ANZCTR search results

This study in pregnant women with asthma investigates the maternal, infant and childhood outcomes following asthma treatment adjustment using FENO, compared to standardised usual care treatment adjustment.

The central aim of the study is to determine if Evoked Compound Action Potentials (ECAPs) can be recorded during Deep Brain Stimulation (DBS). During the DBS lead implant procedure, specialised stimulating and recording equipment will be connected to the lead. Routine stimulation will be applied to the implanted lead electrodes and neural responses (ECAPs) will be recorded from the adjacent electrodes. Measurement of the ECAP responses may provide information to improve the implant procedure and stimulation programming, and provide information on the mechanisms of DBS.

Traditionally patients presenting to hospital with a heart attack are hospitalized for at least 5-7 days to monitor for complications such as increasing shortness of breath, recurrence of chest pain and fast irregular heart rate and also to increase their medications and receive a basic understanding of future management of their chest pain. A randomized trial in Canada showed that early discharge from hospital for low risk heart attack patients was feasible and safe when combined with close nursing follow up at home. We propose to randomize low risk heart attack patients to early discharge (<72 hours) with hospital-in-the-home (HITH) nurses and doctors compared with conventional 4-5 day stay in hospital. The aims of this study are 1. To prove that an early discharge strategy is safe and acceptable to patients with no increase in deaths, adverse events or unexpected readmission to hospital 2. To evaluate the patients’ experience and quality of life in both groups using questionnaires. 3. To examine the cost effectiveness of early discharge from hospital to HITH versus conventional 4-5 day hospital stay. Patients presenting to Box Hill Hospital with a heart attack and have undergone coronary angiogram and are treated with either medical therapy such as medications or angioplasty and stent will be screened using validated tools to assess for low risk. They will then be randomized to either early discharge with HITH (intervention group) or conventional 4-5 day hospital stay (control group). About 300 hundred patients will be recruited for the trial. The intervention group will be discharged from hospital before 72 hours and followed up daily by HITH nurse for at least 3 days. In the first week they will be reviewed by the HITH consultant doctor at the Maroondah clinic. The control group will be discharged home according to standard care at day 4 or 5. The main outcomes to be measured are: all-cause death, readmission or re-presentation to hospital due to chest pain, recurrent heart attacks or heart failure, as well as procedural and non-cardiac complications related to the index event at 30 days. The information will be gathered via phone interviews and medical records. Health-related quality of life and patients’ experiences of in-patient care will be evaluated using validated questionnaires. A telephone call to all patients at 6 weeks and 3 months will remind them about completing the questionnaires, and include a brief interview regarding re-presentation to the hospital, readmission, compliance with medications, attendance at cardiac rehabilitation and smoking cessation. All information collected will remain confidential and be de-identified for research purposes. The cost-effectiveness (reduced length of stay) of the early discharge strategy will also be analysed.

This research has the overall aim of identifying strategies to facilitate the detection and early treatment of eating disorders and related mental health problems in adolescence. It is being implemented in two phases. Phase 1 aims to identify barriers to the detection and treatment of eating disorders and related mental health difficulties in adolescence, with reference to data from adolescents, parents and teachers. This phase involves online questionnaire completion. Phase 2 aims to evaluate the effectiveness of a school-based intervention designed to facilitate the early detection and treatment of eating disorders and related mental health difficulties. This second phase takes the form of a randomised controlled trial comparing a 5 month school-based intervention to a waitlist control group. The waitlits control group will receive the intervention after a 5 month waiting period.

The main aim of this Phase I study is to assess the safety and immune effects of using autologous peripheral blood T cells in GD2 positive patients with metastatic melanoma or refractory solid tumours. Patients who are BRAF positive will be given being treated with dabrafenib and trametinib. These inhibitors are proving to be effective in the up to 60% of malignant melanomas that are found to have a BRAF mutation. However, drug resistance is emerging and many patients relapse affirming the need for further treatment development. Who is this study for and who is it open to? This study is for patients with metastatic melanoma who are BRAF V600E/K/R/D positive or negative, or other GD2-positive malignancies. Those who are BRAF positive must be eligible to receive dabafenib and trametinib Patients who consent to the study will be asked permission to test their archived tissue for GD2 expression. If this test returns a positive result, the patient may then continue with the trial. What will the patients receive? BRAF positive patients will receive dabrafenib 150mg bd and trametinib 2mg od during the 3 week period in which the T-cell product is being prepared. Once produced, the T-cell product will be given as a single intravenous infusion at a dose relevant to the cohort that the patient has been assigned to. The patient will then be monitored as per the follow up schedule specified by the study protocol. For patients who are BRAF negative and not receiving dabrafenib or trametinib, they may potentially receive two further doses of the T-cell product.

Stroke is a major cause of disability in Australia, it affects over 50,000 people annually. Stroke survivors are at increased risk of health problems, particularly a second stroke. Many of the risk factors for a second stroke, such as smoking, poor diet and lack of physical activity could be reduced with increased awareness, education and support. We plan to conduct a longitudinal study to investigate physical activity levels and cardiovascular risk factors in the 2 years following discharge from therapy after first ever stroke. Participants will be reviewed at baseline and at 6, 12 and 24 months following this. They will answer questions around their medical history and health status, complete questionnaires, have physical measurements taken (for example, blood pressure and walking tests) and be given activity monitors to wear for 5 days. At the baseline, 12 and 24 month assessments they will also be asked to have a blood sample taken within the following week. We hope to identify relationships between physical activity, cardiovascular risk, physical function and fatigue levels. This study has not previously been undertaken and will provide essential information for clinicians, allowing them to target their interventions to specific risk factors and reduce risk of further stroke. If a link between physical activity and cardiovascular risk is demonstrated, a strong rationale will be provided for therapies that improve physical activity participation.

Cancer of the liver is becoming more common in Australia. A PET scan is used to diagnose many forms of cancer, but it is not commonly used in cancer of the liver. This study aims to determine whether a PET scan is an accurate way of diagnosing cancers of the liver by performing this scan on someone who we know already has a cancer of the liver. We will also see if a PET scan can provide other pieces of information about the liver cancer that we do not already have. Finally, we will investigate whether a second PET scan done after a certain type of treatment for the liver cancer will tell us whether that cancer has responded to the treatment. If the results from the research project are encouraging, we will begin larger trials. Hopefully in the future, PET scans in liver cancer will become an important part of management and will improve the outcomes for patients with this disease. Who is it for? You may be eligible to join this study if you are aged 18 to 90 years old, with newly diagnosed Hepatocellular Carcinoma (HCC), Barcelona-Clinic Liver Cancer Stage O, A or B, and considered for transarterial chemoembolisation, radiofrequency ablation or resection Trial details In this study, you will receive an 18F Fluorodeoxygluose (FDG) Positron Emission Tomography (PET) scan, as well as an 18F Fluorocholine (FCH) Positron Emission Tomography (PET). One group of participants will receive both scans performed at the time of diagnosis, and a second group will receive both scans performed at the time of diagnosis followed by a second set of scans performed after standard care transarterial chemoembolisation

While effective treatments are available for mild levels of alcohol and drug dependence the repeated and persistent, long lasting nature of the disorder often involves people attending groups to prevent relapse. One type of approach considers whether by learning to accept and just notice the cravings for substances, instead of trying to suppress or fight off the cravings, makes it easier for people to use different or opposing behaviours to prevent relapse. This study examines the effect of an eight session programme designed to disrupt thoughts, feelings, and bodily functions implicated in stress-initiated relapse to alcohol consumption.

In 2008 in Western Australia (WA) there were 30,234 babies born. Pregnancy is a period when the pelvic floor muscles (PFM) are stretched and weakened which may lead to PFM dysfunction causing urinary incontinence. During pregnancy PFM exercises are the recommended treatment to strengthen the PFM and reduce the risk of developing urinary incontinence. Accordingly, pregnant women are encouraged to attend antenatal education which typically includes information on the function and facilitation of the PFM. This study will examine the effect of providing web-based education on pelvic PFM function and PFM exercises for pregnant women in WA. The pregnant women will be evaluated on the knowledge, awareness, intention, self-efficacy and adherence to the PFM exercises. If pregnant women can successfully use web-based PFM education during pregnancy then people with PFM dysfunction and incontinence can be guided to an appropriate evidence-based website. This may improve quality of life for women. Hypotheses: H0: There will be no difference in awareness and knowledge gained on the function of PFM in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care in WA H1: There will be an increase in awareness and knowledge gained on the function of PFM in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care in WA H0: There will be no difference in confidence and motivation to engage in PFM exercises in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care H1: There will be an increase in confidence and motivation to engage in PFM exercises in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care H0: There will be no difference in adherence with PFM exercises by pregnant women who undertake a web-based, PFM exercises intervention programme and pregnant women who only receive usual care in rural WA H1: There will be an increase in adherence with PFM exercises by pregnant women who undertake a web-based, PFM exercises intervention programme and pregnant women who only receive usual care in rural WA

This trial will investigate the effect of two different diets for patients with obstructive sleep apnea who are trying to lose weight. This study will look at changes in sympathetic activity (which controls your fight or flight response) as well as assessing your cardiometabolic health and disease risk factors. All participants who choose to enrol in the study will follow a very low energy diet for three months followed by nine months of free health coaching and weight loss therapy delivered by an accredited exercise physiologist and nutritionist. Those who proceed with the trial will be randomised to a low glycemic index/high protein diet or a standard low calorie diet based on the Australian guide to healthy eating after following a very low energy diet for three months.