ANZCTR search results

Alcohol Use Disorder’s (AUD’s) are a growing burden on Australia’s health care system due to associated cardiovascular and gastrointestinal disease, cognitive deficits, insomnia, suicide and other drug abuse, and have illustrated significant co-morbidity with anxiety. Additionally, anxiety is a strong motive for self-medication with further alcohol use, especially during initial detoxification. A major obstacle in AUD treatment is the significant delay in access to treatment, and motivating patients to continue treatment throughout alcohol detoxification and its associated anxiety. The effectiveness of a self directed cognitive behavioural therapy booklet allowing immediate access to treatment to manage anxiety during AUD treatment will be tested in the current study.

Background Patent foramen ovale (PFO) is a communication or “hole” between 2 chambers of the heart – the right and left atria. A PFO is present in approximately 25% of the population. PFOs can cause strokes, decompression illness in divers, and migraine headaches. Doctors sometimes recommend that a PFO should be closed if these problems occur. The usual technique for closing a PFO is to implant a metal and fabric “plug” known as a “closure device” to seal or plug the PFO. In general this is a safe and effective technique (with a success rate > 95%) but there are some risks and disadvantages with the use of the closure device. Some of the disadvantages and risks include leaving a foreign object in the body forever, a risk of the device eroding into surrounding tissue occurring in about 1 in 1000 cases (e.g. into a blood vessel or heart valve), a risk of the device dislodging in about 1-3 in 100 cases (which may require urgent open heart surgery), risk of the heart beating very slowly in 1-5 in 100 cases (which may require a pacemaker), risk of clot forming around the closure device in 1-2 in 100 cases (which may lead to stroke), and risk of infection. In addition, the closure device prevents subsequent trans-septal puncture which might be required for treatment of arrhythmias or mitral valve disease should these develop in later life. We aim to test new technique to close PFOs. This technique aims to close the PFO without the use of a closure device, and may be safer and cheaper. The technique involves the use of electrical current to “glue” the edges of the PFO together. Recent studies report that this new technique is safe and has success rates of up to ~90% of cases in carefully selected patients with PFO tunnel diameter < 4mm (Sievert et al. Circulation 2007; Walpoth et al. Swiss Med Wkly 2008; Sievert et al. Cath Cardiovasc Interv 2009; Di Biase et al. ACC 2010 Abstract). The total number of patients recruited from these 4 studies totalled 200, with only 2 patients suffering from significant blood loss (and only 1 requiring blood transfusion) as a result of this new technique. There were no other serious adverse complications such as stroke or heart perforation reported. The mean procedure time reported in these studies was between 30-50 mins, which is comparable to PFO closure using the standard technique. 3 of these studies (involving 190 patients in total) used a proprietary radiofrequency ablation catheter with vacuum suction, and 1 study (involving 10 patients) used a standard radiofrequency ablation catheter. In addition, because of similar procedure times, the radiation exposure is not anticipated to be higher as a result of the research study. In fact, we anticipate that the calculated X-ray exposure is likely to be less than the current technique for PFO closure. Aim We aim to test this new technique for closing the PFO without the use of a closure device. Potential Significance This new technique may be safer than PFO closure using the closure device. In addition, it will also be considerably cheaper (approximately $2500-$3000 vs $7500-$9000).

Diabetes is common after renal transplant and gliclazide is often used as a first line treatment. The objective of the trial is to show that Vildagliptin can be safely used to control hyperglycaemia, with less hypoglycaemic episodes than its comparator of Gliclazide. 48 participants will be randomly allocated to either the intervention arm of oral tablets of 50mg once daily or twice daily of vildalgliptin or to the comparator arm of oral tablet 60mg Gliclazide modified release once daily. The patients will be followed for 16 weeks to assess for hypoglyacaemic episodes and safety.

RHD is a priority health issue for Aboriginal and Torres Strait Islander people and improving delivery of secondary prophylaxis is the major outstanding deficiency in our current attempts to control this disease. Surprisingly this topic has never been researched to any substantial extent. This project hypothesises that a package of interventions, primarily aimed at enhancing effectiveness and efficiency of service delivery for RHD at the primary health centre level, will increase the proportion of clients receiving 80% or more of their SP injections, which will translate to reduced recurrences of ARF, and reduced severity and, eventually, prevalence of RHD.

Mandibular Advancement Devices (MAds) are an established treatment for OSA however it is not widely used in people with quadriplegia. This project will assess the feasibility of MAds in people with quadriplegia.

Ectopic pregnancy is an unpredictable, non-viable and potentially life-threatening condition caused by ectopic (abnormal) implantation of an early embryo into the Fallopian tube instead of the uterus (womb). Ectopic pregnancy occurs in about 2% of pregnancies in Australia. Recent research by our group and others has suggested possible reasons for the embryo failing to implant in the correct place in ectopic pregnancy. To allow us to study this further, we are setting up a bank of stored Fallopian tube tissue collected from women who are having the tube removed as treatment for an ectopic pregnancy. To study possible causes of miscarriage and infertility we will compare affected Fallopian tubes to healthy Fallopian tubes obtained from women who are having operation for non-malignant disease or tubal ligation. A Fallopian tube removed during surgery is not usually kept once it has been examined for diagnosis. We have set up a process by which we can collect and appropriately store the tissue after it is examined by the pathologist. The Biobank of human Fallopian tubes, a repository of disease-specific human samples will promote cutting edge biomedical research in the area of fertility, early embryogenesis and implantation, human reproduction, and carcinogenesis by decreasing reliance on animal models and allowing open access to human samples for scientists. The open access Biobank of human Fallopian tubes will facilitate data dissemination and will help to generate more studies refining methodologies in human research.

Active gaming technologies are rapidly evolving and increasingly being used in therapeutic environments. The current range of commercially available software is of limited use in the context of stroke rehabilitation. This research study will investigate the safety, feasibility and effectiveness of a suite of customised gaming activities in a stroke population. We hypothesise that the gaming activities will be safe and feasible to use in a stroke population and will improve physical outcomes when used in additional to usual care.

The primary purpose of this study is to determine if panobinostat maintenance in patients with multiple myeloma (MM) who have failed to achieve complete remission (CR) following high-dose chemotherapy conditioned autologous stem cell transplantation (ASCT) will lead to an increased/improved rate of conversion to CR or very good partial response (VGPR). You may be eligible to join this study if you have previously been treated with a thalidomide, and/or lenalidomide and/or bortezomib containing induction regimen pre-ASCT. Participants in this trial will receive the oral drug panobinostat at a dose of 45mg three times per week every other week as part of a 4-week (28 day) treatment cycle. You will be treated for 6 cycles and then assessed for response. If after 6 cycles you have not achieved a very good partial response (VGPR) or CR, your panobinostat treatment will cease. If, however, you have achieved the required response, you will continue on panobinostat until disease progression or unacceptable toxicity.

This study aims to evaluate the effect of changing the current model of care in 15 BUPA nursing homes, to a model that employs GPs directly within the homes, in terms of resident health and healthcare resource use outcomes (primary outcomes: polypharmacy, unplanned hospital transfers, general practitioners’ out of hours calls). Nursing homes in four states and in metropolitan and regional locations will be inducted into the program in a randomised and step-wise order, with seven weeks of preparation in the facility before the GP is employed. It is envisaged that employment of GPs will improve several important factors, including medical access and care for residents; increased satisfaction to residents and relatives of residents; reductions in medical costs associated with aged care; improved job satisfaction for employees with subsequent decreased turn-over rates and absenteeism.

We know that after an acquired brain injury (ABI), a number of adolescents experience increased levels of anxiety. So far, very little research has looked at the ways we can help young people with ABI overcome these difficulties and improve the way they are able to get along with others at school, home and in the community. Our aim is to trial a program for managing anxiety for adolescents with ABI. The program incorporates cognitive behaviour therapy which previous research has shown to be helpful for adolescents who do not have brain injury. Components of the program have been especially adapted for young people who may have cognitive difficulties associated with TBI (e.g., memory impairments). This study aims to evaluate this adapted program for managing anxiety in a sample of young people who have had an ABI. The program aims to reduce anxiety and increase levels of participation in everyday activities of young people following ABI. If effective, the program used in this trial will be developed into a manual thereby allowing for applicability of the program in a range of therapeutic settings.