ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy and tolerability of sunitinib on a 14/7 schedule with toxicity-adjusted dosing for the treatment of metastatic renal cell cancer (mRCC). Who is it for? You may be eligible to enroll in this trial if you are aged 18-80 years and have been diagnosed with metastatic renal cell cancer with a component of clear cell histology. Study details All participants enrolled in this trial will receive sunitinib capsules to be taken in cycles of 14 days on, then 7 days off, until either the disease becomes resistant to the treatment (disease progression), or due to intolerable side effects despite dose adjustment, in which case treatment will be ceased. Based on the occurrence of any side effects to the medication, the dose may be increased or reduced as required by the treating doctor. The dose is adjusted so as to aim for some side effects for up to four days per cycle. Participants will be asked to complete questionnaires relating to toxicity and quality of life, and will undergo scans to monitor disease progression for up to one year following the start of treatment. It is hoped that the findings from this trial will provide information on whether a 14/7 dosing schedule with toxicity-adjusted dosing is effective and tolerable for sunitinib treatment for mRCC.

Aim: This is a single blind randomised controlled clinical trial comparing a new therapeutic intervention in addition to Treatment As Usual (TAU) with TAU for patients with schizophrenia at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU) who want to work. The new therapeutic intervention is called the Supported Employment Linkage Intervention (SEL).The primary hypothesis tested is the addition of SEL to TAU will improve engagement, by patient choice, with a local employment agency called EDGE and procurement of a competitive job. EDGE has good fidelity to the Individual Placement and Support Approach to Supported Employment. We will also see if psychiatric symptoms, cognition, hope and social inclusion will be improved with the addition of SEL to TAU significantly more than with TAU alone. Method: The outcomes measured will be change in: The Engagement with Edge Questionnaire (EEQ), Job Acquisition Questionnaire (JAQ), Brief Psychiatric Rating Scale (BPRS), Trail Making Test A+B, Digit Span Test (Wechsler Adult Intelligence Scale – Revised),, Adult Hope Scale, and the Activity and Participation Questionnaire (APQ-6). Measures will be collected at baseline by the research mental health nurse clinicians and 6 months and 12 months post recruitment by a blinded research officer unfamiliar with the site. Expected Outcomes: We expect successful engagement with an employment agency called Edge, as measured by the Engagement with Edge Questionnaire (EEQ), to equal a 6 month block of registration with Edge during the 12 month period post recruitment and to be significantly better with SEL + TAU compared to TAU over 12 months post recruitment. We expect yes to a competitive job, as measured by the Job Acquisition Questionnaire (JAQ), to be significantly greater with SEL + TAU compared to TAU at 4 varying time points over 2 years post recruitment. Hope, and social inclusion are anticipated to be significantly improved with SEL + TAU compared to TAU as measured the Adult Hope Scale and the Activity and Participation Questionnaire (APQ-6) respectively at 6 and 12, months post recruitment.

This study will investigate the safety of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a histologically or cytologically confirmed locally advanced or metastatic solid tumor (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists. Study details This study involves the use of an investigational drug called CFA. "Investigational" means that the drug has not yet been approved by the Therapeutic Goods Administration (TGA) for treatment of cancer. CFA consists of three ingredients: mineral oil, surfactant, and heat-killed mycobacterium. Injection of CFA into tumour creates a localised depot of killed bacteria, which are slowly released over weeks. This causes an influx of immune cells to the site on injection, and initiates a powerful immune response. The other drug (pembrolizumab) is an approved novel agent for the treatment of metastatic melanoma. Participants in the study will receive CFA in combination with pembrolizumab. CFA will be administered in 42 day cycles starting at a dose of 0.5 ml for the first cohort of three patients. These patients will be monitored closely and provided there are no safety concerns additional patients will be enrolled and treated with 1.0 ml of CFA and subsequently a third cohort will be enrolled with a starting dose of 2.0 ml of CFA. Once a participant experiences an adverse event as a result of the CFA dose, this dose level will be expanded with three additional patients enrolled. If two of the six participants experience a reaction the dose will be decreased to the previous level and three additional patients will be added. If one of the six patients experience a reaction that dose will be declared the maximum tolerated dose for CFA. Pembrolizumab will be administered following approved guidelines (2mg/kg) on day 2 of the first cycle and then every three weeks. Safety of CFA will be assessed at Day 1 of each 42 day cycle. Participants will be followed for up to 30 days after removal from treatment to determine therapeutic benefit and anti-tumour effect of CFA. Patients removed from treatment for unacceptable adverse events will be followed up until resolution or stabilization of the adverse event.

Most nurses work shifts, and those who work night shifts have poorer lifestyle behaviours than those who work day shift only, placing them at increased risk of cardiovascular disease (CVD) and diabetes. There is strong evidence to show that shift workers have a 40% higher risk of CVD than non-shift workers. Regular physical activity (PA) is associated with reduced risk of CVD and has been shown to improve vascular function. However, shift workers have less opportunity to participate in leisure time PA and have poorer health seeking behaviours than non-shift workers. This research will investigate the impact of physical activity (PA) on intermediary vascular function and CVD outcomes in nurses who work night or rotational shifts. This will be achieved by: (1) measuring current PA patterns and vascular function, and comparing these in nurses who work night or rotating shifts with those who only work day shift; (2) conducting a feasibility trial of a PA intervention program for nurses who work night/rotational shifts. We hypothesise that participants in the intervention group will have increased levels of PA, significantly greater improvements in vascular function, and reduced risk of CVD compared with those in the control group. Intervention and comparison groups: Nurses who work night/rotational shifts and who participate in less than 150 minutes of physical activity per week, will be invited to participate in the intervention. The 8-week intervention will comprise a one-on-one information session during which a research assistant will provide participants with feedback for their baseline results and set physical activity goals. The nurses will also receive an educational leaflet and self-monitoring device (Fitbit Flex) to track physical activity. The shift workers in the control group will also meet with the research assistant (exercise physiologist) to receive feedback on their baseline results and receive the educational leaflet. These participants will not receive the Fitbit flex to monitor physical activity, and will not receive any encouragement to change their physical activity behaviour. Outcome Measures: The main outcome measure is a change in vascular function (assessed using ultrasound) and physical activity (assesed using acelerometers). Secondary outcomes include change in sedentary behaviour, cardiovascular disease risk score and Body Mass Index. These measurements will take place at baseline (Phase 1) and then at 2 (vascular function only) and 8 weeks in the intervention group. The comparison group will have measurements performed at baseline and 8 weeks.

During or after a major operation (such as bones or joints operations, also known as orthopaedic operations), our body increases its heart rate as a response to the stress of the surgery. As the heart pumps faster to manage the stress, it can sometimes damage itself in the process. As previous study observed that up to 52% of patients undergoing major orthopaedic operations demonstrated some evidence of injury to the heart, and these patients have poorer clinical outcomes. This has led to previous studies examining the benefits of heart rate lowering agents to prevent damage to the heart after surgery, to improve clinical outcomes. Unfortunately, many heart rate lowering agents have a common side effect of lowering the blood pressure as well. Hence, whilst these trials demonstrated promising benefit in reducing damage to the heart, they caused significant problems with low blood pressure. Ivabradine is an agent that reduces heart rate, but does not drop blood pressure. It is currently approved for use in Australia for another condition called chronic heart failure. But given its unique properties, we postulate that it can reduce damage to the heart after a major operation as well, without the negative effect of causing low blood pressure. As a result, this trial was conceived to examine this effect.

Fasting plasma triglycerides are currently one of the most used measures to determine the risk of cardiovascular disease. However, we spend 18 hours or more of our day in the post absorptive state and elevated postprandial plasma triglyceride levels have also been linked with increased risk for atherosclerosis and consequently cardiovascular disease. Dietary choices have been demonstrated to modulate postprandial lipemia. Furthermore, manipulation of food structure and composition has the potential to increase or reduce postprandial triglycerides. Therefore, food choices are important targets in the improvement of postprandial lipemia. In this project we aim to determine the effect of three food products with different structures and similar nutrient composition on postprandial blood triglyceride levels. This is a pilot project for the development of a tool to measure the effect of different food products on postprandial lipemia. Healthy adults will be recruited from the community in Newcastle (NSW, Australia) and in Palmerston North (Manawatu, New Zealand). Following an overnight fast participants will attend our clinical facilities and have blood samples collected using finger prick; subjects will then consume a single high fat test meal. Blood samples will be collected again 30, 60, 120, 180, 240 and 360 minutes after meal consumption. After one week wash out, participants will attend our clinical facilities again and repeat the procedure following consumption of the alternative test meal. Blood samples will be assessed for glucose levels and lipid profile (triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol) using a portable whole blood test system. Participants will also provide information on their medical history, physical activity, usual food consumption and eating attitudes at the start of the intervention.

Using a non-randomised design, this project will investigate the effectiveness of a universal, primary prevention program (WISE Teens) based on principles of the existing DBT STEPS-A Framework to promote greater social and emotional well-being amongst young people. Between four to six high schools from NSW will participate in the trial with each school providing a year group to complete the intervention, with another year group serving as the control condition (class as per usual). The primary aims of the current study are as follows: a) To examine the effectiveness of applying DBT principles within a universal, primary prevention approach to promote academic, social and emotional resilience in addition to greater quality of life and psychological well-being in Australian high school students. The study will also investigate the following secondary aims: a) Does level of program compliance (via completion of homework tasks and practice) affect social and emotional outcomes? b) Are the effects of the program mediated via increased levels of emotional awareness, more positive beliefs about emotions and reduced emotion dysregulation? c) Are the results of the program moderated by initial levels of clinical severity as determined at baseline? The following outcomes are hypothesised: a) The WISE Teens program will be effective in promoting more positive social and emotiona outcomes in addition to greater academic resilience compared with participation in PDHPE class as per usual. b) This effect is expected to be mediated by increased emotional awareness, more positive beliefs about the role of emotion and reduced emotion dysregulation. c) This effect is additionally expected to be moderated by clinical severity status, with those showing greater clinical severity of symptoms showing more marked improvements on social and emotional outcomes relative to those showing reduced clinical severity of symptoms.

The Victorian Liver Transplantation Unit at Austin Hospital is a collaborative service providing liver transplant services to residents in Victoria, Australia. Retrospective intra-operative data collection from our institution shows that 72% of patients undergoing liver transplantation are hypothermic prior to reperfusion of the donor liver, despite intense and standardised measures taken to maintain temperature homeostasis. This study is a prospective, single centre, blinded, randomised pilot trial to test the feasibility and efficacy of whether, in addition to the standard temperature measure undertaken to prevent intra-opeartive hypothermia, the additional use of the Fisher & Paykel Humigard (Registered Trademark) Open Surgery Humidification System will prevent hypothermia in adult patients undergoing orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplantation will be included. The primary end point will be core temperature measured five minutes immediately prior to reperfusion of the donor liver.

Laparoscopic (‘keyhole’) surgery is used to perform many different types of gynaecological surgery. These include diagnosis of reasons why pregnancy has not been possible, diagnosis of abdominal pain, and treatment of endometriosis (which is painful, abnormal tissue in the abdomen (belly). It also includes procedures using a robot to aid surgery, and removal of organs or abnormal growths. There are several causes of pain after this sort of surgery. One cause of pain is local damage to the wall of the abdomen due to the tubes that run into the abdomen that make keyhole surgery possible. For a long time surgeons have used local anaesthetic in small amounts that is injected into the holes or ‘port sites’ where these tubes are inserted. More recently a different way of giving local anaesthetic has become popular. This is called the ‘TAP block’ which stands for “transversus abdominis plane” block. The name simply means that it is injected alongside the transversus muscle in the wall of the abdomen. Anaesthetists tend to use an ultrasound probe to take a picture and place this at the right depth, but for surgeons to place it laparoscopically while they operate is also a recognised technique. This study will investigate whether the infiltration method or TAP method of giving local anaesthetic is more effective by measuring pain on a scale of 1 to 10 just after surgery and 24 hours after surgery. The surgeon will be instructed to perform either the TAP block or infiltration based on the patient’s randomisation. The anaesthetist, recovery staff, and patient will be blinded, so unaware of what the patient has received. The surgeon, who is not blinded, will not be involved in any measurement of pain scores. Patients undergoing any type of gynaecological keyhole surgery will be accepted. TAP blocks have been looked at in many trials now. There are some aspects to this trial which would be novel in combination and would add to our knowledge base. The surgeon would be giving the block. This approach has been used relatively rarely. By doing away with the need to keep the patient asleep while the anaesthetic performs the block and gets set up with an ultrasound machine, the block can be performed with minimal delay to the list. This is a ‘real-world’ trial which compares two commonly-used techniques, rather than comparing TAP blocks to injection of saline, which means that a convincing result would guide the choice to use one or the other. This trial is not restricted to some subgroup of gynaecology patient; it would look at a cross-section of any day-case or inpatient laparoscopic gynaecology population.

The transition of patients with chronic and complex conditions from hospital back into the community setting is a critical time with an increased risk of medication misadventure and re-hospitalisation. AIM: The aim of this study is to investigate whether a model of structured GP and pharmacist care reduces unplanned hospital readmissions in patients taking multiple medicines. METHOD: This study will include 2240 people who have been discharged from hospital taking 5 or more medicines and attend an enrolled medical centre. Participants will be recruited at discharge from hospital and the intervention will be in 14 different medical centres across South East Queensland. Depending on when the participant is discharged, they will be placed in the control or intervention phase. Participants in the control phase will receive usual care from their medical centre. This means the patient would consult their GP as per normal standards for that practice for a patient discharged from hospital. Participants in the intervention phase will be followed up after discharge by a pharmacist working in the medical centre they attend. The practice pharmacist will organise a time for the participant to come into the medical centre and to discuss the changes made during their hospital stay and review the participant’s medicines. After a consultation with the pharmacist, the participant will have a consultation with their GP to receive any new scripts they may need and to consider any changes recommended by the hospital or pharmacist. The practice pharmacist will follow up with the participant within five days of the first consultation. The practice pharmacists may also contact other health professionals involved in the participant's care as required. It is hoped that a pharmacist and GP reviewing a patient’s medicines and changes made during hospital will reduce the likelihood of the patient being readmitted to hospital.