ANZCTR search results

This study aims to determine whether E-EDV-D682 in combination with the adjuvant treatment, EDV-GC is safe and effective and to identify the most responsive cancer indications (advanced EGFR-expressing solid tumors) to the E-EDV-D682/GC treatment. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. A life expectancy greater than 3 months, measurable disease per iRECIST criteria, adequate haematological, renal, hepatic and cardiac function. You must have positive EGFR expression on local IHC or liquid biopsy. Study details In Phase I of the study a safety assessment will be performed on 3 participants from each cancer indication. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 20 participants for each cancer indication. The first treatment cycle will involve bi-weekly visits for 7 weeks. Doses of E-EDV-D682/GC in 3mL of 0.9% sodium chloride are administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with iRECIST to determine treatment response. Subsequent cycles will consist of weekly visits for 7 weeks. Following each 7-week treatment period is a treatment free week in which tumour burden is radiologically re-assessed (Week 8). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the funding from this study will help determine the safety and efficacy of EGFR targeted EDVs carrying cytotoxic drug PNU-159682 plus concurrent immunomodulatory adjuvant non-targeted EDVs carrying a-galactosyl ceramide in subjects with advanced EGFR-expressing cancers who have failed second-line therapy or where first- and/or second-line therapy is not appropriate

This pilot study aims to reveal the profiles of extracellular vesicles (EVs) and their associated proteins in periodontal diseases (refers to diseased groups) before and after treatment follow-up (3, 6 , 12, 18 and 24 months). Host and non-host EVs from periodontally healthy (without follow-ups as no need to follow up) will be used as controls. Whole oral samples (saliva, GCF and plaque) will be used as controls. There are two general aims for this project: Aim 1: Diagnosis and prognosis values of EVs and their associated proteins in periodontal disease groups Compare the differences in host and microbial derived EVs and their EV content expressions between periodontally healthy periodontitis and periodontitis undergoing treatment over a 1-year observation period Aim 2: EV profiles after in vitro biofilm culture Examine the microbial EV microbiome and proteome profiles in samples from both healthy and diseased groups following in vitro biofilm culturing It is hypothesised that host and microbial EVs and EV content are differentially expressed in diseased patients compared with periodontally healthy patients, and correlates with the severity of periodontitis. Furthermore, it is hypothesised that EVs will be positively correlated with improvements in clinical parameters after periodontal treatment.

This is an open label, Phase Ib/II trial with a platform design study for treatment of myelodysplasia. The purpose of this trial is to determine safety, recommended dose, and preliminary efficacy of PXS-5505 in combination with a HMA, ASTX727 (35mg decitabine and 100mg cedazuridine) in combination, in patients with transfusion dependent MDS. The initial dose determining part of this domain will be followed by a dose expansion proof of concept cohort. Who is it for? You may be eligible for this study if you are aged 18 or above and have been diagnosed with low or intermediate risk MDS. Study details This study will be conducted in two phases with cycles of 28 days. Phase 1 (Safety and Dose-Determination) will determine safety, tolerability and Recommended Phase II Dose (RP2D). Subjects will initially receive ASTX727 by oral capsule in combination with 200mg of PXS-5505 by oral capsule at the specified starting frequency. Dosage frequency may be altered according to patient responses. Phase II will assess the efficacy of PXS-5505 and ASTX727 combination based on independence to requiring blood transfusions and defined haematologic responses. Patients will continue receiving therapy until experiencing an event as detailed in the MDS05 Master Protocol. It is hoped this research will help us to determine if PXS-5505 and ASTX727 is a safe (minimal side effects/toxicity) and effective combination for treating MDS.

This study aims to assess the efficacy of a "Restorabite" device to treat a disorder called trismus in head and neck cancer patients. Who is it for? You may be eligible for this study if you are an adult with, or who has had in the past, head and neck cancer, and has trouble opening your jaw wider than 35mm. Study details Patients will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10-week study period. Data on changes in jaw opening distance and quality of life will be collected. It is hoped that findings in this study help researchers determine optimal stretching regime for trismus treatment. Participation in this clinical trial is voluntary.

This study aims to evaluate the toxicity and quality of life outcomes (QOL) associated with 2-fraction stereotactic ablative radiotherapy (SABR) for localized prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have intermediate risk localised prostate cancer. Study details: Traditional radiotherapy for prostate cancer typically involves four to eight weeks of daily treatment, Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiotherapy schedules. The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimizing side effects. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 2-treatment prostate SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of 2-treatment prostate SABR.

This study is investigating whether an immunotherapy drug (Cemiplimab) is effective as a treatment for cutaneous squamous cell carcinoma (a skin cancer of the head and neck), particularly for patients who have had their cancer spread to large nerves within the head and neck area. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with stage 3-4 cutaneous squamous cell carcinoma (cSCC) and you also have been diagnosed with a spread of this cancer into large peripheral nerves (also known as large-nerve perineural spread). Study details There is only one treatment available as part of this study, all participants who choose to enrol will be offered the same immunotherapy treatment. Cemiplimab will be given to participants via an infusion into a vein, once every 3 weeks for up to 8 treatment cycles (approximately 6 months). Participants will need to attend their local hospital to receive this treatment and to undergo additional CT and MRI scans to review their nerves that may have been impacted by the cancer. Participants will be asked to undergo CT and MR imaging at the time that they enrol in the study, then at 6 weeks, 12 weeks and then at 12-weekly increments for a maximum of 5 years. It is hoped that this study will help us understand whether cemiplimab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with cSCC of the skin in future and reduce the impact of this type of cancer on the nearby nerves in the head and neck.

Approximately 10% of children under the age of 18 reside with at least one parent who has a substance use disorder. For parents seeking treatment for substance use disorder, this increases to more than 25%. There can be a social stigma associated with using both legal and illegal substances while caring for a child. This does not necessarily mean parents/caregivers who use substances are malicious or unable to care for their child. However, it is often common sense that, for those bearing the task of raising a child, managing their own Alcohol and/or Other Drug (AOD) use and seeking treatment can make parenting/caregiving even more challenging. This project aims to trial and co-develop a group-based pilot parenting program developed for adults seeking treatment for their substance use from AOD services who are also parents/caregivers of one or more children aged 5 to 11. The aim of the plot intervention is to increase the use of effective parenting skills in this population to support parent-child positive interaction and aid in children's positive and healthy developmental outcomes. In this respect, the Alcohol and Drug Assessment Unit (ADAU) at the Princess Alexandra Hospital believes there is a moral imperative to include parents seeking treatment for substance use in the development of parenting programs that are relevant to this population. This is because these parents with substance use disorders often lack a clear voice or perceived legitimacy of their values and concerns in relation to caring for their families. Thus, the outcome here will be a brief group-based parenting support program developed by experts in consultation with parents who seek treatment for their AOD use. This program could, therefore, be offered as front-line treatment for adults in integrated AOD treatment services.

The research project aims to determine the safety of commonly used antibiotics in emergency departments among patient with and without chronic kidney disease, to determine if these antibiotics (gentamicin, tobramycin and amikacin) increase the risk of acute kidney injury in patients with chronic kidney disease.

This study investigates the impact of mechanical vibration on the dental and skeletal effects of different orthopaedic appliance therapies at different skeletal maturities. Orthopaedic appliance therapies are best treated while there is still growth potential at the cartilage but some patients may have missed the ideal treatment period or they are towards the end of growth potential. As a result, these patients may face orthognathic surgery to achieve skeletal correction. The results of this study may shed light on whether these patients who are towards the end of their growth can still be treated orthopaedically which in turns may lead in the avoidance of orthognathic surgery in the future. The hypothesis is that there is no statistically significant difference in the dental and skeletal effects from Class II orthopaedic appliance therapy with mechanical vibration between two different skeletal maturity status.

Vasoplegia is a state of circulatory shock that is a common complication after orthotopic heart transplantation, and increases the risk of prolonged ICU and hospital stay, increases the risk of acute kidney injury, and carries a higher risk of requiring dialysis long-term. It is thought to occur due to an abnormal immune response following the surgery. Currently, there are no licensed therapies to prevent or treat vasoplegia. Cytokine haemadsorption is a form of blood purification therapy, that is believed to reduce the incidence and severity of vasoplegia by removing the immune chemicals contributing to its development. Early evidence has shown improved patient outcomes from using cytokine haemadsorption intraoperatively during heart transplantation, but to date no study has evaluated whether cytokine haemadsorption used post-operatively (in addition to intraoperatively) has benefit. Given the proposed mechanisms of vasoplegia and our institutional experience indicating that it can persist for days after the surgery, we believe that using cytokine haemadsorption intraoperatively and postoperatively may further improve patient outcomes by reducing the incidence and severity of vasoplegia. We therefore propose a randomised trial of cytokine haemadsorption plus standard care vs. standard care alone in adult patients undergoing orthotopic heart transplantation.