ANZCTR search results

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with oesophageal cancer that has spread to another are of the body (metastasised). Who is it for? You may be eligible for this study if you are an adult who has cancer of the oesophagus or gastro-oesophageal junction that has spread to other parts of your body. Study details All participants in this study will receive 10 treatments of radiotherapy to the primary oesophageal cancer, with one treatment given on each working day for two weeks. In addition, all participants will receive chemotherapy (including carboplatin and paclitaxel) given intravenously once per week for the same two weeks as the radiotherapy. Durvalumab, an immune therapy, received intravenously; will be given every four weeks from the beginning of radiation therapy. After this participants will continue to receive immune therapy (Durvalumab), received intravenously once every 4 weeks for up to 24 months or until the cancer worsens. If participants have a metastatic tumour, they will also be given 3 doses of radiotherapy in one week. This radiotherapy will be received 4 weeks after the initial radiotherapy is completed. Safety blood tests will be collected through out the study (every two weeks from week 2 of treatment and then every four weeks from week 9 throughout the treatment and at other times if clinically indicated). Cat Scans to evaluate the response to treatment will be done every 6 weeks up to week 24 of treatment and then every 12 weeks or until the cancer worsens. Study participants will also be asked to complete some questionnaires about their wellbeing and nutritional status periodically through out the study. It is hoped that this trial can help determine if this chemotherapy with immune therapy and radiotherapy combination is effective in increasing the ability of the body’s immune system to prevent worsening of the cancer and improve swallowing.

The main aim of this crossover study is to see whether LAT8881 is safe and effective in relieving acute migraine headaches. Subjects enrolled in the study will be randomised to receive Investigational Medicinal Product (LAT8881 60 mg or placebo), to be taken at the onset of a migraine headache of moderate to severe intensity. Subjects will be given a single dose of IMP, to treat one migraine headache. After treatment of one migraine headache and a 48 hour washout period, the subject will return to the clinic for re-evaluation and crossover to the second treatment.

The aim of this study is to assess the effect of orally-dosed palmitoylethanolamide (PEA) on allergy symptoms in otherwise healthy young males and females aged over 18 years compared to a placebo. This is a double-blind, randomised, clinical trial with a 2-week treatment duration with 2 arms. It is hypothesised that PEA supplementation over a period of 2 weeks will reduce the severity of allergy symptoms compared to the placebo.

This study aims to understand the impact of a nutrition-exercise intervention commenced early during an acute hospitalisation and continued for an extended period post-discharge on frailty. This study will test whether a multi-purpose intervention can be delivered by a trained allied health professional and if successful can have financial benefits in the current times of economic constraints. If found to be effective, it will create a streamlined service that can benefit the increasing population of frail elderly patients.

Impetigo is a common childhood illness which is more prevalent in tropical regions. Australian guidelines recommend treatment with topical or oral antibiotics depending on severity. There is currently insufficient evidence to support the use of non-antibiotic topical treatments. Prescription of antibiotics is an important issue as antimicrobial resistance is currently a serious threat to global health. Consequently, it is imperative that non-antibiotic treatments for common conditions are explored. This pilot study will explore topical antibiotics versus topical antiseptics versus inert vehicle ointment on the treatment of patients with impetigo, providing data to determine the feasibility of a future larger study.

While traditional surgical procedures for heart valve replacement generally require a large incision in the middle of the chest and use of a heart-lung machine, the GATE tricuspid valve is delivered through a comparatively small incision in the chest or neck in a beating heart. This approach can be referred to as being “minimally invasive.” The procedure includes use of a catheter delivery system, through which the replacement valve is delivered to the heart. By replacing the diseased native valve, the purpose of the study is to demonstrate that the GATE system provides a safe and effective means of restoring valve function and improving quality of life for patients at high risk for traditional cardiac surgery. The study hypothesizes that replacing the diseased tricuspid valve in a minimally invasive manner will restore valve function, minimize regurgitation (leaking) and lead to improved quality of life.

The greatest risk factor for glaucoma is pressure within the eye. Management of glaucoma aims to reduce eye pressure and glaucoma surgery involves increasing the outflow of fluid from the eye to achieve this. XEN gelatin stent surgery delivers a consistent non-inflammatory and flexible stent to form a drainage connection between the space at the front of the eye and the outside of the eye, just beneath the surface of the clear skin (conjunctiva). The fluid from the eye drains out along the tube to form a blister (bleb) in the surrounding tissue, which is vital for long term success. This project will allow the long term collection and analysis of data to help improve patient outcomes. Multiple surgical variables may influence post-operative outcomes and success rates of the surgery. These include the entry position, dimensions of the stent within different parts of the eye and the final position of the stent. Other non-surgical factors which are likely to play a role in terms of surgical success include age, sex, racial sub-type and disease (glaucoma) sub-type. We would like to answer questions surrounding which of these parameters are important in determining XEN stent function, eye health after surgery and pressure reduction. The three major endpoints in terms of judging surgical success rates are eye pressure reduction, number of pressure lowering medications (eye drops) used and drainage (bleb bister) area shape and appearance. This will be a prospective observational study over a 12 month period after surgery. Patients who have already undergone surgery will be asked to participate as well as patients about to undergo surgery. We will collect clinical data over a 12 month period following patients' XEN surgery during their routine post-operatively clinical reviews.

The aim of this randomised control trial is to determine if improvements in the nutrition quality of lunchboxes following an app based intervention can be maintained with or without additional support. Schools who have received the app based intervention will be randomised to either receive two additional booster messages via the school communication app, over a one month period or to the control group.

Pathways and Resources for Engagement and Participation (PREP) is a 20-week innovative strengths-based intervention which aims to increase the participation of adolescents with reduced mobility in leisure/recreational pursuits. Occupational therapists collaborate with adolescents to identify 3 goals and use coaching to support adolescents, and if appropriate, their parents, to identify aspects of the environment which either support or create barriers to participation and implement strategies to remove barriers. The program addresses one goal at a time in a staged fashion and progress and outcome measurement is embedded in the program. PREP has been evaluated in Canada with adolescents with moderate physical disabilities and shown to be feasible and effective for increasing participation. We plan to evaluate the implementation of PREP in i) an Australian cultural context, ii) a hospital clinic environment and iii) with an older group, that is, youth aged 18 to 30 (approximately) who are part of the Young Adult Complex Disability Services clinic (YACDS) at St Vincent’s Hospital in Melbourne. Our hypothesis is that PREP, following any modifications required for the Australian context, can improve the participation outcomes of young adults with complex disability.

This proposal aims to evaluate whether liquid melatonin can be used to improve sleep in children aged 5-8 years with or at risk of FASD as per the Australian Guidelines for the Diagnosis of FASD. In addition we will investigate how any changes in child sleep behaviour owing to the intervention will lead to effects on parent wellbeing, child behavioural functioning, and child neuropsychological functioning.