ANZCTR search results

The research project aims to show by offering a choice of three different weight loss diets plus the ability to change diet styles throughout the study participants are more likely to remain in the study and more likely to achieve the study goals of a 10% weight loss at 12 months compared with those having usual clinical care.

Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many patients also experience co-morbidities such as obesity and cardiovascular disease that further add to the OA burden. Interventions that foster appropriate lifestyle behavioural change, particularly in the area of physical activity, are important for chronic diseases such as OA. Physical activity, encompassing both structured exercise and incidental physical activity, is recommended by OA and general health guidelines because of its positive impact on disease outcomes and health status. Both muscle strengthening and aerobic exercise are effective in reducing pain and improving function in the short-term in patients with knee OA. However, benefits are generally not sustained because adherence declines over time. Interventions are therefore needed to facilitate sustainability of physical activity behaviours in patients with knee OA in order to achieve longer-term clinical improvements and to reduce the risk and impact of associated co-morbidities. Evidence-based strategies to improve uptake and adherence to physical activity and/or exercise interventions for people with chronic musculoskeletal conditions include incorporating face-to-face visits with a health professional, support from telephone coaching, refresher or booster sessions, exercise and physical activity plans based on patient preference and individual goals, an educational component, and optional strategies including log-book recording of participation and step counting. Telephone coaching is a relatively inexpensive intervention using widely available technology. It has been shown to improve physical activity behaviours in older adults and in those with other chronic conditions, particularly if combined with face-to-face visits with a health professional. Thus telephone coaching aimed at changing physical activity behaviours may achieve longer-term improved patient outcomes in those with knee OA but there is limited research in this area. This pragmatic trial will investigate the clinical- and cost-effectiveness of a 6-month physical activity intervention on pain and function in people with knee OA. The intervention package incorporates 5 physiotherapy contacts together with 6-12 telephone coaching contacts. The intervention will be compared to a physiotherapy only condition.

The rationale of the study is to evaluate the relative efficacies of Cognitive Behaviour Therapy and Mindfulness in reducing the symptoms of prolonged grief. This study compares the relative effectiveness of (a) Cognitive Behaviour Therapy, and (b) Mindfulness. It is hypothesised that both arms training will lead to grief symptom reduction but that Cognitive Behaviour Therapy will lead to greater symptom reduction at follow-up.

This study evaluates an innovative therapeutic intervention to reduce psychological distress and improve quality of life for men diagnosed with advanced prostate cancer. Who is it for? This study is for men who have been diagnosed with advanced prostate cancer in Queensland, New South Wales, Victoria and Western Australia. Trial details In this study participants are randomly (by chance) divided into two groups. One group will receive patient education, i.e. currently available resource and support materials. The other group will receive a telephone delivered mindfulness-based cognitive therapy group intervention. This intervention includes group therapy phone calls for participants led by trained health professionals and daily meditation practice. The duration of this intervention is 8 weeks. Participants will complete questionnaires at 3, 6 and 9 months after enrolling in the study to evaluate their psychological well-being and quality of life.

The outcome in patients with Acute Myeloid Leukaemia (AML) who fail to respond to treatment or relapse after treatment is extremely poor. There is no standard treatment for these patients. This study aims to investigate the appropriate dose of the drug romidepsin (a type of chemotherapy) delivered with high dose lenalidomide (a type of chemotherapy) in the treatment of advanced AML. The study plans to treat up to 18 patients in a number of sites throughout Australia. The primary aim of this initial study is to find a safe dose of romidepsin when delivered with high dose lenalidomide. This initial stage of the study will flow into a larger study comparing 3 different treatments in advanced AML, however if you participate in this Phase I study, you will not then be eligible for the following Phase II study. Trial details: In this study you will receive the drug romidespin delivered intravenously (i.v) on days 1,8 and 15 of a 6-week treatment cycle at a dose of either 8, 10, 12 or 14mg/m^2, or on days 1 and 15 at 8mg/m^2. The actual dose will depend on what stage of the trial is currently open. At the same time as the romidespin treatment, you will also receive 50mg oral lenalidomide on a daily basis on days 8-28. The strength of the drug and your tolerance of it will be assessed after 2 cycles, and overall, your treatment should continue for at least 6-12 cycles. Beyond this time, the decision as to whether or not your treatment continues will be at the discretion of the study's Principal Investigator (PI). Who is it for? This study is open to male or female patients aged 18-80 with either a diagnosis of Acute Myeloid Leukaemia (AML) and failing previous therapy, either primary refractory or relapsed after no more than 3 previous lines of chemotherapy OR a diagnosis of Myelodysplasia transformed to AML after previous treatment. The full details of this study’s inclusion and exclusion criteria can be found in the relevant sections within this record.

To assess the safety and effectiveness of percutaneous transluminal angioplasty (PTA) for the treatment of extracranial and/or azygous vein stenosis in MS patients as measured by clinical parameters of physical and mental disability progression.

This study is a randomised controlled trial for patients with metastatic or locally advanced pancreatic cancer, comparing a drug named Creon - which acts as a pancreatic enzyme supplementation - to placebo, in order to determine its influence on change in weight. We will also look at the drug's effect on quality of life, nutrition and survival, with our expectation being that Creon will decrease the rate of weight loss, improve quality of life, nutrition and length of life. This study is being performed due to previous research showing a benefit to pancreatic enzyme supplements in patients with pancreatic cancer with a bile duct stent in place to relieve a blockage caused by the cancer. It is known that pancreatic cancer causes weight loss, and thought that poor absorption of nutrients may contribute to that weight loss. This study aims to assess whether aiding the aborption of nutrients leads to better nutrition, weight stabilisation, improved quality of life and improved survival. Trial details In this study you will be randomly assigned to either the active medication (the Creon drug made of pancreatic enzyme), or to an identical, but non-active placebo capsule. In either group, you will take 2 capsules of Creon/placebo with meals, and one capsule with snacks every day. After one month and depending on how you have tolerated the drug, the dosage may be increased to 3 capsules with meals and/or two capsules with snacks, depending on whether you are feeling bloated, flatulent and/or have diarrhoea. Overall, you will continue the treatment for at least 2 months. During the study will be assessed by study personnel including the doctor, nurse and dietitian. The assessments are weight measurement, questionnaires about nutrition, symptoms and quality of life. These visits will be monthly for 2 months, then every three months while you and other participants remain on the study. Who is it for? You may be eligible for this study if you have metastatic or locally advanced pancreatic cancer and aged 18 and over. Full details of whether or not you can participate can be found in the Inclusion Criteria section of this record.

This is a Phase 3, multicenter, open-label, extension study to evaluate the safety, tolerability, efficacy, and immunogenicity of long-term epratuzumab treatment in subjects with SLE. Subjects who complete 1 of the Phase 3, double-blind, placebo controlled studies, SL0009 or SL0010, or terminate prematurely (at Week 16 or later) due to lack of efficacy, are eligible to enroll in SL0012. The study consists of an Open-Label Treatment Period and a Safety Follow-Up Visit. During the Open-Label Treatment Period, all subjects will receive epratuzumab 600mg delivered QW via slow iv infusion for a total of 4 consecutive weeks (CMD 2400mg) over eight 12 week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48 (Year 1), 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87 (Year 2) [96 weeks total duration]). A Safety Follow-Up Visit will occur approximately 4 weeks after Week 96 (ie, no later than Week 100) for subjects who complete the study, or 13 weeks after the final dose of study drug for subjects who discontinue early. Study drug treatment is in addition to the subjects’ existing standard care of oral corticosteroids and any immunosuppressants or antimalarials continued from Baseline in the subjects’ prior study.

The use of topical ocular non-steroidal anti-inflammatory drugs (NSAIDs) has been limited by the common side effects of burning and stinging. It has been reported that lowering the temperature of lubricant eye drops results in improved ocular comfort. This research project is to determine if refrigeration of 0.5% ketorolac tromethamine prior to administration improves patient tolerability of the commercially available preparation. These findings may lead to an improved method of delivery that will reduce the adverse effect profile of topical NSAIDs, increase patient compliance and influence future prescribing trends.

Considering the increasing popularity of mixing energy drinks with alcohol and the very little research to-date, it is imperative that further research is carried out. The aim of the present study is to extend the available research exploring the effects of the combination of energy drinks with alcohol. Specifically, the study aims to investigate the effects of the combination of alcohol and Energy Drink on cognition and mood compared to Energy Drink alone, alcohol alone and placebo. The design of the current study is a randomised, double-blind, placebo-controlled and crossover trial administering 0.6g/kg alcohol and 250ml Energy Drink plus water to form 500 ml. Participants will be randomly allocated to an alcohol, Energy Drink, alcohol and Energy Drink combination, and placebo sequence with a washout period of seven days between each condition. Participants will undergo a practice session where they complete the cognitive task twice and the mood questionnaires once to ensure there are no practice effects in the testing sessions.