ANZCTR search results

This project aims to explore the acceptability and feasibility of a novel therapeutic group yoga program for clients of a specialist Eating Disorder Service at Barwon Health alongside their usual treatment. Research Questions 1. Is an adjunctive therapeutic group yoga program, that includes consumers and carers, alongside treatment as usual (TAU) for the treatment of eating disorders feasible, acceptable and safe? 2.Does an adjunctive therapeutic group yoga program that includes consumers and carers alongside TAU yield additional clinical improvements for people in treatment for an eating disorder? Sub study – Research Question 1. What are the potential secondary or co-benefits for carers who attend a group yoga program to support their consumer in ED recovery?

This is a double blind, placebo-controlled multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in patients with established atherosclerosis, Up to approximately 52 participants with established atherosclerosis will be randomised into this study. The study will be conducted with a multiple dose phase (Part A) and a cohort expansion phase (Part B). Part A cohorts will contain up to 8 participants each with 6 participants receiving BRB-002 and 2 participants receiving placebo. Part B will be a dose expansion phase where a further 20 participants tested with the optimal dosing regimen determined during Part A. For each cohort, a Safety Review Committee (SRC) will review all emerging safety, tolerability, PK and PD data. The next planned cohort will be initiated only after it is confirmed by the SRC that the latest cohort dose was safe and tolerated.

Asthma and other conditions can co-exist in patients with Chronic Rhinosinusitis with Nasal Polyps, which can adversely affect patient outcomes. It is uncertain if it is of benefit or cost effective for these patients to routinely see a Respiratory Physician. This study will answer this question. Patients who are planning to have Sinus Surgery treatment will be randomly allocated to two groups: One group will receive the Usual Care from their Ear Nose and Throat Surgeon. The other group will receive Precision Care, and will attend for an appointment with a Respiratory Physician and be assessed for asthma or other respiratory conditions and other medical conditions that they may have. These patients will then receive treatment for these conditions. It is proposed that patients receiving precision care will report greater improvement in their Chronic Sinusitis symptoms 12 months post surgery.

This trial aims to 1) determine the effect of Cognitive Bias Modification for Interpretation (CBM-I) on pain severity and pain interference in people with endometriosis, and 2) investigate whether imagery can enhance the effects of CBM-I. Participants eligible for this study are those who 1) are aged 18 or above, 2) have a confirmed or provisional endometriosis diagnosis, 3) experience pain associated with endometriosis,,4) have access to the internet and a computer or smartphone over a 3-month study period, 5) are fluent in English. Participants will be randomly allocated (by chance) to receive one of two (CBM-I) interventions or a placebo. CBM-I is an online intervention that aims to alter the way that people interpret ambiguous information. Participants will receive four cognitive bias modification sessions over 30 days and will be required to answer a number of questionnaires before the intervention phase, and both 14 and 90 days after the intervention phase is completed. It is hoped that this study may demonstrate that CBM-I is effective in reducing pain outcomes in people with endometriosis. It also hoped that this study may help to reduce psychological distress (depression, anxiety and stress), fear or progression, and improve quality of life for people with endometriosis pain..

Having a stroke is a life-changing event. Many survivors are left with significant impairments that affect their long-term independence. For many, this can limit their participation in activities which they enjoyed before their stroke. In metropolitan Australia, stroke patients receive an average of 42 days of therapist-guided stroke rehabilitation. Many people in regional and rural areas receive much less. Environmental enrichment is the combination of physical, cognitive and social activities. Previous experimental models of stroke have shown that this can increase brain plasticity, which is an important process for re-learning skills and function after stroke. Group-based (peer-supported) programs can provide a sense of community through sharing information, providing tools for coping, and creating an outlet for stroke survivors and caregivers. This may contribute to improved physical function and psychological outcomes after stroke. The aim of the project, “ Exercising, Socialising and Thinking: an Environmental Enrichment Model (ESTEEM) After Stroke", is to build a sustainable group program based on environmental enrichment for use in community venues by stroke survivors and their carers. The ESTEEM Program has been co-produced in collaboration with people with lived experience of stroke including stroke survivors, carers, health professionals and service providers. Overall ESTEEM project hypothesis: We hypothesise that, compared to stroke survivors receiving usual care in the community, stroke survivors who receive the model of environmental enrichment will have greater physical function and quality of life.

In this study up to 20 subjects will be enrolled at a single study centre. The study will consist of a screening period, placebo run-in period, treatment period and follow-up period. Participants will all have active keloids. Participants will be provided with PXS-6302 to apply topically (and placebo if >1 keloid requires treatment) for a period of 3 months. Safety will be assessed as frequency/type of adverse events. Exploratory measures to assess changes in the keloid (size/symptoms) will also be used.

This study aims to assess the Safety, Biodistribution, and Dosimetry of [68Ga]Ga-A9-6217 in Participants with Select Advanced or Metastatic Solid Tumors. [68Ga]Ga-A9-6217 is a radioactive tracer that is used to assist with visualising potential tumors. Who is it for? You may be eligible to join this study if you are aged 18 years or above with advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer or colorectal cancer. Study details All participants 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 session that lasts for approximately 6 hours to complete at least 2 full body PET scans, which will include an injection of the tracer ([68Ga]Ga-A9-6217) and collection of blood and urine samples at various timepoints. Participants may be asked to complete 2 additional scans and will then be followed up for 2 days, including general monitoring. It is hoped that this study will help determine if [68Ga]Ga-A9-6217 is a safe and effective tracer that can be used in diagnosis or monitoring of tumours in individuals with cancer.

Assessment of bone mineral density on pre vs post contrast computed tomography compared with dual energy x-ray. Many patients have abdominal CT imaging performed to assess for other pathology. If bone mineral density can be opportunistically assessed on these studies with or without IV contrast then patients can be screened for osteoporosis or the need for a formal dual energy x-ray scan to assess for osteoporosis. Opportunistic screening for osteoporosis through CT scans may facilitate earlier diagnosis and treatment, reducing complications, at no additional cost to patients.

People with severe mental illness are much more sedentary than the general population, and therefore more susceptible to life limiting diseases such as cardiovascular disease and clinical obesity. This study aims to assess the feasibility and usability of an app and wrist wearable to promote physical activity snacks (<10min in duration) in people with severe mental illness. We hypothesis that the app will be feasible and acceptable for people with severe mental illness. We also hypothesise that prompting people with severe mental illness to do activity 'snacks' will increase their physical activity levels, decrease sedentary behaviour, and improve quality of life.

This study aims to investigate the impact of plan parameters and optimisation approaches on plan monitor units (MUs) and corresponding physics quality assurance (QA) results. Who is it for? Patients who have been diagnosed with intact brain metastases and/or post-operative cavities after resection of brain metastatic disease, and planned with HyperArc and treated on the stereotactic linear accelerator at Canberra Region Cancer Centre from September 2022 to March 2025 will be retrospectively analysed for this study. Study details Once participants are deemed eligible, their existing radiation treatment plans will be randomly selected to provide a wide range of plan characteristics such as number of lesions, size of lesions, shape of lesions, distance from isocentre, proximity to healthy organs and use of optimisation structures. These plans will be de-identified and replanned, changing one variable at a time to observe the results on plan complexity (MUs) and physics QA results. These plans will be ensured clinical acceptability by the principal investigator. After replanning, the impact of plan characteristics on plan complexity and physics QA results will be observed and from that data, MU limits will be developed which are tailored on specific plan characteristics. It is hoped that the results from this study will provide a better understanding of the change in complexity of HyperArc SRS plans depending on particular plan characteristics and see the implementation of MU limits result in a more seamless SRS planning workflow which balances clinical acceptability with deliverability and safety.