ANZCTR search results

This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. The study will consist of multiple parts that will assess administration of SGR-1505 alone and in combination with another treatment, posaconazole. Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma. Study details The first sub-study will enrol participants and test single doses of SGR-1505. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher single dose of SGR-1505. The second sub-study will enrol participants and test multiple doses of SGR-1505 over a 10-day period. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher dose of SGR-1505 over a 10-day period. It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma

This study aims to: 1. Demonstrate safety and preliminary efficacy of psilocybin-assisted psychotherapy in reducing core eating disorder psychopathology and increasing motivation to change in AN as assessed by the EDE/EDE-Q and RMQ 2. Evaluate effects of psilocybin on depressive, anxious and obsessional symptoms, cognitive flexibility, quality of life and alliance between therapist and patient.

Transgender men on testosterone therapy may experience hair loss as a side effect, which can be distressing as it may not align with their gender expression. There are limited data as to what can be used to minimise hair loss in trans men. Minoxidil is approved to treat hair loss in cisgender population in topical form. The oral form has been used off-label in the cisgender population to treat hair loss as well. This study is conducted in a randomised, double-blinded manner using the sublingual form of minoxidil to see whether or not it will regrow hair on the scalp that can provide cosmetic significance and minimise distress. Furthermore, extension studies are done to assess sublingual minoxidil as a monotherapy and combined therapy. This can improve the quality of life for transgender individuals.

This study aims to pilot a general practice-led intervention to increase participation in the National Bowel Cancer Screening Program (NBCSP) within 100 general practices in two Australian states. Who is it for? You may be eligible for this study if you are an adult aged 45 years or older who is a patient at one of the participating general practice (GP) clinics and you are eligible for bowel cancer screening. Please note that the primary participants in this study are the GPs, however patients may be involved during the study whilst the screening initiatives are being trialled. Study details Participating GPs who agree to participate in this trial will be asked to continue their usual bowel cancer screening procedures for the first 5 months of this study. After 5 months, GP clinics will be randomly allocated by chance (similar to flipping a coin) to one of two groups. GPs who are allocated to the first group will be asked to incorporate a variety of strategies aimed at increasing the number of patients who take up bowel cancer screening opportunities. These strategies have been co-designed prior to the current trial and include the use of decision support tools, reminder prompts, additional education focusing on appropriate screening pathways and communication guides to address screening barriers in non-participant patients. Patients who attend one of the participating GP clinics may be exposed to one or more of these strategies during the trial period. GPs who are allocated to the second group will be asked to continue their usual bowel cancer screening procedures for the duration of the study and will not be given access to the new strategies and tools at this time. It is hoped this research will determine whether including new tools and educational materials into routine care for bowel cancer screening that occurs through GP clinics has a positive impact on the number of patients who undergo bowel cancer screening. If this trial shows that any of the strategies used are effective at increasing screening, they may be expanded to all GP clinics at a national level.

The present study aims to assess the acceptability and feasibility of a recovery-orientated well-being group therapy program for people living with bipolar disorder that was developed to be specifically designed to be delivered via telehealth (Zoom platform) by clinicians using a randomised-controlled pilot design. It was hypothesised that by assessing weekly attendance, drop-out rates, homework compliance and qualitative interview data that the zoom-delivered program would be found to feasible and acceptable program for participants living with BD and that the telehealth platform would be viable as a form of delivery.

On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms. This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet. Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo. Studies suggest that altering microbial composition via FMT might also lead to improvements in cognitive function. Therefore, we will investigate cognitive function at baseline compared to follow-up in a subsample of 20 enrolled participants. In contrast to participants of the overarching clinical trial, sub study participants will undergo additional cognitive testing, which takes around 50 minutes per visit, and will be asked to fill out additional mood and quality of life questionnaires, which will add another 10 minutes to study visits. This result in a total study visit time of 80 minutes for substudy participants, as opposed to 20 minutes for participants of the overarching trial, who will only fill out two questionnaires on IBS-symptom severity. Cognitive function will be assessed via Cambridge Automated Neuropsychological Test Battery (CANTAB), a validated, computer-based, neuropsychological test battery that allows testing for cognitive changes in different cognitive domains, including memory, processing speed, and executive function. To assess the impact of mood and stress on IBS symptom severity, mood will be assess via the Depression, Anxiety and Stress Scale (DASS) and quality of life via IBS-QoL.

Extensive research has demonstrated that yoga is beneficial for general physical and mental health and well-being. However, only limited yoga-based interventions have been developed specifically for children living with Autism, with mixed results in reducing psychological distress and enhancing wellbeing. This study aims to understand the effects of a novel yoga intervention for reducing anxiety in children (aged 6 to 18) with Autism. This intervention is developed and co-designed with considerations of the special needs of children living with Autism, and it is primarily focusing on yoga postures, mindfulness awareness, breathing and relaxation training. The classes will run online, 1 hour per week for 8 weeks in a group setting.

Several studies have shown that the efficacy of non-invasive brain stimulation techniques such as tDCS and tRNS on cognitive function is partially modulated by individual characteristics. One of these characteristics is the amount of the neurotransmitter dopamine (DA) that a person has. Because some of the DA that is available in the human body is derived from our diet, one way of estimating DA availability is by using a food questionnaire which can tell us about someone’s tyrosine intake. Tyrosine is an amino acid that can be found in a variety of foods, and that through a chain of metabolizing steps eventually gets converted to DA. Thus, we hope to able to predict the effectiveness of tDCS/tRNS on planning and memory performance by an individual dietary consumption of tyrosine

An eHealth solution – Music Attuned Technology for Care via eHealth (MATCH) – was developed to support family carers of people living with dementia to use music intentionally to support care. To create scalable solutions for the growing number of people living with dementia, we developed a minimal viable product (the MATCH app) for the HOME setting, which will be adapted for the RAC setting in study 3. MATCH represents a paradigm shift in music and dementia technology because it will: a) embed training programs that guide FCs and professional care staff in the strategic use of music; b) use sensor technology to capture behavioural markers to interpret agitation levels and auto-suggest music using algorithms that learn preferences of the person living with dementia and then suggest music they may like (recommender system); c) be able to continuously adapt the music to match and attune to arousal levels and reduce agitation; and d) be accessible to culturally and linguistically diverse groups (training videos will be available in multiple languages). Stage 2 of this study aims to explore digital markers, using wearable sensor devices, as best indicators of agitation and other symptoms to inform the development of an AI system that can detect changes in agitation in response to music and refine music recommendations to reduce agitation symptoms in residents living with dementia. We expect that data from the sensor devices will be able to support the detection and better management of agitation symptoms in people living with dementia.

The purpose of the study is to assess a new type of closure for deep burn injury. It will evaluate the safety and efficacy of bioengineered human skin equivalent (HSE) for the closure of full thickness wounds in burn patients requiring excision and skin grafting, and will compare the outcomes with areas treated with standard split skin grafting. HSE is skin which is constructed in a laboratory, using skin cells, which have been extracted from a participant’s skin sample. This project involves using and comparing two variations of the HSE, as well as using standard burns treatment, and assessing the outcomes. The participant may receive one or both variations of the HSE, and will also receive split skin grafting to some of their burns. The three different possible treatments for the participant's burn wounds are: • HSE using platelet hydrogel, which is made with platelets supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process. These are combined with a hydrogel, which is a water soluble sheet used to grow the skin cells. • HSE using Novosorb® polyurethane polymer, which is a biodegradable foam, widely used in the treatment of burns. • The remaining burn areas will be treated with split skin grafts. The participant will have skin grafts applied to some of their burn injuries. The treated areas are subsequently assessed and photographed at 7-10 days post HSE application, 4 weeks post HSE application, 6 months post HSE application, and 12 months post HSE application.