ANZCTR search results

The study aimed to determine the degree of association between calculated glycemic load (GL) and glucose and insulin responses in healthy subjects consuming iso-energetic portions of single foods and mixed meals. 10 groups of healthy subjects consumed 1000 kJ portions of 121 single foods in 10 food categories and other 2 group of subjects consumed 2000 kJ of 13 mixed meals. Foods and meals varied widely in macronutrient content, fibre and GL. Glycaemia and insulinemia were quantified as incremental area under the curve relative to a reference food (=100). Then the results were correlated with GL to determine the extent that GL can explain the variability of glucose and insulin responses in healthy subjects.

In some cases, nausea remains refractory to treatment despite multiple lines of treatment, often in combination. This is a randomised controlled double-blind trial evaluating the effectiveness of one drug (levomepromazine) against placebo with rescue antiemetics (BSC) in both arms in patients with nausea that has been demonstrated to be refractory to standard guideline driven targeted antiemetic therapy or single agent therapy with haloperidol. This test drug has not yet been rigorously evaluated in this setting and does not yet have a registered indication for use in palliative care. The hypothesis to be tested is that for cancer patients with nausea not related to anticancer treatment, there is no difference in response at 72 hours to levomepromazine versus a placebo with rescue antiemetics. Response to treatment is defined as a minimum two point improvement from baseline and end score <3 on an 11 point (0-10) numeric rating scale for average nausea in the previous 24 hours, measured 72 hours after treatment.

Nausea in advanced cancer is a multifaceted problem. Recent systematic reviews have concluded that aetiology based guidelines may be effective in reducing nausea, but no rigorously controlled studies have been undertaken to trial this approach. Moreover, evidence to support the implementation of guidelines in practice is limited and contradictory, and a number of barriers to the implementation of the guidelines have been identified. This is a randomised open label study to compare the effectiveness of aetiology based antiemetic guideline therapy (targeted) versus haloperidol (single agent therapy) in improving the management of nausea not related to anticancer therapy in patients with advanced cancer. The hypothesis is that for advanced cancer patients with nausea not related to treatment, there is no difference in response to targeted aetiology-based antiemetic guideline treatment compared to using haloperidol alone, after 72 hours of treatment. Response to treatment is defined as a minimum two point improvement from baseline and end score <3 on an 11 point (0-10) numeric rating scale for average nausea for the previous 24 hours, measured 72 hours after the first study antiemetic administered Participants will be randomised into one of two study arms. In Arm 1, guideline driven antiemetic therapy is given orally or parenterally (subcutaneous or intravenous) according to the presumed cause of nausea using freely available PBS listed antiemetics in a 3 step dose escalation schedule. In Arm 2, Haloperidol is administered in a 3 step dose escalation schedule from 1mg/24 hours to 3mg/24hours orally or parenterally (subcutaneously). The active comparator is standard guideline treatment.

The overall objective of this study is to develop a well tolerated chemo-radiotherapy regimen for patients with Merkel Cell Carcinoma (MCC) of the skin that achieves high rates of control. You may be eligible to join this study if you are aged 18 or over and have been diagnosed with stage II or stage III Merkel Cell Carcinoma of the skin with no evidence of distant spread. All participants in this study will undergo radiation therapy for 5 days per week for 5 weeks whilst being administered Carboplatin intravenously (i.e. directly into the vein) once per week. Three weeks after the end of radiation therapy, patients will commence 3 x 3-week cycles of intravenous Carboplatin, administered on day 1 of each cycle, and intravenous Etoposide, administered on days 1-3 of each cycle. Patients will be assessed by PET scan, CT and/or bone scan, and monitored for therapy side effects and survival every 3-6 months for 5 years. The PET scans will be used to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment. It is hoped that the findings of this trial will lead to a greater understanding of the effect and toxicity of Carboplatin-Etoposide chemotherapy in combination with radiation therapy for stage II and III Merkel Cell Carcinoma.

The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Who is it for? You may be eligible to join this study if you aged 18 years or above and have a confirmed diagnosis of non-small cell lung cancer within 6 weeks of study enrolment. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard of care treatment, which consists of chemotherapy and radiotherapy given in a number of small doses over a period of about 6 weeks. Participants in the other group will instead receive hypofractionated radiotherapy (HypoRT) in three large doses over a period of 2 weeks. All participants will be regularly monitored for up to 2 years in order to evaluate treatment response, survival, toxicity and quality of life. This will help us to determine whether hypofractionated radiotherapy is more effective, results in longer life expectancy and if it is just as safe as standard fractionated radiotherapy.

This study is comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with neurotropic primary melanoma in the head/neck area. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo radiation therapy over 4 weeks, commencing within 3 months of surgery. Participants in the other group will undergo surgery followed by observation only. Participants will be monitored for up to 5 years in order to evaluate treatment effect, survival rates, and quality of life.

X-linked retinoschisis is a genetic eye disorder characterised by abnormal splitting of the retina, resulting in a loss of vision. Currently there is no treatment available for X-linked retinoschisis. However, an improvement in sight has been reported following the use of topical and oral acetazolamide in people with X-linked retinoschisis. Hence, the objective of this study is to investigate whether oral acetazolamide improves the sight of people with X-linked retinoschisis.

Paramedic use of supraglottic airway devices is increaing and it is also seen as a life-saving skill, necessary for protecting and maintaining a patients airway and providing a channel for direct oxygen administration. The current rate for successful insertions of supraglottic airway devices by Ambulance Service of NSW paramedics below optimal. The i-gel supraglottic airway device is a new airway style with a non-inflatable cuff and is structured differently to the Smiths Soft Seal (the device currently in use by ASNSW). This theoretically makes it easier to use and may result in a higher rate of successful insertion. We hypothesise that the i-gel, when compared to the Smiths Soft Seal LMA will result in a higher rate of airway placement.

Several research groups from around the world, including our own group at the Centre for Emotional Health (Macquarie University), have demonstrated the efficacy of theoretically derived cognitive behavioural treatment (CBT) protocols for Social Phobia (Clark et al, 2003; 2006; Rapee, Gaston, & Abbott, 2009). However, despite the effective treatments available there is evidence that treatment outcomes are still less than optimal due to poor engagement and motivation for treatment. For example, Issakidis & Andrews (2004) found that around 30% of clients presenting for CBT group treatment for social phobia did not commence treatment, and a further 10% discontinued their treatment. Similarly, in a large trial in our own clinic, 18% of clients who commenced treatment for social phobia discontinued after less than 3 sessions (Rapee et al, 2009). This suggests that strategies that promote engagement with and motivation for treatment may further enhance treatment outcomes. One approach that has received attention, particularly in the substance use disorders, is motivational interviewing (MI; Miller & Rollnick, 2002). This approach aims to enhance motivation for change and focuses on ambivalence about embarking upon treatment that might lead to clients not engaging fully in, or dropping out completely from, treatment (Arkowitz & Miller, 2008). While this approach has good evidence for its value in the substance-use field (Arkowitz & Miller, 2008), it is only beginning to be considered in the anxiety-disorders literature (e.g., Westra & Dozois, 2008). The aim of the current project is to determine whether the addition of motivational interviewing to a highly efficacious CBT treatment package for social phobia can provide a significantly greater treatment effect and improved maintenance of effects.

There is evidence to support a beneficial effect of dairy products in weight loss programs. This trial hopes to document whether increasing the number of serves of dairy per day will increase the amount of body fat lost or change its distribution to a more healthy profile. We will also study if there are any benefits for cardiovascular disease and type 2 diabetes, by monitoring the changes in some key risk markers for these conditions.