ANZCTR search results

The primary objective is to evaluate the effectiveness of DHA versus placebo and compare the difference between DHA and EPA on the symptoms of depression. Effectiveness will be measured by the mean change in total scores on the HAM-D from baseline to double-blind end point at week 8. Patients with a 50% reduction in HAM-D scores or who have a score equal to or less than 8 will be considered to be in full remission whilst patients with a score of 12 or less will be considered to have improved; (from baseline to Week 8 or dropout). A secondary aim of the study will be to compare the levels of BDNF at baseline and at the completion of the double-blind phase of the study in the patients treated with DHA versus the comparator EPA and placebo. An additional aim will be to measure the change from baseline in cognitive functioning using a brief cognitive battery which assess 5 cognitive domains. Mean change from baseline scores to week 8 will also be used to measure patients Global Assessment of Functioning, sleep and levels of suicidal ideation using Item 3 on the HAM-D.

This study aims to implement and evlaluate an internet-based cognitive-behavioural therapy program for females with sexual dysfunctions. It is anticipated that this study will increase treatment success and lower attrition rates by addressing the limitations of previous internet-based interventions and incorporating mindfulness techniques. Evaluation of the program will be conducted using data collected at pre-treatment, post-treatment and at a 3-month follow-up. A waitlist control group will be included for comparisons. This study will help to determine the efficacy of internet-based treatment options for female sexual dysfunctions and further elucidate the role of mindfulness in female sexual dysfunction interventions.

The hypothesis is that in humans dietary omega-3 fatty acids and aspirin augment the formation of the potent anti-inflammatory metabolites resolvins and protectins. We aim to measure resolvin and protectin levels in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin;

Muscle relaxants are the most common cause of allergic reactions in patients having an anaesthetic. One of the most commonly used muscle relaxants is rocuronium. Recently sugammadex has been made available that reverses the effects of rocuronium by encapsulating the drug and preventing it binding at the neuromuscular junction. No one knows the role of sugammadex in someone who has developed an allergic reaction to rocuronium. It is our hypothesis that when sugammadex is combined with rocuronium the allergenic component of rocuronium is covered. If this is true sugammadex may play an important role in the management of patients who have developed an allergic reaction to rocuronium. We will investigate this by skin testing rocuronium alone and the combination of rocuronium and sugammadex in patients who are rocuronium allergic. We will see the effect on skin testing of the combination of the two drugs. Should the combination cause a negative skin test one could conclude that the allergenic component of rocuronium has been covered by the sugammadex.

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.