ANZCTR search results

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

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33568 results sorted by trial registration date.
  • FIDAA - Understanding the Experience of People Receiving Escalating Financial Incentives for the Testing and Uptake of Direct Acting Antivirals for Hepatitis C - A Feasibility Study.

    Hepatitis C remains a major public health issue, particularly for people who inject drugs, where staying engaged in care can be challenging. This study aims to assess whether offering small financial incentives can improve engagement with hepatitis C testing, treatment, and follow-up care. Using a single-site, non-randomised, single-arm design, participants receive incentives for collecting point-of-care test results. Those who test positive may receive further incentives for attending a pre-treatment clinic visit; collecting direct-acting antiviral medication; attending follow-up testing to confirm cure. The study hypothesises that this incentive-based approach is feasible, acceptable, and can support improved engagement across the hepatitis C care pathway.

  • A randomised controlled trial evaluating the efficacy of multi-wavelength photobiomodulation for providing anaesthesia in intradermal injections

    This study is testing whether a hand-held light device can reduce the pain of needle injections into the skin. Each participant will have the light device placed briefly on one forearm, and a different, inactive-looking light device placed on the other forearm, before receiving a small injection on each arm. We expect that the arm treated with the active device will feel less pain during the needle insertion and injection than the arm treated with the inactive device. Pain will be measured straight after each injection using a simple 0–10 pain rating scale, and participants will also be asked about any side effects up to one week later. We hope this study will show whether this light-based device is a safe and effective way to reduce pain from injections.

  • Effect of intensive telemonitoring on Continuous Positive Airways Pressure (CPAP) adherence

    Obstructive Sleep Apnea (OSA) is a highly prevalent condition that can lead to significant cardiovascular and metabolic complications if left untreated. While Continuous Positive Airway Pressure (CPAP) therapy is highly effective, long-term patient adherence remains a significant challenge, with many patients abandoning therapy within the first month. This study is a prospective non-randomized controlled trial designed to evaluate the impact of an intensive telemonitoring program on CPAP adherence over a 12-month period. Participants with moderate to severe OSA will be allocated into two groups:Intervention Group: Participants receive standard CPAP acclimatization plus intensive daily telemonitoring. Staff will proactively contact patients who show low usage to provide motivational coaching and troubleshooting. Control Group: Participants receive standard CPAP acclimatization and follow-up (usual care) through the public health system in Canberra.The primary objective is to determine if intensive telemonitoring improves the proportion of patients achieving clinical adherence at 12-months. Secondary objectives include assessing improvements in sleep-related functional status, as well as conducting a cost-benefit analysis of the telemonitoring intervention compared to usual care in the Australian Capital Territory.

  • A study of VGT-309 fluorescence imaging during surgery for pancreatic and periampullary cancer

    Who is it for? This study is for patients aged 18 years or above who have planned curative-intent surgical resection for known or suspected pancreatic ductal adenocarcinoma or periampullary adenocarcinoma (including ampullary, distal bile duct, or duodenal adenocarcinoma) Study details This study will evaluate whether the fluorescent imaging agent VGT-309 can be safely and practically used during surgery for pancreatic and periampullary cancer. During surgery, credentialled pancreatic surgeons will perform near-infrared fluorescence imaging using a commercially available imaging system to assess the feasibility of incorporating VGT-309 fluorescence imaging into standard pancreatic surgery. Participants will receive a single intravenous infusion of VGT-309 (abenacianine) at a dose of 0.31 mg/kg (abenacianine sodium free equivalent). The infusion will be administered by clinical staff in a hospital setting. The study will identify whether VGT-309 helps locate the tumour and will compare the relationship between the timing of VGT-309 administration and intraoperative fluorescence image quality. Additionally, the study will compare intraoperative and ex vivo fluorescence imaging findings with routine histopathological assessment, including tumour presence, resection margin status, lymph node involvement, and metastatic disease. It is hoped that the findings of this study will inform the design of future clinical studies evaluating fluorescence-guided surgery for pancreatic and periampullary cancer.

  • Development of a markerless approach to abdominal motion tracking during radiotherapy: an observation-only feasibility study

    Due to normal functional processes such as breathing and digestion, abdominal tumours and organs can move during radiotherapy. The purpose of this study is to determine whether a new software using artificial intelligence (AI) can be used during radiotherapy to track organ motion for more accurate treatment. Who is it for? You may be eligible for this study if you are an adult who is receiving radiotherapy for treatment of an upper abdominal cancer, for example pancreatic cancer, liver cancer or kidney cancer. Study details All participants in this study will continue to undergo their usual radiotherapy treatment schedule. Using AI, we will generate a customised ‘motion model’ specific to each participant. During radiotherapy treatment sessions, additional x-ray imaging will be collected. These images will be used to check the performance of this custom AI model. There will be no follow up of participants and the motion model will not be used to guide or impact treatment of the participant. It is hoped that this study will help researchers understand more about how AI may be safely used during abdominal radiotherapy. This knowledge may help improve the quality of treatment received by cancer patients in the future.

  • A study evaluating SIR4156 together with semaglutide to reduce body fat in adults with obesity

    This study is a Phase II randomised, double-blind, placebo-controlled, parallel-group trial evaluating the effects of SIR4156 in combination with semaglutide in adults with obesity. Participants will receive either SIR4156 or placebo tablets in addition to once-weekly semaglutide injections. The primary objective is to assess the effect of SIR4156 on body fat mass and body composition. Secondary objectives include evaluation of body weight, lean mass, safety, tolerability, pharmacokinetics, and pharmacodynamic effects. The study hypothesis is that SIR4156 in combination with semaglutide may reduce body fat mass and improve body composition in adults with obesity compared with placebo plus semaglutide.

  • A First-in-human Phase-1 PET Imaging Study of [64Cu]IS1051 in Participants with Suspected Infection

    This study is investigating a new imaging method that may help doctors detect bacterial infections in the body. Current infection imaging approaches such as [¹8F]FDG-PET/CT and WBC scintigraphy are useful but have important limitations. [¹8F]FDG-PET/CT provides excellent sensitivity but poor specificity, as uptake is driven by glucose metabolism rather than pathogen-specific processes. WBC scintigraphy offers higher specificity but requires complex handling, longer procedures, and lower spatial resolution. A non-invasive, immune-targeted tracer that enables specific identification of infection remains an unmet medical need. The study uses an investigational imaging drug called [64Cu]IS1051. This drug is designed to attach to certain immune cells that are involved in bacterial infections, allowing the infection to be seen using PET/CT imaging. This is a first-in-human study, meaning this imaging drug has not previously been given to people. The information collected will help researchers determine whether this imaging approach should be studied further in future clinical research.

  • Evaluating an Integrated Trauma Treatment Program (ITTP) for Paramedic First Responders with Post Traumatic Stress Disorder (PTSD)

    This study will evaluate a new three-week (nine day) intensive outpatient trauma treatment program for paramedic first responders experiencing post-traumatic stress disorder (PTSD). The program combines established evidence-based PTSD treatments, including eye movement desensitisation and reprocessing (EMDR), virtual reality exposure therapy, body-based techniques, and group trauma education. The virtual reality component uses personalised scenarios that include work-related environments and equipment relevant to paramedics. The study aims to determine whether this integrated treatment program is acceptable and feasible to deliver, and whether it shows early benefits in reducing PTSD symptoms and improving return-to-work outcomes immediately after treatment and three months later.

  • Feasibility, usability, acceptability and efficacy of virtual reality rehabilitation for Complex Regional Pain Syndrome (CRPS)

    The study aims to: 1) Investigate the safety and efficacy of a 6-week novel VR intervention for people with upper limb CRPS. 2) Determine the feasibility, usability and acceptability of the novel virtual reality intervention for people with upper limb CRPS.

  • Evaluating implementation of the train-the-trainers model to improve access to community-based physical activity for people with spinal cord injury.

    People with spinal cord injury (SCI) often face barriers to being physically active in the community, which can negatively affect their health and quality of life. This study aims to test a program called T3-SCI (Train the Trainers – Spinal Cord Injury), which trains exercise professionals to safely and confidently support people with SCI to exercise in local gyms. The main purpose of this study is to find out whether the T3-SCI program can be delivered effectively in real-world community fitness centres and whether it helps people with SCI become more physically active compared with usual care. We hypothesise that people with SCI who take part in the T3-SCI program will increase their physical activity levels and experience better health and well-being outcomes than those who do not receive the program, and that the program will be acceptable, feasible, and delivered with good quality by trained exercise professionals.

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