ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33465 results sorted by trial registration date.
  • Move to Improve 2: Implementation and scale up of a physical activity service for children with chronic health conditions

    Move to Improve is a program designed to support children with long-term health conditions to participate in physical activity. This study will investigate how well Move to Improve works when expanded across a children's hospital. Who is it for? You may be eligible to enrol your child into this study if they are aged 5 to 17 years living with a primary diagnosis of a chronic health condition in the Perth metropolitan region, and are receiving outpatient services from eligible departments at Perth Children's Hospital. Study details Participants receive one 45 minute physical activity session each week for 8 weeks. Each participant will engage in an individualised program designed to progress towards physical activity goals, build knowledge and confidence in being active, and support ongoing physical activity participation. Information will be collected on physical activity, goal attainment, quality of life and other measures. It is hoped that findings from this study will help identify effective ways to integrate physical activity into routine clinical care and support implementation of similar programs in other paediatric hospitals.

  • Assessment of acute limp or joint pain in children presenting to emergency departments.

    Limb pain in children is common. While often harmless, it can sometimes be caused by serious conditions like infections, cancer, or rheumatic fever. Right now, it’s hard to know which children need urgent tests and which don’t. A good decision-making tool could help doctors make faster, safer, and more cost-effective choices. This study is looking at children who come to the emergency department (ED) with sudden limb pain (like a sore arm or leg or with a limp). The goal of the project is to either validate an existing Clinical Decision Rule (CDR) or create and test a new CDR that helps doctors quickly and safely decide which children might have a serious condition and need further tests like blood work or scans - and which children don’t. This prospective observational study will collect data prior to clinical treatment or investigation of children aged <16 years presenting to the ED with acute onset (within the last 7 days) of non-traumatic limb pain and/or limp at 18 EDs in Australia and New Zealand who are part of the PREDICT research network. This study aims to derive and validate a paediatric ED Clinical Decision Rule (PAL CDR) that (i) accurately detects serious pathology bone and joint infection, malignancy, slipped upper femoral epiphysis, ARF) and (ii) risk-stratifies children with suspected serious pathology* into those who do and do not require blood tests or imaging. Primary Aim: To derive and validate a paediatric ED CDR that (i) accurately detects serious pathology (bone and joint infection, malignancy, acute rheumatic fever (ARF), slipped upper femoral epiphysis) and (ii) risk-stratifies children with suspected serious pathology into those who do and do not require blood tests or imaging. Secondary Aims: (1) To externally validate, in ANZ EDs, current overseas-derived CDRs by assessing (i) the accuracy of detecting confirmed serious pathology; (ii) the ability to accurately identify children who do not need blood tests or imaging investigations; (iii) cost-effectiveness of different CDRs. (2) To determine the performance of the newly derived and established CDRs in settings with low and high prevalence of ARF.

  • SHADE-Predict: A Pilot Study Exploring Genetic and Digital Predictors of Treatment Response to an eHealth Intervention for Alcohol Use in Adults with Moderate to Hazardous Drinking

    This study aims to find out whether certain personal characteristics, including a person's genetics and data collected from a smartwatch and mobile app, can help predict who benefits most from the SHADE online alcohol treatment program. Participants with risky or hazardous alcohol use complete the SHADE program while researchers collect information about their alcohol use, mental health, genetic markers, sleep, physical activity, heart rate, and daily mood and drinking patterns. The researchers will then examine whether these factors are linked to improvements in alcohol use after completing the program. The study also aims to determine whether collecting genetic information and digital data in this way is acceptable and feasible for participants. Ultimately, the findings may help develop more personalized alcohol treatment approaches by identifying which treatments are most likely to work for different individuals.

  • DAY-TRIPPER - Feasibility of rapid-access single-fraction stereotactic ablative radiotherapy for cancer patients in regional and rural NSW

    This study will assess whether single-fraction stereotactic ablative body radiotherapy (SABR) is a practical alternative to multi-fraction radiotherapy for people with lung tumours or bone metastases in regional and rural NSW. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer, or have lung or bone metastases from another type of cancer. Study details Participants will undergo a dedicated radiotherapy planning CT scan and an individualised radiotherapy plan will then be developed which involves receiving their radiotherapy in one treatment session rather than over several visits. A later stage will investigate whether planning and treatment can be completed within 24 hours. The study will examine whether this approach can be delivered successfully and safely across participating regional centres, while also reducing travel, treatment-machine use and the burden of care. Patient experience, treatment accuracy, tumour motion and planning time will also be evaluated. It is hoped that findings from this study can inform future studies on single-fraction SABR in regional and rural settings and can improve patient experience while reducing treatment-related travel and healthcare resource use

  • A Study to Test a New Multi-Analyte Sensor During Meal Tests

    Continuous glucose monitoring (CGM) devices are routinely used to measure interstitial glucose concentrations and support diabetes management. Emerging sensor technologies have enabled the simultaneous measurement of multiple analytes, including glucose, ketones, lactate, and potentially oxygen, using a single subcutaneous sensor. Concurrent monitoring of these analytes may improve the detection of metabolic disturbances, such as diabetic ketoacidosis, and provide broader insights into metabolic physiology. This feasibility study will evaluate the performance of a novel multi-analyte sensor by assessing its ability to detect changes in analyte concentrations during standardized activities that mimic normal daily conditions, including meal consumption and exercise. The study will assess the accuracy, reliability, and feasibility of the sensor under physiological conditions relevant to diabetes management.

  • Understanding Changes in Blood Sugar and Ketone Levels in Hospitalised Patients with or at Risk of Diabetic Ketoacidosis

    Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of diabetes. It occurs when the body does not have enough insulin and starts breaking down fat for energy, causing ketones (acids) to build up in the blood. Currently, clinical practice for detection of glucose and ketone levels are determined at specific time points duirng a hospital admission using fingerstick blood tests, which do not detect changes as they occur. The SiBionics dual continuous glucose and ketone monitor (CGKM) is a wearable device that continuously measures both glucose and ketone levels and may allow earlier detection of DKA than current clinical monitoring methods. This study will use the CGKM to monitor people with diabetes admitted to hospital with DKA and people with type 1 diabetes who are at risk of developing DKA. By examining CGKM patterns, we aim to better understand how DKA develops and assess whether continuous monitoring could support earlier detection and improved management of DKA in the future.

  • A pilot study to assess the safety and feasibility of photobiomodulation (light therapy) for adults with chronic kidney disease

    This study aims to evaluate the safety and feasibility of PBM, a non-invasive light therapy, in adults with chronic kidney disease. PBM has shown potential to reduce inflammation and improve cellular function, but its use in people with chronic kidney disease has not been well studied. Participants will receive PBM treatment twice weekly for 24 weeks and will be followed for a further 24 weeks. The study will assess whether PBM can be delivered safely and whether participants can successfully complete the treatment program.

  • Fat Incorporation through omega-3 Supplementation to determine immune cellular changes

    Omega-3 fatty acids are widely consumed as dietary supplements and are known to have beneficial effects on health. However, it is not well understood how different doses of omega-3 supplementation change the composition and function of human immune cells. This study will compare two doses of omega-3 supplementation in healthy adults over a 4-week period. Blood samples collected before, during and after supplementation will be used to examine how omega-3 fatty acids are incorporated into immune cells and whether this influences their biological function and responses to oxidative stress. The findings will improve our understanding of how dietary omega-3 fatty acids influence the human immune system and provide important information for future studies investigating omega-3 supplementation in health and disease.

  • A prospective randomised controlled trial of an AI-supported model of care for non-contrast Computed Tomography (CT) Brain interpretation in the Emergency Department

    This study evaluates whether using artificial intelligence (AI) to help emergency department doctors interpret CT brain scans can safely reduce patient waiting times. Adults with minor head injury or headache who require a CT scan will be randomly assigned to standard care or AI-supported care. The main outcome is how long patients stay in the emergency department. The study will also assess patient satisfaction and safety outcomes such as missed diagnoses.

  • Phase 1 Safety and Pharmacology Study of Oral GBP-088 in Healthy Adults

    This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called GBP-088. GBP-088 is being developed for the treatment of recurrent kidney stones. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. In Part 1, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Part 2, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. It is hoped that this research will help determine the safety of GBP-088 when given to healthy men or women so that it can be tested in patients with recurrent kidney stone disease

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