ANZCTR search results

A clinical research to evaluate the safety and effectiveness of the Presidio Medical Low Frequency spinal cord stimulation over a 15 day period in patients with chronic, intractable low back and/or leg pain.

This study is aiming to investigate participants thoughts and feedback on their sun protection practices and new technologies to assist with sunscreen reapplication. Who is it for? You may be eligible for this study if you are aged 18 years or over, regularly use cosmetics and very fair to medium skin type Study details All participants will complete a 70 minute audio-recorded focus group at the Institute of Health and Biomedical Innovation. Discussion includes sun safety practices and the concept of technologies to assist with sunscreen reapplication. This research will be used to influence future design and implementation of products that assist with sunscreen reapplication.

The CODEC study (Circulating tumOur Dna in Endometrial Cancer) is pilot project exploring whether circulating tumour DNA (cancer genetic material collected from a simple blood test) can be used to predict endometrial cancer recurrence and potentially guide treatment. Who is it for? You may be eligible for this study if you have had a new diagnosis of a Type 2 endometrial cancer (which includes serous, clear cell, carcinosarcoma and high-grade (grade 3) endometrioid histologies) and are planned for surgery and have not had prior chemotherapy or radiation. Study details All patients enrolled in the study will have a comprehensive genomic tumour assessment and serial blood collections beginning pre-surgery and continuing for up to two years following surgery. Participants will also have MRI and PET scans. It is hoped that this research will help determine if genetic material collected using a simple blood test can help predict recurrence of endometrial cancer.

This study will investigate the real-world use of immunoglobulin therapy on clinical outcomes for patients with myeloma using the Australian and New Zealand Myeloma and Related Diseases Registry. Patients with the blood cancer myeloma are at risk of serious infection because of low levels of protective antibodies due to their condition and its treatment. Immunoglobulin therapy (made from plasma) is used to replace missing antibodies to prevent or treat infections in patients with blood cancers. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with multiple myeloma and participated in the Myeloma and Related Diseases Registry Study details This observational study will collect ‘real world’, up-to date Australian clinical and laboratory information on immunoglobulin use. Information on participants’ disease, progression, infections and immunoglobulin use will be documented in the registry at fixed time points after diagnosis. The results of this study will be important to provide better care for patients with myeloma and other blood cancers and to improve stewardship of the national blood supply. The study will also provide a new and lower cost framework for conducting future large clinical trials of immunoglobulin therapy in Australia in myeloma and in other similar conditions.

For many years, two oral antibiotics, rifampicin (RifadinTM) and fusidic acid (Fucidin TM), have been used effectively in combination in Australia for patients with serious staphylococcal infections. These antibiotics are important as they are one of the few antibiotic combinations available to treat staphylococcal infections resistant to other antibiotics. These antibiotics are known to affect the levels of other drugs that a person might be taking at the same time, however very little is known about how they affect the levels of each other. This study involves taking blood samples from people being treated with rifampicin and fusidic acid and measuring levels of these antibiotics in the blood at different times to see if they affect the levels of each other. Identifying how these antibiotics affect each other could help doctors use these antibiotics in a better way in the future to treat patients and reduce side-effects. Our hypothesis is that there is a drug-drug interaction between rifampicin and fusidic acid but with currently used dosing in Australia, drug levels are appropriate for most patients. We hypothesize that some patients may have elevated or decreased drug levels of one or both drugs and the knowledge of this may be able to help improve treatment for patients in the future.

Acute chest pain is a common reason for patients to present to an Emergency Department (ED). The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients. Currently, high sensitivity troponin (hsTn) is used to aid in the diagnosis of ACS. However, in patients presenting early (i.e. <2 hrs) after the onset of their symptoms, hsTn may not yet have been released in great enough quantities to be detected. This may result in a treatment delay for some patients. Recently a new biomarker, cardiac myosin-binding protein C (cMyC) has been identified that rises more rapidly than hsTn in patients with ACS. Our aim will be to compare the utility of cMyC with hsTnI in the early assessment of low risk patients presenting to the ED with chest pain. We anticipate that because serum cMyC levels rise more quickly than hsTnI, this new assay will be most useful in patients who present soon after the onset of symptoms.

Hypothesis: Balanced fluids (Plasma-Lyte and Compound Sodium Lactate) will lower the prevalence of high chloride rise (greater than or equal to 5mmol/L) compared to 0.9 % sodium chloride solution. Study purpose: To demonstrate if balanced solutions are better than 0.9% sodium chloride as fluid therapy in critically ill children in PICU. Study design: Single centre, open label, randomised controlled trial. Intervention: Random assignment of individual patients (less than 16 yrs) into three groups – 0.9% Sodium Chloride solution, Plasma-Lyte 148 (PL) and Compound Sodium Lactate solution (CSL). Outcomes Primary Outcome • Increase in serum chloride level greater than or equal to 5mmol/L from baseline value to the highest chloride level within 48 hours from the time of randomisation Key Secondary Outcomes • Survival free of Acute Kidney Injury (AKI) • Survival free of organ dysfunction • Survival free of new onset AKI • Duration of ICU / Hospital stay

Acquired brain injuries (ABIs) such as stroke, traumatic brain injury, and multiple sclerosis are commonly associated with cognitive impairment and emotional distress. These changes significantly impact a range of outcomes, including participation in meaningful and valued activities. Valued living (the extent to which a person lives in accordance with their values) has been associated with improved psychological adjustment and functional outcome in ABI survivors (Pais-Hrit, Wong, Gould & Ponsford, 2019). Therefore, interventions increasing valued living within ABI populations may be effective in improving a range of psychological and functional outcomes. Since 2018 our research team has been evaluating the feasibility and acceptability of a new group program called VaLiANT (Valued Living After Neurological Trauma) that aims to enhance psychological adjustment in acquired brain injury (ABI) populations by combining cognitive rehabilitation and psychological therapy using Acceptance and Commitment Therapy (ACT) principles. The 8-week group program for individuals with ABI-related cognitive impairment and/or emotional distress focusses on helping participants reconnect with what gives their lives meaning while providing strategies for cognitive and emotional barriers. A Phase I study has been completed utilising a single case experimental design (SCED). Preliminary results show that wellbeing and psychological flexibility improved following participation in the VaLiANT program, and trends were evident suggesting increased mood and self-efficacy and reduced subjective memory complaints. This Phase II study aims to build on the findings of the SCED through a pilot randomised controlled trial evaluating the efficacy of the program in enhancing psychological adjustment in people with ABI. Up to four groups will run out of the La Trobe University Psychology clinic per year. Participants who would like to increase their participation in valued activities and are experiencing ABI-related cognitive dysfunction and/or emotional distress (reported by self or other) will be invited to take part. Participation will involve attending eight group sessions (2 hours per week for 8 weeks), as well as attending assessments immediately before, immediately after, and 8-weeks following the group (1.5 hours each).

Our team has conducted focus groups with at-risk older adults to co-design an online dementia risk profiling tool. This pilot study aims to examine the feasibility of providing a personal dementia risk profile to help-seeking adults at-risk of developing dementia. The study will provide preliminary evidence on the impact of the personal risk profiles on improving Alzheimer’s disease risk knowledge (personal susceptibility and risk factors). The study will also explore the impact of improving dementia risk knowledge on motivation to engage in behaviour change and psychological effects.

To prevent rupture of any surgically repaired extensor tendon of the fingers, at least 3 to 6 weeks of splint protection is necessary. The RME finger splint positions the injured metacarpophalangeal joint(s) in greater extension than the neighbouring uninjured metacarpophalangeal joint(s). This restricts motion in the repaired finger tendons to a safe range whilst allowing motion in the intact neighbouring fingers. The aim of this study is to compare two relative motion extension (RME) approaches, with the hypothesis that there are no differences between the groups outcomes: (1) RME splint for daywear and a resting splint overnight for the first 4 weeks post repair (RME +), and (2) use of the RME splint only full time for first 4 weeks post repair (RME-only).