ANZCTR search results

Banana pseudo stem tender core contains nutritional compounds that are crucial for health. This project aims to assess the feasibility and tolerability of a dietary supplement derived from banana pseudo stem tender core, which is high in fibre, polyphenols and minerals, and its effect on clinical measures, gut microbiome, and urine markers. To this end, a randomised controlled trial with 46 (23 in each arm) participants will be conducted. Participants will be randomly allocated to receive either the banana pseudo stem powder (intervention) or maltodextrin (placebo) over a period of 4-weeks. Participants, investigators, assessors, and study statistician will be blinded to group allocation.

This study addresses the question of whether an augmented version of a psychological intervention (Cognitive Behaviour Therapy combined with augmentation strategies; CBT/A) to reduce severity of Prolonged Grief Disorder (PGD) more than standard CBT. CBT/A is a novel extension of the gold standard treatment of Prolonged Grief by providing training in emotion tolerance skills and positive affect awareness. The key question of the study is the extent to which this modification to CBT can promote better outcomes relative to standard CBT. This study hypothesises that CBT/A will result in greater reductions in Prolonged Grief than CBT at 6 months following treatment. Participants with PGD will be randomized to 11 sessions of standard CBT or Augmented CBT.

We do not have adequate solutions for upper-limb recovery following stroke. Insufficient therapy is delivered during critical periods of recovery, despite stroke being a life-long disability. Upper-limb recovery is possible, with clear evidence that appropriate amounts of practice are important for improvement to occur. The purpose here is to deliver an intense burst of training, comprising 90h of rehabilitation over a 5-week period. We anticipate that people who receive this intense burst of training will achieve improved upper limb function.

Inulin is a type of dietary fibres commonly found in plants such as Jerusalem artichoke and garlic. Compared to dietary fibres that are non-inulin based such as apple and watermelon, inulin-based fibres have been shown to improve sugar control and digestive health, aid weight loss and improve lipid profiles. From animal studies, we also known that the size of inulin also affects how quickly it gets to the lower gut and is being broken down into various compounds that can produce a positive health impact. However, little research has been done on humans using actual dietary fibres. This study is designed to investigate how quickly different types of inulin and non-inulin based fibres are being digested. We will also test how these different types of fibres alter the biochemical changes in the body.

Every day, two new Australians are diagnosed with motor neuron disease (MND) - a fatal neurodegenerative disease characterised by the progressive degeneration and death of motor neurons that leads to muscle weakness, physical disability, and ultimately death. The aim of this project is to understand if exercise can slow the neurodegeneration in MND, by investigating the neuroprotective potential of 16 weeks of carefully prescribed exercise on the brain, spinal cord, and muscle of patients with MND. Participants enrolled in the study will be randomly allocated to a training (TRAIN) or control (CTRL) group. Participants in the TRAIN group will perform 16 weeks of exercise training, 3 times per week, at the Victoria University Clinical Exercise and Rehabilitation (VUCER) clinic in Footscray. Participants in the CTRL group will continue their standard of care. Before, at the end of the exercise training or standard of care period of 16 weeks, and at 24 weeks, which equates to 8 weeks following cessation of intervention, all participants will be evaluated with brain imaging (magnetic resonance imaging, MRI), neurophysiological (surface electromyography, EMG) and muscle strength measurements, aerobic fitness, respiratory and functional tests. Quality of life (QoL), fatigue and functional questionnaires will be also administered to all participants. In a subgroup of participants, resting needle biopsies will be obtained from the vastus lateralis muscle in the thigh, before and at the end of 16 weeks of intervention. We hypothesise that individuals who exercise will present a reduced motor neuron degeneration in the brain and spinal cord, and a preserved skeletal muscle mitochondrial function and content, with respect to individuals in the control treatment (standard of care). This will result in delaying the disease progression by maintaining strength, physical function and independence. This multimodal approach of investigating the neuroprotective effect of exercise in those with MND will provide a fundamentally new understanding that has the potential to alter the role of exercise in the treatment of MND, and could be used to identify new targets for neuroprotective therapeutics.

The link between oral health and cardivascular disease has been proven. Currently, there is no oral health education within cardiac rehabilitation facilities within Western Sydney Local Health District. Patients living with cardiovasuclar disease and gum disease are at an increased risk of a future cardiac event. Introducing oral health education into this vunerable poopulation may reduce their gum disease and with it their future cardiac event risk.

Single centre, adaptive design, open-label, two period crossover, study to evaluate the safety, pharmacokinetics and ex vivo antibacterial effects of RECCE®327 in healthy male and female volunteers. This study consists up to 4 cohorts with 4 participants at each dose level. The first cohort will involve two infusion rates 45 minutes (Period A) and 30 minutes (Period B) of RECCE®327 at a concentration of 4 mg/ml. Each participant will begin with a single dose with RECCE®327 intravenously over 45 minutes, followed by 48 hours safety surveillance and PK data collection. Safety assessments will be performed by the investigational site study staff and reviewed (sign off) by the PI or designee before the second dose of RECCE®327 infusion over 30 minutes with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose. For the subsequent cohort, a non-DSMB committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and / or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well. the aim of this study is to investigate possible safety dose of RECCE®327 in various dose levels and infusion duration.

What is the project about? This research project aims to evaluate the outcomes of two social media psychoeducation videos. We are inviting people who have had an Instagram account for at least 1-week by the time of study participation, are over the age of 16 years, and are fluent in English. Participants are also required to have access to a smart phone, from which they are able to access their Instagram account. During the intervention, you will be requested to complete a survey to collect demographic and well-being information, before watching one of two (10 minutes or 13 minutes long) online social media psychoeducation videos and then engaging in 10 minutes of Instagram use (using your personal account). You will then be invited to complete another survey immediately following and again 3 days later. How much time will my involvement in the project take? The initial experiment and surveys will take approximately 40 minutes. The follow-up survey is expected to take 5 minutes.

This study will investigate a new drug, sodium selenate, for the treatment of drug-resistant temporal lobe epilepsy (TLE). Up to 124 patients with TLE will be recruited in to the study. Half of the patients will receive 26 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The primary outcome will be the a consumer co-designed DOOR-epilepsy rank, combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment and placebo groups over the whole 52 week period. Secondary outcomes include measures of seizures, epileptiform activity, cognitive and, neuropsychiatric outcome measures, quality of life, and medication burden at the end of 26 and 52 weeks (compared to baseline). Other measures will include safety and tolerability and exploratory biomarkers of treatment response.

Clinical protocols to manage three common complications after stroke (Fever, hyperglycaemia (Sugar) and Swallowing problems [FeSS protocols]) was shown to reduce death and disability by 15.7% for patients in the Quality in Acute Stroke Care Trial. As a result of this trial, a ‘Strong Recommendation’ to support use of the FeSS Protocols was included in the 2017 Clinical Guidelines for Stroke Management. Before the new guideline recommendation there was a significant evidence to practice gap with only 41% of patients receiving care according to the FeSS Protocols in Australian hospitals. Outside of the FeSS Intervention trials, there has been no nationwide systematic implementation efforts to introduce FeSS protocols. The aim of this research is to determine adherence to the FeSS Protocols since their inclusion as recommended care in the 2017 National Acute Stroke Guidelines. Secondary aims of this research are to: i) determine if participation in any of the previous FeSS Intervention studies (QASC, QASCIP or T3 Trial) improved adherence with the FeSS Protocols when compared with hospitals who did not participate; ii) determine if admission to an acute stroke unit when compared with patients who are not admitted to an acute stroke unit improves adherence with the FeSS protocols; iii) determine if FeSS Protocol adherence is greater for hospitals that contributed data to the FeSS optional dataset in AuSCR when compared with hospitals that did not; iv) identify what strategies or interventions have been used to implement the FeSS protocols in individual stroke services; v) identify critical individual and organisational factors, including barriers and facilitators, perceived to influence uptake and adherence of the FeSS Protocols by stroke clinicians; vi) understand barriers and facilitator variability in hospitals with high, low and variable adherence rates to FeSS Protocols, and to compare these with those previously reported in FeSS Intervention studies; vii) explore sustainability of use of FeSS Protocols for hospitals exposed to any of the FeSS Intervention studies.