ANZCTR search results

The SISTAQUIT™ trial provides training to health providers (HP) at Aboriginal Medical Services (AMS) and GP practices in culturally appropriate smoking cessation care for pregnant Aboriginal and Torres Strait Islander women. Almost 1 in 2 Aboriginal and Torres Strait Islander women smoke during pregnancy. Tobacco smoking in pregnancy is the most important preventable risk factor for poor maternal and infant health outcomes, including chronic lung problems and respiratory infections. Pregnancy is an important window of opportunity for health providers to help smokers quit, however they often lack the confidence and skills to address their patients’ smoking. The SISTAQUIT intervention has been developed over many years of research including an extensive Aboriginal community consultation and co-development phase, pre-testing of resources in three states, and the recent Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy pilot study in 6 Aboriginal Medical Services (AMS) in three states (SA, NSW, QLD). The primary aim of SISTAQUIT is to assess the effectiveness of the HP training intervention at increasing smoking cessation among pregnant Indigenous smokers at 4 weeks post-baseline, compared to standard care. Secondary aims include: 1.) to increase the proportion of health providers offering assistance to pregnant Indigenous smokers; 2.) Reduce the episodes of respiratory illness and adverse perinatal outcomes in their babies (to 6 months); 3.) Conduct an economic evaluation of the intervention which includes cost-effective and cost-benefit analyses. We aim to recruit 30 AMS; 15 will be randomised to receive the intervention and 15 will be randomised to continue usual care (cluster Randomised Controlled Trial (cRCT)). The 15 AMS randomised to continue usual care will receive the intervention and SISTAQUIT resources at the end of data collection (i.e. the cluster RCT uses a ‘wait list’ control group). Each site that is formally recruited will receive reimbursement for the research activities undertaken for the trial. Ideally, all HP at each centre randomised to the intervention group will receive the SISTAQUIT smoking cessation training (as a whole of service approach). Pregnant women up to 32 weeks gestation will be invited to participate in the project; women will be followed at recruitment, 4 & 12 weeks post-recruitment, 36 weeks gestation (4 weeks before their due date), and 4 weeks & 6 months after giving birth, Their babies will also be followed for 6 months for respiratory and general health outcomes. The SISTAQUIT trial is coordinated by research staff from the University of Newcastle, and the research team includes both Indigenous and non-Indigenous investigators and research staff. The study is supported by a grant jointly funded by the Global Alliance for Chronic Disease (GACD) and the National Health and Medical Research Council (NHMRC), and supported by fellowships awarded to GGould from the NHMRC and Cancer Institute NSW.

Long-distance truck drivers, most of whom are men, are one of the most important, yet unhealthiest occupational groups in Australia. Heart disease, type 2 diabetes, hypertension and obesity are endemic within the industry, and these health issues in turn impact sleep quality, fatigue and driving performance. Despite these concerns, truck drivers remain an underserved group, with long hours spent driving and geographically challenging work environments limiting health promotion options and services. A compelling case can be made for high intensity interval training (HIIT) as an effective intervention for male long-distance truck drivers. HIIT involves one or more short bursts of high intensity exercise (e.g. 4 minutes, 3 times/week). This exercise mode resonates with men, improves cardio-respiratory fitness (CRF) and cardio-metabolic risks and conditions in obese adults, and benefits sleep quality, alertness and driving safety. Recognising the need to transition HIIT from the laboratory to real-world settings, this study will test the efficacy of ‘Truck-Fit’, a depot-delivered, scalable exercise referral program, led by an accredited exercise physiologist who will progress high risk drivers from supervised to self-administered HIIT over 16-weeks. The study will be a cluster randomised controlled trial, with driver depots randomly allocated to the 16-week HIIT program or usual behaviour control. To assess program efficacy, we will administer laboratory health and fitness assessments at baseline and end-intervention, process evaluation of HIIT, and a post-intervention driver focus group and depot manager interviews to assess barriers and facilitators to implementation. Our main outcome will be cardiorespiratory fitness; secondary outcomes will be HIIT compliance, impact on driver sleep quality and fatigue, and acceptability of the program for drivers and depot managers. The study findings will provide valuable data to support larger effectiveness trials.

Current DMD therapies are aimed at increasing dystrophin levels and reducing inflammation. Improved anti-inflammatory therapies are needed to safely treat this pathology and delay disease progression. This study will be conducted in a single-centre and assess the safety, efficacy and PK of ATL1102 in non-ambulatory patients with DMD.

The reason for this study is to find out which of these two new versions of lumefantrine is better absorbed into the body of healthy volunteers. The purpose of this study is to explore: • Whether there is a similarity between how Formulation 1, Formulation 2 and LUM-SDF are absorbed by the body by healthy volunteers • Whether there is a similarity between how Formulation 1, Formulation 2 and LUM-SDF affects your body with healthy volunteers • Safety and Tolerability of Formulation 1 and Formulation 2 when compared to LUM-SDF in healthy volunteers.

The role of skeletal muscle in the management of knee osteoarthritis (OA) is increasingly recognised in that muscle strengthening exercises form a core part of its clinical management. However, the mechanism behind how the pain-relieving effects of strengthening exercises occur is not known. Moreover, not everyone with knee OA achieves pain relief after strengthening exercises. We also do not know enough about the factors that may stop a person from commencing an exercise program. This study aims to address these gaps in knowledge by studying different states which may predict who responds to strengthening exercise. The states studied will include different intensities of strengthening exercises, stages of knee OA, baseline pain levels, baseline inflammation levels and muscle characteristics. The study will involve participants with early and late knee osteoarthritis who will be randomized to perform high and low-intensity muscle strengthening exercises in a cross-over trial design. The outcomes studied include pain response before and after muscle strengthening exercises, and baseline inflammation and muscle characteristics.

This research project is designed to test the safety, tolerability, pharmacokinetics (how the body processes the study drug) and pharmacodynamics (how the drug affects to body) of INP105. INP105 is a drug-device combination product; the drug is OLZ (Olanzapine); the device is the I231 Precision Olfactory Delivery (POD) device, which is a novel nasal (nose) spray. Approximately 36 participants in general good health (with a minimum of 9 males and 9 females) will be enrolled and will be allocated to receive 2 treatments across 2 treatment periods. In the first treatment period participants will have an equal change of receiving 1 of 3 reference drugs: IM 5 mg Zyprexa, IM 10 mg Zyprexa or Oral Wafer 10mg Zypreza Zydis. In treatment period 2, participants will be allocated to receive either INP105 or placebo in a 3:1 ratio. The dose strength of INP105 (5, 10 to 20 mg) will depend on the cohort the participant is assigned.

Study design: This is a pilot single-blinded randomised sham-controlled clinical trial with three-armed group design. Participants: Eligible participants must fulfil the inclusion criteria a) Being overweight (BMI greater or equal to 25) or obese with BMI between 30 and less 40; b) Adult with age over 18 years old; c) Be available during the period of this clinical trial; d) Agree to provide written consent for participating this clinical trial. The exclusion criteria: a) Serious chronic medical conditions, such as cardiovascular diseases, cancer, HIV; b) Pregnancy or lactation; c) Drug induced secondary obesity; d) Medical conditions which are known to link with obesity, such as polycystic ovary syndrome, hypothyroidism, Cushing syndrome, Hashimoto’s Disease; e) Mental conditions such as clinical depression and anxiety; f) Participants who are not willing to be treated by acupuncture or to practise meditation; g) Difficulties in understanding and reading English; h) Taking blood thinning medications; i) Auditory disorders who cannot listen to audio records; j) Participants who received treatment for overweight in the past 3 months, including medical treatment or participation in weight loss programs. Sample size was calculated based on the study by Gugel et al. (2012) comparing the acupuncture group with the sham acupuncture on BMI after treatment, the effect size estimate was 0.56. The sample size pilot trial will be 10 participants per group. The recruited participants will be randomised in to 3 groups: Electroacupuncture plus Mindfulness Meditation (EAM), Sham Electroacupuncture plus Mindfulness Meditation (SAM) and Electroacupuncture only (EAO). Treatment protocol: After two-week run-in period, all randomised participants will receive 1 session per week for 12 weeks and 8 weeks follow-up. During each session, the EAM group will receive 30-minute real EA using 8 weight-loss specific points and 10-minute MM practice with instructions for daily practice. SAM group will receive 30 minute SAM with 8 sham acupuncture points (1cm away from real acupuncture points and meridian) and10-minute MM practice. The EAO group will receive only real EA without MM. Data collections: The data will be collected at week 0, 3, 6, 9, 12, 14, 16, 20 weeks using validated and licensed instruments (obtained). Outcome measures include weight, BMI, waist and hips ratio, weight-related symptom measure (WRSM) and obesity and weight loss quality of life (OWL-QOL), Food intake and Power of food scale. The ethics application has been submitted to RMIT-HREC for approval. Statistical analysis: All collected data will be analysed comparing between groups and within group using SPSS. Intention-to-treat analysis will be applied to all clinical data collected.

The study is an open-label study of PRAX-944 to assess the safety, pharmacokinetics, and efficacy of escalating multiple oral doses in up to 12 adults with generalized epileptic syndromes with absence seizures. Each patient will complete 3 study periods: Screening, Treatment Period (up to 2 dose levels followed by a taper) and Safety Follow-up.

Aims 1. To determine whether a virtual reality (VR) application results in a significant reduction in pain in people with neuropathic pain following a spinal cord injury; and 2. To determine if the use of VR and changes in pain intensity or negative related perception of pain are associated with corresponding changes in electroencephalographic (EEG) patterns linked to the presence of neuropathic pain. Hypotheses 1. That using a VR application will reduce pain intensity or negative pain-related perceptions in people with neuropathic pain following spinal cord injury 2. That reductions in neuropathic pain using a VR application will be associated with a shift of EEG activity from a dysrhythmic brain wave pattern towards a normal brain wave alert state. Significance Evidence now shows that distraction type VR is useful for people with persistent pain who have difficulty diverting their attention away from ongoing pain by enhancing the level of immersion within a distracting environment. Given that meta-analysis shows no difference in effect between specifically developed computer software and commercially available packages, VR is becoming increasingly affordable and available for use in both clinical and experimental settings. Despite growing evidence of benefit and increased accessibility and affordability, there are no studies that have examined the effectiveness of distraction type VR in people with pain following spinal cord injury. The ability for patients to individually reduce the intensity of their neuropathic pain using affordable VR software would be a major advance for people who currently face major challenges in obtaining satisfactory relief of their pain. Methods Using a randomised crossover design, people with a spinal cord injury and a diagnosis of chronic neuropathic pain will undergo two 20-minute intervention sessions with a one-hour washout period between sessions. One session (active intervention) will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The alternate session (control intervention) will comprise viewing the same scene but directly watching the laptop screen. During each VR session, EEG recordings will be obtained from several cortical sites allowing analysis of cortical regions associated with neuropathic pain. In addition, the numerical rating of pain intensity, previously validated self-reporting measures determining psychological function known to influence pain severity such as depression, anxiety, stress, pain self-efficacy and pain catastrophising will be administered before and after each intervention. Benefit VR applications may be a feasible method for reducing long-term pain in people with SCI. Given encouraging experimental findings using not only specifically developed computer software but more importantly, affordable commercially available VR applications, we propose that people with SCI can use VR immersion to override pain and negative emotions and thoughts associated with SCI.

The purpose of this study is to determine the feasibility of an imaging technique in assessing the spread of cancer in women with cancer of the uterus. Who is it for? You may be eligible for this study if you are a female, over the age of 18, and have been diagnosed with Stage 1 or 2 cancer of the uterus. Study details All patients with early stage endometrial cancer at the Mater Adult Hospital in South Brisbane that are being treated with surgery will undergo sentinel lymph node mapping as part of their staging surgery. The sentinel lymph nodes will then be submitted to the pathologist for analysis. Patients will not need to undergo further tests or follow ups after this. There will be no special blood tests required for this study. All participants will have the routine bloods taken which are needed for surgery. It is hoped that this research will show that sentinel lymph node mapping can safely replace traditional full pelvic lymph node removal in selected women with endometrial cancer.