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Trial of prescribed water intake in polycystic kidney disease
Expand descriptionADPKD is an inherited condition, characterized by the growth of hundreds of cysts (fluid-filled sacs) in the kidney. This results in an enlarged kidney and pain, high blood pressure and an increased risk of chronic kidney disease. Kidney failure usually develops in late adulthood in about half of affected people. There is currently no treatment that can cure ADPKD or stop cysts forming and growing in the kidneys. In the last few years, people with ADPKD have been advised to drink more water to suppress anti-diuretic hormone (ADH, or vasopressin). However, it is not clear if this approach is feasible in the long-term and without risk and/or if there is an ideal amount of water to drink that will benefit disease progression. The aim of this study is to determine the efficacy and safety of prescribed water intake in ADPKD. Eligible patients with ADPKD will be randomised (1:1) to either: Group A (control) to continue with their usual (ad libitum) water consumption (including standard treatment) or Group B (intervention) to adjust their daily water intake to reduce the urine osmolality to less than or equal to 270 mosmol/L for the next 36 months in addition to their standard treatment. The volume of prescribed water consumption will be calculated according to free water clearance based on baseline and progress measurements of 24 hour urine collection. All patients will be expected to have blood collections at 3, 6, 9, 12, 18, 24, 30 and 36 months. In Group B subjects, additional samples will be collected at Week 3 and 6 for safety check and also titration of the water prescription. After the Month 36 visit, Group B patients may return to their previous ad libitum water consumption habits.
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How long rocuronium lasts when given subcutaneously to adult surgical patients
Expand descriptionThis study will examine the effects of rocuronium, a non-depolarising muscle relaxant when given subcutaneously. In this study, we will compare the effects of subcutaneous rocuronium against intravenous rocuronium. We will measure how long until it works, how much effect it has and how long it lasts.
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Tooth and Lung Sickness in Murri Medical Kids
Expand descriptionDespite the burden of acute respiratory illnesses (ARI) among children being a substantial cause of childhood morbidity and associated costs to families, communities and the health system, data on disease burden in urban children are lacking. Consequently evidence-based decision-making, data management guidelines, health resourcing for primary health care services and prevention strategies are lacking. This study aims to comprehensively describe the epidemiology, impact and outcomes of ARI in urban children in the greater Brisbane area.
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Internet treatment for Posttraumatic Stress Disorder (PTSD)
Expand descriptionThe project aims to evaluate the acceptability and clinical efficacy of the online PTSD program; and to examine the role of intolerance of uncertainty and emotion regulation in PTSD symptom change following the PTSD Program. Up to 144 people with PTSD will be randomly assigned to either the active treatment group or a waitlist control group. The treatment group will commence the PTSD program immediately, whereas the waitlist control group will commence once the treatment group has completed. PTSD program efficacy will be determined by comparing the PTSD symptom levels of each group at the time the treatment group completes treatment. The role of intolerance of uncertainty and emotion regulation in PTSD symptom change will be examined using mediation analysis.
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Social Well-being and Engaged Living intervention for Australian youth at risk of mental health and other adverse outcomes
Expand descriptionThis study is a single-blind three-arm randomised controlled trial examining the efficacy of a telephone-delivered social well-being and engaged living (SWEL) intervention for improving the vocational, social and emotional functioning of disengaged youth.A total of 279 young people aged 12-25 years will be randomised to receive either (i) up to 8 sessions of SWEL, (ii) up to 8 sessions of Befriending (non-directive supportive contact), or (iii) Single-Session Psycho-Education. It is hypothesised that disengaged youth in the SWEL group will achieve significantly higher levels of reengagement in social, occupational and/or learning areas. It is also hypothesised that the SWEL group will achieve significantly better results on the secondary outcome variables of social and occupational functioning, social activity; perceived social self efficacy; sense of self; satisfaction with life; and relationship quality. The recruitment of participants will be conducted primarily through youth employment, educational and vocational training services in Queensland, New South Wales and Western Australia. Recruitment will also occur through self-referrals. SWEL and Befriending groups receive 8 weekly therapy calls lasting 20 to 50 minutes. Core components are delivered in the first 4 sessions to maximise impact early on, though participants are encouraged to complete all 8 sessions. Follow-up assessments occur 2, 8 and 14 months post-Baseline.
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Pilot randomised controlled trial of meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections.
Expand descriptionInfections of the blood are extremely serious and require intravenous antibiotic treatment. When the infection results from antibiotic resistant bacteria, the choice of antibiotic is an extremely important decision. Some types of bacteria produce enzymes that may inactivate essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level production of these enzymes can occur during therapy and lead to clinical failure, even when an antibiotic appears effective by laboratory testing. However, this risk of this occurring in clinical practice has only been well described in a limited range of antibiotic classes in a type of bacteria called Enterobacter. There is currently uncertainty as to whether a commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to the same risk of resistance developing while on treatment. Infections caused by Enterobacter (and other bacteria with similar resistance mechanisms) are often treated with an alternative drug called meropenem (a carbapenem antibiotic), which is effective but has an extremely broad-spectrum of activity. Excessive use of carbapenems is driving further resistance to this antibiotic class - which represent our 'last-line' of antibiotic defence. As such, we need studies to help us see whether alternatives to meropenem are an effective and safe choice. No study has ever directly tested whether these two antibiotics have the same effectiveness for this type of infection. The purpose of this study is to randomly assign patients with blood infection caused by Enterobacter or related bacteria to either meropenem or piperacillin/tazobactam in order to test whether these antibiotics have similar effectiveness.
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A 3 month dispensing study of First Care cleaning and disinfecting solution in daily wear, frequent replacement soft contact lens wearers
Expand descriptionFirst Care is the only product on the market of its kind that uses Povidone-iodine as a disinfectant. Povidone-iodine is the most commonly used medical disinfectant, and First Care has been shown to be a safe and efficient care product for all types of frequent replacement contact lenses. First Care is currently approved for sale in Japan. We hope to learn how effective the First Care system is, for reducing microbial contamination (e.g. bacteria and fungi) of used contact lens storage cases over a 3 month period, and to compare the results to other commercially available frequent replacement contact lens cleaning and disinfecting solution storage cases (using historical controls). We hypothesize that the microbial contamination rates of used First Care cleaning and disinfecting system lens storage cases will be lower compared to used lens storage cases of other commercially available frequent replacement contact lens cleaning and disinfecting solutions.
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Changing the Antibiotic Prescribing of General Practice Registrars through better adherence to antibiotic guidelines
Expand descriptionThe primary purpose of the ChAP Study is to assess the impact of an intervention based on online modules, a face to face workshop and one-on-one supervisor contact, on antibiotic prescribing by GP registrars, specifically for acute upper respiratory tract infections (URTIs) and acute bronchitis/bronchiolitis. We hypothesise that an appropriately targeted educational intervention will improve adherence to evidence-based guidelines regarding antibiotic prescribing for respiratory infections by GP registrars participating in a vocational training program.
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Phase I Dose-Escalation Extension Study to Determine the Safety and Tolerability of Intratumoural Injection(s) of EBC-46
Expand descriptionThis study aims to evaluate the safety and tolerability of a new investigational drug called EBC-46 in participants with cancer. Who is it for? Patients may be eligible to join this study if they have already participated in the preceding study (QB46C-H01), are aged 18 years or more and have been diagnosed with a cutaneous, subcutaneous, head and neck*, or nodal tumour. *except for pharyngeal, laryngeal and tongue base tumours and those tumours in the anterior neck (from posterior border of sternocleidomastoid on each side). Study details: All participants in this study will receive an EBC-46 injection(s) directly into a tumour(s). This will occur in the form of consecutive treatment periods, at least a week apart. EBC-46 may lead to breakdown of tumour blood vessels and recruitment and activation of white blood cells. This leads to rapid tumour cell death. Participants will be monitored for 3 weeks following each EBC-46 injection in order to evaluate safety, tolerability and tumour response. Treatments will continue until disease progression or intolerance presents. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.
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A randomised trial assessing the acceptability and effectiveness of providing generic versus tailored feedback about health risks for a high need primary care sample
Expand descriptionThe purpose of this study was to assess the acceptability and effectiveness of providing real time tailored feedback, compared to generic feedback, to patients of Aboriginal Medical Services about their health behaviour risk factors. Participants could choose to show or discuss the feedback with their GP. The provision of tailored feedback to patients pre-consultation is designed to promote opportunities for both the patient and GP or health worker to consider the patient’s health risks and initiate actions to modify these risk factors. The study represents a novel approach to health promotion for the Indigenous population. Such an approach minimises the amount of time demanded of GPs and other clinic staff in screening for risk factors and potentially encourages the discussion of risk factors between the patient and GP, while also increasing the probability that patients are aware of their health status and are receptive to specific advice to from their GP. The acceptability of providing personalised feedback compared to generic feedback to patients on their self reported health risk behaviours, was assessed in terms participant assessment of the utility of the feedback and whether participants showed the feedback to their GP or otherwise used the feedback during their appointment; The effectiveness of personalised feedback compared to generic feedback was assessed in terms of increasing rates of discussion or action (such as referral or follow up appointment) on risk factors during the consultation between the GP and participant.