ANZCTR search results

The study is a multi-site, comparator, retrospective, observational study to evaluate the safety of repeated dosing of methoxyflurane for the treatment of acute pain. The study will collect clinical laboratory and observational data to characterise the safety of methoxyflurane. A comparator group of non-methoxyflurane treated patients with burns or wound injuries will be included to further determine adverse events that may be associated with methoxyflurane administration. All relevant data will be collected from patients admitted to study hospitals for the treatment and management of burns or other wound injuries that will require interventions that may cause pain and/or discomfort and require analgesia for the management of acute pain. Patients included in the methoxyflurane group will have been administered no less than 4 doses of methoxyflurane, including a minimum of 2 doses in the first 7 days. The comparator group will have received analgesia (such as nitrous oxide) for treatment of acute pain. Particular emphasis will be directed toward those patients who have received a larger number of doses for a longer time period, as these patients may be considered at higher risk of an adverse event occurring.

We are aiming to assess the potential differences in immune cell proportions between healthy and diabetic individuals. We hope to identify these differences in order to decipher the gap in knowledge regarding the immune system, diabetes and heart failure.

In Australia, approximately 1 in 6 women has experienced domestic violence over her lifetime. Often the first professional an abused woman sees is her healthcare provider offering a unique opportunity for support. South Asian women are over-represented in domestic violence crisis service data but under-identified in general practice. HARMONY is a cluster randomised controlled trial testing the effectiveness of an intervention in primary care for doctors to sensitively identify, appropriately support and refer women, especially South Asian migrant and refugee women experiencing family/domestic violence. This study is adapted from a successful UK model and is being trialed in 28 general practices in high migrant regions in Melbourne. The intervention combines: (i) family violence training for all clinicians provided jointly by a GP trainer and bilingual family violence advocate; safety and confidentiality training for all reception staff, (ii) secondary consultation and feedback for clinicians by the bilingual family violence advocate, and (iii) family violence advocate support for victims referred from intervention practices. All practices will have innovative software tailored specifically to improve routine recording of family violence and migrant/refugee status in GP electronic data.

The study aims to see if it is feasible and acceptable to patients, families and carers as well as staff to use pulse oximetry to help keep patients safe while they are in a psychiatric intensive care unit. Pulse oximetry is a proven technology that is widely used in other medical and health settings. This is a new application of the technology. Participation in the study is voluntary and non-participation or withdrawal from the study at a later stage will not affect the treatment received at the unit.

We propose to study the effects of 3 month supplementation of CoQ10 on cognition versus placebo using a randomized controlled trial methodology. Our focus will be on older participants as this may be a sensitive age for cognitive improvement given that normal increasing age is associated with cognitive decline-particularly memory, the levels of CoQ10 decreases with age, there is increased deterioration in the cardiovascular system with age and finally there is increased oxidative stress with age and less anti-oxidant protection with age. All of these indicators suggest that supplementation with CoQ10 could improve cognitive function in the elderly. Apart from our sensitive cognitive battery we will also measure changes in blood levels of CoQ10 and oxidative stress (F2 Isoprostanes and glutathione peroxidase) as well as markers of cardiovascular function (Blood pressure, arterial stiffness and blood flow).

Cellulitis, a spreading skin infection treated with antibitoics, is routinely stratified according to severity and patient risk factors. Moderate-severity cellulitis is commonly treated with short-course intravenous antibitoics followed by oral antibiotics. This is some evidence to suggest moderate-severity cellulitis could be safely treated with oral antibiotics. This prospective, single-blinded trial will assess the efficacy and safety of oral antibiotics for the treatment of moderate-severity cellulitis. Participants will be randomized to treatment with either oral or intravenous antibiotics and assessed for rates of treatment success and complications.

In this study pharmacists trained in health coaching will provide coaching to patients with poorly controlled hypertension. Patients will receive three health coaching sessions with the pharmacist. The aim of this project is to determine if there is an association between health coaching provided by a community pharmacists and an improvement in blood pressure and medication adherence. The project will also look at the change in patients health behaviours through the study through assessing patient’s stage of change from a stages of change chart. The project will also look at the opinions and attitudes of the pharmacist health coaches throughout the study as well as those of the patients. An improvement in patients’ blood pressure is also expected at the end of the study as well as their health behaviours. It is also expected that patients will have an improved understanding of high blood pressure and its management.

A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)

Abnormal lung function is common in Parkinson’s Disease (PD) and contributes to reduced physical activity, fatigue, problems with speech and swallowing, aspiration pneumonia, and functional decline. Lung function tests show evidence of airway obstruction, reduced compliance of the lung and chest wall and decreased ventilatory muscle strength. There is limited information available on interventions that improve ventilatory muscle strength in PD. Some studies suggest that such programs may not only improve exercise capacity but also walking, balance, fatigue and sleep in a non-PD population. This study will examine the effects of inspiratory muscle training (IMT) on improvement of lung function, gait and balance, speech and swallowing on a group of mild to moderately affected patients with PD and a group of normal age matched participants for comparison. Participants will be recruited to undergo 8 weeks of High intensity IMT (H-IMT) or a control group undergoing 8 weeks of Sham IMT (S-IMT). After initial supervised training, participants will perform the 21-minute exercise program 3 times a week at home. Lung function, balance, mobility, speech, swallowing and Quality of Life will be measured before and after the 8-week training program and 6 months after starting the training. Since treatment related gains are lost over time participants will continue the training exercises at least twice a week after 8 weeks (maintenance training). Based on preliminary results we will offer H-IMT and maintenance training to those in the sham treatment group after 6 months. The results of the study have the potential to deliver significant functional benefits from a simple, home based, easily performed exercise program.

Multiple sclerosis (MS) is the most frequent neurological disease in young and middle-aged adults in Australia and has a lifelong impact. Abnormalities in gait and balance are common in patients with MS. A number of different mechanisms are known to contribute to recovery from neural injury and relapses in MS. Functional imaging studies suggest that cortical plasticity and reorganization can promote recovery from brain injury in MS (Reddy et al. 2000; Pantano et al. 2002; Rocca et al. 2010, 2002). Balance training is an important rehabilitation intervention for MS patients, and most studies show a small, but significant, effect of physiotherapy on balance in people with multiple sclerosis who have a mild to moderate level of disability (Lord et al. 1998; Cattaneo et al. 2007a; Paltaama et al. 2012). Non-invasive brain stimulation (NIBS) is being increasingly trialled for enhancing brain plasticity after neural injury and shows promising results in patients with stroke, dystonia and Parkinson's disease (Edwardson et al. 2012; Ridding and Rothwell, 2007). Brain stimulation can be used to excite the brain and promote relearning. This study aims to recruit MS patients who have mild to moderate difficulty with balance and walking. We will evaluate if brain stimulation (transcranial direct current stimulation – tDCS) added to a structured balance training program will provide added benefit in mobility. This will be in addition to their regular outpatient therapy program prescribed by their physicians. This study will recruit patients with MS who have mild to moderate impairment of balance and walking. They will be randomly split into two groups: Both groups will complete a structured balance training program (1 hour sessions, 2 days a week for 6 weeks). Group 1 will also receive brain stimulation (tDCS) prior to each balance therapy session, while Group 2 will receive a sham-tDCS session. A physiotherapist who is not involved in the treatment will test each patient's balance and walking, as well as administering some questionnaires and a cognitive test. These assessments will be done before the treatment commences, immediately after the 6 week program and 6 months, 12 months and 24 months after the initial assessment date.