ANZCTR search results

The purpose of this study is to investigate how safe and tolerable BTX 1702 (either as a solution or a gel) is compared to a placebo (either a solution or a gel) when it is applied two times a day for a planned period of 42 days on the face of participants with papulopustular rosacea. The study will also look at whether BTX 1702 (either solution or gel) improves or worsens papulopustular rosacea compared to a placebo (gel or solution) and whether there are differences in the effectiveness of the BTX 1702 solution compared to the BTX 1702 gel. Participants will be monitored for any reactions or signs of irritation that may be caused by BTX 1702.

The primary purpose of this study is to analyse and report on outcomes following treatment for patients presenting to a single orthopaedic surgeon, Mr Timothy Lording, for management of conditions affecting the knee. This clinical registry will collate and store patient outcomes collected routinely as part of the standard clinical pathway for knee treatments. Outcomes will include objective joint function, patient reported outcomes (pain, satisfaction, quality of life), radiological findings and rates of revision surgery or complications. The main hypothesis arising from the registry is that specific factors present before treatment will predict the likelihood of a patient experiencing a positive, or negative outcome (whether clinically indicated or patient-reported) following surgery.

Cisplatin is a medication anti-cancer chemotherapy that can cause damage to the inner ear of patients leading to hearing loss. A medication called DB-020 has been developed as a potential treatment for this hearing loss. The purpose of this study is to test how the body tolerates and processes DB-020 injected into the inner ear and make sure it is safe. Who is it for? You may be eligible for this study if you are aged at least 18 years old and are undergoing chemotherapy for cancer with a medication called cisplatin. Study details This study has two parts. In the first part, all participants will have ear injections. One of the ears will be treated with DB-020 and the other will be treated with a salt-based solution (a placebo). The concentration of DB-020 used and the ear that receives DB-020 will be determined by chance (like flipping a coin). Treatment involves an ear injection in line with cisplatin chemotherapy - every 3 or 4 weeks. In the second part, all participants will have ear injections of DB-020 at a concentration determined by the first part. Depending on the safety analysis from the data in Part A, participants will receive one ear with placebo and the other with DB-020, or DB-020 in both ears. As part of this study, all participants will provide blood samples; answer questionnaires and have hearing tests. It is hoped this research will provide some evidence that DB-020 can be used as a preventative treatment of hearing loss for patients receiving cisplatin treatment and provide the basis for further trials with this medication.

The research project is testing a potential new treatment for Idiopathic pulmonary fibrosis (IPF), called FTP-198. Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. Although laboratory and animal studies have been completed, this is the first time FTP-198 is being tested in humans. Therefore, side effects in human are unknown. Thus, the purpose of this study is to evaluate the safety and tolerability of single and multiple doses of FTP-198. The pharmacokinetics (PK) of FTP-198 in humans will also be determined. PK testing involves taking blood samples to measure how much of the drug gets into the blood stream, and how long the body takes to remove it or excrete it. When testing for PK, your sample will also be tested to determine the amount of LPA in your blood. This is called a pharmacodynamic (PD) parameter.

In our pilot observation, we found women who suffered from menstrual migraine to have poorer blood vessel function in the brain than women who did not suffer from migraine. Therefore, we hypothesise that improving and/or maintaining proper brain blood vessel function may potentially prevent the migraine from occurring. We believe that supplementing with resveratrol (a natural ingredient found in grapes and berries that is known to improve our cardiovascular and brain health) throughout the menstrual cycle may improve blood vessel function and ultimately prevent the menstrual migraine and improve the quality of life in sufferers. In this randomised, double-blind, placebo-controlled crossover trial, we will enrol 145 women aged between 18 and 50 who suffer from migraine +/- 3 days from their period for at least three out of their previous six menstrual cycles. Participants will take one 75mg resveratrol or one matching placebo capsule twice daily for three menstrual cycles before crossing over to the other treatment arm for another three menstrual cycles.

The aim of this study is to assess the safety and performance of a new vaccine delivery device that uses a patch to deliver vaccines. This study will show how the device performs, whether patients could use it themselves to apply the patches, and how long the patch should be left on the skin. No vaccine is used in this study. A placebo coating on the patch is used to represent the vaccine.

This application is for the purpose of conducting a randomised controlled trial (RCT) of a smartphone-based intervention (Anchored) aimed at preventing depression and promoting mental health and wellbeing within Australian workers. The app has previously undergone pilot testing for feasibility, usability and acceptability. Participants will be randomised to one of two conditions: (1) the Anchored app (a CBT, mindfulness, and behavioral activation-based smartphone app) and (2) a psycho-educational online resource. Post-intervention assessment will occur 30 days after baseline, and follow-up assessment will occur 3 and 6 months after baseline. All assessment will be completed online. Key outcomes include: depression caseness, depression symptoms, anxiety symptoms, stress, wellbeing, resilience, function, burnout, work productivity, and lifestyle elements.

Preoperative anaemia is independently associated with an increased risk of postoperative morbidity and mortality and greater health care expenditure. The purpose of this study is to determine the costs associated with preoperative anaemia in patients undergoing major abdominal surgery. Who is it for? Eligible patients will include adult patients who underwent colonic, rectal, pancreatic or liver resections at the Austin Hospital between July 2010 and June 2018. All data will be retrospectively collected. Study details: Costs from the entire inpatients hospital admission will be collected from Austin Health's Business Unit. We will evaluate the association of preoperative haemoglobin levels and hospital costs. It is hoped that this study will: 1) Quantify the costs implicated by anaemia and the impact of anaemia on pharmacological costs, medical costs, operative costs, intensive care unit costs and ward costs. 2) Quantify the impact of anaemia on costs within the following patient cohorts: a. Emergency and elective procedures b. Laparoscopic, open and combined procedures c. Malignant and non-malignant diagnoses 3) Identify key patient and perioperative variables associated with increased costs and adverse patient outcomes to ascertain areas for improvement allowing the development of evidence-based guidelines with the ultimate goal of improving patient outcomes and efficiency of our health services.

This study is hybrid II effectiveness-implementation study with data collected in outpatient clinics at a specialist paediatric children’s hospital. The study will involve a pragmatic randomised controlled trial which will be conducted after the intervention is refined using interviews, underpinned by the Consolidated Framework for Implementation Research framework, and conducted with a sample of children with skin conditions. A mixed methods process evaluation and cost effectiveness analysis will be conducted. Children will be randomised to one of two intervention groups: completion of patient-reported outcome measures plus graphical displays of patient-reported outcome measure information provided to caregivers, older children and treating clinicians in consultations versus completion of PROMs without graphical display of the information in consultations (results will be provided at the end of the study). The primary outcome of the effectiveness trial will be overall health-related quality of life of children.

The purpose of this study is to trial a new method for rebuilding the tongue after cancer surgery Who is it for? You may be eligible for this study if you are aged 18 or over and have tongue cancer which requires at least half the tongue to be removed. Study details All participants in the study will undergo a reconstructive surgery where a piece of thigh muscle will be used to rebuild part of the tongue. This procedure takes place general anaesthesia during the same surgical procedure where the excision of the tongue cancer takes place, and the entire proceduretakes approximately 8-10 hours. As part of the study, all participants will have post-op assessments of tongue function and answer some questionnaires. It is hoped this study will help us better understand and standardize tongue reconstruction to improve speech and swallowing outcomes.