ANZCTR search results

AIM: The aim of this study is to assess the safety, feasibility, and efficacy of using vascular isolation chemotherapy to deliver treatment directly to the pancreas, bypassing the main blood supply throughout the body. WHO IS IT FOR? You may be eligible for this study if you are aged over 18 years, have proven locally advanced unresectable adenocarcinoma of the pancreas, and have received no prior systemic chemotherapy. Study details Once enrolled, patients will have baseline scans and will have the AVAS device implanted. The patient will be admitted to hospital up to twice per 10 day period to be treated with the pancreas directed therapy until they have received up to 12 treatments of gemcitabine + oxaliplatin, after which the device will be explanted. Gemcitabine is approved in Australia as a chemotherapy treatment for pancreatic cancer. Oxaliplatin is a component of the FOLFIRINOX regimen, which is approved in Australia for the treatment of metastatic pancreatic cancer. Neither agent has been approved for intra-arterial infusion to the pancreas using the study method and AVAS device.The patient’s tumour will be scanned 4-6 weeks after the final infusion, and the patient will be followed up for 12 months. The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to locally advanced pancreatic adenocarcinoma whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.

To assess the capacity of a vigilance promoting agent (modafinil) to ‘perpetrate’ metabolic drug interactions that may lead to adverse effects.

This research examines the utility of Let’s Talk About Children intervention for its application in Australian mental health services. The objectives of the project are to determine the effectiveness of the ‘Let’s Talk’ program, an innovative, evidence-based program which involves training clinicians in talking to mental health clients about their children. The research will investigate the impact of Let’s Talk on parenting confidence and family functioning along with aspects of recovery (e.g. self worth, relationships, independent living) and quality of life, as compared to a control group receiving standard treatment.

Conditions of temporary glucose intolerance - such as gestational diabetes - identify people who are at risk from subsequently developing type 2 diabetes. This is important as the prompt diagnosis of glucose intolerance allows earlier treatment and a consequent reduction in complications associated with prolonged and untreated hyperglycaemia, dyslipidaemia and hypertension. The possibility that critical illness-associated hyperglycaemia (CIAH) could be a risk factor for subsequent type 2 diabetes has only been evaluated in one study. This study however has substantial limitations, which severely restrict interpretation of these data. If CIAH is a risk factor for development of type 2 diabetes, and the mechanisms underlying any glucose intolerance elucidated, survivors could be screened for diabetes and prompt appropriate therapy instituted.

The aim of this pilot study is to investigate whether pelvic floor muscle relaxation by maintaining the epidural infusion in the second stage of labour may reduce maternal birth trauma. The primary outcome measure will be pelvic floor trauma namely perineal tears, vaginal tears, anal sphincter injuries and levator ani avulsions. Secondary outcome measures include the length of first and second stage of labour, rate of instrumental delivery and caesarean section, and the clinical efficacy (analgesia, motor and sympathetic block) of the two epidural regimes to be tested. RESEARCH HYPOTHESES 1. Maintenance epidural infusion of 0.2% Ropivacaine + Fentanyl 2microgram/ml throughout the second stage of labour can reduce pelvic floor trauma. 2. Maintenance epidural infusion throughout second stage does not increase duration of labour, rate of instrumental and operative delivery. 3. Maintenance epidural infusion throughout second stage of labour provides effective analgesia with a low complication rate.

Gabapentin and pregabalin are anticonvulsants used in the management of both acute and chronic pain. They offer a potentially useful analgesic adjunct to women in the post-partum period. However, there is limited information about the transfer of these drugs in to breast milk which has lead to safety concerns over their use in breastfeeding mothers. By assigning post-partum mothers not intending to breastfeed to receive a dose of either gabapentin or pregabalin, measurements of plasma and breast milk concentrations can be made without risk of drug transfer to the newborn. This data will then be used to create pharmacokinetic models to estimate absolute and relative infant doses if used in breastfeeding mothers.

This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life, physical activity, and a range of potential mediators of physical activity among adolescent girls living in low-socioeconomic rural and regional settings.

The Nintendo Wii console has been shown to provide both physical and cognitive benefits for the elderly. Playing Wii in groups can also provide an opportunity to interact with others, which may in turn encourage relationships to form. These relationships are based on shared interests and activities. This research aims to investigate the mental health of elderly nursing home residents who are encouraged to participant in group activities involving the Wii console, compared with elderly residents with no intervention. A sample of approximately 40 elderly adults aged 65 years and older who are currently living in a residential nursing home will be assigned to either the intervention group) or a control group (no intervention) based on their place of residence. Participants will complete a mental status examination eligibility questionnaire to determine if they have dementia or other health concerns preventing the use of the Wii. Demographics information, self-rated health scale, geriatric depression scale, social support provisional scale, intervention expectancy scale and three visual analogue scales measuring sense of belonging and mood will also be completed. The scores received on the Wii and time spent playing will be recorded by the residents. Residents will be invited to participate in a qualitative interview at the end of the intervention. The results will provide a theoretical basis for future cost effective intervention programs to be implemented in nursing homes.

To characterize the pharmacokinetics (PK), safety, and tolerability of sublingually administered esketamine hydrochloride from IPX237 at two dose strengths, and to evaluate the effect of formulation retention in the sublingual space.

Obstructive sleep apnoea (OSA), a sleep disorder that results in hypersomnia and sleep fragmentation, is identified as a possible risk factor for cognitive decline in the elderly. Although the occurrence of OSA in certain neurodegenerative disorders, particularly Alzheimer’s disease (AD), has been examined, its role and impact in patients with mild cognitive impairment (MCI) - a group 'at risk' of dementia progression - is yet to be established. Continuous positive airway pressure (CPAP) treatment has been shown to decrease sleep disturbance in patients with AD and OSA over periods of up to three weeks, and positive effects on global cognition, executive functioning and psychomotor speed have been observed. However, there are no known studies examining the efficacy of CPAP on cognition in MCI. Thus, if it is possible that OSA is identified and treated early, cognitive decline could be slowed or ameliorated. We hypothesise that CPAP will be associated with superior cognitive functioning in the domains of processing speed, memory and executive function, than compared to no treatment with CPAP.