ANZCTR search results

Our research team evaluates fetoplacental perfusion using ultrasound and a validated ultrasound imaging tool called Three-Dimensional Fractional Moving Blood Volume (3D-FMBV). Previous experimental work from our group has shown an excellent correlation between 3D-FMBV and accepted ‘gold-standard’ measurements of blood flow. Funding from the Wellcome Leap In Utero (WLIU) project (https://wellcomeleap.org/inutero/) has allowed us to determine normal ranges for fetal organ perfusion (brain, liver and kidney) and placental perfusion. The WLIU project funded production in 2023-2024 of a purpose-designed low-cost ultrasound system though an independent design and engineering consultancy (IDE Group). This was constructed based upon original equipment manufacturer components under full ISO13485 and IEC 62304 regulatory compliance. We will be undertaking an equivalence study in early 2025 to show that our ultrasound machine measures perfusion in a comparable manner to the previously used GE machine. The goal of the Wellcome Leap In Utero research is to develop a low-cost tool for late pregnancy evaluation to determine the fetus ‘at risk’, that can be used in low resource environments. We wish to undertake a study to look at feasibility and acceptability of our ultrasound device and its predictive ability for stillbirth or hypoxic fetal compromise in a high-risk population. Discussions with participants in high-risk priority populations (including Aboriginal and Torres Strait Islander peoples) located in three identified rural/remote centres have identified the urgent need for predictive markers for late pregnancy loss. Our team of clinicians and engineers will work with our collaborators in these priority populations to collect relevant markers (individual fetal organ perfusion or ratios) and validate these against our established normal ranges.

The purpose of this research is to test the effectiveness of using a computer simulation to personalise the force recommendations for jaw stretching and exercise program and compare this to the usual jaw stretching and exercise program. We will do this by using finite element analysis that uses information from CT scans to predict what is the best amount and place to apply pressure to stretch the mouth after undergoing jaw surgery. Once we have the recommendations we can deliver the pressure using a device called RestorabiteTM. RestorabiteTM is a class I medical device that has been approved in Australia by the Therapeutic Goods Administration (TGA) ARTG ID 407358. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo a segmental mandibulectomy and reconstruction at COBL Study Details: This is a randomised controlled trial. Each participant is put into a group by chance (random). In this study, the groups are either control (Low force) or intervention (Personalised force recommendation). Intervention: 1.Maxium Incisal Opening (MIO) will be measured. 2. Standard of care virtual surgical planning (VSP) will be performed prior to surgery and undergo a segmental mandibulectomy and reconstructive surgery. 3. FEA using the VSP and standard of care post-operative CT scans will be conducted to optimise the postoperative exercise program by providing force and location targets (i.e., the ideal amount and location to apply force to the jaw). 4. A jaw-stretching device (RestorabiteTM) will be used to deliver the exercise program starting at 2 weeks after surgery. 5. The exercise program will continue for 10 weeks under the supervision of a speech pathologist. 6. After the 10 week exercise program, participants will be advised by their speech pathologist whether they will require a maintenance program. This will be recommended for any participant with a MIO<35mm. Participants will conduct their maintenance program independently and follow up appointments to monitor MIO, exercise adherence and adverse events. The control group will be patients undergoing the same procedure but excludes Step 3 (FEA to model personalised jaw exercise). This control group constitutes standard care at Chris O’Brien Lifehouse for patients undergoing segmental mandibulectomy and reconstruction. For all participants from both groups, you will have an assessment of your mouth opening and quality of life questionnaire (10 minutes). This will be carried out before surgery, then at 2 and 12 weeks, 6, 12, 18, 24 months post-surgery. This research is testing if using the personalised force recommendations might improve your mouth opening over time after the operation compared to our usual low pressure. By personalising exercises, we hope to prevent or minimise the onset of restricted mouth opening (trismus) after jaw reconstruction surgery. Participation in this clinical trial is voluntary

The focus of this study is to determine whether lung ultrasound (LUS) can predict poor lung outcomes in high-risk patients undergoing cardiac surgery and guide decisions for optimal oxygen delivery methods. This study will be a sub-study within the larger Nasal High-Flow Oxygen Therapy After Cardiac Surgery (NOTACS) Trial (registration record: NCT05308719), ethics registration record, SSA/2021/MNHHS/81052. Whilst cardiac surgery can provide several long-term benefits, the surgery is not without risks. Incidences of post-operative pulmonary complications (PPCs) (or lung complications) for patients undergoing open-heart surgery range from 5-90% depending on the definition of the complication. The identification of risk factors for developing PPCs and early diagnosis in the cardiac surgery population is of major importance. LUS has emerged as an excellent diagnostic tool in identifying a variety of pulmonary diseases and PPCs. We hypothesise that LUS will be an accurate predictor of PPCs and guide optimal respiratory support (oxygen therapy) in the high-risk cardiac surgery population.

This study aims to capture information regarding the effect of chemotherapy and immune checkpoint inhibitor (ICI) treatment for triple negative breast cancer on ovarian function and sex hormone levels. Who is it for? You may be eligible for this study if you are female and aged between 18 and 42 years, you have been diagnosed with triple negative breast cancer and you are planning to receive neoadjuvant chemotherapy and ICI treatment before breast surgery. Study details All participants who choose to enrol in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment/follow up visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Patients will also be asked to participate in an optional pelvic ultrasound at 3 of their scheduled treatment/follow up visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enrol in this study, this is an observational study only. It is hoped this research will contribute important information regarding the potential toxic effects of combination chemotherapy-ICI treatment on sexual and reproductive function in patients with triple negative breast cancer who are receiving neoadjuvant chemotherapy-ICI treatment.

Group A Streptococcus Point-of-Care Testing (GAS POCT) service can play an important role in diagnosing bacterial pharyngitis and optimising antibiotic use. This pilot cluster randomised controlled trial assesses the effectiveness of GAS testing in reducing antibiotic use in general practices for new onset acute sore throat/pharyngitis/pharyngotonsillitis infections. The study also underpins the experiences and challenges of GPs while using the GAS testing in routine patient care through post-implementation interviews.

This study aims to improve the understanding of the genetic basis of inborn errors of immunity (IEI) in patients with lymphoma, with the goal of informing future diagnostic and therapeutic strategies. Whom is it for? You may be eligible to participate if you are aged 18 or older and have a diagnosis of non-Hodgkin lymphoma, either before the age of 40 or with clinical features suggestive of an underlying inborn error of immunity (IEI), such as recurrent infections, immune dysregulation, or early-onset disease. Study Details In this prospective observational study, an initial cohort of 20 patients will be enrolled. Blood and saliva samples will be collected for whole exome sequencing. Phase 1 will focus on 99 genes known to be associated with immunodeficiency, while Phase 2 will explore the full exome to identify novel gene variants potentially linked to IEI and lymphoma. Additional correlative studies will include analysis of clinicopathologic data, chronic viral infections, treatment toxicity, outcomes, and immune profiling using next-generation sequencing. It is hoped that this pilot study will improve the understanding of the genetic basis of IEI in lymphoma and therefore improve diagnosis and therapeutic strategies in this population.

This study is testing whether cannabidiol (CBD), a non-psychoactive compound from the cannabis plant, can reduce irritability and aggressive behaviour in children, adolescents, and young adults with autism spectrum disorder (ASD). Over the first 12 weeks, participants will be randomly assigned to receive CBD at one of three doses or a placebo (inactive treatment) to compare differences in behaviour, sleep, and anxiety. After this, everyone will receive CBD for another 12 weeks, with some participants also receiving melatonin (to improve sleep) and/or N-acetylcysteine (to support emotional regulation). We believe CBD, alone or in combination with melatonin and N-acetylcysteine, will improve irritability, aggression, sleep, and overall quality of life for people with ASD.

The proposed intervention involves a single subcutaneous injection of ketamine (0.75 mg/kg) or a matched placebo (0.9% saline) administered to participants with difficult-to-treat depression (DTD). The intervention is delivered under double-blind conditions at the Royal Melbourne Hospital Clinical Trials Centre. The ketamine dose is administered once only and is not part of any ongoing therapeutic protocol. The intervention is designed to investigate neural and clinical changes following ketamine administration, with a particular focus on the habenula (Hb) - a subcortical region implicated in reward processing and mood regulation. The intervention is embedded within a case-control, pre-post imaging study framework. Participants undergo ultra-high field 7-Tesla MRI scans before and 24-48 hours after the injection to assess changes in Hb activity and connectivity. Secondary behavioural and clinical assessments (e.g., MADRS, QIDS-C, SHAPS, GAD-7, actigraphy, and mobile sensing) will evaluate treatment response, mood, circadian regulation, and anhedonia. This intervention is not intended as a clinical treatment but rather as a mechanism-focused investigation. Participants are fully informed that the intervention is experimental and not part of routine care. Safety monitoring includes cardiorespiratory assessment, adverse event screening, and psychiatric review before and after the injection, following established ketamine research protocol.

This study will test how accurately a new rapid test, StrepSure™, detects group B streptococcus (GBS) in pregnant women. GBS is a common bacteria that can be passed to babies during birth and sometimes cause serious illness. The current test takes up to two days, while StrepSure™ may give faster results at the point of care. Researchers will compare StrepSure™ to the standard test to see how reliable it is. The study will take place at Northern Hospital in Epping and involve women already receiving care there. The results of the StrepSure™ test will not be revealed to the participant or the clinical team. There will be no allocation to an intervention; therefore, this is not a clinical trial.

This pilot, crossover trial will recruit 12 participants aged 10-25 years with dysarthria. Participants will compete 4 weeks of speech therapy using a voice-assistant device, according to a therapy plan provided by the research team. The aim of this study is to describe the parent/caregiver and patient experience of the tolerability, safety and utility of a four-week period of voice assistant-based speech therapy, using the 'Alexa' system. Pre/post changes in speech intelligibility, and perceptual and acoustic speech quality will also be explored.