ANZCTR search results

The primary purpose of this trial is to evaluate the safety and tolerability of Metformin (MET) in combination with sodium valproate (VPA) for the treatment of prostate cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with localised or locally advanced prostate cancer for which radical prostatectomy is planned within the next 6-8 weeks. Study details Participants enrolled in this trial will receive a combination of MET and VPA in increasing doses depending on the cohort they are enrolled in. The study drugs will be administered for a total of 4 weeks just prior to the planned surgery for removing the prostate It is hoped that this trial will provide information on the optimal dose of MET plus VPA to administer to prostate cancer patients, which may be an effective treatment which is safe and tolerated by patients.

Post-operative pulmonary complications (PPC) are the most common complication following upper abdominal surgery (UAS).. Recent unpublished data from a large international multi-centre randomised control trial (LIPPSMAck POP; Boden 2015) found that patients who develop a PPC following major upper abdominal surgery had a mean LOS five days longer, cost an additional $AUD18,000 per episode, and have a significantly higher 30-day mortality rate (9% v 1%, p=0.01) compared to those without a PPC. This is in keeping with meta-analysis data of mortality attributable to postoperative acute lung injury (Neto 2014). Previously reported PPC incidence rates following abdominal surgery vary greatly (anywhere between 10 and 80%). This variance is mostly due to two factors; firstly, the patient group being investigated (for example low risk hernia repair compared to higher risk oesophagectomy) and secondly, the diagnostic criteria used to detect a PPC. There is also limited current prospective evidence to estimate the PPC rate in surgical groups other than elective major abdominal surgery. This includes emergency surgery, organ transplant, neurosurgery, cardiac, thoracic, ENT surgery, and minimally invasive abdominal surgery. The combination of non-standardised measurement of PPC incidence and lack of contemporary incidence rates outside of abdominal surgery means that it is not possible to accurately estimate which surgical groups are at highest risk of developing a PPC. It also means that resource allocation of prophylactic interventions like physiotherapy is not based upon robust evidence. Hospitals could be over-treating some surgical groups and most concerning, under-treating others. This is unknown, as the current physiotherapy practice for these surgical groups has also not been measured robustly (audit rather than survey) and what impact this may have on PPC rate, mortality, and LOS. Considering the high morbidity, mortality, and cost impact of a PPC there is an urgent need to measure PPC prevalence using consistent diagnostic criteria, over a range of hospital types and surgical groups, and a need to investigate the current use of physiotherapy interventions to reduce PPC incidence and improve recovery following major non-orthopaedic surgery.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tremelimumab treatment in combination with durvalumab followed by single durvalumab treatment in patients with advanced cancers and tumours. Who is it for? All participants in this study must have completed screening as part of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437), and been identified as having having no actionable molecular targets. Study details All participants in this study will take the intravenous drugs tremelimumab plus durvalumab once every 28 day cycle. From week 16 of treatment durvalumab will be administered alone once every 28 days. Treatment will continue until progression, unacceptable toxicity or withdrawal. Retreatment will be discussed with you by your doctor. All participants will undergo assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response, safety and tolerability of treatment, health related quality of life during treatment, and overall survival. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that palbociclib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The Compassion Focused Therapy (CFT) study aims to develop and evaluate a first-ever mindfulness-based compassion intervention to treat depression in lesbian, gay, and bisexual (LGB) Australians, a high-risk, underserved population. Participants will be 50 LGB adults aged 18-25 with mild-to-moderate depression, who will be randomly assigned to either the eight week compassion-focussed intervention which will be delivered via Skype, or to an active control condition whereby participants will work through a self-help book for depression which has been evaluated in prior research as effective, over an eight week period. Therapists will be Provisionally Registered Psychologists, with training and supervision from Clinical Psychologist, Dr. Chris Pepping. Participants will complete pre-intervention, post-intervention, and 3-month follow-up assessments to evaluate intervention effectiveness. Study outcomes include depression and anxiety symptoms, suicidal behaviours, internalised homophobia, self-compassion, and shame-proneness.

Mounting evidence highlights the importance of screening for obstructive sleep apnoea in patients with atrial fibrillation. Treating obstructive sleep apnoea in these patients may improve outcomes, such as improving the risk of recurrence of atrial fibrillation after Pulmonary Vein Isolation procedures. We will examine the validity of a portable sleep study device (ApneaLink) for the diagnosis of Obstructive Sleep Apnoea in patients with Atrial Fibrillation.

Treatment options for severe asthma remain limited and oral corticosteroids (OCS e.g. prednisone) are often needed to control severe asthma when it worsens or flares up. One disadvantage of OCS is their side-effects and therefore any measure that would reduce or eliminate the dose of OCS required would be advantageous. This study is designed to test if asthma management is better if a simple blood test is incorporated into clinical care to provide information to the clinician that prevents unnecessary use of OCS in severe asthma management. One type of airway inflammation (called eosinophilia) has been found to be common in some people who have severe asthma. Clinical studies have shown that these people have a high risk of exacerbation or asthma flare ups even in the presence of high doses of inhaled corticosteroids (ICS). Determining if a person with severe asthma has a high level of eosinophils in their lungs requires the induction of sputum that comes from deep in the airways. This is a lengthy procedure, requires specialist equipment and is not easily carried out in the clinic. Recent research has shown that measuring the number of eosinophils in a blood sample is a substitute for an induced sputum sample and is much simpler. In this study we seek to determine if severe eosinophilic asthma can be managed more effectively using blood eosinophil counts.

Elevated blood glucose levels developing for the first time in pregnancy (Gestational Diabetes Mellitus; GDM) is a common complication of pregnancy in our local community. In most cases, the diabetes will resolve after the baby is delivered, although it may return years later (type 2 diabetes). However, we have found that in certain women there is a high chance that the blood glucose levels will remain elevated after pregnancy, with adverse effects on the health of the woman in the long-term, and potentially also on the baby during a subsequent pregnancy. There is strong evidence that diabetes in individuals at high risk can be prevented through lifestyle intervention with diet and exercise. Our study will determine whether in high-risk women with GDM, we can prevent elevated blood glucose levels in the first year after their pregnancy by offering them one-on-one advice about a healthy lifestyle by a health coach (a nurse or other allied health professional) during their pregnancy and for the first year after giving birth. The women who participate in this trial will mostly see their health coach during routine antenatal visits so that inconvenience to the patient will be minimized. We will compare high risk women who had a health coach to those who did not i.e. outcomes during pregnancy and in the first year after giving birth. If our trial is successful, we believe our program could easily be incorporated into routine clinical care in our antenatal clinics..

To our knowledge there have been no studies examining problem-solving therapy (PST) specifically in people with diabetic retinopathy (DR), yet from our first study we established that this group face the greatest risk of depression and reduced quality of life (QoL) as well as showing poorer diabetic control compared to those without DR. PST has been shown to be an essential skill for effective diabetes management and effective in reducing diabetes related emotional distress and depressive symptoms. However there is a need for more research that integrates problem-focused and emotion focused interventions in diabetes management. Addressing diabetes specific distress, stress management and healthy coping, some of the key underlying subjective QoL experiences, may improve glycaemic outcomes. This study also would provide novel research specific to those that have ophthalmological diabetic complications. We propose to adopt a PST designed for primary care that teaches problem solving skills and assists individuals with DR to find practical solutions to vision-related and diabetes-related problems. In doing so we anticipate that participants will adopt a more positive problem solving orientation that will hopefully empower them to subsequently improve their psychological well-being. It has been previously established that developing a problem solving pattern and working through individual solutions assists with perpetuating more positive behavioural habit loops. As a result, this intervention may also have knock on effects in improving diabetes self-management behaviours as this has been shown in previous studies. Hypothesis Individuals with diabetic retinopathy who receive tailored problem solving training will show improved quality of life and psychological well-being compared to individuals undergoing usual care. Aim 1: To develop a tailored, problem solving based program that targets individual quality of life difficulties. Aim 2: To assess, using a randomised control trial, the effectiveness of this program in improving participants’ quality of life and psychological well-being (reducing diabetes related distress and depressive symptoms). Investigation will also be undertaken to assess whether enhancing problem solving skills have a direct influence on a participant’s ability to self-manage their diabetes including improving overall glycaemic control and adopting recommended lifestyle practices.

In Australia, hypoxic peripartum death (stillbirth or neonatal death of mature infants after the onset of labour in an otherwise healthy pregnancy) is one of the top three causes of mortality in singleton term pregnancies. In addition, there is significant neonatal morbidity (neonatal encephalopathy, respiratory distress, acidosis, admission to the neonatal intensive care unit) associated with intrapartum hypoxia. Furthermore, these babies frequently require rapid delivery by emergency caesarean section which carries considerably more maternal and neonatal risk than less urgent procedures. We have found that combining the fetal cerebro-umbilical ratio (CUR) (measured by ultrasound) as a functional measure of fetal wellbeing, and maternal serum placental growth factor (PlGF) as a biomarker of placental function, at >37 weeks of gestation defines women at greatest risk of fetal compromise in labour. We therefore propose a pilot randomised controlled trial (RCT) to test whether introduction of this test can reduce intrapartum fetal compromise at term. Our primary outcome measure of fetal compromise will be a composite of emergency caesarean section for fetal compromise or severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol/L or Base Excess >12 or Apgar <5 at 5 minutes) or fetal/neonatal death. A pre-labour test which identifies babies most at risk of compromise in labour will address a critically unmet need in obstetrics as there is currently no good antenatal test for the prediction or risk assessment for intrapartum fetal compromise at term.

Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity. The study hypothesises that when compared to children attending control services, where continuous indoor/outdoor play is scheduled, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.