ANZCTR search results

The broad objective of this study is to document and assess the utility of current institutional standard-practice staging procedures for patients with early-stage Merkel cell carcinoma, who are managed at Peter MacCallum Cancer Centre (PMCC) or Liverpool Hospital Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically documented cutaneous Merkel cell carcinoma (MCC), stage cT1N0, which is suitable for sentinel lymph node biopsy. Study details Participants in this study undergo standard institutional practice, which involves sentinel lymph node biopsy (SLNB)/ lymphatic mapping and 18F-FDG PET/CT at initial diagnosis. SLNB involves removal and examination of the sentinel node(s) (the first lymph node(s) to which cancer cells are likely to spread from a primary tumor, This involves injection of a radioactive substance, blue dye, or both near the tumor, so that the node can be found using a probe or seen stained with dye. The surgeon then removes the sentinel node(s) to check for the presence of cancer cells. PET/CT scanning involves a small amount of radioactive glucose (sugar) injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Subsequent treatment of the tumour is undertaken with radiotherapy. Extent of radiotherapy treatment is determined by the results of the SLNB, i.e. if SLNB is negative patients receive treatment to the primary tumour site alone. If the SLNB is positive, patients will undergo treatment to both the primary and (involved) lymph node region. Follow up involves clinical examination at 6 weeks after Radiotherapy, then assessment every 4 months with clinical examination and PET scans as per hospital policy for a minimum of 2 years. Patients with a negative sentinel node will also undergo an ultrasound of the area the lymph node was removed from at each visit. Ultrasound involves a procedure that uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen. This study will provide valuable information to guide management for Merkel Cell Carcinoma. There is a lack of information regarding this uncommon, highly aggressive skin cancer.

Age-related macular degeneration (AMD) is the principal cause of blindness in Australia. Therefore, all options to slow down the rate of development and progression of AMD are critical. After smoking, nutrition is the key modifiable risk factor to reduce AMD incidence and no other preventative treatments are currently available. Despite the strong evidence-base, there remains confusion among patients and practitioners about what foods should be consumed in order to maximise absorption of useful nutrients and what supplements to take. An intervention aiming to promote a diet that is regularly rich in vegetables, fruits, and fish, will ensure good macula health. Also, the intervention should appropriately advise on supplementation in the absence of sufficient dietary intake of long-chain omega-3 fats and key micronutrients (lutein/zeaxanthin, zinc, vitamins C and E). However, translation efforts in AMD have so far focused on screening and drug or laser treatments. Therefore, the proposed study will address this evidence-practice gap, by implementing and evaluating a telephone-delivered dietary behaviour intervention targeting patients with AMD. An economic assessment to measure the cost-effectiveness of the intervention will be undertaken. This type of nutrition-focused healthcare is currently not considered in the long-term management of AMD, and represents the first empirical evaluation of a telehealth application encouraging adherence to dietary recommendations for AMD. Further, wide-scale delivery of this intervention has potential to lower the risk of progression to blinding, late-stage AMD in high risk patients.

Childhood overweight and obesity is a significant public health issue. A key contributing factor is sugar sweetened beverages (SSBs) consumption. Promoting increased water consumption and provision of chilled water stations can reduce SSBs consumption. Research question: Can a behavioural intervention and chilled water stations, alone or combined, increase water consumption and effect changes in students’ knowledge, attitudes or consumption of SSBs in year 7 secondary school students? Methods: A twobytwo factorial study design will be used to determine the effect of the Thirsty? Choose Water! behavioural intervention (TCWBI), and the installation of chilled water stations. Sixty secondary schools will be randomised to receive either: 1. TCWBI, 2. Chilled water stations, 3. TCWBI and chilled water stations, or 4. Neither intervention (control arm). Year 7 students in Arm 1 and 3 will receive TCWBI based on the Health Promoting Schools Framework in Terms 2 and 3, 2018. Chilled water stations will be installed in schools in Arm 2 and 3 during Term 2, 2018 with the remainder having water stations installed at the end of the project (if demonstrated to be effective). Baseline measures including student selfreport surveys, a school summary information and an environmental scan will be obtained in Term 1, 2018. Student surveys will be repeated in Term 4, 2018 and Term 1, 2019. Regular water meter readings from the chilled water stations will be recorded, as well as school canteen sales of all drink types, throughout the study period

What is the problem? Skin infections (sores and scabies) are common in Aboriginal communities. At any one time, almost one out of every two children have skin sores, and one in five children may have scabies. If skin sores are not treated, they can lead to serious illness including severe infection (sepsis), bone disease, kidney disease and possibly rheumatic heart disease. Skin infections are potentially one of the most treatable causes of serious disease in Aboriginal communities. Why are so many children affected? There are many reasons for this. One of these may be that as skin sores are very common, they can become “normalised”, which might mean the child doesn’t complain, they don’t go to clinic, or the doctor or health worker doesn’t treat the sores because “everyone has them”. What we want to do - the SToP Trial Skin health has been identified as one of the health priorities by communities and health services in the Kimberley. A number of healthy skin activities are currently underway. The SToP trial study aims to strengthen and build on these existing practices to improve the awareness, detection, and treatment of skin infections in the Kimberley. The SToP trial study will implement several activities aimed at Seeing (S), Treating (T) and Preventing (P) skin infections: Seeing: Provide health worker training to improve detection and treatment of skin infections, and introduce a school-based screening program to check kids’ skin for skin infections, and refer them to their local clinic if they need treatment. Treating: At the local community clinic, provide streamlined treatment medications for skin infections that are safe, effective, less invasive and easier for people to manage. Specifically, Cotrimoxazole (oral syrup or pill medication that you swallow) will be used to treat skin sores rather than an injection of Benzathine Penicillin, which can be painful. Ivermectin (oral pill medication that you swallow) will be used to treat scabies rather than Permethrin medication (an oily cream that needs to be applied to the whole body, which can be messy and may come off). Preventing: We will work with local communities and health services to strengthen culturally appropriate health promotion activities about healthy skin and stopping skin infections. This will increase community awareness about what skin infections (sores and scabies) are, why they are important and why getting treatment is important. We will also work with communities and health services to strengthen the role of environmental health activities in helping to manage skin infections. This will increase community awareness about the importance of environmental health in relation to skin health, and to help ensure community members have access to environmental health services.

We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with spinocerebellar ataxia or Friedreich ataxia. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

To conduct a feasibility study across the Aged Care Wards at Western Health to establish whether a high dose exercise program or use of electrical stimulation is more effective in maintaining quadriceps strength and patient function compared to a low dose exercise program during the NWB period in an elderly, cognitively intact, inpatient population. At Western Health, the orthopaedic management of elderly patients admitted post fall and lower limb fracture can require a period of non weight bearing or touch weight bearing. Elderly people are often unable to function whilst safely adhering to these precautions which can result in an extended in-patient admission due to their high level care needs and requirement for rehabilitation once permitted to return to weight-bearing. These patients who are unable to mobilise whilst adhering to their weight bearing restrictions, receive a low dose physiotherapy exercise program to maintain strength, range of movement and prevent functional decline. However, we recently conducted a systematic review and no evidence exists to support this intervention. It is unclear whether this form of physiotherapy during a period of non weight bearing or touch weight bearing is of any benefit to patients or whether alternative forms of physiotherapy such as higher dosage exercise or neuromuscular electrical muscle stimulation may be superior in improving patient outcomes. Our three groups are as follows: 1) Control (Standard Physiotherapy Care) - Low Dose Physiotherapy 2) High Dose Physiotherapy 3) Neuromuscular Electrical Stimulation. This study will inform physiotherapy practice and potentially improve patient outcomes in this elderly population

A sequential, multi-stage, open-label, multi-national, multiple-center, multiple-dose study to assess the long-term safety and tolerability of ZYN002 (transdermal CBD gel) in child and adolescent epilepsy patients 3 to <18 years of age with seizures associated with developmental and epileptic encephalopathies (DEE) according to the International League Against Epilepsy (ILEA) classification. In Period A patients will undergo a baseline period of 4-weeks, followed by a 2-week titration period, and a 24-week maintenance period. Patients will be treated for a total of 26 weeks. For Patients not continuing to Period B, following Week 26 or Early Termination, study drug will be tapered over a 1 to 3-week period (depending on dose). After the final dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks, the patient will be discharged from the study. Patients progressing to Period B will continue to receive ZYN002 for a further 24 weeks at the same maintenance dose received at Week 26 (e.g. end of Period A). Upon treatment termination, the patient will be required to complete the taper and follow-up period. After the final tapered dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks of follow-up, the patient will be discharged from the study.

The Physical Activity in Venous Leg Ulcer Patients pilot observational cohort study is a prospective multicentre observational cohort study to examine the feasibility of recruitment, the feasibility and acceptability of wearing an accelerometer and data output from the accelerometer as a means of assessing physical activity and sleep in venous leg ulcer patients. Between 20-40 participants will be asked to wear the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) over a 7 day period between Baseline and Week 12 and complete a daily log to record wake and sleep times and actigraph removal greater than 15 minutes. A physical activity questionnaire (IPAQ) will be completed at Baseline and an acceptability survey will be completed at the end of the wear period. Participants will also be asked to complete a questionnaire at three time points (Baseline, Week 12 and Week 24) and their medical records will be accessed twice (Baseline and Week 24). The primary objective is to determine if wound healing within 12 weeks from the baseline is associated with physical activity (and sleep) and the secondary objectives are: to examine factors related to ulcer healing and recurrence within 24 weeks and to examine study feasibility and patient accelerometer wear acceptability.

The aim of this study is to examine a memory training program that not only integrates various strengths of previous training programs, but also provides training that is practical, feasible and transferable to real-world tasks. It is hypothesized that (1) The will be a significant improvement on the Name-Face Task from pre-test to post-test for the experimental group (2) The experimental group will perform significantly better than the control group on the Place-Learning Task, Text Learning Task, and the Name-Face Task at post-test and follow-up.

Transcranial direct current stimulation is a cheap, portable device that may have application as a clinical tool for cognitive remediation. In the current study we will assess the effectiveness of high-definition transcranial direct current stimulation (HD-tDCS) to the dorsomedial prefrontal cortex (dmPFC) and right temporoparietal junction (rTPJ) to affect social cognition in patients with first-episode psychosis. We hypothesize that the patient group will show impairments at integrating and distinguishing between self and other processes across perspective taking and episodic memory tasks. They will also be impaired on an affective theory of mind (ToM) task. We hypothesize that dmPFC anodal stimulation will increase the integration of other into self across perspective taking and episodic memory tasks and improve affective ToM performance. Anodal stimulation to the rTPJ will improve the ability to inhibit the self-perspective in a perspective taking task that relies on mental rotation.