ANZCTR search results

Study hypothesis: The human body has a natural capacity to regenerate and to grow new tissue to fill an empty space. This study applies a new method of breast reconstruction using the patient’s own regenerative capacity. This method provides an alternative to current breast reconstruction techniques and also an opportunity for patients who have no other option for reconstruction. In the operation an acrylic spacer, shaped according to the breast defect, will be placed under the skin of the chest wall to allow a piece of fat with a blood supply to grow over time (3-6 months) to fill the space created by the acrylic spacer. The small piece of fat with a blood supply will be sourced from well-known existing donor sites for breast reconstruction (chest or abdomen). Because the amount of tissue is small the expected donor site scars will be smaller compared with the usual reconstruction methods.

This research project is assessing a new burning catheter, the modular ablation catheter, this catheter will burn the irregular electrical connection that causes an irregular cardiac arrthymia. The catheter is being assessed to ensure that is not inferior to a conventional catheter. The trial catheter has benefits for the clinician in that it can be more adaptable during the clinical procedure than standard catheters and hence it is not inferior to current technology it should provide an attractive catheter choice for the clincian.

This research study is being conducted for the pharmaceutical company Cumberland Pharmaceuticals Inc. You are being asked to take part in this research study because we want to determine the safety, tolerability and pharmacokinetics (the way the body absorbs the drug) of a single dose of ibuprofen administered intravenously (in the vein) over 5-7 minutes. A screening procedure will determine if you are eligible to enter the study. If you are accepted, you will be required to attend the study centre for 2 treatment visits. When you return to the research center, you will be randomised into one of two treatment sequences. Randomised means you will be assigned to a group by chance. The two treatment sequences in this study are: Sequence A: A single dose of intravenous ibuprofen (IVIb) and an oral (capsule) placebo (starch filled capsule) given concurrently on Day 1 of the Treatment Period followed by a single dose of oral ibuprofen (capsule) and intravenous (IV) placebo (saline solution) given concurrently on Day 8 of the Treatment Period. Day 2-7will be a washout period. During the washout period no study drugs or study tests will be done. Sequence B: A single dose of oral ibuprofen and intravenous (IV) placebo given concurrently on Day 1 of the Treatment Period followed by a single dose of intravenous ibuprofen (IVIb) and oral placebo given concurrently on Day 8 of the Treatment Period. Blood samples will be collected in treatment visits 1 and 2 (16 samples per visit) by either cannula (small plastic tube inserted into a vein in your arm) or venipuncture. Approximately a total of 222 mL of blood will be collected during the study, which includes the amount required for the clinical laboratory tests and for the measurement of Ibuprofen in your blood.

Comparison of higher protein, moderate carbohydrate red meat based “Total Wellbeing” diet versus iso-energetic, conventional, low fat, high carbohydrate diet on weight loss, immune function, satiety, metabolic parameters and iron status in young, overweight and obese women. Research Hypothesis: A higher protein, red meat based diet for weight management in overweight and obese young women will improve satiety, eating behaviours, markers of immune function and metabolic parameters when compared to an iso-energetic higher carbohydrate, white meat based diet.

The aim of this study is to ascertain the effects on bowel health of resistant starch (StarPlus (trademark)) when given to participants who are ingesting a high red meat diet. Also to determine if the consumption of this high protein diet causes changes in certain markers for bowel cancer and if adding RS, ( StarPlus (trademark)) to the diet can improve these effects.

This study looks at the feasibility of using Technitium, injected via a bronchoscope, for the detection of the sentinel lymph node in suspected non-small cell lung cancer Who is it for? You can join this study if you are: - about to undergo flexible bronchoscopy for the diagnosis of suspected non-small cell lung cancer - 40-85 years of age - prepared to accept the 2% risk of developing a pneumothorax (collapsed lung) with this treatment. Trial details While having their scheduled bronchoscope, participants will receive injection of technetium dye into the region of the lung which has the lung cancer. The technetium will allow any sentinel lymph nodes to be identified by a non-invasive Nuclear Medicine imaging test called a SPECT/CT scans, 4 hours after the injection. The study will look at the effectiveness and safety of this procedure.

In this study, we will seek whether there is any difference in valve related complications (MAPE: major adverse postoperative events i.e. reoperation, endocarditis, major bleeding or thromboembolism ) and short/long term survival between patients receiving tissue vs mechanical valves. It will be a prospective randomized study using the two most commonly used valves - St Jude Mechanical (St Jude Medical) and Mosaic tissue (Medtronic). Patients requiring aortic valve replacement who give consent will be randomized to either having tissue or mechanical valves. They will undergo echocardiogram and quality of life measures at baseline. They will be followed up during their stay in hospital and periodically thereafter to gather data to obtain the information described below. They will receive an echocardiogram at 6 months, 24 months and ever 24 months thereafter until the end of follow up (up to ten years). They will also receive telephone interview six monthly but the research assistants and yearly by the clinicians. Data will be gathered to identify the following: 1] Predictors of early and late mortality 2] Long term survival 2] Freedom from reoperation 3] Freedom from TIA, stroke and thromboembolic episodes 4] Freedom from endocarditis 5] Freedom from hemorrhagic complications 6] Freedom from hospitalization 7] Rate of readmission 8] Freedom from valve failure

This project will examine the best way for health professionals to predict the ability of stroke survivors to safely recommence driving. Many effects of stroke can impair driving ability. Return to driving after a stroke is an important part of maintaining independence. It is therefore important that assessment of these people is readily available and accurate. Examining driving ability on the road is the ‘gold standard’ test; we will investigate what can be measured in a clinical, ‘off-road’ setting to predict safety in the ‘on-road’ test. These include: medical factors (type of stroke, position of stroke, severity of stroke etc.); impact of the stroke on driving ability (vision, concentration, memory, reasoning etc.); and ability to drive in a driving simulator (an artificial driving machine with a screen). We anticipate that we will be able to identify several tests which, alone or together, can help to predict which stroke survivors can safely return to driving.

Cancer is the leading cause of burden of disease and injury in Australia, accounting for nearly one-fifth of the total disease burden. The diagnosis and treatment of cancer is a major life stress that is followed by a range of well described psychological, social, physical and spiritual difficulties. Approximately 35% of patients will experience persistent clinically significant distress and carers often experience even higher distress than patients. The aim of the proposed study is to assess the efficacy and cost-effectiveness of accessible and affordable psychological interventions for distressed cancer patients and carers who contact community based Cancer Helplines. The study comprises a randomised controlled trial with patients and carers who have elevated psychological distress, comparing minimal contact self management with an individualised tele-based cognitive behavioural intervention.

This study aims to develop effective testing methods for the detection of injected recombinanat luteinising hormone (rLH) excreted in urine. The blood and urine samples taken from male volunteers in this study will be used to develop robust testing for the illicit use of rLH in elite athletes for performance enhancement. Four healthy male adults will be recruited. Two will receive an intramuscular (IM) injection of nanadrolone 200mg, 4 days prior to an intravenous (IV) infusion of 2400iu rLH. Nandrolone is a synthetic androgen which will act to temporarily supress the bodys own LH production. The other two participants will receive an IV infusion of rLH 2400iu ( no nandrolone). Samples of urine will be collected from all participants at 0 to 4 hours, 4 to 8 hours and 8 to 24 hours. Blood samples will be collected at baseline, 1, 2, 3, 4, 6, 8 and 24 hous following rLH infusion.