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A paired double blind randomised comparison of Cavilon TM Durable Barrier Cream TM (CDBC) to 10% Glycerine ('Sorbolene') Cream in the prophylactic management of post-mastectomy irradiation skin care
This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene.
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Programme to Improve Life and Longevity Pilot
Cardiovascular disease (CVD) is the leading cause of hospitalisation and premature death in many countries globally. One of the most hotly debated issues in clinical research is whether a “polypill” (a new combination medication containing aspirin and agents to lower blood pressure and cholesterol) can really reduce cardiovascular disease by three-quarters or more. This clinical trial will assess the safety and tolerability of a polypill, and its effects on blood pressure and cholesterol in people at increased risk of CVD.
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Improving Treatment for Headache by Helping Sufferers Enlist Support from Family and Friends.
Research has shown that individuals suffering from recurrent headaches have inadequate social support. Research results suggest that it should be possible to increase the effectiveness of headache treatment for individuals who have inadequate support by specifically helping them to increase the size of their social networks and to derive more support from their networks. The proposed study compares a pychological treatment (cognitive behaviour therapy) with a focus on social support, with the same treatment given for the same number of sessions but without a focus on social support. It is predicted that the former approach will work best for individuals with inadequate social support and the latter approach will work best for those with adequate social support. Tension-type headaches are the most common type of primary headache and have the highest socioeconomic impact. The study results will have important implications for our understanding of how tension-type headaches can be managed.
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A randomised trial investigating the effect on biomedical (PSA) control and survival of different durations of adjuvant androgen deprivation in association with definite radiation treatment for localised carcinoma of the prostate (RADAR)
Six months of hormone treatment improves the results of radiotherapy for men with early prostate cancer. This trial will determine if adding another 12 months of hormone treatment after radiotherapy is even better. Bones are often affected by prostate cancer and can also be damaged by prolong hormone treatment. Bisphosphonates are drugs that make bones stronger. This trial will also determine if treatment with a bisphosphonate can help prevent these bone problems.
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ANZ 8613: A Phase III trial to evaluate additional versus substitution endocrine therapy in advanced breast cancer
The proposal in this protocol is to determine (in patients with advanced breast cancer) whether it is better, at disease progression, to continue the policy of substituting the original therapy with a replacement; or alternatively to continue the original treatment and add the new therapy to it, since the existing therapy may be controlling some previously active disease sites.
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ANZ 8614: A phase III randomised trial of mitozantrone versus CMFP (cyclophosphamide, methotrexate, 5-flourouracil, prednisone) in advanced breast cancer – a quality of life study
In this protocol, mitozantrone as a single-agent will be compared with combination CMFP chemotherapy as initial chemotherapy in patients with advanced breast cancer. At the point of disease progression, patients will cross over to the other treatment arm. Comparison of treatment arms will be evaluated in terms of time to disease progression, overall survival, quality of life, toxicity and objective response rates. The design of this study allows the primary objective of determining optimal use of existing therapies with particular emphasis on improving quality of life.
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Randomised control trial of monoamine precursors for the treatment of psychostimulant withdrawal
The study aims to: identify the safety and acceptability of monoamine precursor provision in the management of psychostimulant withdrawal; explore the impact of monoamine precursor provision on engagement and retention in treatment; research the effect of monoamine precursor provision on the clinical course and severity of psychostimulant withdrawal; and, explore the impact of monoamine precursor provision in improving abstinence rates.
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Opportunistic referral of smokers to telephone cessation advice from a nurse: a randomised trial in Australian general practice
This trial investigated the effectiveness of opportunistic referral of smokers by their GP to telephone cessation counselling by a trained nurse to improve quit rates and shifts in stage of change at six and twelve months. The trial also investigated the acceptability of the intervention to patients and GPs. Intervention group patients were offered a telephone-based program delivered by a nurse comprising assessment and stage-based behavioural advice, written information and follow-up. Control group patients received ‘usual care’.
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Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy
Standard of care post surgery for GBM is concurrent radiotherapy/chemotherapy followed by 6 months of chemotherapy (temozolomide). We have previously shown that the combination of Temozolomide with liposomal doxorubicin (caelyx) has activity in recrurrent GBM and is well tolerated. This study aims to assess whether the addition of liposomal doxorubicin to six months of post RT temozolomide is efficacious and well tolerated
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Freedom study (Falls Risk Epidemiology:Effect of Vitamin D on skeletal Outcomes and other Measures)
The proposed study will determine the effect of a public health strategy (ie. increased sun light exposure and increased calcium intake) to reduce falls in older people in residential care using a randomised trial. The primary hypothesis of the trial is that increased appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention will reduce accelerated bone turnover, reduce fractures, improve motor function and improve mood.