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Identifying the best way to monitor blood sugar levels in people with diabetes after a heart or lung transplant
Expand descriptionFollowing a heart or lung transplant, medications required to prevent rejection increase the risk of developing post-transplant diabetes mellitus. In many individuals, insulin treatment is required to maintain normal glucose levels and prevent diabetes related complications. Insulin treatment is complex and requires self-monitoring of blood glucose levels using fingerprick testing to avoid prolonged periods of high or low glucose levels. This study aims to determine if continuous glucose monitoring increases the amount of time blood glucose levels are maintained within the normal range compared to standard fingerprick glucose testing.
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Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)
Expand descriptionThe ACT for ICE project uses an Acceptance and Commitment Therapy based intervention called the Recovery and Support Program (RaSP) to support women with a diagnosis of methamphetamine use disorder. The purpose of this study is to look at how well the RaSP program works in alcohol and drug treatment. This will include looking at how many people participate, their scores on some questionnaires, what they liked and did not like about the program, whether they can think more flexibly after completing the program and whether they are using less methamphetamine.
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ACTIVE KNEECAPs! tArgeted effeCTIVE treatments for adolescent KNEECAP pain
Expand descriptionACTIVE KNEECAPs! aims to identify effective and cost-effective interventions for adolescents with kneecap pain. This multicentre randomised controlled trial will investigate whether foot orthoses (shoe inserts) or a targeted physiotherapy program, when combined with advice, are more effective at reducing kneecap pain at 6 weeks, 3 months, 6 months and 9 months than advice alone. We hypothesise that foot orthoses or targeted physiotherapy, combined with advice, will result in greater improvement in kneecap pain than advice alone. Secondary aims are to investigate whether foot orthoses or targeted physiotherapy are more effective at improving function, quality of life, physical activity and pain medication use at 6 weeks, 3 months, 6 months and 9 months, and determine which intervention is more cost-effective.
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Aortic stenosis screening using artificial intelligence in adults 65 years and older living in rural and remote communities
Expand descriptionAs the population ages, aortic stenosis (AS, a heart valve disease involving degeneration and obstruction of the aortic valve) is becoming an increasing problem. This condition is often unrecognized until patients present in a crisis. The goal of the ASSURE-ECHO study is to identify the feasibility and value of AI-guided and-interpreted echocardiography for screening for aortic stenosis in the community. The aims of the project are to confirm the feasibility of AI-guided echo acquisition and interpretation in rural and remote communities, and to show greater recognition of AS than through usual care.
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The Role of Continuous Glucose Monitoring in Hospitalised Patients with Insulin-Requiring Type 2 Diabetes Having an operation: OPERATION GLUCOSE
Expand descriptionOperation Glucose is a clinical trial exploring whether continuous glucose monitors (CGMs) can improve diabetes management in hospitalised patients with insulin-requiring type 2 diabetes who are undergoing surgery. People with diabetes face a higher risk of complications during the surgical period, often due to fluctuations in blood glucose levels. This study aims to assess whether CGMs can help reduce these fluctuations (known as glycaemic variability), to support better blood glucose control and improved clinical outcomes. Participants will be randomly assigned to one of two groups. One group will wear a CGM device (Libre 2 Plus) that displays real-time glucose data to both the patient and the clinical team. This data, alongside regular finger-prick testing, will be used to guide treatment. The other group will wear a blinded CGM device (Libre ProIQ) which does not display glucose data. This group will rely on standard finger-prick testing alone for treatment decisions. The primary outcome will be the percentage of time that a patient's blood glucose levels remain within the healthy target range (4.0 - 10.0 mmol/L).
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Part B & Part D: Phase I Single and Multiple-Ascending Dose Trial of SPT-320 in Healthy Participants
Expand descriptionThis is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part B evaluates single ascending doses of SPT-320 compared with placebo. Part D studies multiple ascending doses of SPT-320 given once daily for 7 days, compared with placebo.
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A study to compare safety, tolerability, and how the body processes a powdered penicillin injection (Extencilline®) given into the muscle or under the skin in healthy adults
Expand descriptionThis study aims to find out how the body absorbs a powdered form of penicillin called Extencilline® when given by two different injection methods, into the muscle (intramuscular) or under the skin (subcutaneous). Penicillin is the main treatment for syphilis in pregnancy, but the current method (muscle injection) is painful and often requires multiple doses. A new method of giving the medicine under the skin may be less painful and more convenient. In this study, healthy adults will receive doses of penicillin using both routes of delivery at different times, and blood samples will be taken to measure how long penicillin stays in the body. The study will also look at side effects, pain, and participants’ experiences with both types of injection. We hope this research will help develop better ways to give penicillin in future studies involving pregnant women.
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A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in primary biliary cholangitis/primary sclerosing cholangitis patients.
Expand descriptionThe study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This registration is for the patient cohort, examining PVT201 in participants with PBC/PSC. All participants will receive a single dose of PVT201 on Day 1 of the study and participants will be followed-up on Day 2 & Day 7 of the study.
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The Effect of Sorbet Containing Australian Native Plant Davidson Plum on muscle recovery in Long-distance Runners
Expand descriptionThis study is a pilot randomised, placebo-controlled clinical trial to determine the impact of a Strawberry sorbet containing Davidson Plum powder on oxidative stress, and muscle recovery following a high-intensity interval training session in long-distance runners. The study incorporates a one week baseline period, 10 day intervention period and 24, 48 and 72 hours follow up.
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SLUMBER: A Study on the impact of Late-night Use of Melatonin in the Burden of Endometriosis-Related Sleep Disturbance
Expand descriptionHave received feedback which we are actively addressing to obtain HREC approval ERM Reference Number: 116499 Monash Health Reference: RES-25-0000-173A This study, called SLUMBER, is investigating whether melatonin—a natural hormone known to help regulate sleep—can improve sleep quality in women with endometriosis, a condition often linked to both pain and sleep disturbance. Participants will take either a placebo, 10 mg, or 20 mg of slow-release melatonin nightly for eight weeks. Researchers will assess changes in sleep, pain, and overall well-being through surveys completed before and after the trial. The study hypothesis is that melatonin use will lead to improved sleep quality, compared to placebo, in women with endometriosis.