ANZCTR search results

This is a randomised controlled study to evaluate the effects of daily 30 g whey protein supplementation on bone structure, muscle mass and strength, renal function, cardiovascular risk factors and body composition in women aged 70-80 years at baseline.

AIMS OF THE RESEARCH Being overweight or obese is a major health issue for Australian women during pregnancy and childbirth. There are well documented risks associated with obesity during pregnancy, including for the mother high blood pressure, diabetes and caesarean section. Babies of mothers who are overweight or obese are more likely to be large for gestational age, need admission to the nursery and to require treatment for jaundice and low blood sugar levels. This randomised trial will assess whether implementing a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit weight gain is effective in improving maternal, fetal and infant health outcomes. EXPECTED OUTCOMES OF THE RESEARCH If dietary and lifestyle advice is effective this would be a highly beneficial and cost effective treatment to redice the burden of disease to mothers and their infants caused by obesity.

The treatment for recurrent bladder tumour following trans-urethral resection (TUR) continues to be problematic. This protocol is a phase ll trial of gemcitabine directly instilled into the bladder of patients with transitional cell carcinoma who have undergone a standard TUR. The objectives of the study are to determine if intravesical gemcitabine is capable of reducing the rate of tumour recurrence in the bladder. Patients with transitional cell carcinoma who are at risk of recurrence following TUR, or who have failed previous standard treatment with intravesical BCG are eligible for the study. Patients will receive weekly bladder instillation of 2000mg of gemcitabine via a catheter, followed by re-evaluation of disease at 3 months by the urologist. Toxicity is expected to be minimal. The results of this trial will allow a phase lll trial comparing intravesical gemcitabine with BCG or mitomycin C to be undertaken.

The primary purpose is to evaluate the effectiveness of a walking program, especially the ‘dose’ of walking necessary to elicit clinically significant improvements in well-being among individuals aged 40 to 75 years with early osteoarthritis (OA) and test whether walking combined with glucosamine offers improvements. Improvements in well-being are defined as reductions in pain, stiffness, depression and anxiety and increases in functional ability, and self-efficacy towards exercise.

This study aims to evaluate the effects of two food bar formulations. One of the bars is wheat bran based, and the other sesame seed based. Both formulations are high in fibre and unsaturated fats, which have been shown in previous studies to reduce heart disease risk factors such as blood cholesterol. This study is designed to assess if different dietary sources of fibre and unsaturated fats will have similar or different benefit in reducing heart disease risk factors. The study will be single-blinded with the study co-ordinator blinded to the sequence of treatment the volunteers underwent. However because of a noticeble taste difference between the two bar formulations, the volunteers will be aware of their treatment.

In Australia and New Zealand, around 5000 patients are admitted to Intensive Care Units (ICU) annually with severe infection (sepsis). Despite aggressive treatment, around 35% of these patients will not survive, making severe sepsis the most common non-cardiac cause of death in ICU patients. Even surviving patients often suffer a period of multiple organ failure. Most patients admitted to ICU receive heparin injections to prevent the formation of blood clots in the leg veins which can travel to the lungs, causing major breathing difficulties. Traditionally, the agent most commonly given to prevent blood clots was unfractionated heparin, but over the last decade, more purified forms of heparin (low and ultra-low molecular weight heparins) have become available. These more modern agents are replacing the traditional heparin for blood clot prevention because of reported increased effectiveness. Recent studies in animals, healthy humans and critically ill patients with severe sepsis have suggested that unfractionated heparin may have beneficial therapeutic effects in infection, additional to its action to prevent blood clots. These immune-active effects are related to molecular size and thus may be lost with the current trend to use purified heparin forms. If this is true, then this additional benefit may be lost as we change to more purified heparin forms. We aim to perform a pilot study to assess the feasibility of conducting a large multi-centre study to investigate whether unfractionated heparin is beneficial for patients with severe sepsis. If unfractionated heparin is shown to be beneficial in these patients, this would be a simple, cheap and widely applicable additional treatment for severe infection that could save lives world-wide, and be accessible in first to third-world environments.

Nasogastric tubes are often used in children to give them fluids or medications or to drain their stomach. This involves the insertion of a narrow tube into their nostril and then down into their stomach. We know that this is a very safe and effective way of managing a number of problems in children. However, we also know that this is a painful procedure and we are looking for a way to relieve this pain. Lignocaine is commonly used in children to provide local anaesthetic before painful procedures. It is given in many ways, as an injection, applied to the mouth as a gel and sprayed in the mouth and nose, but it has not been licensed for administration by a nebuliser. Administering a medication in this way means that it is given through a mask so that it can be breathed in. The use of lignocaine in the manner proposed in this study is experimental. However, lignocaine has been administered by a nebuliser to children having different procedures and shown to be safe. It has also been given to adults by nebuliser before the insertion of a nasogastric tube and was shown to make this less painful. We will be asking families for consent for their child to participate in this study to find out whether administering nebulised lignocaine before inserting a nasogastric tube reduces the pain that the child feels. We aim to include 52 children in this study. Half of the children (26) will get the study drug (nebulised lignocaine) while the other half will get a placebo (nebulised salt water).

The aim of this study was to investigate if a longer time interval between rhDNase nebulisation and chest physiotherapy improves clinical outcomes of subjects with CF. METHODS: A single-blind randomised cross-over trial was conducted on subjects with CF from outpatients of 4 hospitals. Subjects were in stable health and studied over 6-weeks (utilising 14-day blocks of morning or evening rhDNase administration with 14-days washout). Usual regimes for physiotherapy and exercise were unaltered. Thus changing the times altered the dwell time of rhDNase prior to physiotherapy. Long interval was defined as dwell time of >6-hours and short as <6-hours. Outcomes were measured at pre and post each regime.

This study will evaluate the use of I-131 rituximab radioimmunotherapy, together with further doses of unlabelled rituximab immunotherapy, as treatment for advanced stage follicular and low-grade non-Hodgkins lymphoma. Such patients are currently recommended for treatment with systemic chemotherapy and unlabelled rituximab. Many patients are anxious to avoid the toxicity associated with systemic chemotherapy. We have previously demonstrated that I-131 rituximab (as used at Fremantle Hospital) has equivalent efficacy to the licensed agents (I-131 tositumomab and Y-90 ibritumomab) approved for use in the United States in patients with relapsed or refractory non-Hodgkins lymphoma. We expect, therefore, similar efficacy to these agents in patients with newly diagnosed lymphoma Previous North American research has shown that I-131 radioimmunotherapy can achieve response rates similar to those seen with chemotherapy in patients with newly diagnosed non-Hodgkins lymphoma. These investigators used I-131 tositumomab (Bexxar®), a similar product to I-131 rituximab, and achieved an overall response rate of 95%. 75% patients showed a complete remission and, of these, 70% remained in remission for 5 years or more. The 5-year progression-free survival was 60%.

Low systemic blood flow in the early hours after birth is a common problem in very preterm babies. It is associated with a range of adverse outcomes. This trial aims to test the efficacy of the two commonly used inotropes in preterm babies. Inotropes are drugs that improve the pumping performance of the heart.