ANZCTR search results

This is a, randomised, double-blind, placebo-controlled, phase 1b trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic (malaria parasitaemia 18S qPCR, pSTAT3, and immune responses) of artemether-lumefantrine (AL)+ Ruxolitinib (Rux) in healthy adults with P. falciparum IBSM. Twenty-six malaria-naïve, healthy males or females, aged between 18-55 years old, who meet all of the inclusion criteria and none of the exclusion criteria, are planned to be enrolled. Volunteers will be randomised in a 1:1 ratio to receive oral twice daily doses of AL+Rux or AL+placebo on Days 9, 10 and 11.. A sentinel dosing strategy will be used whereby two volunteers (one randomised to AL+Rux and one randomised to AL+placebo) will be dosed initially. The Safety Data Review Team will review safety and tolerability data up to and including Day 15 before dosing of the remaining 24 volunteers. As part of the informed consent process, volunteers will be asked if they agree to be contacted at approximately 3, 6 and 12 months after their end of study visit for blood sampling to investigate anti-parasitic immune response longevity.

This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able to reduce the pathological changes that might possibly cause ALS.

Atrial fibrillation (AF) is one of the leading preventable causes of ischemic strokes worldwide. Screening for AF in post-stroke populations is widely recognised as standard care, however given the paroxysmal and often asymptomatic nature of the disease it can be easily missed using standard 24 hour Holter monitoring. A higher rate of diagnosis can be achieved using longer-term implantable loop recorders (ILRs), but these are invasive and resource-intensive. Withings ScanWatches have the ability, via photoplethysmography (PPG), to continuously monitor heart rate and rhythm and may be a potentially useful diagnostic tool for detecting AF on a larger scale. Furthermore, Withings watches’ new built-in ECG promises to significantly improve accuracy of diagnosis when used in conjunction with PPG. Some previous studies have investigated the usefulness of Withings Watches in diagnosing AF, however no studies have investigating their usefulness utilising this new ECG feature in a post stroke population. Our study hypothesis is to investigate whether the Withings ScanWatch detects atrial fibrillation (an abnormal rhythm which can cause stroke) as effectively as an implantable loop recorder.

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.