ANZCTR search results

Premenstrual dysphoric disorder (PMDD) is a severe, cyclical depressive disorder that affects 2-8% of women of reproductive age. Previously known as late luteal phase dysphoric disorder, PMDD is characterised by irritability, mood changes/swings and physical symptoms of that develop during the luteal phase of the menstrual cycle and resolve after the commencement of menses. PMDD carries significant distress and morbidity, for which limited therapeutic options exist. The urgent and clear need exists for effective and harmless treatments in PMDD. The scope exists to investigate novel therapeutic modalities for this crippling disorder for many. The proposed project meets this need by investigating the efficacy of application of Theta Burst Stimulation (TBS) in PMDD in the form of a pilot study. Transcranial Magnetic Stimulation (TMS) is a non-invasive means of stimulating nerve cells in superficial areas of the brain. TBS (a patterned form of TMS) has been approved by the FDA as a treatment for treatment-resistant major depression. TBS has received minimal research attention as a potential treatment for PMDD. The research project aims to evaluate if theta burst stimulation (TBS) is effective in treating mood and other psychological symptoms in PMDD.

Huntington’s disease (HD) involves progressive decline in cognitive function, often beginning many years prior to clinical diagnosis, and drastically affects quality of life. Further, there are currently no effective treatments for cognitive decline in HD. Cognitive training has been found to be effective in improving cognitive function in other populations, but has not been thoroughly investigated in HD. This study aims to examine the effects of cognitive training on cognitive and clinical outcomes in people with HD, as well as its effects on brain function. This will be done by randomly allocating participants to either an intervention group or a control group. The intervention group will complete cognitive training over 3 months, whereas the control group will receive a monthly newsletter on lifestyle factors associated with cognitive function and will be provided access to the training program after the study period. It is hypothesised that compared to the control group, participants in the intervention group will have: (1) improved cognitive function; (2) improved neuropsychiatric symptoms; (3) improved subjective cognition; (4) improved health-related quality of life; (5) increased connectivity in brain networks involved in cognitive tasks; and (6) increased connectivity in brain networks during rest, after the study period.

Previous research indicates that text-message based programmes can be an effective public health approach to improve adolescent health behaviours, including tobacco use, thus may have promise as an approach to influence adolescent e-cigarette behaviours. We aim to conduct a randomised controlled trial to examine the potential effect of a text-message program targeting parents to prevent adolescent e-cigarette use. Over 12 weeks, parents of adolescents will receive text messages designed to address the factors identified that increase the risk of adolescent use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey.

The National Comprehensive Cancer Network now recommends molecular screening for all patients with advanced pancreatic duct adenocarcinoma (PDAC) to enable patients to benefit from these strategies. The predominant method of obtaining tissue to establish the diagnosis of PDAC is a specific ultrasound guided fine needle biopsy. This study aims to test the use of additional fluids that are collected as part of the tissue biopsy to determine whether the DNA extracted from these fluids is enough to create a genetic profile of the patient's pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with pancreatic adenocarcinoma that is locally advanced or metastatic (has spread to other body systems) and you have undergone an endoscopic ultrasound biopsy to establish the diagnosis of pancreatic cancer. Study details All participants who choose to enrol in this study will consent to having the fluids previously collected during their ultrasound biopsy assessed. Participants will not be asked to provide additional blood or tissue samples as part of this study. Each sample will be assessed to determine whether there is sufficient genetic material present to create a profile of the patient's specific cancer. For participants where a genetic profile can be generated, this information will be sent to a board of cancer experts who will review the profile against a list of new and existing cancer treatments. If a suitable treatment is identified, the participant will be informed within 1 month following review of their comprehensive molecular profiling, and they will then be able to start on the treatment if they agree to. It is hoped this research will demonstrate that it is possible to create a specific cancer profile for patients with pancreatic cancer from previously collected samples, without the need for additional biopsies. It is also hoped that this research may enable identification of personalised treatment options for pancreatic cancer patients, which may improve their quality of life and survival.

It is hypothesised that implantation of the ReActiv8 System will lead to a reduction in pain and/or disability for participants with CLBP, prior decompressive surgery (discectomy or laminectomy), with unsatisfactory pain relief despite continuing medical management (including physical therapy and medications). This Investigator-Initiated Study will be a single arm prospective study using two cohorts. Cohort 1 will be 30 patients who have mechanical LBP for > or equal to 12 months following a discectomy procedure, and Cohort 2 will be 30 patients who have had chronic LBP > or equal to 12 months following a lumbar laminectomy. The study will consist of up to 60 patients implanted with ReActiv8, who are indicated for participation in this study.

A single site, open-label pilot study to examine the feasibility of a randomised controlled trial of N-Acetylcysteine (NAC) on loss of control eating. All eligible participants will receive NAC orally at a daily dose of 2400 mg for 12 weeks. Outcome assessment will be made at baseline and at 12 week using questionnaires and ecological momentary assessment (EMA)

Text-message based programmes have proven to be an effective public health approach to improve adolescent health behaviours, including tobacco use, and so may have promise as an approach to influence adolescent e-cigarette behaviours. Given this potential, we aim to conduct a randomised controlled trial to examine the potential effect of a text-message program to prevent adolescent e-cigarette use. Over 12 weeks, adolescents will receive text messages designed to address the factors identified that increase the risk of their use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey.

Clozapine is an antipsychotic drug given to people with psychosis (schizophrenia and schizoaffective disorder) that in addition to reducing psychotic symptoms can also prevent certain cancers and age-related diseases, but can also cause weight changes. How clozapine causes these effects is unknown. Evidence suggests that disruptions in autophagy, a natural process of repair that occurs inside all cells of the body and slows the ageing process, could contribute to the development of those side effects. For this reason, this research project is aiming to see if clozapine changes a person’s autophagy. This study is the first of its kind, and the results of this pilot study could lead to a better understanding of the currently unknown mechanisms of clozapine’s actions to better assist those being treated with clozapine, and also to help inform the clinical applications of clozapine in additional settings.

The ACUMEN For ALL trial will examine the feasibility and safety of telehealth delivery of supervised exercise and outcome assessment in a subset of women treated for gynaecological cancer living in demographically-challenged circumstances that preclude face-to-face delivery and outcome assessment. Assess the preliminary effectiveness of telehealth-delivered intervention to improve quality of life in women and preliminary utility of telehealth-mediated outcome assessment. Understand the factors that indicate implementation potential. Who is it for? If you are an adult woman who has been diagnosed with gynaecological cancer in the last 60 months, and it has been over a month since you finished an intensive cancer treatment (including surgery, radiotherapy, chemotherapy), within more remote areas of Queensland or those who have access to the internet but are limited by transportation and/or location and would otherwise be ineligible for the main ACUMEN trial. Women will be identified for inclusion in this sub-study if they are unable or unwilling to attend face-to-face exercise training and objective outcome assessment. Study details Participants in this study will be randomly allocated to receive a video-delivered exercise intervention or delayed intervention control after 12 weeks. This comprises a video-delivered baseline assessment (including subjective and objective outcomes) with a trained accredited exercise physiologist or physiotherapist to determine their current fitness levels, after this time, all outcomes will be reassessed via video-delivery in the same manner as at 12 weeks, and repeated 12 weeks later (at Week 24). Participants in this first group will then be prescribed a personalised exercise program that they will follow for the next 12 weeks. The exercise program will include both aerobic and resistance training and participants will be asked to complete 3x 60 minute sessions each week for the 12 week period which will include supervised and unsupervised sessions. The second group will receive a delayed commencement of the personalised exercise program 12 weeks later. Participants in both groups will complete a series of questionnaires, and fitness assessments before and after the intervention. After the intervention, questionnaires, and fitness assessments will occur at two time-points (week 12 and week 24). It is hoped this research will determine whether a personalised exercise program can lead to improved long-term health outcomes for women who have been treated for gynaecological cancer.

This research project aims to enhance our understanding of the association between acute pain management in the emergency department (ED) and hospital acquired complications in older adults (aged 65 years and over). Acute pain is the most common primary complaint for patients presenting to the ED. Despite previous efforts made to improve the quality of acute pain management, recent publications continue to show pain under-treatment remains prevalent, especially among elderly patients. We will be introducing the ED-exit pain score supported by staff education to evaluate its impact on our current acute pain treatment regimen and its feasibility in clinical practice. Outcomes including types and total amount of pain modalities used, the incidence of delirium and other hospital acquired complications specific to older patient population will be collected during the pre- and post-intervention periods. The project findings will fill knowledge gaps in the field and present a strategy that can be easily incorporated in EDs across NSW.