ANZCTR search results

This study will evaluate whether a 12-week Mediterranean-style dietary program can reduce symptoms of anxiety and depression in Australian adults. Participants will be randomly allocated to either a Mediterranean diet intervention involving dietitian support, educational resources, food hampers, supermarket vouchers and a dietary tracking app, or a befriending social support program providing equivalent contact time without dietary advice. The study will also examine whether the intervention improves diet quality, social connectedness and quality of life, and explore potential biological changes including gut microbiome composition and fruit and vegetable intake. We hypothesise that participants receiving the Mediterranean diet intervention will experience greater improvements in anxiety symptoms, depressive symptoms, and dietary adherence than those receiving the befriending control condition

This is a single-centre, two stage, open label study to investigate the tolerability and feasibility of a new intranasal delivery system. 10 healthy controls and 20 schizophrenia consumers will be recruited to self administer an intranasal spray for 14 days and provide feedback on tolerability of the delivery system. We aim to address a gap in the therapeutic options available for individuals using long term antipsychotic treatment.

This study aims to find out whether bronchoscopic radiofrequency ablation can be safely added to standard chemotherapy and immunotherapy that is given before patients with non-small cell lung cancer undergo surgery (IMPRINT study). Who is it for? You may be eligible to join this study if you are aged 18 years and older with confirmed Stage IIA-IIIA Non-Small-Cell Lung Cancer (NSCLC) and recommended for neoadjuvant Chemo-immunotherapy followed by a lobectomy for resection. Eligible participants will have a pre-ablated parenchymal tumour/lesion size of greater than or equal to 20mm and will have a planned ablation zone margin of greater than or equal to 10mm away from the pleural surface, mediastinum, diaphragm and/or spine. Study details Bronchoscopic radiofrequency ablation (RFA) where a RFA catheter is introduced to the lung cancer via a bronchoscope, will be delivered to patients with confirmed resectable non-small cell lung cancer prior to recieving standard of care neo-adjuvant chemo-immunotherapy followed by resection. One ablative procedure per patient will be performed by a trained interventional pulmonologist. Procedure will be performed in an operating theatre under general anaesthesia. Patients will be followed up from time of ablation to resection. This study will identify whether bronchoscopic thermal ablation prior to neoadjuvant chemo-immunotherapy can be performed without compromising the delivery of standard neoadjuvant care and will assess the proportion of eligible patients (Resectable Stage II–IIIA, candidates for chemo-IO) who consent to the add-on ablation procedure, the rates of patients completing treatment and progressing to surgery, patient pathologic responses, and any side-effects or adverse events. It is hoped that the findings of this study will help to determine if bronchoscopic tumour ablation for immune priming can be used to enhance neoadjuvant chemotherapy and immunotherapy in patients with resectable NSCLC.

Epidurals are the most effective form of pain relief during labour, but they can be given in different ways: some provide very strong pain relief but cause heavier legs and less movement, while others provide good pain relief while preserving more movement. Little is known about which of these trade-offs Australian women would prefer. This study will survey women who had an epidural during labour at University Hospital Geelong, 6 weeks to 6 months after birth, by telephone, online or on paper. The survey asks about their experience of the epidural, including the information they received, pain relief, movement, side effects, sense of control and satisfaction, and which epidural option they would prefer for a future labour when presented with a balanced trade-off scenario. The findings will show how many women would prefer a mobility-preserving epidural compared with a stronger, denser epidural, and will help make epidural care better matched to what women value.

The aim of this randomised placebo-controlled trial is to establish the efficacy, safety and cost-effectiveness of RFA compared to placebo in people with chronic lumbar facet joint pain. Efficacy will be assessed in relation to pain, function and quality of life.

This study is aiming to evaluate the feasibility of a dietary intervention to reduce dietary saturated fat intake in people with localised prostate cancer prior to radical prostatectomy surgery to remove their prostate Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with localised prostate cancer with either intermediate- or high-risk disease planned for prostatectomy, with study treatment both planned and able to start within 7 days of enrollment Study details Participants will undergo baseline dietary assessment by a dietitian, and automated self-administered 24-hour dietary assessment. Based on these assessments, participants will be classified as having high saturated-fat intake or low saturated-fat intake. Those with low saturated fat intake will continue their usual diet for the next 3-4 weeks until their planned prostatectomy. While those in the high saturated-fat intake group will be randomly allocated (by chance) to one of two groups to receive either: 1) no change to their diet (usual care) or 2) change to a low saturated fat diet for the next 3-4 weeks until their planned prostatectomy. The low saturated fat diet group will receive dietary education, supervised by a dietician. Feasibility of the dietary intervention will be evaluated using the rate of recruitment and adherence to the dietary intervention. Participants will also undergo routine biopsies and blood testing to determine changes in the profile of fats in the prostate tissue as well as in the blood before and after the dietary intervention. If this feasibility trial is successful, then we aim to perform a larger, definitive trial attempting to evaluate whether the change in diet can affect prostate cancer growth and outcomes from prostate cancer. This would provide a novel treatment strategy of a precision dietary intervention for people with prostate cancer.

International guidelines provide conflicting recommendations regarding the discontinuation of DOACs prior to polypectomy. We are undertaking a multicentre prospective cohort study with patients who are using DOAC therapy while undergoing colonoscopy. Many centres have adopted the strategy to withhold DOAC only on the morning of colonoscopy which has retrospective data showing no increased delayed post-cold snare polypectomy bleeding, but potential reduced thromboembolic events and less changes to patients' procedure timing. This study will only include prospectively collected data.

This study is an early-stage clinical trial to check whether a new medicine called PTC612 is safe for healthy adults to take. Blood samples will be collected to measure the amount of medicine in the body and to look at substances related to inflammation. The study is based on the idea that PTC612 can be taken safely and may help reduce inflammation, supporting its future use in inflammatory diseases.

RECCE®327 topical gel has been developed through a stepwise clinical program from early evaluation of safety, pharmacokinetics (PK), and preliminary efficacy to later-stage development in diabetic-related foot infection (DFI). Early clinical studies demonstrated minimal systemic absorption following topical administration, with systemic exposures substantially below those shown to be well tolerated following intravenous administration, supporting continued clinical development of RECCE®327 as a topical antibacterial therapy. DFI has been selected as the primary target indication because of its significant unmet medical need and the potential advantages of achieving high local antimicrobial concentrations while minimizing systemic exposure. Part A of this study (ACTRN12624000973516) provided the safety, PK, and preliminary efficacy data that informed the design of Part B, a randomized, active-controlled study intended to generate comparative efficacy and safety data. Although conducted under a common protocol and governance framework, Parts A and B have separate objectives, study designs, and statistical analysis plans, and data from each part will be analysed and reported separately.

This Phase 1/2 study is evaluating safety, tolerability, pharmacokinetics and preliminary antitumour activity of different doses of Lutetium-177 in people with fibroblast activation protein (FAP)-expressing pancreatic ductal adenocarcinoma, biliary tract carcinoma and other FAP-expressing solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with locally advanced and/or metastatic cancer expressing FAP, including pancreatic ductal adenocarcinoma, biliary tract carcinoma and other solid tumours. Study details There are 4 parts to this study. Participants will be allocated to different parts based on their tumour type and timing of allocation. Part 1A will assess 4 different doses of Lutetium-177 administered intravenously on Day 1 of each cycle for at least 4 cycles. Safety, tolerability and recommended dose for Part 2 will be assessed in Part 1A using vital signs, laboratory values, electrocardiogram and adverse event monitoring from the time of administration until the end of each cycle. Pharmacokinetics will also be assessed for Part 1A using serum samples at specific time intervals. Part 1B will administer a single low-dose Lutetium-177 administered intravenously on Day 1 of cycle 1. Imaging and dosimetry will be assessed using Dosimetry SPECT scan at specific times within the first 8 days of treatment. Part 2A will administer two recommended dose-for-expansion levels, based on dosages determined from Part 1A, for 4 cycles (6 weeks each) plus 2 optional additional cycles. Safety, tolerability and preliminary antitumour activity will be assessed using vital signs laboratory values, electrocardiogram, adverse event monitoring from the time of administration until the end of each cycle. Quality of life will also be assessed using a questionnaire. Part 2B will administer one recommended Phase 2 dose, based on dosages determined from Part 2A, for 4 cycles (plus additional 2 optional cycles). Safety, tolerability and preliminary antitumour activity using vital signs, laboratory values, electrocardiogram, adverse event monitoring and RECIST v1.1 from the time of administration until the end of each cycle.