ANZCTR search results

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

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32114 results sorted by trial registration date.
  • Home based Education and Learning Program for Gout

    Gout is a common condition, associated with significant illness, and costs to the community and the health care system. However, people with gout generally don’t get good treatment, the health system is failing to provide appropriate care for these people using the routine health care systems in Australia. We aim to develop an educational programme to be delivered in the patient’s home, along with escalation of medicines, to see if this improves the treatment of people with gout.

  • Evaluating the Safety and Efficacy of Full-Spectrum Medicinal Cannabis (FEN164) in Children with ASD.

    This is a 17 to 57-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract containing only 0.08% THC (FEN164) in children with Autism Spectrum Disorder (ASD). The purpose of this study is to determine how safe and effective FEN164 is in patients with ASD when treated with 20mg/kg/day for an 8 week period. Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-three (53) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD.

  • Validation of a method for heparin reversal with protamine in patients undergoing cardiac surgery.

    Patients undergoing cardiac surgery will be the subject of this research. They require administration of heparin and reversal with protamine. This is administered by the anaesthetist, not the cardiac surgeon and as such forms part of the anaesthetic process. The study is designed to test the assumption that calculation of a heparin:ACT dose-response curve at the time of initial administration of heparin allows an estimate of the circulating amount of active heparin from the ACT measured at completion of surgery and after the patient is rewarmed. This then allows an estimate of the dose of protamine required to reverse the heparin. By measuring the clotting times with and without heparinase using viscoelastic testing, it will be possible to determine whether this assumption. is correct.

  • Conversations about Suicide in Australian Men's Sheds

    The MHFA Conversations about Suicide course is a specialised four-hour course focused on recognising and supporting people with suicidal thoughts. It aims to improve participants’ confidence and skills in supporting someone in their social network, such as a friend or family member, who is feeling suicidal. The course is based on suicide prevention best practice guidelines and is delivered by instructors who are trained and accredited by MHFA Australia. The current study is a cluster randomised controlled trial to investigate the effectiveness of the course in Men’s Sheds across Australia. It is expected that the course will lead to an increase in recommended helping intentions and a decrease in non-recommended helping intentions in the intervention group.

  • Tele-Clinical Care Cardiac (TCC-Cardiac): Evaluating the effectiveness and safety of a smartphone application-centric model of care and its patient messaging component as standalone (TCC-Text), as an adjunct to usual care in patients who are being discharged home following an acute cardiac event, for the secondary prevention of cardiovascular events.

    This is a prospective, multicentre pragmatic, randomised trial. The primary objective is to examine the impact of the TCC-Cardiac solution compared with usual standard care alone on 6-month unplanned hospital readmission rates in patients who have recently been discharged following an acute cardiac event including myocardial infarction and decompensated heart failure. Participants will be allocated to 1 of 3 cohorts, using predefined criteria according to their access to technology in a pragmatic design, including 1) TCC-Cardiac randomisation, 2) TCC-text randomisation, or 3) usual care registry. Cohort 1 patients will be randomised at point of hospital discharge in a 1:1 ratio to the TCC-Cardiac program in addition to usual care, or to usual care alone. Cohort 2: patients will be randomised 1:1 to receive supportive text messages (TCC-Text) in addition to usual care, or to usual care alone. Cohort 3 is a registry of patients discharged home per usual care. We will aim to recruit 2500 patients aged above 18 years, comprising 1000 patients in the main randomisation (Cohort 1), 1000 patients randomised in cohort 2 and 500 patients in the cohort 3 registry. Based on a pilot study’s results, it is hypothesised that the Teleclinical Care (TCC) app will lead to a reduction in readmission rates and improvement in clinical indices associated with clinical outcome in patients with myocardial infarction and decompensated heart failure.

  • Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes?

    Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians, and the risk and severity of diabetes complications (cardiovascular disease, kidney failure, blindness) are far greater in this population than in non-Indigenous Australians. We address this problem, targeting Goal 5 of the National Diabetes Strategy. We urgently need effective and convenient ways of improving glycaemic management in Indigenous Australians. New technologies that continuously monitor blood glucose are effective in assisting patients to improve their blood glucose levels through driving changes in behaviour (increasing physical activity), lifestyle (healthier eating habits), and therapy. The devices are worn on the arm and provide continuous, real-time feedback on blood glucose levels, but have not been tested in Indigenous Australians. We will assess the effects of one of these technologies (flash glucose monitoring) on glycaemic control (glycated haemoglobin [HbA1c] levels, achieving blood glucose targets, reducing hypoglycaemic episodes) through a randomised clinical trial in this high-risk population. We will also perform a cost-effectiveness analysis. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels, as indicated by HbA1c >7.5% (n=350), will be equally randomised to use a flash glucose monitor or receive standard care (glucose tested by finger-prick) for 6 months. Anticipated primary outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring. Anticipated secondary outcomes include achieving blood glucose targets, fewer hypoglycaemic episodes, reduced costs, and improved quality of life. The research will likely lead to major, cost-effective health gains for Indigenous Australians, and significantly improved health-service delivery for Indigenous and other high-risk Australians.

  • The effects of morphine on breathlessness and sleep in chronic obstructive pulmonary disease: A randomised, double-blind, placebo controlled cross-over study

    The purpose of this study is to determine the effects of sustained-release oral morphine (20mg) on sleep efficiency, breathlessness, and daytime alertness in breathless people with chronic obstructive pulmonary disease. We hypothesize that low dose morphine will improve sleep efficiency.

  • Controlled Human Infection for Penicillin Against Streptococcus Pyogenes

    The CHIPS Trial is a double-blinded, randomised dose-ranging trial designed to determine the minimum effective steady-state penicillin concentrations required to prevent pharyngitis caused by Strep A. This trial will use a world-first fully validated human challenge model for Strep A infection which has been developed in Australia by members of our team as a tool to test different interventions in the fight against acute rheumatic fever (ARF) and rheumatic heart disease (RHD). If the CHIPS Trial determines that the minimum concentration required to prevent Strep A pharyngitis is lower than the currently accepted target of 20 ng/mL, this will transform the penicillin reformulation landscape toward a new long acting penicillin implant and provide opportunities to make data-driven changes to recommendations of currently available penicillin preparations used for secondary prophylaxis of ARF and RHD.

  • Magnetic and Indocyanine Green (ICG) Sentinel Lymph Node Mapping in Colorectal Cancer: A Feasibility and Validity Clinical Trial

    The purpose of this study is to evaluate the safety of a new magnetic tracer (FerroTrace) and an infrared dye (Indocyanine Green - ICG) to be used together in colorectal cancer surgery to find the lymph nodes the cancer is most likely to have spread to (the sentinel lymph nodes). This study will also evaluate the feasibility and accuracy of the new magnetic tracer (FerroTrace) and infrared dye (ICG) for finding the sentinel lymph nodes. If the sentinel nodes are clear of cancer, there is a very high probability the cancer has not spread. Finally, the study will also investigate whether the new tracer enables better detection of cancer cells in lymph nodes on Magnetic Resonance Imaging (MRI) before surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 75 years, have a confirmed diagnosis of primary colorectal cancer and are scheduled for surgery to remove the primary tumour. Study details All participants will undergo their surgery to remove the primary tumour as originally scheduled, with the addition of receiving the new magnetic tracer (Ferrotrace) and the infrared dye (ICG) during the surgery. Participants will then be monitored for 14 days after the surgery for complications. It is hoped that this research project will demonstrate the new method is safe and feasible, and can enable larger follow on trials to determine if the new method improves staging accuracy and can improve patient outcomes.

  • TaxAdapt: A clinical trial testing the feasibility, acceptability, and safety of docetaxel in men with prostate cancer that has spread

    The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have prostate cancer that has spread and you are offered to take a chemotherapy infusion called docetaxel by your oncologist. Study details If a man about to take docetaxel chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the chemotherapy, using it for long enough to control the cancer, but then stopping and saving it up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.

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