ANZCTR search results

This is an observational research study to identify markers that can predict poor outcome following a concussion. Following a concussion injury, information will be collected on the individual's injury and medical history, and they will participate in an exercise tolerance test, MRI scan, neuropsychological test and blood test. We hypothesize that performance on tests at the time of the injury will help predict which individuals will likely have a delayed or complicated recovery. Identifying individuals at risk of a poor recovery will help doctors modify their management of the injury appropriately, and save those likely to recovery normally from unnecessary follow-up visits.

This trial aims to investigate the use of psilocybin (a psychedelic compound) in conjunction with psychotherapy for the treatment of anxiety and depression in terminally ill patients. Who is it for? Adults aged between 18-85 years with a life threatening illness and currently under the care of a specialist physician are eligible for the study. Criteria for prospective participants includes psychological distress that was brought on by their life-threatening illness. Study details Participants will be rigorously screened, throughly prepared and supported throughout the treatment with two specialist clinicians present at all times throughout the treatment. Participants will be randomly allocated (50/50 chance) to either receive the active medication (Psilocybin 25mg) Arm 1 or a placebo (Niacin 100mg) in Arm 2. The medication or placebo will be taken once in the first arm of the study and have psychotherapy sessions with a health professional before, during and after the dose of medication/placebo. The next dose is 7 weeks later, where all participants will take the active drug, Psychotherapy sessions will take place before, during and after. All participants are followed for 26 weeks following the second dose and will be involved in interviews and questionnaires throughout the study period. Participants are followed up for 26 weeks after the second dose to ensure that we examine all changes that continue after treatment. Questionnaires and interviews are conducted throughout the study to fully understand the impact of the treatment and to monitor for safety. It is hoped that this research could potentially offer a new treatment for terminally ill patients experiencing depression and anxiety, and hopes to alleviate psychological suffering at end of life.

The primary purpose of this study is to determine if being part of an afterschool Aboriginal cultural activity program, which is developed and run by Aboriginal people, can make children healthier. Specifically, this study aims to evaluate the feasibility, acceptability and potential efficacy of an afterschool cultural program in promoting culture connectedness, positive healthy behaviours and educational outcomes, including physical activity, healthy eating, spiritual and socio-emotional well-being and positive school- and home-related behaviours, among Aboriginal children and their siblings aged 5-13 years. It is hypothesised that the afterschool cultural program will give children opportunities to learn culture, connect to Country and engage in activities that promote physical, social, emotional and spiritual health.

Cardiac rehabilitation (CR) is a secondary prevention program for cardiovascular disease with physical activity (PA) being a core component. Despite this, studies have found that PA levels are low and sedentary behaviour (SB) is high in CR patients. The aim of this randomised control trial (RCT) is: 1) to test the efficacy of a behavioural smartphone application (Vire DoACTIVE) and a 6-month online behaviour change program (ToDo-CR) in decreasing SB and increasing PA levels in CR participants (compared to routine CR alone); 2) to explore if this behavioural change intervention is effective at reducing the risk of repeat cardiac events, all cause hospital admissions and emergency department visits over 12-months post commencing CR. We propose to conduct a multi-centre RCT over 12-months with 144 participants from the Canberra Hospital, Calvary Public Hospital Bruce and National Capital Private Hospital CR programs. It is hypothesised that the intervention will increase PA levels, decrease SB and reduce repeat cardiac events, readmissions to hospital and emergency department visits.

Newly diagnosed individuals with T2D can be managed primarily by alterations to diet and physical activity (exercise) patterns, which are used to help control blood glucose. However, uptake and adherence to any behaviour change strategy is typically challenging and therefore low. Recently, time-restricted eating (TRE) has emerged as a promising therapeutic strategy that allows meals to be consumed alongside societal norms. Rather than stipulating the composition of meals, TRE aims to reduce the ‘eating window’ to facilitate a longer overnight fast (i.e. eating between 10 am-6 pm, rather than over periods longer than 12 h). Via TRE, meal timing can be aligned with the biological circadian rhythm. Specifically, an earlier dinner may contribute to better glucose control due to the known deterioration of the hormone insulin to regulate glucose declining over the day. In those with T2D, a later breakfast may also be beneficial to avoid eating at the same time as the morning spike in fasting glucose, which is known as the ‘dawn phenomenon’ in individuals with T2D and coincides with the increased circadian concentrations of cortisol, known to stimulate the liver to release glucose into the circulation. Acutely, to our knowledge, TRE has not been measured in individuals with type 2 diabetes. TRE performed over a period of weeks has been shown to effectively reduce post-meal insulin, blood pressure, and evening appetite; if continued for up to one year it has been demonstrated to result in sustained weight loss. However, there are a lack of studies investigating the acute, one-day effects of TRE, particularly in the context of other behaviours that might influence circadian rhythm. Exercise, for example, is a potent stimulus known to influence both circadian rhythm and glucose control. For individuals with T2D, just 10 minutes of walking in each of the 1 hour post-prandial period across a day is enough to improve blood glucose control. However, it is unknown whether strategically-timed exercise combined with TRE would result in an additive benefit to glucose control over the course of a day. In addition, it is unknown whether the benefits of exercise for glucose control would mitigate the detrimental effect of an extended feeding window on glucose control.

This study aimed to investigate the current vaccination coverage for influenza, pneumococcus, and herpes zoster amongst patients affected by immune-mediated inflammatory disease (IMID) and increase vaccination rates using targeted electronic and printed patient immunisation reminders, electronic health practitioner immunisation reminders, and educational activities in Australian general practice. Patients affected by IMID (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease) attending Australian general practice will be included in the study. Current vaccination coverage will be estimated based on de-identified data on influenza, pneumococcus and herpes zoster vaccinations for patients with IMID from all practices using the Doctors Control Panel (DCP) for 2013-2018, which accept to be part of the study. DCP is a well-established software package that retrieves medical information from electronic medical records and identifies preventive health care activities that are due. In the second part of the study, DCP will generate targeted electronic (SMS text message upon consultation booking and another on the day of the appointment) and printed (read in the waiting room) patient immunisation reminders to inform them about their higher risk of viral and bacterial infections and generate advice about recommended vaccines. All communication will be via the recruited practices, without intervention by the researchers. Patients who have agreed to receive SMS messages from the practice will receive a generic reminder SMS upon booking, and another generic reminder SMS on the day of their appointment. They will also receive a printed letter if they arrive for an in-person consultation. Patients who have refused to receive SMS messages from the practice or who don’t have a mobile telephone will not receive SMS text messages but will receive a printed reminder letter from the receptionist if their consultation with the GP is in the clinic. The DCP will also generate electronic GP immunisation reminders (GP computer) to inform them about patient's status regarding immunisation. The outcome measures at the end of the intervention (18 months including two influenza vaccination seasons) are 1) recorded administration of influenza, pneumococcus, and herpes zoster vaccines to patients with IMID, and 2) documented contraindications to, or refusal of, those vaccines. Compared to the baseline (Stage 1), we expect an improvement of at least 20% in vaccination coverage after the intervention (Stage 2).

Young people with borderline personality disorder (BPD) have difficulty engaging in and maintaining employment or education, despite having the desire to do so. Despite this, no randomised controlled trial (RCT) has investigated the effectiveness of targeted vocational services in this group. This is a single-centre, 52-week, parallel arm, ‘single blind’ RCT of Individual Placement and Support (IPS), compared with Usual Vocational Services (UVS). The primary endpoint is 52 weeks. The background treatment will be standardised across both groups in the Helping Young People Early (HYPE) early intervention program for BPD at Orygen Youth Health. Potential participants will be identified by liaising with HYPE clinicians with regard to clients’ vocational wishes and by using HYPE’s standardised assessment for DSM-5 BPD. Following screening and baseline assessment, participants will be assigned randomly and consecutively in a 1:1 ratio to one of two interventions – IPS or UVS. Research assessments will occur at 13, 26, 39 and 52 weeks. The primary outcome is number of days in mainstream education/competitive employment since baseline. Secondary outcomes are cost effectiveness of intervention, quality of life, and BPD severity.

When swallowed, the Atmo gas capsule consists of several gas and temperature sensors which provides information on oxygen concentrations, and therefore, passage of the capsule between aerobic (small intestine) and anaerobic regions (large intestine). That way, regional transit measurements can be accurately derived. To validate this device, simultaneous ingestion of this and an existing device measuring pH (SmartPill) to determine time comparison of gut transit will be conducted to show equivalence of the two devices in transit measurements.

Who is it for? You may be eligible for the study if you are 70 years or older and have a past history of two or more keratinocyte cancers (BCC or SCC) with at least one on lower limbs( histologically confirmed disease). Alternatively, a past history of one or more keratinocyte cancers and multiple keratotic lesions on the lower limbs. Study details All participants will be randomly assigned (50/50 chance) treatment on one of their legs. The treatment will involve VMAT radiation treatment targeted to the skin cancer. The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up to 4 weeks if necessary). The second treatment segment will deliver the remainder of the 25 fractions (13 - 15 fractions, depending on the number of prior fractions delivered) over 2.5 - 3 weeks. The other leg will serve as the control leg and will not receive any treatment. The overall treatment period will last no longer than 10 weeks. Participants will then be required to attend follow up visits 28 days, 3 months, 6 months, 9 month, 12 months, 18 months and 24 months after the end of treatment. During the study participants will answer questions about their Skin Pain and Quality of life. Benefits of this study The findings from this study will help medical researchers understand how radiation treatment with VMAT may help prevent skin cancers on people who have a high likelihood of disease recurrence.

There is consistent evidence showing that very low energy diets (VLEDs) reduce weight amongst patients with obstructive sleep apnoea (OSA) and comorbid obesity. This method of obesity reduction although effective, may be accompanied by an associated change in body composition in patients with OSA, notably concurrent loss of muscle mass. Excessive loss of muscle mass may be undesirable because this tissue is responsible for the majority of resting metabolic rate, regulation of core body temperature, preservation of skeletal integrity, and maintenance of function and quality of life as the body ages. Our study has a pragmatic design and patients will attend a commercially available high intensity functional exercise training programme. To date, there have been no randomised trials of naturalistic exercise training that is practical and may promote exercise adherence in patients with OSA. We aim to show that this model of training can protect against the loss of muscle mass, as delivered through a programme that can be readily translated to real world settings. Furthermore, we will confirm whether there is an additive benefit of this model of training in addition to a VLED in reducing OSA severity as compared to dietary induced weight loss only.