ANZCTR search results

Paliperidone palmitate (Invega Sustenna) is a recently approved long acting injectable antipsychotic medication to treat schizophrenia that is only required to be administered monthly, unlike others which require daily or fortnightly administration. It is useful in people where previous drugs have been ineffective, or where taking oral medications has been a problem as doses are more closely monitored and clinical staff will know quickly when doses are missed. For Invega Sustenna to be approved for use in adults by the government, a number of studies were conducted in adults aged 18-65 that showed it was effective, and that its benefits outweighed any side effects. It is assumed that this information will be applicable to an elderly population with schizophrenia, but this has not been directly studied. In this study we will explore how effective the medication is as well as its safety and how well tolerated Invega Sustenna is in an elderly population with schizophrenia where a clinical decision has been made to commence treatment using the drug. The study will add a number of measures to standard care to measure whether the symptoms of schizophrenia are changed and also whether there are any significant side effects. After ensuring that all participants meet our inclusion and exclusion criteria, we will conduct frequent assessments of patients over a 6 month period. This information will be used to treat any side effects as soon as they occur and to build up a profile of the side effects that could be expected to be seen in the elderly and add to the knowledge about the side effects of this medication in an elderly population. The results will be published in a medical journal and provided to the drug company so that they can update their product information so that any side effects can be better dealt with.

In this study, we will pilot test an internet-delivered intervention to address co-occurring depression and alcohol use for people residing in rural and remote areas. Participants reporting elevated depressive symptoms and alcohol use exceeding the current Australian guidelines will receive ten sessions of cognitive-behavioural therapy delivered via an internet-based program, with weekly telephone support from a trained member of the research team. The primary outcomes are depression and alcohol use at ten weeks post-baseline.

We will collect placenta samples from male and female fetuses delivered by cesarean section. RNA will be extracted from these samples and will be used for whole transcriptome gene expression profiling. This will provide insight into the sex-specific differences in human placental development.

The purpose of this study is to evaluate a 12-month telephone-delivered weight loss program, as compared to usual care, for women who have recently completed primary treatment for breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged between 18 and 75 years who has been diagnosed with stage I-III breast cancer for which you have finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy). You should also have a Body Mass Index between 25 and 45 kg/m2, indicating overweight/obesity and be able to travel to Brisbane to complete study assessments. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive a telephone-delivered weight loss intervention which involves up to 22 telephone calls from a Lifestyle Coach over a 12 month period. They will also receive program materials, including a detailed workbook, set of digital scales, measuring tape, pedometer, kilojoule/calorie counter book and self-monitoring diary. Participants in the other group will continue to receive their standard medical care plus 6 monthly feedback and newsletters. The program will be evaluated on its ability to achieve weight loss, and improve body composition, physical activity, dietary intake, clinical biomarkers of metabolic health, genomic and DNA methylation-based biomarkers, blood pressure and patient-reported outcomes (quality of life, body image, fatigue, menopausal symptoms).

Caesarean section is one of the most commonly performed procedures in Australia and many other countries. Approximately 80-90% of all caesarean sections performed in developed countries are conducted under regional anaesthesia. Due to the high incidence of maternal hypotension after spinal anaesthesia for elective caesarean delivery (approximately 70-80% in the absence of prophylaxis with sympathomimetic drugs), it has become routine practice in many centres worldwide to administer a sympathomimetic drug to support the blood pressure, either prophylactically, which is more effective, or as treatment. Phenylephrine has been extensively investigated and has become the first-line sympathomimetic drug for prophylactic continuous infusion. Spinal anaesthesia induces systemic vasodilation and a mild fall in arterial pressure, accompanied initially by a compensatory rise in heart rate and cardiac output. Preventing reduced maternal cardiac output and a substantial fall in maternal arterial pressure (and possibly prevention of even minor reductions in blood pressure of less than 10% from baseline values) is considered fundamental to avoiding maternal nausea, vomiting, syncope and neonatal hypoxaemia and acidosis. Phenylephrine, which has almost no beta-agonist activity, and in higher doses causes a baroreceptor mediated reflex bradycardia, reduction in stroke volume because of increased afterload, shift of blood into the splanchnic venous circulation decreasing venous return and thus a dose-dependent fall in cardiac output. These factors may, if severe, be detrimental to placental perfusion. An alternative sympathomimetic drug and alpha-adrenergic agonist is metaraminol. This drug differs from phenylephrine in having mixed direct and indirect alpha- and beta-agonist effects (although direct alpha- effects predominate at clinical doses). It is more effective than ephedrine in maintaining arterial pressure and its pharmacological properties suggest it might have advantages over phenylephrine, by maintaining cardiac output more effectively. Limited evaluation shows it is associated with excellent neonatal outcomes and metaraminol is widely used in non-obstetric clinical practice. There are no human data comparing phenylephrine and metaraminol in pregnancy. We have established that the potency ratio between these drugs is approximately 1:4-5, so infusions will be commenced at equipotency, based on a well supported dose of phenylephrine. The rate of metaraminol will be consistent with the only previous human trials, in which it was used at 250 mcg/min initially and maximum rates approached 500 mcg/min. This non-inferiority study will compare these two well-known sympathomimetic drugs with respect to neonatal and maternal outcome. Should metaraminol be found to compare favourably with phenyephrine, it would provide good evidence that it is a suitable option in this setting.

This project aims to find an effective treatment that provides value for money and is acceptable to patients for the management of moderate-to-severe lateral epicondylalgia, a common, disabling and costly condition.

Obstructive sleep apnoea (OSA) is a disorder characterised by repetitive obstruction of the throat during sleep. People who suffer from OSA have increased risk of heart disease and are often very tired during the daytime. Currently, continuous positive airway pressure (CPAP) is the most common treatment for OSA because it treats the disorder in almost all patients. Many patients, however, do not like using CPAP for several reasons (for example it is bulky, or is uncomfortable), and therefore choose not to use it. For this reason, we wish to find an alternative treatment that is effective and well tolerated by patients. A recent research paper has suggested that acupuncture can lower the severity of OSA. However, the authors did not investigate how acupuncture caused the change in OSA severity. Our study aims to 1) see whether acupuncture treats OSA, and 2) try and work out how acupuncture is improving the severity of OSA. It is hypothesized that patients will experience fewer respiratory events and experience less daytime sleepiness after twelve treatments of acupuncture, but that placebo acupuncture will have no effect on the severity of OSA or sleepiness. It is also hypothesized that for those patients who experience reductions in the severity of their OSA symptoms will show changes in the activity of the airway muscles, changes in the resistance to airflow in their throat and changes in the amount of effort required to wake them from sleep while they are having a respiratory event.

The pituitary gland is an important gland that assists in control and release of hormones in the body. Abnormal growths in the gland, called “pituitary tumours or adenomas” can occur. The most frequent type requiring surgery is the non-functioning pituitary macroadenoma (NFPMA), which are tumours that don’t produce any excessive hormones but can be associated with hormone deficiences. At St Vincent’s Hospital, we have reviewed our own historical series of NFPMA. Between 1995 and 2010, 141 cases of NFPMA were operated on. It was observed that males were more likely than females to be to have 2 or more hormonal deficiencies at presentation. Post-operatively, 2 or more hormone deficiencies occurred more frequently in males and postmenopausal females but rarely in premenopausal females. So it appears that premenopausal females to have better hormonal outcomes. We have hypothesed that it may be related to lower pressure within tumours of premenopausal females. High pressure in the tumour is postulated to reduce blood flow to the pituitary gland and leads to death of normal hormone producing cells, thus less ability for hormonal recovery. This current project has been designed to confirm if gender differences in hormone deficiencies do occur after surgery. Also to demonstrate that pressure within tumours of premenopausal females in lower than males and postmenopausal females. These findings are important as they contribute to the understanding of hormonal differences in genders, which has not been fully examined before.

The assessment of patients presenting to Ed with chest pain aims to identify acute coronary artery syndrome (ACS) promptly and rule out ACS efficiently. This project aims to validate a 2 hour rapid rule out process and the GRACE Freedom for events score.

ATL1103 is being developed as a potential treatment for acromegaly, a disease of excessive growth hormone and insulin-like growth hormone (IGF-I) action. Twenty four acromegaly patients will receive 200mg ATL1103 three times in week one and then either once or twice a week for a further 12 weeks. All treatments will be administered by subcutaneous injection. The primary objectives of the study are to evaluate the safety and tolerability of the two dosing regimens of 1103, and to investigate the pharmacokinetic profiles of ATL1103. The effect of ATL1103 on serum IGF-I levels and on other pharmacodynamic markers will also be measured.