ANZCTR search results

This study is assessing the distribution of [203Pb]Pb-AB102 throughout the body and in advanced solid tumours using Single Photon Emission Computed Tomography (SPECT) imaging in participants diagnosed with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a locally advanced or metastatic cancer, such as breast cancer or squamous cell carcinoma. Study details All participants will receive a single 15-minute intravenous injection of the study drug [203Pb]Pb-AB102 and may also receive an optional single 15-minute intravenous injection of the study drug [68Ga]Ga-AB101. Participants will then undergo Single Photon Emission Computed Tomography (SPECT) and Computed Tomography (CT) scans to determine the distribution of [203Pb]Pb-AB102 throughout the body and within tumours. If participants consent to the optional [68Ga]Ga-AB101 injection, they will also undergo Positron Emission Tomography (PET) and Computed Tomography (CT) scans to determine and compare the distribution of [68Ga]Ga-AB101 throughout the body and within tumours. Participants will be followed for at least 5 days after each study injection to assess any adverse events. It is hoped that this research will improve understanding of how [203Pb]Pb-AB102 distributes throughout the body and tumours, and whether it is safe for use in patients. In addition, researchers hope to determine whether [68Ga]Ga-AB101 can be used to identify patients who may benefit from a future therapeutic agent targeting the same cancer marker.

This study aims to determine whether catheter ablation improves cognitive function compared with optimised medical therapy in adults aged 67 years and older with persistent atrial fibrillation. Participants will be randomly assigned to receive either catheter ablation or guideline-directed medical therapy and followed for up to 24 months. Cognitive function will be assessed using validated neurocognitive assessments at baseline, 6, 12, 18 and 24 months, with cognitive function at 12 months as the primary outcome. Secondary outcomes include cognitive function at 6, 18 and 24 months, quality of life, atrial fibrillation recurrence and burden, healthcare utilisation, and safety outcomes. The study hypothesis is that catheter ablation will be associated with better cognitive function as compared with medical therapy alone.

The Evoke Spinal Cord Stimulator (SCS) System (Evoke System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs and will be used within its commercially approved indication. The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

An open-label trial to investigate the use of vigabatrin to manage alcohol withdrawal in an outpatient setting. Participants will receive vigabatrin 2gm daily for four days, with regular assessments of withdrawal severity and benzodiazepine use. Follow-up will occur at 30 days post cessation of trial medication. We hypothesize that treatment of alcohol withdrawal with vigabatrin in a community setting is safe and tolerable.and will result in an overall use of diazepam of less than 100mg.

Excessive or prolonged foot pronation has been associated with increased mechanical loading of the lower limb and is associated with overuse injuries. Foot orthoses are commonly used to redistribute plantar pressures and modify lower-limb biomechanics, with anti-pronatory design features intended to reduce injurious loads associated with pronation by increasing medial ground reaction forces. However, conventional foot orthoses often produce inconsistent biomechanical outcomes, The research team has developed an approach to produce accessible and low-cost 3D-printed metamaterial foot orthoses with regionally graded stiffness that can precisely control mechanical properties across the device. These orthoses have the potential to provide more targeted anti-pronatory effects than conventional orthoses by selectively increasing medial stiffness while reducing material waste through additive manufacturing. This within-subjects randomised crossover study in healthy adults will compare the immediate biomechanical effects of 3D-printed metamaterial foot orthoses incorporating anti-pronatory graded stiffness with conventional prefabricated anti-pronatory and neutral foot orthoses. Primary outcomes will include plantar pressure distribution and lower-limb kinetics and kinematics during walking. The results of this study will provide insight into the biomechanical effects of graded metamaterial orthoses and inform larger clinical studies evaluating their effectiveness in people with pronation-related musculoskeletal conditions.

This study investigates whether adding a brief, single-session intervention before admission can improve outcomes for young people aged 16 to 21 entering a sub-acute mental health service. Participants will receive a pre-admission session based on either Motivational Interviewing (MI) or Dialectical Behaviour Therapy Pre-Commitment (DBT-PC), and their outcomes will be compared with those receiving treatment as usual. The study will examine whether these interventions increase motivation to engage in therapy, as well as actual engagement during admission, measured through attendance at group and individual sessions and completion of homework. It will also assess whether the interventions lead to better clinical outcomes, including reduced suicide risk, increased psychological growth, and fewer hospital bed days or emergency department presentations at discharge and follow-up. Finally, the study will explore how motivation and engagement interact to influence the relationship between pre-admission symptoms and discharge outcomes, helping to clarify the role engagement plays in young people's mental health recovery.

This is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of cannabidiol (CBD) compared with placebo in reducing alcohol consumption among adults with alcohol use disorder (AUD). Participants who have an Alcohol Used Disorder will be given bottles of CBD (or placebo) to take the recommended dose each day (a few drops, applied orally) for 12 weeks. Participants will attend for regular checks and drug dispensing during the treatment period. At Week 12, participants will have various checks to confirm whether drinking has reduced, again 12 weeks later an appointment will be held to check how participants have managed in the absence of the study drug .

Inpatient withdrawal management provides highly supportive care to allow people to safely and successfully complete their withdrawal episode. This duration of hospitalisation is of significant burden, both at the individual level and health system level. Expert consensus from the Clinical Directors of the five Local Health Districtss involved in this project have identified a potential solution – providing the option of a step-down model of care for patients admitted to hospital for alcohol and/or drug withdrawal. Based on clinical risk assessment, this would allow for patients to complete withdrawal in the community, reducing burden on hospital beds and allowing people to receive care from their own homes with access to personal supports. This project seeks to evaluate the impact of this change on length of stay and clinical outcomes using a stepped-wedge trial design where hospitals will randomly begin offering step-down care as an option to their patients over a 54 week period.

This trial compared two breathing therapies — high-flow nasal cannula (HFNC) and CPAP (the current standard treatment), to see whether HFNC was effective as well, and also tolerated for children with moderate-to-severe obstructive sleep apnoea. We also asked children which one they found more comfortable. Each child was studied for one night while sleeping, using sensors to measure how well they were breathing and sleeping on each therapy.

The study is testing a new internet-based health program that can be done from home. The aim is to find out if it helps improve important healthy actions (such as diet and exercise), as well as emotional wellbeing, in adults who have heart or blood vessel conditions or are at risk for these, and who also have symptoms of depression or anxiety. The program is psychologically-informed and designed to teach skills for setting goals, maintaining healthy actions in the long term, and overcoming common challenges.