ANZCTR search results

Deep Vein Thrombosis ( DVT) is a serious, preventable and treatable medical condition. Without timely treatment, there is significant morbidity and mortality. Optimal patient outcomes require judicious prevention strategy with pressure stocking and prophylactic anticoagulants as well as early recognition of venous thromboembolism and prompt treatment with therapeutic anticoagulants. There is a reasonable amount of literature guiding the management of inpatient thromboembolism prevention. However, there is a paucity of evidence-based recommendations to guide the management for Emergency department patients discharged with lower limb immobilization. We are proposing to target these patients in a randomized Control Trial to determine whether oral aspirin is an effective alternative to subcutaneous (SC) Enoxaparin (Clexane) to prevent DVT on low to medium risk group of these patients. This pilot study can help to design a larger scale trial in this population.

Title: An ALLG phase II, multicenter, open-label trial evaluating the efficacy and safety of ELVN-001 in patients With Chronic Myeloid Leukemia (CML). Purpose of this trial: The purpose of this study is to determine if the drug ELVN-001 is safe and can help patients with chronic myeloid leukaemia (CML) live longer without the disease returning or worsening. ELVN-001 is designed to specifically block the activity of the abnormal BCR::ABL1 protein that causes CML. Who is this trial for: You may be eligible to join this study if you are aged 18 years or above, have a new diagnosis of CML, and have specific changes in the BCR::ABL1 gene. Your treating hospital will assess whether you meet all the requirements. This multi-centre study will recruit a total of up to 100 participants across Australia and New Zealand. Trial details: This is a phase 2 study. Participants will receive an oral tablet of ELVN-001 given once a day with a large glass of water at the same time each day. The total treatment time is about 4-5 years. Participants will be eligible for treatment-free remission (TFR) after taking ELVN-001 for at least 4 years, with no signs of the cancer returning for at least 2 years. Participants will be checked at the hospital after taking the drug for 1 week, then at each month until 3 months, then every 3 months until 5 years. Data will be collected about the participant through the National Blood Cancer Registry (NBCR) for 5 years. Researchers hope that treatment with ELVN-001 will help more patients achieve a deep response to treatment, improve long-term outcomes, and reduce the risk of complications and side effects related to CML and its treatment.

Many people with pancreatic cancer experience severe abdominal pain caused by involvement of the celiac plexus, a group of nerves in the upper abdomen. The INCEPTION study is evaluating a new radiotherapy approach called three-fraction celiac plexus radioablation, which aims to reduce pain while minimising side effects. Who is it for? You may be eligible for this study if you are an adult with pancreatic cancer and cancer-related abdominal pain caused by involvement of the celiac plexus. Participants must have either biopsy-confirmed pancreatic cancer or imaging evidence of a tumour involving the celiac axis. Study details All participants will undergo a planning CT scan, followed by three 15-30 minute radiotherapy treatments each separated by at least 48 hours, over the course of about one week. Follow-up assessments will occur approximately 48 hours, 2 weeks, 4 weeks and 3 months after treatment and will include pain assessments, quality of life questionnaires, opioid medication use and safety monitoring It is hoped that findings from this study will help clinicians and researchers evaluate whether this treatment can be delivered efficiently within routine clinical practice.

This project aims to conduct a controlled trial to investigate the effectiveness of MindWise Leadership, an evidence-based mental health training program for people-leaders in nursing and midwifery. This trial will be used to measure whether this training program will improve managers' and leaders' responsive behaviours, preventative behaviours, confidence, knowledge and stigma regarding employee mental health. It also aims to investigate whether any changes are sustained over a 6-month period. The research aims that this research seeks to address are: Primary objective: Evaluate the effectiveness of MindWise Leadership in improving managers’ behaviour regarding employee mental health matters in the workplace Secondary objectives: Evaluate the effectiveness of MindWise Leadership in improving managers’ confidence, attitude, and knowledge regarding employee mental health. Evaluate the effectiveness of MindWise Leadership on reducing employees’ sick leave and medical errors.

In this study, the safety and tolerability of the study treatment, PNV-8297, will be evaluated in healthy volunteers when it is taken with or without a high-calorie meal over 14 days. PNV-8297 is a potential new treatment for Major Depressive Disorder (MDD) which has not been given to humans before. This study aims to test how the body responds to the study drug in a fed or fasted state, and whether it has any undesirable side effects.

In this study, the safety and tolerability of the study treatment, PNV-8297, will be evaluated in healthy volunteers when it is taken orally as single dose, or in multiple doses over 14 days. PNV-8297 is a potential new treatment for Major Depressive Disorder (MDD) which has not been given to humans before. This study aims to test how the body responds to the study drug, and whether it has any undesirable side effects.

Sleep disorders are poorly identified and managed in shift workers, and associated with considerable risk to worker health and safety; particularly in the early career years. Recognising the additive effects of unmanaged sleep disorders with shift work schedules and insufficient sleep, unmanaged sleep disorders represent a considerable work health and safety issue which require solutions for organisations repsonsible for rostering and managing fatigue-related hazards. The purpose of this study is to explore feasibility, acceptability and appropriateness of a tailored approach to identifying at-risk early career shift workers, and examining the impacts of supporting help-seeking for safety (risky driving), productivity (absenteeism and presenteeism), burnout and turnover intention.

The purpose of this study is to evaluate a new genetic testing method for detecting microbes (including bacteria) during pregnancy. The study will compare this test with the standard laboratory testing currently used in clinical care. We expect that the new test will be acceptable to patients and healthcare professionals and will identify infections at least as well as standard testing, while also providing additional information that may help guide the prevention and treatment of infections in mothers and newborns. The feasibility of using this new testing method in routine antenatal care will be assessed through its performance compared with standard testing, participant feedback, and assessment of the resources and costs required for implementation.

Transvaginal ultrasound is commonly used to assess endometriosis, but the examination can be associated with pain, anxiety and emotional distress. This study aims to find out whether using immersive virtual reality during transvaginal ultrasound is feasible, acceptable and safe for women with endometriosis. Twenty women will be randomly assigned to have either a standard transvaginal ultrasound or a transvaginal ultrasound while using immersive virtual reality. The study will assess whether participants can be recruited and retained, whether virtual reality can be successfully used during the examination, and whether the study procedures are practical and acceptable. It will also explore participants' experiences of pain, anxiety, distress and control to help inform the design of a larger future trial.

.This study is evaluating the safety and efficacy of Dendritic cell Immune activation combined with Venetoclax and Azacitidine as frontline therapy for patients with newly diagnosed acute myeloid leukaemia unfit for intensive chemotherapy Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with acute myeloid leukaemia unfit for intensive chemotherapy and receiving Venetoclax-Azacitidine as frontline induction therapy Study details All participants will receive Vididencel (an off-the-shelf allogeneic dendritic cell immune activator) in combination with standard-of-care Venetoclax and Azacitidine. Vididencel treatment regimen consists of four priming doses administered on Day 1 and 15 of Cycles 1 and 2 followed by two booster doses administered on Day 1 of Cycles 4 and 5. Participants will be assessed for safety and tolerability using clinical examination, blood tests, vital sign monitoring, reporting of adverse events for the duration of their treatment over the first 6 months. Measurable Residual Disease will be assessed using examination of blood cells and molecular markers during each cycle until the end of the study over 3 years