ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Targeted lowering of central blood pressure in patients with hypertension: a randomised controlled trial

    High blood pressure (BP) is the most common modifiable cause of death from cardiovascular disease (CVD). Lowering BP with medication improves patient outcomes, but even in populations with normal upper arm (brachial) BP there remains considerable residual risk for CVD. Our recent pilot work found that much of this risk may be due to persistently elevated central BP. However, there has never been a trial to determine the clinical value of targeted central BP lowering. This remains the most significant question to be answered before central BP can be considered for routine clinical use, and is the aim of this project. The proposed study will be a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial over two years in 300 patients treated for hypertension who have controlled brachial BP but relatively high central BP. Randomisation to spironolactone (and lowering of central BP) is expected to significantly improve CVD risk, despite no significant change in clinic measured brachial BP.

  • A case-series study to explore the efficacy and tolerability of full-length shoe stiffening inserts in treating first metatarsophalangeal joint osteoarthritis

    Project aim: The aim of this project is to determine the effectiveness and tolerability of full-length shoe-stiffening inserts for the treatment of osteoarthritis of the big-toe joint of the foot. Rationale: Osteoarthritis of the big-toe joint is common and painful. Although full-length shoe-stiffening inserts are a recommended treatment for this condition, the evidence supporting their use is lacking.

  • Cognitive control training for major depression: application, evaluation and augmentation.

    Many depressed individuals fail to respond to available pharmacological and psychological therapies and there is a significant need to develop novel antidepressant treatment approaches. Traditionally, both research into and treatment approaches for depression have focused on the emotional disturbance associated with this illness. However, depression also disrupts cognitive processing. There is now considerable evidence indicating that the cognitive and emotional symptoms of depression interact with each other (e.g. causing an individual to remember more negative memories, or to pay more attention to negative thoughts and stimuli), and these interactions directly contribute to the length and severity of depressive episodes. Recently it has been suggested that targeting the cognitive symptoms of depression may also help to improve emotional dysfunction. One way that this could be achieved via cognitive control training (CCT). CCT simply involves a small number of thinking activities that an individual repeatedly practices to improve their ability to sustain and focus their attention and to self-direct their thought processes. The cognitive processes that CCT aims to enhance are largely subsumed by a frontal region of the brain called the dorsolateral prefrontal cortex. Research has shown that a mild form of brain stimulation called transcranial direct current stimulation (tDCS) administered to this brain region can enhance cognitive processing. As such, tDCS may be a useful means of augmenting the efficacy of CCT for depression.

  • “Vaccinate the child, vaccinate the parent” – Evaluating simple strategies to improve awareness and uptake of measles vaccination among adults in South Eastern Sydney (SES).

    We have submitted an application the the University of NSW HREC who have requested we proceed with a clinical trial application. The study is being conducted to trial simple strategies to improve the uptake of measles immunisation in adults born in or after 1966 who may not be fully vaccinated and at risk of being infected with measles. The study is a pre-post intervention design. A random sample of 53 general practices will be recruited to participate. During the intervention, the general practices will be given resources to promote vaccination of adults against measles at the same time as these parents attend the medical practice to have their children vaccinated. The campaign is called "Vaccinate the child, vaccinate the parent".

  • AKTRES study: A Biologic Study of the early effects and determinants of AKT inhibition using GSK2110183 alongside chemotherapy in patients with Platinum RESistant Adenocarcinoma of the ovary

    This is a biological study, which aims to answer novel questions about the molecular status of cells from patients with platinum-resistant ovarian cancer before and after treatment with the AKT inhibitor GSK2110183 given in combination with chemotherapy (in the accompanying PKB116611 study). We will biopsy tumour tissue and collect blood samples from PKB116611 participants with platinum resistant ovarian cancer prior to and following treatment in order to perform the following studies on tissue samples: 1) Immunohistochemical, ELISA and protein array (RPPA) based analysis of tumour biopsies for markers such as AKT, pAKT, PRAS40, pPRAS40, Ki67, LARP1 and multiple components of the extended AKT pathway 2) Genomic analysis of archived tumour samples for mutations in known cancer genes by Sequenom OncoMap assays. 3) Analysis of blood-derived markers in circulating tumour cells (CTCs), peripheral blood mononuclear cells (PBMCs) and plasma. 4) Analysis (where appropriate) of ascites (or pleural effusion) for markers such as AKT, pAKT, PRAS40, pPRAS40, Ki67 and LARP1.

  • A study of super-high flow oxygen therapy in healthy volunteers and its effect on the lungs - the SHOT study

    High flow humidified nasal oxygen therapy (HFNOT) is a recent development that allows the provision of controlled oxygen concentrations and low levels of positive airway pressure via a nasal interface. The HFNOT system can offer clinicians and patients a different mechanism for delivering such pressure, at low levels, without some of the complications and comfort issues associated with these other methods. Some of the reported risks associated with face mask non invasive ventilation include mask discomfort, nasal dryness, oral dryness and eye irritation nasal or eye trauma and gastric distension / aspiration. Over the last three years there have been several studies published regarding the effectiveness and the clinical effect of this new form of respiratory support. Currently HFNOT is used as the standard therapy in patients with mild to moderate hypoxemic respiratory failure requiring respiratory support following extubation to improve oxygenation in patients in the Cardiothoracic and Vascular Intensive Care Unit at Auckland City Hospital. Research conducted previously by our group and others has demonstrated a positive linear correlation between the amount of flow and the resulting airway pressure with flows in the range described above. Since it is technically possible to apply higher flows with HFNOT devices we would like to describe the resulting changes in airway pressure and to see if the correlation remains linear at flows exceeding 50L/min and would like to conduct an initial study on 15 healthy volunteers.

  • Managing Inflammation in Chronic Obstructive Pulmonary Disease (COPD) [Mi COPD]

    In previous research, we have shown that patients with COPD continue to suffer multiple clinical problems despite tertiary based care. Both airway inflammation (swelling in the airways) (74%), and general body inflammation (60%) are common problems and can lead to other diseases. We have also demonstrated that quality of life impairment escalates as the number of clinical problems increases and that reducing these problems, including airway and general body inflammation, significantly improves health status. We have now developed a novel integrated treatment algorithm that addresses the inflammatory components of the disease. The purpose of this study is to examine the efficacy of this treatment decision algorithm in the management of COPD on the outcomes of quality of life and exacerbations. We will compare this approach to placebo treatment. We hypothesise, in patients with COPD, that individualised anti-inflammatory pharmacotherapy will significantly improve quality of life and lengthen the time to COPD exacerbation. We will also examine whether a panel of protein biomarkers are associated with treatment response and airway inflammation.

  • The immediate effect of changing mandibular position on airway and head position.

    The primary purpose is to observe the immediate effect of altering lower jaw position on airway and head position from a person's normal bite position to two other bite positions commonly used when constructing crowns, bridges and dentures.

  • Accelerated Repetitive Transcranial Magnetic Stimulation in the Treatment Of Depression

    Major depressive disorder is a severe illness of high prevalence. A significant percentage of patients fail to respond to standard treatments and continue to experience marked disability and high morbidity. Repetitive transcranial magnetic stimulation (rTMS) has been subject to intensive evaluation as an antidepressant strategy especially in patients with treatment resistant depression (TRD). Previous research conducted by our group and others clearly indicates that rTMS has antidepressant activity and that the response to rTMS is clinically meaningful. It is now being increasingly used in clinical practice in the US and more recently in Australia. A major barrier to the utilisation of rTMS is a relatively slow rate of response to treatment, often requiring daily treatments over a four to six week period. Therefore rTMS, as it currently stands, requires a considerable time commitment from both patients and clinicians. In addition, it is not considered appropriate for acutely suicidal patients, with these patients currently requiring treatment with electroconvulsive therapy (ECT) as this is clearly the most rapidly acting antidepressant treatment. If the time to response to rTMS could be substantially compressed, the treatment would be cheaper to administer and more acceptable to patients. In addition, it would also become a viable alternative strategy for the treatment of patients with acute suicidal ideation and other acute depression related risks, for example patients who have stopped eating and drinking and require intervention with a rapidly acting treatment. Therefore, the primary goal of this study is to investigate whether response to rTMS can be substantially enhanced through the use of an accelerated treatment protocol. We will compare antidepressant response between a standard and an accelerated rTMS protocol.

  • Pre-FIT: a multifactorial interdisciplinary treatment program for older people who are pre-frail

    This is a randomised trial of a multifactorial interdisciplinary intervention for pre frailty. The intervention has previously been shown to be effective in frailty older people (see ACTRN12608000250336, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82814).

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