ANZCTR search results

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

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33563 results sorted by trial registration date.
  • ASPiRATION-2 Liquid: An observational cohort study to assess the impact of longitudinal molecular profiling using circulating tumour DNA (ctDNA) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) after failure of genomically targeted therapy.

    The purpose of this study is to see if the approach of using a blood test called a ‘liquid biopsy’ multiple times throughout the patient journey can improve the management of lung cancer by successfully guiding treatment. We will assess if it is possible to incorporate liquid biopsy into the routine care of Australians with lung cancer, including evaluating the clinical benefits to patients and the economic impact to the health system. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced non-small cell lung cancer and you have received at least one previous targeted cancer treatment. Additional health checks may also be conducted by the study doctors to ensure you are able to take part in this study. Study details: All participants who choose to enroll in this study will be asked to provide a blood sample for molecular testing (liquid biopsy). The liquid biopsy test analyses fragments of DNA released from a person's cancer into their blood, known as circulating tumour DNA (ctDNA). This helps doctors to understand how a person's cancer has changed over time. The liquid biopsy results will be reviewed be reviewed by a board of experts. They will make treatment recommendations based on the liquid biopsy results. These will be provided to the participant's treating doctor, for discussion with the participant. Decisions for treatment are made by the participant and their treating doctor. Options may include a clinical research study, treatment(s) available through special access programs, and/or standard of care treatment that is routinely available. Participants will be asked to provide blood samples multiple times over a period of up to 4 years, including at study entry, each time a new treatment is started, and each time a treatment stops working. If a previous tissue sample is available or will be taken, e.g. during surgery, this may also be tested for new changes. Participants will also be asked to complete questionnaires throughout the study for up to 4 years after they enroll. It is hoped this research will determine whether adding liquid biopsy into the routine care of Australians with lung cancer is achievable, the economic costs and value of adding this procedure and to identify possible benefits to individuals with lung cancer by finding new targeted treatments for them.

  • An open-label, randomized, single oral dose, three-treatment, one period, parallel comparative bioavailability study of ANY-004 (Oral Tirzepatide 20 mg and 40 mg Tablet) of Anya Biopharm Inc., Taipei, Taiwan (T) with MOUNJARO (Tirzepatide) 2.5 mg Subcutaneous injection of Eli Lilly and Company, USA among healthy, adult male and/or females under fasting conditions.

    To study the comparison of the PK profiles of single doses of ANY- 004 (Oral Tirzepatide 20 mg and 40 mg Tablet) of Anya Biopharm Inc., Taipei, Taiwan (T) with single dose of MOUNJARO (Tirzepatide) 2.5 mg Subcutaneous injection of Eli Lilly and Company, USA among healthy, adult male and/or females under fasting conditions. To monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Tirzepatide formulations (Tablet and Subcutaneous injection) under fasting condition.

  • Implementation and effectiveness of a novel model of multimodal prehabilitation for patients living with Cancer in regional and rural NSW: Supported PRehabilitation – Improving fiTness, Ensuring well-being before Surgery (C-SPRITES)

    This study aims to improve access to prehabilitation (exercise, nutrition, and psychological support) before surgery, for people with cancer in regional and rural NSW. The goal is to help participants be physically and mentally fitter before surgery, which is known to reduce complications and improve recovery after surgery. Who is it for? You may be eligible for this study if you are a male or female aged 18 years and over who have been diagnosed with cancer within the past 12 months and are planning to undergo abdominal surgery that requires a hospital stay of more than one day. Study details Five hospitals will participate in the trial. All sites will begin by collecting participant baseline data. Each hospital will then be randomly assigned to change to the intervention at different time points. Participants in the intervention group will take part in a prehabilitation program for up to four weeks before their scheduled abdominal surgery, with a minimum of two weeks if time is limited. The program combines telehealth and in-person sessions and includes exercise guidance, nutrition education, and psychological support. Participants will be loaned a wearable activity tracker (Fitbit) to monitor physical activity and will complete assessments related to physical activity, nutrition, and wellbeing. It is hoped this research will support wider delivery of prehabilitation services in regional and rural areas, helping improve surgical recovery and health outcomes for people with cancer.

  • PRECISION-SAH: A multi-centre prospective observational cohort study of patients with aneurysmal subarachnoid haemorrhage

    PRECISION-SAH is a national research project focused on improving care for patients admitted to ICUs with a serious type of brain bleed called aneurysmal subarachnoid haemorrhage (aSAH). Although medical care for this condition has improved over time, many patients still face serious risks, including brain damage and death. PRECISION-SAH will collect detailed clinical information from patients at hospitals around Australia. The goal is to understand how different hospitals manage care, identify which treatments work best, and find early warning signs of DCI.

  • Building Reasonable adjustments, Inclusion, and Dignity in Emergency care for people with Disability (BRIDGE-ED)

    BRIDGE-ED will implement and evaluate a Disability Liaison Office (DLO) model of care within Victorian emergency departments to improve the identification and management of health issues in people with disabilities. The primary aim of this study is to reduce the length of stay in emergency for people with disabilities. The study will be a multi-site stepped-wedge cluster-controlled trial across nine public emergency departments in Victoria, Australia.

  • Does cardiac surgery alter the response of the body to infection?

    Cellular immunosuppression – an acquired dysfunction of the cellular component of the immune system which predisposes to nosocomial infection – has been described as part of the inflammatory response to sepsis. While it has been postulated that such a phenomenon might also occur following major surgery (due to the mechanistic similarities between the innate immune response to sepsis and trauma), this hypothesis has not been proven. PRISM is a prospective observational study that will explore the effects of cardiopulmonary bypass on cellular immune function in the immediate postoperative period and the time course of any observed phenomenon. If we can demonstrate that impaired cellular immune function occurs following cardiac surgery on cardiopulmonary bypass, we will have sufficient equipoise to trial new therapies in this population to restore immune function and potentially reduce the risk of postoperative nosocomial infection.

  • Supporting Child Mental Health: Evaluating a training program for parents, carers, teachers and educators of primary school aged children

    This study will evaluate the Supporting Child Mental Health (SCMH) training program, which aims to improve adults’ knowledge, skills and confidence in providing mental health first aid to primary school children. The program includes self-paced eLearning and live instructor-led sessions that teach adults how to recognise child mental health problems, respond to crises, and support help-seeking. Adults from schools and organisations will be randomly allocated to receive the training immediately or after completing all study surveys. The hypothesis is that adults who receive the training immediately will show greater improvements in knowledge, skills and confidence than those in the waitlist group.

  • Virtual reality immersion therapy in awake ICU patients: potential uses and feasibility study

    The purpose of this study is to see if virtual reality immersion therapy can be further tested as a potential therapy for alleviating symptoms in intensive care patients while in hospital. The information obtained will help us to learn strategies, such as time and frequency of usage of therapy, to potentially help many patients in the future. Study participation: Participants will undergo virtual reality immersion sessions daily while in the Intensive Care Unit (ICU), in addition to standard medical care. Daily symptom assessments will be conducted by the investigating team. An experience related questionnaire will be applied from day 3 during hospital stay (or after discharge if that happens sooner). Symptom assessments: Participants will be invited to answer verbally a questionnaire grading a variety of symptoms from 0 to 10 daily. These will last between 2 to 5 minutes. From day 3, they will be asked, only once, questions related to the experience with Virtual Reality immersion up until then including tolerability and the device and duration of therapy. This questionnaire is expected to last between 10 and 15 minutes. Risks and side effects of the therapy are uncommon, but may include dizziness, vertigo nausea, vomiting, anxiety and discomfort. The benefits might include symptom improvement but will certainly help us learning more about this possibly helpful tool.

  • Psychological treatment of Posttraumatic Stress Disorder for refugees

    This project aims to evaluate massed delivery of Narrative Exposure Therapy (NET) for refugees with Posttraumatic Stress Disorder (PTSD). The research questions/hypotheses that this study seeks to address are: Does massed NET reduce PTSD symptoms in refugee participants? Is massed NET feasible and acceptable to refugee participants? We hypothesize that massed NET will be feasible and acceptable to refugee participants, and will result in significant reductions in PTSD symptoms.

  • Providing Novel Insight into Skin Microvascular Physiology in Humans: Integrating Optical Coherence Tomography with Cutaneous Microdialysis

    OCT has been used for decades in ophthalmology to visualise small blood vessels at the back of the eye (retina), but we have recently modified it and developed breakthrough and novel ways to assess the diameter, velocity and blood flow through blood vessels in the skin that are around the size of a human hair. Microdialysis is a technical approach that involves embedding a small plastic tube containing a semi-permeable membrane beneath the skin surface. This permits delivery of very small doses of specific drugs directly into a small patch of human skin, above which imaging is performed. The delivery of these drugs, which stimulate or block specific biochemical pathways, provides a way to study individual mechanisms that may be responsible for microvascular dysfunction and cardiovascular disease development in humans. This approach is sometimes referred to as pharmaco-dissection. By combining microdialysis with OCT imaging, we will establish an unprecedented and powerful new platform to provide insights into the specific physiological mechanisms controlling microvascular function in humans.

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