ANZCTR search results

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide. Surgical ablation for the treatment of AF during concomitant cardiac surgery is a class I recommendation per STS and HRS guidelines. The AtriCure Isolator Synergy EnCompass-S Ablation System will be used to treat AF as part of planned cardiac surgery. The objective of Encompass-S First in Human study is to evaluate the performance of Encompass-S in patients undergoing AF ablation concomitant to cardiac surgery.

This study aimed to test whether passive increases in muscle and core temperature following a single session of hot-water immersion affect force steadiness and motor unit discharge rate variability. It was hypothesized that increased muscle temperature would impair force steadiness and increase the coefficient of variation in motor discharge rates. Additionally, it was expected that elevated core temperature would exacerbate these changes due to central activation fatigue. To test these hypotheses, the study evaluated force steadiness and motor unit discharge rate variability immediately after a 90-minute hot-water immersion at 42ºC, with elevated muscle and core temperatures, and again 15 minutes later, when muscle temperature remained elevated but core temperature had returned to baseline.

This study aims to evaluate the feasibility of inserting Tutelix (perirectal spacer) to reduce the dose of radiation to the rectum during radiotherapy for prostate cancer. Who is it for? You may be eligible for this study if you are a male with histologically proven low to intermediate risk prostate cancer, life expectancy greater than 10 years, and fit for Tutelix insertion as determined by radiation. For participants in cohort 1, you must be suitable for LDR brachytherapy for cohort 2 you must be suitable for EBRT. Study details Participants will receive Tutelix solution injected through a fine gauge needle and forms a cohesive hydrogel matrix upon administration. In cohort 1, participants will receive LDR brachytherapy 145Gy with lodine 125 permanent seeds as part of definitive RT for prostate cancer. For Cohort 2, participants will receive 60Gy in 20 fractions as part of definitive RT for prostate cancer. Post Tutelix insertion participants will be assessed for dose of radiation, dosimetry, toxicity, and product performance. It is hoped the findings from the study will show the reduction in radiation exposure will decrease bowel-related side effects of gastrointestinal symptoms, as well as an improvement in patients' bowel-related quality of life.

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.