ANZCTR search results

Evidence from scientifc studies demonstrate positive effects of ingredients Ginseng (Cereboost), Bacopa and Coffee fruit extract as isolated components, on various mechanisms that impact cognitive performance and mood. For example, Ginseng and Gingko have been shown to enhance cognitive performance after acute dosing whilst Bacopa has been shown to have effects primarily with chronic dosing. To date however, the effect of these combined ingredients on cognition, behaviour and brain functioning as a result of chronic dosing has not been evaluated. The study involves a four-week supplementation period followed by a two-week washout period. Measures of cognitive performance, behaviour, and BDNF levels are undertaken at baseline (presupplementation), postsupplementation (week 4) and at the end of the washout period (week 6) to assess potential supplementation effects on cognitive performance and functioning. This research seeks to understand any changes in cognitive performance and brain activation patterns using standardized cognitive tasks and a non-invasive functional near infrared spectroscopy (fNIRS), measured both before and after taking the active or placebo supplement.

Breathlessness is a distressing and incapacitating symptom, responsible for a high proportion of healthcare separations and costs with far-reaching consequences in terms of affected individuals’ quality of life, independence, community interactions and workforce participation. Patients suffering refractory breathlessness and their caregivers feel that awareness of the symptom burden amongst healthcare providers and provision to address this burden within healthcare services is lacking. Breathless Clinic (BC), is a 9 week, predominantly home-based, multidisciplinary “clinic” for COPD patients with refractory dyspnoea. Through BC an individualised treatment plan is developed, comprising a variety of non-pharmacologic interventions to help patients manage their breathlessness in the community. Hypothesis: Participation in BC will result in an improvement in patients' ability to cope with breathlessness, as evidenced by improvements in measures of breathlessness impact (breathlessness severity and intensity, symptoms burden, depression and anxiety, health status status and health-related quality of life). Participation in BC will also reduce healthcare outcomes such as healthcare usage and respiratory exacerbations (flares of COPD).

A randomised controlled trial (RCT) will be conducted at Monash Children’s Hospital on infants less than 6 months of age with suspected Hirschsprung disease, requiring a suction rectal biopsy. The study will be an open-label (unblinded) randomised controlled trial: due to the nature of the intervention (i.e. different appearance of the rbi2® and SBT200®) biopsy forceps blinding is not possible. The hypothesis to be tested is that the SBT200® SRB forceps will have lower rates of inadequate specimen sampling, lower re-biopsy rates and lower or comparable complication rates. The proposed sample size for this trial is 40 children in total with 20 in each arm. Since the SBT200® is a brand-new device, no data is available regarding the rate of insufficient biopsy. The sample size has been chosen on feasibility based on the number of patients investigated for Hirschsprung disease each year at Monash Children’s Hospital (20-30) with the aim of completing the trial within 18-24 months. Primary endpoints for the trial will be the effectiveness and the complications with each SRB forceps - Number of biopsies attempted at each episode - Number of inadequate specimens obtained - Number of biopsy episodes performed - Complications: o Bleeding requiring admission/blood transfusion o Rectal perforation o Pelvic abscess/sepsis

Endometriosis is a common inflammatory condition affecting women during their reproductive years, with potentially debilitating sequelae in the form of subfertility and chronic pain. Endometriomas are common, occurring in up to 44% of endometriosis cases. Surgical cyst excision is the mainstay treatment for endometriomas, however surgery is often detrimental to ovarian reserve. Conventional technique using manual stripping of endometriotic cyst from the ovarian cortex is commonly associated with inadvertent removal of healthy ovarian tissue. Therefore, current standard surgical treatment of endometriomas carries the caveat of further contributing to the fertility burden of patients, in whom ovarian reserve might already be compromised. A surgical technique using vasopressin has been shown to result in reduction in the need for bipolar diathermy in several small studies. This promising benefit of VIT also appeared to improve post-surgery ovarian reserve in one study. However, the data on the proposed benefits of this technique remains limited in the literature. Therefore, given the clear need for a less damaging surgical approach than standard approaches and the dearth in the literature of evidence of the efficacy of the use of vasopressin for the excision of endometrioma, we seek to elucidate the purported usefulness of this technique for the treatment of endometrioma and its potential benefit on ovarian reserve and endometriosis-related quality of life.

There is overwhelming evidence that adverse social and economic conditions have a negative impact on the health, welfare and development of children. Poor education, unemployment, financial and food insecurity and housing instability are linked with poor nutrition, developmental problems, increased risk of dysfunctional psychosocial behaviour and short- and long-term diseases of childhood and into adulthood. The American Academy of Pediatrics recommends that healthcare providers should routinely screen for and adopt interventions that address social risks as a mandatory aspect of healthcare. Innovative multidisciplinary team-based approaches are critical in hospital systems to identify social risk factors, and to refer families with unmet needs to community-based resources. The Lyell McEwin Hospital is the principal tertiary hospital serving a substantially disadvantaged community, with several suburbs in its catchment having significant relative disadvantage across a number of indicators. Australian Bureau of Statistics data show that families living in this catchment area have poorer educational achievement, greater unemployment, lower income and greater mortgage or rental stress compared with other areas. This is a 2-arm randomised control trial that will test electronic collection of a new social needs screening tool that will be adminstered either face-to-face with a health worker/researcher or be self-completed. The study will be conducted at the Lyell McEwin Hospital. The proposed study population includes adult parents/legal guardian(s) of children aged 0-5 years admitted to the Children’s Ward. Currently, there is no screening tool used in the Children’s Ward to identify social needs of families and this study will help determine the acceptability and feasibility of implementing such a tool.

The earlier KARVIAH Project recruited (n= 105) participants who took either curcumin or placebo orally for a period of 12 months. Participants were between the ages of 65-90 years living in retirement living accommodation or similar. Each participant undertook a health review, including general demographics, age, education, health and medication history and vital signs. During the study a comprehensive cognitive assessment was taken, blood drawn, lifestyle questionnaires completed (exercise, nutrition and sleep quality), as well as cerebral Magnetic Resonance Imaging (MRI); amyloid beta positron emission tomography (Aß- PET) and fluorodeoxyglucose (FDG-PET), The KARVIAH_XTND study will investigate biomarkers and longitudinal quality of life measure post curcumin intervention, as well as non-modifiable and modifiable lifestyle and health risk factors which may influence cognitive function.

The purpose of this study is to assess the safety and tolerability of GBT021601, as well as the pharmacokinetics (PK- how your body uses the drug) and whether ingesting food has an effect on how your body uses the drug. GBT021601 will be tested in 124 healthy participants aged 18 to 55 years. In Part A 64 participants will be administered a single dose of GBT021601 as oral tablets or capsules and followed up for 98 days for safety and PK assessments.

The first five years of life is an important period for establishing children’s liking and intake of vegetables. About half of Australian children aged 2-5 years attend formal early childhood education and care, where they consume 40-60% of their daily food intake. Therefore, early care and education settings can play a pivotal role in shaping young children’s dietary intake and there is a need to better support early care settings to provide supportive environments for promoting vegetable intake. The aim of this study is to evaluate to effectiveness of a multi-component initiative package for increasing children’s vegetable intake in long day care. The multi-component initiative package will comprise initiatives developed and tested in an earlier study, which support cooks to provide more vegetables on the menu, provide training for educators to encourage children to taste and enjoy vegetables at mealtimes, and support educators to teach a sensory and experiential vegetable-focused curriculum.

Anxiety disorders affect up to 40% of children on the autism spectrum, with many more showing sub-clinical levels of elevated anxiety. As anxiety can negatively impact many areas of a person’s life, including well-being and academic performance, it is important to develop ways to minimise its occurrence. One such intervention targeting anxiety is the Cool Little Kids group parenting program. Although originally developed for typically developing pre-schoolers, this intervention has shown promise in reducing anxiety in children on the autism spectrum. To better tailor this program for this population, the intervention has been modified to incorporate topics pertinent to anxiety in autism, specifically the intolerance of uncertainty. This study aims to determine the efficacy of this modified Cool Little Kids program on the reduction (or prevention) of anxiety in young children with autism (4- to 5-years-old). It is predicted that parental participation in this program will be associated with a reduction (or prevention) in their child’s anxiety level.

Within Australia, suspected cardiac chest pain represents nearly 1 million emergency department (ED) presentations every year. Most patients are eventually not diagnosed with acute coronary syndromes (ACS). Further, the clinical work-up of patients with suspected ACS is laborious and complex, often leading to unnecessary invasive tests. In an effort to improve decision-making, and thereby reduce unnecessary risk to patients and associated health-economic impacts, this study will elucidate the pivotal role of artificial intelligence (AI) as an aid in ACS diagnosis. This study will implement and evaluate the system-level intervention of AI-based decision support for clinical assessment of suspected cardiac chest pain in the reduction of death, myocardial infarction and 12-month readmissions. Further, the study will also provide the cost-effectiveness of embedding AI-based decision support in routine clinical assessment of suspected chest-pain and ACS.