nations-led approach. The model is currently being developed with input from local GPs and community members. If you choose to take part, you will receive either the current standard of care or the new model of care, depending on which group your GP clinic has been allocated to. The study will compare the two groups to see whether the new model improves access to care, the quality of skin cancer care, and patients' quality of life.

Young adults living in rural Australia face barriers to healthy eating, including limited access to affordable fresh produce, with vegetable intake remaining low. Digital healthy eating interventions are accessible to rural communities but may not address structural barriers to food access. Veg4Me, a co-designed web / mobile application to support vegetable intake using food literacy and local food environment resources, has been shown to be feasible, engaging, and acceptable among young rural adults. Adding vegetable prescription to this intervention may provide further support for increasing vegetable intake. The Veg4Me Plus One Serve Study aims to test the feasibility of adding a vegetable prescription program to Veg4Me among young adults living in rural Australia. An 18-week blinded, two-arm, parallel randomized controlled trial will be conducted in rural Victoria, Australia. Up to 140 eligible young adults (aged 18–35 years) will be randomized to receive access to the Veg4Me app plus vegetable prescription (intervention) or access to the app alone (control). Intervention participants will receive vegetable boxes free of charge during weeks 1–12, at 50% cost during weeks 13–15, and at full cost during weeks 16–18. Process evaluation interviews will be conducted with a sub-sample of participants and stakeholders. Primary outcomes are recruitment, participation, and retention. Secondary outcomes include vegetable prescription satisfaction, app engagement and usability, vegetable intake and variety, diet quality, eating habits, food security, digital health equity, and indicators for future cost-effectiveness evaluation. Primary outcomes will be summarized descriptively, and secondary outcomes will be analyzed using intention-to-treat regression models adjusted for baseline values. Interviews will undergo thematic analysis. This study will determine the feasibility of integrating vegetable prescription with a co-designed digital intervention. Findings will inform the design of scalable approaches to support vegetable intake among young adults living in rural communities.

People undergoing a stem cell transplant often experience a decline in their strength, fitness, nutrition, emotional wellbeing, and ability to perform everyday activities. This study aims to determine whether a coordinated multidisciplinary program provided before and after stem cell transplantation can improve recovery compared with standard care. Adults aged 18 years or older undergoing an autologous or allogeneic stem cell transplant at the Royal Adelaide Hospital will be invited to participate. Participants will be randomly allocated to either receive the multidisciplinary prehabilitation and rehabilitation program in addition to their usual care or receive usual care alone. The program includes supervised exercise, nutrition support, occupational therapy, psychology, social work, and oral health care delivered by a multidisciplinary healthcare team before and after transplantation. It is expected that participants receiving the multidisciplinary program will have better physical function, improved quality of life and emotional wellbeing, fewer hospital-related complications, shorter hospital stays, and better recovery than those receiving standard care. To evaluate this, participants will complete physical assessments and questionnaires at several timepoints before and after transplantation. Information on hospital stay, complications, readmissions, and survival will also be collected from hospital records, and some participants will be invited to complete an interview about their experiences. The results of this study will help determine whether this model of care should become part of routine supportive care for people undergoing stem cell transplantation.

Intravitreal injections are commonly used to treat a range of retinal conditions, and patients may experience anxiety or have questions about the procedure. This randomised controlled trial investigates whether providing an educational video explaining the injection process, potential risks and benefits, and aftercare improves patients’ experience compared with standard clinician consent and counselling. Patient-reported outcomes, including pain, anxiety and satisfaction, are assessed immediately after the injection using a 0-100 numeric rating scale.