ANZCTR search results

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

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33057 results sorted by trial registration date.
  • Evaluation of the Clinical Performance of the ColoSTAT Diagnostic for colorectal cancer biomarkers

    Purpose of study. To determine if a simple blood sample can be used to accurately test for colorectal cancer Who is it for? You may be eligible for this study if you are an adult over 40 years of age who has either been very recently diagnosed with colorectal cancer and is progressing to surgery or is scheduled to undergo a colonoscopy in the next 90 days. Study details: All participants in this study will be required to attend a short visit with researchers in order to provide a sample of blood and answer a few questions. Participants will also be asked to provide a faecal sample and give access to their colonoscopy reports. Researchers will then contact participants by phone within a month of the visit for a short check-up. It is hoped that this research will help determine if a simple blood test is effective in detecting colorectal cancer.

  • Acute effects of interval training for interstitial lung disease

    The interstitial lung diseases (ILDs) are a debilitating group of over 200 chronic lung conditions characterised by scarring of the lungs, progressive decline in lung function and few treatment options. Exercise-induced hypoxaemia and dyspnoea on exertion are key features of the ILDs. Pulmonary rehabilitation is a recommended treatment for the ILDs, providing short-term improvements in exercised capacity, symptoms and quality of life following pulmonary rehabilitation. Despite this robust evidence for pulmonary rehabilitation at a group level, only one third of individuals with ILD who undertake PR appear to experience a clinically significant benefit. In our RCT of PR in ILD, thirty-three percent of participants with ILD achieved improvement in 6MWD that exceeded the minimal important difference at the end of PR. The proportion of participants who achieved a clinically significant benefit was slightly greater for those with IPF (42%) and more so for those with asbestosis (55%). Therefore, it appears traditional exercise prescription in PR is inadequate in at least 50% people with ILD. Alternative training strategies may prove more effective in both minimising symptoms and improving exercise tolerance in people with ILD. Interval training (IT) consists of periods of relative high intensity exercise interspersed with periods of low intensity exercise and/or rest. In healthy, interval training induces similar or even superior physiological changes to traditional endurance training. In COPD, interval training delivers equivalent improvements in exercise capacity and quality of life with less dyspnoea and leg discomfort. Whether interval training is tolerable and feasible in patients with ILD is not known. The ideal length of the interval is also unknown. This is a prospective, randomised, crossover trial will investigate the acute physiological effects of high intensity interval cycle training compared to lower intensity interval training and standard continuous training in people with ILD participating in pulmonary rehabilitation.

  • Role of bile acids in glucose lowering by metformin

    Metformin is the first-line oral glucose-lowering medicine in almost all clinical guidelines on the management of type 2 diabetes (T2DM). It was long thought that metformin’s main action was to suppress glucose output from the liver. However, newer evidence suggests that the gastrointestinal tract is a key site of metformin action. In this study, we want to define the role of bile acids in the anti-diabetic action of metformin in type 2 diabetes. We wish to investigate whether the addition of exogenous bile will induce substantially more glucagon-like peptide-1 (GLP-1) secretion when compared to the removal of endogenous bile.

  • Effect of a lung recruitment strategy lung gas function during general anaesthesia

    A major contributor to postoperative pulmonary complications after major surgery is collapse (atelectasis) in poorly ventilated lung segments during and after general anaesthesia (GA). Atelectasis arises from the reduced muscle tone caused by nearly all anaesthetics,and the non-physiological pattern of distribution of ventilation that characterizes controlled mechanical positive pressure ventilation (CMV), and occurs early in the course of anaesthesia. Strategies to reduce lung atelectasis and postoperative pulmonary complications include the use of positive end-expiratory pressure (PEEP) and lung recruitment manoeuvres. Recently, Maquet Critical Care AB (Sweden) have released a new functionality on their Flow-i anaesthesia machine which allows targeted lung recruitment using a stepped increase in PEEP and lung inflation pressures. The system simultaneously monitors airway pressures and dynamic lung compliance, The latter is used to identify the optimal level of PEEP to minimize lung atelectasis, where measured dynamic lung compliance (Cdyn) is maximal. We wish to measure the effectiveness of this new technology on improving lung function and gas exchange in patients under GA for elective surgery.

  • Monitoring Of Stroke Endovascular Services (MOSES) study

    Stroke affects millions of people worldwide. Endovascular treatment is an effective treatment for stroke patients with a blockage in a large brain artery. By collecting information about the brain scan changes from acute stroke patients, MOSES study aims to improve the way doctors use brain imaging in the future to guide endovascular treatment for stroke, leading to improved patient outcomes . Research questions: - Is there a certain volume of ischemic core (dead brain) (for example >100ml) beyond which benefits from thrombectomy are negated. -As age increases, does pre-treatment volume of dead brain for which a favorable outcome can be achieved decline? - Is the benefit of thrombectomy the same for distal (small) blocked arteries comparable to large blocked arteries? - How can we more accurately predict the outcome from thrombectomy in patients who will have long transfer times to a comprehensive stroke centre? - What is an ‘acceptable’ outcome, particularly in patients with a large volume of pre-treatment dead brain and/or premorbid disability. - For which groups of stroke patients does thrombectomy confer good ‘value for money’?

  • Reducing the risk of post-operative delirium in elderly hip fracture surgical patients by implementing a multidisciplinary approach to analgesia, education, and medications

    Delirium is a common complication of patients admitted for hip fracture surgery, and is associated with increased risk of mortality, morbidity, and loss of functional independence, as well as high social, nursing and health care costs. National guidelines describe care plans and delirium reduction strategies, but inadequate education and lack of coordinated clinical management results in large variations in quality of care in Australian and New Zealand hospitals. This study will investigate if a multidisciplinary care bundle, which includes evidence based clinical interventions and regular educational initiatives reduces the risk of delirium in hip fracture patients classified as intermediate or high risk by 40%.

  • Pharmacokinetics of Intravaginal Lactoferrin Preparations

    This research study in BV patients is testing the safety, tolerability, pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a formulation of a drug called Metrodora Therapeutics bovine Lactoferrin (MTbLF) when it is given Intravaginally (into the vagina). Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of Bacterial Vaginosis (BV). The overall goal of this study is to optimize the formulation to test in future studies as a treatment for BV. BV patients will receive 10 daily doses of study medication; 3 doses of a single formulation in the clinical unit separated by 24 hours in consecutive days of their preference and the remaining days, they will self-administer the same formulation daily. A series of vaginal swabs and blood samples will be collected over a 24-hour period following each of the two first doses in clinic, once approximately 12 hours after the third in-clinic dose and after each home dosing and at the Follow Up visit 21 to 35 days after first dose of study medication .

  • Time to Oxygenation during ‘CICO’ Simulation: Rapid-O2 insufflation Device versus Manujet Ventilator

    We aim to investigate the time taken for medical and nursing anaesthesia staff to set up the Rapid-O2 oxygen insufflation device and compare this with the Manujet ventilator in a simulated ‘CICO’ (Can’t Intubate, Can’t Oxygenate) scenario. A Can’t Intubate/Can’t Oxygenate (CICO) scenario arises when attempts at oxygenation of the patient via the anatomical conduits of the upper airway have failed. In such a scenario, the creation of a patent airway via the front-of-neck either by cricothyroidotomy or tracheotomy remains the only option for rescue oxygenation. A variety of rescue techniques are advocated currently, including cannula-, or scalpel-based techniques as well as wire-guided techniques . Regardless of technique chosen the CICO scenario in anaesthetic practice is often poorly managed with potentially catastrophic outcomes. Important contributory factors include institutional ill-preparedness and equipment not fit-for-purpose. Delays in providing rescue oxygenation, even when appropriate equipment is available, is an additional factor implicated in poor outcome. Our hypothesis is that the Rapid-O2’s simplicity and intuitiveness allow for its setup by naive operators in a clinically acceptable timeframe versus the manujet during a simulated CICO scenario.

  • Enabling mobility in labour for women with complex pregnancies with beltless TransAbdominal Monitoring (TAM) technology: feasibility of use in Australian clinical setting

    Women identified as having complex pregnancies are often advised to have continuous intrapartum fetal monitoring – commonly referred to as CTG monitoring. Conventional forms of CTG monitoring require the labouring woman to wear two tight elastic belts around her abdomen and to be tethered to a machine by wiring, thus restricting her mobility during labour and her choice of position whilst giving birth. In the Australian context, this affects over half of the 310,000 women giving birth each year. However, enabling women to have mobility during labour and birth results in a shorter labour, lower likelihood of caesarean section, fewer epidurals as well as providing psychological benefits by strengthening women’s sense of choice and control. A new wireless and beltless monitoring device, the transabdominal fetal electrocardiogram (referred to herein as TAM) will be released in Australia by Philips Healthcare in early 2019. Although there is a body of international evidence supporting the safety and efficacy of the device, and it has been registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia, little is known about the implementation of TAM in authentic clinical settings. To investigate this, use of the device will initially be trialled in an Australian tertiary maternity care facility. This is the first stage of a broader investigation of the impacts of TAM in clinical practice.

  • High-flow nasal oxygenation in sedated lung transplant patients during transbronchial biopsy

    Post-lung transplant bronchoscopy is a commonly performed diagnostic procedure, typically performed under sedation with Low Flow Nasal Cannula (LFNC) oxygenation. Procedural desaturations are not infrequent. Recently High Flow Nasal Cannula (HFNC) oxygenation has been demonstrated to be a safe alternative to LFNC oxygenation in a number of clinical scenarios. This trial will assess the use of HFNC oxygenation as an effective alternative to LFNC oxygenation in sedated lung transplant patients undergoing diagnostic transbronchial biopsy. We hypothesise there will be fewer, and shorter, desaturations in the HFNC group as well as fewer airway interventions.

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