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A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B
Expand descriptionThis is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.
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SHED-IT Recharge: Evaluation of an online weight loss program for men with low mood.
Expand descriptionDepression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men who are overweight or obese are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. Behavioural weight loss programs have shown promise to reduce depressive symptoms and improve weight status in people who are overweight or obese, but few interventions have engaged men and most have included components that are not scalable (e.g., intensive face-to-face support). E-health programs targeting men’s physical and mental health may represent a more scalable solution to these concerns, but the evidence-base supporting their efficacy is limited. Primary aim: To develop and test the efficacy of a gender-tailored, e-health weight loss program (SHED-IT: Recharge) to improve the physical and mental health of overweight and obese men with elevated depressive symptoms. Primary hypothesis: Men in the SHED-IT: Recharge group will show greater improvements in i) weight and ii) depressive symptoms at 3 months post-baseline, compared to a wait-list control group. Secondary aim 1: To determine the effect of SHED-IT: Recharge on men’s weight and depressive symptoms at 6 month follow-up. Secondary aim 2: To determine the effect of SHED-IT: Recharge on a range of lifestyle health behaviours (e.g., physical activity, dietary habits), mental health outcomes (e.g., anxiety) and other health indicators (e.g., blood pressure, blood lipids). Secondary aim 3: To identify which behavioural changes (e.g., diet, sleep) result in the largest, independent contributions toward the overall intervention effect on weight and depressive symptoms.
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An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Contouring.
Expand descriptionA prospective study to evaluate the Focal Contouring System to determine whether it is safe and efficacious in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.
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Does a consumer co-created infographic improve knowledge and self-efficacy about physical activity for women with gestational diabetes mellitus?
Expand descriptionThe goal of this research is to explore if a consumer co-created infographic (a visually appealing and easy to read and understand information resource) is effective in improving knowledge and self-efficacy about physical activity for women during a gestational diabetes mellitus (GDM) pregnancy. This is important because although physical activity is known to be beneficial to pregnant women with GDM more than 60% of women with GDM do not exercise as recommended. This study is being undertaken in response to the findings of a previous study reporting that women with GDM needed clear and simple information about physical activity during their GDM pregnancy. This research is designed as a randomised controlled trial with GDM Education classes being randomly allocated to either the intervention or comparator to evaluate the effectiveness, of an evidence based, consumer co-created infographic, on women's knowledge and self-efficacy (confidence) about physical activity during a GDM pregnancy.
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Ovarian rejuvenation for menopausal or perimenopausal women using autologous platelet rich plasma (A-PRP) injection into the ovaries, for women seeking in vitro fertilisation (IVF) treatment, aiming to improve IVF outcomes.
Expand descriptionIt is anticipated that ovarian rejuvenation using autologous platelet-rich plasma (A-PRP) injected into the ovaries will improve IVF outcomes in subsequent IVF cycles using mild ovarian stimulation for perimenopausal and menopausal women. In the non-randomised prospective trial, around 30mLs of your own blood (autologous) will be collected to produce around 4-5mLs of A-PRP. Around 2-2.5mLs of A-PRP will be injected into each ovary using transvaginal ultrasound guidance or laparoscopy, either at the same time as a transvaginal egg collection, or at a separate event. Follicle, egg and embryo numbers, pregnancy rates, and hormones levels (anti-mullerian hormone (AHM) and follicle stimulating hormone (FSH)) will be compared pre and post the injection of A-PRP.
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Droperidol vs Ondansetron in Nausea Treatment in the Emergency Department (DONuT)
Expand descriptionOndansetron is an anti-emetic drug that is commonly used in the emergency department to treat nausea and vomiting. Droperidol is an older anti-emetic medication where usage had fallen out of favour until recently, due to unfounded fears concerning QT prolongation. There is anecdotal evidence that IV droperidol is superior to ondansetron for treatment of nausea and vomiting. Although no difference was noted between the two drugs in a recent study, the dose of droperidol that was used was less that what would commonly be used in an emergency department setting. The question is if a higher dose of droperidol will likely demonstrate a difference.
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Effect of KFibre in heartburn
Expand descriptionK-fibreTM is produced in Australia by KFSU Ltd from sugar cane as a whole cane product. Informal observations of KFSU customers indicated that of K-fibreTM was effective in controlling of symptoms in heartburn or gastroesophageal reflux disease (GERD). Gastroesophageal reflux disease (GERD) is a condition that affects around 20% Australians and causes drastic reduction in quality of life.This preliminary human clinical study is proposed with a hypothesis that KFibre will reduce/control gastroesophageal reflux disease and associated heartburn or indigestion symptoms.
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Constipation after elective laparoscopy for benign gyneacological indications – a prospective observational study
Expand descriptionWe aim to investigate the prevalence of constipation in patients undergoing elective laparoscopy for benign gynaecological indications. We also aim to investigate the negative impact that this has as well as factors that may predispose to this This will be a prospective observation study. The participants will perform three surveys. Prior to surgery to assess baseline bowel function. One week post surgery to assess the immediate effect of surgery on bowel function. Three months after surgery to determine if symptoms are persistent or resolve
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Improving the diet quality: "My Nutrition Score" of Australian adults using a brief, online, tailored, nutrition messaging intervention: A Randomised Controlled Trial with a nested Cross-Over Trial study design
Expand descriptionCSIRO’s Nutrition and Health program conducts research to understand how we can do better to motivate and support people to improve their eating habits. Advances in technology means we are starting to move towards delivering online interventions which can reach more people and be tailored more easily for different people. For this project, we are testing tailored and standard nutrition messages delivered online, in a short 5-week intervention. We expect that a tailored intervention approach will be more effective in improving eating habits, compared to a standard 'one size fits all' approach. The findings from this project will help to guide the development of larger, digital programs which aim to improve the health and well-being of Australians.
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Immunoglobulin use and outcomes in Chronic lymphocytic leukaemia And Non-Hodgkin lymphoma - The ICAN Study
Expand descriptionThe purpose of this study is to evaluate the outcomes of immunoglobulin (Ig) therapy in people who have non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukaemia (CLL). In Australia, Ig therapy is commonly used to prevent infection in patients with CLL and NHL, but there is limited evidence from clinical studies to guide doctors on which patients are most likely to benefit, when treatment should start, and for how long it should continue. Whos it for? Individuals 18 years or older with newly diagnosed B-cell Non-Hodgkin lymphoma or Chronic Lymphocytic Leukaemia. Study Details Participants will attend their medical appointments at the discretion of their treating clinician. Data will be collected for the ICAN database at six-monthly intervals (6, 12,18 and 24 months) starting from the date of diagnosis. Additional assessments involve questionnaires about the participants quality of life. Participants of the biobank sub-study will be asked to provide non-fasting blood samples (30mL) at baseline (before treatment), 6-months, 12-months and 24-months. Once collected the blood samples will be stored for future testing and analysis. Results from this study will be valuable in assisting research that improves the prevention, diagnosis and treatment of infections in people with these illnesses.