ANZCTR search results

Deoxycholic acid is a treatment for excess adiposity an an ARTG registered medicine. There are limitations to the total amount that can be administered. In this case, we will treat one side of the body first, then the other side to minimise the total amount of deoxycholic acid administered.

The purpose of this study is to evaluate the feasibility of a new laser therapy system (called ProFocal­-Rx Laser Therapy System) for the treatment of certain prostate cancers. Who is it for? You may be eligible for this study if you are aged 50 or older and have a diagnosis of prostate cancer. Study details All participants in this study will undergo a general anaesthetic and targeted treatment (called ‘ablation’) of their prostate cancer in an outpatient setting. Immediate following the procedure, an MRI scan will be performed to determine the extent of the laser ablation. Six weeks after the procedure participants will have a targeted biopsy of the prostate to assess the outcome of the laser therapy. It is hoped this research will demonstrate the feasibility of this technology to treat prostate tumours, reduce discomfort and improve patients quality of life.

The purpose of this observational study (no treatment) is to determine the amount of postoperative astigmatism compared to the preoperative astigmatism for participants implanted with TECNIS toric ZCT100 IOL. For eyes implanted with the TECNIS toric ZCT100, the amount of postoperative astigmatism should be lower than the amount of preoperative astigmatism. For eyes implanted with the TECNIS ZCB00, the amount of postoperative astigmatism may be unchanged compared to the amount of preoperative astigmatism. This trial will collect preoperative, operative, and postoperative data from the participant’s clinical records for the visits already occurred, and data for the single visit to be collected for the prospective visit.

This study will specifically investigate whether functional electrical stimulation (FES) reverses myelin abnormalities in peripheral nerves of people with spinal cord injury. Participants who are scheduled to undergo nerve transfer surgery will be asked to undertake a program of FES using the ReGrasp device (Rehabtronics Inc, Edmonton Canada) for at least one hour dail, 5 days per week for 6 weeks prior to the surgery. This device enables a person to close and open the hand and can be operated independently by simple head motions detected by an earpiece. Biopsies of the relevant nerves and muscles will be obtained during the surgery, and these will be processed, analysed and compared with those obtained from previous nerve transfer surgery participants (historical controls). The primary outcome measure is the axon/nerve fibre ratio. Secondary outcomes include clinical assessments of hand function, independence, pain, well-being and quality of life, with participants being followed up for 24 months post-surgery. A cost-utility analysis will also be conducted.

This is a single centre, randomized, double-blind, placebo-controlled, sequential, single dose-escalation study of AK-119 administered to healthy adults and multiple dose-escalation study of AK-119 administered to healthy adults. The study comprises three parts A,B & C. Part A of the study is a single dose escalation arm. The safety data will be reviewed after each Cohort prior to dose escalation. The selected dose cohort will participate in a two-way crossover design and return to the clinical unit to receive AK-119/placebo administration of the same for evaluation of the food effect after a washout of at least 7 days. In Part B All subjects will be admitted to the Phase 1 unit on Day -1 for pre-treatment assessments then given a single dose of AK-119 or placebo once or twice daily from Day 1 to Day 7. They will remain inpatients until Day 10, returning as outpatients for follow-up assessments on Day 14. Part C will start after completing the multiple dose, dose escalation components in healthy volunteers in Part B, one cohort with healthy volunteers will be enrolled to receive 1 dose level of AK-119/placebo, as determined from the Part B in healthy volunteers. The dosing period will be upto 28 days as once or twice daily, commencing on Day 1 (dosing regimen to be determined from Part B).

This is a double blinded prospective randomised pilot study to investigate whether the use of a combination of analgesic medications (ketamine, lignocaine and pregabalin), when combined with conventional general anaesthesia, influences the incidence of chronic pelvic pain in women undergoing surgical management of moderate to severe endometriosis. Chronic pelvic pain (CPP) is common in women with endometriosis, and can develop despite surgical treatment of the disease. CPP is defined as the presence of non-cyclic daily pain of 6 months duration or longer that localizes to the anatomic pelvis and is severe enough to cause functional disability and require medical or surgical treatment. Endometriosis causes pain through a variety of mechanisms including direct compression/infiltration of nerves by the lesions, inflammation, and damage to pelvic nerves during surgery and may lead to changes in the central nervous system which propagate chronic pain. The medications being investigated in this study have potentially beneficial effects in preventing the central nervous system changes which may lead to chronic pelvic pain. Patients will be recruited from the endoscopy and pre-admission clinics and the day of surgery admission unit at King Edward Memorial Hospital. They will be eligible for the study if they have an American Fertility Society Score of 2 or 3 on previous laparoscopy and are scheduled for laparoscopic treatment on endometriosis. At recruitment patients will undergo a visual analogue scale (VAS) assessment for pain and will complete a quality of life (QOL) assessment. Patients will be randomised to either a standard care group who will be managed with a conventional general anaesthesia approach or to the intervention group, who will receive pre-medication with paracetamol and pregabalin, followed by an IV bolus and infusion of lignocaine and ketamine intra-operatively, with regular pregabalin in the post-operative period. The standard care group will receive oral placebos to replace pre-operative paracetamol and pregabalin, and post-operative pregabalin. Repeat pain scores will be recorded on day 1, and repeat pain scores and QOL scores at 6 weeks, 3 months, 6 months and 12 months post-operatively.

The purpose of this study is to determine if breast cancer genetic material (known as circulating tumour DNA (ctDNA)) can be detected in the bloodstream. Who is it for? You may be eligible for this study if you are aged 18 or over and have confirmed non-metastatic adenocarcinoma of the breast. Study details You will require a blood test every 3 months for two years from the time of registration to the main study. As part of this study, you will also need to complete questionnaires that ask about your feelings towards the regular blood tests and thoughts of cancer return. If the ctDNA levels are detected in your bloodstream during the 2 year period, you will be asked to return to have a CT and/or bone scan. It is hoped that this research will demonstrate the utility of this circulating material as an early marker of breast cancer activity.

It is well-established that exercise is associated with a variety of physical and psychological benefits; however, certain post-exercise behaviours, such as consuming excess or unhealthy foods in the aftermath of an exercise session, may counteract some of these benefits. The effect of exercise on food consumption appears to be influenced by both exercise format (e.g., overall intensity and structure of exercise) as well as psychological experiences during exercise. In relation to exercise format, it has been shown that high-intensity intermittent exercise, relative to traditional exercise performed at a moderate-intensity, suppresses appetite and energy intake at the post-exercise period. As for psychological experiences of exercise, it appears that more autonomously motivated individuals may be less likely to endorse the use of food rewards post-exercise. Despite this evidence, numerous issues with this relationship remain unresolved. For instance, no previous work has explored the interactive effects of exercise format and psychological experiences during exercise on subsequent food choices. As such, the aim of this research is to examine which exercise conditions, both in terms of the format and psychological experiences of exercise, have the strongest influence on post-exercise appetite and food intake.

Emerging evidence of preclinical studies suggests that bitter substances in the gut can reduce appetite and slow the emptying of meals from the stomach, by stimulating gut hormone release. The proposed project will evaluate the hypotheses that, in patients with T2DM, activation of gastrointestinal bitter taste receptors(BTRs) substantially slows gastric emptying and reduces postprandial glycaemia after a standardized meal (Part A), and suppresses energy intake at an ad libitum buffet meal (Part B), in association with augmented secretion of glucagon-like peptide-1 (GLP-1)), peptide YY (PYY), cholecystokinin (CCK) and insulin, and suppression of ghrelin and glucagon. We will stimulate BTRs, as previously, using denatonium benzoate, the most potent BTR agonist known, to which humans are reproducibly sensitive.

Muscle wasting, or atrophy, is a widespread problem in elderly human populations, and greatly increases the chances of falls and metabolic diseases such as type 2 diabetes. Ursolic acid (UA) is a natural food-derived nutrient (found in many herbs such as Rosmarinus officinalis (rosemary), Origanum vulgare (oregano), and the peel of fruits such as apples) has been shown in rodents to prevent muscle atrophy and promote muscle growth. However, the bioavailability, safety and tolerability of orally ingested ursolic acid in humans is not fully known. Therefore, our aims for this study are: To determine the bio-availability, safety and tolerability of 3 different forms of orally ingested Ursolic Acid in healthy men. We hypothesise that UA will be adequately absorbed to elicit a measurable appearance in the blood and expect to see the greatest bioavailability of UA from the UA-Oil > UA-Phy > UA-Pow, with no severe adverse events, safety or tolerability complications with any of the UA supplements taken.