ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Food product health warnings promote healthy dietary decision making.

    Following successful use in tobacco control, health warnings on food products and at point-of-sale have been proposed as a potential obesity prevention measure. This study aims to investigate the efficacy of food product health warnings for promoting healthy dietary decision making. Additionally, the study aims to investigate the degree to which two key health warning design factors (text-based health warnings versus text-and-graphic health warnings; health warnings featuring positively versus negatively framed messages) influence health warning efficacy. Ninety-six participants will be recruited to complete a mixed design dietary self-control experiment conducted as a single session. The experiment features four stages; the rating stage, the unprimed decision stage, the priming stage, and the primed decision stage. In the first stage, participants will be shown a selection of 100 common Australian snack foods (including chocolate, chips, cookies, fruit, nuts and vegetables) and asked to provide subjective health and taste ratings for each food item. In the unprimed (baseline) decision stage, participants will be shown half of the food items they rated in the first stage and asked to indicate which of these items they would like to eat at the end of the experiment. Prior to the priming stage, participants will be randomly allocated to one of five health warning format conditions; text-based, negative framing (n = 16); graphic, negative framing (n = 16); text, positive framing (n = 16); graphic, positive framing (n = 16); control group (n = 32). During the priming stage, participants will be exposed to health warnings of their allocated format only. In the primed decision stage participants will be shown the remaining half of the snack food items and again asked to indicate which foods they would like to consume at the end of the experiment. A measure of dietary self-control will be calculated based on the proportion of healthy but not tasty items chosen for consumption and the number of unhealthy yet tasty items rejected. Participants will be granted one of their chosen items to eat and will be asked to complete demographic and dietary behaviour questionnaires at the end of the experiment.

  • Effect of air polishing with erythritol powder in the treatment of chronic periodontitis

    “Periodontal diseases are chronic, microbially induced inflammatory disorders that affect the structures that support teeth” (Philstrom et al 2005) The treatment has traditionally been the thorough mechanical removal of the microbial environment; the biofilm. The aim of this study is to examine the clinical and microbial outcomes by the supplementary use of air polishing with erythritol powder.

  • Pilot trial evaluating the efficacy of different antibiotic treatments for the treatment of prosthetic joint infection in adults who have undergone joint replacement surgery.

    Prosthetic joint infection is a common and expensive problem. Over 100,000 elective joint replacements are performed in Australia each year and this number is growing. Approximately 2% of these will become infected. Prosthetic Joint Infections are a devastating complication of joint replacement, as they are difficult to cure, and treatment generally involves multiple operations and prolonged courses of antibiotics. There is a lack of high quality evidence to inform us of the management of Prosthetic Joint Infections. Acute Prosthetic Joint Infection is most commonly managed with open debridement of the prosthesis, followed by a period of antibiotics, aiming for cure. Despite the overall burden to the health sector and variable outcomes for individuals there is a lack of high quality evidence to inform the management of these infections.The correct duration of intravenous antibiotics is unknown. Following surgical debridement, patients are treated for a variable period with intravenous antibiotics, followed in most cases by a course of oral antibiotics (ranging from none at all to over 12 months, depending on the institution and situation). However, there is a lack of evidence to guide decisions about choice and duration of antibiotic regimens. This uncertainty is reflected in international guidelines: the Infectious Diseases Society of America guidelines recommend “from 2 to 6 weeks” of IV antibiotics (with no guidance or evidence about how to choose this duration). The Musculoskeletal Infection Society guidelines also recommends between 2 and 6 weeks. Both guidelines also recommend 3 to 6 months of oral antibiotic therapy, In adults with acute prosthetic hip or knee joint infection treated with debridement and implant retention is 2 weeks of intravenous antibiotics superior to 6 weeks (with both arms receiving 10 to 12 weeks of oral antibiotic therapy), in terms of an ordinal outcome including clinical cure 12 months after randomisation and antibiotic-related adverse events.

  • Investigating exercise based interventions for elbow pain.

    Lateral epicondylalgia (tendinopathy of the wrist extensors at the lateral epicondyle) is a common condition seen in middle aged people, and despite this, best management is poorly understood. Isometric exercises have been shown as effective in treating tendinopathies in the lower limb, however no-one has investigated the impact of different exercise protocols on immediate pain in the upper limb, and thus for lateral epicondylalgia. A two part cross-over study will examine whether different isometric protocols have better results on pain in this condition, and whether the superior isometric exercise is better than isotonic exercise for immediate impact on lateral epicondylalgia.

  • A study trialling the drug Gastrografin for use in patients with a bowel obstruction due to cancer.

    The primary purpose of this pilot trial is to evaluate whether a full-scale clinical trial for gastrografin is feasible, and to provide an initial estimate of the efficacy of gastrografin for the resolution of malignant bowel obstruction (MBO). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with MBO. Study details All participants enrolled in this pilot trial will receive the same treatment. This involves a single oral dose of gastrografin administered as a 100ml solution. Participants will then be followed up for 5 days to assess whether the treatment has reached the bowel, whether it has been effective in clearing the obstruction and any side effects which may have occurred. It is hoped that the findings from this trial can be used to inform future clinical trials on the use of gastrografin in palliative care.

  • Insulin Pump therapy for Reducing Diabetic complications (InsPyReD) study

    This study aims to determine whether insulin pump therapy can prevent nerve injury in patients with type 1 diabetes Who is it for? You can join this study if you have type 1 diabetes, aged 18-45 years and have not received insulin pump therapy before Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive an insulin pump free of charge for a period of 2 years. The other group will receive standard insulin injection therapy. Participants will undergo non-invasive nerve and eye tests to determine their suitability for the trial and when enrolled, will undergo these follow-up assessments at 6, 12, 18 and 24 months, coinciding with their usual endocrinology appointments. Both groups will receive continuous glucose monitoring at the beginning and end of the trial to determine the effect of glucose variability on nerve function. Participants will also undergo assessments of their quality of life specific to any nerve damage they may have.

  • Can thinking about movement improve movement speed in older adults?

    Motor imagery is an imagining of an action without its physical execution; it is a dynamic state during which the representation of a given motor act is internally rehearsed or imagined within working memory without any overt muscle activation. Motor imagery activates brain regions that are activated during actual task performance and motor imagery training has been found to improve task performance. Motor imagery has been found to improve static balance in the elderly but its effect on dynamic balance or functional performance in older adults is unknown. The aim of this study is to determine whether imagining certain movements repeatedly promotes improvements in mobility. It is hypothesised that motor imagery will improve mobility but a point of diminishing gains will occur after multiple repetitions.

  • Does telehealth delivery of the 'Care of People with dementia in their Environments' (COPE) program provide a non-inferior alternative to face-to-face treatment for community dwelling people with cognitive impairment?

    The "COPE" program is a structured program provided by occupational therapists for people with dementia and their carers. The program aims to improve independence and support the caregiver to manage stress and provide care. The program has been shown to be effective in a large randomised trial in the United States. However, neither the COPE program, nor similar evidence based occupational therapy programs for people with dementia have been translated into clinical practices. One of the main barriers is that these programs involve up to ten home visits; this is too resource intensive for many organisations and can not be delivered in the country. This project is a randomised controlled trial. The aim of this project is to compare two methods of delivering the COPE program: 1) traditional facetoface delivery, and 2) telehealth delivery. The content of the program will be the same but the method of delivery will be different. 174 participants will be randomised into the two groups of the trial and outcomes will be assessed at the end of intervention and at 9 months (following randomisation).

  • Victorian study of Echocardiographic detection of Left ventricular dysFunction (Vic-ELF)

    Heart failure (HF) is a problem that is assuming epidemic proportions, especially among the elderly. Unfortunately, its clinical diagnosis is associated with late-stage disease, which has a poor prognosis and responds poorly to medical therapy. At present, there is no effective strategy for identifying and preventing HF, with the result that patients present late in the course of the disease where hospitalisation is inevitable and treatment responses are poor. The Vic-ELF study (Victorian Study of Echocardiographic detection of Left ventricular dysfunction) study is a randomised trial to explore the benefits of screening selected patients at risk of developing heart failure. We will do this with a special new imaging technique (strain imaging), in which we at Baker IDI Heart and Diabetes Institute have special expertise. Screening of "at risk" patients with a combination of clinical scores and echo imaging is able to identify patients who are liable to develop HF. The question that now needs to be answered is whether surveillance with GLS could change HF outcomes in at risk patients. We anticipate that the prompt initiation of therapy in these patients that are recognized to have the earliest phase of HF will result in improvement in their functional capacity, and arrest in the subsequent progression to HF.

  • The 200-Rep Trial: 200 repetitions of isolated muscle contractions for partially-paralysed muscles

    An important goal of physiotherapy for people with spinal cord injuries is to increase strength. In those who are very weak (with muscle groups of less than grade 3 strength), physiotherapists tend to rely on repetitious contractions to increase strength. This is based on theories about neural plasticity and the need for repeated movement to prompt neural recovery. Despite the widespread use of repetitious contractions to increase strength in very weak muscles, it is not known whether this is an effective training paradigm. The trial will be a pragmatic multi-centre, assessor-blinded between participant randomised controlled trial. The aim of our project is to determine the best way of providing physiotherapy treatment, specifically to compare the therapeutic benefits of repetitious practise with usual care, to usual care alone to increase strength in very weak partially-paralysed muscles of people with recent spinal cord injury. One target muscle group with less than grade 3 strength will be selected on one side of the body from the following muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensors, ankle dorsiflexors or ankle plantarflexors. Eligible participants will be randomised to either the Treatment group or the Control group. Participants allocated to the Treatment group will do 200 repetitions of isolated contractions of the target muscle on one side of their body as well as usual care. Participants allocated to the Control group will receive usual care alone. The intervention will be provided for 8 weeks. All outcomes will be collected at baseline and at 8 weeks.

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