ANZCTR search results

The primary purpose of this trial is to assess whether the addition of durvalumab to patients who have achieved less than partial response to 4 cycles of lenalidomide and dexamethasone will cause an improvement in disease progression free survival. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant. Study details Eligible participants will all receive lenalidomide and dexamethasone treatment in 28 day cycles, with those patients failing to adequately respond receiving durvalumab in addition. Treatment will continue until disease progression, unacceptable toxicity or patients otherwise coming off study. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical examination to monitor treatment safety and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of durvalumab in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma patients early in the course of their disease.

This study aims to compare the diagnostic and treatment pathways between Culturally and Linguistically Diverse (CALD) and Anglo-Australian lung cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and be diagnosed with primary lung cancer at the study sites within the past month or during the recruitment phase. Study details You will be asked to complete a patient survey and/or have a face-to-face interview with the researcher. We will also ask whether we can access your hospital medical records and contact your GP for medical information related to your cancer diagnosis. Study significance This study will provide important information about the barriers existing along the lung cancer pathway from symptom appraisal to treatment in CALD populations and is essential to any future intervention to improve early diagnosis and treatment for lung cancer.

Obesity is a chronic disease, and it has typically been purported to result from a range of causes including metabolic factors. But weight loss and weight maintenance are complex issues, and research indicates adults who are overweight or obese do benefit from psychological interventions to enhance weight reduction as well as behavioral approaches. Emotional Freedom Techniques (EFT) is one strategy and is a type of exposure therapy which includes a somatic and cognitive component for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. Likened to a version of psychological acupuncture but without the use of fine needles, EFT combines components of traditional approaches (including cognitive and exposure therapy) with acupoint stimulation. There is now 10 years of EFT research for food and weight issues. Recent research has also indicated regulation of six genes associated with inflammation and immunity after EFT, but it has not been unambiguously established how brain activation and neural mechanisms might be affected by EFT. This study had two objectives: 1: To ascertain the differences in brain activation (using fMRI) in response to food craving stimuli in overweight/obese adults, and compare to a control group, and 2: To investigate neural mechanisms of symptom improvements in overweight/obese adults following EFT treatment in order to conduct a larger trial.

The aim of the study is to evaluate the effectiveness of combining weight loss therapy with a CBT group program that specifically addresses negative responses to body dissatisfaction and weight stigma in young, obese women. This will be compared to a standard care CBT and weight loss program, which does not specifically address body dissatisfaction or weight stigma.

We will collect observational data on patients undergoing cardiac surgery under general anaesthesia with volatile agent maintenance (sevoflurane or desflurane). We will collect simultaneous samples of end-tidal gas concentrations, and arterial and mixed venous blood samples for partial pressure measurement for O2 and CO2, and anaesthetic gases, as we done in several previous studies), along with measurements of alveolar ventilation, and of pulmonary blood flow using bolus thermodilution. We will study 10 patients with sevoflurane and 10 patients with desflurane. Samples will be collected once in the pre-cardiopulmonary bypass period and once post-cardiopulmonary bypass. In a further group of 10 patients we will also perform the Multiple Inert Gas Elimination Technique (MIGET). This is the gold standard method for measuring precise distributions of V/Q ratios in patients. We have developed and validated an adaptation of the MIGET for use in ventilated patients under general anaesthesia. The V/Q distributions generated will be used for application within the model, to obtain precise measurements of shunt fraction and alveolar deadspace. These models will allow us the plot the precise pattern of distribution of anaesthetic gas uptake across the lungs in these patients. An index of severity of V/Q scatter will be obtained by calculations of shunt fraction and alveolar deadspace using the traditional 3-compartment Riley model, from the Shunt equation and the Bohr-Enghoff equation. Parallel calculations of shunt fraction and alveolar deadspace will be made using measurements of volatile agent for comparison.

A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year 7. Interestingly, this effect appears to be dependent on actual reaction occurrence, suggesting opportunities to intervene to reduce fear, anxiety, and adverse reactions are critical to improving retention. In addition, it is well-documented that donor adverse events with or without self-report of fear/anxiety are related to future intention to donate and are an independent predictor of retention, particularly for first time donors. For example, France, Radar, & Carlson (2005) reported, in a 1-year prospective study of nearly 90,000 blood donors, return rates of 64% for individuals without an adverse reaction, in comparison with just 40% for those who did experience a reaction. Although there are few studies examining pain and donor behaviour, there is evidence that blood donors who report lower levels of needle pain are typically less anxious, and lower needle pain ratings have been associated with greater donation satisfaction, which is in turn related to intention to return to donate. Taken together the research to date suggests that provision of methods that reduce or even eliminate pain and/or reduce anxiety and fear are likely to enhance the safety and comfort of blood donors and improve retention. The primary aim of the feasibility trial is to assess the feasibility and acceptability of the Coolsense(R) device in a donor centre environment from the perspective of staff and donors whilst evaluating any clinical and potential safety events.

Aim: To explore the feasibility of mouthpiece ventilation (MPV) use in the intensive care environment for patients who are extubated after suffering a cervical spinal cord injury and the barriers and enablers from a practice perspective. Significance: Respiratory failure and the need for re-intubation for those suffering acute tetraplegia is a known risk which extends ICU stay and costs, delays rehabilitation and increases stress for patients and their families. This is the first time that early application of MPV combined with standard conventional treatment in patients with cervical spinal cord injury (SCI) has been evaluated. This team will lead the way by taking the first steps towards determining if MPV can be utilised to deliver post extubation breathing support. The findings from this study will form the foundations to determining if MPV can impact on outcomes such at extubation success, need for re-intubation and ICU length of stay (LOS). Outcomes: This study will provide much needed pilot data about a MPV intervention for catastrophic injury populations. More importantly, this study will inform of relevant factors that will likely lead to effective translation of this intervention into routine clinical practice, including the resources and education. Data from this pilot study will inform a larger study to determine the effectiveness of MPV and the health and economic benefits for individuals and the health care system. The internal and external connections established with the clinical advisory group during this study will support collaboration for a larger future trial.

Currently there is no proven effective medication to combat fatty liver disease. The aim of this study is to determine whether sympathetic nervous system (SNS) function is linked to liver disease. The study will help to investigate how “overly-active” your SNS in the presence of liver disease and whether there is an association between liver fat quantity and the SNS’s degree of overactivity. Finally, we would like to see if an “SNS-blocking agent” which could reduce your SNS activity could have a favourable impact on your liver and general metabolism. The “SNS-blocking agent” that we will use in this research project is called moxonidine .

This pilot study will assess the feasibility and the outcomes of using digital breast tomosynthesis (3D-mammography) for routine breast screening. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above and are attending a BreastScreen service at Maroondah BreastScreen. Study details Women who attend for routine breast screening will have an opportunity to have tomosynthesis screening (3D-mammography acquisition with synthetic 2D-mammography) in place of standard 2D-mammography, those declining to participate will have standard 2D-mammography. 3D mammography screening involves having x-rays of both breasts (taken as two views of each breast, with the breast transiently compressed similarly to conventional 2D mammograms). There are two mammography units that operate at the Maroondah service, both units can perform 2D screens however only one unit can perform 3D acquisitions. If the woman consents to participating, she will then receive either 2D or 3D acquisition, this being by chance of which mammography unit is available when they are taken into the screening procedure. All other aspects of screening, reading and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes. Screening detection measures and feasibility of using 3D mammography will be assessed. It is hoped that this pilot feasibility study will inform planning of future larger studies using 3D mammography or further evaluation in BreastScreen Australia.

The goals of this research project are to evaluate the feasibility and effectiveness of an attachment-based and trauma-informed parent program for kinship and foster carers and children in their care. The program aims to promote carers' understanding of and sensitive responding to their child's behaviour and emotions, and, in turn, strengthen the carer-child relationship and promote children's behavioural and emotional wellbeing.