ANZCTR search results

The UP LATE service will provide a senior medical and nursing team to facilitate pro-active patient management out of hours, provide senior decision making and leadership to current after-hours personnel and improve organisational throughput. There will be a specific focus on better identifying and proactively reviewing "Patients of Concern" after-hours, including some pre-specified cohorts that have been identified organisationally as being at higher risk of clinical deterioration. There is limited evidence on the value of high quality after-hours leadership and clinical coordination. This initiative will be the first time such a service has been attempted for the Royal Brisbane and Women's Hospital, Queensland and a key output upon completion is to furnish data on the potential benefits to patients, staff and the organisation.

The Wound Healing in Patients with Venous Leg Ulcer Observational Cohort Study is a prospective multicentre observational cohort study that has been designed to follow patients with a venous leg ulcer who are deemed ineligible when screened for the ASPiVLU Study. This observational cohort study will gather real world evidence about time to healing in people with venous leg ulcers who are unable to be recruited or refuse to participate in the ASPiVLU RCT. The observational cohort study will take advantage of the screening conducted for the RCT to identify patients for inclusion in the observational cohort study which will collect data from 300 patients by accessing their medical records twice and asking them to complete a questionnaire at three time points. As with the ASPiVLU RCT, the primary objective is to determine wound healing within 12 weeks from the baseline screening visit. The secondary objective is to examine factors related to ulcer healing and recurrence within 24 weeks.

The primary purpose of the study is to evaluate the efficacy of probiotic and prawn oral immunotherapy compared to placebo in achieving sustained unresponsiveness. 8 weeks post end of treatment phase the participants will be challenged to test if they have achieved sustained unresponsiveness. The trial will include proven prawn allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. The treatment phase will last for 18 months. The trial will last for 5 years.

Knee osteoarthritis affects around 25% of adults over 55. While exercise is the recommended primary intervention, pain, deconditioning and fear of falling impacts on exercise adherence, and adds to the disability cycle. A feasibility study, using quantitative and qualitative methods, will be undertaken determining viability of a larger clinical trial. A Feldenkrais Method intervention, using guided ‘awareness through movement’ lessons, will be used aiming to minimise pain-related habitual patterns, and improve sensorimotor planning and mobility. Fifteen participants (55yrs+) will be recruited from the community and randomised to a control or intervention group, with a cross-over arm. Three to 4 movement workshops of ~ 3hrs duration will be undertaken, with a control physical activity diary. Pre/post and follow-up measures will be undertaken at week 1, 4, 8 and 12. Clinical and patient reported measures will be used, and exit focus group / interviews to evidence a larger robust clinical trial.

This trial (MONARCC) seeks to determine what the best initial treatment is for a patient population with metastatic colorectal cancer that cannot withstand the expected side effects of the commonly used combination chemotherapy regimens. Who is it for? You may be eligible to join this study if you are aged 70 years or above and have a confirmed diagnosis of untreated metastatic colorectal cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive low intensity targeted therapy, panitumumab, which is generally well tolerated as a single treatment without chemotherapy. Participants in the other group will receive panitumumab combined with chemotherapy (5FU), a standard treatment. All treatments are administered via the intravenous route (i.e. directly into the vein) and will be administered every 2 weeks until disease progression or unacceptable toxicity. All participants will be followed up to 18 months in order to assess treatment efficacy and safety. The hypothesis is that panitumumab will be a safe, acceptable, effective and convenient regimen to elderly patients with newly diagnosed advanced colorectal cancer.

This study aims to determine if ibudilast, an anti-inflammatory drug, can prevent acute neurotoxicity and chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible if you are over 18 years old, have been diagnosed with metastatic gastrointestinal cancer and have at least two cycles of chemotherapy with oxaliplatin planned. Study details Participants will be required to take the study drug, twice a day, for one cycle of chemotherapy treatment (2-3 weeks depending on the length of the chemotherapy cycle). Participants will also be observed for one cycle of chemotherapy treatment. Participants will also need to complete questionnaires, take blood tests and complete a physical assessment with a clinician. This will occur at the beginning of the study, during the chemotherapy cycles and one more time 3 months later. This study will help to inform research into minimising side effects for patients while undergoing chemotherapy.

This is a prospective study of individuals who have acquired spinal cord injury. Part 1 is a prospective study that will identify risk factors associated with the development of a sitting acquired pressure injuries (SAPi) in acute and chronic cohorts with SCI. Part 2 will assess individuals who develop a SAPU to measure the loss of health related quality of life and to quantify the costs of treating their SAPi. Subjects will be recruited from 6 sites – 3 state spinal cord injury units in Australia and 3 in Canada and it is intended that 480 subjects will complete the study. 240 will be acute (first 3 years post SCI) and 240 will be chronic (more than 15 years post SCI). Both cohorts will be followed and 9 Risk Factor Groups will be measured – degree of impairment/activity limitation, nutritional status, local tissue status including cutting edge ultrasound and Finite Element Modelling, wheelchair seating environment, psychological factors, co-morbidities, injury duration and country. Those factors that are significantly associated with the development of a pressure injury will be identified through Logistic regression modelling and a risk assessment tool will be derived.

Knee stiffness is treated using exercise and manual therapy. Manual therapy techniques utilize accessory movements to increase the range of movement of joints. The accessory movements aim to replicate those that occur during the normal joint movement. In order to increase knee flexion, the accessory movement is a posterior glide achieved by applying pressure to the top of the tibia in an anterior to posterior direction. This is based on the concave/convex rule which is applied to all joints. However, recent 4D in vivo kinematic modelling conducted by our group indicates that posterior to anterior pressures better replicate knee joint movement at the end of flexion. The aim of this study is to compare the results of both techniques in patients presenting with stiff knees. The aim of this as a pilot study, is to explore the feasibility of running this study, as well as collect data on effect size, responsiveness to intervention, and information on dose-response to inform a later clinical trial. The primary outcome is change in knee flexion range and secondary outcomes include measures of pain and function. The clinical significance of this project is to change practice in physiotherapy to ensure the most effective manual therapy techniques will be used to restore movement and relieving pain.

The READY study is a double-blinded randomised controlled trial with two parallel arms. A 2 week web-based employee decision aid tool and a control website. Participants will have open access to the website for 2 weeks, this is to assist the participants in being able to make a decision by understanding that the decision aid tool will come to an end at the 2 week period with an expectation of a decision to be made at this point as informed in the PIS. Assessments will occur at baseline, post-intervention (immediately after intervention) and follow-up 6 weeks post-intervention.

In Australia cashew nut allergy is the most common of the tree nut allergies in adolescents. The 2016 revised Australasian Society of Clinical Immunology and Allergy (ASCIA) infant feeding and allergy prevention guidelines recommend: all infants should be given allergenic foods including peanut butter, cooked egg, dairy and wheat in the first year of life. However there is no specific mention of tree nut foods, like cashew nut spread. This is because we still need to establish evidence of the effect of regularly eating tree nuts or tree nut spreads in early childhood as a tree nut allergy prevention strategy. Cashew nut spreads are now readily available in supermarkets. With the texture of a paste like peanut butter, they could feasibly be introduced into the diets of infants once they have established the developmental readiness for eating solid foods. We propose to investigate two different doses of cashew nut spread regularly eaten by infants from 6 months of age onwards. This study will enable us to examine whether babies regularly eating cashew nut spread should be further investigated as a cashew nut allergy prevention strategy in a larger multi-centre randomised controlled trial. This evidence will contribute towards providing specific recommendations to also include tree nut spreads introduction during infancy in allergy prevention guidelines.