ANZCTR search results

This project aims to investigate if chewing gum will increase circulating nitrite and nitric oxide and if these effects are associated with cognitive and vascular benefits.

This study looks at whether testing for 'biomarkers' may be used to select the best treatment for patients with metastatic pancreatic cancer. A biomarker is a biological characteristic that can be measured in tumour tissue or blood, which may provide information on the behaviour of cancer or help predict the likely effect of a given treatment. We know that not all cancers or patients are the same, and that some patients may respond better to certain treatments. This study will help increase our understanding of how we might be able to select treatments to suit individual patients and their cancers. By doing this we hope to obtain the best outcomes for future patients while minimising side effects from treatment. Who is it for? You can join this study if you have radiologically and histologically confirmed metastatic pancreatic adenocarcinoma, confirmed by biopsy. This is a phase II multicentre, randomised, open label study to evaluate biomarker directed treatment of metastatic pancreatic cancer. Trial Details Participants will be in two groups. Group 1 will receive Gemcitabine, and Group 2 will receive a combination of Oxaliplatin, Leucovorin and 5-fluorouracil (mFOLFOX6). Treatment will continue as long as it seems to be helping, provided participants do not have troublesome side effects. Through this study we hope to gain information about the following: 1) Can testing for hENT1 help us to identify patients who are more likely to benefit from initial treatment with gemcitabine chemotherapy? 2) Is it possible to do the tests in patients quickly enough to enable use in routine clinical practice? 3) How effective is FOLFOX chemotherapy as treatment for metastatic pancreatic cancer? 4) Are there any other biomarkers in cancer cells or blood that may help us determine the best drug to use against an individual cancer? This randomised phase II exploratory study is vital in understanding the optimal design of future studies evaluating this novel approach to the management of pancreatic cancer, and may be expanded to a phase III study if this approach is validated.

This study will examine the safety and pharmacokinetics (the study of the way the body absorbs, distributes: and gets rid of the drug) of AA4500 following concurrent administration of two injections of AA4500 0.58mg into the same hand of subjects with Dupuytren's contractures and palpable cords.

BMS-943539 is a non-therapeutic Adnectin (Trademark) with binding affinity for human serum albumin (HSA). It is intended to serve as an albumin binder to extend the serum half-life (T-HALF) when integrated into a single polypeptide chain with a separate therapeutic Adnectin or other protein that would otherwise be rapidly eliminated. Cohorts of subjects will be treated with 0.1, 0.3, or 1.0 mg/kg BMS-943539 or placebo once every two weeks for a total of two drug administrations.

6 month observational study in general practice using a diabetes educator program to initiate and titrate insulin

The aim of the study is to evaluate cognitive-behaviour therapy (CBT) for adolescents with delayed sleep. It is hypothesised that CBT will result in more night-time sleep and fall asleep earlier.

Bone loss occurs at an accelerated rate in women after the menopause. This has been attributed to reduced calcium absorption in the gut and increase excretion of calcium in the urine. This bone loss may be greater in those on low calcium diets compared with those on high calcium diets. This has been shown in animals and some human studies have been able to link low lumbar spine density to low calcium diets.

Headache is a common condition associated with significant socio-economic impact and reduced quality of life (Schwartz, Stewart, Simon & Lipton, 1998). Cognitive Behavioural Therapy (CBT) is an effective treatment for headache, however it has several limitations, precluding it’s successful use in many headache sufferers (Fumal & Schoenen, 2008). Particularly, CBT requires considerable time for both therapist and patient, and encourages avoidance rather than coping with headache, which may increase sensitivity to headache triggers and aggravating factors (Martin, 2001). Brief mindfulness based therapy (BMBT) is an emerging behavioural intervention not subject to the above limitations of CBT. Several reports support the efficacy of BMBT in reducing pain and improving functioning in chronic pain conditions such as back pain (Morone et al 2008), fibromyalgia (Creamer et al 2000) and groups of heterogeneous chronic pain sufferers (Kabat-Zinn et al 1985; Kabat-Zinn et al 1986; Kabat-Zinn 1982). BMBT has also been shown to reduce acute pain sensitivity in healthy subjects (Creamer et al 2000, Zeiden et al 2009). This is particularly relevant to headache, in which increased pain sensitivity is a common finding, and thought to be of pathophysiological significance (Cathcart et al 2009). We recently demonstrated that headache is triggered by factor aggravating the already increased pain sensitivity in headache sufferers. Despite the potential benefits of BMBT for treating headache, the efficacy of BMBT as an intervention for headache has not been reported to date. BMBT may reduce headache by inhibiting increased pain sensitivity in headache sufferers. The present project therefore examines effects of BMBT on headache activity and pain sensitivity in frequent headache sufferers.

This project sought to determine whether specialist mental health consultation was more effective in treating the depressions of aged care residents with dementia than standard care. We screened 389 aged care residents for dementia and major depression. Forty-four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were allocated to an intervention condition involving the provision of multidisciplinary specialist consultation surrounding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and General Practitioners (GPs). All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia (CSDD). This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. We found that specialist mental health consultation was significantly more effective in treating the clinical depressions of aged care residents with dementia than care as usual. At follow-up, the majority of the intervention group no longer met criteria for major depression, nor did they score above critical values on the CSDD. These results suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation.

The aim of this project is to compare the effect of home-based exercise plans and telephone follow-up to a 12 month gym program with health professionals. 114 participants will be recruited from Southern Health’s community-based health programs in Melbourne’s south east, following their participation in health service based exercise program. Participants will have at least one risk factor for readmission that include: multiple co-morbidities, impaired functionality, aged 65 and over, recent hospital emergency department admissions, poor social support, and history of depression. Base-line data will be collected upon participant recruitment that include: demographics, health and medical history (obtained from the clients’ health record), endurance and strength will be assessed. Outcome measures include: health-related quality of life, depression scale, social isolation, health and labour questionaire, health care utilisation, endurance and strength tests. Participants will then be randomly allocated to either a control group or intervention group. The control group will receive the usual care, a 12 month home exercise program with telephone follow-up. The intervention group will involve a 12 month individualized gym-based exercise program supervised by an exercise physiologist from the health service. At 3 months post-discharge, participants will be re-assessed over the telephone (survey instruments only). At 6 months post-discharge, the participants will be re-assessed on both survey instruments and physical capacity tests for endurance and strength, health related quality of life, depression, social isolation, At 9 months post-discharge, participants will be re-assessed over the telephone (survey instruments only). At 12 months post-discharge, the participants will be re-assessed on both survey instruments and physical capacity tests for endurance and strength, health related quality of life, depression, social isolation.