ANZCTR search results

This 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.

Participating 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.

Fatty 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.

Chronic 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.

Participants 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.

This 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.

The overall aim of this project is to investigate the extent to which a carer assessment tool of support needs in end of life home care (CSNAT) improves perceived support, carers’ psychological and physical wellbeing, carer burden, bereavement outcomes and the likelihood of the patient achieving their preferred place of death. The CSNAT is a brief tool (14 items on two A5 pages), and is used to elicit carer concerns early, in a systematic way to achieve better outcomes pre and post bereavement. The tool has two sets of items which cover: 1. support that enables the carer to care for the patient at home 2. support for the carer in their caring role

This pilot study wishes to investigate whether the consumption of an oral hydration solution (OHS) during bowel preparation will affect the faecal effluent in terms of colour or quality. The investigators will examine whether the endoscopist can detect which colour OHS has been used in conjunction with bowel preparation (if any), and whether the use of an OHS in conjunction with current bowel preparations pre-colonoscopy can reduce the effects of dehydration (ie nausea, dry mouth, headache, lethargy, increased thirst). This may aid in the tolerability of bowel preparation, which in turn may result in better compliance with bowel preparation, with adequate fluid consumption being achieved. The researchers will also investigate whether the inclusion of an OHS has an impact on bowel cleanliness, polyp/adenoma detection, caecal/terminal ileal intubation rate, and time taken to complete the colonoscopy.

This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers. Who is it for? You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital. Trial details All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas. Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.

This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for young adults (18-24) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment. We expect that the guided interventions will result in superior outcomes to the unguided interventions.