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This study will evaluate the safety and infectivity of a P. falciparum K13 artemisinin-resistant malaria parasite in healthy participants using the IBSM model. P. falciparum K13 was isolated from a person with malaria infection and is resistant to the antimalarial drug artemisinin and related drugs such as artesunate. We expect that artesunate treatment will kill the K13 parasites, although at a slower rate compared to drug sensitive isolates. In addition, the P. falciparum K13 isolate retains sensitivity to other antimalarial drugs including piperaquine and atovaquone. Participants will be treated with artesunate to characterise the parasite clearance profile of P. falciparum K13 in response to artesunate .If artesunate does not clear parasitaemia participants will be administered piperaquine, which is known to be active against P. falciparum K13 (as a single oral dose of Eurartesim ‘Registered Trademark’ piperaquine tetraphosphate/dihydroartemisinin tablets) The availability of a P. falciparum artemisinin-resistant isolate in the IBSM model will allow investigation of the efficacy of novel antimalarial drug candidates in clearance of artemisinin-resistant P. falciparum, which is a growing problem in South-East Asia and threatens to spread across the world.

Emerging evidence suggests that the anti-diabetic action of metformin resides primarily in the gut. Metformin has been shown to increase plasma concentrations of GLP-1 which are released from enteroendocrine L-cells located in the ileum and colon. GLP-1 has the capacity to restore blood glucose homeostasis in type 2 diabetes via pleiotropic actions including stimulation of insulin secretion and suppression of glucagon in a glucose-dependent manner, slowing of gastric emptying, and inhibition of hepatic glucose production and energy intake. Hence, the region of the gut exposed to metformin may be an important determinant of the lowering of blood glucose in type 2 diabetes. In this trial, we wish to investigate whether administration of metformin into the 'distal small intestine' (190cm beyond the pylorus) results in a lower glycaemic response to oral glucose when compared with administration into the 'proximal small intestine' (10cm beyond the pylorus) and evaluate the associated changes in plasma GLP-1, insulin, glucagon, 3OMG, lactate and metformin and rate of gastric emptying in patients with type 2 diabetes. There is increasing evidence that the incretin system has important cardiovascular effects and hence, we also wish to assess the changes in blood pressure and heart rate, in response to oral glucose, in the presence and absence of "proximal" or "distal" metformin.

Cells release diverse types of small membrane vesicles called exosomes and microvesicles and collectively are known as extracellular vesicles. Exosomes have an endocytic origin and are released upon multivesicular body fusion with the plasma membrane. Microvesicles are released from the cell surface, and are a rich source of non-conventionally secreted proteins lacking a conventional signal peptide, and thus not secreted by the classical secretory pathways. Both types of extracellular vesicles play major roles in intercellular communication by serving as vehicles for transfer between cells of membrane and cytosolic proteins, lipids and RNA. These extracellular vesicles are fragments of virtually all cell types (mainly endothelium, platelets, leukocytes) released into all types of body fluids during cell apoptosis or cell activation. They are characterised by an integral plasma membrane containing a subset of proteins, lipids and nucleic acids that are derived from the cell from which they originated. Extracellular vesicles may have important roles in intercellular communication, both locally and systemically, by transferring their contents between cells. Endothelial microvesicles play key roles in coagulation, inflammation and angiogenesis and can be quantified by flow cytometry using specific endothelial markers. Diabetic nephropathy is a prevalent major microvascular complication defined by functional, structural and clinical abnormalities of the kidney that is caused by diabetes. This complication has become the most frequent cause of end-stage renal disease. Additionally, it is strongly associated with cardiovascular morbidity and mortality. Diagnosis is usually based on the measurement of high levels of albumin in the urine and evidence of reduced kidney function.

Spinal cord stimulation (SCS) has been employed for the management of chronic pain for over 50 years. Over this time SCS has become a well-established mode of treatment for neuropathic pain. Until recently most success with SCS has been obtained with pain involving the limbs (e.g. CRPS, sciatica, ischaemic limb pain and peripheral neuropathy). Relief of axial back pain has been more difficult to achieve. In response to problems associated with SCS (stimulation variance with body position, MRI lead incompatibility, difficulties covering certain pain sites) a wide range of device options have developed. As a result the number of companies manufacturing implantable spinal cord stimulators continues to increase with each company claiming specific benefits for their device range. The most dramatic recent change has been the introduction of high frequency (HF) SCS (500 Hz to 10,000 Hz). Early work on HF SCS demonstrated potential benefits on axial back pain. The additional feature of “paraesthesia-free” stimulation to avoid the need for paraesthesias required by the more conventional tonic low frequency (LF) SCS (<100Hz) has made this form of stimulation more attractive. Paraesthesias have the potential for discomfort particularly with changes in position (standing to lying). In 2015, a landmark prospective randomised trial was published (Kapural et al) reporting superiority of HF SCS over LF SCS for axial back pain. While the mechanisms of action for conventional SCS are still being investigated, even less is known about HF stimulation. Given the positive results reported by Kapural et al it is likely that the use of HF SCS will dramatically increase. While no definitive evidence of neural damage has been found on clinical examination concern has been raised in animal studies about the potential for long-term neural changes with HF SCS. In addition certain patient subpopulations may be more vulnerable to stimulation induced changes in neural function particularly those with spinal canal stenosis (personal communication). Given Kapural et al has only recently been published consensus regarding the long-term use of HF SCS in axial low back pain is yet to be reached. This pilot study will monitor changes in neural function associated with propriety LF (<100Hz) and HF (10kHz) SCS implantation in people with chronic low back pain over twelve months. The project will inform the development of a full-scale trial. The Global Burden of Disease study now ranks low back pain (LBP) as the number one cause of disability in Australasia. Three million Australians now have long-term disability due to chronic LBP, costing more than $14 billion each year. As a result of a recent successful high profile multi-centre trial HF SCS implantation for chronic LBP is likely to increase. It is crucial therefore to obtain long-term safety data on this treatment to better inform patient selection and future cost benefit analyses.

COPE is an evidence -based non-pharmacological program developed by Professor Laura Gitlin from John Hopkins University. COPE is proven effective in reducing dependency and engagement of the person with dementia, and in improving carer wellbeing in a randomised trial in the US. The program uses occupational therapy skills with complimentary nursing skills, centring the needs of both the carer and the person with dementia. This implementation research project aims to integrate the COPE intervention within existing health and aged care systems in Australia. The project will examine facilitators and barriers at therapist, organisation and policy levels, explore funding models and building in features of sustainability. There will be a process evaluation (interviews, focus groups and observation) and a cost-benefit evaluation (questionnaires and data collection forms) included in the research project. The final output for the project will be an Implementation Strategies Document to influence policy and address how COPE can be rolled out wide-scale.

The primary purpose of this trial is to evaluate whether deep inhalation breath hold (DIBH) is feasible and effective for reducing the radiation dose to the heart during radiotherapy for cancer of the left breast. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with breast cancer (left or right breast) for which radiotherapy treatment is planned following breast conserving surgery or mastectomy. Study details There will be two groups enrolled in this trial. The first group of participants with left breast cancer who have demonstrated that they can successfully complete the DIBH for 15 secs (2 repeats) will complete the DIBH procedure at every radiotherapy delivery for 5 weeks. DIBH involves taking a deep breath in and holding that breath whilst the radiotherapy dose is delivered over approximately 10 to 15 seconds. Any left breast cancer participants who are not able to complete DIBH, plus right breast cancer participants will undergo standard radiotherapy treatment with no breath holding intervention. It is hoped that the results of this trial will provide information on whether DIBH is feasible for patients undergoing radiotherapy, and initial information on whether the technique is effective for reducing the dose of radiation delivered to the heart.

This project involves evaluating the effectiveness of a new teacher-delivered body image program for early primary school children, 'Achieving Body Confidence for Young Children' (ABC-4-YC). The aim is to assess improvements in 5- to 8-year-old children's body image, weight stigma, and appearance-based teasing by comparing children who receive ABC-4-YC with children who receive their usual classroom curriculum. School classes will be assigned to receive ABC-4-YC or their usual curriculum. Children will be interviewed to assess changes in body image weight stigma, and appearance-based teasing at baseline, post-test, and 6 week follow-up.

This Phase 1b study entails administration of GS-9688 in CHB subjects for the first time with the objective of evaluating its safety, tolerability, PK and PD, and thereby understand the clinical pharmacology profile of GS-9688 to determine if it is suitable for clinical development as a treatment for CHB. The results from this study will form the basis for further evaluation of GS 9688 and dose selection for a Phase 2 study in subjects with CHB. This study will proceed in two parts, governed within and between parts by reviews of safety data and application of stopping rules, as applicable. Based on safety and available PK and PD data, and at the discretion of the sponsor in consultation with the investigators, any cohort may be repeated at the same dose level, be held until further safety, PK or PD data are available, or not be initiated.

The aim of this study is to evaluate whether Chinese herbal topical wash (Huo Xue Tong Luo Decoction) can relieve and/or prevent Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you aged 18 years or above and are going to receive XELOX chemotherapy for gastrointestinal cancer. Study details Study participants will be allocated by chance (allocation ratio of 2:1) to one of the two intervention groups. One group will receive Huo Xue Tong Luo Decoction solution while the second group receives a placebo solution. Participants will use provided solutions to separately soak hands and feet for 20 minutes once a day for five consecutive days during each chemotherapy cycle (8 cycles). Participants will be required to complete a quantitative thermal testing from baseline, midway through each chemotherapy cycle and at the end of 3 months follow-up along with pain and QoL questionnaires in order for researchers to monitor whether the intervention is safe and whether it is effectively treating Oxaliplatin-induced peripheral neuropathy. It is hoped that the findings of this trial will establish the benefits of Huo Xue Tong Luo Decoction as topical wash for the prevention and treatment of Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients.

Our pilot study will establish baseline carriage prevalence in approximately 500 first year university students. The findings will assist in a more refined estimation of sample size required for a cross sectional study of first year university students to be conducted in 2018 and 2019. It will also be used to validate study processes including delayed freezing of samples.