ANZCTR search results

This is a single-site, phase 1, randomized bioavailability study to assess a patch delivery system with and without crystals to be used in Alzheimer's type dementia. The study will enroll 48 healthy volunteers with approximately equal distribution of male and female volunteers. The total study duration is 133 days and includes a 42-day screening window and 2 treatment periods of 36 days each. There will be a washout period between Period 1 and Period 2. In the first treatment period, each participant will receive a single application of once weekly Corplex Donepezil TDS (with or without crystals), applied to either the left or right side of the back according to his or her randomization. After the washout period, the participant will have the other Corplex Donepezil TDS type applied on the opposite side of the back during Treatment Period 2.

Obesity is a major public health problem in both the developed and the developing world. A therapeutic approach that includes both bariatric surgery and medical management is more effective than medical management alone. However, bariatric patients are more prone to post operative complications that include post operative nausea and vomiting (PONV) and obstructive sleep apnea (OSA) both of which are caused by opiate administration. Despite the potential for both total intravenous anaesthesia (TIVA) and lignocaine infusions to reduce both of these morbidities there are few published reports in the literature on their use in bariatric patients. We propose to perform a pilot study in which patients are randomised to opiate free TIVA (Dexmedetomidine, Ketamine, Lignocaine and Propofol) or standard volatile-opiate based general anaesthesia and post operative care. We postulate that opiate free TIVA will provide improved analgesia, reduce PONV, cause less respiratory adverse events and lead to better post surgical rehabilitation. Ultimately we seek to establish a program of research which assesses the best method of Anaesthesia in Bariatric Patients. Pilot data will be used in grant applications to the Australian and New Zealand College of Anaesthetists (ANZCA) and the National Health and Medical Research Council (NHMRC).

The project is a randomised controlled trial to evaluate the clinical effects of a deep learning system, (IVY). IVY studies the images of each embryo during culture. Previous work shows that it is a good predictor of which embryo has highest chance of implanting. This project aims to investigate what effects, if any, this has on the success rate from IVF.

Given the wide spectrum of metabolic consequences post SCI in conjunction with age-related co- morbidities with increased life expectancy in recent years, it is imperative to implement timely and targeted risk modification strategies. There is evidence that dietary and lifestyle modifications minimise several CVD risk factors in individuals with SCI and good evidence in the role of physical activity in improving cardio-metabolic outcomes in the population. Therefore, this study aims to examine the association between diet quality on lipid profile and body weight of spinal cord injury patients. Hypothesis: Compliance with a Mediterranean style dietary pattern is associated with lower CVD risk in adults with SCI.

The Australian Placental Transfusion Study (APTS) and other studies provide strong evidence that deferring umbilical cord clamping at birth for up to a minute is a simple, safe procedure that reduces the proportion of preterm infants who need a blood transfusion by 10%. The mechanism is not fully understood – but one potential mechanism is an increased volume of transfusion of blood from the placenta to the baby after birth. Alternatively, deferred cord clamping may reduce severity of illness in the first weeks after birth. This could lead to fewer blood tests, greater tolerance of anaemia, and better opportunities for babies to make their own red cells. The Transfusions In The APTS Newborns Study (TITANS) is designed is to obtain and analyse more data about the babies in APTS to investigate the mechanism behind the reduced need for red cell transfusions, and to explore whether there are other changes in clinical care that could reduce the need for transfusion.

The overall goal of this study is to see whether we can improve the knowledge patients have about their hospital stay, their satisfaction with their hospitalisation, and their ability to complete the visits and testing that are recommended for when the patient goes home. The reason it is important to conduct our study is that patients may have more complications if they don’t fully understand hospital events and future recommendations at the time of discharge from hospital. An earlier small study showed that a patient’s understanding and satisfaction of their hospital admission improves when they are provided with a personalised one-page Patient Directed Discharge Letter (abbreviated as PADDLE) discussed with them by the doctor at the bedside. The purpose of this study is to see whether a newer and more uniform version of the PADDLE letter will be beneficial for patients compared to those who receive the standard hospital discharge letter. The individualised PADDLE will be explained by the treating doctor at the time of hospital discharge and the letter will include the reason for the hospital admission, the tests and treatments received as well as the recommendations for future management.

Patients can develop strictures (narrowings) of the oesophagus (gullet) following therapy for head and neck cancers. These strictures can impair swallowing. They are treated by dilatation (stretching open) during endoscopy, but in some patients can recur frequently and lead to need for frequent and repeated procedures. We are examining the effect of patients self-dilating their strictures at home on the recurrence rate of such strictures. Our study hypothesis is that patients treated with self-dilatation have reduced clinically significant re-stricturing necessitating endoscopic dilatation, compared to those treated with endoscopic dilatation on-demand.

TFF Pharmaceuticals Australia Pty Limited is developing the study drug TFF tacrolimus as a potential new treatment to lower the risk of rejection for lung transplantations. Tacrolimus is an immunosuppressive drug used mainly after an organ transplant to lower the risk of organ rejection. Immunosuppression has been a key factor for the success of organ transplants. Tacrolimus as inhalation therapy (TFF tacrolimus) is being investigated specifically to lower the risk of rejection for lung transplantations. Tacrolimus is available as oral capsules and as intravenous injections (into the vein). The purpose of this study is to determine safe and tolerable inhaled doses that will be investigated further in future human studies.

Adequate physical activity and a healthy diet are important in reducing the risk of having a stroke. Stroke recurrence is common and medical management alone is not sufficient to manage the risk of stroke recurrence. This study aims to test the safety and feasibility of a diet and/or exercise program for stroke survivors aimed at reducing their risk of having another stroke. The programs run for 6 months duration. Both the diet and the exercise programs will be delivered via telehealth using teleconferencing technology, and this should make the program accessible to people who have had a stroke or transient ischaemic attack (TIA) all over Australia. We will be assessing how feasible the programs are by measuring the rate we can recruit people to the study, participants’ adherence to the programs and the completion rate by participants. We will also be asking participants about their experience to identify if improvements can be made. We will also be measuring each participants’ risk of having another stroke by measuring the amount of physical activity they do, their diet, and their blood pressure. If successful this study will be used to support further research in the area.

Historically, the management of knee OA has been variable, and often limited to pharmaceutical management and total joint replacement. Recently, evidence-based recommendations for the management of knee OA have been developed by scientific societies and health organisations. Best-practice guidelines for the treatment of knee OA focus on conservative (non-operative) multidisciplinary management that encompasses education, exercise, lifestyle modification and weight-loss where relevant, while promoting self-management. This body of evidence demonstrates that multidisciplinary conservative management of knee OA is efficacious. This observational study aims to discover how knee osteoarthritis patients are currently been managed by community physiotherapists, and if this aligns with recommended guidelines.