ANZCTR search results

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

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32882 results sorted by trial registration date.
  • A pilot study of two new imaging scans after high precision radiation therapy for patients with limited secondary spread of cancer to the lung.

    Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be very effective in controlling cancer. After the treatment is given, however, with standard scans we have not been able to reliably assess how well the treatment worked. We propose to research SBRT with state-of-the-art scanning tools in patients with cancer spread to the lung. We aim to better understand how cancer responds to this therapy. This is the first step of the research, and is a small ‘pilot’ study. The ‘pilot’ is designed to assess whether the research can be completed. Who is it for? This trial is for patients who have cancer which has spread to the lung. We aim to enrol ten patients in total to participate in the research. These patients will be invited through Peter MacCallum at East Melbourne. Trial details: If you participate in this study you will have two different types of scans as well as a single stereotactic body radiotherapy session (SBRT). The two types of scans we are researching are called a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan. Both scans are slow and recorded along with your breathing, which allows us to see how much your organs move as you breathe in and out. Each 4D-PET scan is broken down into many separate scans, each showing where your organs and the cancer are at a specific point of your breathing, for example, just as you start breathing in. For us to know whether you are breathing in or out, we will monitor your chest movement using breathing equipment. This will be done by either putting a belt around your chest or abdomen which senses your breathing, or a small lightweight reflective box on your chest and watch this using a special camera in the room. Both devices can tell us at which part of your breathing cycle each CT or PET image was taken, so we can make sets of images from each phase. Either device can be used during your scan, and this will depend on the particular machine on which you have your scan taken. The CT perfusion scan is similar to a standard CT scan, but is taken over a longer period of time with more contrast. This allows us to record the flow of contrast and blood flow into the cancer. Specifically, the research involves: 1. Before treatment, you will have a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan, as a baseline. 2. After treatment, you will have another 4D-PET scan and a CT perfusion scan at day 14 and day 70. These will be compared with the first scans in order to assess how your cancer responded to the treatment. The stereotactic body radiotherapy (SBRT) treatment itself will routinely involve a third type of scan: a cone-beam CT. This scan is performed on the treatment machine, and is used to make the treatment more precise. Specifically, the stereotactic radiotherapy treatment involves as standard: 3. Prior to treatment whilst being set-up on the treatment machine, a cone-beam CT will be used to check the position of the cancer. This will be repeated immediately before the treatment and again mid-way through the treatment (a total of 3 cone-beam CTs). 4. A single high-precision, high-dose radiotherapy (SBRT) treatment directed against the cancer. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. Participation in this study will involve no extra cost due to either having these scans or the treatment.

  • The stroke-IMPACT trial (Improving Physical Activity via Treadmill Training): A single blinded Randomised Controlled Trial.

    Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the effectiveness of implementing a combined high intensity treadmill training program embedded in a self-management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care.

  • The D-Health Trial: A trial of vitamin D for prevention of mortality and cancer in older Australian adults.

    Vitamin D in your body comes from exposure to the sun or from your diet. Having enough vitamin D in your blood stream is important for maintaining healthy bones, but we don’t really know how much our bones need. Having higher vitamin D levels might also reduce risks of diseases such as diabetes, heart disease, multiple sclerosis and some cancers, but this is uncertain. To fully understand the health effects of vitamin D we need to do studies with very large numbers of people. We are aiming to recruit about 25,000 Australians aged 60-79. The aims are to see if taking a vitamin D tablet changes the risk of a person being diagnosed with health conditions such as cancer, heart disease or infections (like flu). D-Health will give us much-needed information so that we can advise people correctly in the future.

  • A pilot study to test recruitment methods, feasibility and study procedures for a planned randomised controlled trial of the MindBabyBody program: an antenatal mindfulness intervention to reduce depression, stress and anxiety

    Mindfulness interventions are emerging as a potentially promising intervention to reduce mental health problems in the perinatal period, however there is a need for more robust evidence supporting their efficacy. The current proposal outlines a pilot study with the primary aim of exploring feasibility issues to inform the development of a randomised-controlled trial of a mindfulness-based intervention in pregnancy. We propose to test and evaluate a range of recruitment strategies designed to maximise uptake of a program offered to women booked in to give birth at the Royal Women's Hospital. We aim to recruit around 45 women to this pilot study. Participants in the project will complete study questionnaires at three time-points: pre-intervention, post-intervention, and at a three months postpartum follow-up. Questionnaires will include standardised measures of depression, anxiety, stress, and mindfulness. The postnatal follow-up questionnaire will include items on maternal postnatal quality of life and child outcomes (cry-fuss-sleep behaviour). Analysis will focus on uptake via different recruitment methods and assess rates of ongoing participation, engagement, and acceptability of study instruments. The data collected in this study will be used to inform the development of a large scale randomised controlled trial evaluating a mindfulness-based group intervention in pregnancy for reducing perinatal anxiety and depression. In addition, the pilot study will support and develop collaborative links between staff at The Royal Women's Hospital and researchers in the Healthy Mothers, Healthy Families group at the Murdoch Childrens Research Institute.

  • An unblinded, randomised, controlled trial to assess patient care and outcomes of standard outpatient care and telephone consultation.

    This project is to assess the feasibility of comparing the current standard care of a patient referred to the Sunshine Coast Hospital and Health Service-renal services, with a novel approach where the referred patient has a telephone consultation with the specialist while with his/her GP.

  • Couselling to improve symptoms of anxiety or depression for heart transplant recipients

    This pilot study will assess the feasibility of undertaking a larger study to determine if telephone-delivered cognitive behaviour therapy followed by communication with on-going specialist and primary care providers is a successful and sustainable treatment option for adult heart transplant recipients with anxiety or depression. Additionally, this study will also help determine the accuracy of simple, self-adminsitered questionnaires to screen for anxiety and depression.

  • A Blood Diagnostic test for epidermal growth factor receptor (EGFR) mutations

    This study is exploring whether a blood test might be a feasible additional or alternative diagnostic test to a biopsy in patients with lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have stage IIIB or IV adenocarcinoma of the lung. You should have had a lung tissue biopsy that is archived and available for testing, or be a candidate for a new biopsy. Trial details All participants in this study will provide 2 blood samples (one before drug therapy and another taken between 14 to 21 days after drug therapy has commenced) to be tested for the epidermal growth factor receptor (EGFR) mutation using a new test kit. The results of this test will be compared to the EGFR mutation status reported via tissue testing for those patients where this information is available. Knowledge of EGFR gene status (positive or negative) can help guide treatment decisions. Based on these results we aim to determine whether the blood test is a feasible alternative or additional approach to a 'traditional' biopsy in evaluating EGFR mutation status.

  • Nebulised Heparin for Heart Surgery

    Hypothesis and Outcomes: This study will test the primary hypothesis that nebulised heparin improves lung function, assessed by the change in the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) over the operative period. Secondary outcomes include the extent of post-operative organ supports and duration of intensive care and hospital stays. Significance: Nebulised heparin offers the possibility of a cost-effective strategy to prevent respiratory failure developing in patients following heart surgery. Health benefits and healthcare cost savings could be substantial. An effective strategy could save the Australian healthcare system at least $8.5 million per year in intensive care costs alone.

  • An open label, single centre, phase II pilot study of neoadjuvant dabrafenib + trametinib in patients with resectable AJCC Stage IIIB-C BRAF V600 mutation positive melanoma

    This study is evaluating the effect of the drugs dabrafenib and trametinib given prior to surgery and after for the treatment of melanoma. 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 AJCC (American Joint Committee on Cancer) Stage IIIB or IIIC BRAF V600 mutation positive melanoma. Trial details: All participants in this study will take dabrafenib 150 mg tablets twice daily and trametinib 2 mg tablets once daily for 3 months. They will then undergo complete lymph node dissection surgery, followed by treatment with twice daily dabrafenib 150 mg and once daily trametinib 2 mg for a further 9 months. Participants will be assessed at 12 weeks post treatment in order to evaluate treatment response and surgical outcomes.

  • Evaluation of a randomised control trial of a cognitive behavioural intervention for symptoms of depression in adolescents with autism spectrum disorders

    The current study aims to evaluate the effectiveness of a cognitive behavioural therapy in reducing depression in adolescents with autism spectrum disorders. We hypothesise that there will be a significant reduction in mean depression scores post-intervention relative to baseline depression, and relative to the wait-list control.

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