ANZCTR search results

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.

Pregabalin and gabapentin are two medications commonly used to treat neuropathic pain. While both are moderately effective, there is significant variation between individuals, with patients often responding to one medication but not the other. N-of-1 trials are clinical trials that study a single patient, facilitating personalized data collection and reporting. We hypothesize that N-of-1 trials are a feasible method of comparing between pregabalin and gabapentin for individual patients with neuropathic pain.

This is a prospective, randomised, openlabel, activecontrolled, multicenter trial comparing treatment effects of CAM2038 (BPN depot injection) with BPN standard of care (for example, sublingual [SL] BPN or BPN/naloxone [BPN/NX]) in adult outpatients with opioid dependence. Opioid dependent patients who are either currently receiving medication assisted treatment (MAT) with SL BPN or BPN/NX, or patients who are actively seeking BPN standard of care treatment but who have not yet begun a treatment regimen, may be eligible for the trial. Patients will be randomised in a 1:1 ratio to either CAM2038 (involving either weekly or monthly depot injections based upon prescriber and patient choice) or BPN standard of care MAT. Stratification by new to treatment will be applied. The trial will consist of a Screening Period of up to 4 weeks duration, a Treatment Period of 24 weeks duration, and a Followup Period of 2 weeks duration. Outcomes relevant to study include the treatments’ perspective impact on patient’s satisfaction of treatment and other patient reported outcomes (PROs), as well as understanding the potential health economic impact and resource utilization with CAM2038 treatment.

After undergoing Carpal Tunnel release surgery, Peninsula Health patients currently are provided with a written leaflet developed by the hand therapy team at their first post-operative appointment. This is usually 10-14 days post-surgery. It is possible that patients may recover faster if they also receive a face-to-face consultation with a hand therapist, however there is only low level evidence from a retrospective case series study (Mack et al., 2017) to support this. We propose to complete a pilot study to see whether a randomised control trial would be feasible at Peninsula Health. The pilot study will take place over a 3 month data collection period, which is predicated on research honours student availability. Based on 2017 data, it is anticipated that the study could recruit a minimum of 20 patients (note: the original target of 50 was revised due to a downturn in the number of surgeries performed at this site, and a reduced recruitment period due to changed student project parameters). In this pilot study, participants will be randomised to two groups: 1: control group who will receive usual treatment (written information provision) 2: treatment group who will receive usual treatment plus one face-to-face hand therapy appointment We aim to collect data pre-operatively and then on three occasions over a 12 week timeframe: initial post-operative phase (10-14 days after surgery), 6 weeks and 12 weeks. Patient-rated outcome measures will include the Boston Carpal Tunnel Questionnaire; Quality of Life (using the EQ-5D-5L) and patient satisfaction with their recovery. We will also report on any complications such as Pillar Pain, infection and wound breakdown. Participants will be offered the choice of paper, on-line or phone-based completion of these measures. We will also conduct a basic cost-benefit analysis using utility scores calculated from the EQ-5D-5L and information regarding time off work and other health resource usage.

The overall aim of the project is to explore the communication between bone and muscle in older-adults over the age of 60years and, whether older-adults with or without low muscle function respond differently to acute-exercise. We will explore how different type of exercise affect bone and muscle metabolism as well as identify potential targets for future treatments tp prevent muscle loss associated with ageing. The intervention include three studies: study 1: a cross-sectional study to explore the characteristics of older-adults with and without low muscle function. Study 2: Utilising a resting muscle sample, this study is an in-vitro cell culture study where we will grow the sample in the laboratory and then treat the sample with different drug treatments to examine directly how the muscle responds. Study 3: is a randomised, cross-over, controlled trial to examine responses to acute exercise under three different conditions: aerobic cycling exercise, resistance exercise (including leg press and jumping) and control (complete rest). This study will include blood sampling at rest and following exercise. In addition, optional muscle sampling after each condition will help us to examine the direct effect of the different exercise modes at the muscle. This project is important as a limited information on older-adults is available. This study will generate novel knowledge as it has the potential to identify new communication pathways between the bone and muscle with implications for future drug targets and the management of sarcopenia or sufferers at risk of/with reduced muscle function.

The risk of pre-eclampsia (elevated blood pressure in pregnancy) can be predicted through a screening test at 11-13+6 weeks' gestation. Previous work has shown that 'high risk' women benefit from taking aspirin through their pregnancy - resulting in a 62% reduction in pre-eclampsia prevalence before 37 weeks. Current treatment does not alter the prevalence of term pre-eclampsia (i.e. after 37 weeks). This study will test whether adding another treatment (esomeprazole) will cause a further reduction in blood pressure at the end of pregnancy. Pregnant women will take one esomeprazole or placebo tablet each day from before 16 weeks until delivery, in addition to aspirin, and will have their blood pressure measured throughout the study.