ANZCTR search results

This study aims to assess if the administration of a clot busting medication (tenecteplase) administered at the site of the clot in the brain following intravenous administration of the clot busting medication is safe and feasible in patients with acute ischaemic stroke within 4.5 hours of symptom onset. The approach in our study is to carefully select the patients with disabling strokes within hours of their symptoms commencing. If the clot can be dissolved at this point the damage to the brain can be prevented. Patients will receive the treatment with a clot busting medication (tenecteplase) shown in multiple trials to be likely more effective and at least as safe in opening up brain vessels compared to the standard medication used. This is followed by an angiography and if the clot is still present and visualised in a medium sized vessel, which is deemed too small to be treated with mechanical removal, a small dose of the same clot busting medication will be administered directly into the clot. (These patients are still at risk of having disabling stroke deficits if the vessel cannot be reopened.) The administration of a clot busting medication directly at the site of the clot in the brain has been safely tested in multiple trials, but not targeting the specific patient group as in our study. The participants will be monitored for their immediate stroke symptom outcomes and followed up until three months after their stroke for any disabling effects. We will assess if the participants are able to return to their pre-stroke function and lifestyle. This is a pilot study including 18 patients with the expectation that it will be followed by a larger trial involving multiple centres comparing this intervention with a group receiving the current standard treatment. We hypothesise that the administration of a clot busting medication directly into the clot is safe will lead to better outcomes in stroke patients who are not suitable for the standard therapy.

This is a study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the clinical utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with ductal carcinoma in situ of the breast. Study details All participants will have had a tumour sample taken and agreed to have that sample tested using the DCISionRT test. Physicians will be asked to provide information on their treatment decisions before and after they receive the results of the DCISIonRT test. Participants will not be required to have additional tests or procedures as a result of participating in the study. The registry is designed to be hypothesis-generating, rather than focusing on a specific hypothesis. The main objective is to accumulate a sample size (1,500) that could accommodate future hypotheses based on subsets of the general population of DCIS patients across the country.

Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a pyrrolizidine alkaloid-free A. conyzoides extract on alleviating osteoarthritis symptoms and measures of quality of life in a healthy, ageing adult population. It is hypothesised that A.conyzoides will improve symptoms of osteoarthritis such as pain, joint function and inflammation while also improving quality of life.

This study investigates the feasibility and safety of managing acute uncomplicated diverticulitis using remote virtual monitoring and treatments, as opposed to standard inpatient care. Acute diverticulitis is a common condition; in 2019, almost 5,000 bed days were recorded across the Sydney Local Health District for this condition alone. There is some evidence that certain cases (primarily those with uncomplicated diverticulitis) may be managed entirely in the community with oral antibiotics, but there is apprehension amongst surgeons to use this treatment approach because of challenges in patient monitoring and early detection of clinical deterioration. One strategy to circumvent these challenges is to use virtual healthcare which allows the remote monitoring and treatment of patients, whereby current standard care may be translocated to the patient's home. This study will investigate the safety and feasibility of this approach, on the belief that such a treatment strategy may also improve patient-reported outcomes and experiences.

This trial aims to determine the effect of exercise training and whey protein supplementation on body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer undergoing androgen-deprivation therapy. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with prostate cancer, and are undergoing androgen deprivation therapy. Study details All participants will receive 36 sessions of resistance training, and 36 doses of whey protein supplementation over a total duration of 12 weeks. The resistance training will involve whole-body exercise using resistance training machines that overload the lowering phase of the repetitions. Before, during, and after the exercise program, participants will undergo body composition scans, have blood samples taken, perform a number of tests of muscle strength, and complete a series of questionnaires. It is hoped that this study may demonstrate that the combination of exercise training and whey protein supplementation is effective in improving body composition, muscle strength, and blood markers of metabolism and inflammation in patients with prostate cancer receiving androgen deprivation therapy.

Botanix is developing BTX 1702 for the topical treatment of moderate to severe papulopustular rosacea. This is a randomised, double-blind, vehicle-controlled, parallel-group, Phase 1b study in adult patients, aged 18-65 with moderate or severe papulopustular rosacea. The objective of this study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel and BTX 1702 20% (w/w) Gel in patients with papulopustular rosacea. Eligible patients will be enrolled and randomised 1:1:1 to BID treatment with BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or Vehicle Gel for a planned 56 days. Approximately one hundred and twenty (120) patients (80 active: 40 vehicle) will be enrolled. The primary outcome for the study is to determine the safety and tolerability of BTX 1702 10% (w/w) Gel, BTX 1702 20% (w/w) Gel, or BTX 1702 Vehicle Gel following 56 days BID applications in patients with papulopustular rosacea. The safety and tolerability outcome measures will be assessed through the collection and review of AE's, laboratory parameters evaluated throughout the duration of the trial and via information recorded in participant diaries. Exploratory analysis will be conducted via change in inflammatory lesion counts, change in Investigator’s Global Assessment (IGA-PP), change in Clinician’s Erythema Assessment (CEA) scale and Patient Reported Outcomes (PRO).

The purpose of this study is to compare the addition of a low-dose antibiotic with properties that reduce inflammation to the therapy regimen after endoscopic surgery in chronic sinus disease, versus our current standard of care,

This study will investigate the feasibility and validity of Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer Who is it for? You may be eligible to join this study if you are female, aged between 18 and 75 years, have a confirmed diagnosis of primary breast cancer and are scheduled for a lumpectomy and a sentinel lymph node biopsy (SLNB) procedure as part of the surgical plan. Study details All participants in this study will receive single dose of FerroTrace and a single dose of radioisotope via intraparenchymal injections into the breast tissue the day prior to, or on the morning of, surgery. During surgery, a modified sentinel lymph node biopsy (SLNB) will be performed, using a magnetometer probe to locate the magnetic tracer in sentinel nodes, followed by the standard gamma probe. At least one follow-up MRI of the breast will be performed 30 days after surgery, to assess tracer clearance, with additional MRIs at 90 days and 180 days after surgery if there is not complete clearance on the earlier post-operative MRI. It is hoped that this research project will lead to further studies and eventually the technology will be widely available so that patients with can have breast cancer surgery without the use of radioactive isotopes and dye.

Modern navies are focused on trying to shrink the size of their crews to exploit the benefits of new achievements in automation of ships systems. While technological advances are enablers, the performance of these advanced systems is only as good as the crews who man them. The ability to remain vigilant for an automation failure is impacted more severely by fatigue than are other mental functions. From a fatigue management point of view, most navies have sub-optimal watch systems that unnecessarily fatigue naval crews which results in sub-optimal crew performance. An overlooked opportunity exists on Subsurface vessels in that the natural light dark cycles can be manipulated. Theoretically this would be advantageous for a 2 watch system, but this is never been attempted under laboratory conditions. We hypothesise that sleep, cognitive performance, and physiological measures will differ between the watches within both a two-watch routine, and a three-watch routine. The research question is whether a two-watch or three-watch routine lead to better sleep, cognitive performance, and physiological functioning.

Atrial fibrillation (AF) is common, and makes people often feel symptoms, or have complications such as stroke. Doctors have many options for AF treatment, but these all have drawbacks. Tablets for AF often have side effects, and AF ablation is the most effective option we have, but unfortunately comes with risks of major complications. Researchers have therefore been looking for other options. SGLT2 inhibitors are medications, which are used to treat diabetes. Unexpectedly, this drug class was shown in a trial of 17,160 patients with heart failure, to reduce the rates of AF. This class of medication was developed as a diabetes medication, working on the kidney to increase the amount of sugar that the body gets rid of into the urine, and therefore lowering the sugar levels in the body. These medications have also been shown to reduce cardiovascular death, reduce heart failure and reduce renal failure. Researchers and doctors don’t exactly understand all the different ways that these medications lead to benefits, in particular how they reduce AF. There may be many different pathways in the body that impact the way that cells work. This project is to try and examine if dapagliflozin (an SGLT2 inhibitor) changes the electrical properties of the heart, to try and explain the reduction in AF that has been shown in trials.