ANZCTR search results

This study aims to assess the safety and effectiveness of a specialised treatment called basivertebral nerve ablation (BVNA) for people with ongoing low back pain coming from changes in the bones of the spine (called Modic changes). This study also aims to assess the effectiveness of BVNA in other conditions which haven't been reported in the literature. We hypothesise that BVNA may provide extended benefits to patients outside of its proven clinical indications.

This study aims to co-design BCT intervention to support smoking and vaping cessation that is easy to use, acceptable, and tailored to the needs of mental health consumers.

This is an investigational combination treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. This treatment arm (PHI-101) will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details PHI-101 will be given orally at a dose of 160 mg on an empty stomach. It should be administered at least two hours after a meal, preferably following an overnight fast. After taking PHI-101, you must continue fasting for an additional two hours.PHI-101 will be administered on days 1-28 (every day) of each 28-day cycle. Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6, cycle 8, cycle 10, cycle 12 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that PHI-101 will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

This study aims to evaluate digital health promotion resources targeting Australians aged in their 50s, 60s and 70s who engage in risky alcohol consumption. Traditional messaging about long-term alcohol-related disease risks can often fail to resonate with this group. To address this, this project has developed short videos based on what this demographic has told us they want: real stories and real people that model positive changes in alcohol use. The intervention seeks to empower individuals with alternative social and relaxation strategies to support healthy ageing, while also shifting attitudes, norms, and knowledge toward lower-risk drinking behaviours.

Abdominal bloating/distension is a common and often debilitating condition that affects patients with Disorders of the Gut-Brain Interaction (DGBI). There are very few effective treatments. We believe that bloating and distension of the abdomen is caused by an abnormal response from the abdominal muscles causing them to relax and protrude. Electrical Muscle Stimulation (EMS) is a non-invasive, commercially available technology that is often used by physiotherapists, sports physicians and athletes. EMS devices can also be purchased and used in the home for various indications. Like an electrocardiogram (ECG) or ‘heart trace’, the EMS device is connected to the abdominal skin via gel pads (electrodes). This study will evaluate whether EMS to the abdominal muscles can improve symptoms of chronic abdominal bloating through activation of the abdominal muscles in response to meals. The outcomes of this study will guide future research and inform clinical management strategies for functional gastrointestinal disorders. We believe that EMS applied to the abdomen can improve symptoms of abdominal distension in people with chronic abdominal bloating/distension.

Current dietary advice for individuals with an ileoanal pouch is based on general healthy eating guidelines, rather than tailored recommendations. However, people respond to food differently, and it may not be appropriate to recommend the same dietary advice to everyone with a pouch. Our group is conducting a two-phase study to develop more personalised dietary recommendations. Phase 1 (Trial ID: ACTRN12624000912583) involved a lab-based investigation using fresh stool samples to assess how gut microbes break down specific food components. This registration refers to Phase 2, where the same participants will follow two different 7-day diets in a randomised crossover design. Stool samples collected after each diet will be tested using the same in vitro assay developed in Phase 1. The goal is to determine whether the assay can detect meaningful differences in microbial fermentation based on dietary intake. We believe people with an ileoanal pouch respond differently to different diets, and that our lab test can pick up these differences. This could help us move away from one-size-fits-all advice and towards personalised fibre recommendations.

This project aims to understand how certain factors like age and PCOS impact the endometrium by using menstrual fluid. Like all tissues in the body, the endometrium also changes over time. In Australia, more women are getting pregnant for the first time later in life. However, as we age, fertility naturally declines and the endometrium changes as well. As the endometrium plays a key role in pregnancy, we want to understand how aging affects it and the impacts this may have. Similarly, people who have been diagnosed with PCOS, typically have longer, irregular menstrual cycles. We think this could impact the endometrium in a similar way to aging. We will assess markers of ageing in endometrial cells isolated from menstrual fluid. This research is important because if the endometrium isn’t functioning properly, it can impact fertility, regular menstruation and reproductive health overall.

Historically, AS severity has been assessed using transvalvular gradients and valve area estimates derived from echocardiography, however, cardiac MRI provides more precise assessment of LV systolic parameters which are more accurate measures of pressure overload. Systolic LVWS, calculated using a combination of TTE and cardiac MRI data, has been demonstrated to be a helpful adjunct to echocardiography and symptom assessment in aortic stenosis. This study aims to investigate the correlation between TTE and MRI derived systolic LVWS and symptom status, traditional echocardiographic markers of AS severity, and clinical outcomes including progression to SAVR or TAVI.

This is an open label, short term, ascending multiple dose study to investigate the safety, tolerability, and efficacy of guanethidine in patients with pulmonary hypertension heart failure and a preserved ejection fraction (PH-HFpEF). The primary objective of this study is to determine if guanethidine can reduce exercise-induced increases of central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) in patients with PH-HFpEF. The secondary objectives of this study are to: • Evaluate the safety and tolerability of guanethidine in patients with PH-HFpEF. • Determine the optimal dose for phase II-III trials of guanethidine in PH-HFpEF. Up to 15 patients will be enrolled in this study. The duration of individual patient participation will be a maximum of 5 months, including up to a 4-week screening period, up to 3 months of daily administration of guanethidine after the initial catheterization, and telephone follow-up contact 4 weeks after the second catheterization and discontinuation of guanethidine. Eligible participants will be administered escalating doses of guanethidine daily, starting at 5 mg/day. Drug dose will be increased every 2 weeks as tolerated by orthostatic blood pressure evaluations, symptomatic orthostasis, a blood pressure not less than 120 mmHg or dose limiting toxicity (DLT), sequentially, to 10, 15 and 25 mg/day. If a dose is not tolerated, it will be decreased to the prior tolerated dose. A repeat exercise hemodynamic assessment will be performed on the final tolerated dose of guanethidine (up to 25 mg daily) which has been administered for at least 2 weeks.

Existing small portable oxygen concentrators use pulsed delivery that claim some equivalency to continuous flow. This is an area of study that has little to no clinical validation and continuous flow (primarily from cylinders and large home stationary concentrators) is considered the gold standard by the medical community. This pilot study will evaluate oxygen saturation and six-minute walk distance in patients requiring ambulatory oxygen. Two six-minute walk tests will be performed with the subjects using both the battery powered Juno delivering continuous oxygen flow and the continuous flow oxygen cylinder in randomized order. The study aims to establish non-inferiority between the new battery powered device and the current oxygen cylinder gold standard. A non-inferiority margin of 7% will be evaluated, as this was the mean difference in repeat 6 minute walk tests in a large cohort study. (Hernandes 2012) This study will inform future product development and a larger follow up study as a genuine, renewable alternative to oxygen cylinders.