ANZCTR search results

In this study we plan to evaluate the maximum tolerated dose (MTD) of the drug Abraxane, which can be safely given to patients concurrently with radiotherapy in locally advanced pancreatic cancer (LAPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with locally advanced adenocarcinoma of the pancreas, which is not amenable to curative surgery. Study details Participants in this study will receive the chemotherapy drug Abraxane (nab-paclitaxel) by intravenous infusion (i.e. directly into the vein) over 30 minutes on a weekly schedule, concurrently with radiotherapy for 6 weeks. The first participants will receive Abraxane at a dose of 25 mg/m2 and if this is tolerated the dose will be increased for the subsequent groups until the maximum tolerated dose can be determined. Participants will be regularly monitored for safety and tolerability throughout treatment. On completion of treatment they will also be followed up for up to 5 years in order to evaluate efficacy of treatment in terms of disease response and survival.

Greater numbers of children now survive preterm birth. Dysphonia is a newly-recognised long-term complication of extremely preterm birth, yet remains a relatively little-researched entity. Voice outcomes have been associated with gestational age, birthweight and cardiac surgery. However, the strongest association found has been with intubation in the neonatal period. Thus, there is a need to investigate voice quality of all who may be intubated. Laryngeal pathology of very preterm children has not been systematically documented in the literature. Yet knowledge of laryngeal pathology is essential for intervention planning. Laryngeal pathology is investigated jointly by the Ear, Nose and Throat medical speciality and the Speech Pathology Voice allied health speciality. Further, there has been no investigation of treatment effects in preterm voice disorders. Having identified that dysphonia is a long-term voice outcome for some preterm children, treatment options should be investigated. Finally, many preterm children participate in paediatrician follow-up programmes to maximise medical and developmental outcomes. As dysphonia can now be considered a possible long-term complication for some preterm children, a screening tool for voice difficulties could be incorporated into existing follow-up programmes. The ideal measure would have: i) diagnostic accuracy to correctly identify the presence of dysphonia; ii) sensitivity to change in voice quality due to therapy; and iii) be quick and simple to administer to minimise cost. This study consists of three phases: an observational study of voice quality and its impact on quality of life in 200 children born at less than 32 weeks gestation; assessment of the nature and extent of laryngeal pathology visualised in those children with moderate to severe dysphonia; and a quasi-randomised, non-blinded, controlled trial of behavioural voice therapy in the children with moderate to severe dysphonia. Additionally, the sensitivity to therapeutic change of an objective voice assessment, the Acoustic Voice Quality Index, validated by our laboratory as a measure of dysphonia severity in children, is being measured. This registration pertains to Phase III Intervention.

The CROPP trial evaluates the hypothesis that 2 drug regimens are equally effective to deliver pain relief after a caesarean section. The drug which we are testing is called Oxycodone. We deliver the Oxycodone to participants in the test group in controlled release form on a regular basis over 2 days. The participant is also able to request immediate release Oxycodone for the breakthrough pain. These tablets are swallowed with water. In the control group the participants will receive Morphine into a vein each time a computer called a Patient controlled analgesic device is activated by the participant. The primary aim of the research project is to see if the 2 types of drugs have the same ability to relieve pain. The secondary aims are to see if these 2 drugs have the same safety profile, nausea, vomiting and pruritis incidence and if patients in both groups are equally satisfied with their treatment.

The study aims at evaluating new methods of sound processor fitting, performance assessments and intra-operative measurements for Nucleus Cochlear Implant recipients.

This study aims to use an online survey to gather information on the incidence and clinical impact of Aromatase Inhibitor-Induced Musculoskeletal Syndrome (AIMSS) in Australian women. Who is it for? You may be eligible to join this study if you are 18 years or older, female, have had a diagnosis of early breast cancer since 2007 and have been taking an aromatase inhibitor at any time since your diagnosis. Trial details. Many women with breast cancer are prescribed aromatase inhibitors as part of their breast cancer treatment. It is known that some women experience side effects from aromatase inhibitors which disrupt their quality of life. Some women may even choose to stop taking their medication before they have completed the recommended course (usually five years). This survey will ask a number of questions about women's experiences with side effects from aromatase inhibitors. The survey focuses specifically on joint, muscle and tendon pain, stiffness and discomfort. Women who have not had joint or muscle symptoms are also welcome to take part. The survey will assist the researchers to: * Better understand how the side effects of aromatase inhibitors affect Australian women. * Investigate possible ways of reducing these symptoms * Look at ways of improving the way doctors and other health professionals measure women’s symptoms and their impact on quality of life.

A renewed focus on malaria elimination has increased the priority of research towards development of interventions to block malaria transmission, including transmission blocking vaccines (TBVs). This Phase I clinical trial is designed test if our established malaria challenge system is suitable to study transmission to mosquitoes. A Plasmodium vivax malaria infection will be established in 6 human volunteers. Vector transmission studies will be undertaken with a laboratory strain of Anopheles stephensi mosquitoes to assess the transmission of parasites to the mosquitoes, both by direct feeding on volunteers and by artificial membrane feeding. Assessment of infection of the mosquitos will be done by mid gut dissection and microscopic visualisation, to evaluate the production of oocysts following the feeding experiments. Once feeding experiments have been completed, participants will then commence curative anti malarial treatment.

The role of temporal self-regulation theory variables and implementation intentions in breakfast consumption will be investigated in a sample of healthy individuals from the community. Participants who join the study will be randomised to one of two groups (1) implementation intention group (2) no implementation intention group. All tasks will be completed online. All participants will complete a baseline assessment that measures perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), frequency of breakfast consumption in the past week, and relevant demographic variables (e.g. age and gender). Participants in the implementation intention group will also complete an implementation intention task that involves the generation of If-Then plans to overcome barriers to breakfast consumption (e.g. ‘If I wake up late on a weekday, then I will eat a tub of yoghurt for breakfast while waiting for the bus!’). At one week post-baseline all participants will be emailed an invitation to complete the follow-up assessment. This assessment will reassesses perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), and frequency of breakfast consumption in the past week.

Amblyopia, also known as lazy eye, is a developmental disorder of vision whereby the brain ignores the information from one eye. This leads to a reduction in the vision of that eye. Also, the two eyes fail to work together resulting in a lack of binocular vision. This study is designed to test a new treatment for amblyopia implemented as a videogame on an iPod touch device that aims to strengthen binocular vision. The treatment is expected to establish stereopsis (3D vision) and to improve monocular acuity in participants with lazy eye. Participants will be given real or placebo treatment for 6 weeks and standard clinical tests of monocular and binocular vision will be used to assess treatment outcomes.

Hyponatremia, which describes low blood sodium levels, occurs frequently in patients who are in the hospital after aneurysmal subarachnoid haemorrhage, a condition where there has been bleeding in the brain. Hyponatremia can cause confusion and seizures, and possibly long term effects on a patient’s ability to function. A substantial amount of resources are used in treating this condition. This study looks at determining whether a medication called fludrocortisone can help in reducing the severity and duration of hyponatremia in this setting.

We know very little about how ED clinicians adjust care practices to accommodate for the needs of cognitively impaired older Australian experiencing acute pain. Given the front line positioning of emergency services, emergency department nurses are well placed to become active leaders and innovatively responsive in reducing human suffering. Pain, is costly both in human suffering and lost productivity. Therefore, ensuring timely pain assessment and appropriate analgesic interventions for older people with cognitive impairment is critical. International studies have demonstrated the benefits of the Pain in Advanced Dementia Screening Tool (PAINAD), but no study has taken place in Australasian EDs. This research proposes to explore pain management in older (>64years) Australians with suspected long bone fractures and to randomise the use of the validated pain assessment tool (PAINAD tool) for patients with cognitive impairment. The aim of the study is to conduct a cluster randomised controlled trial of the PAINAD screening tool for cognitively impaired older people (>64years) presenting to emergency departments with suspected long bone fracture and compare results to standard treatment.