ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 140 women aged 42 to 62 years experiencing menopausal symptoms will be randomly assigned to receive 2 grams daily of a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark (Khapregesic) or a placebo for 28 days. Changes in menopausal symptoms, sleep, and fatigue will be assessed before, during, and after the intake of the investigational product. It is hypothesised that compared to the placebo, Khaya Senegalensis will be associated with greater improvements in menopausal symptoms, sleep and fatigue.

The purpose of this protocol is to allow for subjects who have previously been enrolled in and completed an Avalyn Pharma Sponsored study of an inhaled antifibrotic, such as AP01, to continue therapy until drug approval, study termination, or withdrawal of the subject from the study.

This study aims to evaluate (1) the effectiveness outcomes for older carers participating in the Carer Health and Wellbeing Service; (2) the implementation outcomes associated with the Carer Health and Wellbeing Service – including feasibility, reach, acceptability (carers, Service staff, referrers), maintenance and fidelity; and (3) the cost-utility of the Carer Health and Wellbeing Service. It is hypothesised that the Carer Health and Wellbeing Service will improve carer preparedness to care and other carer outcomes, be cost effective, and will be acceptable and feasible to implement.

This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery via a novel insulin patch pump in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 72 hour period, along with device survival over the same period. Accuracy of the device will be tested in both a free living state, as well as over two seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.

The purpose of the study is to investigate the intra-articular injection of growth hormone in combination with a carrier for arthritis in the knee and ankle. The hypothesis of the study is the intra-articular injection of growth hormone will increase healing of arthritic or injured joints when compared to standard treatment. The patients are to be referred by their GP to be recruited to the private surgical clinic. The pain and mobility of the joints will be measured by using the American Orthopaedic Foot and Ankle Society (AOFAS) and American Knee Society (AKS) indexes to test the mobility of the ankle and knee respectively.

The purpose of this study is to test the effectiveness and safety of the investigational medication in the threatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in at risk adults. This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of (MASH). Approximately 60 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 2:1. GL0034/Placebo is administered weekly as a subcutaneous injection for a period of 24 weeks, The dose will be increased gradually for a period of 20 weeks (called the Dose Titration Period) and then will remain at a fixed dose for 4 weeks (called the Final Dose Period)

Paramedics worldwide have a higher prevalence of PTSD, anxiety, and depression than the general population. Paramedicine students predominately enter the profession without preventative techniques to manage stress, depression and fatigue. The objective of this study was to examine the effect of Transcendental Meditation Technique (TM) on the well-being and resilience of paramedicine students.

A 2-arm randomised clinically controlled trial to determine if there is a difference in palatal volume and surface area between conventional expander appliance and appliances fabricated by a clear aligner company. The study intervention includes the placement of rapid palatal expander appliances or clear aligner expander appliances. The rapid maxillary expanders are adjusted at home by the participant using a key which expands the device; the clear aligner expanders are removed and replaced at home with sequentially expanded appliances. The palate is then scanned and the palatal volume measured digitally. The palatal volume is used to determine if there are any significant differences in expansion of the palatal between the appliances..

Rising inadequately- or un-treated disruptive disorders are expected to increase family dysfunction and violence, academic underachievement, school drop-out, psychiatric and physical illness, harmful substance use, poor quality of life, and impairing financial, occupational, and relationship difficulties, raising annual societal costs for disruptive disorders that exceed $20.4 billion. This project aims to overcome these major obstacles to improving the mental health and wellbeing of the most vulnerable Australian children by delivering an accessible, comprehensive school-based early intervention—iteratively co-designed with school endusers—to diverse children with disruptive behaviour disorders living in culturally and linguistically diverse (CALD) and rural communities. The effectiveness and cost-effectiveness of this enhanced intervention and its mechanisms of action will be evaluated from baseline, posttreatment and follow-up assessments conducted by clinically trained research staff, within a cluster randomised controlled trial design. A novel technology- and interpreter-assisted intervention protocol will be used to deliver treatment to non-English speaking CALD families for the first time. If successful, the outcomes of this research will provide new knowledge to the field on how to address the critical shortcomings of current gold-standard interventions for child disruptive behaviour problems.

The Chronic Myeloid Leukaemia: Treatment-Free Remission Registry (CML-TFR) is an observational registry for participants with CML in chronic phase who are in molecular remission on Tyrosine Kinase Inhibitor (TKI) treatment and are planning a trial of TKI drug cessation with the objective of Treatment-Free Remission (TFR). Who is it for? Participants may be eligible for this study if they are an adult who has been diagnosed with chronic myeloid leukaemia, have completed a minimum of 3 years TKI therapy, and are intending to stop TKI treatment based on their treating clinician’s advice. Study Details All participants in this study will enter this registry before stopping their TKI treatment. No intervention will be provided to participants as part of this study, participants will stop their TKI treatment as prescribed by their treating clinician. For this study, participants will undergo an informed consent process. Following this the screening process will begin where a series of data including blood test results relating to the participant’s CML diagnosis are collected from participants medical records. A research blood sample will be collected on the day before stopping their current TKI treatment. Results from CML blood tests requested by the treating clinician will be collected from participants medical records every 3 months for up to 5 years unless a participant experiences relapse or requires re-treatment. If a participant requires retreatment with TKI, participants will be followed for a further 1 year from commencing re-treatment. This registry will provide valuable descriptive data on TFR in Australia and will enable the validation of biomarkers to identify patients with a higher chance of achieving long-term TFR, as well as those with a lower chance of TFR in whom investigational approaches might improve the TFR outcome.