ANZCTR search results

To date there has been no documented research on patients cared for in a depot clinic of a private setting (i.e. outside the public mental health sysytem) in Australia. This pilot study aims to evaluate the feasibility of conducting a RCT on the Quality of Life (QoL) amongst schizophrenia patients receiving Abilify Maintena and other anti-psychotics, as managed in a Private Depot Clinic. This study aims to evaluate the benefits of Abilify Maintena in the private specialist setting, independent of the public health service. This will ultimately validate the hypothesis that it can improve Quality of Life of patients, and achieve significant cost savings for the public services, thereby validating increased use of Abilify Maintena in the community.

Prospective feasibility trial with historic controls to explore the implementation and effectiveness of NHF in hospitalised COPD patients to facilitate discharge and 30 days of ongoing usage following discharge in the HITH setting to reduce 30 and 60 day readmission rate.

Lung ultrasound is widely used within adult critical care with international evidence based recommendations for its utility in the assessment of patients with respiratory compromise. Further research is required to validate its clinical application within neonatal intensive care. Lung ultrasound is an attractive bedside clinical tool that is simple, non-invasive, quick to perform and well tolerated by even the most preterm of babies, using ultrasound equipment already in routine use. Bronchopulmonary dysplasia (BPD) is a process that starts soon after birth in preterm infants, with scarring and inflammatory changes within the lungs that may be slow to appear on conventional chest x-ray. Lung ultrasound performed in the first week of life may be more sensitive in recognising these changes earlier with the potential to assist in prediction of BPD and better direct therapeutic interventions (Raimondi et al 2014). A prospective observational cohort study will be undertaken performing lung ultrasound in 100 preterm infants born <28 weeks’ gestation admitted to KEMH neonatal intensive care unit receiving respiratory support. The study aims to determine if lung ultrasound can predict the development of BPD and respiratory outcomes.

The hypothesis for this study is that a proportion of patients with schizophrenia may not respond to medication because the medication does not cross the blood brain barrier well enough. The blood brain barrier keeps substances out of the brain and is made up of several parts. One part is a group of proteins called “efflux pumps” or “transporters” which act to pump foreign substances out of the brain, back into the blood stream. We believe that some patients who do not respond to medications for schizophrenia have such fast and efficient efflux pumps that the medications cannot get into the brain effectively. The speed and efficiency of these efflux pumps are determined by the genes for these pumps. The particular pumps that are of interest in this study are called P-glycoprotein (PgP) and Breast Cancer Resistance Protein (BCRP). This study will test the addition of a natural product, quercetin, to the patient’s regular medicine. Quercetin is known to slow down these pumps. The aim of the study is: To show that quercetin has beneficial effects when added to the usual medications used in in schizophrenia Objectives: -To figure out the how quercetin has a beneficial effect. -To identify the symptoms of schizophrenia which responded best to quercetin use -To see if there are groups of genes that indicate fast efflux pumps in patients with schizophrenia who do not improve with the usual medications.

This is a double blind, placebo controlled, randomized crossover, pilot study assessing the therapeutic effects of RM191A in participants suffering from neuropathic pain. Each participant receives both treatment (separated by three days of washout period) and randomisation is used to determine the order in which the participant received each treatment. The 10% RM191A spray will be applied four times a day at 8AM, 12PM, 4PM and 8PM with up to eight sprays per area. Changes in intensity of neuropathic pain will be assessed by NPRS.

This project aims to discover new understanding regarding whether an increase in dietary fibre will improve the profile of gut flora (i.e., the micro-organisms that aid digestion), bowel habit and sense of wellbeing. There is strong evidence suggesting dietary fibre is essential for good health. This project aims to understand better the fibre-health relationship.

A behavioural intervention targeting reducing sedentary behaviour and increasing physical activity will be rolled out across Victorian primary schools. This is a scale up of a previously registered successful trial: Transform-Us! an intervention promoting children’s health (ACTRN12609000715279). To determine real world effectiveness and maintenance (at the individual level), a quasi-experimental pre post non-equivalent group design with follow up will be used. A sub-sample of 20 schools from different socioeconomic urban and rural areas of Victoria will be selected and 20 schools of similar size and area-level disadvantage in NSW not implementing similar health or physical activity-related programs will be recruited as matched controls. Our findings will determine the effectiveness of implementing an efficacious program at scale so that it can be rolled out nationally and become part of routine best practice.

AIMS: The aim of the vanguard Co-POC trial is to assess the safety and feasibility of the trial protocol and to obtain important preliminary data on the effect that colchicine 0.5mg once daily for up to 3 days pre-operatively and 30 days post-operatively has on the incidence and extent of post-operative myocardial injury after coronary artery bypass graft (CABG) surgery. DESIGN AND METHODS: The Co-POC vanguard trial is a RCT of colchicine v placebo nested in the Australian VISION Cardiac Surgery cohort. Eligible patients recruited into the VISION Cardiac Surgery study who are undergoing isolated coronary artery bypass graft surgery will be offered the opportunity to participate in the vanguard Co-POC trial. We will recruit 204 patients into this pilot trial (1:1 recruitment). Patients will be randomised to colchicine 0.5mg once daily or matching placebo. Treatment will be commenced 3 days prior to surgery (but can be commenced up to 24 hours pre-operatively if necessary) and will be continued for 1 month after surgery. Medications will be provided by Aspen Pharmacare Australia according to the US Food and Drug Administration current good manufacturing practice regulations. All concomitant medications will be provided at the discretion of treating clinicians and in keeping with clinical guidelines. Patients will have blood samples collected for hs-cTnI <4 hours pre-operatively and post-operatively at 6-12 hours and on days 1 to 3 (in keeping with the VISION Cardiac Surgery protocol). Analysis plan: All analyses will be by intention to treat. Groups will be compared using the Mann-Whitney U and chi-square tests as appropriate. Kaplan Meier curves will be used to demonstrate event free survival and groups compared using the log-rank test.

The primary purpose of this trial is to assess whether the addition of datatumumab to a velcade, cyclophosphamide and dexamethasone treatment regime 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 be assigned to either a velcade, cyclophosphamide and dexamethasone (VCD) or velcade, cyclophosphamide, dexamethasone and daratumumab (VCDD) treatment arm. Both arms will receive 9 35 day cycles of treatment with the VCDD arm continuing on daratumumab maintenance monthly until disease progression, unacceptable toxicity, or withdrawal of consent. Paricipants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of daratumumab in combination with VCD for the treatment of multiple myeloma patients early in the course of their disease.

The aim of this study is to assess whether in patients who have surgery of the first ray, a flat rigid soled shoe, when compared to a reverse camber offloading shoe is associated with the level of post operative pain, satisfaction and bony healing. (union and maintenance of correction.)