ANZCTR search results

Evaluation of a newly developed educational information package which provides information on alchol consumption during pregnancy, links to support, and alternatives to drinking for pregnant women. Study hypothesis states that the intervention will improve knowledge about the effects of alcohol consumption during pregnancy significantly more than standard antenatal care.

This study will investigate the combined use of stereotactic ablative body radiosurgery (SABR) treatment followed by an investigational drug, called MK-3475, as treatment for metastatic breast cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer that has metastasised to the bones, lungs, or isolated nodes. Study details: The study aims to describe the safety profile and biological effects of combining SABR treatment with MK-3475 in patients with oligometastatic breast cancer. All participants will receive SABR treatment (one or more sessions, as required) followed by 8 cycles of MK-3475 (venous infusion, one cycle every three weeks). During each cycle, the doctor will review your general health and conduct a physical assessment as well as blood tests and a quality of life questionnaire. Radiological assessments may also be performed as necessary during and after treatment. Participants will be followed up for up to 2 years from the completion of the SABR treatment.

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of advanced or metastatic solid tumour for which no effective standard therapy is available. Study details All participants in this study will receive treatment with a new drug known as BGB-283. Treatment will be administered by oral capsule [once daily for 24 days (Cycle 1 only) and 21 days (Cycle 2 onwards) each cycle]. Initially a low dose will be administered to participants. If this dose is tolerated, then it will be increased in the next group of patients and so on until the maximum tolerated dose is determined. All participants will be regularly monitored for safety and tolerability of the medication for about 1 year. They will also be required to give blood samples (on days when frequent pharmacokinetic sampling is required), FDG-PET scan (screening and the first day of Cycle 2) and CT scans (screening and subsequent every 6 weeks) during the study. This will provide us with supportive data for further development of this medication.

External ventricular drain (EVD) catheters are integral to the management of patients with severe traumatic brain injury (TBI). EVDs are routinely used in the management of severe TBI, and are recommended by international consensus guidelines. These catheters monitor and can help to lower the pressure within the brain that is often raised as a result of the brain injury. This process is not without risks. The EVD catheter provides a pathway between the brain and the external environment, which can become colonised by bacteria and lead to infection in the brain, called 'meningitis' or 'ventriculitis'. This infection may worsen brain damage, produce seizures, and increase length of stay in the hospital. One potential way of reducing this risk of EVD-associated infection is to use antibiotic-impregnated catheters. These EVDs release antibiotics over time, with the aim of preventing bacteria from contaminating the drains. Despite previous research it is still unclear if there is benefit to using these drains, which are considerably more expensive than the standard EVDs. The aim of this project is to determine if antibiotic-impregnated EVDs reduce the rates of infection in patients with TBI. In this study, patients with TBI who are planned for EVD insertion will have a 50:50 chance (like flipping a coin) to receive either a standard or antibiotic-impregnated EVD. After insertion, patients will be monitored until the EVD is removed (generally within 10 days following injury) to see if they develop catheter-associated infection. Results will then be compared to see if there is a difference between each group.

We will trial a family carer support program following the discharge of older patients (recipients of family care) from the Sir Charles Gairdner Hospital Medical Assessment Unit. To do this, we will assign family carers to receive either usual care or usual care plus the support program. We will compare outcomes between the two groups in terms of: a. family preparedness to sustain the caregiving role b. re-presentations and readmissions of care recipients to any Western Australian hospital - and length of stay when readmissions do occur c. costs to the healthcare system. We will also seek feedback on the program from family carers, patients, and the hospital staff.

The project will explore the use of mobile phone based app technology to improve the mental health and wellbeing of young men. The RCT will help determine if the intervention is effective with an expected reduction in psychiatric morbidities.

The proposed project involves conduction of a randomised double-blind placebo-controlled clinical trial to test the efficacy and safety of oral ingestion of Chinese herbal medicine granules, PTQX for children with moderate to severe atopic eczema. The primary objective of this trial is to evaluate whether the oral ingestion of PTQX can reduce severity of the condition and improve the quality of life in children with moderate to severe AE. It will also assess the safety of PTQX for AE. The 16-week trial includes 12 weeks of treatment and a 4-week follow-up period.

The study is comparing two different techniques to diagnose acute pulmonary embolism in patients referred to the Peter MacCallum Cancer Institute. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for suspicion of acute pulmonary embolism. What is the purpose of this research? Lung scan (also known as lung scintigraphy, ventilation/perfusion scan or V/Q scan) and CT pulmonary angiogram (called CTPA) are imaging tests that are used to diagnose pulmonary embolism (clots in the blood vessels supplying the lungs). This research project is assessing the diagnostic value of a new imaging test called lung PET/CT. PET/CT stands for Positron Emission Tomography/Computed Tomography. The conventional lung scan uses a different technology called SPECT/CT (Single Photon Emission Tomography/Computed Tomography). PET/CT produces images of better quality than the conventional SPECT/CT scan, which may improve diagnosis of pulmonary embolism. The research project is designed to compare the diagnostic value of lung PET/CT and CTPA for the diagnosis of pulmonary embolism. Our hypotheses are that V/Q PET/CT is an alternative modality to CTPA for diagnosis of PE and that the combination of both imaging may improve PE diagnosis. What does participation in this research involve? You will undergo both CTPA and lung PET/CT scans. For the lung PET/CT scan, a small quantity of a substance called Galligas, which are particles labelled with a radioactive substance called Ga-68, is breathed in and thereby deposited into your lungs. After this, you will be required to lay still on the PET/CT camera bed for about 10 minutes whilst images are obtained. Whilst you are in the PET/CT scanner, you are then injected with a substance called Ga-MAA via the intravenous catheter. Ga-MAA stands for Ga-68 macroaggregated albumin (MAA) and is radioactive substance that localises in your lungs’ blood vessels. You will then be imaged again for a further 10 minutes. Lung PET/CT is a diagnostic procedure only, not a treatment. Lung PET/CT and CTPA will be initially interpreted separately. CTPA and V/Q PET/CT images will then be interpreted together by a consensus reading. It is anticipated that 50 patients will participate in this project.

The Victorian WorkCover Authority (VWA) is an injury compensation system in the state of Victoria, Australia which provides financial, as well as health and related support, to Victorian workers who have sustained an occupational injury. In 2014, VWA introduced a compensation claims process change for key elective surgical procedures. The aim of the proposed research is to determine whether the compensation claims process change improved injured workers' perception of the service quality of the compensation claims process, as well as whether the compensation claims process change reduced injured workers' time away from work and compensation claims costs, and improved injured workers' ratings of health-related quality of life.

When patients suffer infections or have damaged organs they may develop an excessive inflammatory response called the systemic inflammatory syndrome (SIRS). This SIRS manifests as changes in heart rate, breathing, white cells release into blood, fever and carbon dioxide production. While a small amount of SIRS may be helpful for the healing process, uncontrolled SIRS may contribute to making intensive care unit (ICU) patients unwell, leading to a low blood pressure, organ failure, need for artificial life support and, in some cases prolonged time in ICU and hospital and even death. Finding safe, effective and inexpensive ways to decrease the severity of SIRS is an important goal of modern ICU medicine. Unfortunately, no medications have been shown to do this. Recently, however, a safe drug used by millions of people every day has been shown to have unexpected properties that might reduce the severity of SIRS. This drug is Aspirin. Every day, Aspirin is given to millions of patients at low dose because it protects from heart attacks and strokes through its ability to block clotting. Over the last three to four years, however, multiple studies in animals and observational studies in man have shown that low-dose Aspirin (as given to patients with heart attacks and strokes) also inhibits excessive inflammation. Aspirin does this by stimulating the production of newly discovered helpful molecules called resolvins, protectins and maresins. These molecules combat inflammation and help the body to recover. Observational studies have reported that SIRS patients treated with Aspirin were more likely to live than similar untreated patients. In addition, patients who were on Aspirin before admission to ICU were similarly more likely to survive. On the other hand, it is also known that Aspirin therapy may increase the risk of bleeding, stomach inflammation and maybe even kidney impairment. How the risks and benefits of aspirin therapy balance each other in patients with SIRS is unknown because no controlled studies have been done so far. Because of this, we plan to conduct a pilot randomized controlled trial to study whether Aspirin treatment in patients with SIRS is safe, feasible, and shows preliminary evidence of beneficial effects. The primary outcome is the concentration of a substance which indicates severe inflammation, called interleukin 6 (IL-6) in the blood 48 hours after randomisation. We wish to test the hypothesis that Aspirin improves the resolution of high levels of IL-6. If our findings support the feasibility, safety and possible benficial effect of aspirin when used in this way, we will be able to conduct larger studies to asses its benefits in terms of patient-centred outcomes.