ANZCTR search results

This research study in healthy subjects is testing the safety, tolerability, and pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a bilayer tablet formulation of a drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) when it is given Intravaginally (into the vagina) as a bilayer tablet. Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of Bacterial Vaginosis (BV). The overall goal of this study is to optimize the formulation to test in future studies as a treatment or prevention of recurrence of BV. Healthy subjects will receive 3 doses of study medication in the clinical unit separated by 24 hours on consecutive days of their preference . A series of vaginal swabs and blood samples will be collected over a 24-hour period following each of the three doses in clinic and once on the final day of the study (Day 4).

The aim of this clinical trial is to determine if the study ointment assists with skin conditions including mild eczema and/or rash, cracked or dry skin on heels, insect bites and sunburn. The study ointment is currently in use in Australia as a topical treatment. The effectiveness of the study ointment for skin conditions has not been assessed in a clinical trial. The study team will identify a treatment patch and a similar patch that will not be treated and will be the control site. You will be asked to apply the study ointment 3 times per day to the treatment patch and not to the control patch. Participants with mild eczema and/or rash and cracked or dry skin on heels will be treated with the ointment for 21 consecutive days. Participants with insect bites and sunburn will be treated with the ointment for 10 consecutive days. The response will be assessed using daily photos that will be assessed by the study team using a skin irritation score as well as by a participant rating tool.

A prospective randomised controlled pilot trial investigating the effectiveness of a reduced carbohydrate enteral formula in improving clinically important surrogate markers (reduced insulin administration, glycaemic variability and hypoglycaemic episodes) associated with increased mortality in hyperglycaemic critically ill enterally fed patients when compared to standard care Aims: To determine if the use of a reduced carbohydrate formula improves overall blood glucose control and clinical outcomes when compared to standard care in critically ill patients with hyperglycaemia. Hypothesis: Patients receiving a reduced carbohydrate formula will have improved glycaemic control during their ICU admission when compared to patients receiving standard care.

This study is aiming to assess whether a 'prehabilitation' exercise program that is completed prior to any cancer treatments, is feasible and beneficial for patients with non-small cell lung cancer. Who is it for? You may be eligible for this study if you are aged 18-85, you have been diagnosed with inoperable (not eligible for surgical removal) non-small cell lung cancer, and you have not yet started any chemotherapy or radiotherapy to treat your cancer. Study details All participants who choose to enrol in this study will be given an individualised exercise program to complete 2-4 days per week, depending upon their health and ability to complete the exercises. At least two 60 minute sessions will be completed each week at the hospital rehabilitation centre under the supervision of a senior physiotherapist. An additional 1-2 sessions will be completed by participants at home. Each exercise session will include walking on a treadmill or outside, as well as some resistance exercises that target different muscle groups. The exercise sessions will run between 4-8 weeks prior to any cancer treatment that doctors have prescribed, this will vary for each participant. It is hoped this research may be used to improve health outcomes for people with inoperable lung cancer by determining whether a pre-treatment rehabilitation program is feasible and whether it has any impact on their overall health after starting medical treatment.

We aim to prospectively validate a scoring system, the SALT score, in a cohort of patients with anterior skull base tumours undergoing endoscopic endonasal skull base surgery. We will assess how much patients drink and urinate in the days after surgery, as well as routine blood tests, to establish if patients develop diabetes insipidus, a condition where patients are not able to concentrate their urine. We will then assess whether the SALT score was able to predict which patients developed diabetes insipidus.

This project will look at the effects effect of a single 30-minute session using the MetaNeb® device versus a single session of directed huff and cough (control) on the primary outcome of lung structure, regional perfusion and ventilation and secondary outcomes of respiratory mechanics, airflow obstruction, sputum expectoration and symptoms related to CF in adults with stable CF. Our hypothesis is, in this population, a single MetaNeb® treatment, will be more effective in changing and/or improving these primary and secondary outcomes than huff and cough alone.

This study aims to evaluate the effects of an enhanced, online parenting program that provides parents with strategies to reduce their adolescent’s risk of developing depression and anxiety disorders in the context of the COVID-19 pandemic. An existing parenting program (Partners in Parenting, PiP) will be enhanced to include COVID-19-specific content, online peer support groups, and responsive content added to the program based on topics identified by parents in the peer support groups. The new program, PiP-Plus, will provide parents with: 1) tailored feedback about their current parenting; 2) up to 10 interactive online modules designed to support parents to make changes to their parenting, including content about parenting during the COVID-19 pandemic; and 3) access to an online peer support group with other parents completing PiP-Plus. All parents of teenagers aged 12-to-17 years in Australia, who speak English and have internet access, can take part in the trial. We aim to find out whether completing the PiP-Plus program can help improve parents’ confidence in parenting during the COVID-19 pandemic, as well as their feelings of psychological distress, social support, parenting behaviours associated with adolescent depression and anxiety, and in turn symptoms of depression and anxiety in their teenagers.

standard method will include a verbal explanation of the procedure including: surgical complications, potential benefits, details of the injury and surgical management. The detailed method will include the same information as the standard but the process will be supplemented by a written tool, including procedural information and visual aids. We hypothesise that the patients that are consented utilising the detailed method will have greater overall post-operative recall in comparison to the patients that receive the standard consent method.

This study aims to determine whether injection of a corticosteroid (triamcinolone acetonide) directly into squamous cell carcinoma (SCC) lesions of elderly patients (older than 70) is safe and whether this drug has any effect on the size of the lesions. Who is it for? You may be eligible for this study if you are aged 70 or older, you have at least one lesion on either of your legs clinically consistent with low-grade SCC, and you have been deemed to be at high risk of surgical complications because of pre-existing lower limbs conditions (such as diabetes mellitus, chronic venous disease affecting the lower limbs, previous lower leg cellulitis, previous poor wound healing at the legs, lower limb oedema). Study details All participants who choose to enrol in this study will undergo a biopsy of one of their SCC lesions to determine the severity of the lesion and whether they are eligible to enrol in this study. Two weeks after this biopsy, eligible participants will be randomly allocated by chance (similar to flipping a coin) to have their SCC lesion injected with either the corticosteroid drug or a placebo (sterile injection solution). A maximum of one injection will be made over a 5 week period. Prior to this injection and after the last review at 5 weeks, all participants will be asked to complete two questionnaires about their lower limb function and quality of life. These questionnaires are anticipated to take 20 minutes. No further study visits will be required after the 5 weeks. It is hoped this research will demonstrate that corticosteroid injection into SCC lesions is safe and able to reduce the size of the lesions, which may then be used to improve health outcomes for future patients with SCC.

Local anaesthetic injections to the nose may be painful and patients often require intravenous sedation. At the same time, local anaesthetics injections to the nose may lead to sneezing especially when performed in a sedated state. Sneezing during these injections however poses potential patient safety concern, potential infectious spread via aerosol generation and an occupational health hazard. We hypothesise that administering intravenous fentanyl (a strong opioid) as part of intravenous sedation may lessen the incidence of sneezing in these circumstances. The primary aim of the study therefore is to determine whether administration of intravenous fentanyl as part of propofol-based intravenous sedation given prior to nasal injection of local anaesthetics will reduce the rate of sneezing compared to propofol-only intravenous sedation in adults undergoing plastic surgery to the nose.