ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • Quantifying the effect of the sedative alprazolam on brain electrical activity using the Brain Anaesthesia Response monitor

    This study is designed to evaluate a new method for monitoring the effects of sedatives on the brain's electrical activity. The method involves a sophisticated, physiologically motivated, algorithm for the analysis of the scalp recorded electroencephalogram.

  • Integrated blood glucose monitoring with insulin pumps versus standard method - a randomised crossover trial

    Good control of diabetes is essential to reduce the risk of developing diabetes-associated complications such as blindness, amputations or kidney failure. Intensive management of diabetes ensures better control and this is pursued in our population by multiple daily injections, or use of an insulin pump (~30% of population). Insulin pumps better mimic natural insulin delivery, being infused on a constant basis at varying adjustable rates throughout the day. Extra insulin is bolused for meals, or if blood glucose recordings are above target range. Good control on a pump is directly related to the number of blood glucose readings tested so insulin can be titrated to requirement. These glucose readings are optimally used when inputted into the pump, a step which must be done manually by the user. This is suboptimal in our population relative to international data, recently established as a mean of 3.1 readings per day versus 4.8 per day in other centres. A novel blood glucose meter has been developed which automatically inputs the measurement into the pump via bluetooth shortly after it is taken. This device is TGA approved for use in the paediatric population and widely used in Europe. We wish to examine whether or not it significantly increases the number of blood glucose measurements in a patient’s pump and if this has an overall effect on diabetes control, as measured by HbA1c. We aim to randomise 50 users to either using their own regular insulin pump, or the new integrated pump system for the first six months. After the first six months, participants will 'crossover' i.e. people using their own pump will then have the opportunity to use the new pump for six months and those who had the new pump would revert back to using their own pump. We intend to examine the effects of the different pumps, if any, on the number of blood glucose tests recorded and on overall metabolic control.

  • Does examination with traction on the cervix pre-operatively increase the reproducibility of the degree of uterine prolapse intra-operatively

    Studies have shown that different conditions in which the POP-Q examination was performed and, variations in examination techniques eg. patient position, use of vaginal specula, retractors or tractors used, the type of straining used to develop the prolapse maximally, fullness of bladder and rectum, can affect the reproducibility of the measurements. Recent evidence suggests that intra-operative examination of prolapse under anaesthesia could be significantly different from pre-operative examination even if POP-Q system is used. Many pelvic surgeons use the moment directly before the start of the surgery, when the patient is already under anaesthesia to perform a final examination using traction and plan the exact operation. We propose that using the same examination technique ie. traction on the cervix, pre-operatively and intra-operatively under anaesthesia will increase the reproducibility of the POP-Q measurements obtained pre-operatively for uterine prolapse. The aims of the study are 2 fold. 1. To determine whether or not using traction on the cervix with an instrument pre-operatively to determine the severity of uterine prolapse reduces the difference between pre-operative and intra-operative POP-Q measurements of Point C 2. To determine the patient’s acceptability of using a traction instrument to assess uterine descent without anaesthetic

  • A randomised controlled trial to compare the effect breakfast cereals differing in fibre content on short-term appetite and mood in 8-12yo children

  • Staying Fit Adolescent Weight Management Study

    Staying Fit has been designed as an Internet-based adolescent weight management program for overweight or mildly obese Australian young people. Goals of the program include: targeting weight loss, promoting weight maintenance, decreasing weight and shape concerns, healthy eating and increasing physical activity. We propose to conduct a project, commencing in July, 2011, in metropolitan Melbourne, involving approximately 570 young people aged 12-17 years. We will be recruiting voluntary participants from the community via advertisements in local media, posters in youth friendly services and through school nurses and general practitioners. Parent consent will be sought using an active consent process; young people will not be able to participate without a signed consent form from their parent or guardian. Participation for the young person is completely voluntary and they will also be required to provide written consent. Half of the participants will be randomly assigned to the intervention group, and will participate in the program with access to all modules. The other participants will be randomly assigned to the control group, and will receive a list of health websites and handouts on healthy food choices and physical activity recommendations. There are 12 sessions in the program and it takes approximately 1-2 hours to work through each session. Sessions are released at the rate of one each week. Online interactive monitoring of key behaviours (e.g., food and physical activity logs) and an online discussion group are used to encourage participation. Data will be collected at the start of the program, at 3 months, 6 months and 12 months. Data from the project will be collected and analysed by the Centre for Adolescent Health (CAH) at the Royal Children’s Hospital.

  • The effect of taping on pain and function in people with knee osteoarthritis.

    The purpose of this study is to investigate the effect of applying sports tape to the patella in OA knees and measure whether there is a decrease in pain, and or a change in the kinematics at the knee during a step descent task. The hypothesis is that taping the patella will improve a person’s functional control of their knee, thereby decreasing the pain experienced during the task.

  • Neonatal Core body temperature investigation

    Pilot observational study of 5 body temperature sites on critically ill neonates.

  • Ecstasy Check-Up: A multi-site trial of a brief intervention for ecstasy use

    Our long-term goal is to decrease ecstasy use in Australia by motivating ecstasy users, through brief and early information and discussion, to reduce their use through providing research based information and discussion. The objective of the proposed research is to evaluate a brief discussion based on motivational interviewing (Ecstasy Check-Up) for regular ecstasy users (1 session) compared with an educational control discussion, which involves provision of an informational booklet regarding the facts and fiction on ecstasy use. The primary hypothesis of the proposed study is that the one-session brief motivation interviewing discussion will be associated with lower levels of ecstasy use and dependence than the education only discussion. E Check Up sessions in which the specialist more strongly adheres to motivational interviewing principles are expected to have better outcomes. Additionally, our secondary hypothesis is that participants in the study will like and gain some positive aspects from both conditions, regardless if they have been assigned the research or the education discussion. The research is of benefit to participants as it offers an opportunity for them to manage their ecstasy use. This lifestyle change has many benefits including improvements in physical and mental health. This benefit, however, cannot be guaranteed; it is dependent on participants’ engagement with the discussion. At the baseline session, all participants will be assured that any information they provide will remain strictly confidential (within the limits of legal confidentiality and duty of care). After written informed consent is provided and all questions and concerns have been answered, the baseline assessment will occur. At one-, four-, and six-month follow-ups the research assistant will conduct face-to-face follow-ups with all participants using the measures collected at the baseline assessment. The outcome measures will be modified to assess the relevant durations at each visit. For example, the measures will assess the last 90 days during the baseline assessment, and the past 30-days at the one-month follow-up.

  • Screening and Treatment for Alcohol Related Trauma using Brief Interventions (START Brief Interventions) project

  • Pilot Study of Intraperitoneal Bevacizumab for the Palliation of Malignant Ascites

    Malignant ascites is a frequent complication of advanced cancer. It is most commonly associated with adenocarcinoma of the ovary, breast, colon, stomach and pancreas. Ascites has a significant impact on quality of life. Increasing abdominal pressure causes distressing symptoms such as abdominal discomfort, early satiety, nausea and vomiting, dyspnoea, impaired mobility and lethargy. In severe cases vomiting and bowel obstruction may occur. Approximately half of patients with malignant ascites present with ascites at the time of cancer diagnosis. For the other 50% of patients, ascites is a sign of progressive disease or treatment failure. Median survival for all tumour types after the diagnosis of malignant ascites is 20-25 weeks. If ascites is present at diagnosis systemic cancer therapy can provide early palliation, particularly for those with chemotherapy-sensitive tumours. However in end stage disease tumours are often refractory to cytotoxic chemotherapy and other management options must be considered. Current guidelines advocate repeat paracentesis, indwelling catheter placement or peritoneovenous shunting for symptom control in malignant ascites. However all of these treatments have significant limitations. Repeat paracentesis is most commonly performed, however this provides only short-term relief, necessitating repeat trips to hospital for further intervention. The average time to repeat paracentesis for patients with malignant ascites is 10-13 days. There is no evidence to support how long the drain should remain in place, whether the drain should be clamped to regulate output, whether intravenous fluids should be administered or whether vital signs should be regularly recorded. The alternatives to repeat paracentesis are less than ideal. In-dwelling catheters risk infection and dislodgement. Peritoneovenous shunting is an invasive procedure and is associated with potentially fatal complications. Vascular endothelial growth factor (VEGF) is a glycoprotein secreted by tumour cells. VEGF stimulates tumour angiogenesis and increases vascular permeability via interaction with tyrosine kinase receptors on the endothelium of both normal and tumour-induced blood vessels. Malignant pleural and ascitic fluid demonstrates markedly elevated VEGF concentrations, up to 60 fold higher than in matched serum. The role of VEGF on vascular permeability is thought to be central to the pathogenesis of malignant ascites. Preclinical studies have demonstrated the efficacy and safety of intraperitoneal inhibition of VEGF as therapy to prevent accumulation of ascites. Bevacizumab is a recombinant humanised monoclonal antibody that binds and inhibits the biological activity of VEGF. Intraperitoneal administration of bevacizumab may be the route of choice when the goal of treatment is to palliate malignant ascites. These patients are routinely managed with repeat paracentesis and intraperitoneal bevacizumab administration can be performed during this procedure. Intraperitoneal administration also has the benefit of directing therapy in to the peritoneal cavity where high VEGF concentrations promote fluid secretion. One pilot study and two case studies have reported the safety and efficacy of intraperitoneal administration of bevacizumab for the treatment of malignant ascites. Systemic administration of bevacizumab is usually well tolerated but has been associated with an increased risk increased risk of bowel perforation. This rare but serious complication occurs in 1-2% of patients. Risk factors have not been well defined but may include bowel implants, large tumour burden, prior radiotherapy, recent surgery and bowel obstruction. The mechanism of bevacizumab-associated bowel perforation is likely to be related to the anti-VEGF effects on bowel perfusion and/or tumour regression. Gastrointestinal perforation has not been described following intraperitoneal administration of bevacizumab. Other side effects of systemic treatment with bevacizumab include hypertension (3-14.8% Grade III/IV), venous and arterial thromboembolic events (0-3%), bleeding, proteinuria, delay in wound healing, and fistula formation. Our pilot study will evaluate the safety and efficacy of intraperitoneal administration of bevacizumab to prevent the recurrence of malignant ascites. Given the significant cost of bevacizumab, the aim of the study is to find lowest effective dose. As the published data suggests an average time to repeat paracentesis in malignant ascites is 10-13 days, our treatment would be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.

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