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This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 3. Part 3 is an open label study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the antimalarial activity of a single-dose oral administration of ZY-19489 to healthy, malaria naïve, male and female subjects aged between 18-55 years old. Part 3 will be conducted in up to 3 cohorts of 8 subjects each, enrolled sequentially. Each subject will be intravenously inoculated with approximately 2,800 viable P. falciparum 3D7 parasite infected human red blood cells (RBCs) on Day 0. Adverse events and concomitant medications will be followed throughout the study. The study will be overseen by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.

What is this research about ? Lumbar disc herniation (LDH) also known as disc prolapse or bulge in the lower back that may cause severe pains down the leg. This research project aims to improve our understanding on the condition and choosing between surgery versus spinal injections. What is the hypothesis ? Is there any benefit when we use non surgical injections to treat sciatica from a disc herniation ? What does it mean to be part of this trial ? You will be randomly allocated a treatment option that either involves a spinal injection procedure under x-ray scanning control or spinal surgery. You will not able to choose a treatment option. Aside from this allocation, the medical care you receive is the same as that you would have received as part of standard care. At regular intervals you are required to complete forms that provide information on your symptoms and quality of life.

The present study is designed to explore a link between cognitive decline post-surgery as a cause of vitamin C decline following the surgery. The aim of the study is to to determine whether surgery has an effect on vitamin C levels and cognition with the use of a neuropsychological test battery. It is hypothesised that elective hip surgery will result in significantly depleted plasma vitamin C concentrations which will contribute to compromised cognitive function on the cognitive assessments. Cognitive tests will involve both paper and pen and computer tests, while blood tests will be undertaken to measure plasma vitamin C and serum vitamin B12 levels and levels of inflammation. Testing will be conducted roughly 1-2 weeks prior to the scheduled surgery and subsequent testing sessions will be performed within 1 week, 4-6 weeks, 3 months and 6 months after surgery.

Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. While efficacious, CPAP is poorly tolerated. Nightly use may be inadequately brief and 50% of patients do not continue CPAP therapy beyond 3 months. Although alternative treatments such as mouth guard devices and surgery exist for CPAP-intolerant patients, individual responses to these treatments are difficult to predict and as such many clinicians and patients are stuck in a trial and error paradigm for these treatments. Traditionally OSA has been thought to be a disorder of aberrant upper airway anatomy. Recently, it has become clear though that OSA can be caused by both anatomical and non-anatomical pathophysiology. Much of this paradigm change can be attributed to recent developments to the ability to measure this physiology – work that has been carried out by our research team at Monash Health and Monash University. We have developed readily applicable clinical tool that can predict the patient’s response to upper airway surgery and mandibular advancement splint treatments. The tools we have developed are now ready for direct translation to the clinical setting. In this exciting research project we will run an observation study to assess the impact of making physiological information available to clinicians at the time of OSA diagnosis on the treatment referral patterns and treatment outcomes of OSA patients. We hope that this extra physiological data will be able to predict patient response to CPAP-alternative treatments and give clinicians and patients extra treatment options that are tailored to patients personal physiology.

This is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.

Depression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men who are overweight or obese are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. Behavioural weight loss programs have shown promise to reduce depressive symptoms and improve weight status in people who are overweight or obese, but few interventions have engaged men and most have included components that are not scalable (e.g., intensive face-to-face support). E-health programs targeting men’s physical and mental health may represent a more scalable solution to these concerns, but the evidence-base supporting their efficacy is limited. Primary aim: To develop and test the efficacy of a gender-tailored, e-health weight loss program (SHED-IT: Recharge) to improve the physical and mental health of overweight and obese men with elevated depressive symptoms. Primary hypothesis: Men in the SHED-IT: Recharge group will show greater improvements in i) weight and ii) depressive symptoms at 3 months post-baseline, compared to a wait-list control group. Secondary aim 1: To determine the effect of SHED-IT: Recharge on men’s weight and depressive symptoms at 6 month follow-up. Secondary aim 2: To determine the effect of SHED-IT: Recharge on a range of lifestyle health behaviours (e.g., physical activity, dietary habits), mental health outcomes (e.g., anxiety) and other health indicators (e.g., blood pressure, blood lipids). Secondary aim 3: To identify which behavioural changes (e.g., diet, sleep) result in the largest, independent contributions toward the overall intervention effect on weight and depressive symptoms.

A prospective study to evaluate the Focal Contouring System to determine whether it is safe and efficacious in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.

The goal of this research is to explore if a consumer co-created infographic (a visually appealing and easy to read and understand information resource) is effective in improving knowledge and self-efficacy about physical activity for women during a gestational diabetes mellitus (GDM) pregnancy. This is important because although physical activity is known to be beneficial to pregnant women with GDM more than 60% of women with GDM do not exercise as recommended. This study is being undertaken in response to the findings of a previous study reporting that women with GDM needed clear and simple information about physical activity during their GDM pregnancy. This research is designed as a randomised controlled trial with GDM Education classes being randomly allocated to either the intervention or comparator to evaluate the effectiveness, of an evidence based, consumer co-created infographic, on women's knowledge and self-efficacy (confidence) about physical activity during a GDM pregnancy.

It is anticipated that ovarian rejuvenation using autologous platelet-rich plasma (A-PRP) injected into the ovaries will improve IVF outcomes in subsequent IVF cycles using mild ovarian stimulation for perimenopausal and menopausal women. In the non-randomised prospective trial, around 30mLs of your own blood (autologous) will be collected to produce around 4-5mLs of A-PRP. Around 2-2.5mLs of A-PRP will be injected into each ovary using transvaginal ultrasound guidance or laparoscopy, either at the same time as a transvaginal egg collection, or at a separate event. Follicle, egg and embryo numbers, pregnancy rates, and hormones levels (anti-mullerian hormone (AHM) and follicle stimulating hormone (FSH)) will be compared pre and post the injection of A-PRP.

Ondansetron is an anti-emetic drug that is commonly used in the emergency department to treat nausea and vomiting. Droperidol is an older anti-emetic medication where usage had fallen out of favour until recently, due to unfounded fears concerning QT prolongation. There is anecdotal evidence that IV droperidol is superior to ondansetron for treatment of nausea and vomiting. Although no difference was noted between the two drugs in a recent study, the dose of droperidol that was used was less that what would commonly be used in an emergency department setting. The question is if a higher dose of droperidol will likely demonstrate a difference.