ANZCTR search results

The TNT trial is a multicentre, cluster randomised controlled study that aims to examine the effectiveness and cost effectiveness of an organisational change intervention in reducing smoking rates among clients attending drug and alcohol treatment centres across Australia. Intervention and control treatment centres will be compared. Clients attending control group centres will continue to receive usual care. Clients (who consent to participate) in the control centres will complete online surveys about their smoking three times over a 6 month period. The intervention group treatment centres will receive organisational change interventions including assistance in smoking policy development, creating client champions, and staff training. Clients (who consent to participate) in the intervention centres will complete online surveys about their smoking three times over a 6 month period. Participating clients will also be offered brief smoking education, counselling and nicotine replacement therapy by the centre staff as part of their usual centre appointments. Intervention effectiveness will be measured by smoking cessation in the intervention versus control treatment centre clients at six weeks and six months follow-up. The primary outcome measure will be the client self-reported 7-day point prevalence abstinence at 6 weeks follow-up which will be biochemically verified.

Renal Denervation in Heart Failure (RDN HF) is a physician-initiated pilot study involving staff of the Cardiology, Radiology and Nephrology Departments of the John Hunter Hospital, Newcastle, NSW. RDN HF is a first-in-human clinical trial of catheter-based renal denervation in heart failure patients. It uses a TGA approved device called the EnligHTN System, manufactiured by St Jude Medical. The study aims to evaluate the safety of renal denervation using the device and the effectiveness of the technique in improving the symptoms of heart failure. This is a prospective, randomised, controlled single centre study that will enrol approximately 20 participants with symptomatic congestive heart failure despite maximal medical treatment.

For chronic illnesses such as Lyme-like Illness, Chronic Fatigue Syndrome, and Chronic Pain, differential diagnosis is regularly made on the basis of signs and symptoms rather than specific medical tests. This means that the cause of such illnesses often remains unidentified. For Lyme Disease or Borreliosis, standard diagnostic testing typically involves indirect serology testing of antibodies made by the body in response to an infection or foreign agent. However, such indirect forms of testing can be problematic as antibodies produced in response to infection by a specific foreign agent can bind not only with antigens of the specific foreign agent, but also to antigens of other infectious agents. For instance, cross-reacting antibodies can be produced in response to both Borrelia burgdorferi bacteria (causative agent for Lyme disease) and certain types of viruses or other infections, potentially causing diagnostic confusion in interpreting the results of serological testing (such as Western blot technique). “Many diseases have been reported to cause significant cross-reactivity in IgM and/or IgG assays. Among such diseases are autoimmune disorders, Epstein-Barr virus infection, bacterial endocarditis, syphilis, other spirochetal infections, and Helicobacter pylori infection.” [Ref: Reed, Kurt D. "Laboratory testing for Lyme disease: possibilities and practicalities." Journal of clinical microbiology 40.2 (2002): 319-324.] Moreover, antibodies may circulate in the body long after an acute infection (for example, around ten to twenty years after a Borrelia infection), further adding to the diagnostic confusion. This observational study aims to identifying DNA containing non-human cells or pathogens present in a patient’s blood sample. The study combines blood filtration, microscopy and PCR-DNA genetic analysis.

Family meetings are recommended as standard practice, as a way for health professionals, together with family members and patients (where able) to discuss goals of care, site of care options, psychosocial issues, and plans for the future. However, family meetings do not occur consistently and are rarely conducted according to best available evidence. This research project aims to determine whether conducting a structured family meeting on admission to palliative care improves outcomes for patients and family members. This project also aims to determine the cost and resource implications of implementing family meetings into routine care. This research is significant because it will provide important evidence about what is optimal care for patients receiving palliative care and their family members. Further, it will provide information on the cost and resource implications of implementing family meetings into routine care. It is hoped that clinical practice will be improved as a result of this project.

This is a Phase I, randomized, double-blind, analytically masked, placebo-controlled, sequential-panel, ascending single-dose, and repeated twice daily-dose, single-center study to evaluate the safety, tolerability, pharmacokinetics and antinociceptive effects of escalating single and multiple doses of CMX-020 administered orally to healthy male and female subjects.

In this study, a number of specific between-groups hypotheses will be tested in the randomized controlled trial as detailed below: H1: Participants in the experimental group will experience improved sleep quality, relative to the study controls, between baseline and follow-up at 3-months; H2: Participants in the experimental group will lose a greater amount of weight, relative to the study controls, between baseline and follow-up at 3-months; Further, a number of within-subjects hypotheses will be tested: H3: The relationship between study group (i.e. hot/cold bath vs. study controls) and weight loss between baseline and 3-months follow-up will be mediated by the drop in mean core body temperature and improved sleep quality; and, H4: The relationship between study group and weight loss between baseline and 3-months will be mediated by a reduction in binge- and/or night-time eating, which is due to the longer time spent asleep and less time sitting up at night. That is, participants who do not engage in eating late at night are expected to lose more weight than those who do eat late at night. In the analyses pertaining to the hypotheses, we will control for all variables that are correlated with the outcome variables (i.e. sleep quality, and BMI), including symptoms of anxiety/ depression and a lack of exercise/physical activity, as well as certain conditions (e.g. hypothyroidism) or treatments (e.g. antidepressants), if appropriate.

The study is assessing the costs and patient related outcomes associated with chemotherapy delivered at home versus chemotherapy delivered in the hospital setting for breast cancer patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to receive at least four cycles of chemotherapy for breast cancer and are suitable for day-case administration. Study details All participants in this study will receive their first two cycles of chemotherapy in a hospital day unit as per standard care. Provided that the participants do not experience any severe adverse events, they will then be randomly (by chance) allocated to receive their next two chemotherapy cycles either in the hospital day unit or in their home setting. In the home setting, chemotherapy will be administered intravenously by a trained nurse. Your chemotherapy treatment regime will not change. All participants will be asked to complete a number of questionnaires before, during and after chemotherapy treatment in order to evaluate their patient experience, quality of life, anxiety and depression, nausea and vomiting, and treatment safety. Treatment-related costs will also be analysed. It is thought that treatment at home may provide not only a better patient experience, but may deliver a more sustainable health service model of care for the WA Health Department.

Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered. The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.

Phase 2a open label, randomised study to evaluate the pharmacokinetics and safety of MicroCor hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in healthy postmenopausal volunteers

High blood pressure is a leading risk factor for mortality. Diet and lifestyle change, which can reduce the need for costly blood pressure medication, can have the largest potential impact on high blood pressure in the community. Large randomised controlled trials demonstrate that consumption of diets rich in plant foods (fruits, vegetables, legumes and whole grains) lower blood pressure. We propose that the amount and type of vegetables consumed is important for blood pressure, and that focused advice to consume nitrate-rich vegetables will result in lower blood pressure. Acute and very short-term studies clearly demonstrate that an increase in nitrate intake can significantly reduce blood pressure. The objective of this study is to establish if these effects on blood pressure are sustained over a 4 week period. In a separate investigation we also wish to determine if daily consumption of nitrate-rich vegetables can lower the cardiovascular response to stress. Secondary objectives of this study are to explore the role of nitrate-rich vegetables in improving blood vessel stiffness and cognitive function and mood.