ANZCTR search results

This is an open-label, fixed regimen clinical study. Enrolled patients were administered low dose metformin (250mg or 500mg) to examine the effect and exposure of metformin in patients with chronic renal impairment. Patients were monitored frequently to ensure metformin concentrations and lactic acid concentrations were not high. The aim of this study is to determine whether metformin can be safely administered to patients with renal impairment.

We have conducted a RCT sub-study within the recruitment phase of a larger project utilising an Australian Cancer Registry to recruit survivors of a haematological study. This sub-study aimed to test the effect of two different patient invitation and reminder letters on participation rates to the study from patients. The first invitation and reminder letters were the standard letters sent by the Cancer Registry. Patients receiving this letter acted as the control arm of the intervention. The second invitation and reminder letters were modified versions of the standard letters incorporating specific changes to wording and formatting which have been identified as potentially increasing suitability, readability and legibility.

Arthralgia (joint pain) and other joint related symptoms are common side effects of taking letrozole (hormone therapy). As such, some patients stop taking their hormone therapy earlier than the recommended 5 years after breast surgery. The purpose of this study is to find out if glucosamine can ease joint pain in patients taking letrozole, and therefore reduce the chance that they will stop their hormone therapy early. Participants (ER and/or PR receptor positive, postmenopausal, early breast cancer) will receive either crystalline glucosamine sulphate (1500mg tablet) or placebo that will be taken concurrently with letrozole and will be followed for a total of 24 months (maximum treatment period of 18 months followed by an off study treatment visit 6 months later). The discontinuation rate of letrozole will be determined at 12 months and 18 months. Off study treatment visit should be 24 months post-randomisation or, if discontinued study treatment prior to 18 months post-randomisation, off study visit should be 6 months post permanent cessation of CGS/placebo.

The aim of this study is to evaluate a new evidence based model for increasing the adoption and maintenance of physical activity in sedentary community dwelling middle aged individuals. Specifically targeting those individulas who are less likely to adopt and maintain exercise as they do not normally access the currently available community group exercise programs. We hypothesize that (i) There are a large number of individuals in the community aged 50-65 years who are not interested in group exercise, the common method used to increase the population's level of physical activity. (ii) A proportion of this group would commence exercising if an alternative method of increasing physcial activity was available, such as a home based approach. (iii) The home based program would produce health benfits equivalent to those seen in the group based exercise program for sedentary adults 50-65 years old. (iv) Those that commence the home based program are more likely to continue with an increase in physical activity in the long term, as compared to a group based program. (v) A home based approach to increasing physical activity with minimal support is more cost effective than a group based intervention, taking into consideration long term physical activity maintenance.

The project is a pilot study of the therapeutic efficacy of Deep Brain Stimulation (DBS) in patients with severe depression that has not responded to treatment with all other standard antidepressant treatments. DBS involves the placement of small stimulating electrodes into the brain which are connected to a pacemaker like device which is implanted under the skin. The electrodes are used to stimulate a small brain area called the nucleus accumbens. DBS is now widely used in Australia and overseas for the treatment of neurological conditions, such as Parkinson’s disease and essential tremor. When performed by an experienced team it appears to be gnerally safe and well tolerated. A small body of work looking at the impact of DBS in obsessive compulsive disorder has indicated that DBS can affect mood and may be an effective treatment for major depression. There are a small percentage of patients with major who do not respond to any of the standard antidepressant treatment options. these patients are debilitated by their illness and remain at very high risk of death by suicide. We aim to trial DBS in a small number of carefully selected patients in an open trial. We will evaluate the efficacy of the treatment by video recording interviews with patients describing their depression and having the severity of depression rated by a trained rater who is unaware of whether the interview was conducted before or after the procedure. All patients will be carefully selected and assessed to ensure they can provide informed consent. The participation of each patient will be independently reviewed by the Victorian Government Psychosurgery Review Board, an independent statutory authority.

This study will compare two medications (Avastin (bevacizumab) and Triesence (Triamcinolone) given at the time of cataract surgery for patients with, or at high risk of developing, diabetic macular oedema. Patients will be seen monthly and outcomes include visual acuity, centra macular thickenss, time to retreatment and assesment of adverse events.

A randomised controlled trial will be conducted to determine the efficacy of two physical activity (PA) counselling strategies on PA behaviour over a 12 month period amongst insufficiently active adults attending general practices in the Newcastle, Lake Macquarie, Hunter, and Inner West Sydney areas of New South Wales. Participants will be randomly allocated to one of 3 groups: a) face-to-face counselling by an exercise specialist; b) one face-to-face visit followed by telephone counselling by an exercise specialist; or c) receive generic print materials in the mail promoting PA. The primary outcomes will be pedometer steps at 12 months.

We are looking to investigate the effect of alcohol on simultaneous touch sensation. There are specific areas within the brain that are vital for deciphering touch. When two areas of skin are touched simultaneously, some of these brain areas are excited and some are inhibited. A greater ability to determine between two simultaneous stimuli (a reduction Two Point Discrimination threshold) has been associated with increased inhibition in the brain. Recent research has shown that alcohol can increase inhibition within the brain. With this in mind we look to explore the possibility that alcohol could improve tactile acuity, lowering the Two Point Discrimination threshold.

Being overweight and gaining too much weight in pregnancy increase the chances of complications of the pregnnacy for the mother and baby. We believe that by giving women simple dietary advice and encouraging them towards healthy weight gain targets in pregnancy, these outcomes may be improved

Antibody mediated rejection post kidney transplant has become a significant clinical problem given that over 25% of kidney transplant candidates have antibodies to potential organ donors. There is no approved treatment for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplantation in sensitized patients.