ANZCTR search results

This is a phase I clinical trial designed to assess the pharmacokinetics and safety and tolerability of IHL-675A compared to the reference listed drugs Epidiolex (CBD) and Plaquenil (HCQ). The trial will recruit at least 36 healthy subjects. Initially, 3 sentinels will be enrolled and randomised into Treatment 1, 2, and 3. Treatment 1 - Two IHL-675A softgel capsules (75mg CBD, 100 mg hydroxychloroquine sulfate per capsule, 150 mg CBD, 200 mg hydroxychloroquine sulfate total). Treatment 2: One 200mg hydroxychloroquine sulfate tablet (Plaquenil), Treatment 3: 1.5mL of 100 mg/mL (150 mg) CBD (Epidiolex) The sentinels will be dosed at least 24 hours prior to the remainder of the subjects. If there are serious adverse events associated with the dose the trial will be paused and the risk of further subjects receiving IHL-675A will be assessed. Each Treatment group will enrol at least 12 subjects each, for a total of at least 36 subjects. Subjects will be randomised into the treatment groups. The healthy subjects will be informed of the study and pre-screened. Screening will include blood and urine tests, screening for mental and cardiac health using a series of mental health questionnaires and 12-lead ECG in triplicate, respectively. Post screening, subjects will be admitted to the clinical unit, where they will undergo baseline assessments, including safety bloods and urine sampling to screen for pregnancy and drugs of abuse. On Day 1, subjects will be given a high-fat/high-calorie meal 30 minutes prior to dosing. At least 30 min before the time of dosing, the 24-hour telemetry period for cardiac monitoring will commence. Blood samples for plasma pharmacokinetic analysis, will be taken throughout the study. These samples will be assessed for the Active Pharmaceutical Ingredients as well as metabolites 7-OH-CBD and 7-COOH-CBD, and desethylhydroxychloroquine, desethylchloroquine, and bisdesethylhydroxychloroquine. Blood samples will also be taken for safety analysis. Subjects are discharged from the clinical unit on Day 2, at least 24 hours post dose, and will return to the clinical unit for outpatient visits on Days 3, 7, 14, 21, and 28 for blood sampling and/or to assess any existing or new Adverse Events, and concomitant medications. Subjects who have completed Cohort 1 and who continue to meet study entry criteria may be permitted to screen for participation in Cohort 3.

The study is testing the effectiveness of a new web-based intervention for mothers and their partners. The intervention is designed to provide parents with accurate and up-to-date information about their unborn child’s development during pregnancy and how to help manage problems with infant sleeping or crying, and how to best cope when parents are feeling stressed by the demands of caring for young infants. Parents who are allocated to the intervention group will meet online with our research psychologist at approximately 25 weeks of pregnancy to learn how their baby is growing and how to better get to know their baby during pregnancy. They will also have 4D ultrasounds at 28 and 34 weeks of pregnancy when they can view their baby in real time, and together with our psychologist observe what their baby is doing. After their baby is born, they will meet online with our psychologist when their baby is 2 weeks and 6 weeks old for support about how to care for themselves and their baby during stressful times, like when babies are having difficulty sleeping or settling. We hypothesise that parents undertaking the intervention will form a stronger attachment to their child, be able to better undertake health-promoting behaviors during pregnancy, and will be better equipped to manage personal distress, infant crying and sleep problems,

This study will compare three methods of relocating a dislocated shoulder. The three different methods being compared will use different positioning of the patient and their shoulder joint to relocate the shoulder. These methods are called the chair method, FARES method and Cunningham's method. The main purpose of the study is to determine which method is most effective at relocating the shoulder on first attempt.

There is convincing evidence that OAB reduces iSSI in elective colorectal surgery. However, although there is a trend in AL many of these papers have mixed results. A recent network meta-analysis Woodfield et al had elaborated the need for future high-powered studies for assessing AL in elective colorectal surgery. Currently, there are no local studies looking into the effect of pre-operative oral antibiotics as part of mechanical bowel preparation in the Australian and New Zealand context. We aim to conduct a multi-centred randomised controlled trial on the efficacy of OAB in elective colorectal resection with anastomosis and the risk of post-operative AL and iSSI. Our hypothesis is that the addition of oral antibiotics to standard care for patients undergoing elective colorectal resection will reduce anastomotic leak and incisional surgical site infections.

This is a phase 1 study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract) in healthy volunteers.

Chronic disease, such as lipoedema, has a negative impact on mental health and is associated with increased psychological distress, depression and anxiety. This project uses a randomised-controlled design (with an active intervention and waitlist control condition) to investigate the impact of an online, group based psychological intervention using compassion focused therapy (CFT) to improve the mental well­being of women with Lipoedema. Using a 10-week intervention design and follow-up at 8-weeks and 24-weeks post intervention completion, participants will engage in an online delivered group intervention, Participants will complete measures at baseline, post intervention and follow-­up. In addition, a subset of participants will contribute to an understanding of the biological mechanisms underpinning psychological change through gut-­brain related changes in microbiome. This project aims to improve the mental health of participants and provide critical, integrated bio­psychological and therapeutic focused research to promote well­being in lipoedema.

People who complete mindfulness programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a popular four-week online mindfulness program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. While this program has been rated very positively by individuals who have completed it in the past, further research is required to evaluate its effectiveness.

The advent of technology that can enable immersive and engaging, high-dose practice, has led to new opportunities for restoring function in neurological patients. ECU’s Neurorehabilitation and Robotics (Edwards) Lab has acquired the Mindpod motion capture and gaming system, that enables fun exploration and practice using whole arm-hand in large movements to guide a dolphin to swim in a gaming environment. We test if this immersive digital gaming system in patients with MS, can safely and feasibly be conducted and can have positive effects on cognition, motor function, fatigue and quality of life.

The Nutromics Sensor Device is a wearable device that is minimally invasive and can be placed on the skin peripherally or centrally. The device will provide vancomycin measurements once cleared and in clinical setting to be used in the diagnosis and treatment of vancomycin overdose and in monitoring of levels of vancomycin in order to help ensure appropriate therapy.

The ENIGMA (Evaluation of Nitrous oxide In the Gas Mixture in Anaesthesia) Trial was a large (n = 2,050) pragmatic multicentre randomised trial in patients undergoing major surgery. The incidence of clinically significant postoperative pulmonary complications (PPCs) measured by routine chest radiography and postoperative full blood and microbiology testing, as well a septic complications, were found to be increased with N2O. The larger ENIGMA 2 Trial (n = 7,000) did not confirm the findings of ENIGMA that N2O increased rates of wound infection or sepsis. Unfortunately, ENIGMA 2 did not prospectively collect data on pulmonary complications. Given the pragmatic nature of the protocol for measurement of PPC incidence used in ENIGMA, it was seen as feasible to replicate it post hoc in the ENIGMA 2 trial sample, using data collected as part of routine postoperative clinical management in these patients. This was done in the cohort of patients recruited to the ENIGMA 2 Trial within Australia, which consisted of over 2,500 patients or approximately 35% of total trial recruitment.