ANZCTR search results

Major pregnancy complications such as preeclampsia and gestational diabetes mellitus are associated with development of type II diabetes mellitus and coronary heart disease, which are becoming ever more prevalent in young women. Despite clinical recommendations to optimise cardiovascular disease (CVD) risk factors after a complication of pregnancy, tailored lifestyle programs have poor adherence and are not suited to the lifestyle of a mother during the early postpartum period. Breastfeeding (lactation) is associated with a reduction in hypertension and diabetes later in life, however there has not been a direct focus on elucidating how breastfeeding affects certain components of cardiometabolic health in women with a previous pregnancy complication within the early postpartum period. We hypothesize that those who have a higher lactation intensity over 6 months postpartum (>=0.8 intensity score) will have a lower risk of metabolic syndrome at 6 months postpartum following a major pregnancy complication. This project aims to determine if lactation intensity is associated with a reduction in the rate of metabolic syndrome at 6 months postpartum in women with a maternal complication of pregnancy.

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. Study details Participants will receive Tutelix solution injected through a fine gauge needle and forms a cohesive hydrogel matrix upon administration. 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.