ANZCTR search results

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

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32901 results sorted by trial registration date.
  • The impact of providing feedback on adherence in childhood asthma

    The purpose of the study is to determine whether the act of measuring and providing feedback on adherence will result in a change in adherence with preventive medication and as a secondary outcome disease control. Subjects who are aware that their use of medication is being monitored may change their behaviour. Providing feedback may provide them and thier physician with additional information which may improve the accuracy and quality of clinical decisions that are made.

  • DOES EXTERNAL PROFICIENCY TESTING AND METHOD INTERVENTION IMPROVE INTER-SCORER AND INTER-LABORATORY POLYSOMNOGRAM SCORING RELIABILITY?

    Polysomnography (PSG) is a clinical test that is used to diagnose breathing disorders that occur during sleep. The most common of this type of disorder is Obstructive Sleep Apnoea (OSA). People with OSA experience periods of partial or complete obstruction of the throat during sleep. It is a serious disorder when severe, with good treatments available. Accurate diagnostic tests are therefore very important. The main outcome measures from the PSG test are the number of obstructions per hour of sleep, the number of arousals from sleep and the amount and quality of sleep. Scoring these features from PSG recordings relies heavily on visual pattern recognition by trained observers applying pre-defined rules. The recognition of features and application of the rules is therefore subject to interpretation by individual scorers and this has the potential to affect measurement reliability. Inter-scorer variations in PSG outcome measures may affect the accuracy of clinical evaluation of individual patients and also decrease statistical power in research studies, particularly multicentre research studies. Several studies have examined the reliability of scoring PSGs. All have demonstrated significant variability in scoring of PSGs and there is therefore a strong incentive to investigate sources of inter-scorer variability and to develop methods aimed at achieving improvements. Our group has recently developed methods that allow measurement of PSG scoring reliability to be assessed and potentially improved through external proficiency testing (EPT). They rely on distributing test PSGs to participating laboratories and determining the consistency of scoring using a purpose-written computer application. However, there are no studies that evaluate whether applying the principles of EPT to PSG scoring is effective in improving scoring consistency. If EPT proves to be ineffective, then it is likely that an active process that aims to align scorer technique will be necessary. The purposes of this study are therefore to: 1. Evaluate whether a program of EPT improves scorer consistency 2. Evaluate whether an active process for identifying and correcting causes of discordance (alignment process) in addition to EPT further improves scorer consistency The demonstration of effective methods for improving scorer consistency will have important benefits for both patient care and research.

  • Use of botulinum toxin a to manage upper limb spasticity in children with cerebral palsy

    Objective: To investigate the impact on of conventional therapy and resistance therapy augmented with botulinum toxin A (BoNTA) in children with hemiplegic cerebral palsy (CP) on upper limb (UL) function and quality of movement. Assessment of movement quality was considered important, because early brain injuries are more susceptible to 'maladaptative' plasticity, which might result in abnormal movement behaviours. Study Design: Single blind, randomised control trial (RCT) using matched pairs. Methods: A control group continued with their usual community based ‘conventional’ therapy. The treatment group received either 1. BoNTA injections to the upper limb with conventional therapy or; 2. BoNTA injections to the upper limb with conventional therapy plus upper limb resistance training at the peak effect of the BoNTA. Twenty-five participants aged between 8 and 16 years were enrolled. Assessments for this group included the Melbourne Assessment of Unilateral Upper Limb Function (MUUL); goal attainment using goal attainment scales (GAS) and kinematic analysis of reaching with the quantification of normalised jerk (NJ) reflecting movement fluency, and directness index (DI) reflecting movement efficiency. CNS changes were measured using Transcranial Magnetic Stimulation to map corticospinal pathways. Results: GAS improved significantly in recipients who received resistance training augmented with BoNTA relative to controls at 1, 3 and 6 months (mean 58.1, SD 11.1, p<0.05). Therapy augmented with BoNTA resulted in improvements in movement fluency and efficiency and neuroplastic changes in some, but not all the children studied. The children who had preserved contralateral corticospinal pathways displayed less maladaptive movement behaviour with lower variability of NJ and DI, and higher MUUL score. Conclusion: Augmenting physical therapies with BoNTA improves function, movement fluency and induces CNS changes in children with hemiplegic spastic CP. More significant gains in UL function were achieved in a shorter time when muscle resistance training was combined with BoNTA and maintained after the effect of the BoNTA had worn off.

  • The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia

    Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e in the treatment of depressed mood and general symptoms of fibromyalgia (FMS) As such, salient clinical and pathological parameters will be assessed over a 16-week period in 70 patients who will be provided with the supplement (8 weeks) and placebo preparation (8 weeks). On the basis of previous literature, it is hypothesised that patients in the active treatment group will experience moderate but significant improvements across the clinical measures, and that these gains will be significantly greater than any reported in the placebo group. All patients will provide informed consent. All procedures will be conducted under medical supervision and the preparation itself is very safe when used in the manner proposed for the trial.

  • The effect of botulinum toxin-A on the functional ability of the very young child with spastic hemiplegia due to cerebral palsy.

    Cerebral palsy (CP) is a disorder affecting around 2.5 in 1000 live births. Commonly, children with CP have spasticity in their muscles causing stiffness. Children with spasticity move differently because of this stiffness. When botulinum toxin-A (BOTOX) is injected into a spastic muscle, it helps relax the muscle for around three months, after which the effect begins to wear off. During this time, the muscle is able to move more freely through a greater range, allowing the child to use more normal patterns of muscle recruitment. BOTOX is recommended and PBS rebatable for children with CP who are over two years of age and who are ambulant. Usually, by two years of age these children have developed an abnormal pattern of movement, especially around the ankle. Currently, the most important clinical question is whether BOTOX should be used to prevent this early imperfect standing and walking practice rather than be used after two years of age to correct the problem that has developed. Injections of BOTOX at a younger age may provide the child with an early sensation of more normal movement and lay down patterns of movement that will be useful in the long term. The aim of this study is to compare, over a three year period, the effects of early (beginning at the motor stage of "pull-to-stand") repeated BOTOX injections on gross motor function and the development of walking with the effects of later ( beginning after two years of age) standard repeated BOTOX treatment. The main measures will be the gross motor function measures and quality of walking. Measurements (such as muscle spasticity, muscle length, parent questionnaires and functional ability of the upper limb) will also be made to determine which program most positively affects walking, other gross motor functions and /or quality of life.

  • Rowing joint mobilisation project

    Joint mobility is a key factor in determining stroke length in rowers. The aim of this project is to determine whether increasing the mobility of restricted joints in rowers by manual mobilisation can increase a rower's stroke length and consequently rowing performance.

  • The effect of bronchodilators on lung ventilation in chronic obstructive pulmonary disease

    Chronic Obstructive Pulmonary Disease (COPD) is a common disorder which causes changes within the airways and blood vessels of the lung. As a result of these changes, it can cause problems with breathing and the way air and oxygen travels to different parts of the lung. We have several different ways of looking at how bad COPD is, however none of these are perfect. By understanding better the way in which airways behave in COPD, and the effects this has on blood flow within the lung, the better able we will be to investigate, develop new medications, and treat COPD. In this study we will be investigating the way COPD affects breathing and blood flow by looking at changes in lung function. We will then compare this information with pictures of breathing and blood flow obtained from a nuclear medicine scan.

  • Evaluation of an Internet-based Weight Loss Program for Men

    Obesity is a major public health issue in Australia with approximately 67% of men and 52% of women overweight or obese. Obesity is associated with a number of life threatening diseases and is an independent risk factor for a range of cardiovascular diseases. Although group programs that involve weekly visits are regarded as the most effective strategy for treating obesity, there is an urgent need for the development of effective weight loss programs that are more widely accessible. The Internet may have considerable potential to deliver weight management programs for individuals who cannot access clinical programs or where frequent face-to-face contact is a substantial barrier. To date, little is known about the efficacy of online weight loss programs. The aim of the current study is to evaluate the feasibility and efficacy of an Internet-based weight loss program for men that incorporates key behavioural strategies including social support and self monitoring.

  • Arthroscopic Treatment of Painful Snapping of the Scapula by using a New Superior Portal

    Pain and crepitus (a scraping feel and sound) can occur at the scapula (shoulder blade) restricting the shoulder's normal gliding motion. Previous studies have shown that removing a small supero medial portion of the scapula bone can correct this. This can be done arthroscopically (key hole surgery) but this area is difficult to see and access. We have previously published an article on anatomic studies demonstrating a safe new 'key hole' position which allows experienced arthroscopists better access to enable removal of the 'troublesome' bone. In this study we evaluated the outcome of patients who had this procedure with regard to their good and excellent return to work and sport. All patients thought it was worthwhile having the operation.

  • The protection of left ventricular function during right ventricular pacing.

    For many years the standard approach to lead placement has been the right ventricular apex (RVA). However, early evidence suggests that right ventricular high septum (RVHS) pacing may be more beneficial compared to RVA pacing. Patients with complete heart block requiring more than 90% ventricular pacing will be randomised into two groups; RVA vs RVHS pacing. The two pacing modalities will be compared to assess left ventricular function as measured by the left ventricular ejection fraction.

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