ANZCTR search results

This is a double-blind, placebo-controlled study to assess the safety of TRX-100 and how this drug acts in the body in healthy volunteers. TRX-100 may be indicated for use in patients with influenza, but a trial of the drug in healthy volunteers is needed before trials in influenza patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 64 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive a single dose of TRX-100 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of TRX-100 that can be administered safely without causing severe reactions. Once the dose of TRX-100 has been determined in healthy volunteers, a trial investigating the efficacy of TRX-100 as a treatment for patients with TRX-100 may proceed.

Contraint Induced Movement Therapy (CIMT) is an evidence-based therapy that improves the functioning of the more-affected hand in children with unilateral cerebral palsy (CP), also known as hemiplegia. Children with hemiplegia also have difficulty with gross motor skills as the movement of the leg on the same side of the body as the more-affected hand is also impacted by the brain injury. We have developed a therapy called CIMT-Leg, based on the principles of CIMT, that aims to improve the functioning of the more-affected leg. This could improve the child's ability to walk, move, climb, play, and participate in things that are important to them such as sports. CIMT-Leg is delivered by trained physiotherapists. We will test the feasibility of 6 weeks of CIMT-Leg treatment, including how safe it is and how much it works to improve gross motor and mobility function in children with unilateral CP between 4-8 years of age.

Brain waves (also known as neural oscillations) in the brain’s default mode network (DMN) and visual cortex (VC) appear to be functionally and clinically relevant targets for the treatment of post-traumatic stress disorder (PTSD). Novel non-invasive brain stimulation techniques can directly target neural oscillations, potentially providing a safe and effective means to treat this complex disorder. Using transcranial alternating current stimulation (tACS), this research project will directly investigate for the first time whether stimulating alpha oscillations (8-12 Hz) to treat pathophysiological DMN activity results in improved clinical outcomes in patients with PTSD. This essential research is a crucial first step in demonstrating the potential of tACS as a novel therapeutic treatment option for those with PTSD. The aim of the proposed research is to conduct an exploratory study demonstrating the behavioural and electrophysiological impact of personalised tACS in participants with PTSD. Specifically, we will aim to confirm whether we can successfully use personalised tACS to enhance alpha oscillations in the prefrontal cortex and visual cortex to reduce clinical symptoms in participants with PTSD.

The BEYOND Study is a multi-centre, open-label pilot study that utilises a participant-centric clinical trial protocol for epilepsy. It aims to assess the effectiveness, safety, and tolerability of Epidyolex as an adjunctive therapy for beyond seizure outcomes in individuals aged 2 to 65 years with DEE. The study will enrol 20 participants from metropolitan and regional areas in New South Wales, including rural and remote locations. The acceptability of this model will help guide health economists and medical affairs teams in collecting cost-effective data that can be used to optimise Pharmaceutical Benefits Advisory Committee (PBAC) submissions with regulators.

Type 1 and 2 Diabetes Mellitus is a major cause of severe and irreversible vision loss in children and adolescents globally, with Australia having one of the highest rates of T1DM in the world. The most important cause of vision loss due to diabetes is the development of diabetic retinopathy; nearly 100% of children with Type 1 Diabetes Mellitus will eventually develop the condition. Currently, there are only a limited number of strategies to manage diabetic retinopathy until sight-threatening complications arise and current treatments are costly, associated with discomfort, risk and may not be able to reverse any loss of vision that has already occurred. Previous experimental studies in animals have shown that the earliest stages of diabetic retinopathy involve abnormalities in retinal capillaries and retinal perfusion. Optical Coherence Tomography Angiography (OCTA) is a fast and non-invasive clinical technique that allows high-resolution imaging of retinal capillaries. OCTA provides an imaging technique able to detect the earliest blood vessel changes due to diabetic retinopathy, prior to the occurrence of sight threatening complications. We have developed a novel method to quantify retinal perfusion in human eyes using OCTA and therefore propose a new method for detecting the very earliest changes to retinal capillaries in eyes with diabetic retinopathy. Furthermore, as there is an intricate link between diabetic eye disease and diabetic kidney disease we propose that it may be possible to use OCTA to detect early kidney disease using the same ocular biomarkers. This project will investigate if retinal vessel perfusion abnormalities captured on OCTA are an early and leading factor in the development of diabetic retinopathy that occur prior to structural changes detected using conventional screening techniques such as colour photography. The project will compare children with Type 1 and 2 diabetes with no retinal pathology against healthy controls to see if retinal vessel changes are present in diabetic vs healthy children. These children will also have blood and urine markers of kidney function compared to investigate if retinal vessel changes are associated with renal dysfunction makers. The study will investigate if changes in retinal vessel abnormalities over time are associated with clinical changes in children with Type 1 and 2 diabetes. To collect this data, the project will follow Type 1 and 2 diabetic children and a matched number of healthy children over 5 years at annual visits.

The study was approved via the Low or Negligible Risk review pathway. It is recommended practice when introducing a new model of care or a new element into a model of care, that it be evaluated properly. In this study, we will observe the effect of the new addition to the clinical pathway - a hospital in the home or HITH program. HITH programs have been included as part of management pathways after low-trauma (osteoporotic) hip fracture since the late 1970s in the United Kingdom. HITH programs are a priority for NSW Health, but their uptake appears to be limited by available resources and published documentation of their effect. In trialling a HITH program here, we aim to establish whether such a program is feasible/practical in our patients. We are not testing a hypothesis, but we will specifically monitor program uptake/acceptance by patients/carers and safety. If the program is feasible, it is hoped its continuation (plus or minus any refinements) are supported by the organization.

The purpose of this study is to implement and evaluate a health promotion campaign on social media, which aims to raise awareness of the potential impacts of e-cigarette (vaping) use among Australian youths. The campaign aims to use three types of messages to: - raise awareness of the potential impact of e-cigarette use on health outcomes - raise awareness of the potential impact of e-cigarette use on the environment - raise awareness of unethical industry behaviour promoting vaping The outcomes will assess overall engagement with social media message content, comparing engagement across different messages.

This study involves real-time molecular profiling of brain or other CNS tumours by analysing tumour tissue, cerebrospinal fluid (CSF), and blood plasma at critical points throughout cancer diagnosis, treatment, and recurrence. Molecular profiling is like taking a detailed snapshot of a tumour's genetic makeup, helping doctors identify specific changes or mutations to guide effective treatment choices. Who is it for? You may be eligible for this study if you are a male or female age 18 or older with a known or strong suspicion of primary CNS cancer, suitable for systematic treatment. Study details Biospecimens including tumour tissue, blood and cerebrospinal fluid (CSF) will be collected longitudinally from participants during routine care procedures and/or by accessing stored material. Clinical data will be collected throughout the study. Biospecimens collected will be molecularly profiled. Molecular profiling analysis will include targeted panel sequencing, whole genome transcriptome sequencing and methylation array using tumour tissue samples. Results will be returned to the treating clinicians, accompanied by interpretation and recommendations from the molecular tumour board. By integrating clinical, molecular, histopathological, and radiological data, the project seeks to improve patient outcomes and establish feasibility of molecular profiling in CNS tumours.

The primary purpose of this study is to demonstrate the safety of the use of non steroidal medication in women who have high blood pressure (hypertension) in pregnancy. Traditionally the use of non steroidal medication has been avoided due to theoretical concerns of exacerbating preexisting hypertension. The hypothesis is that there is no increase in events of severe hypertension that would occur in the postpartum population and actually it is an effective pain killer and avoids the need for stronger pain killers like endone.

This study will evaluate a diagnostic test for cancer risk before surgery women with an ovarian mass Who is it for? You may be eligible to join this study if you are aged 18 years and above and have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination that requires surgery. You will already have had a CA125 test and a transvaginal ultrasound, and your doctor will have made a decision to send you to a specialist for further examination. Study details Cleo Diagnostics Ltd has developed a novel Ovarian Cancer Adnexal Mass Assessment Score test system. Participants in this study will have a single blood sample taken prior to surgery for testing using the novel Ovarian Cancer Adnexal Mass Assessment Score test system. This test measures five analytes in serum, and combines their values into a single score. This score indicates the likelihood that a mass might be malignant, before surgery is undertaken to determine the nature of the mass. In this trial the risk score will be compared to pathology findings after surgery, to retrospectively assess its accuracy to predict malignancy. It is hoped that the test will enhance clinical decision-making and assist in patient referral for further surgical exploration.