ANZCTR search results

To conduct a prospective, randomized, double-masked pilot study testing the hypothesis that near-infrared (NIR) laser acts as a neurorecoverant and improves contrast sensitivity in glaucoma patients. This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature. WHAT IS THE PURPOSE OF THE STUDY? We are trying to assess the effectiveness of a new type of low-energy laser. This laser is currently being studied in diabetic eye disease and we believe that it may be effective in glaucoma. The laser improves the energy supply to sick nerve cells at the back of the eye, especially those affected by glaucoma. We are hoping that this laser may actually improve vision in glaucoma. It is a very safe laser and if successful is likely to be used in conjunction with eye pressure lowering treatment. The purpose of this study is to establish a proof of a principle known as neuroprotection. Neuroprotection: refers to the ability to directly promote survival of the optic nerve. The optic nerve is the nerve that transmits visual information from the retina to the brain. Contrast sensitivity: is the ability to differentiate between light and dark (contrast). This study is to assess whether low doses of Near Infrared (NIR) laser light are beneficial in improving contrast sensitivity in glaucoma patients. Lasers are routinely used and are approved in Australia for treating a variety of eye diseases these lasers are called Thermal Lasers and are usually green in colour. They are applied to the retina through a special type of microscope and many laser spots are individually placed over the affected area. In all cases, these lasers work by burning small areas of the retina in order to trigger the required healing response that, with time, decreases the amount and extent of the swelling. We are trying to assess the effectiveness of a new type of NIR laser that is about 100 times lower in power density than a Thermal Laser. The NIR laser causes no burn; however, it appears to stimulate a healing response to injured cells and reduces edema and enhances cellular function. Hypothesis NIR laser improves contrast sensitivity in glaucoma patients

This study is a multi-centre, mixed method, retrospective, observational study in children aged 0 to 16 years presenting to an Emergency department with head injuries of any severity. We are assessing the use of CT scanning of the brain in the diagnosis of head injury and exploring the clinician and organisational related factors influencing the use of CT scanning by conducting interviews with clinical staff employed in Emergency departments.

The primary purpose of this trial is to evaluate the efficacy and safety of a new radionuclide therapy (177Lu-PSMA617) for advanced prostate cancer, in comparison to the standard care, cabazitaxel. 177Lu-PSMA617 is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Who is it for? You may be eligible to participate in this trial if you have been diagnosed with metastatic castration resistant prostate cancer for which you have previously received docetaxel. Study details All patients enrolled into this trial will be randomly allocated (by chance) to receive either 177Lu-PSMA617 or the standard care cabazitaxel chemotherapy. Patients in the 177Lu-PSMA617 arm will receive up to six six-weekly doses of 177Lu-PSMA617. Patients in the cabazitaxel arm will receive up to ten three-weekly doses of cabazitaxel. Treatment in both arms will continue until your cancer progresses, you have unmanageable side effects or until the maximum number of treatments has been reached. All patients will complete scans and questionnaires as part of this trial, up to every 3 weeks, to assess the impact of the treatment on your cancer, on your pain levels and your quality of life. It is hoped that this trial will provide further information on the risks and benefits of 177Lu-PSMA617 treatment compared with cabazitaxel in men with advanced prostate cancer.

The Australian health care system is facing many challenges as a result of an ageing population, rising rates of chronic and complex disease and a strong demand from consumers for more and higher quality health care services. A high performing and adequately resourced primary health care sector is needed to address these challenges and produce better population health outcomes and sustainable health care funding into the future. Flinders QUEST will test whether Australian general practices that are assisted (logistically and financially) to deliver enhanced services can produce better patient health outcomes and improved health service use.

This is a surgical study comparing traditional methods of ORIF (plates and screws) versus a new technique of hindfoot nailing in elderly patients with ankle fractures. The proposed benefit of hindfoot nailing is that participants can put weight through their ankle earlier, however it locks the ankle and does not allow it to move. At this point in time it is unknown which technique has better outcomes.

This study will offer the cell free fetal DNA blood test, NIPT, to all pregnant women visiting the Nepean Hospital Perinatal Ultrasound Department who have singleton pregnancies and have been referred for their combined first trimester screening test for Down syndrome risk. Once they have agreed to participate in the study, All will receive genetic counselling via either face-to-face consult or web-based education. The participants in the study will undergo their first trimester screening test, consisting of ultrasound and serum biochemistry, free ßHCG and PAPP-A, regardless of their choice to undergo NIPT. The NIPT will be offered to them free of charge. The aim is to include 1000 patients. The proposed time line is twelve months, with nine months of data collection and three months to complete analysis and write up results. The primary aim is to define the uptake of NIPT in the Australian Public Hospital system. A secondary aim is to compare the overall cost to the healthcare system of offering NIPT as a first line screening test for Trisomy 21 to the current contingent model in detecting each correct diagnosis of Trisomy 21. Analysis will include the detection rate of screening, results and outcomes as well as the cost per ‘correct’ result, taking into account extraneous factors such as additional need for further counselling for false positives, invasive procedures and losses due to invasive procedures. The efficacy of each protocol (NIPT versus the contingent model) using a dollar value per correct case detected, will also be determined. The tertiary aim will be to analysis the effectiveness of alternative methods of genetic counselling in providing appropriate education and support will be compared to the traditional face to face model. Hypotheses to be tested: That there will be a large uptake of NIPT within our population after either type of counselling. That both traditional counselling as well as web based counselling will be effective counselling methods and will enable patients to make an informed decision regarding their first trimester screening. That performing NIPT as the preferred method of screening for Down syndrome might be more cost effective to the public system compared to the current model.

The Vivid Vision system is a commercially available device for the treatment of amblyopia. The system is a virtual reality headset connected to a PC with motion and hand detection software. The Vivid Vision software gives the user tasks where they must use their hands and fingers to point to or move objects that they see in the VR headset. The colour, size, contract and clarity of these objects are altered depending in the person’s performance in the tasks. The company claim that this immersive but controlled experience is extremely effective for treating amblyopia. Vivid Vision make claims that with regular use of the system there is a benefit for children with amblyopia. These claims are reasonable and within accepted ophthalmic standards. The company also claims that the system can benefit adults with amblyopia. Such claims are contrary to the generally accepted belief that there is no treatment for adult amblyopia. It is important to subject these claims because • If the Vivid Vision system does in fact help adults with amblyopia improve their amblyopic eye then this is a huge breakthrough. We must be able to offer adults this treatment if it is effective. • If the Vivid Vision system is not effective then it is important that the company’s claims are subjected to closer scientific scrutiny. The patients will be identified from the clinician's existing population of patients Physical examination • Patients will be examined by an ophthalmologist, Dr Brendan Cronin and an orthoptist to ensure that there is no strabismus and that none of the exclusion criteria are met. There will be a full dilated retinal examination, colour vision assessment, stereopsis testing and refraction. Electrodiagnostics • An objective visual acuity will be performed at the Queensland Electrodiagnostic and Imaging Clinic at 140 Melbourne Street South Brisbane. Vivid Vision Training • Participants will have 30-60 minutes of training on the Vivid Vision system once per week • The system is an Oculus Rift virtual reality headset exactly like those that are used in computer game systems. After 6 and 12 months participants will have the electrodiagnostic testing done again. At 6 and 12 months they will have an examination by Dr Cronin and an orthoptist as well for refraction and stereoacuity testing.

COPD is the fifth greatest contributor to the overall burden of disease in Australia. Breathlessness is the primary symptom that limits exercise in people with COPD. Reduced exercise is associated with higher hospitalisation rates and increased mortality rates. Lung hyperinflation which is characteristic in COPD contributes to spinal rigidity which may further contribute to exertional breathlessness and subsequent reduced exercise capacity. Previous research has shown that manual therapy has immediate effects on reducing breathlessness and improving lung function. There is a known link between joint mobilization and SNS function showing immediate effects on local and centrally mediated pain, muscle and SNS function. It may therefore be hypothesized that improvements in pain and muscle function would be associated with reduced spinal rigidity, potentially improving lung function and reducing breathlessness. Several studies that have pharmacologically inhibited SNS activity have reported reduced breathlessness, so it might also be hypothesised that thoracic mobilisation may have a similar effect on breathlessness. To the best of our knowledge no studies to date have investigated the impact of manual therapy on lung function or breathlessness associated with a functional relevant activity such as walking. This study aims to investigate, in people with stable COPD who experience exertional breathlessness, whether a single treatment involving 6 minutes of Grade III central PA accessory joint mobilisation of the thoracic spine decreases breathlessness and improves lung function more than a placebo intervention. We hypothesis that joint mobilisation of the thoracic spine will decrease breathlessness and improve lung function following a 6 minute walking exercise task. If proven successful, this may permit patients to exercise more frequently and at higher intensities optimizing the benefits of exercise. This along with the potential to increase participation in physical activity may lead to a reduction in exacerbations, hospital admissions and associated cost savings.

This is a Phase I, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose, single-center study to evaluate the safety and tolerability, and describe the pharmacokinetics of escalating single doses of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects. The study population will be comprised of up to 48 healthy male and female subjects aged 18-50 years, inclusive, considered eligible on the basis of study inclusion and exclusion criteria. Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo. Each escalating dose group will consist of 8 subjects; 6 will be randomized to receive a single dose of CMX-020, and 2 will be randomized to receive a single dose of placebo. Treatment groups will be dosed in an escalating order, each dose level increased by no more than 2-fold over the previous dose level. The decision to escalate the dose will be based upon review of the safety and EEG data for all subjects in each previous dosing panel. No subject will receive more than one dose of study medication.

The aim of this project is to evaluate the Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow Transplant. Who is it for? You may be eligible to join this study if you have persistent or relapsed B-cell malignancy post related donor allogeneic stem cell transplant and a donor willing and available to donate peripheral blood for the generation of CAR19 T-cells. Study details Matched related donor derived CAR19 T-cells will be administered intravenously after lymphodepleting cyclophosphamide and fludarabine. This T-cell therapy may be administered alone or in addition to salvage chemotherapy. Three CAR19 T-cell dose levels will be assessed within each patient: 1x10^7cells/m^2, 5x10^7cells/m^2 and 1x10^8/m^2. Dose escalation will be determined 4 weeks after the last dose dependent on persistence of disease, no severe toxicity and falling CAR19 T-cell numbers. Patients will be monitored for early and long term toxicity, persistence of CAR T-cells and disease response. If successful, this treatment will enable the widespread application of CAR19 T-cells to patients with few other effective treatment options.