ANZCTR search results

Protagonist Therapeutics, Inc. is developing PN-10943A as a potential oral therapy for patients with ulcerative colitis (UC). This study will be conducted in upto 80 normal healthy male subjects who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the safety and tolerability of PN-10943A to normal healthy volunteers. This includes vital signs, safety labs, ECGs, and physical examinations The drug will be given in single ascending then multiple ascending doses. The study will also evaluate the PK and PD of the drug after dose administration. Participants will be entered into standard study cohorts.

This study will evaluate the effect of MH-PR on a range of biomarkers and cognitive tests associated with age-related decline. Additionally, this study aims to evaluate additional health benefit through measuring change in QOL and blood pressure.

The study is a multi-site, comparator, retrospective, observational study to evaluate the safety of repeated dosing of methoxyflurane for the treatment of acute pain. The study will collect clinical laboratory and observational data to characterise the safety of methoxyflurane. A comparator group of non-methoxyflurane treated patients with burns or wound injuries will be included to further determine adverse events that may be associated with methoxyflurane administration. All relevant data will be collected from patients admitted to study hospitals for the treatment and management of burns or other wound injuries that will require interventions that may cause pain and/or discomfort and require analgesia for the management of acute pain. Patients included in the methoxyflurane group will have been administered no less than 4 doses of methoxyflurane, including a minimum of 2 doses in the first 7 days. The comparator group will have received analgesia (such as nitrous oxide) for treatment of acute pain. Particular emphasis will be directed toward those patients who have received a larger number of doses for a longer time period, as these patients may be considered at higher risk of an adverse event occurring.

We are aiming to assess the potential differences in immune cell proportions between healthy and diabetic individuals. We hope to identify these differences in order to decipher the gap in knowledge regarding the immune system, diabetes and heart failure.

In Australia, approximately 1 in 6 women has experienced domestic violence over her lifetime. Often the first professional an abused woman sees is her healthcare provider offering a unique opportunity for support. South Asian women are over-represented in domestic violence crisis service data but under-identified in general practice. HARMONY is a cluster randomised controlled trial testing the effectiveness of an intervention in primary care for doctors to sensitively identify, appropriately support and refer women, especially South Asian migrant and refugee women experiencing family/domestic violence. This study is adapted from a successful UK model and is being trialed in 28 general practices in high migrant regions in Melbourne. The intervention combines: (i) family violence training for all clinicians provided jointly by a GP trainer and bilingual family violence advocate; safety and confidentiality training for all reception staff, (ii) secondary consultation and feedback for clinicians by the bilingual family violence advocate, and (iii) family violence advocate support for victims referred from intervention practices. All practices will have innovative software tailored specifically to improve routine recording of family violence and migrant/refugee status in GP electronic data.

The study aims to see if it is feasible and acceptable to patients, families and carers as well as staff to use pulse oximetry to help keep patients safe while they are in a psychiatric intensive care unit. Pulse oximetry is a proven technology that is widely used in other medical and health settings. This is a new application of the technology. Participation in the study is voluntary and non-participation or withdrawal from the study at a later stage will not affect the treatment received at the unit.

We propose to study the effects of 3 month supplementation of CoQ10 on cognition versus placebo using a randomized controlled trial methodology. Our focus will be on older participants as this may be a sensitive age for cognitive improvement given that normal increasing age is associated with cognitive decline-particularly memory, the levels of CoQ10 decreases with age, there is increased deterioration in the cardiovascular system with age and finally there is increased oxidative stress with age and less anti-oxidant protection with age. All of these indicators suggest that supplementation with CoQ10 could improve cognitive function in the elderly. Apart from our sensitive cognitive battery we will also measure changes in blood levels of CoQ10 and oxidative stress (F2 Isoprostanes and glutathione peroxidase) as well as markers of cardiovascular function (Blood pressure, arterial stiffness and blood flow).

Cellulitis, a spreading skin infection treated with antibitoics, is routinely stratified according to severity and patient risk factors. Moderate-severity cellulitis is commonly treated with short-course intravenous antibitoics followed by oral antibiotics. This is some evidence to suggest moderate-severity cellulitis could be safely treated with oral antibiotics. This prospective, single-blinded trial will assess the efficacy and safety of oral antibiotics for the treatment of moderate-severity cellulitis. Participants will be randomized to treatment with either oral or intravenous antibiotics and assessed for rates of treatment success and complications.

In this study pharmacists trained in health coaching will provide coaching to patients with poorly controlled hypertension. Patients will receive three health coaching sessions with the pharmacist. The aim of this project is to determine if there is an association between health coaching provided by a community pharmacists and an improvement in blood pressure and medication adherence. The project will also look at the change in patients health behaviours through the study through assessing patient’s stage of change from a stages of change chart. The project will also look at the opinions and attitudes of the pharmacist health coaches throughout the study as well as those of the patients. An improvement in patients’ blood pressure is also expected at the end of the study as well as their health behaviours. It is also expected that patients will have an improved understanding of high blood pressure and its management.

A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)