ANZCTR search results

Pouchitis is the most common inflammatory condition for those living with an ileoanal pouch (whereby the large bowel is removed due to medically unresponsive ulcerative colitis (UC) or familial adenomatous polyposis (FAP) and its cause is largely unknown. We aim to assess whether specific diet components and psychological factors such as stress can predict pouchitis. We also aim to assess whether faecal calprotectin (a marker of inflammation found in faeces) can be used as a test to predict worsening in pouch function or pouchitis. This study will follow patients with an ileoanal pouch prospectively for 18 months to evaluate if diet, stress and faecal calprotectin play a role in predicting pouchitis or worsening of pouchitis. This is important because there are currently no dietary guidelines to help ileoanal pouch patients.

This study will assess the use of a dye (indocyanine green or ICG) to identify lymph nodes within the oesophagus and stomach during surgery to remove lymph nodes in patients with stomach and/or oesophageal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with oesophagus, gastro-oesophageal junction and/or stomach cancer and you will be undergoing surgery as the primary treatment for your cancer. Study details All participants who choose to enrol in this study will have an additional step of a dye injection (ICG) at the start of surgery. The planned surgery will then be conducted as per usual process with as many lymph nodes removed as are identified. At the end of the surgery, the surgeon will then use a near-infrared camera to scan the tissue to identify and remove any additional lymph nodes containing ICG in the surgical field. It is hoped this research will determine whether a greater number of lymph nodes can be identified and removed with the ICG dye and camera scanning compared to usual care. If this method is found to be more successful at identifying and removing lymph nodes for patients with oesophageal and stomach cancers, it may be included in the usual care practices to improve outcomes for future cancer patients.

Studies have shown that capsaicin may possibly be effective against weight gain and fat accumulation by inhibiting fat absorption and activating fat metabolism in the liver. Previous studies have demonstrated that it stimulates lipolysis, energy expenditure and thermogenesis. There is evidence that capsaicin stimulates resting energy expenditure, lipid mobilization and fat oxidation. It has also been found that ingestion after a glucose load promotes glucose consumption in young healthy males. This study will determine if the same effects are seen in young healthy females over the course of a normal oestrous cycle. The results of this study will then allow for translation to a pre-diabetic population to use capsaicin to augment diet and exercise to manage weight loss.

Approval was granted to run trials of a 3 day weekend intervention for children and parents in families where one child is screen disordered. This application was carefully scrutinised by the HREC, a separate meeting was organised to discuss more sensitive issues, and all ethical aspects were carefully addressed to HREC satisfaction before final approval was given. The trial will be run through Macquarie University, and the first trial will be filmed and paid for by Channel 7 for their Spotlight program. Prospective participants are given two information and consent forms - one from Macquarie and one from Channel 7 - and will speak to Channel 7 at length before making a decision to apply to participate, as we believe it is crucial participants are fully informed about the implications of the trial being televised before agreeing to participate. Final vetting of applications are by Prof Warburton and Mr Marshall, with the key criterion being no reasonably identifiable indication of potential harm to participants and an assessed likelihood that the child will benefit from the program.. Participants are fully informed and not coerced in any way to participate. Prof Warburton and Mr Marshall are not paid to create or run the program and have no conflicts of interest. It is hypothesised that child participants in the intervention will show reduced screen disorder symptoms and greater insight into their screen use immediately after the intervention, with continued benefits at 3 months after the program. It is also hypothesised that parents will report feeling more able to manage screen use issues in the home post intervention and will report improvements in their child's screen habits and symptoms 3 months after the program.

This study will adopt a multi methods approach to assess the effect of the HypnoBirthing program (Mongan Method) on analgesia use during labour and the birth experience. Data sources will consist of routinely collected clinical data from perinatal datasets, validated psychometric surveys, questionnaires and individual participant interviews. Clinical outcomes will be compared to a control population of birthing women using propensity matching of demographic, clinical and potentially confounding variables.

This pilot study will examine the efficacy of transcutaneous (non-invasive) vagal nerve stimulation in people with spinal cord injury. Many people with spinal cord injury suffer from abdominal pain and gastrointestinal symptoms that do not respond to treatment target usual pain receptors. It has been postulated that these symptoms are mediated by the vagus nerve. Modulating the vagus nerve by transcutaneous stimulation may provide relief from these symptoms. Efficacy will be examined by patient-reported pain scores, pain maps, as gastrointestinal motility study.

Exclusive Enteral Nutrition (EEN) reduces inflammation and allows complete gut healing in up to 80% of people with Crohn’s Disease (CD). EEN involves removing all food and replacing it with a liquid containing all essential nutrients for 6-8 weeks. This treatment is superior to steroids in treating inflammation and is being increasingly used across Australasia as first-line therapy, particularly in children. Despite EEN having been shown to be effective in numerous studies, the ways in which it works to reduce inflammation is still unknown and this study seeks to address the hypotheses by assessing how EEN works. The best way to assess how a therapy works to treat disease is to examine its impact in a 'normal' gut with limited confounders.

Detrusor overactivity with detrusor underactivity (DO-DU) is classically described in frail institutionalized elderly patients, but we have also observed this diagnosis in younger populations. This research attempts to retrospectively compare demographic characteristics, clinical presentations, and urodynamic findings between two age groups of DO-DU patients: those younger than 70 years and those aged 70 years or older. Our hypothesis predicts that the younger group would exhibit a higher prevalence of risk factors in their demographic data, while the elderly group will demonstrate a greater incidence of urgency and urge incontinence, likely attributed to limited mobility. Additionally, the urodynamic findings are expected to reveal less bladder contraction in the elderly group, which can be attributed to the effects of advanced age.

Laryngomalacia is the most common congenital airway abnormality in young children. In the most severe cases, surgical intervention is necessary to prevent serious complications from arising and to allow for the normal development of breathing and feeding. Supraglottoplasty is the most common surgical procedure employed to address severe laryngomalacia. The procedure reduces or stabilises the problematic laryngeal tissue preventing further obstruction from occurring. Existing literature on the efficacy of this surgery has demonstrated that this procedure is not always effective at resolving symptoms. The factors that contribute to the success or failure of supraglottoplasty have been difficult to elucidate but are likely closely related to the patient’s pre-operative clinical condition. We propose a prospective study investigating the use of continuous pre-operative pulse oximetry as a tool to better understand the nature of the laryngomalacia present and identify patients most likely to benefit from supraglottoplasty surgery.

This is a combination drug treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. The combination of Low dose cytarabine (LDAC) and venetoclax will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details: Venetoclax will be administered orally once daily (QD) Days 1–28, of a 28-day cycle, with a designated dose of 600 mg daily. Please note that Venetoclax dose ramp-up is required only for patients commencing therapy with bone marrow blasts of greater than or equal to 5%: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4 onwards. LDAC (20 mg/m2) is administered subcutaneously (SC) QD following administration of Venetoclax on Days 1-10 of every cycle Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Low dose cytarabine and Venetoclax will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.