ANZCTR search results

This study will explore if it is possible to administer NanoCBD™ (MC_1020) oro-buccal spray so as to reliably achieve mucosal absorption of CBD and to understand some of the factors affecting mucosal absorption of CBD administered with the NanoCBD (MC-1020) oro-buccal spray . Ingested CBD has poor and erratic bioavailability and is subject to up to 75% first-pass metabolism, which could be improved by oro-buccal delivery. However, attempts at oro-buccal delivery to-date have failed as evident from the high levels of first pass metabolites present in the plasma. Preliminary data from micellized cannabinoid oro-buccal sprays indicate that the NanoCelle™ technology used to create these cannabinoid micelles, may be able to facilitate oro-buccal mucosa absorption; however, successful administration has been inconsistent. If reliable oro-buccal mucosa absorption can be demonstrated and the critical factors for achieving this is better understood, a delivery mechanism for cannabinoids that is suitable for routine medical use could be provided.

Sexuality is a fundamental aspect of the human experience and is widely considered to be a crucial component of holistic healthcare. While up to 50% of individuals with TBI will experience persistent changes in sexual functioning or wellbeing, post-TBI sexuality is rarely addressed in acute and rehabilitation treatment settings. Addressing TBI sexuality should be a priority healthcare concern alongside other rehabilitation outcomes such as return to work, driving and social participation. The aim of this study is to evaluate the efficacy of routine psychoeducation on post-TBI sexuality in improving patient sexuality outcomes and general satisfaction levels with sexuality-related rehabilitation experiences. With the severe lack of evidence-based interventions for sexuality issues after TBI, this study may potentially provide empirical evidence to support the practice of using simple psychoeducation to ameliorate sexual problems, which is relatively inexpensive and easily implementable across most healthcare settings.

This primary aim of this study is to establish the effectiveness of a new brief online parenting program for parents of children aged between 2 and 8 years 11 months of age. Families taking part in this study are randomly allocated to receive the new program immediately, or to wait 4 weeks before receiving the program. Parents will be asked to complete some questionnaires about their child’s behaviour, and their own experiences as a parent to help us examine the following outcomes: 1) child externalising behaviours; and 2) parenting, parent-child interactions, and parental well-being. It is hypothesised that: 1) at post-assessment (4 weeks after randomisation), relative to the waitlist group, parents in the intervention group will report significantly lower levels of child externalising behaviour problems, dysfunctional parenting; parenting stress, inter-parental conflict, as well as improved parenting confidence and parental well-being. 2) the improvements across child and parent domains at post-assessment will be maintained at two-month follow-up for the intervention group. 3) fathers (i.e., male caregivers) will receive as much benefit from program participation as mothers.

Prostate cancer spreads primarily to the lymph nodes and bones, and to a lesser degree to other organs. Prostate-specific membrane antigen (PSMA) is a protein that is found in high concentration in prostate cancer cells. PSMA can be used for increasing the accuracy compared to conventional imaging like CT scan. PSMA PET scan accurately detects prostate cancer spread by measuring PSMA. However, PSMA SPECT may be a suitable alternative to a PET scan because it’s cheaper and more readily available. There has been limited research comparing these 2 methods of assessing prostate cancer spread. The purpose of this study is to assess and compare PSMA PET/CT and PSMA SPECT/CT scans in monitoring patients with metastatic prostate cancer and in assessing response to treatment or progression. Who is it for? You may be eligible for this study if you are an adult male who has been diagnosed with metastatic prostate cancer. Study details All participants in this study will be asked to provide a blood sample and complete two scans (PSMA PET/CT and PSMA SPECT/CT) on a single day, taking approximately 3 hours total. You will then continue with treatment with your clinician as normal and any additional scans or blood test results completed within 14 weeks will be sent to study investigators. It is hoped that this study will help determine whether PSMA SPECT is a suitable, readily available, alternative to a PET scan.

Depressed new fathers rarely access traditional support services and their symptoms go largely unacknowledged and untreated. We aim to evaluate the efficacy, in a randomised controlled trial, of a new online treatment for postnatal depression in men ('DadBooster'). DadBooster is a 6-session only treatment program for paternal postnatal depression that was co-designed with fathers. Previous research confirms that symptoms of depression can be reduced through internet interventions, but no research has examined the efficacy of such interventions specifically for the treatment of depression in fathers with a new baby. We aim to test whether the newly developed DadBooster online program is effective in reducing the severity of symptoms of depression and anxiety compared to standard care. We hypothesise a reduction in depression symptom severity of >50%. Fifty depressed fathers will participate, with 25 randomly allocated to receive the DadBooster program immediately and 25 allocated to a waitlist control condition, receiving standard care and being offered DadBooster at the end of the study. The primary outcomes are depression symptom severity and remission from a diagnosed depressive episode at 12-weeks post-enrolment.

It has been shown that one-third of patients are not engaged in discharge conversations with health care professionals; receiving large volumes of one-way information, immediately prior to being discharged home. Once home, patients identify medication-related problems that they would have liked to voice in hospital or learn more about in hospital. The purpose of this study is to develop and pilot test an intervention that enhances patients’ discharge medication literacy and communication. The primary aims of this study are: * To assess the feasibility of study processes and the intervention to inform a future effectiveness trial. * To assess patients’ and healthcare professionals’ perceptions and experiences of intervention acceptability. This is a single site pilot randomised control trial. A group of consumers and healthcare professionals co-designed the intervention which is a poster placed in the patient’s room. The poster has 3 QR codes, which when scanned, take the patient to: 1) an online search engine to find out more information about medications; 2) a website with information patients may need to help manage their medications once home; and 3) an online question builder to encourage patients to ask questions about their medications in hospital.

This is a first-in-human (FIH) study to assess the safety, tolerability and pharmacokinetics of single-dose study of NP-201 acetate injection in healthy volunteers, Approximately 32 participants (8 participants per dose group) will be randomized across 4 sequential treatment dose groups. Participants will be randomized to receive either the NP-201 acetate or the placebo in a ratio of 6:2 (6 participants will receive the IP and 2 participants will receive the placebo). The study consists of screening (Day - 35 to Day -2), Baseline (Day -1), end of study visit (Day 29). Oversight of the study will be provided by a safety monitoring committee (SMC) comprising of the PI, local Medical Monitor (MM), and the Sponsor’s MM.

Over their lifetime, 15% of Australians will experience major depressive disorder or bipolar disorder. Of those who access treatment, 20–50% will not achieve symptom remission with standard therapies. There is now consistent and compelling top-tier efficacy data from controlled research settings that lifestyle interventions targeting diet, exercise, sleep and/or substance use can improve the symptoms of mental disorders. Despite these significant advances and its enormous potential to alleviate the burden on GPs and psychological service providers, lifestyle-based mental health care is not available as part of mainstream mental health care. There are a range of complex reasons for the evidence–translation gap, one critical deficit is that almost no data exist from real world settings that compare effectiveness to standard care for individuals presenting to their GP with clinical depression. The HARMON-E Trial is a nationwide, non-inferiority trial that aims to determine the effectiveness of a group-based lifestyle program for reducing depressive symptoms compared to group-based psychotherapy. Participants include adults who have a diagnosis of either major depressive disorder or bipolar disorder, who are randomised to receive six telehealth group-based sessions with either psychologists for the psychotherapy arm, or a dietitian and exercise physiologist for the lifestyle arm. It is hypothesised that changes in mental health symptom outcomes for participants in the lifestyle program will not be inferior to those in the psychotherapy program.

This Phase 1 study will comprise a single group conducted in up to 8 participants who will receive a single dose of EmtinB in an open-label fashion. In addition to safety, tolerability and pharmacokinetics (PK), a single cerebrospinal fluid (CSF) sample will be collected from each participant via lumbar puncture to assess the ability of EmtinB to cross the blood brain barrier.

Community pharmacies are accessible health services where the public can access the ECP over-the-counter and have their MS-2 Step prescriptions for EMA filled. All women should receive information about and be offered effective contraception as part of their care when seeking ECP and EMA: this is because delayed contraceptive provision is associated with higher odds of repeat unintended pregnancy. The study's primary aim is to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking EC or MS-2Step medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. We will utilise a pragmatic stepped-wedge cluster randomised trial across three Australian states. In the intervention phase, women purchasing EC or medical abortion medicines will be offered contraceptive counselling and referral to contraceptive providers when appropriate. Pharmacists will be supported through: online education, academic detailing (co-designed with consumers and pharmacy stakeholders), assistance identifying referral pathways, peer-support through AusCAPPS online community of practice and remuneration. It is anticipated that this trial will equip community-based pharmacists with the resources, networks, knowledge and skills to expand their scope of practice to include the delivery of high-quality, patient-centred, effectiveness-based contraceptive counselling. This will result in improved access to and more effective use of contraception by Australian women, and reduce their risk of subsequent unintended pregnancy after ECP or EMA.