ANZCTR search results

Patellofemoral Pain syndrome (PFPS) is a condition associated with anterior knee pain in the absence of other pathology. Kinematic variations have been identified in this condition. Physiotherapy management of this condition aims to correct neuromuscular imbalances and the use of patella taping is a common adjunct to manual therapy and exercise prescription. With the advancement in taping materials and variation in application methods further investigation into the influence patella taping has on knee kinematics is justified. Aim To investigate if the application of patella tape influences the knee kinematics in three planes of motion compared to baseline untaped data. Objectives Analyse knee kinematics during three functional tasks of walking, step descent and single leg squat for each individual Compare the effects of the two different taping materials (rigid and dynamic tape) on the repeated functional tasks versus the control data

Neural Regeneration Peptide 2945 (NRP2945) is an experimental drug being developed by CuroNZ Pty. Ltd for the potential treatment of severe childhood-related refractory epilepsy such as Lennox-Gastaut Syndrome (LGS). In animal models, NRP2945 has been shown to be a driver molecule in central nervous system (CNS) neural regeneration processes during stages of disease or injury. In this first time in human study, single ascending doses and multiple ascending doses of NRP2945 will be assessed in healthy male volunteers. NRP2945 will be administered by subcutaneous injection in the abdomen. Assessments of safety, tolerability, pharmacokinetics and pharmacodynamics parameters following administration of NRP2945 will guide decisions to further develop the drug.

A 2-arm randomised waitlist-controlled trial to test the efficacy of a m-health intervention to promote physical activity and sleep health in adults. The two main outcomes (MVPA and sleep quality) will be assessed after 3 months (primary endpoint) and followed up at the 6-month time point. The study will deliver a combined program including an app and message-based support to facilitate goal-setting, self-monitoring and feedback on progress towards goal for both behaviours. Physical inactivity is highly prevalent among adults and a large proportion of the population reports poor sleep health (characterised by inadequate sleep duration, low quality of sleep and inappropriate sleep timing, leaving people feeling insufficiently refreshed and unsatisfied with their sleep). Both behaviours independently influence risks for chronic disease and mortality and may have a bidirectional relationship, as such synergistic effects on health may be achieved. No studies to date have targeted the two behaviours simultaneously in a mobile device-delivered behaviour change intervention. In addition to testing the efficacy of such an intervention, we seek to identify potential moderators of intervention efficacy (e.g., age, gender, education) and test mediators of behaviour change (social cognitive factors, sleep hygiene).

Summary: Q fever is a highly infectious disease caused by Coxiella Burnettii. Each year in Australia there are over 450 cases notified, (2013 n= 485, 2014 n=452). This equates to approximately 8-10 cases per week. Currently there is an efficacious Q fever vaccine which is recommended for those considered to be in “occupational at risk” groups, such as abattoir workers, veterinarians and farmers. However, several recent studies have highlighted that the risk in the non-traditional “at risk” groups, such as children, metropolitan dwellers, is higher than previously thought. The epidemiology of Q fever disease in New South Wales has changed and amongst notified cases the relative importance of non-abattoir contact with livestock, wildlife or feral animals appears to be increasing. Importantly the only vaccine available in the world is QVax, manufactured by CSL and is only licensed for those over 15 years old. Therefore under current Australian Immunisation guidelines children under 15 years old, who are at risk of contracting Q fever, because they live on farms, near abattoirs or, are children of “at risk” workers cannot be vaccinated. The main reason for this age restriction is not because of an identified safety risk but because the initial trials did not include children under 15 and therefore restricted the licensure of the vaccine. Vaccinating children, particularly children of farmers or animal breeders, is an important preventive measure and has not been studied at all. In this pilot study the safety and efficacy of Q fever vaccine in children aged 10 to 15 years old will be measured.

This study investigates the effect of exercising different limbs (arm vs. leg), and timing (pre- vs. post-) on responses to vaccination. A single bout of exercise has been shown to improve vaccination responses, the proposed mechanisms include increased blood and lymph flow of the exercising muscle. This suggests that arm exercise would have stronger effects than leg exercise (if a vaccine is given in the arm). All studies of exercise effects on vaccinations have used exercise pre-vaccination. But post-vaccination exercise might be more effective as the antigen can benefits from increased blood and lymph flow and increased immune cell numbers.

Approximately 1% of all patients (around 95,000 per year), who go to hospital acquire a urinary tract infection (UTI). It has been suggested that up to 80% of hospital associated UTS’s are caused by the use of a urinary catheter. Insertion of the catheter is an important part of reducing the risk of infection. There is wide variation in practice relating to cleaning the urethral meatus area before catheter insertion. This study intends to ascertain if cleaning the urethral meatus with saline 0.9% (Control) or an antiseptic chlorhexidine 0.1% (Intervention) reduces the instances of infection. The benefits relating to the outcomes of this study are to reduce the risk of infection and therefore it’s associated cost savings. The research hypotheses 1. When undertaking meatal cleaning prior to indwelling urinary catheter insertion, there is no difference between the use of normal saline (0.9%) and chlorhexidine (0.1%) solution on the incidence of catheter-associated urinary tract infections (CAUTIs). 2. The use of chlorhexidine (0.1%) solution for meatal cleaning prior to urinary catheter insertion is not a cost-effective intervention to reduce CAUTI. Study design A multi-site stepped wedge randomised controlled trial will be undertaken in three large tertiary hospitals (approximately 2640 participants) over a 32-week period, with a random sequential allocation of the intervention to three hospitals. The study design enables each hospital to act as its own control, which removes the potential for some confounders such as variations in hospital size and case mix and differences between public and private hospitals. Staggered commencement and duration of the intervention, either 2,4 or 6 months, supports feasibility while maintaining the rigour of the study. The number of catheter associated UTIs will be analysed using Poisson regression, with the number of cases as the dependent variable and number of patient catheter days as the denominator. This denominator will help control for changes in catheter use during the study period. The key independent variable will be the intervention.

This study aims to improve sleep and pain post operatively after rotator cuff repair. It will compare three well known medications used for pain and sleep management post operative.

Mild cognitive impairment (MCI) causes a slight but noticeable decline in cognitive abilities, and is conceptualised as a transitional prodromal stage between healthy ageing and dementia. It is estimated that up to 35 % of Australians aged 70 and older have MCI, and 15 % of those individuals will go on to develop dementia within a year. Currently, there are no treatment options for MCI, and anti-dementia pharmaceuticals are largely ineffective as they act on a single therapeutic target, which does not address the multifaceted pathophysiology of MCI. The project aims to evaluate the mechanisms of action and test the efficacy and safety of a novel multi-target treatment for MCI due to Alzheimer's disease: Sailuotong (SLT), a standardised herbal medicine formula. SLT capitalises on the multi-system approach of Chinese herbal medicine, containing multiple standardised active components including Panax ginseng, Ginkgo biloba, and Crocus sativus (saffron), and has already shown promise as a potential treatment for vascular dementia. This project will involve a 12 week randomised, double-blind, placebo-controlled trial of 180 mg/day SLT for cognitive function in people with MCI due to Alzheimer's disease. The co-primary outcome measures are episodic memory as measured by Logical Memory Story A - Delayed Recall, perceptual processing speed as measured by Digit Symbol Coding, and executive function as measured by the D-KEFS (Delis-Kaplan Executive Function System) Trail Making Test Condition 4 and the Rey Complex Figure Test (RCFT). Secondary outcome measures include: the Montreal Cognitive Assessment (MoCA), Block Design, Digit Span, Logical Memory Story A - Immediate Recall, D-KEFS Trail Making Test Condition 2, Rey Auditory Verbal Learning Test (RAVLT), Benton Visual Retention Test, 15-item Boston Naming Test, Semantic Fluency, the Controlled Oral Word Association Test, the Functional Activities Questionnaire (FAQ), Quality of Life in Alzheimer's Disease scale (QoL-AD), and the 21-item Depression, Anxiety, Stress Scale (DASS-21). We will also examine the mechanisms of action of SLT in people with MCI by assessing brain activity via electroencephalograph (EEG), autonomic activity via skin conductance and electrocardiograph (ECG), cerebral blood flow via carotid artery ultrasound, and serum inflammatory markers including IL-6, IL-1beta, and TNF-alpha.

The MOST+ project will pilot the implementation of an enhanced moderated online social therapy model within the eheadspace youth mental health services. The project aims to determine the feasibility, acceptability and safety of the MOST+ intervention for young people (16-25 yeas) who have accessed eheadspace services for mental health support. Secondary aims will assess changes in key psychosocial outcomes (i.e., psychological distress, functional impairment, satisfaction with life) and collect qualitative data for subsequent intervention refinement, using a participatory design framework. The MOST+ intervention is expected to demonstrate feasibility, acceptability and safety among the pilot cohort.

This study will be conducted in three parts: the first part will investigate the effect of a single dose of ABN019 on healthy participants; the second part will investigate the effect of a single dose of ANB019 on psoriasis patients and the third part will investigate the effect of multiple (weekly) doses of ABN019 for 4 weeks on healthy participants. The single dose study will explore different doses of the study drug given either via a subcutaneous (under the skin) injection (SC) or via an intravenous (into the vein) infusion (IV). The results from this part will be used to determine the dose and route of administration to be used for the psoriasis patient part and the multiple dose part of the study. Over the entire study a total of 87 people will be enrolled over 10 dosing groups/ cohorts. In each group of 8 healthy participants, 6 will receive the active drug, ANB019 and the other 2 will receive an equivalent placebo (an injection/ infusion that looks identical to the active drug, but contains no active drug). In the psoriasis patient group, out of the 15 patients, 10 will receive the active drug, ANB019, and the remaining 5 will receive placebo. This study is a dose escalation study meaning that the first group/ cohort will receive the lowest dose of study drug. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with the next higher dose strength in the next group. The next group will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. As this is a first in human study, the primary objective of the study is to assess the safety and tolerability of single and multiple doses of ANB019 administered to healthy humans.