ANZCTR search results

The purpose of this study is to determine cardiac function in pregnant women at the time of the diagnosis of preeclampsia and before any treatment is commenced. The cardiac function at this time will be compared to healthy gestationally matched pregnant women and also to non-pregnant healthy women.

The aim of this study is to determine whether naloxone, an opioid reversal agent, is as effective for the treatment of acute opioid overdose when administered via the intranasal (IN) route compared with the intramuscular route. The term 'opioid' refers to a class of drugs that includes heroin, and the prescription medications oxycontin and morphine. Injection of naloxone into a muscle is currently the standard method of emergency treatment for an opioid overdose on site at the Sydney Medically Supervised Injecting Centre. However, Naloxone can be administered as an intranasal (IN) spray using a 'mucosal atomisation device’. Evidence suggests that IN naloxone may be an effective and practical alternative. The significant benefits of IN administration include removing the risk of needlestick injury (and thus any blood borne virus transmission risk) to treating personnel. This is particularly relevant to ambulance officers and paramedics, as well as other emergency health care workers, such as in the hospital emergency department setting. Additionally, given the ease of administration and reduced issues regarding disposal of used needles, the availability of IN naloxone may potentially be extended. This may include non health care workers who regularly deal with opioid overdose in community settings, and drug users’ peers, who are likely to be present in the event of an overdose. The Sydney Medically Supervised Injecting Centre (MSIC) provides the ideal setting for this study.

This is a randomized controlled trial comparing intensive ongoing dietetic management vs usual hospital care, using an intention to treat protocol. Those patients that volunteered were randomly allocated to either the hospital model of care(HMoC) or Ambulatory model of care (AMoC). The HMoC intervention consists of dietetic management throughout the hospitalisation period with referral to other healthcare providers upon discharge ( such as the local community doctor or community support groups or private dietitian). The AMoC intervention consists of the same dietetic management throughout the hospitalization period but with formal requirement to provide ongoing support from a team of community based dietitians for up to 6 months after discharge. The primary outcome measures will be ; the change in nutritional status, evaluation of the patients dietetic management goals, assessment of the quality of the patients’ diet and patient level of satisfaction with the service provided. The secondary outcome measures collected will be mortality, readmission rates and total bed days occupied during the six month study period,

The strongest risk factors for prostate cancer are age and having a family history of the disease. Men at increased risk for prostate cancer on the basis of family history are confronted with difficult decisions regarding the management of their cancer risk, particularly in view of the ongoing controversary surrounding the balance of uncertain benefits and harms of PSA testing. An online screening decision aid was developed to assist unaffected men with a family history of prostate cancer to make informed decisions about prostate cancer screening. The aim of this study is to compare in a randomised controlled trial the efficacy of general information about prostate cancer screening with that of an online screening decision aid, developed specifically for men with a family history of prostate cancer. The control information is comparable to the decision aid in identifying the general benefits and risks of prostate cancer screening. However, it does not include features commonly used in decision aids e.g., a personal worksheet and provision of details about the pros and cons of each option. The randomised trial will involve 120 unaffected men with a family history of prostate cancer who will complete three questionnaires at three time points: i) Questionnaire 1: before reading the online decision aid or general information (control) materials; ii) Questionnaire 2: immediately after reading the materials; and iii) Questionnaire 3: 12 months after reading the materials, to assess the longer term effect of the information. The sample will be randomised such that there will be approximately 60 participants in each group. The following hypotheses will be tested: Compared to men receiving the control materials, men who receive the decision aid will have:- (i) less decisional conflict and uncertainty about their risk management options (primary outcome variable); (ii) better knowledge of the genetics of prostate cancer and their screening options; (iii) more accurate perceptions of their risk of developing prostate cancer.

This study aims to improve the likelihood that people with a mental illness who are trying to return to work will do so successfully. Unemployment and subsequent poverty and welfare dependence are major problems for people with a severe mental illness. The use of interventions such as supported employment has improved the chance of person with a severe mental illness obtaining and keeping employment, however a significant number, if not the majority of these people still experience under or unemployment. An important, but virtually untreated determinant of continued poor functioning in the community is the level of cognitive deficits found in severe mental illness. This study will employ computer assisted cognitive remediation, an approach that has been demonstrated to improve cognitive function in severe mental illness, to improve cognitive functioning and then test to see if this intervention improves overall employment outcomes. This study will be conducted in a community based setting in cooperation with the Schizophrenia Fellowship of New South Wales, a non-government organisation that is operating 6 supported employment centres through regional and metropolitan areas in New South Wales, thus making this study an important demonstration of effectiveness of psychosocial treatment in community care.

This study aims to determine the effect of pre-operative chemotherapy in patients with resectable pancreatic cancer. Patients may be eligible to join this study if they are aged 18 years or more and have been diagnosed with cancer of the pancreas for which they plan to undergo surgery. All participants in this trial will undergo pre-operative chemotherapy with the drugs gemcitabine and nab-paclitaxel. The chemotherapy will be administered intravenously on day 1, day 8 and day 15 of a 28 day cycle. Patients will receive 2 cycles before undergoing surgery to remove their cancer. Participants will be assessed after surgery to determine whether all the cancerous tissue has been successfully removed. If all the cancer has been removed the patients will have another 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. If all the cancer is not removed during surgery, the treating clinician may decide that patients will receive radiotherapy everyday for 5 weeks, at the same time as receiving a continuous infusion of 5-flurouracil which will then be followed by 4 cycles of chemotherapy with gemcitabine and nab-paclitaxel. They may also decide to to treat patients with chemotherapy as described for patients who have had all their cancer removed. Blood tests and safety assessments will also be regularly conducted throughout the 12 month duration of the trial. The results from this study will be compared to previous data to determine whether pre-operative chemotherapy will improve resection, and thus, survival outcomes in patients with pancreatic cancer.

This is a clinical trial for patients with sleep apnea who cannot use the standard treatments: continuous positive airway pressure machines or mandibular advancement splints. In this study we are testing two types of treatments at the same time, one a drug-based treatment and one a diet and exercise treatment, in combination we hope these will reduce sleep apnea and control its daytime symptoms. Patients will be randomly assigned to one of two types of diet for 12 months, a standard low calorie diet versus a diet which is high in protein and low in glycemic index (Low GI). Both of these groups will participate in the same lifestyle program promoting activity, exercise and healthier choices. The drug based treatment is testing a drug called Armodafinil for 9 months. Armodafinil is a drug that promotes wakefulness but does not improve your sleep apnea directly. So we think that it may improve other secondary outcomes including ability to concentrate, particularly whilst driving. We will be comparing Armodafinil to an inert placebo which does not have any active ingredient.

This is a prospective, multicentre, single arm observational non-interventional investigator initiated study by members of the Australian Liver Association Clinical Trials Network. This study will examine the distribution of the known IL28B polymorphisms (rs12979860 and rs8099917 SNPs) in patients with treatment naive genotype 1 chronic hepatitis C being considered for treatment in Australian clinics. In addition to describing the IL28B distribution in the Australian cohort, we will investigate if there is any correlation between the IL28B genotype and pre-treatment factors such as the extent of liver fibrosis, viral load and HCV genotype 1 subtype.

Genital prolapse is a common condition with at least 1 woman in 10 undergoing surgery for this condition. It may be associated with urinary stress incontinence. Paradoxically, women suffering of severe genital prolapse may be continent. By reducing the prolapse during urodynamic assessment (barrier test), one can unmask urinary stress incontinence, called occult stress incontinence (OSI). Reducing the prolapse during urodynamic testing aims at mimicking the postoperative state. It is however unclear from the literature whether a positive barrier test is an indication for anti-incontinence surgery performed at the same time as prolapse surgery. Tensionfree Vaginal Tape (TVT) is an efficient anti-incontinence procedure and can be easily performed at the same time as prolapse surgery. Our study intends to randomise patients undergoing surgery for severe prolapse in two groups, one with usual prolapse surgery without any anti-incontinence procedure, the second with prolapse surgery and TVT. Urodynamics studies on patients with severe prolapse describe 36 to 80% of OSI. Our hypothesis is that 50% of patients operated for prolapse with a positive barrier test will develop urinary stress incontinence. TVT cures or improves stress incontinence in about 90% of patients. Combining TVT with prolapse surgery may therefore reduce the post-operative rate of stress incontinence from 50% to 10%. However, systematic use of TVT may expose patients to complications like voiding difficulties or de novo detrusor instability. The other option is to operate patients for prolapse and perform TVT under local anaesthesia only in those who develop distressing stress incontinence post-operatively.

Eye Movement Desensitisation and Reprogramming (EMDR) and exposure therapy are well established first line psychological treatments for Post-Traumatic Stress Disorder (PTSD)(Boudewyns et al., 1993; Boudewyns & Hyer, 1996; Edmond & Rubin, 2004; Lee et al., 2002; Montgomery & Ayllon, 1994; Power et al., 2002; Vaughan et al., 1994; Van Etten & Taylor, 1998). There have been few studies to date exploring changes in brain functioning following treatment in EMDR, which has left the underlying question of 'what is the mechanism by which the two therapies acheive their therapeutic effects' unresolved. Evidence as to what neurological changes occur as a result of treatment may help vindicate the efficacy of treatment modalities and aid understanding of treatment function. Positron Emission Tomography (PET) scanning enables research into changes in activation of different parts of the brain by measuring regional cerebral perfusion (blood flow), providing insight into this question by measuring brain activity. Magnetic Resonance Imaging (MRI) will enable accurate interpretation of the PET/CT scans and will aim to replicate or refute findings from a recent study that suggests effective treatment of PTSD is associated with an increase in hippocampal volume (Bossini et al., 2011). This project aims to also explore the therapeutic efficacy of EMDR and exposure therapy (in terms of symptom reduction), and the significance of the participant's experience of therapy; the impact of this experience on therapeutic efficacy and on the participant's quality of life and levels of functioning. Although there is an abundance of data evaluating the effectiveness of EMDR and prolonged exposure therapy in relation to symptom reduction (see refrences above), there are very few studies investigating participant's experience of therapy and the significance of this experience in their recovery both short and longer term; and only three major qualitative studies published on EMDR (Di Giorgio, Arnkoff, Glass, Lyhus & Walter, 2004; Edmond, Sloan & McCarty, 2004 and Ricci, Clayton and Shapiro, 2006). It was reported that due to the unusual nature of EMDR with the eye movements, exploration of participant's experiences of treatment was relevant, furthermore qualitative methods were felt to be the logical approach to gaining insight into these questions (Edmond, Sloan & McCarty, 2004).