ANZCTR search results

Overview & Rationale: Borderline Personality Disorder (BPD) is a serious and highly prevalent (5.9%) psychiatric disorder. BPD sufferers experience severe emotional instability, social and occupational dysfunction, and engage in chronic self-mutilation and suicidal behaviours, with associated high levels of mortality, morbidity, and health service use. BPD patients are a complex group that are challenging to treat. Current psychological treatments are expensive and difficult for BPD patients to access, and there is currently no clearly designated pharmacotherapy. Underpinned by psychosocial causes, the pathogenesis of BPD is only now beginning to be understood. Childhood trauma is reported in most patients (>80%) and is linked to abnormalities in the development of the hypothalamus-pituitary-adrenal stress axis and, consequently, abnormalities in the hypothalamus-pituitary-gonadal axis. Both neuroendocrine axes have been reported as abnormal in BPD, indicating the neuroendocrine system as a potential therapeutic target for BPD symptoms. Significantly, cyclical fluctuations in ovarian hormones affect emotional and cognitive behaviours relevant to BPD. We propose to conduct a 12-week, double blind, placebo controlled two arm trial of i.) transdermal estradiol gel 2 pumps (1 pump =1.25mg gel = 0.75mg estradiol, total = 1.5mg daily estradiol) vs ii.) placebo inactive gel 2 pumps daily (in addition to treatment as usual), in a total of 72 women with BPD/CPTSD (48 for the estradiol arm and 24 for the placebo arm) over 12 weeks. Primary Aim: To determine whether estradiol is effective in treating symptoms of BPD/CPTSD. Secondary Aims: To determine if estradiol has effect on specific BPD/CPTSD symptom domains including: a) social - emotional regulation; b) cognition, including memory, decision making and executive functioning; c) concomitant mood and quality of life; and d) biological markers

For those with Multiple Sclerosis (MS), weight-bearing exercise can pose many challenges for both patients and their therapists. Due to physical demands and safety issues, those with severe mobility impairment are often denied the opportunity for weight bearing, task specific training. This type of training is essential if the recovery of functional abilities such as independent transfers and mobility are to be achieved. Advances in robotic technologies have led to the development of wearable lower body exoskeletons. These can be used to assist sit to stand, weight bearing activities and gait. This research team is in the fortunate position to be provided access to an exoskeleton (HELLEN) to research its applicability in people with MS, having already commenced a sister trial with participants with Acquired Brain Injury. This device has the potential to assist therapists to increase patient opportunities for weight bearing training at higher intensity and dosage to maximise their potential for recovery. This is ground breaking research with no previously published literature on this topic with this device. Our aim is to examine the potential health benefits and feasibility of using a lower limb exoskeleton as an adjunct tool for neurorehabilitation in those with severe mobility impairment due to MS. This is a Phase I, wait-list controlled trial with 20 participants. Baseline measurements will be taken on enrolment into the study followed by a 12week waitlist period. They will then receive 12 weeks of intervention, provided by a physiotherapist (Nicola Postol). This will involve two 1 hour sessions of individualised upright weight-bearing exercise facilitated by HELLEN, per week. Participants will be provided with a home exercise program, updated throughout the trial as required. Reassessment will occur after 6 and 12 weeks of intervention and after 12 weeks follow-up and will comprise of a battery of impairment, function and quality of life measures.

Infants are susceptible to a large number of illnesses and diseases. As a result, Australia has a strict protocol for immunising infants and young children at various ages. One of the few immunisations which is not mandatory for infants is the influenza vaccine. Influenza is often perceived as an 'adult' illness, however, as with many illnesses infants are even more susceptible than adults and it is recommended that both children and adults are immunised annually. The Aboriginal and Torres Strait Islander community in Victoria are considered a high-risk group for illnesses such as influenza and as a a result, the vaccine is offered for free for Indigenous infants and children and has been so since 2010. Unfortunately, the rate of immunisation is only around 2% which means many children are at risk of contracting this preventable disease. The aim of this project is to develop and test different messages for parents of Indigenous children to educate and encourage them to seek out the free flu vaccine for their infant/young child.

The harm that junk food marketing poses to children’s health has been acknowledged by leading health agencies, such as World Health Organization. Online marketing of foods to children is particularly pervasive yet relatively little is known about how this may affect children’s food preferences. The purpose of this experiment is to explore how children respond to online food marketing. It will investigate the marketing techniques used in branded online games, using a between subjects design, and will explore how this influences what they subsequently choose to eat. The key aims are to determine if food branded games can influence subsequent food choice and whether choice and consumption will vary across condition, indicating the ‘effectiveness’ of the employed marketing technique. To investigate this, children (N=150, age 7-12) are required for 25 minutes to complete some questionnaires, play a 4 minute online game, choose a snack from a selection of items and then have their height and weight measured. The results from the study will be used in a wider body of work (as part of an Australian Research Council project) which aims to inform future public policy decisions to further limit children’s exposure to unhealthy food marketing.

The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. We would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.

The investigational product pentosan polysulfate (PPS) has various effects which suggest it may be useful in osteoarthritis. Preclinical (laboratory and animal studies) and clinical (human) studies have supported its potential role in OA. PPS has been shown to:; 1.Inhibit the cartilage degrading enzymes which play a key role in OA progression 2 Have anti-inflammatory effects including blocking the effects of the pro-inflammatory cytokines which are involved in osteoarthritis 3. Have antithrombic, antifibrotic and antilipidaemic effects which may assist with improved blood circulation in the bone. In this trial, patients with Osteoarthritis of the knee and associated Bone marrow lesions, who meet the study inclusion criteria, will be treated with either PPS or placebo, in a ratio of 1:1 according to a computer generated randomisation. The treatment will be given in double-blinded fashion (so that neither the patient, nor the person administering the treatment and assessing responses will know which treatment the patient received) The treatment will be given by subcutaneous injection, twice weekly for 6 weeks. Patients will visit the clinic according the the study schedule for the duration of treatment and up until Day 81, for monitoring and assessment of treatment responses, safety and adverse events recording. Treatment responses will be measured by changes in symptom scores according to KOOS questionnaire and NRS pain score at various time-points, and evolution of MRI images before treatment and at day 53. Patients will be further followed up with a phone call and symptom questionnaire on day 109 and 165.

The Gardasil quadrivalent 3-dose human papillomavirus (HPV) vaccine, which protects against genital warts and most cervical cancers, is provided in Victoria through a secondary school program, administered by local government (i.e., councils). In order for a student to be immunised within this program, their parent or guardian must complete and return a vaccine consent card. Unfortunately, approximately 9% of students do not return a consent card, and without further contact from council are prevented from receiving vaccines within the school program. This also occurs when parents/guardians return the consent card with missing or incorrect information leaving follow-up actions necessary for a valid consent. With this backdrop, efforts to improve consent card return rates and data quality have the potential to increase vaccination rates. The aim of this trial was to assess whether these outcomes could be improved by modifying using a new consent card (card incorporated plain language and social norming principles) alongside a new mode of card delivery. Specifically, DHHS distributed the consent cards directly to schools along with a letter to the school Principal and the school immunisation coordinator (the letters also incorporated social norming principles). They did this during December 2016. They also distributed a smaller batch of cards early in the school year (February 2017) so schools could re-distribute the consent card to any students who had not returned a consent card. It was hypothesized that this intervention (i.e., new and card and mode of delivery) would 1) increase the likelihood that a parent would complete and return the consent card, 2) the parent would be more likely to complete the card with no missing or incorrect information, and 3) more students would receive the HPV vaccine at the first school visit.

This study evaluated the efficacy of specific bandwidth phototherapy as an adjunctive treatment for the treatment of Parkinson’s disease. This study examined a non-invasive non-significant risk device to be used in combination with ongoing pharmacotherapy for Parkinson’s disease, in Parkinson’s patients already undergoing light therapy using broad spectrum, polychromatic light. While light treatment has been found to be effective in treating various forms of Parkinsonian symptoms it was originally employed to determine if it might be effective in treating comorbid symptoms of depression and insomnia associated with Parkinson’s disease. In several preclinical and clinical studies to date, not only has it been found that light therapy improves these parameters but the primary symptoms of bradykinaesia, rigidity, tremor and nocturnal myoclonus improved as well [Willis and Turner, Chronobiology International, 2007; Willis et al, Reviews in the Neurosciences, 2012; Rutten et al, Parkinson's Disorders, 2012; Videnovic et al, Movement. Disorders, 2017]. However, with continuing work on this theme the parameters surrounding the use of phototherapy have become better defined as to the frequency, time and duration of light use, the concomitant use of drugs and the management of physiological function so as to define the most effective treatment strategy for use in a double blind, placebo controlled trial. A preliminary blind trail has been undertaken which reports significant improvement in various Parkinsonian parameters (Paus et al, Movement. Disorders. 2007) and the present study implemented a more effective treatment regimen in a controlled design.

APL-9 is formed by a pentadecapeptide (combining a cyclic tridecapeptide active C3-inhibiting moiety and a 2-amino acid linker) covalently coupled to each end of a linear 10 kDa PEG chain, such that there are two peptide moieties per molecule of APL-9. APL-9 is a broad inhibitor of the complement cascade, a biological process that is part of innate immunity and is involved in multiple inflammatory processes. The PEGylation of the molecule imparts slower elimination following administration. APL-9 for intravenous route of administration is currently being considered as a potential treatment for acute conditions that would benefit from rapid and short-term inhibition of the complement system. One of the acute conditions is ischemic stroke. This single ascending dose study is the second in a planned series of studies for the clinical development of APL-9. The primary objective of the study is to assess the pharmacokinetics (PK) of single intravenous doses of APL 9 in healthy volunteers. The secondary objective of the study is to assess the pharmacokinetics of single intravenous doses of APL 9 in healthy volunteers. An exploratory objective of the study is to assess the pharmacodynamics (PD) of single intravenous doses of APL 9 when administered to healthy volunteers. The study will recruit 35 subjects in six dose cohorts. Subjects will participate in only one cohort and will receive a single dose of APL 9 or placebo administered intravenously. Safety will be assessed throughout the study; serial blood samples and urine samples will be collected for these assessments. Blood samples will also be collected for the PK, PD, and immunogenicity assessment of APL 9. Dose escalation to the next dose level (i.e. next cohort) will not take place until a Safety Monitoring Committee comprised of the Principal Investigator and the Sponsor have determined that adequate safety and tolerability from the previous cohort has been demonstrated to permit proceeding to the next cohort. Subjects will be resident in the clinical facility (Nucleus Network Ltd) from the day before dosing until 168 hours (Day 8) after dosing. Subjects will return to the clinical facility for follow-up visits and the exit visit for subsequent study procedures.

Like many countries around the world, Australia is committed to vaccination as evidenced by programs and regulations at all levels of government. However, these initiatives have generally not drawn upon behavioural science to influence vaccination rates. The Gardasil quadrivalent 3-dose human papillomavirus (HPV) vaccine, which protects against genital warts and most cervical cancers, is provided in Victoria through a secondary school program, administered by local government (i.e., councils). This study aimed to test the hypothesis that sending an SMS reminder to parents/guardians who had consented to their child receiving the HPV vaccine would lead to greater HPV vaccine uptake within the council delivered school vaccination program. The secondary aim was to assess the effect of self-regulatory versus motivational message content in the SMS.