ANZCTR search results

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.

The administration of systemic antibiotic adjuncts following scaling and root planing to further expedite healing of the periodontal tissues is a topic of considerable interest, given the lack of evidence-based guidelines for their use in periodontal treatment. The aim of this study was to evaluate and compare the clinical and inflammatory cytokine effects between scaling and root planing alone, adjunctive azithromycin, or adjunctive amoxicillin plus metronidazole in the treatment of patients with generalised moderate-to-severe chronic periodontitis. It was initially hypothesized that patients receiving scaling and root planing + azithromycin would demonstrate greater reductions in clinical attachment level (greater than or equal to 1 mm) and inflammatory cytokine levels compared to the other treatment groups, after 2 months.

The purpose of this study is to investigate the safety and efficacy of stereotactic ablative body radiotherapy (SABR) plus Avelumab in patients with metastatic castration-resistant prostate cancer (mCRPC). Who is it for? You may be eligible for this study if you are an adult with metastatic castration-resistant prostate cancer (mCRPC) and have a predicted life expectancy of at least 6 months. Study details This project will investigate the combination of SABR and Avelumab for metastatic castration resistant prostate cancer (mCRPC). SABR is a noninvasive, high precision radiotherapy technique. The high precision of SABR allows a high dose of radiation to be delivered to the target areas with minimal toxicity to the surrounding areas. Avelumab is a monoclonal antibody that works against a protein called PD1 on the surface of the cancer cells. It is thought that cancer cells with increased levels of PD1 avoid detection by the body’s immune system. In this study, we hypothesise that combining Avelumab with standard therapy high dose precision radiotherapy (SABR) may enhance the antitumour efficacy of Avelumab in mCRPC. This study will evaluate the patient survival, tumour regrowth and side effects with this combined treatment in patients with mCRPC.

The laparoscopic sleeve gastrectomy (LSG) is currently the most commonly performed bariatric procedure in Australia. Long-term data is beginning to appear in the literature and indicates that up to half of patients who have undergone the surgery regain a significant amount of weight in the years following the surgery. These patients often progress to have further surgery to promote more weight loss. In some patients, the regain in weight is thought to be caused by the stomach stretching in size and the patient can then eat more again. Some surgeons have started placing a silastic ring around the stomach with the original surgery to prevent the stomach from stretching. Long-term data on the efficacy and safety of inserting a ring with a sleeve gastrectomy is scarce. It is also possible that a ring may have an effect on reflux and what foods a person can tolerate. This study will be a randomised prospective study with the purpose of evaluating the efficacy of a silastic ring in preventing sleeve dilatation (stomach stretching) and deduce any effect on complication rate; reflux; and food tolerance. The study will provide three-year data to assist in determining whether a banded LSG (using a ring) should become the preferred surgical option for the treatment of obesity. Approximately 95 patients who undergo a banded LSG and 95 patients who receive a standard LSG will be followed for a period of thirty-six months. Patients will be randomised into one of the two study groups. Anthropometric and metabolic data will be collected pre-operative, and at 6, 12, 24 and 36 months after surgery. Food tolerance and reflux evaluated . Stomach capacity will be measured by a Computerised Tomography (CT) Fizzogram at 36 months post-operative. Participants will be asked to have a nasopharyngeal 24 hr pH probe placed at 36 months’ post-operatively irrespective of symptoms as per current clinical practice. Patients presenting before 36 months with weight regain and /or symptomatic reflux will have a CT Fizzogram or oropharyngeal pH monitoring performed earlier, as per normal clinical practice.