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This study will involve taking a venous sample from both persons receiving warfarin treatment (experimental group) and persons not receiving warfarin treatment (control group). All persons are currently undergoing testing at a clinic. Samples collected are tested by laboratory staff on the experimental point of care device, commercially available device and standard laboratory reference instrument. The aim of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving warfarin treatment on an experimental device, commercially available point of care device and a standard laboratory method. It is expected that International Normalised Ratio(INR) values from the Universal Biosensors device will correlate with results obtained from the Roche CoaguChek and the laboratory reference method.

This phase II study is a single centre open-label, multiple dose study intended to determine the preliminary efficacy of MDX-1097. Up to 27 previously treated kappa light chain restricted multiple myeloma subjects with stable measurable disease will be enrolled in the study. Weekly i.v. infusion of MDX-1097 for a total of 8 weeks at a dose level of 10 mg/kg is planned for all subjects. Subjects will be assigned to the clinical trial in the order of study entry. The study will consist of 3 phases: Screening Phase, Treatment Phase and the Follow-up Phase.

Obesity is now the most important avoidable cause of ill health in Australia today. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death. In Australia, 67% of men are considered to be overweight or obese compared to 52% of women, yet men are less likely to attempt weight loss than women. Men are notoriously difficult to recruit to weight loss programs, despite being more susceptible to many of the serious consequences such as CVD. Overweight men have greater abdominal adiposity than women, which is associated with increased risk of CVD. There is an urgent need to develop and evaluate novel and cost effective approaches to weight loss that engage large numbers of men. The primary aim of the current study is to explore the efficacy of two SHED-IT behavioural intervention strategies developed specifically for men and involving different modes of delivery in a large community weight loss trial. Key secondary objectives include: - Determine the relative benefit of two different weight loss programs (Resources and Online) designed to be incremental in extent of interaction & intensity of intervention on weight and other health outcomes; - Evaluate strategies to improve adherence to online programs and examine what attributes of individuals and website features may predict compliance; - Determine the characteristics of men for which each program is most effective; - Compare the effects of the different programs in defined subgroups (age, education, occupation, marital status, SES). It is hypothesised that: (1) Compared to baseline, both the SHED-IT Resources and Online interventions will result in a clinically important and statistically significant (a) reduction in weight and (b) improvement in other important secondary outcome measures; at 3 and 6 months post-baseline (2) The Online intervention, compared to the Resources Intervention, will result in greater improvements in primary and secondary outcomes at 3 and 6 months post-baseline. RESEARCH PLAN Study design: Assessor-blinded randomised controlled trial. Men randomised to one of three study arms: (i) Resources (ii) Online (iii) Wait list. Participants - Overweight/obese men (BMI >25 <40kg/m2) aged 18 to 65 years. Intervention Descriptions: (i) WL Resources (Information and self-help control) resource package includes: DVD on weight loss in men; program booklet; calorie counter. (ii) WL Online (Basic + Internet behavioural therapy): ‘WL Basic’ resources plus access to study website; website user manual; individualised online feedback. Outcomes: At baseline, 3- and 6-months: weight, waist circumference, BMI, fat free mass, dietary intake (FFQ), physical activity (pedometers), sedentary behaviours, blood pressure, perceived physical/mental health (SF-12), demographics & SES. Analysis: Linear mixed models to assess all outcomes for the impact of treatment, time and the treatment by time interaction, with these three terms forming the base model.

Psoriatic arthritis (PsA) is a type of inflammatory arthritis that presents with erosive joint disease (which may lead to joint deformity) and a psoriasis rash on the skin. It is considered an auto-immune disease which means that the person's own immune system is responsible for the disease. Within the blood of patients with PsA, there are lots of proteins called Inter-Leukin-17 (IL-17). These are inflammatory messengers, which cause inflammation. These messengers tell the body that the inflammation process should occur. RO5130074 is an anti-body against IL-17 messangers. It is also a protein, and it binds to IL-17 making it inactive, and therefore stopping the inflammation process. This study will aim to look at the safety and how well RO5130074 is tolerated in the body of patients with PsA. Nonclinical data supporting IV administration of RO5310074 to humans were obtained from one single-dose and two repeated-dose studies in cynomolgus monkeys. RO5310074 was previously tested clinically in the Roche study PP22712 (a single assending dose study), to assess the safety and tollerability in healthy patients. All doses were well tolerated, with no drug-related, clinically significant adverse events (AEs) reported.

The aim of this project is to assess how accurately we can predict what the level of Propofol is in the blood. We will be assessing the accuracy of two paediatric pharmacokinetic algorithms (Paedfusor and Kataria) that are designed to deliver Propofol at a specific blood concentration. The two different programmes deliver the Propofol at different doses according to the target blood level, age and weight. We will do this by comparing measured arterial plasma concentrations of Propofol (cm) with concurrent predicted (cp) plasma levels.

Our project objective is to evaluate a program that will engage children and their parents to adopt positive behaviours relating to healthy eating. The intervention is a family focussed approach to be implemented in an after-school setting. We will evaluate its effectiveness as a childhood obesity prevention program for children.

This study looks at the role of exercise in improving the quality of life in prostate cancer patients commencing treatment with the drug Lucrin. Who is it for? You can join this study if you are a man with prostate cancer which has not spread to distant sites (metastases) and you are about to begin therapy with the hormonal treatment Lucrin. Trial details: Participants will be divided into two groups. One group will take part in progressive supervised resistance & aerobic exercises (e.g. upper and lower body resistance-based exercise using weight machines as well as aerobic exercise including walking, jogging, cycling and rowing) twice weekly (60 minutes session) for 12 weeks. The second group will receive usual care only for 12 weeks and then will take part in the 12 week exercise program. Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Physical and muscle function, body composition and psychological distress will also be assessed.

The treatment known as selective internal radiation therapy, or SIRT has been used in human patients since 1998 for the treatment of liver cancer. This study will be the first time that SIRT treatment has been used in human patients for the treatment of kidney cancer. The primary purpose of this study is to test the safety of SIRT as a treatment for patients with kidney cancer (also known as renal cell carcinoma) that is not suitable for treatment using the standard treatment options available. While SIRT treatment has been used for over a decade to treat liver cancer, it has not been used before to treat kidney cancer. In this study, four separate groups of patients will be entered into the study. The four groups of patients will each receive a certain dose of selective internal radiation therapy for their kidney cancer. The dose of radiation will start with a low dose in the first group of patients. The dose of radiation will then proceed to successively higher doses of radiation for patient groups two, three and four, if it has been shown safe to do so. SIRT treatment uses SIR-Spheres microspheres, which are tiny beads about a third the width of a human hair that emit radiation that is designed to kill tumours. Millions of SIR-Spheres are injected by a specially trained doctor known as an Interventional Radiologist into the blood vessel(s) that supply blood to the tumours. After being injected into the blood vessels that supply the tumours, the SIR-Spheres lodge in the tiny blood vessels of the tumour, where they emit their radiation directly into the tumour, with the aim of destroying the tumour.

More than 50% of all Caucasian Australians will develop non-melanoma skin cancer (NMSC) during their lifetime, and more than one in 30 will develop melanoma. Ultraviolet radiation (UVR) from sunlight is the major cause of NMSC. In humans, both the ultraviolet A (UVA) and ultraviolet B (UVB) wavebands cause immunosuppression and DNA damage and therefore both UVA and UVB are likely to contribute to induction and development of NMSC. Broad-spectrum sunscreens, which filter both UVB and UVA can reduce UV immunosuppression, but sunscreens are generally much better at preventing sunburn than immunosuppression. As immunosuppression can occur with less than half the amount of UV needed to cause sunburn, the immune protection afforded by sunscreens “in the field” is likely to be low. Oral nicotinamide (vitamin B3) is available as an over-the-counter vitamin supplement and has been effective for over 50 years in the treatment of autoimmune and inflammatory skin disorders including bullous pemphigoid and rosacea. Unlike nicotinic acid, nicotinamide does not cause significant vasodilation or flushing and has few or no potential side effects. The most commonly used dose in autoimmune blistering disorders is 1500mg daily, with these patients often taking nicotinamide for several months. Adverse effects are exceptionally rare at these doses. In mice, nicotinamide reduces skin cancer numbers by 60% when applied as a 2.5% lotion. Our group has demonstrated that nicotinamide lotion completely prevents UV immunosuppression when applied in a double-blinded placebo-controlled manner to the backs of healthy human volunteers. We subsequently found that oral nicotinamide was also immune protective in healthy, Mantoux-positive volunteers, without adverse effects, at doses of either 500mg daily or 1500mg daily. Recently, we tested topical 1% nicotinamide on numbers of actinic keratoses, and found a significant reduction in numbers of keratoses at 3 months compared to placebo. We now plan to assess the effects of oral nicotinamide at an intermediate dose (500mg daily) on AK numbers. We hypothesise that nicotinamide will be well-tolerated, and could be used together with sunscreens to reduce UV immunosuppression and potentially treat or prevent actinic keratosis, premalignant lesions which act as a surrogate marker for squamous cell skin cancers.

Intensive care units (ICU) provide treatment and care to critically ill patients. Frequently, invasive monitoring and intrusive treatments delivered via artificial airways are required, which limit the ability to communicate. These factors, symptoms of illness and the busy environment may lead to discomfort, in particular the inability to sleep. The adverse health effects of poor quality sleep are understood and ICU patients are in greater need of sleep. Therefore, the aim of this study is to minimise sleep disruptions and improve the quality and quantity of ICU patients’ sleep. Thirty intensive care patients’ sleep has been measured using a portable sleep monitor. Simultaneous records were made of interruptions to the patients’ sleep and sound and light levels. The results from the first group have been discussed with ICU health care personnel who have decided which sleep promoting practices to implement, i.e. organisational and behavioural changes, such as blocks of uninterrupted time and noise reduction. Sleep data will be collected on a further thirty patients to assess the effectiveness of these interventions. No studies of this type have been conducted in Australian ICUs and few published studies have been performed with the purpose of improving sleep for ICU patients. This study is a unique opportunity to obtain data on ICU patients’ sleep in Australia using the most objective measure available, polysomnograph. It also has the potential to provide data on the effectiveness of sleep promoting activities.