ANZCTR search results

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Up to twenty eligible, healthy volunteers will receive one (1) subcutaneous (SC) injection of 225 international units (IU) per day for seven (7) consecutive days to evaluate the safety, pharmacokinetics, and pharmacodynamics of GB-hMG.

This study will evaluate the efficacy of a blended care intervention (which combines a smartphone app called myNewWay with up to 10 psychological therapy sessions) for adults with anxiety disorders compared to a usual care control group, and a group who receives a self-guided version of myNewWay. The primary aim of the trial is to compare the efficacy of the blended care and usual care control groups in the reduction of anxiety. The secondary aims are to compare the efficacy of blended care to the control group in changing other symptoms and outcomes (eg quality of life, depression), compare the blended and self-guided groups in reducing anxiety, and other outcomes, as well as compare the acceptability, engagement and satisfaction of blended care versus self-guided care. Participants will be assessed at baseline, week 6, week 12, and week 24 on self-report outcome measures. People randomised to the control group will receive the self-guided myNewWay program after completing the week 12 self-report outcome measures. The study is Australian based, done online, so recruitment will cover all states and territories of Australia.

The study aims to examine the impact of dietary fibre on markers of gastrointestinal integrity, function, and symptoms in response to physical exertion. This will be done by comparing the effects of consuming a low- or high-fibre diet for two days before running in hot temperatures. Additionally, the study will assess how consuming a kiwiberry gel (containing carbohydrates, fibre, and FODMAPs) during exercise influences gastrointestinal integrity, function, and symptoms. Markers of gastrointestinal perturbations and perceptive gastrointestinal symptoms will be measured to better understand how these dietary factors impact gut health and performance during exercise in the heat.

This project aims to evaluate the efficacy, fiesability and acceptability of conducting a 12-session imagery rescripting intervention (an emotion-focused, cognitive-behavioural technique) with a sample of individuals diagnosed with hoarding disorder, in order to inform the suitability and design of a larger, future randomized controlled trial. It is hypothesised that the imagery rescripting intervention will produce reductions in clinical symptom severity among individuals with a primary diagnosis of hoarding disorder. The research questions that this study seeks to address are: 1. Do participants with hoarding disorder report any benefits of participation, particularly in terms of symptom reduction? 2. What are the estimated recruitment and retention rates during the intervention and follow up periods? 2. Is the intervention credible and acceptable to participants? 3. Do participants report any harms or adverse events associated with imagery rescripting?

Breathing and coughing difficulties are extremely distressing for people living with MND, and therapies that improve breathing capacity and related symptoms are needed. This research project will evaluate whether combining two breathing therapies together (lung volume recruitment with expiratory muscle strength training) is feasible and acceptable to people living with MND and clinicians (e.g. physiotherapists trialing the intervention with people). This observational study will also collect information about whether the combined therapy improves breathing and cough symptoms in people affected by MND.

This study aims to assess the safety of the study imaging tracer in Participants with Advanced Solid Tumours. The study imaging tracer is a radioactive tracer that is used to assist with visualising tumors during a specific type of PET scan. Who is it for? You may be eligible for this study if you are aged 18 years or above with advanced or metastatic triple negative breast cancer, squamous non-small cell lung cancer, oesophageal squamous cell cancer or head and neck squamous cell cancer. Study details All participants who choose to enrol in this study will be asked to attend a Screening Visit which may need to take place over more than 1 day. Participants deemed eligible following their screening visits will be required to attend a single study visit that lasts for up to 8 hours. During this visit participants will be asked to complete at least 3 full body PET scans, which will include an injection of the study tracer and collection of blood samples at various timepoints. Participants may be asked to complete 1 additional scans and will then be followed up for 6 days, including general monitoring. It is hoped that this study will help determine if the study imaging agent is a safe and effective tracer that can be used in the imaging of tumours in individuals with cancer.

VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic) is a recently discovered rare disease (incidence less than 1 in 20,000 persons) characterized by severe inflammatory symptoms and no known effective treatment. Although the disease superficially appears similar to typical autoimmune rheumatological diseases, emerging research suggests that it is driven by proinflammatory monocytes that are produced in the bone marrow by the cytokine granulocytemacrophage colony stimulating factor (GM-CSF). Patients are often misdiagnosed and there are no effective therapies and at least half of VEXAS patients also suffer with myelodysplastic syndrome, according to our local VEXAS Registry. Our preliminary studies suggest that the combination of azacitidine and Lenzilumab can be effective in reducing progenitor cells. Secondly, ongoing clinical trial of CMML (ACTRN12621000223831) this combination is found to be safe and effective. We will conduct a pilot study to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS

This study is to determine the efficacy of use of single use Negative Pressure Wound Therapy products in the community at varying pressures to determine which device would effectively heal patient wounds more rapidly and that is comfortable and easy to apply.

Hyperkalaemia is a potentially life-threatening condition caused by high blood potassium levels. It is commonly treated with insulin and glucose, but insulin can lower blood sugar too much, leading to hypoglycaemia—a condition that can cause confusion, shakiness, or even loss of consciousness. We want to find out whether glucose alone, without insulin, can safely and effectively lower potassium levels in people without diabetes. This may be possible because glucose stimulates the body to produce its own insulin. We are conducting a clinical trial at the Royal Brisbane and Women’s Hospital Emergency and Trauma Centre to compare standard insulin–glucose therapy with glucose-only treatment. The trial will assess both safety (risk of hypoglycaemia) and effectiveness (potassium reduction). If glucose-only therapy is found to be safer and just as effective, it could change the standard treatment for hyperkalaemia.

This study aims to test a new way to deliver radiation therapy to people with cancer that has spread to their bones to enhance local control of metastatic lesions while maintaining acceptable toxicity profiles. Who is it for? You may be eligible to join this study if you are aged 18 years and older, are with Pathological diagnosis of a solid tumour, no planned change to main medication on the first day of protocol radiotherapy. You must have a imaging confirmed bone metastases, estimated life expectancy greater than 3 months. Study details All participants who meet the eligibility criteria in this study will be given either: once a day for 5 days over 1 week, or once a day for 10 days over 2 weeks (Monday to Friday, with weekends off unless needed). The treatment includes a standard radiation dose to the affected bone area, along with a more focused, higher-dose boost to the main tumour area using advanced imaging. This boost is designed to better target the cancer while protecting healthy tissue. During and after completion of the treatment participants will be assessed for pain response and patient outcomes using questionnaires, fractures using imaging, and need for reirradiation and salvage surgery to treatment sites through clinical follow-up and medical record review. It is hoped that this research project will help determine if this combined approach is safe, effective, and practical to deliver in routine care to improve pain relief and tumour control while keeping side effects low