ANZCTR search results

The study will examine the feasibility, usefulness and acceptability of using the anal plug Coloplast PERISTEEN amongst stroke survivors with persistent Intractable Faecal Incontinence (IFI) during the rehabilitation phase. Patients from Bentley rehabilitation hospital will be recruited to the study and their primary carer over a period twelve months. The use of the anal plug will be compared to the usual care during this phase using a number of validated tools. In addition, both patients and carers will be asked to participate by completing a pre and post satisfaction survey which will also include a quality of life measure.

World-wide cervical cancer is the fourth leading cause of cancer in women. Infection of the uterine cervix with human papillomavirus (HPV) is very common, with a small proportion of those infected progressing to cervical cancer. To date, no treatment of viral infection has been available and only the cell changes brought about by the virus relatively late in the infection are treated by one of the standard surgical methods which remove parts of the cervix affected by the virus. This proof of concept research is to trial application of iodine via a novel delivery device to the upper vaginal vault, ectocervix (outside of the cervix) and endocervical canal (passage that leads from the cervix to the uterus). Women who have persisting HPV despite standard surgical treatment to the cervix are to be recruited and treated as an outpatient procedure, the trial assessing the duration of treatment required for successful eradication of the virus. Should the treatment be found to be effective, women at long term risk of acquiring cervical cancer or adenocarcinoma as a consequence of persistent HPV infection will be offered treatment to eradicate the infection, the HPV vaccine if unvaccinated, then returned to normal follow up as mandated by the accepted guidelines. Health savings will be significant to the WA government by offering a treatment that eradicates an infection linked to potential cancer development (not currently possible) and the necessary follow up the infection entails.

This RCT will test whether a lifestyle intervention in early pregnancy optimizes gestational weight gain and reduces offspring adiposity. The intervention will use smart phone web based applications to deliver diet, physical activity and well being advice to overweight or obese pregnant women in early pregnancy (commenced prior t0 10 weeks gestation) to optimise their gestational weight gain (weight gain during the course of the pregnancy) within the recommended medical guidelines. The project will then follow up to assess neonatal and infant outcomes in relation to fat percentage and anthropometry.

The purpose of the research is to explore the perceptions of health care professionals posing as patients to the provision of a simple patient care activity by a specially programmed humanoid Robot. The sentinel questions to be addressed are: Will study participants accept a humanoid Robot in a care provider role? Is it possible for study participant to place trust on such a humanoid? Can a machine effect care with empathy by displaying appropriate emotions? What concerns arise among the study participants? Study participants are Doctors, Nurses, allied health professionals who provide direct clinical care. They will 'pose' as a patient before the humanoid robot and assess some components of the core clinical skills of the robot namely sense of safety, efficacy of care, empathy, communication skills, supportiveness, trust level and acceptance. Their responses on a standardised scale will be analysed and published. This study could pave the way to explore the utility of robots as real health care providers by systematically understanding the perceptions of health professionals as a first step.

This parent-assisted social skills program (Program for the Education and Enrichment of Relational Skills: PEERS) aims to help teenagers develop the social skills needed to make and maintain friends. The program reduces the complexity of social behaviour and teaches simple rules, using modelling and practice. Parents participate in separate concurrent sessions to help them support their teenager with real world practice. The program has not been tested with teenagers with acquired brain injuries (ABI) and cerebral palsy (CP) . This study aims to pilot test PEERS for 40 youth with ABI and CP in a randomised waitlist controlled trial across two sites in Australia to improve social competence and friendships. Secondly, we will explore caregiver's and youth's experiences of participating in the PEERS program.

Consumption of sugar sweetened beverages (SSBs) such as softdrinks, cordials, flavoured milks and sports drinks is linked to increased risk of becoming overweight or obese and developing Type 2 Diabetes and dental decay. Increasing sugar sweetened beverage prices by taxing them and discouraging people from buying them using educational messages have both been proposed as strategies to discourage consumption. This study aims to explore the characteristics of beverages that people consider when deciding which beverage to buy. It will also examine preferences for different educational messages and pricing changes designed to reduce purchasing of sugar sweetened beverages. In this Discrete Choice Experiment (DCE) participants will be asked to choose between different beverage options with variable prices, volumes and under different conditions including after seeing an educational message. We hypothesise that increasing the price of sugary drinks and showing participants an educational poster about the negative health effects of sugary drinks will both decrease the likelihood participants will select a sugary drink. The results will be relevant to government and policy makers, by helping them to understand which types and size of pricing strategies are useful in reducing sugar sweetened beverage consumption in different groups of consumers, for example those with low and high incomes.

Immune-responsive cells of the brain – namely microglia and astrocytes – activate in response to brain injury or pathogens. This activation leads to a local neuroinflammatory response that serves to isolate and protect the tissue, remove the noxious agent, and promote recovery. However, while beneficial in the short term, the chronic release of pro-inflammatory chemicals (cytokines and chemokines) becomes increasingly toxic, and actually begins to contribute to neuropathology in its own right. Chronic neuroinflammation is thought to play a central role in the progressive neural morbidity that underlies neurodegenerative disorders such as Huntington’s Disease (HD), Alzheimer’s Disease (AD), and Parkinson’s Disease (PD). However, there is little current understanding of the link between in vivo neuroinflammation and in vivo brain atrophy in humans, particularly as it relates to how the disease spreads to regions beyond primary sites of pathology. In this study, we will use a novel multi-modal neuroimaging approach that combines positron emission tomography (PET), magnetic resonance spectroscopy (MRS), and magnetic resonance imaging (MRI) to investigate the contribution of neuroinflammation to brain atrophy in individuals with neurodegenerative disorders. This work has direct implications for (i) developing more complete models of the pathological processes underpinning disease expression, (ii) assessing the sensitivity of neuroinflammatory measures as disease biomarkers, and (iii) providing support for (or against) the value of pursing novel disease monitoring and intervention approaches that respectively involve measuring or mitigating chronic neuroinflammatory processes.

The primary purpose of this trial is to evaluate the efficacy, safety and feasibility of osimertinib and gefitinib for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been diagnosed with EGFR-T790M mutation positive advanced non-small cell lung cancer which has acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Study details All participants enrolled in this trial will begin with induction therapy which involves taking an osimertinib tablet once per day for eight weeks. Participants will then move onto the alternating phase, which involves alternating four-weekly cycles of treatment with gefitinib and osimertinib (i.e. four weeks gefitinib then four weeks osimertinib) until disease progression or unacceptable side effects. Following progression, some participants may be eligible to continue with alternating treatment or switch to continuous osimertinib treatment until further progression, depending on whether your doctor believes that this would be of benefit to you. All patients will be reviewed up to every four weeks by blood samples, CT scans and side effect assessments. It is hoped that the findings from this trial will provide information on whether alternating treatment with osimertinib and gefitinib is feasible, safe and effective for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer.

The purpose of this trial is to investigate the dose-related effects of small intestinal administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on the motor and hormone functions of the upper gastrointestinal tract, appetite, energy intake and blood glucose. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. This study aims to characterise the dose-related effects of quinine, when delivered to the small intestine, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine.

The primary purpose of this study is to investigate the effects of varying doses of L-valine (a branched chain amino acid (BCAA)) on gastrointestinal motility, gut hormone release, glycaemic control, and appetite and energy intake in healthy lean individuals. The other BCAA’s are isoleucine and leucine, and there is some evidence that valine and isoleucine, when added in combination with leucine to the diet, may be associated with decreased energy intake, improved postprandial blood glucose and weight loss. Valine is widely used in BCAA mixtures, however evidence for its effects on blood glucose metabolism and gastric function is limited. Thus, it is of special interest, in terms of potential therapeutic approaches for obesity and type 2 diabetes, to characterise the dose-related effects of L-valine when administered in isolation, in a healthy sample. The exploratory nature of this trial bears no formal hypothesis, as its purpose lies in finding the effects of L-valine on the outcomes listed, which may then guide specific hypotheses for future research.