ANZCTR search results

Experiments in animals and research data in humans strongly suggests that IL-17A is involved in the formation of joint inflammation in rheumatoid arthritis. The primary purpose of this study is to establish the safety of blocking the effects of IL-17A with SCH 900117 in healthy subjects and in patients with rheumatoid arthritis.

Apomab is a monoclonal antibody, which is a type of protein that is normally made by the immune system to help defend the body from infection and cancer. In preclinical studies Apomab selectively induced programmed cell death, or apoptosis, in cancer cells while sparing normal cells. Apomab is being studied in this clinical trial in combination with Rituximab to evaluate whether it is safe for patients with follicular NHL and whether it can delay the further spread of follicular NHL.

Fatigue is one of the most troublesome symptoms of many neurological conditions, including multiple sclerosis. It is also one of the least well managed by medication. Self-management programs provide people with chronic conditions with information, problem-solving skills and strategies to manage life with a chronic condition. This includes not only management of the symptoms but also the emotional consequences of living with a chronic condition and the day to day roles and responsibilities. Self-management interventions assist people with chronic conditions to manage their symptoms and retain a higher level of quality of life and activity participation. This study will test a novel way to manage fatigue secondary to multiple sclerosis. While the only evidence-based fatigue self-management program (Packer et al., 1995) is offered face-to-face in some parts of Australia, most Australians cannot access it. Therefore the aim of this study is to evaluate the effectiveness of an online fatigue self-management group intervention in comparison with a face-to-face group and a control group on quality of life, activity participation and fatigue impact on life among a sample of adults with multiple sclerosis. If effective, people with MS in Australia will have available an evidence-based intervention, accessible to people who face transportation barriers, the tyranny of distance or inability to attend at set times.

The incidence of mental illness in young people is the highest of any age group, with the onset of high prevalence disorders such as depression, anxiety and substance use peaking within the age range of 15 to 24 years. In this age group, disorders are likely to be emerging or sub-threshold, with a definitive diagnosis often difficult to make. This creates specific challenges for young people in terms of accessing appropriate youth-specific programs, treatment options, or services. Early intervention in youth mental health aims not only to prevent the progression of a disorder but importantly to reduce the likelihood of ongoing problems with social, education, and vocational functioning. Given that mental health issues are likely to be in the early stages of disorder in this age group, it is essential that any intervention is simple yet effective and delivered in the least threatening environment. For example, milder disorders in an early stage may respond to simple measures such as psychosocial support and psychoeducation. The proposed research aims to assess whether emerging mental health disorders in young people aged 15-25 respond to simple interventions delivered in an enhanced primary care setting. Approximately 160 young people will be randomised to receive a combination of the following treatment packages for 6 weeks: 1. Psychosocial – Problem Solving Therapy (active condition) or supportive counselling (control condition) 2. Exercise – behavioural intervention (active) or psychoeducation (control). Clinical measures will be taken at baseline, midpoint, endpoint, and at 6 and 12 month follow-ups. The clinical data will be measured by a range of questionnaires assessing symptoms and functioning. As the current project is exploratory in nature, hypotheses will be stated as primary and secondary aims. Primary aims 1. To evaluate whether preventively-oriented, simple treatments are acceptable and effective treatments for managing emerging mental health disorders in young people and if so, 2. Which interventions (or their combination) are most effective for various types or severities of clinical presentations Secondary aims 3. To characterise diagnostic issues in emerging or subthreshold disorders by identifying symptom and demographic clusters which predict mental health trajectories 4. To identify possible markers in those who are likely to respond to less-complex interventions.

Our previous research indicates that the Shyness Program, an Internet-based treatment program for people with social phobia, is effective at helping people to learn to manage their symptoms of social phobia. This trial is to assess whether a similar approach to Panic Disorder would be as effective. CBT is well recognised as the treatment of choice for Panic Disorder and trials of internet based CBT have been shown to be effective, however they tend to have high drop out rates. We aim to see if retention is improved by addition of a clinician and if this treatment is effective.

This is a preliminary study to test methodology for a large intervention trial to be conducted later. This study aims to determine whether participants can be adequately blinded in a study where decaffeinated coffee and caffeinated coffee are the intervention and control conditions. In this study, participants will be randomized to receive either caffeinated or decaffeinated coffee, and be provided with enough coffee for a week. Participants will be asked to replace their regular coffee with the study coffee for one week, and refrain from consuming any other forms of caffeine (tea, cola, chocolate etc). They will not be told which coffee they are drinking, and, at various times throughout the week, they will be asked to guess what coffee they are drinking.

The key objective of the current study was to address the shortcomings of previous universal eating disorder prevention programs by evaluating in a methodologically rigorous manner if a theoretically-informed prevention program (media literacy) can be effective in reducing eating disorder risk in a controlled trial with a universal, young-adolescent, mixed gender audience.

The primary purpose of the study was determine the influence of antenatal educational sessions on second stage of labour. the aim being to test the effectiveness of structured antenatal education for pushing in the second stage of labour versus normal care and its impact on delivery outcome.This study has been completed and submitted for publication

Pressure ulcer development is a significant risk for hospitalised patients and health care facilities. Pressure ulcer related costs in Australia have been estimated at $285 M per annum. Preventative measures are generally based on estimating the patient’s risk, using screening tools such as the Waterlow scale. Despite the widespread use of the Waterlow scale as an intervention to prevent pressure ulcers, its effectiveness has never been tested using rigorous methods. We propose to conduct a three group, single centred randomised controlled trial to compare the Waterlow Scale, with a simpler, one item measure; and with clinical judgement. We will also investigate risk factors for pressure ulcer development in an acute hospital setting.

The transversus abdominis plane (TAP) block is a local anaesthetic technique that has been developed in recent years for pain relief after abdominal surgey. It has been shown to work after caesarean delivery when performed by skilled operators. We aim to test an ultrasound guided approach to this block for pain relief after caesarean section. Women having elective caesarean sections will be randomly allocated to receive an ultrasound guided TAP block with local anaesthetic or placebo in addition to standard pain relief including morphine. We hope to find women who receive the local anaesthetic have better pain relief, need less morphine and have fewer side effects from morphine after caesarean section.