ANZCTR search results

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

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31306 results sorted by trial registration date.
  • DEFROST: A clinical trial testing metformin as a treatment for frozen shoulder or shoulder tendinopathy.

    The Department of Orthopaedics and Traumatic Surgery at Royal North Shore Hospital is conducting research to test a new treatment for frozen shoulder and tendinopathy. The treatment being investigated is a drug called Metformin. Metformin is currently approved to treat Type 2 diabetes. It is not currently approved to treat frozen shoulder or tendinopathy. The aim of the study is to determine whether Metformin is effective in reducing pain and loss of movement, and speeding up recovery in patients suffering from a frozen shoulder or tendinopathy. Our investigations in the Department of Orthopaedics and Traumatic Surgery's laboratory at Royal North Shore Hospital have shown that this drug acts on the cause of the stiffness in these shoulder conditions and may be effective in reducing the pain and its duration. Results of research undertaken in our laboratory, also suggest that blood tests may help diagnose these conditions and indicate if a patient is recovering well. Current treatments for these conditions have limited success. It is therefore important that more research is done into new treatments, including drug treatments. Frozen shoulder and tendinopathy cause enormous pain, which can lead to loss of sleep, difficulty in dressing and toileting, and participating in occupational and recreational activities. This drug may enable patients to return to their usual activities more quickly. This research has been initiated by the study doctor, Professor Sonnabend, who is an orthopaedic surgeon at Royal North Shore Hospital. Patients are eligible for this study if they: * Are aged between 40 and 70; * Have shoulder pain in only one shoulder, which may or may not be following an injury; * Have pain at the ends of the range of movement of their shoulder in all directions; * Have a loss of movement in the shoulder; * Have had symptoms for less than 3 months; * Have an x-ray that is normal; * Are non-diabetic. Participants will be given either metformin or a placebo to take twice daily for 3 months. The one taken will be chosen randomly. Participants and the study doctor will not know which treatment a participant is receiving. Participation in the study will involve 4 medical appointments at Royal North Shore Hospital, which would be at least the usual number of visits that would be made to a specialist, but in addition to the consultations, questionnaires will be completed and blood samples will be taken. Participation in any research project is voluntary. This study will not cost participants anything.

  • Mini Movers: A study evaluating the efficacy of a program to reduce sedentary behaviour in 2- to 4-year-old children.

    The primary purpose of this study is to pilot test the feasibility and potential efficacy of a parent-focused program to reduce sedentary behaviour in 2 to 4 year old children. The program will include a short group session with parents in their existing playgroups, followed by personalised text messages for parents for the next 6 weeks.

  • An observational study of sociodemographic, lifestyle, health and dietary characteristics and socio-cultural behaviours of Greek Australians from MEDiterranean ISlands: the MEDIS-Australia Study.

    MEDIS-Australia is an observational study with cross-sectional design conducted by La Trobe University, Melbourne, Australia. Convenience sampling of a non-probability sample of participants will be used. Older Greek Australians (>65 years of age) originally from Cyprus and Greek islands such as Crete will be invited to participate, predominantly from elderly Greek community groups in Melbourne. Adjunct strategies to reach the target cohort include provision of study information and the researcher's contact details to Greek print media, radio, Greek language schools, Greek Orthodox Church community groups and the Australian Greek Welfare Society. Information will be provided to each group and recruitment sessions will be arranged with community group support. The primary aim is to assess the impact of migration on adherence to a Greek Mediterranean dietary pattern. Secondly, to evaluate the relationships between socio-cultural characteristics and behaviours with adherence to traditional Greek Mediterranean dietary pattern and cuisine and the presence of CVD risk factors and risk of MetS. A comparison of the study cohort of elderly Greek Australian migrants from islands to their counterparts living on these islands will be conducted. Data collection is underway. The impact of migration upon health and nutrition status of older Greek Australians originally from islands and the retention of culturally-specific behaviours which may be associated with diet adherence provide greater insight into the Australian Greek migrant paradox.

  • Consumer Evaluations of Pre-Packaged Foods that Systematically Vary by Front-of-Pack Label, Health Claim, Price and Healthiness

    Poor diet is a leading risk factor in global preventable morbidity. It can lead to high blood pressure, high blood cholesterol, obesity and metabolic outcomes, which in turn are associated with a range of chronic illnesses such as coronary heart disease, hypertension, type 2 diabetes and some forms of cancer. One public health intervention aimed at promoting the consumption of a balanced diet that has been widely adopted across the world is the provision of nutrition information on packaged foods. Nutrition information can appear on food in a variety of formats (such as the Nutrition Information Panel, front-of-pack labels and health claims). Although these sources of information often occur together on food packs, most previous studies have focused on the isolated effects of individual forms of nutrition information and either do not include or do not measure the impact of more than one source of nutrition information. An understanding of how consumers process this high volume of information on food packs or how they reconcile contradictory nutrition information is currently lacking. The primary aim of this study is to investigate how nutrition information format, healthiness and price interact to affect the perceived healthiness of a product, consumer purchase intentions and the amount of the product considered desirable/appropriate to eat.

  • Combined application of brain stimulation and sensorimotor retraining for low back pain

    Low back pain (LBP) is one of the most common reasons for people to seek health care. Of those that report LBP, 44-78% experience a re-occurrence within 12 months, and approximately 25% of individuals develop chronic pain. Despite high prevalence, current treatments for chronic LBP demonstrate at best, small effect sizes. One avenue to improve outcomes in chronic LBP is through the application of combined treatments with synergistic clinical and mechanistic effects. Sensorimotor retraining is a novel treatment that incorporates motor control exercise and lumbar tactile retraining and has been shown to be effective in early randomized controlled trials and case studies of chronic LBP. The mechanism underpinning improvements in pain and function with sensorimotor retraining is thought to involve normalization of motor and sensory cortical plasticity and improved pain system function. The addition of a second treatment that targets similar mechanisms may boost the effectiveness of sensorimotor retraining in people with chronic LBP. Transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, is thought to promote cortical plasticity and improve pain system function through direct effects on the cortex and thalamus, as well as “downstream” effects on the anterior cingulate cortex and upper brainstem. Studies of healthy individuals and people with some forms of chronic pain suggest that anodal tDCS applied to the primary motor cortex can reduce pain. In addition, the cortical effects of tDCS are hypothesised to increase the brain’s receptiveness to other treatments, a phenomenon known as priming. Thus, tDCS may optimise the responsiveness of the brain to sensorimotor retraining and improve outcomes beyond that which can be achieved with sensorimotor retraining alone. Despite this, no study has examined the effect of a combined tDCS and sensorimotor retraining therapy in chronic pain. This pilot RCT protocol will outline study methods, and resources required in order to determine the feasibility, acceptability and safety of tDCS combined with sensorimotor retraining for people with chronic LBP. The specific aims are to i) determine the feasibility, safety, perceived patient response to, and acceptability of, a combined tDCS and sensorimotor training intervention in chronic LBP and ii) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present.

  • Parenting help study: Evaluating the use of Teachback delivered by nurses in a parenting helpline.

    This study is trialing the Teachback method to improve service delivery and health communication for the government funded telephone parenting service (Pregnancy, Birth & Baby Helpline, Healthdirect Australia). The primary outcome is assessing the effectiveness of Teachback compared with the usual care delivered through the PBB Helpline on a range of topics, testing chiefly if knowledge, understanding and satisfaction has increased by the Teachback intervention. This is a stepped wedge cluster randomised trial in which all nurses will be invited to participate in the study and will cross over to the intervention according to a training schedule. Both nurses and callers to the PBB Helpline are participants and Teachback will be evaluated by both interviewing callers and feedback from the nurses. Callers to the PBB Helpline will be interviewed one week after their initial call by an independent organisation. Nurses will be asked to reflect on their communication during their calls by completing a short survey throughout their shift. Nurses will also be invited to provide further feedback about the study through qualitative interviews/focus groups.

  • A randomised controlled trial of a smartphone application for people wanting to reduce or quit their use of cannabis

    The study is a randomised controlled trial of an app for cannabis users wishing to reduce/quit their use of cannabis. Specifically, the study involves a randomised controlled trial of three app versions to determine the effectiveness of the app, and its various active components, in helping cannabis users reduce their use.

  • Parenting Resilient Kids: Evaluating a Personalised Online Parenting Program

    This study aims to evaluate the effects of an individually-tailored online parenting program on parenting behaviours associated with childhood depression and anxiety disorders, and in turn child anxiety and depressive symptoms. The program is designed to provide parents with (1) personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their child' risk of depression and anxiety, and (2) specific modules of the mobile-compatible online parenting intervention, recommended based on their survey responses, to support them in making changes to identified areas for improvement in their parenting.

  • Safety and Efficacy study of CRD-102 in patients with Heart Failure with Preserved Ejection Fraction

    Heart failure is a condition where the heart’s pumping cycle does not function as it should. There are two types of heart failure, with about half of patients with the condition falling into each group. One where the pump/contraction function of the heart is reduced. That is called systolic heart failure. In the other type, the heart does not fully relax, so it does not fill properly with blood. This is called diastolic heart failure or “heart failure with normal pump function”. The official medical term is “heart failure with preserved ejection fraction”, and is abbreviated as HFPEF. At the moment, there are no established medical therapies for HFPEF. Our research has shown that people with HFPEF develop breathlessness very quickly during physical activity because the heart muscle cannot relax normally. In this study we want to test the effect of a medicine, CRD-102, on the pressure in the heart during exercise in HFPEF patients. The use of CRD-102 tablets in this study is considered experimental. CRD-102 tablets have not been approved for marketing by the Therapeutics Goods Administration (TGA) in Australia. Because of its actions on the heart we hope that it may be helpful in patients with diastolic heart failure.

  • Multi-centre medical scribe study - testing scribes in Victorian public Emergency Departments

    Medical scribes are clerical assistants to doctors. ED docs currently spend 48% of their time on clerical data entry into computers. Scribes undertake secretarial/clerical data entry tasks in Emergency departments to enable the doctor to leave their desk and get back to the bedside to treat more patients in a safe, cost-effective way. There is economic equipoise about whether the scribe role should be introduced to Australia. Work to date has been undertaken at Cabrini ED and shows promise. There is a need for a mulit-centre public ED evaluation of the role. There is no equivalent study anywhere in the world. We are undertaking a multi-centre randomised controlled trial of scribes, using Australian scribes we have trained at Cabrini this year in a research capacity. Cabrini is auspicing the study and the principle investigator is Dr Katie Walker. Scribes will be randomly allocated to consenting doctors to work at each site for 5 months FTE (100 scribed shifts and 100 control shifts at each site) and administrative data on consultations per hour per doctor will be gathered. We will evaluate the role and its impact on medical productivity in four sites which represent typical public Emergency departments across Victoria and Australia. The sites are Bendigo, Austin, Monash Paeds and Dandenong. We have gathered a team of national and international experts who work in Victoria to ensure robust delivery of the project with expert methodology and execution. We have the only medical scribe workforce available in Australia ready to participate. This will enable a determination on whether scribes provide a cost-effective way of delivering medical care in Australian EDs.

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