ANZCTR search results

To provide a structured and specialized Survivorship Clinic for 5-year plus survivors of Hodgkin's Lymphoma who were originally treated in The Queen Elizabeth Hospital and The Royal Adelaide Hospital in South Australia. The purpose is to reduce the severity of 'late effects' resulting from the curative treatment these survivors received by early detection of problems.

In this study, we aim to improve the evidence-based management of moderate to severe COPD patients with concurrent obstructive sleep apnea. Our primary hypothesis: Treatment of moderate to severe OSA with CPAP in patients with GOLD Stage III COPD leads to reduced systemic inflammation. Our secondary hypotheses: 1. This reduction in inflammation is associated with an improvement in respiratory outcomes (Quality of life, symptoms) in COPD. 2. CPAP therapy is well-tolerated in COPD patients with significant OSA.

This study will assess how a sample group of approximately 3000 angina patients are being managed in Australia.

Attention deficit hyperactivity disorder (ADHD) affects up to 7.5% of Australian children. Between 50 and 70% of parents also report that their ADHD child has a sleep problem. Such sleep problems are associated with poorer child behaviour, concentration, and school attendance as well as poorer parent mental health and work attendance. We want to know if managing sleep problems in ADHD children can improve these outcomes. We plan to conduct a pilot study to determine the acceptability and feasibility of two different models of managing sleep problems in children with ADHD. Model 1 will consist of a single consultation about normal sleep and sleep cycles, sleep hygiene advice, and providing parents with generic written information around common child sleep problems. Model 2 will consist of 2 to 3 consultations including normal sleep and sleep cycles, sleep hygiene advice and behavioural strategies tailored to the child’s specific sleep problem(s). Results will inform a planned, randomised controlled trial (RCT) to determine the effectiveness of the most acceptable and feasible approach.

Women identified as carrying a gene fault that increases their risk of developing breast or ovarian cancer (BRCA1/2) live with the fear that they are likely to develop these cancers. They also experience feelings of guilt about passing the gene onto their children, anxiety over informing family members, and grief. Research has found that BRCA1/2 gene fault carriers experience similar levels of distress to breast cancer patients within a year of their diagnosis and that distress among carriers does not decrease with time. Currently in Australia formal support services for cancer gene mutation carriers outside the Familial Cancer Centres (FCCs) are lacking. The NHMRC’s, “Familial aspects of cancer: a guide to clinical practice” calls for research to identify effective intervention strategies to reduce morbidity associated with genetic testing. BRCA1/2 gene fault carriers have an unmet need for support, and for help in reducing their sense of isolation, guilt, fear of the future and concerns about communicating test results with family members. We propose to address these unmet needs with a peer support program for women identified as carrying the BRCA1/2 gene fault and examine whether this intervention can reduce psychological distress. The project’s aims are: 1. To determine the effectiveness of a telephone based peer support program for women with a BRCA1/2 gene fault on psychological distress using a randomised controlled trial. 2. To determine how feelings of isolation, unmet needs for information and confidence in risk management decisions relate to psychological distress and how these factors are influenced by the intervention. 3. To explore the impact of providing support among support providers. The design will be a prospective randomised controlled trial with female BRCA1/2 gene fault carriers. Participants will be recruited through Familial Cancer Centres in Victoria and NSW. Participants will complete a baseline survey that will allow the identification of those with unmet support needs. This group will then be randomised to receive either the intervention (peer support program) or usual care. Women in the intervention group will be assigned a peer support provider and will have telephone contact with the peer at least 6 times over a 4-month period. Women who report no unmet needs for support at baseline will remain in the study and provide useful information about issues affecting people with this genetic mutation. All participants will complete follow-up questionnaires at 4-months and 6-months post study entry. Women who indicate on the baseline survey that they have no unmet needs for information and support will remain in the study and follow the same procedure as the usual care group.

In this study, we will examine the effects of n-3 fatty acids on the electrophysiology of the heart in a bid to determine possible mechanisms for anti-arrhythmic effects of n-3 fatty acids

Postoperative nausea and vomiting remains a significant problem in modern anaesthetic practice. One of the most effective anti-sickness agents (antiemetics) available is a steroid drug: dexamethasone. Steroids are also used to suppress the immune system and inflammation in the body. This immune supression can also predispose to the development of infection. We wish to investigate whether the small doses of dexamethasone used in anaesthesia affects the nature and function of important immune system cells known as lymphocytes.

Treatment strategies for motor neuron disease are limited. The investigators hope to show that a sodium channel blocking agent slows progression in this devastating disease.

Chronic kidney disease (CKD) is associated with a twenty-fold increase in the death from heart and blood vessel disease (cardiovascular disease -CVD). Patients with CKD have multiple risk factors for CVD and include high cholesterol, hypertension, anaemia, abnormalities of blood chemistry, diabetes, obesity and sedentary lifestyle. Intervention may decrease the progression of CVD and treatment guidelines have been developed. However, patients with CKD have complex health issues and audit data suggests that within the current model of care, many do not reach treatment targets. Co-ordinated care clinics utilizing a nurse led, case management approach and a multidisciplinary team have been demonstrated to optimize CKD care and decrease progression of kidney dysfunction. However, the impact on progression of CVD has not been studied. The hypothesis of this proposal is therefore: Nurse led co-ordinated care approach to cardiovascular risk factor and lifestyle modification will reduce the progression of CVD when compared with standard care, in patients with CKD. Additional hypotheses are: The nurse led clinic improves service quality and patient satisfaction AND This model of care will be cost effective.

This Phase I study is a single-center, open-label, between-patient, single ascending dose study intended to determine the safety, tolerability and maximum tolerated dose (MTD) of MDX-1097.