ANZCTR search results

The proposed study is a randomized controlled trial of two evidence-based treatments for late-life depression for patients who also have at least one co-morbid health problem. Participants will be randomised to two active interventions (ie PST or CBT) or treatment as usual (TAU). Randomization will be stratified by diagnosis: major depressive episode or minor depression/dysthymia, using computer-generated random numbers. All assessments will be completed by a researcher that remains blind to the allocation throughout the study. Participants will be assessed, using a range of questionnaire measures and a diagnostic interview, at pre and post-treatment, 6, and 12 months follow-up.

This study aims to determine the safety and efficacy of treatment with a tyrosine kinase inhibitor (TKI) and pegylated interferon in patients with previously untreated chronic myeloid leukaemia (CML). Who is it for? You may be eligible to join this study if you are aged at least 18 years and have been diagnosed with CML. You must have received no previous treatment for CML. Trial details All participants in this trial will commence treatment with the TKI oral nilotinib alone for 3 months. Provided the drug is tolerated, participants will commence injections of pegylated interferon at a dose of 30 micrograms per week. After a month of pegylated interferon and nilotinib treatment, and provided the pegylated interferon is tolerated, patients will escalate pegylated interferon treatment to a dose of 50 micrograms per week in combination with nilotinib. Participants will be assessed at regular timepoints until the end of the trial to determine the safety and clinical benefit of the treatments. Treatment duration will be a minimum of 24 months. This Phase II study will: Investigate the survival benefit, the rate of remission and safety of the patients allocated to each group and compare the groups to eachother.

The Brien Holden Vision Institute (previously known as the Institute for Eye Research) conducted a clinical trial to test commercially-available multifocal contact lenses for their potential to control the progression of myopia in children(IERP2007-009, ACTRN12611001148965; http://www.anzctr.org.au/trial_view.aspx?ID=347659 ). The trial was completed in 2008. Approximately half of the 40 children who participated in trial IERP2007-009 were enrolled in a subsequent myopia control trial at the Brien Holden Vision Institute (IER2008-001, ACTRN12611001141932; http://www.anzctr.org.au/trial_view.aspx?ID=347655 ) in which all participants wore the test product of trial IERP2007-009. Both IERP 2007-009 and IER2008-001 have provided valuable information on the efficacy of the multifocal contact lenses in controlling the rate of progression of myopia. This research is based on the hypothesis that the peripheral retina plays a role in controlling the refractive development of the eye as shown in animal experiments (Smith et al. 2007). In this study, the participants will continue to wear the commercially available multifocal contact lenses used in the previous two trials (IERP2007-009 and IER2008-001) to see whether the efficacy of controlling myopia with this lenses will still remain true for a longer period of time.

This study aims to assess a number of new treatments over time. The aim is to continue to improve treatment by comparing a number of new drugs which have shown some benefit in early stage trials with the existing standard treatment. The current treatment option which will be tested in Australia is standard treatment, low dose Cytarabine alone compared with standard treatment, low dose Cytarabine in combination with Tosedostat in elderly patients with either acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). Who is it for? You may be eligible to join this study if you are aged 60 years or over and have been diagnosed with AML or MDS. You must have received no previous treatment for AML. Trial details Additional experimental treatments may be added or removed from the study as further information becomes available. The current treatment option which will be tested in Australia is standard treatment, low dose Cytarabine alone compared with standard treatment, low dose Cytarabine in combination with Tosedostat in elderly patients with either acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). All participants in this trial will undergo chemotherapy for four cycles. Participants will be randomly (by chance) allocated to one of two groups. One group will receive the together subcutaneous injections of low dose cytarabine together with Tosedostat tablets in a dose of 120mg (2 capsules) orally once a day with a glass of water after food, preferably in the morning at about the same time every day to ensure an even dose interval. Treatment should commence on day 1 of the first course of Low dose Ara-C and continue daily for 6 months. Patients may stay on treatment if they are deriving benefit. The other group will receive low dose cytarabine by subcutaneous injection alone. Participants will be assessed at regular timepoints until the end of the trial to determine the safety and clinical benefit of tosedostat treatment in combination with low dose cytarabine, compared to the current effective treatment of low dose cytarabine alone. Treatment Duration will be a minimum of 4 courses between 28 and 42 days each. This Phase II/III study will: Investigate the survival benefit, the rate of remission and safety of the patients allocated to each group and compare the groups to each other

This study aims to determine the safety and efficacy of treatment with the drug midostaurin, in combination with intensive chemotherapy for adults with previously untreated core binding factor (CBF) acute myeloid leukaemia (AML). Who is it for? You may be eligible to join this study if you are aged between 15-65 years and have been diagnosed with AML with CBF subtype. You must have received no previous treatment for AML. Trial details All participants in this trial will undergo intensive chemotherapy over a period of 18 months, that will include the addition of midostaurin twice a day during some of that time. Midostaurin is a new chemotherapy drug thought to be particularly effective in CBF AML. Participants will then be assessed at regular timepoints for between 1 to 5 years to determine the safety and clinical benefit of midostaurin treatment in combination with chemotherapy. This Phase II study will: Investigate the clinical benefit, safety and potential extended survival following therapy with frontline midostaurin in combination with chemotherapy and during maintenance therapy in adult AML

Regulation of the factors that control food intake, the function of the stomach and small intestine and release of gut hormones is complex, and our understanding of this field is far from complete. There is increasing evidence that nutrient stimuli in the gut, especially in the small intestine, induce changes in gut motor and hormonal functions that play a central role in the control of energy intake and blood glucose. In particular high-protein diets have been found to be very effective for weight loss and for improving blood glucose in obese with and without type 2 diabetes. This study aims to investigate the effects of the amino acid, L-phenylalanine, on gut motility, gut hormone release, blood glucose control and energy intake in humans. We hypothesise that L-phenylalanine as building block of proteins, may substantially contribute to the beneficial effects of whole protein on gut functions and energy intake regulation. This has not been evaluated in detail and will be important in order to enhance our understanding of the mechanisms underlying the effects of dietary protein on eating control.

This trial investigates the use of a guidelines based approach (Project Air Strategy, 2011) to supporting families, partners and carers of people with a personality disorder

Treatment for personality disorder is effective but only specialist long-term approaches have been studied on specific subsets of patients with highly trained staff. This study aims to evaluate a whole of service approach in a large public mental health service. The treatment is guidelines-based approach based on a relationship model (Project Air Strategy for Personality Disorders 2011). A delayed randomised controlled trial compares this approach to standard care.

This study will investigate the effect of including a small amount of adrenaline in the local anaesthetic (ropivacaine) solution used for the abdominal wall nerve blocks commonly performed now to provide pain relief after abdominal surgery. Ropivacaine is commonly used for these nerve blocks because it is a longer-acting local anaesthetic. Adrenaline is a naturally occurring substance in the human body. It is commonly added to local anaesthetics to increase the duration of their effect, and to reduce the rate local anaesthetic is taken up into the blood stream (to limit the risk of side effects to the local anaesthetic). The specific purpose of this study is to determine how much, if at all, the inclusion of adrenaline reduces uptake of the local anaesthetic ropivacaine, with these particular blocks, and thus whether or not it increases the safety. Currently, adrenaline is routinely added to local anaesthesics for certain types of nerve blocks but its potential safety benefit in abdominal wall blocks using ropivacaine is unclear.

This study will describe the usual dietary nutrient profile of a patient group with NAFLD and associations with a range of indicators of liver disease severity and cardiovascular risk. After a 3-month dietary intervention with a Mediterranean-style test diet vs. a low-fat control diet, the influence on measures of cardiovascular risk and liver fat, will be assessed. Patients will maintain their weight during this 3-month period to allow for assessment of the influence of diet, independently of the known effects of weight loss. By re-examining the same markers of liver disease severity and cardiovascular risk, the effects of the intervention and control diets will provide insight into whether there is a superior nutrient profile to improve cardiovascular risks and/or liver fat in this patient group. This will also determine if there is a role dietary therapy in NAFLD for patients who are unable lose or maintain weight loss.