ANZCTR search results

Observational multicentre cohort study on the long term outcomes of ulcerative colitis patients on ustekimumab therapy (post UNIFI study, NCT02407236), including time to flare, need for escalation and co-therapy for disease control. Time on treatment will be assessed from the first dose of ustekinumab, and 'survival' analysis performed with time on medication (with resutls censored at any loss to follow up. The primary outcome is proportion of patients who relapsed on ustekinumab, defined as a recurrence of flare/colitis symptoms with commensurate biochemical, endoscopic, histological, and/or radiological evidence of disease activity that led to commencement or dose escalation of medical therapy

In this waitlist-controlled pilot study we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve movement in people with knee osteoarthritis (KOA). In this study, we will see whether the light device has any benefit compared to no treatment. Although only half of the participants will receive the light treatment, all participants will be seen at home at pre-determined times by the researchers to assess their progress. Today, the usual approach to pain relief and improved movement is a combination of pain-relief drugs (analgesics that include opioids that may be addictive or have side effects) and exercise rehabilitation. These strategies can work well, but the new light treatment may result in good outcomes without the side effects of drugs, and may promote greater activity in people who have KOA. Almost 70% of all drug-related health disorders are related to opioid use, so reducing the intake of these medicines by using alternative forms of pain relief is a desirable aim. We have previously carried out a small feasibility study (Vassão and Laakso, 2022; not registered) to work out the protocol details for this research study. In the feasibility study, we found that patients who were planned for knee replacement surgery due to severe KOA accepted and tolerated the light device, that it was easy for patients to apply at home, and the device provided good pain relief. Based on this previous research, we expect that using a low dose of light therapy daily for two weeks may decrease pain and improve function. The device we are testing is called CareWear. CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation. [Vassão PG, Laakso E-L. ‘Photobiomodulation therapy (PBMT) is feasible and acceptable in preconditioning and post-operative recovery of patients after total knee arthroplasty (TKA): A clinical case series’. OBM Integrative and Complementary Medicine 2022; 7(1) doi:10.21926/obm.icm.2201012.]

Learning disorders are one of the greatest causes of morbidity in children with the genetic syndrome, neurofibromatosis type 1 (NF1) and result in academic underachievement, reduced quality of life, and are of significant concern to families and their teachers. There are minimal evidence-based interventions for these problems in NF1, and there is an urgent need for trials targeting this area of clinical need. This registration form details the extension study from the Treating Auditory Problems in NF1 "TAP-iN" trial. The extension study described on this registry form will enable us to establish the efficacy of an RML device in treating central auditory deficits in children with NF1 and will allow us to determine whether treatment benefits extend to broader areas of learning and behaviour. Outcomes are clinically meaningful and include measures of speech perception, literacy skills, attention, fatigue, social function and quality of life. If realized, this study will provide powerful evidence for a novel, non-invasive intervention targeting a common and impairing problem in NF1.

Learning disorders are one of the greatest causes of morbidity in children with the genetic syndrome, neurofibromatosis type 1 (NF1) and result in academic underachievement, reduced quality of life, and are of significant concern to families and their teachers. There are minimal evidence-based interventions for these problems in NF1, and there is an urgent need for trials targeting this area of clinical need. The parent TAP-iN study described on this registry consists of a randomised controlled four-week crossover trial conducted in children with NF1 and auditory processing difficulties. The proposed study will enable us to establish the efficacy of remote microphone listening devices in treating central auditory deficits in children with NF1. Outcomes are clinically meaningful and include measures of speech perception and functional hearing ability. If realized, this study will provide powerful evidence for a novel, non-invasive intervention targeting a common and impairing problem in NF1.

This is a prospective, multi-center, single-arm phased study assessing the safety, feasibility and efficacy of the ETLA system for the treatment of severe emphysema with hyperinflation. The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA therapy will be delivered sequentially over two (2) procedures. The magnitude of clinical benefit associated with ETLA is anticipated to correlate with the relative volume of diseased tissue removed/reduced, therefore it is anticipated that higher relative volume treated may result in larger improvement.

Obesity and its associated diseases have rapidly risen to become a significant burden on health systems across the world. Australia is not immune to this upheaval, with nearly 2 in 3 adults in this country classified as overweight or obese. In line with rising obesity, rates of diabetes have also risen dramatically. In the 2017-2018 Australian Bureau of Statistics Health Survey, 4.9% of respondents reported a diagnosis of diabetes. Furthermore, it is estimated that diabetes was an associated or underlying cause for 11% of deaths in the year 2018. Even without progression to diabetes, obese individuals are at risk of a host of other health issues such as the development of Nonalcoholic fatty liver disease (NAFLD). There is an urgent need for new ways to manage the metabolic diseases of obesity. However, there is a lack of diagnostic tests that can accurately predict diabetes before to the appearance of the symptoms that indicate that the first steps into full disease have already occurred. New evidence shows that inflammation of the deep fat stores that surround our organs plays a key role in health and obesity. It is now known that fat tissue is not just a passive storage site for excess energy but rather a complex organ that can disrupt the healthy hormonal and metabolic profile of obese patients. This inflammatory process occurs very early on in the development of disease, before the onset of diabetes and pre-diabetes symptoms. Ongoing inflammation of organ fat results in high rates of cell death in this tissue and the release of unwanted cell free DNA into the surrounding tissues and blood circulation. This free DNA can actually increase the level of inflammation via a negative feedback loop that serves to strengthen this unwanted response. At CSIRO, we have developed a new blood test that can measure the amount of DNA being released by these fat cells. This new test may provide a window into health for obese patients that can help doctors predict and monitor long-term health well before a diabetes diagnosis could be determined using current measures. This study will test the validity or our new blood test, in a group of patients who will be profiled for a well defined set of biomarkers that measure metabolic and liver health. This study is funded by CSIRO.

CareNET is an intervention that is integrated into existing discharge processes and uses the Carer Support Needs Assessment Tool- Intervention (CSNAT-I) to identify and meet the carers needs preparing for the person they care for to return home from hospital. This study aims to determine whether it is feasible to deliver the CSNAT-I to carers both in the hospital setting and in the first few days when they person they care for returns home. Who is it for? You may be eligible for this study if you identify as a carer for someone who has advanced cancer. For this study a carer is someone who is in a close supportive role who share in the illness experience of the patient and who undertake vital care work and emotion management for the patient. Patients with advanced cancer who are currently in-patients at a specialist cancer centre will also be invited to participate. Study details Patients who choose to participate in this study will be asked to meet with an occupational therapist to determine their needs related to achieving discharge home. While the patient is still in hospital, carers who choose to participate in this study will also be asked to meet with the occupational therapist (OT) to identify and prioritise their caring needs using the CSNAT-I tool. Following this initial assessment, the OT will meet again with the carer to develop an action plan for prioritised needs prior to the patient being discharged. Within 3- 7 days after the patient has been discharged home, the carer and OT will review and discuss whether the identified needs have been addressed, including review of any new needs identified by or referring to relevant service providers (e.g., GP, community palliative care service, nurse coordinators). It is anticipated that these meetings may occur face-to-face or via video- or teleconference per the carer's preference. Meetings should take no more than 30-40 minutes. Carers and patients will be asked to complete a series of surveys regarding their experience with the intervention and their health, they may also be asked to participate in a one-on-one interview with a member of the research team to discuss their experiences of the study. It is hoped this research will determine whether it is feasible to deliver the CSNAT-I intervention to carers of patients with advanced cancer. This includes understanding what is required to conduct a larger trial that can test how effective it is in benefiting the patients and carers and how we can translate it into everyday practice. The results of the larger trial may then lead to improved health and wellbeing for future carers and patients.

This project aims to examine the efficacy of a smartphone application [the Build Back Better app] in providing evidence-based prevention strategies for psychological distress, anxiety, depression, and posttraumatic stress (PTS) symptoms in people who have experienced potentially traumatic experiences. Based on user feedback of a previously conducted feasibility pilot study (Meuldijk et al. 2022, in preparation) within a sample of Emergency Service Workers (ESWs) (n=63) the Build Back Better app has been refined and a fully functional version is ready for formal testing in a randomized controlled trial (RCT).

A randomized cross-over feeding study conducted in free-living healthy adults aged 18 years and older old recruited from the local Hunter region. Participants will be enrolled in an 8-week dietary intervention consisting of a 2-week run-in period (habitual/usual diet) followed by 2 x 2-week dietary intervention periods that include a 2-week washout between them. The 2-week diet periods will consist of a ‘Healthy Australian Diet’ that aligns with Australian recommendations and a ‘Typical Australian Diet’. These will be allocated in a randomized order. During the 2-week washout period the participant returns to their / usual diet). The entirety of the diet (i.e., 3 main meals and snacks per day) will be provided to participants during dietary period 1 and 2. Participants will supply their own meals and foods during the run-in and washout periods. Study participation involves completing self-administered questionnaires (e.g., food frequency, health. demographic, physical activity questionnaire); collection of biosamples (fasted blood sample, urine and faecal sample) and physical measurements such as blood pressure, arterial stiffness, anthropometry and body composition. Researchers hypothesise that distinct nutrition biomarkers will be detected that are representative of each diet phase.

The brain pulse monitor is a new non-invasive method that uses light to monitor brain oxygen levels and blood flow. The purpose of the study is to determine if the brain pulse monitor accurately detects falls in brain oxygen and blood flow associated with stroke. The study will enrol adult patients with or at risk of developing a stroke. The target group are patients presenting to hospital with stroke, patients with sub-arachnoid haemorrhage that develop vasospasm and patients undergoing surgeries associated with a risk of stroke, such as carotid and cardiac surgery. The major outcome is to assess the accuracy of the brain pulse monitor to detect reduced brain oxygen and blood flow changes associated with stroke.