ANZCTR search results

This study is comparing the extent to which the drug Afuresertib can be used by the body when administered to healthy volunteers in 3 different formulations under fasted and non-fasted states. Who is it for? You may be eligible to join this study if you are a healthy male or female aged between 18-40 years, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. Trial details: This is a trial examining the bioavailability of a total of 4 doses of 3 different formulations of the same drug (Afuresertib), in both fasted and non-fasted states. The 3 formulations are a Gelatin Capsule and two prototype formulations of Afuresertib, which are another capsule and the other, a tablet. This means that throughout the study you will be asked to take a tablet or a capsule on 4 different occasions and on each of these occasions, you will be asked to either eat (non-fasted state) or not eat (fasted state). Whether you will receive a tablet formulation or one of the 2 capsule formulations will depend on what treatment sequence you are randomly allocated to. Likewise, whether you will be receiving your dose in the non-fasted state or fasted state will again depend on what treatment sequence you are randomised to ('randomisation' is like flipping a coin, where the outcome cannot definitely be determined). Throughout the trial, apart from other assessments, blood samples will be taken from you to measure the absorption and elimination of the drug in your body. This is measuring the 'bioavailability' of the drug. You will also be assessed for Adverse Events to be able to evaluate the safety of the drug. You will be on-study for a total duration of 9 weeks (3 weeks for screening, 5 weeks for the treatment phase and 1 week for a Follow-up Visit). You participation maybe be less should the screening phase of your participation take less than the maximum of 21 days. It is hoped that eventually, the data obtained from this study will help us to determine the best formulation of the drug Afuresertib to administer to cancer patients diagnosed with, for example, multiple myeloma or other haematological malignancies].

This study evaluates the short and medium term efficacy of assessment and treatment at the MindSpot Clinic in Australians aged 18+ with symptoms of anxiety or low mood.

A convenience sample of patients receiving regional citrate hemodialyis by means of the Canberra Hospital Protocol are assessed for calcium and citrate flux during dialysis by means of a complete dialysate collection.

To see the tolerance patients have after a general anaesthetic of nasal oxygen as opposed to facemask oxygen (which is normal). Previous studies show that compliance with oxygen therapy is better with nasal oxygen than facemask oxygen. Also we believe this technique gives patients as effective oxygenation. Therefore potentially improving patient safety.

This randomized comparison trial will test the efficacy of a novel rehabilitation (Move it to improve it' (MiTii) which involves the use of a web based, intensive, individualized, multi-modal therapy program with therapists acting as virtual trainers, over a 20 week period, and comparing this approach to standard care received in children with acquired brain injury.

The strongest risk factor for depression is having a family history of the condition. Many individuals with a family history of depression are concerned about their personal risk for depression. In this study we will develop and evaluate the first online psycho-educational intervention nationally and internationally targeted to individuals with a family history of depression. An intervention incorporating a risk assessment tool and delivery of education tailored to people with a family history of depression will be developed and pilot tested. The intervention will be delivered by general practitioners (GPs) and evaluated using a cluster randomised controlled trial (RCT) methodology.

BIT225 powder has been used in several trials to date to investigate safety and effectiveness. A capsule formulation, being a more acceptable dose form than the powder, has been developed for use in future trials and as a possible future marketed formulation. This trial is to compare a single dose of the capsule to a single dose of the powder to see how much of the drug gets into the bloodstream and how long does the body take to remove it, what is the maximum concentration of the drug in the bloodstream after a single dose, and how well the capsule is tolerated compared to the powder form.

The purose of this study is to understand how well oxycodone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of a patch.

Heart disease is the leading cause of death in Australia, and patients with existing coronary heart disease (CHD) are at increased risk of further cardiac events. Most secondary prevention guidelines recommend that patients with CHD modify their cardiac risk factors. To do this, patients require an adequate level of health literacy including awareness of their own condition and risk factors, and the knowledge to be able to make essential lifestyle modifications. The Heart Foundation recently updated a key resource My Heart My Life, which provides comprehensive information on recovery from heart disease. This project seeks to evaluate the effectiveness and impact of the My Heart My Life resource on patient knowledge, behaviour change and health literacy in Victoria. Patients who have been admitted to Eastern Health with an acute coronary syndrome (ACS) will be asked to complete a Health Literacy Questionnaire (developed by Deakin University). Questions will also be asked to determine understanding of terminology and actions to take to reduce health behaviour risk factors. Participants will then be randomised into two groups – one group who receive the My Heart My Life resource and a control group who receive usual in-patient education. A follow-up phone call will be done at one month to determine differences between the two patient groups in terms of cardiac knowledge and health-related behaviours. The results of this evaluation will determine whether patients who received the My Heart My Life resource obtain a greater understanding of their condition, report they are able to manage risk factors and are more likely to attend cardiac rehabilitation, compared with usual care.

More than one in ten infants are born preterm, with increased risk of disability. To guide public policy reliably, cost-effectiveness analyses of interventions to prevent disability require a long-term societal perspective, including costs of hospital treatment, special education, family or community care, and lost parent and child productivity. Methods: We evaluated (i) the proportion of cost effectiveness analyses with a long-term societal perspective and (ii) whether analyses with a long-term societal perspective were more frequent within randomised controlled trials (RCTs). Original, peer-reviewed research articles in English from 1 January 2002 through 31 December, 2012 were eligible for inclusion in the review if they described cost-effectiveness analyses of interventions before or after preterm birth and reported disability. Searches by two reviewers in The Cochrane Library, EconLit, EMBASE and MEDLINE databases yielded 220 articles. Reference lists from those articles yielded another 5 articles. Of these 225 articles 25 described cost-effectiveness analyses that met the inclusion criteria.