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Improving adherence with PEP (Positive end expiratory) chest physiotherapy in children with cystic fibrosis though the use of an electronic device, the PEP PT (Personal trainer)
Expand descriptionThis trial is investigating whether a new physiotherapy device used in children with cystic fibrosis meets the needs of clients better than the current technology and thus is used more often and effectively used than the standard device. Cystic fibrosis is a genetic condition associated with significant lung disease. Chest physiotherapy helps move infected secretions out the lung and is a standard part of daily therapy. However, adherence with this therapy is low for many reasons. This device has been designed to address many of these problems and hopefully will improve adherence. The type of physiotherapy being addressed in thus study is call PEP (which stands for positive expiratory pressure) and would be well known to patients and those involve in patient care. The prototype device measures the pressure produced during each blow. The active device connects wirelessly to a tablet computer. Each blow is displayed on the screen. There are features including a game controlled by the blows, an alarm function, points which are earned with each correct blow which can be redeemed and the capacity to download adherence data at clinical reviews. Subjects will be randomly allocated to use either the new device or a control device which measures adherence but otherwise looks the same as a normal device for 6 weeks. Subjects will be aged 4-16 years. The main outcome will be adherence with the device. Those who don't get to use the device in the first 6 weeks will get to use it during a second 6 week period.
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Structured monitoring of blood glucose for people with non-insulin-treated type 2 diabetes: Structured Testing Program Implementation Trial – Updated Protocol (STeP IT UP)
Expand descriptionThis study (STeP IT UP) aims to examine the effectiveness of a structured approach to self-monitoring of blood glucose (SMBG) for adults with non-insulin-treated T2DM in an Australian primary care (general practice) setting, with a focus on the clinical utility of structured SMBG in this group. The STeP IT UP study also aims to build on the available evidence from the original STeP study by refining the structured SMBG training provided to participants with use of DVD training resources to ensure a sustainable approach, and by optimising psychosocial outcome measures used. It is hypothesised that the findings from STeP IT UP will demonstrate to healthcare professionals (especially those working in primary care) that (a) structured SMBG, when embedded in care and performed in the context of education and support, has clinical benefits, and (b) that it is feasible for doctors and their patients to develop the necessary knowledge and skills to conduct SMBG in an effective manner. Key resources to be used in STeP IT UP (e.g. educational DVD for participants) can be made freely available on the internet, and so sustained implementation of this structured SMBG intervention is possible beyond the life of the study. We, therefore, anticipate that the findings of the STeP IT UP study will have the potential to influence the approach to SMBG in Australian primary care for people with T2DM who do not use insulin, such that effective approaches to SMBG are recommended and adopted.
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Augmenting internet-delivered cognitive behaviour therapy (iCBT) with daily SMS prompts for adults with chronic pain: an open trial to examine efficacy and acceptability.
Expand descriptionThis project is part of a research program to develop and evaluate an Internet-based education and treatment program for people with chronic pain. This project extends an earlier trial (ACTRN12612000556842) to examine the efficacy and acceptability an iCBT program for people with chronic pain, when augmented with daily SMS prompts reminder participants to practice self-management skills.
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A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal formulation containing Testofen, on symptoms of Andropause and serum testosterone levels in otherwise healthy males aged between 45-75 years.
Expand descriptionThe aim of the study is to assess the herbal formulation in reducing the symptoms of andropause and influencing serum testosterone levels. The inadequate production of testosterone in men as they age has been associated with Andropause, a variable complex of symptoms, including decreased androgen production, occurring in men after middle age. Andropause has an obvious effect on male sexual health, but may also affect general health in men as they age. The key features of Andropause include: Lethargy and fatigue Diminished sexual desire/libido Increased abdominal fat (waist circumference greater than 102cm) Depressed mood or irritability Decreased cognitive function Hot flushes or sweating Decreased lean body mass and muscle volume/strength Decreased body hair and skin alterations Low bone mineral density or increased incidence of fractures Sleep disturbance
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ANZ 1103 Study of Olaparib Clinical Effect in Patients with Breast Cancer or Ovarian Cancer
Expand descriptionThis aim of this study is to determine the maximum tolerated dose of Olaparib combined with cyclophosphamide in patients with breast cancer or ovarian cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with either metastatic BRCA-associated breast cancer, triple negative breast cancer or serous ovarian cancer. Trial details Olaparib is a highly active agent when used as a single therapy in a standard dose of 400mg twice a day. However, olaparib frequently results in suppression of the immune system when combined with chemotherapy. Cyclophosphamide is a DNA-damaging agent widely used in breast cancer and epithelial ovarian cancer in metronomic (low dose, continuous therapy) doses and does not have significant suppression of the immune system. It is suggested that combining full-dose olaparib with metronomic cyclophosphamide might result in better treatment of cancers without causing extra difficulties with the immune system. In this study, participants will be administered olaparib as 300mg tablets twice per day in combination with Cyclophosphamide, which will be administered as 50mg tablets at a pre-specified schedule (the schedule will differ slightly for each dose level). Patients will enter the study as a cohort of 3 patients per dose level. Each dose level cohort will be assessed for toxicity until the maximum tolerated dose (MTD) is determined. Two extension cohorts will be treated at the MTD. Each cohort will consist of nine or more patients: one cohort of patients with breast cancer, the other cohort of patients with ovarian cancer. Treatment duration will be up to a maximum of 8 x 21 day cycles. All participants will be regularly monitored throughout treatment to evaluate toxicity, and to assess response rate, progression free survival, and overall survival.
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Assessing blood levels of ketorolac ( Toradol) injected in around the hip and knee joints in patients undergoing joint replacements
Expand descriptionParticipating patients will be screened as per the study protocol and will have prior informed consent. Ten patients with normal renal function undergoing total knee or hip replacement surgeries are chosen for the study. As per the usual procedure in the hospital, surgeon infiltrates the joint with 100ml of 0.2% ropivacaine with adrenaline along with 30mg ketorolac at the end of surgery. Serial blood samples are taken at 30 mins, 1,2,4,8 and 24 hours post infiltration. Serum concentrations of ketorolac will be analysed using HPLC at Biochemical lab, University of Queensland. The results will be analysed by the research team.
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Postprandial effects of white meat versus red meat consumption on blood lipids.
Expand descriptionFatty acids are a necessary key energy source in the body, however, when present in excess, can be detrimental. Increased fasting blood fat (lipid) levels have long been accepted as a risk marker for chronic diseases such as cardiovascular disease, metabolic syndrome, obesity and diabetes, however, there is now increasing evidence which points to postprandial lipemia being a more accurate indicator of risk. The rate in which fats from the foods we consume are digested, absorbed and appear in the bloodstream is dependent on various factors, including (but not limited to) the quality and quantity of fat and the nature of the matrix in which fat is embedded in the food. Postprandial monitoring of lipids therefore can reveal the variable response to food intake not seen under fasting conditions. It is this variation which is referred to as the Lipemic Load. Analysis of the Lipemic Load provides a simple and accurate means of predicting the ability of a food in modulating blood lipid levels, and can be used as a tool to help consumers choose foods for optimal health.
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The Which Heart failure Intervention is most Cost-effective in reducing Hospital stay (WHICH? II) trial.
Expand descriptionChronic heart failure is one of the leading causes of death and disability within our ageing population. Chronic heart failure management programs now form part of the gold-standard care for patients hospitalised with the syndrome to prevent costly recurrent readmissions and prolong survival. However, there is still a need to apply these cost-effectively - particularly in respect to meeting the needs of high risk individuals and those living remotely to a heart failure service. Following on from the original WHICH? Trial we are now testing two different ways of applying chronic heart failure management to determine which is most cost-effective in reducing recurrent hospital stay. Specifically, we are testing a more intensive program of care, based on each person’s needs and where they live, with a standard program of care and support. We will compare the impact of standard care in the community (Group 1) with more intensive care in the community (Group 2). Health outcomes will be compared at 12 months with plans for more prolonged follow-up to 5 years post index hospital discharge.
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A pilot study on function and symptom changes with the use of foot orthoses in the flat footed adult.
Expand descriptionParticipants will be required to have measurable flexible pes planus, meet inclusion and exclusion criteria and be willing and able to attend four sessions at the University of South Australia’s biomechanics clinic. Participants will be aware that they will randomly receive either a soft or firm orthoses. Initial assessment: If consent and inclusion criteria are satisfied foot health measures will be undertaken and a practice session of walking tests completed. Casting: Casting of the feet will be undertaken. Randomising of allocation occurs into semi-rigid functional foot orthoses or soft, non-functional insoles. A practice session of walking tests completed. Dispense: Foot health measures undertaken. Inserts are dispensed. Two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person. Follow up: Foot health measures undertaken, two walking tests completed wearing armband monitor with and without inserts in participants shoes (randomised order) supervised by principal researcher. Walking tests are timed and recorded by an independent and blinded person. Data Analysis: Data will be collated and entered into the computer by an independent person blinded to the allocation. Statistical analyses will determine if measured changes between the insert conditions (functional vs non-functional and shoes vs insert) are significant with a predetermined clinically significant outcome being set at 5% improvement for both energy cost and walking distance changes. Foot health will be reported as a percentage change for pain and fatigue VAS outcomes, the FHSQ will be transformed into an overall foot health score as determined by the protocol for this tool. Statistically analyses will determine if (any) measured changes are significant.
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm Study of the Safety, Tolerability and Pharmacokinetics of Oral BTD-001 in Healthy Volunteers
Expand descriptionThis is a randomized, parallel arm, double-blind, placebo-controlled study. Subjects will be randomized to one of 5 arms, 4 dose levels of BTD-001 (25mg, 50mg, 100mg or 200mg) or placebo. Each arm consists of 6 subjects for a total of 30 subjects. Subjects will complete a Screening period of up to 28 days, and will be admitted to the Clinical Research Unit (CRU) on Day -1. First dose will be administered on the morning of Day 1. Plasma samples for PK analyses, vital signs and ECGs will be collected at multiple time points on Days 1 and 2. To allow full PK characterization of the first dose, no evening dose will be administered on Day 1, though dosing will be BID subsequently. Subjects will be discharged on Day 2 with their evening dose of medication and a diary card. Subjects will report to clinic each morning on Days 3-6 for the AM dose of medication. On Days 3, 4 and 5, they will be issued with the evening dose and a diary card. Subjects will be readmitted to the research unit of Day 6 and will receive the evening dose of study drug in the unit, approximately 12 +/- 1 hours prior to the scheduled AM dose for Day 7. Following the AM dose on Day 7, subjects will remain in the CRU for at least 8 hours, during which PK and safety measures will be collected. Subjects will then be discharged home. A final Safety Follow Up visit will take place on Day 14, one week after the last dose of study drug.