ANZCTR search results

This study will test the safety and effectiveness of ADAM™ 2.0, a new contraceptive device for men, in a group of 30 healthy males aged 25 to 55 who are considering a vasectomy. Researchers believe that ADAM™ 2.0 can block sperm flow safely and could offer a reliable, non-hormonal, non-permanent alternative to traditional vasectomy. Participants will be closely monitored to assess how well the device works and to ensure their safety. The study aims to gather valuable information on the potential of ADAM™ 2.0 as a long-term contraceptive solution for men. The study hypothesis is that implanting a pre-formed, water-soluble hydrogel into the vas deferens will effectively block sperm flow into the ejaculate, thereby reducing sperm counts to near zero and preventing pregnancies.

This study is taking a novel approach to using predictive biomarkers to select people for lipid (fat) targeted treatments, to attempt to overcome hormone resistance in people with metastatic hormone resistant prostate cancer. There is increasing evidence that abnormal lipid (fat) metabolism promotes the growth of prostate cancer cells. We have previously shown that abnormal patterns of blood-borne lipids (called ceramides) can identify a group of people with metastatic hormone resistant prostate cancer who are likely to be resistant to the usual hormone treatments: abiraterone and enzalutamide. In the DARO-LIPID study, we will first identify which participants with metastatic hormone resistant prostate cancer have the high ceramide lipid signature through a blood test. Participants who do not have this lipid signature will receive usual care by their oncologist. Participants with this lipid signature who consent to the study will all receive darolutamide as standard of care. Participants will then be randomly split into two groups with one group also receiving the lipid drug called Opaganib to target the abnormal lipid changes and the second group receiving a placebo. The study is designed to see if Opaganib can increase the number of people who respond to darolutamide, and increase the time that they get benefit from the treatment. We will also look at how the Opaganib is affecting lipid/fat metabolism in the body/tumour.

This pilot trial will evaluate the feasibility and acceptability of a 12-week co-designed, dyadic physical activity intervention for autistic adults. Participants will invite a partner (e.g., a family member, carer, friend, mentor, or trainer) to co-plan, schedule, and engage in chosen physical activities. The partner acts as a supporter, and the pair has full autonomy to set goals and plan activities. The research team will provide workshops on the benefits of physical activity, the risks of sedentary behavior, daily personalized prompts, reminders, and fortnightly feedback. Autistic participants will also receive Fitbit and Sens devices to monitor their physical activity and sedentary behavior throughout the program. The intervention’s impact will be measured by changes in physical activity levels (measured in minutes per week), sedentary behavior (measured in minutes per week), and motivation for physical activity (measured by self-reported physical activity motivation scales). It is hypothesized that the intervention will lead to increased physical activity, reduced sedentary behavior, and improved motivation for physical activity at the end of the intervention compared to baseline measures.

The BREATHE SMART study aims to test a computerised system to screen for breathlessness among patients presenting to primary care in Australia. All patients with a scheduled GP appointment will complete a screening questionnaire via their SmartPhone prior to their GP consultation. The patient's screening results will be automatically transferred to the patient's electronic medical record and will be available to the GP prior to the patient's scheduled appointment. Each patient identified as having chronic breathlessness and consents to the BREATHE CDSS project will participate for 12 months. In this study we will assess the benefits of these tools for patients and GPs in reaching a diagnosis, commencing evidence-based management and achieving relief of breathlessness.

BREATHE CDSS study, which is an open label, cluster-randomised controlled trial of standard of care compared to a CDSS intervention. It will recruit for 12 months, and the will follow-up patients for 12 months. General practices in urban, regional and rural settings will be recruited to the trial. BREATHE CDSS is a stud that uses an clinical decision system to guide GPs with managing and diagnosing breathlessness, Patients will be followed up for 12 months from time of commencing study and the study will be conducted across a number of practices in ACT, NSW, TAS.

The PANDA study aims to explore whether a personalised nature prescription can encourage physically inactive adults aged 45 and older, who have cardiometabolic diseases, to increase their physical activity over 12 months. The study compares two groups: one that receives standard advice on physical activity, and another that gets tailored encouragement to spend time in nature through personalised text messages. We hypothesise that participants who receive the nature prescription will engage in more physical activity compared to those who only receive standard guidance. By examining changes in activity levels and health outcomes, we hope to determine if spending more time in natural environments can lead to improved health and well-being in this population. Additionally, we will evaluate the cost-effectiveness of the intervention and its impact on various psychological and social factors.

The overall purpose of this trial is to evaluate the acceptability, feasibility and usability of the Miranda Impact Study App among people with obesity post bariatric surgery and on a supervised medication in selected tertiary care weight management clinics in NSW and VIC. The hypothesis is that the Miranda Impact Study App is applicable and feasible to use in a tertiary care weight management clinic and that its use will increase engagement, self-efficacy, consumer satisfaction and quality of life.

This study aims to explore neurobiological and blood-based biomarkers that may indicate response to ketamine and determine changes in PTSD symptoms. In doing so, the study also aims to establish the evidence base for precision medical care for the use of ketamine as a treatment for Australian Veterans with TRD and PTSD.

The purpose of this study is to investigate if a single bout of resistance exercise can acutely reduce tumour hypoxia in prostate cancer patients who are scheduled to receive external beam radiation therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or over, have a diagnosis of localised or locally advanced prostate cancer, and are scheduled to receive conventional or hypofractionated external beam radiation therapy in the Perth metropolitan area. Study details: Participants in this study will attend a single supervised exercise session before starting their radiation therapy treatment. The study intervention involves performing resistance exercises at a medical research facility. Specifically, the exercise session is 20 minutes in duration and takes place at the Harry Perkins Institute of Medical Research, where you will also have an MRI scan immediately before and after the exercise session to measure tumour blood flow and tumour oxygen levels. All participants will also complete a baseline assessments at the Exercise Medicine Research Institute (Edith Cowan University) to evaluate their physical activity levels, aerobic fitness and muscle strength. It is hoped this research will contribute to new knowledge that will help improve treatment outcomes and survivorship care for prostate cancer patients by demonstrating the benefits of engaging in physical exercise while undergoing external beam radiation therapy.

This study is testing the safety, tolerability (if any side effects occur), pharmacokinetics (PK; the amount of experimental drug or any breakdown products in the blood), of a single dose/food effect of an experimental drug called radiprodil in the presence or absence of food (food effect). This entry in the ANZCTR describes Part B: a food effect study, assessing the effect of consumption of food prior to a single oral dose of radiprodil and the effect of food after a single oral dose of radiprodil (dose to be determined). Radiprodil is being developed as a new treatment of tuberous sclerosis complex (a rare genetic disease that causes non-cancerous tumours to grow in the brain and several other areas of the body) and focal cortical dysplasia (a malformation of neurons in a region of the brain called the cortex). Radiprodil is expected to reduce the risks of seizures and negative developmental outcomes that are characteristic in patients with these conditions. In patients with these disorders nearly all will have a form of epilepsy (seizures) from a very young age that does not respond to current treatments available. Seizures can affect the process of normal development and cognitive skills leading to behavioural issues and negative developmental outcomes. Radiprodil has the potential to normalise the pathways in the brain that are involved in seizures and therefore reduce the risks of seizures, negative developmental outcomes and other significant symptoms that are characteristic in patients with these conditions. The purpose of this study is to test the safety and tolerability of a new version of oral radiprodil called Sprayed Dried Dispersion (SDD) radioprodil when taken as a single dose either with or without food. The study will also assess the plasma pharmacokinetic profile (how a drug moves through the bloodstream over time) of the SDD radiprodil.