ANZCTR search results

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

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32876 results sorted by trial registration date.
  • A randomised double-blind controlled trial of lignocaine/phenylephrine nasal spray vs placebo for pain and distress of nasogastric tube insertion in children

    Nasogastric tube insertion is consistently rated as one of the most painful and distressing procedures undertaken in the emergency department. Multiple adult studies have demonstrated that use of local anaesthetic prior to insertion markedly reduces this pain and distress, however, the only study undertaken in children did not show any benefit. We plan to undertake a randomised trial in children aged 6 months to 5 years of age. The trial will compare the effects of a spray of salty water (saline) to a spray of local anaesthetic (lignocaine and phenylephrine) into the nose prior to insertion of the nasogastric tube. An observer will measure pain and distress experienced by the child before, during and after the procedure. The child's carer will also be asked to rate the child's pain and distress. Insertion of a nasogastric tube usually takes approximately 5-10 minutes. The anticipated duration of the study is 20-30 minutes, including time for explanation and consent. Approximately 100 children will need to be recruited to complete the study We hypothesise that lignocaine / phenylephrine spray and intranasal placebo spray will be equally effective in the prevention of pain and distress associated with nasogastric tube insertion in children

  • Targeting pain mechanisms from the 'top-down' and the 'bottom-up' in chronic tension-type headache

    Tension-type headache (TTH) is the most common and costly primary headache disorder. Up to 2-5% of individuals with TTH experience severe, persistent and disabling headaches (chronic tension-type headache; CTTH). CTTH is a major health problem and currently, there are few effective therapies available for CTTH, which only target generic symptoms. Recent work has revealed a role for biological mechanisms in affecting pain in CTTH. Therefore, novel therapies that aim to target the biological mechanisms are needed to reduce the social and economic burden on sufferers and the wider community. Here we aim to conduct a 'proof of concept' study to investigate the use of an innovative 'top-down' and 'bottom-up' approach to therapy through the combined application of transcranial (tDCS) and transspinal direct stimulation (tsDCS). This study will provide the initial test of the feasibility, safety and potential benefit on pain outcomes. We anticipate that the combination of tDCS and tsDCS will have an affect on improving CCTH intensity, frequency and duration by targeting the biological mechanisms that contribute to pain.

  • Spironolactone in myocardial dysfunction with reduced exercise capacity

    The main aim of this study is to use aldosterone blockade for the treatment of exercise intolerance in the presence of diastolic dysfunction (DD) and preserved LV systolic function. The responses will be sought by measurement of: 1) exercise capacity, 2) techniques to quantify myocardial structure and function. Our primary hypotheses are that spironolactone therapy is associated with improved; 1. Exercise capacity by reduction of myocardial fibrosis and improvement in LV compliance with aldosterone blockade, 2. Post-exercise LV filling pressure. Our secondary hypotheses are that spironolactone therapy is associated with; 3. Avoidance of a hypertensive response to exercise, 4. Improvements in myocardial deformation properties.

  • Resistance training with Partial Vascular Occlusion (VOT) in Inclusion Body Myositis (IBM). A single group interventional study: a pilot study to corroborate prior findings of VOT in the IBM population

    To explore whether the relatively new form of resistance exercise which employs low resistances accompanied by restricting blood flood to targeted muscles (as know in Japan as Kaatsu training) can play a role in reducing the disability caused by inclusion body myositis.

  • Does targeted management of sub-acute back pain patients on a surgical clinic waiting list reduce chronic pain and disability? Phase 1: Risk screening.

    This investigation involves the collection of data via postal questionnaires from patients with low back pain who have been placed on a waiting list for surgical opinion. The questionnaires aim to identify those at risk of developing chronic back pain and will be evaluated for their usefulness in this patient group. Additionally, this study will ask the question of whether screening itself reduces pain and disability. This investigation will lay the critical platform for an investigation of treatment aimed at reducing risk.

  • REducing AntiPsychotic use in residential care: Huntington Disease. A pilot Randomised Controlled Trial

    The rationale for using antipsychotics for behavioural management in Huntington Disease is weak, and antipsychotics are potentially harmful. REAP-HD intends to change clinical practice in residential care facilities (RCFs) so that antipsychotics are used as second line, time-limited therapy subject to regular review. REAP-HD will implement two different strategies, and compare their efficacy in helping health care professionals reduce antipsychotic use.

  • Pilot study of the treatment of patients with sporadic Inclusion Body Myositis with the Anaplerotic medication Triheptanoin

    Sporadic Inclusion body myositis is the most common acquired muscle disorder in patients over the age of 50. The cause of IBM is not known and there is no effective therapy. IBM is a slowly progressive disorder with increasing weakness and muscle atrophy involving particularly the thighs, long finger flexors and bulbar muscles resulting in progressive loss of mobility, loss of hand function and impaired swallowing. It progresses to disability over 5-10 years with wheel chair dependence, loss of hand function, impaired nutrition due to inability to swallow, increasing debility and susceptibility to aspiration. Theories for IBM pathogensesis can be divided into primary inflammatory hypotheses and primary degenerative hypotheses. Treating IBM with immunosuppression is not effective and steroids may accelerate the disorder possibly by stimulating catabolic pathways. Degenerative hypotheses can be grouped into several catagories, myofiber injury by beta-amyloid, myofiber injury due to other accumulated molecules, a myonuclear disorder, a disorder of protein degradation and a disorder of mitochondria. The most consistent finding in IBM is an abnormality of protein degradation with accumulation of degradation products in autophagic vacuoles. There is also a deficit in Proteosome 26-ubiquitin protein degradation. The proteosome-ubiquitin and autophagy pathways are activated in the presence of energy depletion and starvation to provide an alternate source of energy to fuel the citric acid cycle and maintain energy homeostasis. It is not certain as to whether there is an acceleration of protein breakdown or a defect of disposal of breakdown products or both in IBM. The crucial protein and organelle disposal pathway of autophagy is critically overloaded and this is probably the most important mechanism for myofibre damage. It is probable that this overloading is the result of catabolic pathway acceleration and this may result from a deficit in energy metabolism leading to activation of the catabolic cascade. Progressive muscle atrophy and increasing weakness indicate the predominance of protein catabolic over anabolic activities in IBM. It is hypothesised that repairing energy deficits and increasing anabolic activity will be beneficial in IBM and will in turn inhibit and “switch off” the harmful autophagic process. Trihepatanoin (TGC7) is a triglyceride containing three C7 fatty acid chains. After cleavage in the gut, heptanoate is absorbed through the gut and can be metabolised in most tissues. As a medium chain fatty acid, uptake into mitochondria is via diffusion and independent from the shuttle system, thereby providing fast energy. Each heptanoate provides both substrate (acyl CoA) and intermediates (oxaloacetate; via carboxylation of propionyl-CoA) for the CAC in muscle and brain. Therefore, TGC7 has the ability to refuel the CAC, increase ATP production and reverse the catabolic cascade. It is hypothesised that administering Triheptanoin, up to 30% of daily caloric requirement, by fuelling the CAC to enhance anabolic pathways and inhibit catabolism will have a significant benefit in the treatment of IBM to maintain and improve muscle strength and swallowing.

  • Tablets and Technology During Stroke Recovery

    TNT is a pilot randomised control trial to determine the effect that access to and use of tablet technology within the first month following inpatient stroke rehabilitation has on stroke survivor quality of life. The primary aims of our pilot study TNT are to: 1. Determine the effect that access to and use of tablet use has on stroke survivor:quality of life, mood, cognition, communication, self efficacy and activity participation. 2. Estimate the frequency and nature of tablet use when stroke survivors are given training and access to tablet technology within the inpatient rehabilitation and community setting. We hypothesise that stroke survivors who use an iPad during the first month following discharge from rehabilitation will experience a better quality of life than those survivors who do not use this technology. Furthermore, we predict there will be a trend towards better mood, cognition, communication, self efficacy and higher levels of activity participation in survivors whom have access to iPads. Data from this pilot RCT study will be used to inform the design of future trials to determine the functional efficacy of tablet use during stroke rehabilitation.

  • TAsmanian Study of Echocardiographic detection of Left ventricular dysfunction (TAS-ELF)

    The aim of this project is to reduce the deaths caused by Heart Failure in Tasmania. This will be achieved through implementation of a screening program for cardiac dysfunction and the use of protective therapy that will limit the development of heart failure. We plan to show the benefit of testing by recruitment of "at risk" subjects from the community and randomising them to a screening program based on echocardiography. Patients with abnormalities will be entered into a program of cardio-protective therapy, supervised by their general practitioner. Endpoints: 6-minute walk at a minimum of 24 months and comparison of the rate of heart failure among groups.

  • Fruit and vegetable supplement study in obese adults aged 50 years or older

    This study will investigate the molecular mechanisms by which a fruit and vegetable supplement modulates systemic inflammation. Based on previous studies utilising fruit and vegetable supplements and our own fruit and vegetable withdrawal study, we hypothesise that the extract will modify systemic inflammatory pathways, including NF-kappaB, AMPK, MAPK, PPARalpha/gamma and TLR2/4, among others. In addition, various proteins associated with inflammation, lipid metabolism and insulin resistance will be improved. Determining whether the supplement is an effective treatment for reducing systemic inflammation in obesity and identifying the mechanisms involved may assist in reducing the risk of chronic diseases, including CVD and diabetes. This is critically important for reducing the burden of disease in this subgroup of the population for whom weight management/ weight loss has not been achievable.

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