ANZCTR search results

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

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31356 results sorted by trial registration date.
  • The Preview Study Australia: prevention of diabetes through lifestyle intervention and population studies in Europe and around the world.

    The primary goal of the Preview intervention study is to identify the most efficient lifestyle pattern for the prevention of type-2 diabetes in a population of pre-diabetic overweight or obese individuals (i.e those at high risk of diabetes). This will be done by conducting a clinical randomized intervention trial of 3 years duration in a total 310 pre-diabetic adults in Australia.

  • Metformin for Mind and Metabolism

    Metformin is a medication originally derived from French Lilac which has been used to treat diabetes for over 50 years. The aim of this study is to see whether metformin can improve mood and memory in people who have depression and obesity. We will recruit 30 adults who feel depressed despite currently taking an antidepressant medication and who also have a large waist measurement (more than 88cm for women and 102cm for men). The study will last for 12 weeks. Participants will be randomized to either metformin 1000mg twice per day with food or placebo. At the beginning and the end of the study mood will be rated by self-report and by the doctor’s impression. Memory will be measured using a series of computer based tests, similar to playing simple computer games. The hope is that metformin will help obese adults with depression by reducing levels of the hormone insulin as well as markers of inflammation, within the brain, thereby improving mood.

  • Evaluation of a single iron infusion versus oral iron tablets in the treatment of pregnancy anaemia among Tasmanian women

    This study is aiming to show that by having normal haemoglobin and iron studies at the time of delivery, the patients will not only feel better, but will perform better during and after pregnancy. It is hoped that their pregnancy will be less eventful without any complications. By improving antenatal haemoglobin, we expect to reduce the incidence or necessity for blood transfusions in this cohort of patients thereby relieving the strain on the supply of blood from an already stretched Blood Blank and also to avoid the risks/complications of transfusion. Because of its national and global significance, this project merits significant health improvement for pregnant women. To identify the best treatment approach to iron deficiency anaemia in pregnancy. Effective management of iron deficiency anaemia has a major impact on the health, educational and economic potential of populations in Tasmania and Australia. This and future work may lead to replacement of iron as first line therapy of the world’s most common nutritional disorder, affecting more than 2 billion people.

  • Modified SHoes for osteoARthritis of the Knee: the SHARK study

    Knee osteoarthritis (OA) affects many older people and is a major public health problem. Afflicted individuals suffer from knee pain and physical dysfunction that impacts dramatically on quality of life. Osteoarthritis has no cure and often gets worse over time. Non-toxic treatments that reduce symptoms and assist patient self-management over the long-term are needed. Increased joint loading (force across the knee) is central to pain development and increased risk of disease progression in people with knee OA. The type of shoes a person wears can increase or decrease their knee load depending on the shoe design features. This randomised controlled trial will test the efficacy of modified shoes (designed to unload the knee joint) for reducing symptoms and improving physical function in people with knee OA.

  • Test of a new, technology-assisted motivational intervention for substance misuse in early psychosis.

    A lifetime diagnosis of substance use disorder is seen in 40% of Australians with psychosis, and has substantial symptomatic and functional impacts. Both problems have detrimental effects on motivation, hindering treatment gains. A newly developed intervention, Functional Imagery Training (FIT), uses individually tailored imagery (multisensory mental 'pictures') to consolidate motivation, rehearse coping strategies and enhance confidence. Personal smartphones are used to assist in use of imagery and to set reminders, while the OnTrack Get Real Internet program supports self-management of psychotic symptoms. The current study aims to: 1. Examine the effectiveness of FIT with 20 young adults aged 16-25 years who are experiencing early episode psychosis and using cannabis; 2. Qualitatively explore participants' experiences of the treatment and solicit suggestions for enhancement of the intervention. Participants are recruited from the Early Psychosis Team, Princess Alexandra Hospital. Case managers obtain verbal consent from the consumer to pass on their details to the research team. If the consumer is less than 18 years of age and has a parent/guardian involved in their care, staff also obtain consent from the parent/guardian. The research team contact the consumer to provide more information about the study, and to make an appointment for the baseline assessment. The baseline assessment lasts up to 60 minutes and includes questions about cannabise use, psychiatric history and symptoms, and quality of life. The FIT intervention commences one week later and comprises two face-to-face treatment sessions of 1 hour duration, held one week apart. Sessions combine motivational interviewing with the use of imagery to identify reasons for cannabis reduction, possible goals and strategies, and to build confidence. Imagery involves creation of multisensory mental pictures relating to the goal, reasons for change and success with similar goals in the past. Session 2 concludes with instruction in how their smartphone can be used to assist them to use the intervention techniques in their everyday life. Treatment support phone calls of 10-15 minutes occur in weeks 3, 4, 8 and 12 after baseline. Support calls reinforce goal committment and problem-solve difficulties. Cannabis use and goal motivation are also assessed in the 4 week call. A follow-up interview of 60 minutes duration occurs 13 weeks post-baseline and assesses cannabis use, psychiatric symptoms, quality of life, and experiences of the treatment. Throughout FIT, participants remain engaged with routine care and are encouraged to use the OnTrack Get Real Internet program for assistance with their psychiatric symptoms.

  • Work Injury Screening and Early intervention (WISE) Study

    The primary aim of the study is to determine if implementation of an early identification and intervention protocol for injured workers (who have been assessed as being at high risk for delayed return to work) results in better outcomes compared to usual care (current practice) for similar high risk injured workers. The better outcomes we anticipate are: reduced costs of workers compensation claims and earlier sustained RTW in the 12 month follow-up period.

  • Using Positron Emission Tomography (PET) imaging to measure kidney function

    The study is comparing two different techniques to assess kidney function in patients referred to the Peter MacCallum Cancer Institute. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for assessment of kidney function. Trial Details. The determination of kidney function is utilised for a wide range of clinical decision making. At Peter MacCallum Cancer Centre, common clinical indications include dose adjustment for renally excreted chemotherapy agents (eg. carboplatin), determination of overall and split renal function prior to abdominal radiotherapy and monitoring of renal function during radionuclide therapy. Radionuclide techniques such as 51Cr-ethylenediaminetetraacetic acid (EDTA) blood clearance counting is a well-established method for estimation of GFR but requires blood samples from the patient at multiple time points and requires a well counter to accurately measure radioactivity at each time point which is not available in many nuclear medicine facilities. Positron emission tomography (PET) offers several advantages for imaging the kidneys over the conventional nuclear medicine technique. It has an order of magnitude higher sensitivity for radiotracer detection, enables dynamic tomographic (three dimensional) imaging, incorporates scatter and attenuation correction enabling accurate quantification of regional uptake and has superior spatial and temporal resolution. EDTA can be labelled with 68Ga, a positron emitting isotope which can be imaged on a PET/CT scanner. 68Ga EDTA PET/CT offers a non-invasive imaging-based alternative to 51Cr EDTA for GFR estimation. 68Ga EDTA PET/CT also has the ability to assess both overall and differential or regional renal function in a single study. Currently, many patients undergo both a 51Cr EDTA and a 99mTc-DMSA or 99mTc-DTPA to calculate overall and regional function, respectively. Although 68Ga EDTA standalone PET has been performed, there is limited experience and no data on its use in the PET/CT era or utility in comparison to 51Cr EDTA for GFR estimation. There are also no published reports, to our knowledge, using 68Ga EDTA to assess regional renal function. All participants in this study will undergo two different techniques to evaluate kidney function. This involves having an injection into a vein of a small of dose of two radioactive substances (68Ga and 51Cr-EDTA). A 20 minute PET scan is then performed looking at your kidneys. A small amount of blood is taken at 2, 3 and 4 hours.

  • A mixed methods trial of a family-based, parent-led intervention to improve resilience and wellbeing of families living with a childhood chronic illness.

    Children who live with a chronic illness and their families face a multitude of challenges and are often more vulnerable to mental illness due to persistent levels of stress experienced in relation to the illness and other issues. The Child Illness and Resilience Project (CHiRP) aims to develop and evaluate the acceptability and effectiveness of a family resilience based mental health promotion intervention designed to enhance the well-being of this vulnerable population. The testable hypotheses are; 1. that the provision of a Family Resilience and Well-being booklet containing information, strategies and self-directed activities designed to promote family resilience to parents/carers of children with a chronic illness will improve psychological well-being and family resilience (as measured by scores on standardised measures of relevant constructs such as psychological distress, family functioning, social connectedness, family beliefs and help-seeking behaviours); 2. that for parents/carers of children with a chronic illness who experience above normal levels of psychological distress, participation in an Family Resilience Information Support Group will further improve psychological well-being and family resilience (as measured by scores on standardised measures of relevant constructs such as psychological distress, family functioning, social connectedness, family beliefs and help-seeking behaviours), relative to receiving the booklet only. 3. that the CHiRP Family Resilience resources build the capacity of the health sector to standardise provision of information, support and resources to families who have a child with chronic illness (as measured by evaluation data from participants and health sector staff).

  • Molecular determinants of glucose sensing in human gastrointestinal tract of patients with type 2 diabetes and healthy volunteers.

    It has been recently revealed that distinct mechanisms trigger the release of the incretin hormone glucagon-like peptide-1 (GLP-1) in the proximal and distal intestine in rodents. Stimuli for incretin release vary considerably between species, and whether such distinct proximal and distal mechanisms exist in humans has not been assessed. Specific aims of the proposal are to: 1 - Determine the release of GLP-1 during acute colonic perfusion with glucose or the potassium ATP ion channel (KATP) inhibitor, glibenclamide, in healthy subjects and patients with type 2 diabetes; 2 - Determine the expression of glucose sensing molecules in functionally identified colonic cells, activated by glucose or glibenclamide, in healthy subjects and patients with type 2 diabetes. We hypothesise that L-cells in the human colon can release endogenous GLP-1 following local inhibition of KATP channels. This signalling pathway may provide an avenue to augment endogenous GLP-1 release in patients with type 2 diabetes, which could potentially be used to optimise blood glucose control.

  • A clinical evaluation of a novel olive leaf formulation for heart health.

    Lifestyle risk factors such as lack of regular exercise, poor diet, ageing, excess body weight, high blood fats and high blood sugar levels can lead to narrowing and hardening of arteries, thus increasing our blood pressure. Long term elevated blood pressure can eventually increase our risk for developing cardiovascular diseases. Certain ingredients from food sources such as extracts from olive leaf, green coffee bean and beet may help lower blood pressure by enhancing the ability of blood vessels to dilate. These ingredients have independently been shown to have blood pressure lowering effects; however, their combined effects on blood pressure are unknown. In this study, we are looking to see if a novel formulation consisting of extracts from olive leaf, green coffee bean and beet can lower blood pressure in adults. We will also look at its effects on blood fats, blood sugar and insulin levels.

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