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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.

The primary objective of this project is to evaluate the effects on physical actviity (PA) levels (daily steps) of the addition of a PA intervention (PA counselling and feedback [tri-axial pedometer]) into standard exercise rehabilitation in patients attending the CDCRS programs across the NSLHD. The hypothesis is that patients undertaking the PA intervention will increase their daily physical activity levels. A secondary objective of this project is to evaluate the effects on sedentary behaviour levels of the addition of a PA intervention into standard exercise rehabilitation in patients attending the CDCRS programs across the NSLHD.

Physical activity is an effective intervention for managing many chronic diseases. The majority of the general population are not sufficiently active to meet physical activity guidelines and physical inactivity is more prevalent in people living with chronic disease. People with chronic disease require guidance from healthcare professionals to make lifestyle changes to manage their condition and improve health outcomes, however, there is a lack of healthcare professionals and services available people living in regional and remote NSW. PhyzX 2U is a new mobile service that uses a combination of face to face consultation, mobile exercise tracking and a health coaching service via telehealth to provide exercise programs to people living with chronic disease in remote rural communities of NSW’s Central West. Objectives: To evaluate the delivery of the PhyzX2U service in its pilot phase. The specific aims are to determine the (i) feasibility, uptake and impact of the PhyzX 2U program in improving health and quality of life for people with chronic disease living in rural and remote communities; and (ii) acceptability of the PhyzX 2U program, including facilitators and barriers to implementation, from the perspectives of the providers and recipients. Study plan: An observational mixed methods study will be used. Health and goal outcomes from recipients of the PhyzX 2U program will be compared between program initiation and following completion of the 12-week program. Client adherence to the 12-week exercise intervention and PhyzX resources to run the program will also be determined. Semi-structured interviews will be conducted with a subsample of program recipients and program providers to determine the acceptability of the program, and to identify facilitators and barriers to program implementation. Data will be collected between September 2017 and 30 June 2018.

Research has found Dialectical Behaviour Therapy (DBT) to be an effective treatment model for adolescents who have a variety of mental health concerns and difficulties coping with their emotions. This study involves the use of an online DBT skills-only training program for the management of emotional dysregulation for young people aged 18-25 years. The study will recruit young people through headspace and allocate them to either a 4-week, an 8-week, or a TAU+ 4-week online skills training in DBT skills. The study will test the effectiveness of the online skills training program in improving participants’ emotional regulation and coping skills. Understanding the role such programs can play and has the potential to greatly benefit clinical practice and further inform prevention and intervention policies.

OVERALL AIM: This pilot study aims to determine the feasibility and acceptability of treatment of male partners of women with bacterial vaginosis (BV). OTHER AIMS: To examine the impact of dual partner treatment (male and female treatment) for BV on BV-associated bacteria on the male and female genitalia for 1 month after treatment. BACKGROUND AND SIGNIFICANCE: BV is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. It can be associated with important complications such as miscarriage, premature birth, low birth weight, pelvic infection, and increased risk of HIV and sexually transmitted infections. We have shown that BV recurrence (getting the infection back again) in women is common even after they take the recommended antibiotic treatment. A number of investigators have shown that BV-associated bacteria (BVAB) are present in male partners of women with BV on the penile skin and also at the end of the urethra (the tube you pee through), but male partner treatment is not currently recommended by current treatment guidelines. Studies of recurrent BV indicate that reinfection from sexual partners may be contributing to the high rates of recurrence but this requires more evaluation. Metronidazole and topical clindamycin are both antibiotics approved for use in Australia to treat BV in women. As BV has not previously been thought to affect men they have not been licensed for use to treat BV in men. Metronidazole is however a commonly used antibiotic in men and women and has been approved for use for many conditions affecting men and women, including gastroenteritis, abscesses, dental infections and types of pneumonia, to list a few. There is extensive experience in using it in men for these other conditions. Topical clindamycin cream has not been approved for use for any conditions in men; however men may get exposed to the cream if they are having sexual intercourse with their partner while she is using the cream to treat BV. Clindamycin cream and oral metronidazole are therefore considered is an experimental treatment for BV in men. This means that they are being tested to see if they are an effective treatment to get rid of BV-associated bacteria in men.