ANZCTR search results

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

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31349 results sorted by trial registration date.
  • Exenatide -LAR in addition to standard care in Indigenous Australians with type 2 diabetes and effect on glycaemic control

    To demonstrate, as part of a pilot study, the feasibility and safety of a clinical trial to demonstrate the efficacy, safety and acceptability of a once weekly injection of exenatide LAR in addition to weekly clinical contact and otherwise usual care in Aboriginal Australians and/or Torres Strait Islanders (Indigenous Australians) with sub-optimally controlled type 2 diabetes.

  • Radionuclide therapy using Lutetium-177 prostate specific membrane antigen (PSMA): a pilot study in men with castrate-resistant prostate cancer (LuPSMA trial)

    The primary aim of this study is to test the safety and effectiveness of prostate specific membrane antigen (PSMA) labelled with a radioactive substance called Lutetium-177 (177Lu) in men with metastatic prostate cancer refractory to hormonal therapy and chemotherapy. Who is it for? You may be eligible to join this study if you have metastatic prostate adenocarcinoma that has progressed despite hormone treatment and chemotherapy. Study details: In this study, we will use a radioactive molecule (called Lutetium-177) that, after injection into vein, specifically attaches to cells with high PSMA Expression. This substance is taken up into prostate cancer cells, wherever they have spread (most often bones or lymph nodes) and enables targeted delivery of high doses of targeted radiation to sites of prostate cancer whilst sparing most normal tissues. This is called radionuclide therapy and uses radiation to kill prostate cancer cells. All participants who pass the screening visit selection will receive this therapy with up to 4 cycles separated by 6 weeks. You will not stay in hospital overnight but several scans will be performed requiring you to come back to the hospital for additional visits. From these scans, we will see where the radiation has gone and also quantify how much radiation was delivered to both tumours and normal tissues. Following treatment you will be mildly radioactive for a few days and there may be some restrictions on close personal contact including with pregnant women or children, but otherwise we anticipate that most patients feel will feel well and be allowed to go home the same day. Overall, participation will require you to visit the hospital approximately 14 times over around 18 months. The drug used in this study is not approved by the Therapeutic Goods Administration (TGA). This study will help inform the efficacy and side effects of LuPSMA in treating metastatic prostate cancer, and design of future larger studies assessing this therapy.

  • The effectiveness of Pilates versus usual care on pain and disability in people with chronic nonspecific low back pain

    The primary purpose of this randomised controlled trial is to investigate the effectiveness of Pilates versus usual care on pain and disability in people with chronic non specific low back pain in short term(6-12 weeks) and long term (26 weeks).The research hypothesis is that the Pilates exercise will show short term and long term effects in decreasing pain and disability in people with chronic non specific low back pain more than usual care.The alternative hypothesis is that there is no difference in pain and disability in participants who undertake Pilates exercise and those that continue usual care.

  • A randomized controlled trial of propofol versus placebo for the Emergency Department treatment of acute migraine in adults.

    Acute migraine is a common and often debilitating condition for which people often seek treatment in Emergency Departments. A number of treatments have proven efficacy compared with placebo, including metoclopramide, prochlorperazine, chlorpromazine and sumatriptan. These drugs are reported to lead to headache resolution by 2 hours from initial treatment in about 60% of people. Recent observational studies have suggested that propofol, a sedative and anaesthetic agent, may lead to headache resolution (migraine and tension type headache) by one hour from initial treatment in about 80% of people. These studies have used regimens where incremental small doses of propofol (20 to 40mg) are given every 3 - 5 minutes until either the headache resolves, or a maximum dose of about 140mg has been given. The mechanism of action remains unclear. No studies to date have compared propofol with placebo in adults with acute migraine, which is important, since the placebo response has been reported in previous migraine trials to be up to 40% (although it is most often around 10%). If this study does demonstrate that propofol is significantly superior to placebo, then studies directly comparing propofol with other agents will be warranted.

  • A parallel group randomised, controlled, multi-centre phase II open label trial with two cohorts testing the combination of capecitabine and temozolomide (CAPTEM) and peptide receptor radionuclide therapy (PRRT) for the treatment of advanced pancreatic or midgut neuroendocrine tumours that are not suitable for surgery.

    The CONTROL NETS study aims to determine the activity of capecitabine + temozolomide (CAPTEM)/peptide receptor radionuclide therapy (PRRT), alone and in combination, in both pancreatic neuroendocrine tumours (pNETS) and mid-gut neuroendocrine tumours (mNETS) patients. Who is it for? Participants must be at least 18 years of age, with advanced, non-operable mNETS or pNETS who have received 2 or fewer lines of treatment for their disease. Study details The study involves randomly allocating (by chance) participants to receive treatment. pNETS patients will receive either CAPTEM alone, or the experimental combination of CAPTEM/PRRT, whilst mNETS patients will receive either PRRT alone or CAPTEM/PRRT. Participants have a 2 in 3 chance of being allocated to the PRRT/CAPTEM treatment arm. Treatment on each arm continues for 32 weeks, followed by 12 months of follow-up (pNETS), and 24 months (mNETS). CAPTEM is chemotherapy (Capecitabine and Temozolomide) taken as tablets. PRRT is an injection of a radioactive compound called Lutate which is given into a vein on 4 occasions during treatment. Study participants will be asked to come to the clinic for study visits between 9 to 12 occasions during the treatment stage, depending on which treatment they receive. The visits will vary in length between 2 and 6 hours. CONTROL NETS will look at rates of progression free survival, overall survival, adverse event rates, quality of life, and cost-benefit analyses across both cohorts. It is hoped that this study will shed light on the activity of the combined CAPTEM/PRRT treatment in patients with pNETS/mNETS, and inform the design of larger future clinical trials aimed at determining the best treatment for these diseases.

  • The influence of high-intensity compared with moderate-intensity exercise training on the health of colorectal cancer survivors: a randomised controlled trial

    Overview: The primary purpose of this study is to investigate the effect of moderate (MIE) as compared with high intensity exercise (HIE) on a number of outcomes related to the health of colorectal cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or over, and have finished treatment for colorectal cancer at least one month prior. Study details: Participants, will undertake baseline testing including a fitness test, blood sampling, a body composition scan and questionnaires. Participants will then be randomly allocated (by chance) to one of three exercise programs for 8 weeks. Exercise sessions will last approximately 40-50 minutes and be carried out 1-3 times per week, depending on the program allocated. The exercise will be in the form of stationary cycling. Patient outcomes will then be assessed through further fitness testing, blood sampling, body scan and questionnaires at 4 weeks into the program, at the end of the 8 week program and 4 weeks after the end of the exercise program. This study will be used to inform exercise prescription recommendations to enhance prognosis following colorectal cancer diagnosis and treatment.

  • A Prospective MultiCentre Randomised Controlled Trial comparing unassisted Pelvic Floor Exercises with the PeriCoach Registered Trademark system assisted Pelvic Floor Exercises in the management of female stress urinary incontinence.

    The purpose of this study is to evaluate the efficacy of the PeriCoach Trademark system in females with stress, or mixed with predominantly stress, urinary incontinence as well as the degree of satisfaction of the user in terms of outcome and ease of use.

  • Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Heart Failure

    This project will investigate if 7 days of dietary inorganic nitrate supplementation (beetroot juice) versus placebo in a randomized, double blind, cross-over design, can improve exercise tolerance in heart failure (HF) patients with preserved ejection fraction (HFpEF, n=15) and with reduced ejection fraction (HFrEF, n=15). The testing protocols are designed to investigate the oxygen consumption system at multiple levels that may mediate exercise performance. These include assessments during exercise of gas exchange, cardiac function, VO2kinetics, skeletal tissue oxygen extraction and nitric oxide metabolism. Additional resting measures of vascular function and stiffness, tissue perfusion and mitochondrial function (biopsy) will be performed. The hypothesis of this proposal is that in subjects with HFpEF and HFrEF, regular consumption of beetroot juice for 7-10 days will produce a clinical benefit in exercise tolerance (increase in VO2peak and time to exhaustion) versus a placebo.

  • The impact of the Dementia Care in Hospitals Program in improving the quality of life and adverse events in acute hospital patients with cognitive impairment: A stepped wedge cluster trial

    Dementia was the third leading cause of death in 2010, with 9,003 deaths recorded across Australia. For people aged 65 and over, dementia was the second leading cause of burden of disease and the leading cause of disability burden. Dementia is now the ninth National Health Priority Area in Australia. Bail et al. (personal communication) from the Hospital dementia Services Project (2012) indicates that patient with dementia in medical and surgical services have 2.5 times increased risk of adverse event compared to the no dementia group matched for age and other comorbidities. In the acute hospital setting patients can have difficulties with memory and thinking because of dementia or for other reasons such as delirium or specific brain injury such as stroke. Irrespective of the cause, disorders of memory and thinking or more succinctly Cognitive Impairment (CI) are a source of risk in the complex hospital environment. While dementia can also occur in younger people, the current study will focus on patients in acute hospitals aged 65 and over with cognitive impairment as this is the largest hospital group. Rationale for study: It is recognised that hospital staff are not adequately equipped to identify or respond appropriately to people with dementia. The Dementia Care in Hospitals Program (DCHP) is an all of hospital education program to improve communication with and awareness of patients with Cognitive Impairment (CI) linked to a bedside alert: the cognitive impairment identifier (CII). This program was first developed and introduced at BHS in 2004 in partnership with people with dementia and their families. The DCHP has been adopted by 25 public and private hospitals in Victoria. The program involves comprehensive training for clinical and non-clinical hospital staff. Unpublished evaluations of the program found that 80% of staff reported it improved their practice and 40% reported that it had improved their response to carers. Carers also reported greater satisfaction with the care their family member received (AIHW 2013). However, while staff perceptions and carer and patient satisfaction were measured, the effect of the DCHP on clinical outcomes such as adverse events and cost effectiveness has not been measured. The Department of Social Services has now funded a roll-out of the DCHP to other Australian jurisdictions and requested a national evaluation which is the basis for this study. There are three interrelated but separate elements to the evaluation that is the subject of this protocol- 1. Change in patient quality of life, carer satisfaction and staff knowledge and perceived difficulty with care 2. Change in nursing modifiable adverse events in patients over 65 with cognitive impairment 3. Cost effectiveness of the DCHP Element (2) is the basis for a PhD to be completed by A/Prof Mark Yates

  • A Single and Multiple Daily Injection Study of DUR-928 in Healthy Volunteers.

    This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intramuscular injection to healthy volunteers. The study will look at the study drug’s effect when given as a single dose at 4 different dose levels, and then once daily for 5 days at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream).

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