ANZCTR search results

This study aims to investigate the side effects, safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy in treatment of BRAF V600E/K mutation-positive melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have received dabrafenib and trametinib (for 2 weeks or more prior to enrolment) for treatment of BRAF V600E/K mutation-positive melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic). Study details: Melanoma that has spread to other parts of the body may benefit from radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma may be sensitive to radiotherapy and that it can help to improve quality of life. All participants in this study will receive palliative radiotherapy concurrently with their dabrafenib and trametinib treatment. The radiotherapy dose, frequency and duration will be determined by your treating radiation oncologist and dependent on the location and size of your tumours. Up to 3 areas of disease can be irradiated at the same time. Regular follow up visits will be performed up to 12 months to monitor patient response and any toxicities experienced. CT scans will also be performed every 8 weeks to monitor response to treatment.

Menopause is a natural transition in every woman’s life, marking the end of fertility. Some women transit with little or no symptoms, while others suffer from the mood swings, hot flushes, insomnia and ‘brain fog’, which can last for many years. Eventually, these menopausal symptoms will disappear or lessen in intensity post-menopausally but there is nothing to celebrate. This is because women will no longer have the heart protective benefits of estrogen (a hormone that regulates menstruation). Reduced production of estrogen increases a woman’s risk of osteoporosis, heart disease, high blood pressure, stroke and dementia. These disease conditions are closely related to poor blood circulation; estrogen targets the blood vessels to promote blood flow to tissues and organs like our heart, lungs and brain. Our brains require the effects of estrogen to increase blood flow to specific regions responsible for memory and learning. When circulating estrogen levels fluctuate they alter blood flow to the brain, triggering mood swings, irritability and poor mental performance (brain fog). It is believed that a persistent decrease in blood flow to the brain marks the start of brain function decline. Hormone replacement therapy (HRT), or estrogen therapy, is effective in reducing menopausal symptoms; some post-menopausal women continue HRT indefinitely. Estrogen can positively affect mental abilities such as concentration, memory, reasoning and reaction time. Resveratrol is an ingredient found in grapes and berries that has multiple benefits for heart health. It can work through multiple mechanisms including mimicking the action of estrogen on blood vessels to improve circulatory function, thereby having the potential to increase blood flow in the brain and enhance mental abilities and mood. We aim to determine if regular resveratrol supplementation can enhance blood flow response to cognitive demands in specific regions of the brain and thereby improve mood and mental abilities such as short-term memory and the ability to concentrate better in postmenopausal women (at least 6 months after ceasing menstruation). Blood flow to the brain will be measured non-invasively with ultrasound. We will also use surveys to monitor their mood, sleep, quality of life (including chronic pain) and menopausal symptoms during the study.

ATL1103 is being developed as a potential treatment for acromegaly, a disease of excessive growth hormone and insulin-like growth hormone (IGF-I) action. Approximately four acromegaly patients will receive 300mg ATL1103 twice a week for 13 weeks. All treatments will be administered by subcutaneous injection. The primary objectives of the study are to evaluate the safety and tolerability of a high dose of ATL1103, and to investigate the pharmacokinetic profiles of ATL1103. The effect of ATL1103 on serum IGF-I levels and on other pharmacodynamic markers will also be measured.

This feasibility study will determine the local effects of thermal vapour ablation of operable cancer lesions in the lung. Who is it for? You may be eligible to join this study if you are aged 18 to 75 years and have been diagnosed with non-small cell lung or metastatic lung cancer suitable for resection. Study details: All participants will receive one treatment of thermal vapour ablation via a bronchoscopy procedure before undergoing surgical lung resection within 3 days of the thermal vapour ablation treatment. Resected tissue will be examined to determine effectiveness of treatment. Participants will be followed-up according to standard lung resection procedures. Official study follow up is completed once the resection occurs but patients will be monitored for Adverse Events in the standard lung resection follow up procedure, in order to determine efficacy, safety and feasibility of the study.

Obesity is a growing global public health problem in developed nations. It is estimated that half of all Australian women of childbearing age are overweight or obese. Obese pregnant women are more likely to deliver their babies by caesarean section and are also more likely to have complications such as surgical site infections after caesarean section than non-obese women. Wounds that fail to heal may cause considerable distress to patients and negatively affect the physical, social, emotional and economic aspects of their life. Wound complications also add to the cost of health care. Negative Pressure Wound Therapy has been used to aid healing since it was first developed in the late 1990s. The treatment is based on a closed sealed system that produces negative pressure to the wound surface. The wound is covered and sealed with an occlusive dressing and suction tube which is connected to a vacuum pump which provides intermittent or continuous suction. Negative Pressure Wound Therapy is being used more frequently as a way to prevent wound complications especially surgical site infection, but it has not been well tested yet. This study will test the effectiveness of two different methods to dress surgical wounds following caesarean section. These include Negative Pressure Wound Therapy compared to current care (standard care). We are doing this research study to find out the best practice for preventing Surgical Site Infections in obese women. To do this we need to study women with a body mass index (BMI) greater than or equal to 30 for one month following their surgery, and closely monitor their surgical wound.

This trial will compare the clinical performance of somofilcon A and formofilcon B contact lenses worn for two weeks. The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.

Nutritional support during allogeneic stem cell transplantation is imperative to prevent malnutrition. Nutrition support can be provided via either enteral (nasogastric) or parenteral (intravenous) feeding. Despite increased risks of infections and complications parenteral nutrition is used routinely at most transplant units due to patient's gastrointestinal toxicity at the time feeding is required. Recently a few small studies have shown benefits with early enteral nutrition in this group, including less infections, reduced risk of complications such as graft versus host disease, earlier neutrophil engraftment and improved survival. This study aims to assess tolerability of enteral feeding versus standard care (parenteral feeding) when commenced the day after transplantation, before the onset of gastrointestinal toxicity. This research study will determine which is the best form of nutritional supplementation for patients undergoing stem cell transplantation and the results will directly improve patient care as it will inform future clinical practice and lead to new clinical guideline development.

The aim of this study is determine if data collected on a mobile device has the same accuracy and reliability as the traditional paper based method of data collection. Data collection using mobile technology (including iPads) has the capacity to improve the efficiency of data collection and reduce transcription errors in large data sets. Measurement of subjective measures such as Pain, Fatigue, Exertion, Enjoyment and Perceived benefits of an intervention allow researchers to determine valuable information, from the perspective of the participants, in any intervention that they are carrying out. These factors have been identified as important barriers or facilitators to participation in in physical activity or exercise programs. Tools to measure these parameters have been validated in paper form. In larger studies the ability to collect this data electronically has huge potential to improve research efficiency, but to date no validation studies have been done using the iPad and these tools in an older population. Advantages: *Reduced time for data collection *Improved storage of data (no paper copies required) *Reduced research time (no data transcription required) *Easy ability to securely gain and store de-identified/re-identifiable data

The aim of the research is to explore the interaction between different types of caloric and non caloric sweeteners in snack foods on glucose and triglyceride levels to see if there is an optimal sweetener. High levels of sugars and high fructose corn syrup in particular have been associated with weight gain and type 2 diabetes but it is not clear if it is the type of sweetener or just the increased caloric load that causes this effect. Current tests of the role of fructose use extremely high amounts that would not be found in normal food items. Biscuits, cakes and muffins all contain a much lower amount of fat and sugar, but contain wheat starch and components of food that will moderate the glycemic and triglyceridemic response such as fibre and protein. We need to know if changing the sweetener in this kind of snack alters the response of glucose and triglycerides.

Multiple clinical trials have shown that perioperative hypothermia affects multiple organ systems and leads to adverse surgical outcomes. Cocoon Forced Air Warming (FAW) Blanket is one of the devices being used in Austin Hospital to minimise intraoperative hypothermia. Our aim is to compare the efficacy of Easywarm self-heating blankets with Cocoon FAW blanket in preventing intraopearative hypothermia by conducting a small randomised control trial. Patients undergoing relaxant general anaesthesia in supine position will be randomised into two groups. The control group will be warmed using Cocoon FAW and the other group will be warmed using Easywarm blanket. Easywarm blanket has not yet been compared with the FAW devices. The information we obtain from the project will help us to choose the optimal warming device in clinical practice.