ANZCTR search results

This is a pilot feasibility trial of freeze-dried plasma vs standard therapy for patients with haemorrhagic shock receiving pre-hospital blood (Population). This will be an open label, randomised controlled trial. The Intervention will be freeze-dried plasma, obtained for the trial from the German Red Cross (LyoPlas N-w). The Comparator will be standard care, which in the Australian context is no plasma or other clotting factor replacement. The primary Outcome will be feasibility of implementation, measured by the proportion of randomised patients who complete the intervention. Secondary outcomes, assessed for possible use as primary outcomes in any subsequent definitive trial, will include mortality at 24 hours and at hospital discharge, coagulation status on arrival to hospital, and total blood product use within 24 hours of hospital arrival.

This trial will examine the use of Transcranial Magnetic Stimulation (TMS) in outpatient settings for moderate to severe MA dependance. Specifically protocols of TMS involving intermittent Theta Burst TMS (iTBS) to the left Dorso Lateral Pre Frontal Cortex (DLPFC), followed by continuous TBS (cTBS) to the left Orbito Frontal Cortex (OFC). Methamphetamine (MA) use and dependance is widespread with significant harms to individuals and others, but limited treatment options of modest effectiveness are available. TMS/TBS are non-invasive treatments that place a coil on the scalp to create magnetic fields that excite/stimulate cells in specific areas of the brain. It is is a promising treatment for substance dependance, with studies documenting positive outcomes for cravings in tobacco, alcohol and cocaine dependance. Importantly, the safety of TMS/TBS protocols have been extensively documented with over a decade of use in a wide variety of clinical settings including depression. There is expert agreement of the safety of TMS /TBS for substance use disorders.

Aim The aim of this project is to determine if adults who stutter have superior quality of life (QOL), psychological well being, and speech functionality following 5 months access to an online social anxiety treatment for adults who stutter, known as iGlebe, compared to standard psychological services in the community. Objectives Primary objective: To compare quality of life with adults who stutter pre­-treatment and 12 months post­-treatment who have been randomly allocated to iGlebe or standard community practice, using the Overall Assessment of the Speaker's Experience of Stuttering (OASES). We are comparing the outcomes of participants from two groups: an online cognitive behaviour therapy program for social anxiety and standard psychological services in the community. Standard community care may consist of various service provisions, varying in cost, for example, private service providers or community health services. Participants in the standard care group can choose whichever option suits their individual circumstances. Secondary objectives: To measure levels of speech related anxiety and speech functionality pre-­treatment and 12 months post-­treatment for adults who stutter and who have been randomly allocated to iGlebe or standard psychological services in the community. Measures include self­-reported stuttering severity, situation avoidance and a range of anxiety measures. Hypotheses 1. Participants who receive treatment with iGlebe will demonstrate significant improvements in Quality of life as measured by the Overall Assessment of the Speakers Experience of Stuttering (OASES), total score, at 12 months post­ randomisation compared to standard community services. 2. Participants who receive iGlebe will demonstrate significantly greater improvements in social anxiety than participants in the standard care group. 3. Participants who receive iGlebe will report significantly lower self-­reported stuttering severity ratings than participants in the standard care group.

Sixty-thousand people in Australia die every year in residential aged care facilities (RACFs) but the quality of their end-of-life care varies. The IMPART program aims to improve palliative care in residential aged care (RAC) using telehealth. We will provide training and palliative-geriatric support to aged care staff and general practitioners (GPs) to enable timely end-of-life discussions, improve documentation of care preferences, and therefore enable preference-based care, reduce unplanned hospitalisation and improve residents' quality of care at the end of life.

This study is being conducted in partnership with the Stroke Foundation by Professor Ian Kneebone, Dr Brooke Ryan, and PhD student Rebecca El-Helou. Additionally, Dr Jeffrey Rogers, Dr Di Marsden, and Professor Andrew Baillie also are members of this research project and informed it’s development.The purpose of this research is to evaluate the online Mood Assessment Post Stroke Training program. The aim is to determine whether the training improves self-efficacy, knowledge, and skills in screening for mood problems in stroke survivors, including those with cognitive or communication deficits.

Mastectomy (breast removal) and reconstruction surgery is a common treatment and preventative measure for women who have or are at risk of developing breast cancer. Reconstruction of the breast using artificial implants is common but not without risks. This study aims to investigate the safety of a novel 3D bio-scaffold device that can be implanted together with the patient's own fat tissue for reconstruction of the breast post-mastectomy. Who is it for? You may be eligible for this study if you are an adult woman aged between 22 and 69 years of age who is scheduled to undergo a mastectomy and breast reconstruction surgery either for confirmed breast cancer, or as a precautionary measure for the prevention of breast cancer. Study details All participants who choose to enroll in this study will undergo a mastectomy (breast removal) and reconstruction surgery. During the reconstruction surgery, rather than inserting an implant the surgeon will insert a 3D bio-scaffold that is designed to give shape to the breast. After an initial month of recovery, fat from other regions of the body will be transplanted to the scaffold to create the breast shape. It is anticipated that the bio-scaffold will absorb into the body over the 12-18 months post-surgery. All participants will be asked to complete a series of questionnaires at yearly intervals for up to 5 years post-surgery. These are anticipated to take no more than 20 minutes at each yearly interval. It is hoped this research will contribute to the process development of new interventions to help other women facing breast reconstruction after breast loss. Participants may also benefit from an overall improved self-assessment of their body image as liposuction from areas with excess fat is needed for redistribution to their breast mound.

There is some evidence that A2 beta-casein versus A1/A2 beta-casein milk has beneficial effects on immunity, inflammation, gut health, and cognition function through multiple blinded RCTs (Trivedi 2017; Jianqin 2015; Ho 2014; Deth 2015). We hypothesise that consumption of A2 milk will reduce markers of inflammation and improve gut health and cognitive performance in healthy individuals. This study will test the effect of A2-only beta-casein milk as compared to A1/A2 beta-casein containing milk in a double-blind, randomised controlled trial. Healthy young adults will be randomised to recieve either cow's milk containing only A2 beta-casein protein, or cow's milk containing both A1/A2 beta-casein for 14 days. Participants will be asked to complete questionnaires, have a blood sample collected, and provide a faecal sample at the start and end of each intervention period. Participants will also be asked to follow a standardised diet for the entire study and will have their main meals provided, including during a run-in period (14 days), during each intervention period (2 x 14 days), and washout period between interventions (14 days).

Depressive symptoms are common in young people with early or emerging psychosis (YPEEP), occurring in up to 75% of this client group. It is essential to establish safe, effective and acceptable treatments for depression in YPEEP as depression is associated with poor outcomes. Meta-analyses show that Behavioural Activation (BA) therapy is as effective in the treatment of depressive symptoms as Cognitive behavioral therapy (CBT) in the general population. "BA is a structured, brief psychotherapeutic approach that aims to: (a) increase engagement in adaptive activities (which often are those associated with the experience of pleasure or mastery), (b) decrease engagement in activities that maintain depression or increase risk for depression, and (c) solve problems that limit access to reward or that maintain or increase aversive control”(Dimidjian et al. 2011:3-4). Theoretically, BA may also help depressed YPEEP reconnect with positive experiences by using activity monitoring and goal-led activity scheduling. Importantly, BA is an intervention that can be delivered high levels of fidelity by non-specialist clinicians and requires minimal training, which would be of particular benefit in areas with a lack of psychologists, such as the NT. The project will establish the feasibility of clinician delivered BA as an adjunct to usual care for young people with early or emerging psychosis (YPEEP). This will inform the design of a subsequent full, appropriately powered randomized controlled trial.

There is some evidence that A2 beta-casein versus A1/A2 beta-casein milk has beneficial effects on immunity, inflammation, gut health, and cognition function through multiple blinded RCTs (Trivedi 2017; Jianqin 2015; Ho 2014; Deth 2015). Another component of milk, lactoferrin, is thought to have immuno-modulating properties (Kell, 2020). When consumed orally, lactoferrin is mostly absorbed, with a small amount reaching the lower bowel (Yamuchi, 2006). In humans, orally consumed bovine lactoferrin has improved systemic and gut immunity (Sachdeva, 2009; Yamuchi, 2006). We hypothesise that consumption of A2 milk, in conjunction with lactoferrin, will reduce markers of inflammation in healthy individuals. This study will test the effect of A2-only beta-casein milk fortified with bovine lactoferrin, as compared to A1/A2 beta-casein containing milk without lactoferrin fortification in a double-blind, randomised controlled trial. Healthy young adults will be randomised to recieve either cow's milk containing only A2 beta-casein protein plus lactoferrin, or cow's milk containing both A1/A2 beta-casein without lactoferrin for 14 days. Participants will be asked to complete questionnaires, have a blood sample collected, and provide a faecal sample at the start and end of each intervention period. Participants will also be asked to follow a standardised diet for the entire study and will have their main meals provided, including during a run-in period (14 days), during each intervention period (2 x 14 days), and washout period between interventions (14 days).

ConsCIOUS-3 is a single site, randomised control trial, using the trial drug dexmedetomidine or placebo given during general anaesthetic induction. The primary objective of this study is to determine whether a commonly used anaesthetic drug and sedative, dexmedetomidine, may reduce rises in the Bispectral Index. Healthy participants, aged 18-40, will be recruited from surgical lists and enrolled prior to surgery. Data collection will occur intra-operatively, post-operatively in recovery and at 24-hours and 7-days post-operation.