ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Medicinal Cannabis Detection Trial

    The introduction of legal medical cannabis in Australia presents a unique challenge for the current roadside drug testing (RDT) approach which was designed to deter driving after illicit drug use and mitigate associated road safety risks. Having a legal prescription for a THC-containing medical cannabinoid product is not at present a valid legal defence against the charge of driving with a detectable concentration of a prescribed illicit drug, which means that medical cannabis patients are effectively prohibited from driving. Understanding the detectability of medical cannabis products using the Securetec DrugWipe® TWIN and investigating the driving-related effects of medical cannabis use, are important research priorities that can help to inform effective road safety policy and law enforcement strategy in this area. This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD.

  • Coronary Physiology and Imaging to Identify the Culprit Artery in Non-ST Elevation Myocardial Infarction: The CAPTURE-NSTEMI pilot study

    The purpose of our study is to improve the identification of the lesion responsible in patients presenting with NSTEMI (a form of heart attack), as these patients often can have multiple lesions and our ability to identify the culprit is still limited. All patients participating in this study will undergo a heart MRI before their scheduled invasive coronary angiogram to identify the area damaged by the heart attack. They will then proceed to scheduled coronary angiogram as planned. After the angiographic images are obtained, further anatomical and functional information of the heart vessels will be obtained with advanced intracoronary imaging (using OCT) and coronary physiology measurements (FFR, CFR, IMR). We will then see if the interrogation of this further information can help operators in identifying the correct artery responsible for the heart attack.

  • The accuracy and reliability of current angiographic assessment methods for identification of significant dissections during endovascular treatment of femoropopliteal arterial disease

    The aim of this research is to establish how good current x-ray methods are at identifying artery wall dissections that are severe enough to require further treatment. Dissections are tears of the inner layer of the artery wall caused by angioplasty (the deliberate stretching open of a blocked or narrowed artery using a balloon placed inside the artery). Dissection is a common complication of treatment with most being minor and requiring no further action, however some dissections are severe enough that they need further treatment. Currently very little is known about the accuracy of the current x-ray-based methods of identifying severe dissection. We also don’t know how much variation in diagnosis of dissection there is between doctors or whether there is a difference in the results of treatment at one year between mild and severe dissections. In this research project we will be obtaining several other measurements in addition to x-rays (including conventional ultrasound imaging, intravascular ultrasound (a miniaturised form of ultrasound mounted on a catheter that is placed within the artery), and pressure measurments within the artery) to assess the severity of dissections seen after initial treatment. We will also follow up participants for one year after the treatment to check on the success of the treatment. If current x-ray methods are found to perform poorly, it may be possible to develop better methods using some of these other measurement methods. We hope that this research will improve the diagnosis of dissection in the future and ensure that patients in the future will have better outcomes from their angioplasty treatment.

  • Efficacy of COVID-19 Vaccination in People with Follicular Lymphoma and Waldenström Macroglobulinaemia – A Prospective Cohort Study

    People with haematological malignancies are at increased risk of severe disease and death from COVID-19. New vaccines from Pfizer and AstraZeneca are reporting high immunogenicity and efficacy in clinical trials, but there is lack of data regarding how well people with haematological cancers respond to vaccines, to what extent and how durable responses may be. It seems reasonable that responses will differ in patients with haematological malignancy, based on both disease factors and factors related to specific anti-cancer treatments. Follicular lymphoma (FL) and Waldenstrom Macroglobulinaemia (WM) are two low grade non-Hodgkin lymphomas that offer potential models to study the impact of immunocompromisation on the immunogenicity of the COVID-19 vaccines. This study, combined with our evolving understanding of which types of vaccine responses are most important in conferring long-term protection against COVID-19, will allow people with FL and WM to make better informed decisions about treatment induction and maintenance options when indicated. It will also provide patients who have already completed treatment a better idea of how much protection to expect and what additional precautions might be required (e.g. preventative pharmacological agents in development, ongoing isolation if necessary, or additional vaccination if evidence emerges to support that).

  • Sequential compression alone for the prevention of deep venous thrombosis in operating theatres

    Venous thromboembolism (VTE) is a condition whereby a blood clot forms inappropriately in the veins. This clot may dislodge from its point of origin and be carried to the lung vasculature, which may be a fatal event. It has been estimated that the Australian annual incidence of VTE is 0.83 per 1000 individuals and is associated with significant morbidity and health related economic costs. In 2008, the estimated cost to the Australian economy was $1.7 billion dollars. Venous thromboembolism may be provoked by major surgery. The risk of surgically provoked VTE may be mitigated by the combined use of mechanical thromboprophylaxis, as recommended by the 2012 American College of Chest Physicians (ACCP) clinical practice guidelines and more recently, the 2019 American Society of Hematology (ASH) clinical practice guidelines. Despite this, there is no clear recommendation as to the type of mechanical thromboprophylaxis that should be used, with either or both graduated compression stockings (GCSs) or sequential calf compression devices (SCCDs) used. We wish to perform a cohort study of all laparoscopic cholecystectomies (elective and emergency) with a standardized mechanical prophylaxis protocol, to determine if we can maintain a low rate of VTE on SCCDs alone compared with the historical cohort of patients managed with combined SCCDs and GCSs, whilst maintaining safety including the risk of bleeding. The hypothesis of this study is that there is no difference between combined SCCDs and GCSs when compared with SCCDs alone. If this is true, GCSs could be removed from normal care, reducing GCS related complications and producing substantial cost savings for hospitals.

  • A randomised controlled trial of Dexamethasone for Emergency and Life-Threatening Admissions due to COVID-19 in Virtual Care: the DELTA study

    The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution. Once patients have consented to participate in the study, they will be randomised to receive either 6mg oral dexamethasone or 150mg thiamine (placebo). Study information will be collected from electronic Medical Records (eMR). Only routinely collected data will be used for this study, and will include disposition, intensive care admission, ventilation days and total hospital length of stay. Data managers and/or clinical nurse consultants will assist with data extraction. Data will be collected and entered into SLHD RedCap. Data analysis will follow.

  • Effect of a longer length peripheral intravenous catheter on interruptions to intravenous antibiotic delivery in general medical and surgical inpatients: a randomised controlled trial

    Intravenous (IV) antibiotic therapy is a very common reason for inpatient admissions. Traditionally a short peripheral intravenous cannula (PIVC) (<4 cms) has been the ‘default’ device for short term (1-14 days) antibiotic therapy however 33 – 54% of short-PIVCs fail during treatment, resulting in delayed antibiotic administration and repetitive insertion procedures. Interruption to antibiotic treatment has been linked to re-emergence of infectious disease, increased hospital stays, and antimicrobial resistant organisms. Recently, longer peripheral IV devices (4.5 -6.4 cms) have been introduced for short-term peripherally-compatible IV therapy. While observational data appears to suggest that long-PIVCs (with a greater catheter length within the vein) out-perform short-PIVCs, this has not been evaluated in a randomised controlled trial (RCT). We will conduct a single centre, two-arm, parallel RCT whereby initially 70 patients will be randomised to receive either a short-PIVC (control) or long-PIVC (intervention) for antibiotic administration. Should feasibility criteria be met a total 192 will be randomised to a fully powered study. We the investigators hypothesise that long-PIVCs will result in less antibiotic therapy interruption, with patients requiring fewer subsequent PIVC insertions.

  • A Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer (RESOLUTE)

    This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment for metastatic colorectal cancer. Who is it for? You may be eligible for this trial if you are aged 18 years or over, have metastatic colorectal adenocarcinoma, have between more than 3 lesions, and are receiving first-line systemic treatment. Study details Participants will receive metastasis-directed LAT such as surgery, radiotherapy, microwave or thermal ablation following 3-6 months of initial standard first-line systemic treatment, Those receiving LAT will return to systemic treatment 16 weeks after enrolment only if they did not complete 6 months of first-line treatment prior to enrolment. Information on progression-free survival and treatment outcomes will be collected. Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer.

  • NeuroMuscle Association between acute muscle wasting and functional deficits following severe traumatic brain injury: observational cohort study

    This study aims to observe acute muscle loss in patients with an acute severe traumatic brain injury over the first 28 days. To date acute muscle loss following the first 7 days following traumatic brain injury has not been reported. This study will assist to determine if there is an association between acute muscle wasting and functional impairments following a severe traumatic brain injury. The study will also determine if enteral or parenteral nutritional intake whilst admitted to intensive care (energy and protein) is associated with acute muscle wasting. This observational study is expected to lay the foundation for future interventional studies to assess the effect of exercise or nutrition (or a combination of both) on muscle loss and functional recovery following a severe traumatic brain injury.

  • Comparison of Treatment Satisfaction between the Omnipod Insulin Pump and Usual Care in Adults with Type 1 Diabetes in Australia

    This study will compare treatment satisfaction with Omnipod-DASH insulin pump with usual care with insulin pump therapy without sensor or multiple daily insulin injections in adults with Type 1 diabetes. We hypothesize that adults with Type 1 diabetes will report a more positive experience using Omnipod-DASH compared with their usual care.

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