ANZCTR search results

The main aim of the study is to test the safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of APG333. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as asthma and chronic obstructive pulmonary disease, which is the anticipated main therapeutic use for APG333.

The objective of this study is to assess the tendon healing rates and clinical outcomes of arthroscopic rotator cuff repair (aRCR). This randomised control trial (RCT) will compare the standard aRCR (Control group) with two treatment groups, aRCR augmented with either intra-operative administration of concentrated bone marrow aspirate (cBMA) or leukocyte-poor platelet rich plasma (LP-PRP). We hypothesise that augmented rotator cuff repair will result in statistically significant benefits for rotator cuff healing on ultrasound and MRI as well as clinical shoulder scores.

This study will investigate the acceptability and impact of a hybrid paper- and web-based Australian Decision Aid on shared decision making for low-risk Papillary Thyroid Cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above with a clinical suspicion of low-risk thyroid cancer Study details Participants in this study will be allocated to one of two groups based on the time point of clinical review: one group will receive standard care, where a decision on thyroid treatment is made in consultation with the patient's clinician. The other group will be provided with a hybrid (paper and web-based) decision aid for initial management of low-risk thyroid cancer. These decision aids will assist in providing the patient with relevant information and awareness, therefore creating choices for patients and their individual preferences. Information is tailored to patients and their treatment options, to enable shared decision making with their specialist. Clinicians’ and patients’ acceptability of the support aids in clinical practice will be assessed. Patients will answer questionnaires to determine decisional conflict, regret, satisfaction and health related quality of life. Total thyroidectomy remains the predominant procedure, despite recent guidelines advocating a de-escalation approach to thyroid cancer surgery. Treatment decision making in low-risk thyroid cancer is complex. This research will address the information gap in low-risk thyroid cancer management and examine the effect of a patient decision aid on the clinical encounter.

This early phase study is to assess the pharmacokinetics (how the body processes a drug), safety, and tolerability of ILYX-002 administered as an eye drop. ILYX-002 is being developed as a potential treatment for Dry Eye Disease. In this study, approximately 16 generally healthy male and female adults will be enrolled. Fourteen will receive ILYX-002 and two will receive vehicle, which is an eye drop of similar makeup except no active drug substance. Participants will stay at the study center for a total of 9 days. While residing at the study center, participants will receive their assigned study treatment approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.

Major depressive disorder (MDD) is a prevalent chronic psychiatric disorder associated with reduced quality of life, hence posting substantial socioeconomic challenges to the community. Yet, effective routine strategies, pharmaceuticals and non-pharmaceuticals, that are in use in mental health management to reduce this burden are limited. Considering a clear unmet clinical need and the development of new technologies, this project proposes to conduct a pilot study, We hypothesise that the virtual sailing exercise over a 6 week period will reduce depression and improve the quality of life for people with MDD. We also hypothesis that the virtual sailing program could result in neuroplastic changes in the brain that restore altered functional connectivity MDD. Investigating the therapeutic potential of virtual sailing in the treatment of adults with MDD to establish evidence-informed strategies for future clinical translation.

The aim of the study is to see whether taking a drug known as a COX-2 inhibitor (used for arthritis), and another known as a Beta blocker (used for heart rhythm management), for a number of days before and after surgery, has an impact on inflammation and stress hormones in patients with Stage III melanoma (such as melanoma in lymph nodes). Who is it for? You may be eligible for this study if you are an adult patient with known metastatic cutaneous melanoma in lymph nodes and/or in transit recurrences in skin, measuring at least 0.5cm in largest diameter, appropriate for surgical management and where surgery is expected to render the patient clinically disease free. Study details Participants will be randomly allocated to take a regimen of two drugs (propanolol and celecoxib) orally for a number of days before and after surgery, or to a standard care arm where participants will undergo surgery without an additional drug regimen. Participants will be asked to provide blood samples and complete questionnaires relating to their quality of life at baseline and up to 4 months after surgery. It is hoped that findings from this study will inform future studies on the effect of perioperative propanolol and celecoxib on recurrence rates of melanoma in patients with Stage III disease.

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.