ANZCTR search results

This is a first in human single-center vaccine study on Dengue Vaccine.The research vaccine is being developed to help protect against a type of virus called dengue virus. Infection with dengue virus can cause a flu-like illness (dengue fever) that sometimes develops into a severe complication (dengue haemorrhagic fever) The study will consist of 3 periods including the Screening Period,Treatment Period and Follow-up Period. After providing the written consent, subject will be screened for eligibility between Day -45 and Day -1. . Approximately 60 participants will participate in this study at one study centre in Australia. All participants will receive two vaccinations, with either the research vaccine or placebo given each time. A placebo is a sterile fluid that has no active vaccine in it. The study consists of 2 parts-Part 1 or Part 2.Participants in Part 1 will receive either low dose research vaccine or placebo. Participants in Part 2 will receive either standard dose research vaccine or placebo.The purpose of this research study is to check whether the research vaccine is safe and how well the subject can tolerate vaccination with the research vaccine (tolerability). The study will also test whether the research vaccine activates an immune response against dengue virus by measuring levels of antibodies (a type of protein involved in the immune response that may protect from future dengue infection) and immune response cells in the blood.

A single centre, open label, sequential dose study to assess the safety and tolerability of two strengths of PA5108 ocular implant in adult who have Open Angle Glaucoma. Participants who are currently administering combination drop therapy for Open Angle Glaucoma will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Elevations and excessive fluctuations of intraocular pressure (IOP) are associated with the development and progression of glaucoma. To date, limited research has examined the effect of topical treatments on the patterns of IOP fluctuations in glaucoma patients throughout the course of the day. Access to a novel self-measurement device (Icare HOME), in addition to the research team’s experience in a completed clinical trial and access to an existing glaucoma patient cohort will allow the facilitation of a project which aims to: • Evaluate the effect of topical glaucoma treatments (prostaglandin analogues and beta blockers) on diurnal IOP • Identify glaucoma progression risk in patients with previously undetected, inadequate IOP control • Provide the basis for translational research integrating rebound self-tonometry into clinical protocols for improved glaucoma patient management Results from this study could influence clinical management protocols for glaucoma patients and suspects. Identification of diurnal IOP-related risk factors for disease progression could help clinicians manage at-risk patients appropriately to prevent irreversible vision loss.

The purpose of this study is to determine if specific immune system cells, called dendritic cells, have a role in patients with non-small-cell lung carcinoma undergoing anti-PD-1 immunotherapy. Who is it for? You may be eligible for this study is you are an adult who has confirmed non-small-cell lung carcinoma. Study details Patients from Monash Medical Centre with non-small-cell lung carcinoma to be treated with anti-PD-1 immunotherapy who consent to this study, will have blood samples taken at baseline (before commencing therapy) and prior to each treatment cycle (approximately every 2 to 3 weeks). The blood and serum samples will then be used to test for inflammatory markers. Additionally, participants archival tissue samples will also be used to detect dendritic cells and expression of PD-1. The identification of markers associated treatment response would allow for greater accuracy in selecting potential responders to treatment.

Randomised Controlled Trial of DBT Interventions for Young People with Emotion Dysregulation 1.0 Project Overview Previous research has predominantly examined the efficacy of DBT in reducing self-harming or suicidal tendencies, BPD symptoms and improving emotion regulation in adult populations, with efficacy for DBT therapies being demonstrated across a range of therapeutic settings (Groves, Backer, van den Bosch & Miller, 2011; Stoffers et al., 2012). Despite promising research findings, the body of DBT research on younger populations is limited and lacks methodological rigour. The study is a randomised controlled trial of 120 clients, with study arms designed to mirror routine clinical care. Participants will be assessed at baseline and followed up at 8, 16 and 24 weeks. Primary outcome variables include: emotion regulation, and BPD symptoms. Secondary outcomes include: suicidal ideation, coping skills, mindfulness, depression, anxiety, stress, functioning, and severity of drug use. 4.1 Rationale/Justification When compared to treatment as usual, there is some evidence that DBT can result in significant improvements in youth populations across a range of outcomes. Despite these promising research findings, the body of DBT research on younger populations is limited and lacks methodological rigour. 4.2 Research Aims In this RCT we aim to investigate and compare the efficacy of two programs for young people experiencing difficulties with emotion regulation: 1) an 8-week group DBT informed skills training program; and 2) a 16-week intensive DBT program. It is hypothesised that both groups will experience improvements, but that these improvements will be greatest for the 16 week intensive DBT group compared to the 8 weeks skills training group at 24 week follow-up in terms of the: (i) primary outcome variables of emotion regulation, and BPD symptoms; and (ii) secondary outcome variables of suicidal ideation, coping skills, mindfulness, depression, anxiety, stress, functioning, and severity of drug use. 5.0 Project Design 5.1 Project Design Overview This project is a RCT comparing the effectiveness of two DBT interventions (8 week skills-based group training and 16 week intensive DBT program) for young people aged 16-25 years presenting to Headspace (Southport) with symptoms of emotion dysregulation and/or borderline personality disorder. Approximately 120 young people will be recruited to the project (through self-referral, with 60 per study condition. The trial will be conducted over 24 weeks. Headspace Southport (the implementation site) already delivers the 8 weeks skills-based group program and 16 week intensive DBT program on-site.

Hepatic resection remains the standard of care for both malignant and benign tumours of the liver, despite numerous advances in tumour ablation, targeted radiation therapy, immunotherapy, and chemotherapy for liver cancers and related pathologies. As perioperative outcomes have improved over the last two decades, along with developments in the diagnosis and management of liver tumours, indications for hepatic resection have broadened. Accordingly, increasing knowledge of liver anatomy and physiology, alongside improving outcomes following hepatic resection, has fostered an increase in the complexity and extent of disease that is considered operable, with repeat and two-stage resections becoming increasingly more common. Increasing complexity and extent of hepatic resection carries an increase in the incidence and severity of postoperative complications, with typically more than 50% of patients experiencing complications even in high volume centres. Complications following liver resection not only carry a substantial clinical burden, they also place a growing economic burden upon healthcare providers. Complications present the greatest contribution to increased costs following hepatic resection, and consequently provide an important target for interventions seeking to reduce healthcare expenditure. As the demand for healthcare grows, utilising limited resources in an era of mounting costs is becoming paramount in maintaining an effective and universally available healthcare system. Despite this, there is limited health economic data available on the topic of hepatic resection, and even less so quantifying the cost of complications. Aiming to address this need, we aim to identify the relationship between the extent of liver resection, the incidence and severity of complications, and the ensuing costs. Additionally, we seek to examine the sources of cost differentials between complicated and uncomplicated patients. Secondary objectives aim to assess the impact of surgical technique on the incidence and severity of complications and associated costs. We also aim to identify patient and anaesthetic factors associated with the clinical and economic outcomes. We hypothesised that as more extensive hepatic resection was performed the incidence and severity of complications would increase, and accordingly an increase in costs would be associated.

Colonic spirochaetosis (CS) was first described in humans in 1967. The role of CS in human health and disease has been debated in the literature and historically it was considered to be a commensal organism. Recent studies have shown that CS is associated with abdominal pain and diarrhoea in multiple population samples and that CS is associated with subtle but clinically significant submucosal eosinophilia. This supports the hypothesis that CS is a pathologic finding that should be considered in cases of diarrhoea predominant irritable bowel syndrome (IBS-d). Despite this there is no clear treatment recommendation for CS. CS prevalence in developed countries is estimated to be 2-7%. Furthermore, the risk of IBS-d symptoms in patients with CS is three fold. In western populations the prevalence of the irritable bowel syndrome is 7-16%. If a conservative estimate is taken it is possible that 2% of the general population is infected with CS and experiences potentially treatable symptoms of IBS-d that have a significant personal and economic costs. Our research question follows on from this to ask whether treating CS in patients with IBS-d will lead to an improvement in symptoms. This question has not been adequately answered in a prospective high quality trial. A positive result would demand confirmation and further trials to estimate sustainability of the effect. This has the potential to change the diagnostic and treatment algorithm for IBS and affect a substantial number of people. It is interesting to note that metronidazole is used to empirically treat chronic diarrhoea in the community with anecdotal benefit and this may represent unknowing treatment of CS.

The aim of this study is to assess feasibility, tumour response, adverse events, and quality of life of aerosolised chemotherapy in peritoneal cancer/s Who is it for? You may be eligible for this study if you are ages 18 or above and have clinical confirmation of unresectable peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer Study details This study is for patients who have unresectable peritoneal metastases and have not responded to standard systemic chemotherapy. All eligible patients will receive the intervention. In a operating theatre, your belly/abdomen will have chemotherapy pumped directly into it. This study will involve blood tests, imaging, questionnaires and physical examinations. It is hoped this research will demonstrate the safety and effectiveness of this technique in the management of peritoneal metastases.

The purpose of this study is to assess the effectiveness of the percutaneous flexor tenotomy when performed in the outpatient setting in people with diabetes, digital deformity and loss of protective sensation with a toe ulcer or pre-ulcerative lesion. Percutaneous flexor tenotomy is a minimally invasive procedure that involves cutting one or both tendons underneath the toe using a fine scalpel blade or needle. The procedure serves to remove the deforming force that causes deformity of a toe that generates an ulcer. Percutaneous flexor tenotomy is an alternative to conventional open surgical procedures performed in an operating theatre. Participants enrolled in the study are reviewed weekly until the percutaneous incision is healed, or until ulcer healing. Participants are then followed up at 3- and 6-months post procedure. The time to ulcer healing, re-ulceration rate, frequency of complications, such as infection or transfer lesion (a new onset ulcer or pre ulcerative lesion on an adjacent toe) and patient satisfaction are recorded.

This is a phase 2, randomized, double-blind, placebo-controlled study of intravenous FDY-5301 in tourniquet induced sarcopenia in patients undergoing unilateral TKA. Study patients will be recruited at each investigational site (or referred to the investigative site from another institution) for first unilateral TKA. Patients will be screened and written informed consent will be obtained prior to initiation of any study related procedures in those patients who meet the inclusion and exclusion criteria for the study. A minimum of 30 evaluable patients will be enrolled and randomized to receive either FDY-5301 1.0mg/kg or volume-matched placebo. Study drug administration will occur by bolus injection at any time between 10 and 5 minutes prior to tourniquet release/limb reperfusion. All patients who receive study drug and have tourniquet use will be followed up for safety and efficacy for 6 weeks post-study drug administration.. Patients who do not undergo toirniquet inflation for any reason who received study drug will be followed up for safety, but will be replaced with a new patient.