ANZCTR search results

This is a randomised, double-blind, placebo-controlled study investigating the effects of the herb ashwagandha on cognition, sleep, and energy in children with parent-reported concerns in attention, memory, and concentration. In this 8-week, multi-national study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two gummies a day containing 150mg of ashwagandha or placebo. We will assess changes in cognitive performance through the completion of a computer-based test that assesses various cognitive skills (e.g., attention, working memory, and episodic memory), and parent-report questionnaires that assess children’s mood, cognitive/executive function, fatigue, and sleep. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, sleep and energy levels.

This is a randomised, double-blind, placebo-controlled, multi-national study investigating the effects of the herb ashwagandha on cognition, energy, and mood in adults presenting with self-reported cognitive complaints and low energy. In this 8-week, study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two capsules a day containing 300mg of ashwagandha or placebo. We will assess changes in cognitive performance through the completion of a computer-based test that assesses various cognitive skills (e.g., attention, working memory, and episodic memory), and self-report questionnaires that assess, mood, cognitive/executive function, and fatigue. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, mood, and energy levels.

Estimated to affect one in eight adults, osteoarthritis (OA) is a highly disabling disease resulting in the unsurpassed risk for mobility disability, especially in those above 65 years of age. Medical treatments for OA have mainly targeted the symptoms of the disease, rather than the underlying pathologies responsible. Pain management with analgesics and steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) were, and still remain, the mainstay of treatment with joint replacement the only option for end-stage OA. There is no evidence that steroidal or NSAIDs provide any beneficial effects on the underlying pathologic abnormalities which exist in OA joints. Dyslipidaemia is the presence of abnormal concentrations of lipoproteins in the blood; more specifically, high levels of low-density lipoproteins (LDLs) and, usually, low levels of high-density lipoproteins (HDLs). Hypercholesterolemia was associated with both unilateral and bilateral knee OA and high serum cholesterol and/or triglycerides were associated with both knee and generalized OA. PPS mediates the release, from endothelial cells and the liver, of lipoprotein lipases which split triglycerides into free fatty acids and glycerol providing a lipolytic effect. PPS has other useful properties for the amelioration of the pathophysiology and symptoms of OA. It inhibits the formation of activated factor Xa resulting in a limited anti-coagulant activity. In human patients, a recent pilot open-label study (ACTRN12619000047190) conducted by the University of Sydney aimed to target dyslipidemia in OA participants by oral administration of PPS. Pain and function information from participants were collected to determine if improvements in dyslipidemia would also result in clinical improvements of symptoms associated with knee osteoarthritis. The study outcomes revealed oral PPS significantly improved pain, stiffness, and other functional measures in these patients. The study's secondary outcomes also showed a statistically significant decrease in total and LDL cholesterol and a positive change in self-reported outcomes and severity knee pain score, measured using KOOS and NRS scale together. The self-reported pain, stiffness, and functional outcomes show a significant positive improvement. This indicates good potential for the further randomized double-blinded placebo-controlled study to demonstrate the beneficial effects of PPS in knee osteoarthritis clinical outcomes.

The overall aim of this research is to test whether Emotional Working Memory Training (eWMT) can be used as a form of treatment for Social Anxiety Disorder (SAD) symptoms. eWMT will be compared with the treatment outcomes of internet-based Cognitive Behavioural Therapy (iCBT; eWMT vs iCBT). An initial pilot study testing the methodology of this experimental study with a mixed non-clinical and clinical sample has already been completed. The experimental study will also contain individuals diagnosed with SAD and elevated levels of social anxiety.

A pilot randomised controlled trial of a co-designed health/education model aiming to improve educator identification and support of children with emotional and behavioural difficulties and family uptake of services to manage child emotional and behavioural difficulties. Hypotheses Primary hypothesis - a structured collaborative model will be feasible and acceptable within Victorian primary schools Secondary hypotheses - the model will result in: - earlier and more accurate teacher identification of children with emotional and behavioural difficulties - A reduction in emotional and behavioural difficulties - increased referral to and parent uptake of health services for the assessment and treatment of these difficulties

This study is investigating the usefulness of a new type of positron emission tomography (PET) scan, targeting “prostate specific membrane antigen” (PSMA), in patients being treated for metastatic clear-cell renal cell carcinoma. Who is it for? You may be eligible for this study if you are 18 years of age or older and have metastatic clear-cell renal cell carcinoma, are about to commence treatment with at an anti-VEGF TKI and can tolerate PET scan procedures. Study details Participants will undergo usual standard of care treatment including standard CT diagnostic imaging and blood tests, which all treatment decisions will be based upon. They will also undergo a PSMA-PET scan at 3 timepoints; baseline, 4 weeks and 12 weeks, and these results will purely be for research use. The additional PSMA-PET scans are anticipated to take approx 180 mins and will involve injection of a small dose of radioactive tracer into one of your veins. Information from this study will be used to better understand whether such PSMA-PET scans are useful for visualising patients’ tumours after they have been treated.

Bulimia Nervosa (BN) and Posttraumatic Stress Disorder (PTSD) commonly co-occur, and cause great distress to sufferers. One suggestion for the lack of treatment success for patients with this co-morbidity is the lack of attention paid to the maintaining factors, such as PTSD symptoms. Thus, this study will address a treatment gap by focusing upon whether addressing the traumatic memories of patients with BN/PTSD improves eating disorder and trauma related outcomes. The data gained from this study will facilitate modifications to the newly developed therapy, Memory Reconsolidation Therapy, which may improve the effectiveness of the treatment for patients. The information may also be used to inform pilot randomised controlled trials, or studies in populations with other disordered eating behaviour (e.g., binge eating disorder). This is a case series trial, which will recruit approximately 6 participants with BN and PTSD. Questionnaires will be administered prior to treatment, immediately after treatment, and three months after treatment concludes. Progress questionnaires will be administered every session. The treatment will consist of four phases, including: intake and assessment; brief psychoeducation on emotions; memory reconsolidation therapy with imagery rescripting; and termination of the therapy. Primary Hypotheses • It is proposed that adult participants diagnosed with Bulimia Nervosa BN and PTSD will significantly improve in eating disorder symptoms, as measured by the EDE-Q, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that adult participants diagnosed with BN and PTSD will significantly decrease scores on the PCL-5 over 12-16 sessions of treatment. This improvement will be maintained three months post-treatment. Secondary Hypotheses • It is proposed that adult participants diagnosed with BN and PTSD will report significantly decreased negative beliefs about emotions, as measured by the BAEF, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that adult participants diagnosed with BN and PTSD will report significantly decreased posttraumatic cognitions, as measured by the PTCI, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that the self-reported frequency of objective binge eating episodes, self-induced vomiting, laxative misuse, and excessive exercise will decrease over the course of treatment.

Each year, researchers and doctors work to find better tests, treatments, and services for children. They often use questionnaires that ask about a child’s general health (also called ‘health related quality of life’ (HRQoL)) to understand how these tests, treatments and services improve children’s lives. However, sometimes this can be hard as there is a lack of HRQoL questionnaires available for children aged 2-4 years old as well as a lack of evidence for how these questionnaires perform in children of this age group. This study has adapted a commonly used questionnaire for slightly older children (EQ-5D-Y) for children aged 2-4 years. We will compare how this new adapted questionnaire performs compared to the other currently available HRQoL questionnaires for children in this age group. This will involve collecting an initial and follow-up survey from participants. The follow-up survey will be a simplified version of the initial survey that will be sent 2-8 weeks after completion of the first survey. The performance of the new adapted questionnaire will be analysed and compared to the performance of other HRQoL questionnaires for children aged 2-4 years. We will also look at how the performance compares by child age and disease group. We plan collect data on 400 Australian children aged 2-4 years (from children who are well through to those that are very sick). The primary objective of the study is to understand how well the new adapted questionnaire (adapted version of the EQ-5D-Y) performs compared to other currently available child HRQoL questionnaires for children aged 2-4 years (i.e. consistency, acceptability, feasibility, reliability, responsiveness and validity). Another objective of the study is to provide a validated EQ-5D-Y version for young children that is ‘fit for purpose’ in judging the effectiveness and cost effectiveness of child interventions.

The primary objective of this study is to evaluate the feasibility of conducting a trial comparing the efficacy of a multifaceted, non-surgical intervention (including self-management advice, footwear, foot orthoses and foot exercises) versus usual care (self-management advice) for reducing pain associated with hallux valgus (also known as 'bunions') in women aged 40 years and over. Feasibility will be assessed using measures of demand, acceptability, adherence, adverse events and drop-out rate. The secondary objective is to obtain statistical parameters to inform the main trial sample size calculation and providing signal of efficacy to justify the future main trial.

This study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of an experimental new drug, ANPA-0073 being developed for the treatment of Pulmonary arterial hypertension