ANZCTR search results

The primary purpose of this study is to determine the feasibility and efficacy of an exercise program to ameliorate the primary physical and mental health problems faced by men on prostate cancer active surveillance and to explore potential mechanisms underlying the influence of phsical exercise on markers of disease progression. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer in the previous year, currently undergoing active surveillance. Study details Participants will be randomly allocated (by chance) to receive either the exercise program or usual care. Participants in the exercise program group will receive supervised resistance and aerobic exercise sessions, each lasting approximately one hour, three times per week for six months. These participants will also be encouraged to complete additional aerobic exercise at home to create a total of 150 minutes of moderate aerobic exercise per week. Participants allocated to receive usual care will be encouraged to complete a walking program and will be given an information booklet detailing the current national aerobic exercise recommendations for cancer survivors along with a log-book to record their physical activity. The aim will be to complete a total of 150 minutes of aerobic exercise per week by month 6. Patient outcomes will then be assessed through blood samples, fitness tests and questionnaires at 3 months and 6 months. It is hoped that the findings of this trial will provide information regarding the feasibility of implementing an exercise intervention for prostate cancer patients on active surveillance, as well as the efficacy of such a program on mental and physical health outcomes, as well as on disease progression.

People with cystic fibrosis (CF) often have thick mucus in the airways of the lungs that is hard to cough up. The mucus builds up and eventually leads to chronic cough and lung infections. Research has shown that even young children with CF may have thickened mucus in the lungs. Inhaling a concentrated salt solution, called hypertonic saline (HS), may help thin the mucus in the lungs. Thinning the mucus can make it easier to cough up. This helps to clear the lungs and improve lung health. Research studies about the safety and effectiveness of inhaled HS have been done in adults and children with CF 6 years of age and older. Patients in these studies took HS for up to a year. HS appears to be a safe treatment in these age groups. The main side effects were cough, throat irritation, and wheezing. The use of HS in older children and adults decreased the need for antibiotics for acute respiratory infections. It also improved lung function and quality of life. HS is now routinely used by many CF patients over 6 years of age. Because HS treats a very early step in the chain of events that leads to chronic lung problems in people with CF, it may be particularly helpful when started early in life. Based on several studies, HS appears to be safe in children less than 6 years of age, but its effectiveness has been difficult to measure. In a previous study, children less than 6 year-old receiving HS had the same number of lung infections as children receiving normal saline. However, we think that children this young need a more sensitive test to see if HS works in preventing lung damage. In this study Computed Tomography (CT) scans will be used to get an image of the lung. In addition a new type of breathing test, called Multiple Breath Washout (MBW), will be used. This is relatively easy for preschool children to perform, and may allow us to measure the effectiveness of HS in preschool children with CF. The MBW tests measures lung function. This study will be conducted in parallel with the North American SHIP001 clinical study, registered on Clinicaltrials.gov NCT02378467.

The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Surgery is usually reserved for patients who fail to respond to conservative treatment. Greater understanding of the cellular and molecular pathology of tendon injury led to the development of biological scaffolds to augment tendon repair. The scaffold promotes cellular migration, adhesion and proliferation. This results in rapid ingrowth of host tissue and assists with transition of remodelled tissue into mature tendon in the bioactive chamber created by the membrane-tendon interface. Scaffolds are not intended to replace normal body structure or provide full mechanical support for tendon repair. Commercially available scaffolds for tendon repair are manufactured from animal or human connective tissues such as dermis, small intestine mucosa and pericardium. The tissues are processed to extract lipids, DNA and other non-collagen components, and may be cross-linked to increase mechanical strength before sterilisation. Removal of non-collagenous components is critical to avoid foreign-body reaction or rejection by the host. The final product is a membrane composed predominantly of type I and III collagen fibres. CelGro(tm) is an acellular type I/III collagen membrane of porcine origin manufactured in Australia by Orthocell Ltd and is intended for use as a resorbable bioscaffold in surgical applications. It is a Class III Medical Device. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin. CelGro(tm) presents as a white to off-white sheet of collagen fibres with both a smooth and slightly rougher surface. Due to the natural origin of this product, small variations in thickness and surface texture may be noted. The CelGro(tm) bilayer structure has a rough, porous side that allows for the ingrowth of cells and a smooth side which prevents invasion of connective tissue. The rough side has a random and loose distribution of collagen bundles of varying size and length. The smooth side is composed of parallel arrangements of densely packed collagen bundles with abundant knitted collagen holes which enable cells and fluids to pass through to the rough side. CelGro(tm) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type. This trial is a pilot study to explore the use of CelGro(tm) collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.

Many children with cerebral palsy participate in fewer physical activities than peers without a physical disability. Some studies have tried to increase participation in physical activities for children with CP through programs that develop their physical skills and remediate physical impairments like low muscle strength. Participation depends on many things however, not just the presence of physical limitations; participation is related to environmental barriers like lack of accessible venues, and personal factors like self-efficacy. This project will test whether a new integration of physiotherapy and a positive counselling technique called motivational interviewing can increase the participation of children with cerebral palsy in physical activities, compared to a control group who receive usual care. We think the intervention will work because it primarily focuses on environmental and personal factors, and because it may help parents to be supportive of their child's autonomy (making choices).

To evaluate the rate of sustained virological response among HBeAg-negative chronic hepatitis B patients who discontinue long-term NA therapy.

The ingestion of excess energy, particularly fat, is largely responsible for the current epidemic of lifestyle-related diseases such as obesity, diabetes and sarcopenia (the progressive loss of muscle mass with increasing age). The development of sarcopenia is exacerbated by low levels of physical activity and also in overweight or obese individuals through an increase in body fat and concomitant decrease in muscle mass. However, performing resistance and aerobic exercise in combination with the ingestion of high quality protein sources (e.g., dairy-based protein) has been shown to enhance and/or maintain muscle mass. This has important health implications for reducing the risk of developing sarcopenia, obesity or other debilitating health conditions such as diabetes. Accordingly, the aim of this research is to investigate whether a short-term (9 day) high fat diet (HFD) decreases muscle protein synthesis (MPS) and, whether performing resistance exercise during consumption of the HFD can in part relieve the repressive effects of fat toward skeletal muscle anabolism; hence, MPS.

This study's purpose is to compare photodynamic therapy with radiation therapy (RT) for superficial skin cancer. Who is it for? You may be eligible to join this study if you have received a biopsy-proven diagnosis of superficial basal cell carcinoma or Bowen’s disease, for which you have received no previous treatment. Study Details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive photodynamic therapy, which involves the application of a topical agent to the area to be treated, and then application of a certain type of light. A red light will be placed 5-8cm away from your skin surface for approximately 9 minutes. You will receive two sets of treatment 1-4 weeks apart. Participants assigned to the other group will receive radiation therapy, which involves highly-focused radiation from outside the body onto the lesion site to destroy cancerous cells. Participants will be asked to undergo clinical assessments (including photos to assess cosmetic outcomes) and complete questionnaires before treatment and 3 months, 1 year and 2 years post-treatment. It is hoped that this research will provide insight in the efficacy and cosmetic outcomes of two different types of non-surgical intervention of skin cancer.

There is increasing concern that over 50% of mothers and 60% of breastfed young infants in disadvantaged areas globally have micronutrient malnutrition and iron deficiency anaemia (IDA), with similar rates found in Aboriginal and Torres Strait Islander communities. Despite a decade of substantial investments in Continuous Quality Improvement (CQI) programs, many barriers still remain to the provision of antenatal care in remote areas. There have been no studies of the effectiveness of peer led clinical governance to improve antenatal in remote and disadvantaged communities who are likely to benefit most. We have been funded by the National Health and Medical Research Council (NHMRC) to undertake a study of a new locally driven enhanced support model (clinical governance and peer led targeted support) to reduce anaemia rates and improve the quality of maternal and infant primary care. The study will be based in the Kimberley region of Western Australia. The intervention is clinical governance and peer led targeted support for maternal and early infant care delivered by dedicated local midwife coordinators. We will evaluate this model of enhanced support using a rigorous stepped wedge design approach. Structured questionnaires and data collection will be used to assess acceptability, feasibility and sustainability. Our primary outcome measure is improved iron deficiency anaemia in infants aged six months. Secondary outcome measures are improved iron deficiency anaemia in mothers at six months post-partum; improved Bayley neurodevelopmental scores in infants aged six months; improved satisfaction of mothers about maternal health care. We will also assess the cost effectiveness of the model of enhanced support. Although we are aiming to measure the primary outcome at six months post-partum we will be accepting measures from 4-8 months due to difficulties in finding all infants at exactly six months post-partum. This study will be conducted over a five year period in partnership with service providers in the Kimberley. This is the first population and region based study of clinical governance and targeted peer led support in a remote region. The results of our study will be used to develop improved primary care models and to improve health outcomes for all Aboriginal and/or Torres Strait Islander mothers and infants. These are vital steps towards more equitable health service delivery for Aboriginal and Torres Strait Islander peoples in Australia.

The aim of this proposal is to conduct the first study of the impact of subcutaneous administration of PT-141 on key mechanisms involved in social communication in adults with autism. We hypothesize that PT-141 will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.

Supporting centre based childcare services to provide healthy food can make an important contribution to promoting health of young children at a critical stage in their development. This study aims to assess the effectiveness of a large scale intervention aiming to increase childcare service implementation of menu nutrition guidelines. The study will recruit 60 long day care services that will be randomised to receive the intervention to support nutrition guideline implementation, or a usual care wait list control group. The intervention will consist of multiple strategies including staff training, executive support, performance feedback, resources and ongoing support. Menu assessments before and after the intervention will be conducted to assess the effectiveness of the initiative in improving compliance with setting nutrition guidelines. We hypothesis that childcare service's implementation of nutrition guidelines will improve as a result of the intervention.