ANZCTR search results

This is a phase 1, open-label, randomised, single-centre study to evaluate the safety, immunogenicity, pharmacokinetics, and pharmacodynamics of a single administration of GB-hMG in healthy premenopausal females. Thirty eligible, healthy volunteers will be randomised to one of four single doses and receive one (1) subcutaneous (SC) injection of 150 international units (IU), 225 IU, 300 IU, or 450 IU, to evaluate the pharmacokinetics and dose proportionality of GB-hMG. GB-hMG contains follicle stimulating hormone (FSH), luteinizing hormone (LH) and human chorionic gonadotropin (hCG). FSH, hCG and LH are produced by your body as part of your regular hormonal cycles. It is thought that GB-hMG will be able to stimulate the ovaries to increase fertility and ability to produce healthy ova.

The aim of this study is to validate a previously developed machine-learning algorithm for identifying spinal anatomy on ultrasound scanning in patients with BMI >35. We will assess the success-rate of spinal anaesthesia needle insertion using the ultrasound algorithm. Our hypothesis is that the use of ultrasound and the algorithm will improve the first-time success rate of spinal anaesthesia, by making identification of the important landmarks easier for the anaesthetist. This will also reduce complication rates and improve the safety of spinal anaesthesia.

This study aims to determine whether a medication called tirzepatide is effective for weight loss and improving blood glucose levels and metabolic health in people with type 1 diabetes and obesity. This study will also look at the effects of an exercise program on weight loss and changes in the proportion of muscle and body fat seen with tirzepatide, and how continued participation in this exercise program after stopping tirzepatide treatment affects body weight and body composition. We hypothesise that tirzepatide will lead to significant weight loss benefits in comparison to usual care in adults with type 1 diabetes and obesity.

The purpose of this study is to evaluate the safety and tolerability of JNJ-95597528 after single and optional multiple ascending dose administration in healthy participants.

This pilot study aims to reveal the profiles of extracellular vesicles (EVs) in periodontal, peri-implant diseases (refers to diseased groups) before and after treatment follow-up (3, 6 and 12 months). EVs from periodontally healthy and peri-implant health patients (without follow-ups as no need to follow up) will be used as controls. Whole oral samples (saliva, GCF/PICF and plaque) will be used as controls. There are three general aims for this project: Aim 1: Diagnosis and prognosis values of EVs in periodontal disease groups Compare the differences in host and microbial derived EVs and their EV content expressions between periodontally health, periodontitis and periodontitis undergoing treatment over a 1-year observation period Aim 2: Diagnosis and prognosis values of EVs in peri-implant disease groups Compare the differences in host and microbial EVs and their EV content expressions between peri-implant health, peri-implant mucositis and peri-implantitis and peri-implant disease patients undergoing treatment over a 1-year observation period Aim 3: EV profiles after in vitro biofilm culture Examine the microbial EV microbiome and proteome profiles in samples from both healthy and diseased groups following in vitro biofilm culturing It is hypothesised that host and microbial EVs and EV content are differentially expressed in diseased patients compared with healthy or peri-implant health patients, and correlates with the severity of periodontitis or peri-implant disease. Furthermore, it is hypothesised that EVs will be positively correlated with improvements in clinical parameters after periodontal or peri-implant treatment.

This study is testing the safety, tolerability (if any side effects occur), pharmacokinetics (PK; the amount of experimental drug or any breakdown products in the blood), of a single dose/food effect of an experimental drug called Radiprodil in the presence or absence of food (food effect). This entry in the ANZCTR registry describes Part A: a single oral 15 mg dose of radiprodil SDD. Radiprodil is being developed as a potential new treatment of tuberous sclerosis complex (a rare genetic disease that causes non-cancerous tumours to grow in the brain and several other areas of the body) and focal cortical dysplasia (a malformation of neurons in a region of the brain called the cortex). Radiprodil is expected to reduce the risks of seizures and negative developmental outcomes that are characteristic in patients with these conditions. In patients with these disorders nearly all will have a form of epilepsy (seizures) from a very young age that does not respond to current treatments available. Seizures can affect the process of normal development and cognitive skills leading to behavioural issues and negative developmental outcomes. Radiprodil has the potential to normalise the pathways in the brain that are involved in seizures and therefore reduce the risks of seizures, negative developmental outcomes and other significant symptoms that are characteristic in patients with these conditions. The purpose of this study is to test the safety and tolerability of a new version of oral radiprodil called Sprayed Dried Dispersion (SDD) radioprodil when taken as a single dose either with or without food. The study will also assess the plasma pharmacokinetic profile (how a drug moves through the bloodstream over time) of the SDD radiprodil.

A study to test the use of a hydrogel containing 0.1%w/w mometasone furoate applied once a day in the treatment of chronic leg wounds. Adults meeting the study entry criteria will be identified and randomised to apply either the active product or a placebo over a period of 28 days, with follow-up after an additional 7 days. Hypothesis: A hydrogel containing 0.1%w/w mometasone furoate will shorten the healing time of chronic leg wounds in adult patients, as measured by reduced wound size and reduced inflammatory mediators.

This study will use EIT to define the patterns of tidal ventilation within the chest in infants undergoing inguinal hernia surgery with four different anaesthetic types, two where they are spontaneously breathing, and two where they are having a general anaesthetic with either spontaneous ventilation with laryngeal mask airway or mechanical ventilation. This study will determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and the four types of anaesthetic techniques.

This study will determine if there are any changes in sleep difficulties in relation to menopause, and other symptoms of menopause as well as looking at the rate of adverse events after using medicinal cannabis. This study will provide data for future clinical trials if potential benefits are found. We hypothesise that medicinal cannabis can improve sleep quality in relation to menopause, alongside other symptoms.

The aim of this project is to identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program. Up to 90 participants who identify as Aboriginal and/or Torres Strait Islander, have been diagnosed with type 2 diabetes and have recently recorded a HbA1c >7.5% will be recruited from multiple locations. This study follows a basket trial methodology with 2 groups assessed at each stage: participants taking insulin &/- sulfonylureas and other diabetes medications; and participants on other diabetes medication (NOT taking insulin &/or sulfonylureas). Fifteen participants will be recruited for each group at each stage. It is expected that LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program will be of sufficient promise to be taken forward to a Phase IIb-III trial and subsequent translation into clinical care. This will be based on the combination of efficacy, safety and feasibility with type 2 diabetes treated with insulin AND/OR sulfonylureas & other diabetes medications or treated with other diabetes medication (excluding Insulin AND/OR sulfonylureas) respectively.