ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32901 results sorted by trial registration date.
  • A randomised placebo controlled trial of intensive psychosocial treatment plus or minus anti-psychotic medication for first episode psychosis with low-risk of self-harm or aggression. The STAGES Study: Staged Treatment and Acceptability Guidelines in Early Psychosis

    Background Over the last decade, there has been a significant shift in psychiatric services towards a greater focus on early intervention for psychotic illnesses. This has raised the question of what the most appropriate form of treatment is for people (very) early in the course of a first psychotic episode. It is also possible that due to the efforts of early detection programs, the composition of first episode psychosis (FEP) cohorts may have changed towards including those who may have a more benign course of psychotic symptoms and thus may respond to more benign treatments. Aims The purpose of this project is to investigate whether a sub-group of young people can recover from FEP with intensive psychosocial intervention but without taking antipsychotic medication. Although we know that antipsychotic medication is usually helpful in assisting recovery from psychosis, medication may not be essential for effective treatment in all cases. Furthermore, there is also evidence that psychological treatment is helpful and may be sufficient and more acceptable to young people who are experiencing FEP. Design Participants will be young people, aged 15 - 25 receiving treatment from the Early Psychosis Prevention and Intervention Centre (EPPIC) of ORYGEN Youth Health. Approximately 95 young people will be randomised to two treatment groups: 1. Medication (risperidone) plus intensive psychosocial treatment (MIPT) 2. Placebo plus intensive psychosocial treatment (PIPT) The trial will be of 6 months duration. Intensive contact with participants will be maintained by case managers and psychiatrists throughout this time. Clinical, neuropsychological and neuroimaging measures will be taken at baseline and at various follow-up points (3, 6, 12, 24 months). Outcomes The primary outcome of interest is functional and symptomatic outcome (at 6, 12 and 24 months) in each treatment group. Specifically, it is of interest whether participants in the PIPT group achieve similar levels of functional and symptomatic improvement compared to the MIPT group at short- and long-term follow-up. Another outcome of interest is the proportion of the PIPT group who are not placed on antipsychotic medication during the 6-month period. These participants will have achieved satisfactory remission without antipsychotic medication. This sub-group will be compared on functioning and symptom scales to those randomised to the medication group and to those for whom antipsychotic medication was commenced due to worsening mental state and/or risk. Characteristics of this group will be analysed to determine the sub-group of FEP patients who may achieve remission from symptoms without antipsychotic medication. A PhD project has been added that will recruit a healthy comparison group to examine changes in physical health and neuropsychological functioning over time in the study age group.

  • Comparison of different models of providing physiotherapy care for people with simple musculoskeletal injuries presenting to Emergency Department

    Physiotherapists are being used more often in Emergency Departments to help treat people with simple musculoskeletal injuries. The physiotherapist in the Emergency Department can treat directly (primary contact physiotherapy), or treat after the patient is first seen by a doctor who then refers on to physiotherapy (secondary contact physiotherapy). The aim of this project is to compare the different models of physiotherapy services for people with simple peripheral musculoskeletal injuries presenting to Emergency Departments. It is hypothesised that compared to secondary contact physiotherapy, primary contact physiotherapy will reduce length of stay in the Emergency Department, without having any adverse effects, such as an increased re-presentation rate.

  • The Effect of Detailed Anchor Point Descriptors on Patient Self Report of Health-Related Quality of Life.

  • A study looking at the effect positron emission tomography (PET) scans have on the treatment decisions specialists make in patients with suspected cancer of the pancreas.

    In addition to the standard pre-operative investigations you will also undergo a PET scan. Your results will be compared to people who only receive the routine pre-operative investigations, to see if the use of the PET scan changes the treatment plan. A PET scan is a non-invasive nuclear imaging test. In other cancers, particularly lung cancer, this scan can detect the spread of cancer better than other tests. If you have a suspected pancreatic cancer, the usual tests might include a CT (computed tomography) scan, ultrasound, MRI (magnetic resonance imaging) scan and an ERCP (endoscopic retrograde cholangiopancreatography). If a PET scan helps show the extent of the cancer better, your diagnosis will be more accurate and this might spare you unnecessary major surgery.

  • Does Palliative Chemotherapy Improve Symptoms in Women with Recurrent Ovarian Cancer?

    In this research project we will study quality of life issues related to having advanced ovarian cancer and undergoing chemotherapy. We are interested in knowing how women are doing during chemotherapy for ovarian cancer and whether symptom improvement occurs with treatment.

  • Bronchoscopic Vapour Therapy for Emphysema

    The primary purpose of this study is to established the side effect and benefit profile of BTVA in patients with heterogeneous upper lobe emphysema. The results will help to support subsequent clinical trials in a larger patient sample.

  • A Randomised, Single Centre Study of the Equivalence of Two Intraocular Lenses Used in Cataract Surgery

    Prospective randomised study is to assess the safety and efficacy of the two intraocular lens (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.

  • Healthy Eating to Reduce Overweight in people with type 2 diabetes

    This study investigates if the inclusion of a high PUFA food, walnuts, shows favourable trends in body composition in subjects with type 2 diabetes mellitus over the long term (12 months). We assumed that dietary fat-driven changes in body composition take time. Further we examined how the dietary change occurred through food patterns and whether these changes might impact on clinical (glucose homeostasis, lipids), and metabolic (resting energy expenditure and leptin levels) variables.

  • Study in healthy Australian adult subjects comparing the standard commercial flu vaccine with an enhanced flu vaccine containing a natural plant-derived immune enhancer

    A major challenge in influenza vaccines is to find a way to deliver considerably lower doses of influenza vaccine while still being able to elicit a protective immune response. This is because the number of doses of seasonal influenza vaccine able to be generated is limited by production capacity and cost.Extensive animal data indicates addition of a natural plant sugar called Advax results in enhanced immunity and/or reduced antigen requirements compared to current unadjuvanted human influenza vaccines. This study will test the safety and effectiveness of a low dose flu vaccine containing Advax to the standard full dose commercial flu vaccine.

  • Safety study of an improved aluminium-free Hepatitis B vaccine based on a natural plant sugar

    The basic goal for hepatitis B vaccination is to achieve a protective immune response with a minimum of discomfort and without any risk of serious side effects. Current hepatitis B vaccines whilst safe are associated with significant injection site discomfort. In addition they contain aluminium salts which pose uncertain long term risks of toxicity. This study was designed to collect preliminary data on the safety and tolerability of a new hepatitis B vaccine where the aluminium component has been replaced by a natural plant derived sugar which in animal studies has been shown to markedly reduce injection pain while enhancing the protection conferred by the vaccine.

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