ANZCTR search results

The purpose of this study is to assess the safety and tolerability of BMS-929075 in healthy subjects.

This study will compare novel pulmonary rehabilitation (community nurse telephone-delivered) with rehabilitation. Community nurses will be trained in the ‘CENTREd’ Model of Self-Management Support. There is a focus on walking for exercise and other health-behaviours identified in the ‘SNAPPS’ Health-Management Framework according to current guidelines (Smoking cessation, Nutrition, Alcohol consumption, Physical activity, Psychosocial well-being, Symptom management). The study addresses the continuum of care for people with COPD from referral from the Royal Hobart Hospital (RHH)/private practitioner until discharge from out-patient pulmonary rehabilitation.

The number of Australians with dementia is increasing and so is the frequency of people with dementia presenting to general medical practice. This project aims to improve the care of people with suspected cognitive impairment in general practice. We have conducted interviews with 30 GPs from urban and rural settings in Victoria, Australia to determine their clinical behaviours and knowledge with respect to the detection, diagnosis and management of cognitive impairment and dementia and their perceived barriers to implementing evidence-based recommendations. A national survey is currently being conducted to further explore GPs’ current clinical practice in this area. Using this information we have designed a targeted theory-based intervention to implement these evidence-based recommendations into clinical practice once cognitive impairment is suspected by the GP. We will conduct a cluster randomised controlled trial to test the effect of this targeted intervention and establish if the intervention is effective in increasing the number of cognitively impaired patients in whom the GP undertakes the recommendations to formally diagnose or exclude dementia. Automated search strategies will be developed to extract evidence-based recommendations from de-identified patient electronic medical files including completion of a Mini-Mental State Examination and a screen for co-morbid depression using a validated scale. General practices (n= 126) will be randomised to receive either the targeted theory-based intervention, or to a control group receiving access to the evidence-based clinical practice guideline alone. This project will contribute to the body of knowledge about how to bring about practice change. The outcomes of the study have the potential to improve the detection and diagnosis of people with suspected dementia in primary care.

This is a double-blind, randomised, placebo-controlled study to evaluate the efficacy of an orally-dosed herb Fenugreek seed extract, on libido and general quality of life in healthy women. We are looking to see if the herbal medicine can change libido, weight, stress levels, and energy levels over 2 menstrual cycles (approximately 8 weeks). We are also looking to see if there is any change in hormone levels after taking the herbal medicine for the 8 weeks. In this type of study, we use a placebo as the control group (only contains inactive ingredients) to determine if the product is effective. Participation in the study will last approximately 10 weeks. Participants will be asked to take the medication for 8 weeks, exactly 2 menstrual cycles, with questionnaires and a blood test at the beginning and follow-up at week 4 and week 8. This kind of treatment assignment and randomization (study herb selection by chance) are only carried for research studies. These procedures are being performed for the purposes of the study and are not part of your routine care. The chance of you receiving the active treatment is 50%.

Patients fitting the inclusion criteria will be consented. Half their wound will be stitched with a barbed suture (v-Loc) and the other half of their wound will be stiched using a traditional monocryl suture . The wound will be assessed at one, six and twelve weeks after wound closure. Photographs of the wound at these times will be assessed by a blinded independant plastic surgeon to rate wound cosmesis.

The primary outcome of this study is to establish construct validity and reliability of the RAPS checklist. Construct validity describes the ability of the tool to measure the criteria under assessment, and its discriminatory power to differentiate novice versus skilled proceduralists. Reliability of the tool is its ability to be reproducible between different assessors.

Type 2 diabetes can be prevented and managed through lifestyle modification programmes that include physical activity of a moderate intensity for at least 150 min per week in conjunction with dietary modification and caloric restriction. Yet, only 40% of people diagnosed with the disease are meeting these physical activity targets. This study will investigate if the active video game Nintendo WiiTM sports programme is a safe form of physical activity and has the potential of increasing the self-efficacy of sedentary people with diabetes to increase their overall physical activity levels.

This study is a prospective evaluation and follow up looking at the utility of a decision aid for patients considering participation in a RAVES (Radiotherapy - Adjuvant Versus Early Salvage) Prostate Cancer trial (NCT00860652; TROG 08.03). It will compare participants who receive the decision-aid with those who receive a notebook to write down personal thoughts in relation to rates of recruitment and decision-making outcomes. Clinical trials are crucial to determine the best possible care for patients. However, low accrual and retention rates slow the introduction of new treatments in health care. This study will assess whether a decision aid for participating in a clinical trial improves accrual and reduces dropout rates. This mechanism for standardising information delivery about trials may ease the pressure on health professionals and the health system and transform the process of gaining informed consent. Who is it for? You may be eligible for this study if you are 18 and above, male, and eligible to participate in RAVES (TROG 08.03), i.e. you have prostate cancer with positive margins and/or stage pT3 disease following radical prostatectomy. Trial details In this study you will receive either the RAVES Decision Aid (DA) including an evidence-based representation of risk of prostate cancer recurrence for men eligible for the trial, their treatment options, the rationale for trials in general and the RAVES trial in particular, or a blank notebook for participants to write personal notes. The materials (DA or notebook) will be randomly distributed to eligible participants by the urologists and radiation oncologists involved in this study at their initial consultation, and form part of a package that contains the patient information sheet, consent form and questionnaires. Each participant will be sent follow-up questionnaires at 1 month and 6 months after recruitment. Thus the duration of participation for individuals is about 6 months. Recruitment to the study will continue over a period of two years.

The aim was to investigate the effect of high dose oral cholecalciferol (vitamin D3) on pancreatic beta-cell function and glycemia in adults with type 2 diabetes. The hypothesis was that vitamin D would improve beta-cell function and glycemia. Beta-cell function was assessed by measuring glucagon stimulated C-peptide. Insulin resistance was measured by calculating a HOMA-IR index from plasma insulin and glucose levels. Glycemia was assessed by measuring fasting plasma glucose, post-prandial capillary glucose and serum glycosylated haemaglobin.