ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Engaging men to maintain weight loss using innovative and cost-effective interventions: The SHED-IT Weight Loss Maintenance pilot study.

    Obesity in men is one of the greatest public health challenges facing Australia. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death and disability. With 70% of Australian men overweight or obese, the current and predicted financial and human costs are alarming. Despite men being more susceptible than women to many of the serious consequences of obesity such as CVD, men rarely engage in weight loss (WL) programs, and when they do lose weight they rarely maintain the WL. There is an urgent need to develop and evaluate novel and cost effective approaches that achieve long-term WL in men. The aim of this pilot study is to develop and evaluate the feasibility and efficacy of a WL maintenance (WLM) program specifically for men.

  • Pilot study to determine the effect of nutrition education on dietary intake in people with diabetes

    The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in fruit, vegetables and dairy and lower in fats, signficantly reduced blood pressure in people without diabetes. At present their has been no investigation of the effect of the DASH diet in people with diabetes. The aim of this pilot study is to investigate the feasibility of a DASH like diet in people with diabetes

  • A randomised control trial to test an educational innovation of diabetes care in general practice

    The data in this study offer evidence for the value of Spaced Education Diabetes (SED), a tailored, adaptive, online diabetes education program, in improving evidence-based management of type 2 diabetes, by GPs. Spaced Education Diabetes (SED) is an innovative approach that can be delivered by email and tailored to individual GP knowledge levels. It will deliver education to improve management of hyperglycaemia, hypertensive and hyperlipidaemia. The study aims to improve GP management and control of metabolic targets in type 2 diabetics, and improve patient outcomes.

  • A Phase I/II trial to determine the Safety, Toxicity and Efficacy of Iodine-131-Rituximab and the Histone Deacetylase Inhibitor Panobinostat in Relapsed and Refractory Indolent B-cell Lymphoma

    This study aims to investigate the safety, toxicity and efficacy of a treatment combination of the drugs Iodine-131-Rituximab and Panobinostat in patients with Relapsed and Refractory Indolent B-cell Lymphoma. The trial will be conducted in Melbourne at the Peter MacCallum Cancer Centre and in Fremantle at Fremantle Hospital. Who is it for? To be eligible for this study, you must be aged 18 or above with a histologically confirmed relapsed indolent B-cell non Hodgkin's lymphoma. Further details of the inclusion criteria for this trial can be found in the corresponding section of this trial record. Trial Details There are two phases for this study, with three dose levels of panobinostat considered in phase I of the study, which is the dose finding phase. This will be followed by phase II, which consists of an expanded cohort at the phase I determined dose of panobinostat. In phase I, you will receive oral panobinostat which will be administered at a dose of 20, 30 or 40mg in 5, 15 and 20mg tablets. This will commence on day one on a Monday and will continue to be given on Monday, Wednesday and Friday weekly for four weeks. A tracer activity of 200 MBq131I-rituximab will then be administered intravenously after an intravenous dose of 375 mg/m2 rituximab unlabeled antibody, with both given on day four. Whole-body imaging and background scans will be performed within one hour in the administering department, and be repeated four and seven days later under the same imaging conditions. Full details of the treatment regime can be found in the Description of intervention(s)/ Exposure field of this trial record.

  • A randomised control trial of two different speech therapy approaches (Rapid Syllable Transition Treatment and Nuffield Dyspraxia Programme 3rd edition) to treating Childhood Apraxia of Speech.

    Childhood Apraxia of Speech (CAS) is a motor speech disorder. Children with CAS have difficulties planning the movements required for speech sounds and melody. The difficulties associated with CAS often persist through life and are deterimental to academic, social and vocational development, despite normal intelligence. Currently a number of single case designs are available yet few treatments have been tested or replicated. We intend to complete the first randomised control trial to compare two treatments for CAS. The speech therapy treatments we want to compare are 1) the Rapid Syllable Transition Treatment (Ballard et al, 2010) and 2) the Nuffield Dyspraxia Programme (3rd edition) (Williams & Stephens, 2004). Both treatments have preliminary promising evidence. We want to know if these treatments improve speech sounds and melody in children with CAS age 4-12 years. We also want to know which treatment will make better gains in treated sounds/words/sentences AND untreated but similar sounds/words/sentences.

  • Can a participatory workplace intervention improve sedentary behaviour and physical activity in office workers?

    Physical inactivity is one of the major causes of many chronic preventable diseases such as obesity, diabetes and cardiovascular disease. There is a growing understanding that low energy activity or sedentary behaviour and breaks in sedentary time are also independently linked to cardiometabolic risk factors. Furthermore, in the “technological” age, occupational physical activity has reduced. Currently, it is estimated that office workers spend approximately 75% of their working hours sedentary (sitting) and are therefore at risk of many of the adverse health consequences associated with prolonged sedentary behaviour. Workplace activity intervention programmes have focussed on increasing moderate/vigorous physical activity typically by encouraging walking before and after work or during breaks. To date, there is no research that has examined the effect of modifying office work to incorporate short bouts of light intensity physical activity and encouraging breaks in sedentary behaviour. Aims 1) To assess if a participatory work-based programme to encourage incidental and light intensity physical activity can reduce sedentary time of office workers 2) To assess if a participatory work task focussed intervention to promote reduced sustained sedentary time and increased incidental activity is more effective at reducing sedentary time than interventions focussed on physical activity in discretionary time or an office workstation ergonomics intervention 3) To assess if changes that result from a participatory work-based intervention programme are sustained 3 months following the intervention 4) To determine if there is a relationship between participatory workplace health programmes and musculoskeletal pain and job satisfaction

  • An exploration of the role of pharmacists within general practice clinics: the Pharmacists in Practice Study (PIPS)

    The aim of this study is to develop, implement and evaluate a practice pharmacist role in primary care practices to improve the quality use of medicines by patients and health professionals. Part-time practice pharmacists will be located in two primary healthcare clinics in Victoria. The pharmacists provide long and short patient consultations, education sessions, drug information services and quality assurance activities. Patients receiving long consultations with a pharmacist will be followed over 6 months. Medication-related problems, medication adherence, health and well-being, and patient satisfaction will be assessed. Patient and staff experiences with the service will also be explored.

  • Evaluating a parenting program for grandparents

    The purpose of the study is to evaluate whether Grandparent Triple P is effective in assiting grandparents supporting their grandchildren. Specifically it is hypothesised that compared to a control group, grandparents participating in Grandparent Triple P would have increased parenting self-efficacy; increased relationship satisfaction with biological son or daughter (the parent); decreased reliance on dysfunctional parenting strategies; and decreased levels of depression, stress, and anxiety. Additionally, it was hypothesised that grandparent participation in the intervention would result in positive childhood outcomes, specifically a reduction in childhood behavioural problems. The secondary hypotheses were that grandparents would experience higher marital relationship satisfaction and decreased partner conflict over parenting strategies. It was predicted that these positive treatment outcomes would be maintained at six-month follow-up. Finally, a secondary outcome hypothesized was that parents would report an increase in relationship satisfaction with the grandparents, and that parents would also report a reduction in childhood behavioural problems.

  • A pilot study to assess low dose ovarian stimulation using local anaesthetic to collect oocytes for women having IVF treatment

    In the last 5-10 years there have been major advances in the technology and knowledge of assisited reproductive technology treatments. These include improved media and control of the environment for culturing human embryos. As a result there have been significant improvements in pregnancy rates and a significant increase in the transfer of a single embryo, to prevent the complications associated with multiple pregnancy. Historically, pregnancy rates have increased with greater numbers of eggs collected. Therefore superovulation procedures designed to enable the collection of 10-15 eggs per IVF cycle were a required part of the treatment strategy. However, with the recent advances of improved embryology techniques and pregnancy rates the requirement for a large number of eggs to be collected from young women has reduced. Modelling from our own laboratory has shown that pregnancy rates in young women plateau at 3-4 eggs. Therefore in this group of women production of more than four eggs in a stimulated cycle does not increase pregnancy rates but are associated with the risk of complications such as ovarian hyperstimulation syndrome (OHSS) (Reviewed in Verberg et al., 2009). Futhermore, there is increasing evidence in both animal models and also in the human that there are increased benefits of low dose stimulation. High doses of stimulation are associated with increased rates of poor quality oocytes and embryos (Valbuena et al., 2001) and have been reported to affect endometrial competence as well as reportedly increasing the incidence of aneuploidy (Baart et al. 2007). As a result of this new information, there has been the development of a more physiological style of ovarian stimulation in IVF for good prognosis patients, involving very low dose stimulation coupled with high quality embryology. These protocols are designed to produce a small number of eggs (aim 3-4 eggs) which can be fertilised, cultured and the best embryo transferred. As the literature presents such diverse findings we are initiating a pilot case-matched study to establish the efficacy of and patient feedback of tolerance to minimal stimulation regimes in an IVF cycle. Therefore, this pilot study is designed to assess the outcome of a low dose minimal stimulation treatment regime in a selected group of women undergoing IVF treatment.An interim analysis will be conducted after 10 cycles and if significant problems are identified, or average oocyte retrieval rates are below 2 eggs, the study will be abandoned at that point.

  • The pain relief after key hole surgery for gall bladder : Is infiltration of wound with Local anaesthetics is better than the injecting in to the abdominal wall.

    The key hole gall bladder surgery is one of the commonest surgery performed. there are various methods used for pain relief after the surgery.Traditionally local anaesthetics is injected into the wounds.Recently by ultrsound guidance local anaesthetics were injected into the abdonminal planes (transverses abdominis plane).The nerves supply the the entire abdominal wall. Recent trials did show they benefit in abdominal surgery. So far only one trial compared these two methods.The purpose of this trial is to find out which one of them did better in regards to pain releief. Also patient satisfaction score may reveal which of these methods were acceptable

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