ANZCTR search results

The aim of testing this product to ensure its safety and dose before commencing a clinical trial for efficacy in participants experiencing dizziness and vertigo. The trial will enroll 20 healthy volunteers who will receive either 4 tablets a day or 4 tablets twice a day for 15 days and then have 15 days without the tablet to monitor for safety.

The past decade has seen a rapid increase in mobile smartphone ownership, particularly among adolescents. Smartphone has been associated with mental health disorders (such as anxiety and depression), cyberbullying, poor sleep habits, poor posture and neck problems, and problematic mobile phone use (smartphone addiction), together with a decrease in general wellbeing, ability to concentrate (including in school time) and lower levels of physical activity. There have been increasing concerns regarding smartphone use among adolescents and the potential impact on health and wellbeing, including some concerns on the impact of smartphone use at school on educational and health outcomes. For example, concerns have been raised regarding students’ mobile phone use during school hours (in the classroom and playground) as a significant source of disruption impacting on attention and learning. Banning or restricting access to smartphone use in schools has been recommended by Governments across the United Kingdom, France, Canada, and in some Australian states as a potentially effective strategy to improve student health, well-being, and learning. With a change of Government in NSW, the introduction of policy within Government secondary schools, to restrict access to mobile phones during school hours, has been announced to commence from Term 4, 2023 (October). However, despite the introduction of Government policy to address the concerns surrounding mobile phone use amongst adolescents, research examining the school and student level impact of such initiatives is sparse, and so the suggested benefits are largely speculative. Prior to the introduction of new policies, a unique opportunity exists to address a current international evidence gap and undertake rigorous research to quantify the school and student level impacts of smartphone restrictions in secondary schools as well as to understand key stakeholder (teachers, parents, and students) attitudes towards and barriers to the implementation of such policy. To date, no such research has been undertaken in Australia or internationally. This study aims: to evaluate the efficacy of a secondary school environmental intervention to Restrict Access to Mobile Phones (RAMP) during school hours on student wellbeing, educational and health outcomes, and to determine the acceptability, appropriateness, and feasibility of the intervention from a teacher, parent/carer, and student perspective. A parallel-group cluster randomised controlled trial (RCT) will be conducted in secondary schools located across New South Wales (NSW). Schools allocated to the intervention group will participate in an environmental intervention designed to support the implementation of a school-level policy to restrict access to mobile phones for secondary school students during school hours.

This is an exploratory observational study of biomarkers in adults undergoing therapy for hepatocellular carcinoma (HCC). Who is it for? You may be eligible for this study if you are aged 18 and above, are undergoing therapy for HCC. Study details All participants in this study will have blood samples taken during their scheduled visits with their physician. Time points for blood tests include baseline (just prior to therapy), immediately after therapy then every 3 months, for up to 2 years. An additional time point for blood sample collection will be added at approximately week 4-6 for patients who receive routine follow imaging at the time and also for patients receiving systemic therapy. In the subset of patients with HCC referred for consideration of liver transplant assessment, blood samples will be taken every three months, prior to liver transplantation. This will be performed during their routine imaging as part of standard of care. Following liver transplantation, these patients will be followed at the same timepoints as the main HCC group. The following biomarkers will be evaluated: alfa-fetoprotein (AFP), Des-gamma-carboxy prothrombin (DCP), as well as exploratory somatic mutation and methylation markers. It is hoped that this research will help identify circulating biomarkers that can predict outcome and response to therapy for HCC.

The purpose of this implementation trial is to develop and evaluate an eHealth end-of-treatment model of care called "Emerge" for paediatric patients treated for Acute Lymphoblastic Leukaemia (ALL) and their families. Who is it for? You may be eligible for this study if you are a paediatric patient aged between 2 and 18 years (or older if you are still receiving active surveillance in the paediatric setting) who has been diagnosed with ALL or Lymphoblastic Lymphoma (LLy) and you are within the final 4 months of maintenance treatment or you have completed treatment within the last 12 months at either the Royal Children’s Hospital (Melbourne) or the Monash Children’s Hospital. Parents and caregivers of paediatric patients will also be invited to participate in this study and provide feedback on the Emerge model of care. Study details All participants who choose to enrol in this study will be asked to complete a series of screening questionnaires before receiving at least 2 online telehealth consultations with a nurse and psychosocial clinician. The screening questionnaires are aimed at identifying information needs and supportive care requirements for patients and their families so that the telehealth sessions can be tailored to best meet each participants needs. Some participants may be offered more than two sessions depending upon their needs, these will be monitored throughout the study to ensure that all participants receive the best possible care. Overall participation in this study will take 12 months. Participants may also attend interviews after their telehealth sessions to outline the components that they found to be helpful or less useful. It is hoped this research will determine whether it is feasible to deliver an online, personalised model of care to paediatric patients who have been treated for Acute Lymphoblastic Leukaemia (ALL) and their families. If this study finds that the online model of care is feasible and well received by participants, a larger trial may be conducted where the model of care will be expanded to a greater number of patients.

This study aims to assess the safety, and tolerability of ELVN-001 in healthy participants following a single and multiple ascending doses of ELVN-001 or matching placebo in three parts Part A (SAD), Part B (MAD) and Part C (FE) Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that Normal healthy male and female participants with no clinically significant medical history, and no clinically significant abnormalities on physical examination at Screening will be enrolled for this study. Study details This is a Double-Blinded, Randomized, Placebo-Controlled, Single- and Multiple- Ascending Dose Study To Assess The Safety, Tolerability, and Pharmacokinetics of ELVN-001 in Normal Healthy Participants. Part A (Single Ascending Dose): Participants will be randomly assigned to receive ELVN-001 or matching placebo at a ratio of 6:2. Participants in the Part A (SAD) will receive a single dose of ELVN-001 or matching placebo on Day 1 after a minimum 10 hour fast. Participants in Part A will remain fasted for at least 4 hours after dosing. Part B (Multiple Ascending Dose): Participants will be randomly assigned to receiving ELVN-001 or matching placebo at a ratio of 6:2. Participants in the Part B (MAD) will receive a daily dose of ELVN-001 or matching placebo after a minimum 2 hour fast from Day 1 to Day 10. Participants in Part B will also remain fasted for at least 1 hour post-dose. Blood samples will be drawn from participants on every day of the study. It is hoped that this research will determine the safe maximum dose of ELVN-001 that can be trialled as a therapy for patients with chronic myeloid leukamia. Part C (Food Effect) After SAD Cohort 5(120mg), 12 Participants will be randomly assigned to sequence 1(S1) or sequence 2(S2) with a ratio of 1:1. Participants in S1 will receive a single oral dose of 120mg ELVN-001 on Day 1 in fasted conditions and Day 6 in fed conditions and in S2 will receive a single oral dose of 120mg ELVN -001 (with water 240mL) on Day 1 in fed conditions and Day 6 in fasting conditions.

The increasing prevalence of neurodevelopmental disorders is a global concern. Autism spectrum disorder (ASD) affects approximately 1/100 children worldwide. More so, sleep disorders (SD) co-occurring with autistic traits have been more frequently reported in 40-80% of children diagnosed with ASD. These symptom constellations are strongly associated with concomitant parental stress, reduced quality of life and an economic burden to family and society. Consequently, the National Sleep Foundation identifies children with ASD as one of the highest-priority populations for sleep research. Several risk factors have been identified in the aetiologies of ASD and SD. For instance, abnormal organisation and maturation of grey matter have been linked to a negative correlation to sleep architecture. Other studies indicate that an imbalance in GABAergic and glutamatergic systems disrupts neural signalling and development with corresponding presentations of ASD behaviours linked to SD. A study suggested a correlation between more severe core ASD symptoms in children and disruption in sleep architecture. Interventions that target these shared pathologies could hold clinical benefits for ASD and SD outcomes. Repetitive Transcranial magnetic stimulation (rTMS) is an intervention of interest due to its effect on abnormal brain functions implicated in ASD. rTMS is a non-pharmacological and non-invasive brain stimulation that uses the magnetic field generated from an electromagnetic coil placed on the scalp to alter neural structures and functions. Its clinical potential has been demonstrated in several neurological conditions, with FDA approval for use in depression. A recent study demonstrated rTMS to be effective and safe in children with ASD and SD. The study showed improved sleep outcomes based on the children's sleep habit questionnaire (CSHQ) following the use of the same rTMS protocol across participants. Such one-shoe-size-fits-all (standard) treatment approaches are thought to limit the optimisation of rTMS potential, especially within a heterogeneous population. The heterogeneous characteristics such as individual alpha frequency (IAF), stimulation frequency, and age are known determinants of the intervention outcome. A chart study of IAF-guided rTMS documented improvement in ASD symptoms and sleep outcomes. Consequently, there is a sparse study on the efficacy and safety of IAF-guided rTMS in children with ASD and SD. This study aims to evaluate the efficacy and safety of IAF-guided rTMS on ASD symptoms and comorbid SD and quality of life in children and their primary caregivers based on pre-post objective and subjective measures. For the primary outcome, the study hypothesis is that IAF-guided rTMS improve sleep quality and quantity and other SD parameters. The study design is a randomised, waitlist-controlled, open-label pilot trial.

In Australia, nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease, and results in significant healthcare burden from both liver and metabolic complications. NAFLD is defined by the presence of fat in the liver which can cause liver related morbidity and mortality through its progression to liver fibrosis, cirrhosis and increases the risk of developing liver cancer. It is strongly associated with obesity, insulin resistance and the metabolic syndrome, and weight loss is the mainstay of treatment. Weight loss can reduce the amount of fat in the liver, improve the level of liver fibrosis and improve individuals overall metabolic and cardiovascular risk. Current treatment guidelines advise dietary energy restriction, with many recommending a Mediterranean Diet (MD) which has been shown to improve liver fat and reduce the risk of developing T2DM. Despite this current treatment practices are heterogenous, and weight loss is difficult to achieve and maintain. We aim to examine whether the treatment strategies used in the medical management of obesity, such as the use of very low energy diets (VLED) and appetite suppressing (AS) medications, can be adapted to the management of NAFLD which is a related but separate disease entity. This study is a single centre, randomised control trial evaluating the effect of the VLED compared with the standard of care MD in overweight and obese individuals with NAFLD. Participants will be randomised to a 12-week program of either: 1. VLED: a ketogenic 800kcal/day diet utilising meal replacement supplements 2. The standard of care MD: a predominantly plant based diet supplemented with monounsaturated fatty acids (MUFAs) At the end of the 12 week diet, all participants will enter a weight maintenance phase where they will be instructed to follow a calorie controlled but ad-libitum diet in order to maintain their weight, with the VLED group also commenced on low dose Semaglutide as an adjunctive AS medication for 12 weeks. We will compare the impact of these two programs on the severity of NAFLD (change in degree of liver fat on MRI and liver fibrosis on liver biopsy). Other outcome measures include the degree of weight loss and weight maintenance achieved, body composition, and impact on physical activity, mood and quality of life.

Aim of the study: To evaluate the effectiveness of a culturally and contextually informed Aboriginal Diabetes Workforce Training Program (hereafter training program) on Aboriginal primary health care workforce knowledge, attitude, confidence, skill and practice relating to diabetes care. Objectives: 1. To implement the training program in Aboriginal primary health care services across South Australia. 2. To evaluate the effectiveness of the training program on Aboriginal Health Worker, Practitioner and multidisciplinary team knowledge, confidence, skill, practice and attitude related to diabetes care, and secondary outcomes relating to quality of diabetes care and patient outcomes. HYPOTHESIS It is hypothesized that the primary health care services whose workforce participate in the training program will have: - a workforce with increased knowledge, confidence, and skills to manage diabetes within the local primary health care setting, - in the longer term, improvements in the quality of diabetes care provided and patient biomedical outcomes.

The aim of this project is to assess the acceptability, usability and impact of VR in patient education to help improve patients' understanding of head & neck reconstructive surgery and decrease anxiety levels. Who is it for? You may be eligible for this study if you are aged 18 years or older and are scheduled to undergo reconstruction of the mandible for any head and neck pathology (malignant or benign). Study details Participants will undergo a 1-hour session where they will familiarise themselves with the VR technology before receiving a virtual education experience regarding aspects of the surgery and recovery. Following this, they will be asked to complete questionnaires regarding their experience of the VR system, knowledge of the treatment and anxiety levels. It is hoped that this research will help inform the development of VR for managing psychosocial outcomes in patients with head and neck pathologies.

This project aims to determine the impact of Experiential Immersive Education (iED) delivered via Virtual Reality for people with chronic pain. The project will examine the extent and nature of altered pain beliefs and attitudes after the iED treatment, and will explore perceptions of acceptability and utility. Objectives: 1. To quantify change in pain attitudes and beliefs following iED, relative to a weight-list, and minimal intervention control. 2. To establish iED feasibility, acceptability and preliminary efficacy 3. To explore potential mechanism of effect We hypothesise, that: 1. iED will lead to greater positive changes in pain beliefs and attitudes, than either control groups 2. iED will appear feasible, acceptable, and effective; and 3. Improvements in pain and disability will be mediated by fear of pain, pain catastrophising, and self-efficacy.