ANZCTR search results

Interstitial Fluid (ISF) is thought to be a surrogate matrix to blood for many small clinical biomarkers (including metabolites) and its potential for in situ physiological real time monitoring as an alternative to typical sample collection for laboratory testing is an area subject to much research and commercial interest. Better understanding the ISF will accelerate research and provide insights into further opportunities and metabolites for continuous biosensing. In this study, a novel Nutromics ISF Collector will sample small volumes of the ISF (<4 uL) at the same time that a small amount of blood is taken (<10 mL). The two different samples will be evaluated, to identify and quantify the metabolites present in the contemporaneous samples.

Video assisted thoracoscopic surgery (VATS) has become the standard of care for pulmonary lobectomy but the optimal perioperative analgesic regime remains unclear. Further, acute perioperative pain has been identified as one of the strongest predictors for the development of chronic pain after VATS which is seen in in over 30% of post VATS patients. Methadone has emerged as an alternative agent which provides prolonged analgesia lasting 24 to 48 hours; with the potential to reduce the requirement for short-acting opioids in the postoperative period An audit at Fiona Stanley Hospital also demonstrated that the current standard of care using paravertebral catheter block may not provide adequate pain control for patients after VATS lobectomy. Our study will explore whether IV methadone alone or a combination with paravertebral catheter block is an effective way of improving analgesic outcomes for patients after VATS lobectomy

This study will investigate the effect Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab (Anti-VEGF Antibody) Immunotherapy Before Surgical Resection Versus Surgical Resection alone in Hepatocellular Carcinoma Patients Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a first diagnosis of hepatocellular carcinoma and a recommendation of curative resection. Study details Participants in this study will be randomly allocated (by chance) to one of two groups: one group will receive immunotherapy of atezolizumab (Tecentriq) and bevacizumab (Avastin) followed (within a few days of receiving the second cycle of immunotherapy) by surgical resection and will be followed up with active surveillance every 3 months for 3 years. The other group will receive surgical resection only with active surveillance every 3 months for 3 years. Active surveillance will involve MRI/CT scans and blood tests. It is hoped this research will improve outcomes for patients with early-stage Hepatocellular Carcinoma by reducing the risk of disease recurrence.

We hypothesise that amongst pregnant women across all BMI categories, there exist subgroups of at increased risk for adverse outcomes as a result of the interplay of cardiometabolic risk factors – that is, alongside obesity, factors such as a sedentary lifestyle, poor dietary quality, certain ethnic groups, and possibly mood compound cardiometabolic risk.

This study aims to evaluate the effects of psilocybin on mental health in an open-label setting, where all participants are aware of the treatment being administered. The hypothesis is that psilocybin will lead to significant improvements in mood and overall well-being.

This research is designed to determine the clinical utility of a human amnion membrane (biological) product and assess whether it is safe and effective in a group of patients that have a failed full thickness skin graft (FTSG) on their nasal tip or nasal ala in the previous 3 months. It is hypothesized that participants who receive an amnion membrane allograft will have superior epithelization and revascularization resulting in improved healing and a reduction in scar contracture compared with patients receiving standard of care management. Who is it for? You may be eligible to participate in this study if you are male or female aged 18 years or older, fluent in written and spoken English, is a Southeast Queensland (SEQ)-based resident, and within 3 months of a failed full-thickness skin graft (FTSG) characterised by ongoing pain, numbness, erythema, oedema where this clear tissue breakdown and a presence of necrotic eschar. Study details At the time of screening, study participants will be randomized to receive active treatment with an amnion membrane allograft or standard of care. For participants in the amnion membrane allograft group, the nasal wound bed will be cleaned and previous failed graft removed. Then amniotic membrane will be transplanted in to the wound bed and secured with Hypafix tape. A secondary dressing that enables moistened wound healing will be applied above the amnion membrane allograft. After the procedure is complete, patients will be discharged following a review of their vital signs. Study participants will return to clinic at Day 6 (+/- 2) and Day 11 (+/- 2) after intervention, to have their outer dressing changed and the amnion bandage reviewed. At one month and 3 months post-operatively, the study participants will return for further assessments of the wound bed. Imaging investigations of the graft site will be conducted at each follow up visit using a 3D surface scanning device, along with a symptom-directed physical exam and collection of vital sign measures, concomitant medications, and adverse events. A final follow up visit will be conducted at three months after amnion membrane allograft transplant. At the End of Study visit, the wound bed will be assessed for epithelial repair and graft function. It is hoped the finding from this study will show human amnion membrane (biological) is a superior epithelization and revascularization in treating FTSG, improve healing and a reduction in scar contracture compared with standard care management.

This study aims to learn about the safety and tolerability of the study drug, paxalisib when taken by female participants with advanced breast cancer. Who is it for? You may be eligible for this study if you are a female at least 18 years of age, with a life expectancy greater than 12 months, at least one confirmed lesion, and satisfy haematologic, renal and hepatic function tests. For Arm 1 cohort, you will need to have a HER2-negative stage IV breast cancer diagnosis, confirmed gBRCAm (BRCA1, BRCA2 or both) and prior treatment with chemotherapy in the metastatic setting. For Arm 2 cohort, you will need to have a recurrent, unresectable or metastatic triple-negative breast cancer diagnosis, confirmed PD-L1 positive, treatment in combination with chemotherapy, and no prior PD-1/PD-L1 therapy. Study details Participants in Arm A will be randomly allocated to cohort A1 or cohort A2, and administer Paxalisib (15mg or 30 mg orally once daily) plus Olaparib (300mg orally twice daily) in 28 day cycles. Participants in Arm B will be randomly allocated to cohort B1 and cohort B2, and administer Paxalisib (15 mg or 30 mg orally once daily) and Pembrolizumab (200mg intravenous infusion once daily) over 21 days together with chemotherapy (intravenous nanoparticle albumin-bound paclitaxel, or gemcitabine–carboplatin) administered per standard of care protocol. During the study period, participants will be assessed for adverse events, circulating tumour cells count, immune cell signature, and clinical activity of Paxalisib. It is hoped this research will determine whether paxalisib, when given in combination with either olaparib or pembrolizumab/chemotherapy, is safe and well tolerated, has any side effects and if there is any clinical activity that may improve outcomes for participants with advanced breast cancer.

This study is testing the safety and tolerability of a single dose of SCS1 in healthy participants. Approximately 40 participants will be enrolled consecutively across multiple escalating dose cohorts to receive a single oral dose of SCS1 or placebo. Cohorts will proceed following satisfactory review of the prior cohort data (including the safety and tolerability data). Cohorts will be determined by escalations of not more than 5-fold. The study hypothesis is that the doses planned for administration will be safe and well tolerated.

Low-dose testosterone therapy is used by an increasing number of trans people, particularly those with a non-binary gender. However, very little is known about the impact of low-dose testosterone on gender dysphoria, gender euphoria, mental health and physiological outcomes. Currently, in our Austin Health gender clinic, following initial assessment of suitability and informed consent, due to large demand for appointments, there is a minimum 3-month waitlist prior to initiation of gender affirming hormone therapy. This is standard care. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to immediate low-dose testosterone therapy or delayed testosterone therapy (commencement of low-dose testosterone after the standard care 3-month waiting list). This will be followed by a 12-month extended follow-up following initiation of testosterone, At 6 months post-commencement of the intervention, a subgroup of participants from both groups will be invited to participate in semi-structured interviews with one of the study investigators. These interviews will explore the participants' motivations and goals for initiating low-dose testosterone, as well as the impact of testosterone on their gender dysphoria, gender euphoria, mental health and quality of life. This project is a trial of trans people newly commencing low-dose testosterone therapy. We aim to establish the influence of low-dose testosterone on gender dysphoria, gender euphoria, depression, suicidality and quality of life. We also aim to gain a greater understanding of the impact of low-dose testosterone on serum testosterone concentrations, and common biochemistry markers. In particular, we hypothesise that immediate access to low-dose testosterone, compared to no treatment, will reduce gender dysphoria, depression and suicidality, improve quality of life, and increase gender euphoria. We also hypothesise that low-dose testosterone will increase testosterone levels to an intermediate range between those expected for cisgender men and cisgender women.

The aim of this study is assessing the safety and tolerability of a single administration of an experimental radiotracer 99mTc-3BP-4961 (Investigational product or IP) and then perform a single photon emission computed tomography (SPECT) scan. Who is it for? You may be eligible for this study if you are male or female over 18 years of age, presenting with clinical suspicion of active cancer during investigation for a possible new cancer diagnosis profession in a patient with know solid tumour. Study details Participants will receive a single IP intravenous administration of 10-15MBq /Kg of 99mTc-3BP-4961 but not more than 1200 MBq total. Participants will then be scanned using SPECT and CT for cancer lesion. After completion of the intervention, participants will be assessed for safety and tolerability using laboratory parameters and observation of adverse events. It is hoped that findings from this study will help further investigation for histopathological confirmation or tumour presence or tumour recurrence. Note: this brief summary is intended for lay audience.