ANZCTR search results

Institutionalised individuals with dementia often suffer from symptoms or behaviours that significantly impact their well-being and quality of life. Depression, poor sleep quality and agitated behaviours are common elements that contribute to a reduction in life quality. Research continues to show that exposure to natural environments intrinsically creates a positive biological and psychological response. Using these same principles, the study aims to identify the influence a pseudo-natural environment has on dementia symptoms and behaviours that negatively affect quality of life.

The study is a prospective, parallel-group randomized controlled trial comparing an exercise versus control intervention across a range of cannabis detoxification outcome measures during a 7-day inpatient admission, with follow-up at 28 days post-discharge. Specifically, the study will compare severity of cannabis withdrawal and cannabis cravings, detoxification completion rates, and adverse events between the two conditions in an intention-to-treat analysis. Mechanisms by which exercise affects cannabis withdrawal will be assessed through the analysis of markers of endogenous cannabinoids, and plasma and urine THC levels.

This study will determine the effect of pre-operative sexual counselling on sexuality and quality of life after risk reducing salpingo-oophorectomy (RRSO) in women at high risk of ovarian cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, at high risk of ovarian cancer and have decided to undergo risk-reducing salpingo-oophorectomy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a single pre-operative counselling session with a sexologist to discuss the potential effects of surgery on sexual function and physical changes, potential changes to intimacy, loss of sexual self-esteem related to body image changes, menopausal symptoms and confidence, changes to sexual response such as reduced arousal, loss of libido, difficulty reaching orgasm, menopausal symptoms related to treatment including hot flushes/night sweats, disturbed sleep, poor memory and weight gain, all of which may impact on one’s sexual self esteem, sexual functioning and general wellbeing (quality of life). While participants in the other group will receive routine care which is the initial consultation with your gynaecologic oncology specialist who may or may not discuss such issues with you. Participants will be followed-up for up to 12 months post-surgery to determine the effect on sexual function, the prevalence and severity of sexual difficulties after RRSO, and any other factors that significantly affect sexual function and quality of life. Serum testosterone levels will also be tested to determine whether there is a correlation with sexual function after RRSO.

High flow oxygen therapy has been successfully trialled in a multitude of clinical scenarios. High flow oxygen therapy is known to provide more support than standard methods of oxygen delivery. This study aims to trial and assess the use of high flow as respiratory support during bronchoscopy as an alternative method to standard practice. We aim to establish whether high flow maintains end expiratory lung volume and improves other physiological parameters.

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.