You can narrow down the results using the filters
-
MOM NOSE Best: Mothers Own Milk Intranasally or Standard Care in Preterm Babies with Intraventricular Haemorrhage
Expand descriptionDespite improvements in neonatal intensive care for preterm infants, the burden of brain bleeds, termed Germinal Matrix-Intraventricular Haemorrhage, remains unchanged. Complications of GMH-IVH, including post-haemorrhagic ventricular dilatation (PHVD), are associated with significant long-term morbidity, including cerebral palsy and cognitive impairment. There are currently no readily available treatment options to treat GMH-IVH, prevent progression to PHVD and lessen neurodisability. Fresh maternal breastmilk, a rich source of reparative proteins, immune cells and stem cells, represents a promising treatment pathway. We propose that treating babies with GMH-IVH with a few intranasal drops of fresh mothers' own milk twice a day for 28 days will reduce PHVD. In this study babies will be randomly allocated to receive intranasal mothers' own milk or to standard care. All other aspects of the baby's care, including head ultrasounds and longer term developmental follow up, will be in accordance with routine care.
-
A First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of EBMC-710GO in Healthy Adults who are Overweight or have Obesity
Expand description710GO-HV-01 is a first-in-human, double-blind, placebo-controlled study evaluating the safety and efficacy of EMBC-710GO as a single dose or multiple ascending doses in healthy adults who are overweight or have obesity. You may be eligible for this study if you are aged between 18 and 55, are male or female, have a BMI between 25-40kg/m2 and do not have clinically significant (CS) medical history. The aim of this study is to determine a safe and tolerable dose of 710GO, and to assess how the study drug interacts with the body. Part A (SAD) will evaluate different doses of 710GO to determine the maximum safe and well-tolerated dose. Part B (MAD) will investigate two dose levels from Part A in greater detail.
-
A First-in-Human, Phase 1, Open-Label, Crossover Study Evaluating the Effect of Food on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of EBMC-710GO in Healthy Adults who are Overweight or have Obesity
Expand description710GO-HV-01 Part C is a first-in-human, open-label, crossover study evaluating the safety, efficacy and pharmacokinetics of EMBC-710GO as a single dose when taken with food in healthy adults. You may be eligible for this study if you are aged between 18 and 55, are male or female, have a BMI between 18-30kg/m2, and do not have clinically significant (CS) medical history. The aim of this study is to determine a safe and tolerable dose of 710GO, and to assess how the study drug interacts with the body when unfed, or when taken with food. Part C will evaluate the effect of food intake on the study drug's safety, tolerability and interaction with the body.
-
Patient Navigation and Peer Support to Improve Survivorship for Chinese- and Vietnamese-speaking People Affected by Cancer
Expand description -
A Phase 1 Randomized, Double-blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
Expand descriptionThe research study is looking at a new treatment for Diabetic Kidney Disease. The treatment is called MTX-439. This study is being conducted to learn how safe MTX-439 is and how well the body reacts to it. This is the first study of MTX-439 in humans and will look to recruit both healthy volunteers as well as patients with Diabetic Kidney Disease.
-
Ear Nose Throat (ENT) Probiotic Trial in Adults with Acute Streptococcal Pharyngitis/Tonsillitis
Expand descriptionThis dual-centre, randomised, double-blind, placebo-controlled trial will evaluate the effectiveness of a probiotic formula compared to a placebo over six weeks. The trial will recruit male and female adults aged between 18 and 65 years who have been recently diagnosed with acute symptomatic streptococcal pharyngitis and/or tonsilitis. The research project will investigate the number of symptomatic days, symptom severity, antibiotic use, health-related quality of life, detection of throat Streptococcus pyogenes, changes in oral microbiota composition, inflammatory biomarkers, safety and tolerability. The outcomes of this project will provide robust evidence on a targeted probiotic approach that addresses the high clinical burden of streptococcal pharyngitis and tonsilitis, the persistent antibiotic prescribing rates in primary care, and the need for non-antibiotic adjunctive strategies through mucosal immunity support and the modification of local microbial ecosystems.
-
Schizophrenia and Weight Improvement From Tirzepatide (SWIFT)
Expand descriptionThe SWIFT study is a conducted under the SPIRIT Master Protocol (Adaptive Platform Trial) and is a randomised, placebo-controlled single-blind parallel-group trial: over a 24-week period . The primary objective in this study is to determine percentage change in body weight with 24-week treatment with subcutaneous tirzepatide versus placebo, adjusted for baseline weight for participants schizophrenia or schizoaffective disorder. Specifically, it is hypothesised those participants allocated to the active arm tirzepatide treatment will have a greater reduction of percentage body weight at week 24 compared to participants taking placebo.
-
An Observational Study on the Effect of Gamified Virtual Reality Intervention (Myo-Hand XP) on the Rehabilitation of People Living with Upper Limb Loss or Differences
Expand descriptionThis project aims at understanding how virtual reality (VR) interventions help people living with upper limb loss or difference in their rehabilitation journey through observing how they use the technology and how they progress in the process. Individuals living with upper limb loss or difference will be recruited through the participating clinics. Potential participants will be screened by clinicians first to assess their suitability for VR-based trainings. Confirmed participants will need to have their details (demographics and limb conditions) recorded for the study, and have initial assessments taken on their first visit. Their progress and exercise will be recorded on each visit as organised with the clinicians. On their last visit, another assessment will be done to measure the outcomes. The findings of this study will help us understand the effectiveness of VR-based interventions on functional prosthetic rehabilitation, and develop implementation guidelines for such VR interventions.
-
The effect of treating bowel cancer presenting with bowel obstruction with relief of obstruction and chemotherapy prior to surgery on long-term abdominal recurrence risk
Expand descriptionThis study aims to investigate the effect of bridge-to-surgery strategy and chemotherapy prior to definitive surgery for patients with obstructing bowel cancer, compared to upfront surgery, on long term outcomes and recurrence. Who is it for? You may be eligible for this study if you are an adult with clinically and/or endoscopically obstructed colon adenocarcinoma, considered potentially resectable with curative intent and suitable for either upfront resection or a bridge-to-resection strategy. Study details Participants will be randomly allocated to undergo a 'Bridge-to-surgery' strategy (either colonic stenting or stomal diversion) with neoadjuvant systemic chemotherapy once effective relief of obstruction obtained, followed by definitive surgery (Intervention group) vs upfront surgical resection (Standard of care group). Data on peritoneal disease recurrence and survival outcomes will be collected. It is hoped that findings from this study will help clinicians and researchers determine the safest and most effective way to manage obstructed bowel cancers at their index presentation.
-
Hepatitis C testing and treatment in people with serious mental illness: a cohort study of hospital inpatients and community outpatients (Reach Out)
Expand descriptionIn Australia it is estimated that over 68,000 people are still living with hepatitis C, despite the introduction of highly effective direct acting antiviral (DAA) treatment for hepatitis C in 2016 and improved access via primary care. The number of treatments annually decreased from 2016 – 2022. People with serious mental illness are at higher risk of hepatitis C infection than the general population. Although the Royal Australian and New Zealand College of Psychiatrists recommends that psychiatrists encourage people to engage in hepatitis C testing on entry to the mental health service, uptake of this practice is unclear. Reaching people with SMI to offer hepatitis C virus testing may help achieve World Health Organization elimination targets by 2030 and enable this population to realise the benefits of hepatitis C cure. The Reach Out program will offer point of care HCV antibody testing on a finger prick of blood, to community outpatients with SMI. The Reach In inpatient quality improvement activity will offer standard of care HCV antibody testing on a routine blood test, to hospital inpatients with SMI.