ANZCTR search results

This study will evaluate the safety (i.e. incidence and type of adverse events) and efficacy (i.e. change from baseline in the 4 symptom nasal score for the entire double-blind treatment period) of CMP administered three times daily intranasally over a four week period to people with seasonal allergic rhinitis (SAR) as compared to placebo.

The aim of this clinical study is to determine how well a new prolonged release oxycodone/naloxone combination tablet works in reducing constipation whilst still giving the patient the required amount of pain relief in patients suffering from cancer pain.

The primary purpose of this study is to determine whether PES is an effective treatment choice for people with osteoarthritis of the knee. The hypothesis is that PES will produce a clinically important and sustained improvement in pain, function, patient global assessment, quality of life and physical activity when compared with placebo treatment in individuals with osteoarthritis of the knee.

The primary purpose of the study is to investigate the effects of vibration platform training on bone health in postmenopausal women. The primary hypothesis is that vibration training will be associated with an increase in blood borne markers of bone metabolism after 8 weeks.

There is no update to the original ethics submission

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.

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.

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.

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.

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.