ANZCTR search results

The purpose of this study is to determine if an imaging method called confocal endomicroscopy can accurately identify the margins of breast cancer during surgery. Who is it for? You may be eligible for this study if you are an adult who has breast cancer and is undergoing primary wide local excision with cavity shave. Study details Participants in this study will undergo their usual treatment, meaning their primary wide local excision procedure. During this procedure the surgeon will take some cancerous tissue and perform the imaging test and then send the tissue for standard pathology tests. There will be no additional involvement from participants. If it is determined that confocal endomicroscopy can accurately determine the margins of breast cancer then it would lead to a larger study. It is hoped that the larger study will determine whether using confocal endomicroscopy during surgery can better define the surgical margin at the time of the operation and significantly reduce the likelihood of a second operation.

The purpose of this study is to determine the use of sublingual ketamine drug to help with relieving pain for patients with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have significant pain associated with advanced cancer, your body weight is more than 40 kg and are willing to comply with the study requirements. Study details Participants in this study will receive three cycles of two treatment drugs in random orders: 1. sublingual ketamine wafer (flat tablet placing under tongue) for 7 days 2. non-active (sham) wafer for 7 days The first 2 days of each period will be considered analytical washout days and hence will not be analysed for efficacy regardless of whether study medication is taken. Participants will be expected to complete a daily and weekly questionnaires and also have interviews with study staff through either video-conferencing or visit to hospital after each 7-day study period. It is hoped that this research will determine if a larger trial can be completed on evaluating the effect of sublingual ketamine drug as pain relief for management of moderate to severe pain in patients with advanced cancer.

The study will be a randomised, placebo-controlled double-blind parallel-group trial; over a 6 week period. The primary objective in this study is to determine the dose of sodium benzoate which maximises the clinical benefits in patients with treatment refractory schizophrenia. Specifically, it is hypothesised those participants allocated to the active arms (1000mg daily or 2000mg daily or 4000mg daily) of Sodium Benzoate treatment will have significant reductions in PANSS total score at week 6 compared to individuals taking placebo.

Many patients who present to the Emergency Department with painful conditions have extensive delays to receive pain relief. This may result in unnecessary discomfort for patients and can also mean that patients have an extended length of stay. This study focusses on improving the pain relief given to patients who present to the Emergency Department with chest pain. The study has multiple aims. The first is to identify how long patients presenting to emergency department with chest pain wait to receive adequate pain relief. The second is to document how delays to pain relief impact on the patient and on the healthcare system (in terms of greater hospital admissions, longer length of stay and the types of cardiac testing that can be performed). The third aim is to see whether a novel education campaign highlighting the importance of providing pain relief as soon as possible after the patient presents to the Emergency Department can reduce the length of time before a patient is provided pain relief. This campaign will particularly focus on the nursing staff and will empower them to advocate for rapid pain relief. It is anticipated that this campaign will reduce the time taken to provide pain relief to patients. It is also hoped to reduce hospital length of stay and hospital admissions. This study is important for improving patient comfort and improving patient and health service outcomes.

Increasing young people's mental health literacy and action could reduce the alarming rise in mental health challenges predicted due to COVID-19, by improving youths: understanding of mental health and stigma, help-seeking and giving, and also coping. The current study aims to evaluate a school-based mental health literacy and action program, called Youth Education and Support (YES) Program, with 12 to 16 years within an Australian context.

Glaucoma is the leading cause of irreversible blindness worldwide. The SINERGGI study will determine if early laser treatment in high-risk individuals can prevent glaucoma blindness.

Infectious complications following solid organ transplantation remains a major concern for transplant recipients. It is now firmly established that a delay in mounting virus-specific immune responses following transplant is a critical factor in allowing virus reactivation and viral disease. In particular, a group of immune cells called ‘T cells’ is important in fighting viruses. In this project we are focussing on four common viruses that cause complications in transplant patients: Epstein–Barr virus, cytomegalovirus, BK polyomavirus and adenovirus. In this trial we will test a therapeutic T cell therapy for solid organ transplant patients who are experiencing virus reactivation or disease. The T cell therapy has been grown from healthy donors and is ready to be administered to the transplant patients. Patients will receive four intravenous infusions of T cells over a period of approximately 4 weeks, and will then be followed up for approximately 14 weeks. One aim of this trial is to see if this T cell therapy is safe for transplant patients. In addition, we would like to see if the proportion of virus-specific immune T cells increases from before the first treatment, to the end of treatment and the end of follow-up.

Scar formation following a burn for skin injury is a considerable health issue worldwide, After an injury, humans are unable to regenerate normal skin. Instead the repair process leads to scar formation. Scars are both aesthetically and functionally inferior to normal skin, leading to significant psychological and physical problems. A key factor in the poor appearance and pliability of scars, and in particular hypertrophic scars, is the changes to collagen in the dermal layer. In scar tissue the collagen (predominantly Collagen I) is more densely packed and closely aligned in parallel bundles. In normal skin collagen is not densely packed and is more of a ‘basket-weave’ structure. These changes both in structure and quantity of collagen largely underlie the poor appearance of scar and lead to loss of pliability, discomfort and functional problems. Lysyl oxidase is an enzyme that, in humans, is encoded by the LOX gene. Lysl oxidase catalyzes the conversion of lysine molecules into highly reactive aldehydes that form cross-links in extracellular matrix proteins and are key to regulating collagen structure. Under normal physiological conditions, cross-links are essential for the stabilisation of collagen. However, the correct balance of cross-linking and stability is essential to normal matrix being established post-injury and being maintained through life. The cross-links bind the collagen tightly, stabilize the bundles of collagen in the scar and reduce physiological degradation of scar tissue. This sentinel Phase I first in human trial will determine the safety and tolerability of a novel topical compound for the inhibition of Lysl Oxidase. This phase I study will inform the recommended phase 2 dose for a subsequent Phase II trial for safety and efficacy.

In this study, we are trying to find out if using stereotactic radiosurgery to treat tremor is safe and effective in patients who have tremor dominant Parkinson’s or essential tremor and are unable to undergo conventional therapy. Some patients with tremor do not respond to, tolerate or are unsuitable for conventional medical drug therapy. In this group of patients, uncontrolled tremors can have a negative impact on everyday activities, which may result in a decline in their quality of life. Today, the standard treatment for these patients is deep brain stimulation which involves a surgical procedure to place electrodes or needles into the central part of the brain and a stimulator into the chest wall. However, some patients are not able to have deep brain stimulation because of advancing age and/or poor health, and some patients are not willing to undergo surgery. Stereotactic radiosurgery can be used as a non-invasive alternative to deep brain stimulation to treat tremor in these patients. Stereotactic radiosurgery is a form of radiation therapy that delivers high doses of radiation to a specified target while sparing surrounding tissue and organs. Until now, stereotactic radiosurgery for tremor has mostly been delivered using a system called Gamma Knife. Our study is exploring the use of a different delivery system called a linear accelerator or ‘linac’. A linac, unlike the Gamma Knife, generates x-rays from electricity and is very similar to the radiation delivery systems used widely in conventional radiation therapy for cancer treatment. Participants will be asked to provide some basic information about themselves, such as medical history, and undergo a set to study assessments prior to treatment. These assessments include neurological examination, which would include testing for things such as strength and sensation, balance assessment looking at their ability to sit, stand, walk (if possible) and perform fast movements with their hands, assessment of abnormal positioning of their limbs during movement (called dystonia) and rating of the severity of their tremor from mild to severe using a specific scale. In addition, participants will be asked to complete two questionnaires that ask about the impact of their tremor and their ability to perform specific tasks and their overall mood. These assessments will be repeated at six months and twelve months post-treatment. Study doctors will also ask participants about any side effects they are experiencing after the treatment. We will then use this information to evaluate the impact of the study treatment on tremor in this group of patients.

In this study we have chosen to compare two methods to secure an endotracheal tube placed via a surgical airway (cricothyroidotomy). Whilst there are numerous descriptions in the literature about how to undertake the technique of cricothyroidotomy there is a paucity of evidence regarding the best methods to prevent inadvertent extubation.