ANZCTR search results

A new mobile app, (Niggle) has been developed by QUT staff, to be used independently, or in conjunction with Kids Helpline's counselling services. This project will aim to evaluate the effectiveness, acceptability and usability of the new app among help-seeking young Australians, contacting Kids Helpline (KHL) for support. Help-seeking young people, aged 13-25 years, who contact Kids Helpline will be invited to take part in a Randomised Controlled Trial evaluating the efficacy of their counselling services. Interested participants will be randomised to receive treatment as usual (TAU), or TAU + the access to the ToolKit app. Participants will complete surveys at Baseline, 1, 2 and 3 months post baseline.

Motor Neuron Disease (MND) is a fatal neurodegenerative disease. MND is thought to arise from a combination of genetic susceptibility and environmental exposure, possibly due to a multi-stage process. There is considerable evidence that gut health is important in human disease and particularly in neurodegenerative disease. Given the lack of proven therapies in MND, there is an urgent need for new approaches. A range of approaches have been suggested and could involve diet, probiotics, prebiotics or antibiotics or therapies to antagonize the effects of the toxic molecules. This trial will study the effects of squalamine, an antibacterial first discovered in the dogfish shark that has a novel mode of action, and its efficacy as treatment aimed at improving gut health in MND patients. Squalamine is effective against methanobacter, which are difficult to detect, but are the likely organism responsible for methylation by gut microbes. Squalamine is rare, being one of the few non-toxic antibacterials which is active against this class of gut microbes. Squalamine is an attractive candidate because it is already widely available as a natural product in the dietary supplement Squalamax. This study will assess the safety and efficacy of squalamine (at a daily dose of 1.2 mg) in the dietary supplement Squalamax in patients with MND. The study includes 2 main periods: an unblinded treatment period (3 months) and an open label long term follow up phase (9 months). Patients in the standard care arm (i.e. no drug) will be switched to Squalamax treatment after 3 months. This study will test: - the tolerability of squalamine in patients with MND (indicated by diarrhoea or other symptoms). - the effects of squalamine on levels of gut derived toxins (before and after treatment with squalamine) - the effects of squalamine on levels of gut microbes in MND patients (collection of faecal samples for later analysis) - the effects of squalamine on MND standardised assessments (Amyotrophic Lateral Sclerosis Revised Functional Rating Scale (ALS-FRS R), Respiratory function testing (RFT)) and comparing treated and untreated patients over 3 months.

Intermittent exotropia (IXT), characterised by periodic divergence of visual axes and exacerbated when tired or sick, is the most common subtype of ocular misalignment among children affecting about 25% of the total strabismic population. Minus lens over-correction is one of the most common non-surgical method used in the treatment of IXT. Although improved control has been reported, no clear clinical guideline exists in determining the over-correcting minus lens strength; some adopted ‘one-for-all’ approach prescribing a constant power (-2.0D or -2.5D) while others used a ‘trial and error’ method. In this study, a novel method of customising minus lens over-correction based on angle of deviation, AC/A ratio and amplitude of accommodation will be used. Primary outcome is the IXT control after using customised minus lens where the success defined as the improvement of greater than 1 control score from the pre-treatment (baseline) score. Additional outcomes include measurement of angle of deviation, range of fusional vergence, suppression, distance stereopsis, and progression of myopia. This is a single site, prospective, randomised clinical trial. Subjects will be block-randomised depending on severity of IXT among children aged between four and fifteen years old. The treatment group will receive custom minus lens overcorrection whereas the control group will receive only their refractive correction, if any. The study will be conducted at ophthalmology department of Queensland Children’s Hospital under strict ethical guideline subject to approval from the relevant ethical committee. 2. OBJECTIVE The major objective of the study is to investigate efficacy of uniquely customised minus lens over-correction in the treatment of IXT. Additional objectives are to compare effectiveness in controlling distance deviation and to assess improvements in distance stereopsis, fusional vergence and suppression. 3. HYPOTHESIS Maximum tolerable minus lens overcorrection without compromising visual acuity and comfort is governed by available accommodative amplitude. Similarly, minimum strength of minus lens required to control IXT is governed by angle of deviation and fusional vergence in reserves. Having knowledge of these factors, a clinician can determine an individualised optimum over minus prescription. Therefore, we hypothesise that custom optimised minus lens based on angle of deviation, AC/A ratio and accommodative amplitude produces improved control of the IXT without compromising visual acuity and comfort.

The proposed trial aims to determine if the use of a novel smartphone insulin bolus calculator, “OptimAAPP” which calculates insulin for carbohydrate, fat and protein in meals improves blood glucose levels in comparison to usual care (insulin dosing for carbohydrate only). We hypothesise that OptimAAPP will improve blood glucose control in people with Type 1 Diabetes (T1D) using multiple daily injection therapy, as measured by an increase in time spent in a blood glucose target range of 3.9-10.0mmol/L without an increase in time spent in hypoglycaemia compared to usual care.

Retinopathy of Prematurity (ROP) is a vaso-proliferative disorder of the retina affecting extremely preterm or low birth weight infants. The most devastating consequence of ROP is retinal detachment and blindness, which in most developed countries is reduced by careful screening and early treatment with either laser ablation of vessels or intravitreal injection of anti-vascular endothelial growth factor (VEGF). However, ROP remains the leading cause of visual loss in children. Photobiomodulation using 670 nm red light might provide a novel treatment strategy to reduce the hyperoxic stage of ROP, by reducing the harmful effects of ROS and restoring normal vessel development. Photobiomodulation using 670nm red LED light in oxygen induced retinopathy animal models (which mimics facets of ROP including neonvascularisation and photoreceptor cell death) reduced the extent of oxygen induced retinal neovascularisation, decreased pulmonary haemorrhage and improved survival.The aims of this pilot randomised controlled trial were to: 1) determine feasibility of randomisation within 24-48 hours after birth; and 2) determine if treatment with 670nm red LED light at a distance of 25cm providing 9 J/cm2 in very premature neonates provided similar results to previously published animal studies in reducing ROP and improving survival.

In the past 5-10 years fertilisation rates after IVF have stayed the same (~65%), with the chance of a cycle cancelled due to failed fertilization after standard IVF insemination up to 10% higher than that of intracytoplasmic sperm injection (ICSI), which is usually less than 1%. As our understanding of sperm biology has advanced we know that the female reproductive tract activates the sperm to improve the ability of the sperm to bind and fertilize an egg. Currently, the media that are used for IVF only result in less than 20% of sperm to undergo this activation process. We have developed a new sperm media (SpermFAST) which induces these naturally occurring changes in sperm to a much higher rate (approximately 60%). Based on our understanding of sperm biology these changes should make it easier for the sperm to bind to and fertilise an egg in a dish like in IVF. This small pilot study is to determine if sperm incubated in our new sperm media (SpermFAST) are able to bind to and fertilise an egg. This will be the first time that this method has been used to activate sperm for the purpose of fertilization.

Background Early life exposure to antibiotics causes significant imbalance to the healthy intestinal flora (dysbiosis), and increases the risk of non-communicable childhood conditions such as allergic disease, asthma, immune function as well as vaccine responses. Probiotics have been shown to be useful in reducing dysbiosis and having a positive effect on health. Aims This novel study aims to: 1) Study the effect of antibiotic exposure in early life and subsequent imbalances to the gut flora, 2) Study the efficacy of probiotic administration on improvement in gut flora 3) Study the effect of probiotic administration on vaccine responses and gastrointestinal symptoms. Methods This will be a double blinded, randomised controlled trial that will recruit 70 term infants that have received antibiotics from the neonatal unit at Joondalup Health Campus. Thirty-five of the infants will receive a placebo and 35 will receive a probiotic (containing lactobacillus acidophilus, bifidobacterium bifidum and bifidobacterium infantis) for a total of 4 weeks. Infant stool will be collected for microbiome analysis, blood will be collected for vaccine response and a gastro-oesophageal reflux questionnaire and a behavioural chart will be completed to review gastrointestinal and colic symptoms. Outcomes The two main analyses are: 1) Microbiome diversity and composition of operation taxonomic units of the stool will be compared between the two groups at baseline, 1 week, 2 weeks, 1 month and 8 months; and 2) antigen-specific antibody levels to vaccines will be compared between the two groups at baseline and 8 months. Benefits This study will address a major child health issue, which is to explore the negative effects of antibiotic exposure in newborn infants and provide an affordable but effective intervention (probiotics) to modulate these effects. The findings from this study will have direct benefits to infants as well as provide further evidence that early life antibiotics may have long-standing consequences. The findings will be easily translated into clinical practice and will have a significant national and international impact.

Knee osteoarthritis (OA) is one of the leading causes of physical disability in adults. It leads to symptoms of pain, reduced functional mobility, poor quality of life, and causes a substantial burden to the healthcare system. Mechanical loading patterns at the knee are believed to play a major role in the pathological cartilage and bone changes seen in people with knee OA. Therefore, there has been increasing interest in gait modification strategies that act to reduce loading in the knee. One such strategy is altering the foot progression angle (FPA) via a toe in or out method. FPA refers to the angle formed by the long-axis of the foot, constructed from the mid-heel through to the second toe, and the forward progression of the body. The typical FPA during normal gait tends to occur with the toes pointing slightly outward at approximately 5 degrees. Toe-out gait is thus achieved through increasing the FPA by externally rotating the foot, whilst decreasing the FPA through internal rotation of the foot is referred to as a toe-in gait. The primary objective of this study is to evaluate the effects of toe-in gait retraining intervention compared to toe-out gait retraining intervention on pain, physical function and proxy measures of medial knee load over 6 weeks in people with medial knee osteoarthritis. The design of the study will be a randomised clinical trial. Community dwelling individuals with medial knee OA will be recruited, screened and then randomly allocated to either a toe-in or toe-out gait retraining group for a 6 week intervention. To fulfil this knee OA diagnosis, participants must be over 45 years or older, with knee pain. To control for confounding variables, participants need to be free of neurological or systemic rheumatological conditions. Men and women will be invited to participate from the Sydney metropolitan region. The total sample size will be 60. Participants will be randomised with a 1:1 allocation to either receive toe-in intervention (30 participants) or toe-out intervention (30 participants).They will undergo a gait retraining intervention program for 6 weeks and are required to attend the laboratory a total of 7 times (including assessments). The first training session will run for 1 hour and will involve education of the participant, baseline assessments and commencement of the intervention program (week 0). The following five sessions (week 1 to 5) will be spaced one week apart, consisting of supervised gait retraining sessions of 30 minutes. The final session will be performed one week after the sixth session (week 6) at the completion of the gait retraining program and will involve re-assessment of outcome measures. The participants will also be prescribed a home-based program of 30 minutes per day during this 6-week period.

MedAl Cardiology is a software tool that will enable health care professionals to diagnose various heart conditions in real time using Artificial Intelligence (AI). It would provide a diagnosis of heart functioning by analysing heart sounds recordings. The MedAI Cardiology algorithm will classify the patient status as “Normal” or “Abnormal” and will provide in-depth insights about various heart conditions. An automated analysis capability will support medical practitioners in deciding whether or not to refer the patient for further investigation.

This study will evaluate the effect of a drug called Simethicone versus no bowel preparation on rectal volume and side effects in men undergoing radiotherapy for their prostate. Who is it for? You may be eligible to join this study if you are male aged greater than 18 who is scheduled to receive external beam radiotherapy (ERBT) to the prostate. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group take an anti-flatulent medication, called Simethicone, 3 days prior to their planning CT scan, and then throughout radiotherapy treatment. Simethicone is administered as an oral capsule three times a day. Participants in the other group will receive treatment as usual without medical means of bowel preparation. All participants will undergo weekly Cone Beam CT scans throughout the 7 weeks of radiotherapy, in order to evaluate rectal volume and volume of gas in the rectum. They will also be asked to complete questionnaires to evaluate any radiotherapy side effects. It is hoped that this research will contribute to the further improvement of the accuracy of radiation treatment to prostate cancer patients.