ANZCTR search results

This study is a two-armed, multi-centre, pragmatic, randomised clinical trial designed to examine the effect of osteopathic care (OMT) on breastfeeding dyads experiencing breastfeeding difficulty. The trial will be conducted in two stages: preliminary and full. Both stages have the same design. The preliminary stage will pilot the design at a single clinic in Melbourne by recruiting 16 mother-infant-dyads (MIDs) experiencing breastfeeding difficulty. The full stage will extend the pilot to multiple clinics across VIC, TAS, ACT, NSW and QLD. Participants in both stages will be randomly allocated to one of two groups: international board-certified lactation consultant (IBCLC) - Standard care (Control) or IBCLC plus osteopathic intervention (OMT) (Experimental). The full stage will continue the pilot stage and see a further 54 MIDs (total N=70) experiencing breastfeeding difficulty randomly allocated to the same two groups. Recruitment for this stage will be from osteopathic clinics, maternal health centres and breastfeeding drop-in centres across metropolitan Melbourne and Canberra. Each participant will undergo 4 weeks of intervention with a follow-up phone call one-month post-intervention. The primary outcome of the study is change in infant breastfeeding function as measured by the Bristol Breastfeeding Assessment Tool (BBAT). Secondary outcomes include maternal breastfeeding confidence, as measured by the Breastfeeding Self-efficacy Scale – Short from (BSES-SF) and changes in breastfeeding symptoms such as maternal breastfeeding-related pain, infant ability to latch and maintain latch to the breast and feeding noise at the breast measured using a series of visual analogue scales (VAS).

In this prospective observational study, adult participants undergoing elective cardio thoracic surgery requiring cardiopulmonary bypass are assessed preoperatively by a kidney functional reserve test and by kidney damage biomarkers (i.e., urine DKK3) and postoperatively by kidney damage and stress biomarkers (i.e., urine KIM-1, urine NGAL, urine Nephrocheck) for the first 3 postoperative days. These will be assessed as predictors of AKI as per KDIGO guidelines within the first 3 postoperative days. Kidney function will be assessed by serum creatinine within 1 and 3 years after the surgery. The hypothesis is that the suggested preoperative assessment will help to identify people at higher risk of developing postoperative AKI and that postoperative AKI defined by kidney damage and stress biomarkers will identify people at higher risk of developing worsening kidney function at long-term (i.e.: 1 and 3 years after the surgery).

Cognitive impairments are common for individuals with brain conditions, however adequate assessment and intervention for such cognitive impairments continue to remain an area of high unmet need. In today’s era of resource-limited healthcare, it is becoming increasingly important to determine the value and impact of health services, including neuropsychology, through high quality clinical trial research to facilitate resourcing and allocation of such services. This trial therefore aims to evaluate the value and impact of neuropsychological assessment on improving outcomes for individuals with brain conditions and their families. Specifically, this project aims to evaluate whether comprehensive neuropsychological assessment with feedback, compared with brief cognitive screening with no feedback, results in: a. improved participant and/or support person understanding of the presenting cognitive and behavioural problems, and how to cope with and manage these problems; b. increased referrer satisfaction; c. more changes to clinical management; and/or more improvements to depression/anxiety symptomatology, self-efficacy, health-related quality of life, and carer burden.

The study aims to examine the effectiveness of a video-based CPR lesson plan to aid in classroom CPR video-based training delivered by existing school teachers in the Australian High Schools with a particular focus on students’ self-efficacy and ability to perform compression only CPR. The study will function as a pilot to establish the feasibility of classroom CPR training delivered by existing school teachers in the Australian High Schools. The study uses a prospective, non-randomised cohort design. It is hypothesised that the proposed video based lesson plan will be an effective and acceptable method of teaching school aged children CPR in an Australian practice context.

PCNSL is a subtype of diffuse large B-cell lymphoma (DLBCL) that affects the brain. While regular DLBCL (found outside the brain) responds well to treatments such as chemotherapy and immunotherapy, these approaches don’t work as well for PCNSL as the brain is protected by the blood-brain barrier. Past treatments such as stem cell transplants or whole brain radiation cause serious side effects and don't lead to good outcomes. There are many clinical trials testing new treatments for relapsed systemic DLBCL but these trials do not include patients with PCNSL. Patients with relapsed PCNSL have very few treatment options available. The NHL41 clinical trial is testing a new approach that combines three treatments across three phases; Zanubrutinib, CAR-T cell therapy and Tislelizumab. The main goal of this study is to assess if this combination is a safe and feasible treatment option. Who is it for? You may be eligible for this study if you are aged between 18 and 80, and have been diagnosed with PCNSL. Study details Participants who choose to participate in this trial will undergo treatment in three phases: Part I: Zanubrutinib induction therapy Patients will receive Zanubrutinib as induction bridging therapy until lymphodepletion prior to CAR-T cell therapy. Part II: Lymphodepletion chemotherapy and single CAR-T cell infusion Standard Lymphodepleting chemotherapy will be administered. On the day of CAR T cell infusion, CAR-T cells will be delivered fresh and infused intravenously. Part III: Tislelizumab followed by combination Tislelizumab and Zanubrutinib consolidation The first cycle of Tislelizumab will commence as a single agent. Zanubrutinib will be added in on day 1 post the 2nd infusion of Tislelizumab. This study aims to address this major unmet need by determining a safe and feasible treatment option for rPCNSL patients.

The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing outdoor shoes more acceptable than the minimalist outdoor shoes.

The overall aim of this randomised controlled trial is to evaluate the comparative effectiveness and acceptability of CBT-T for non-underweight clients with EDs aged 15 years and above to CBT-TA. To achieve this, participants will be randomised to either receive CBT-T or CBT-TA. We hypothesise that gradual responders in CBT-TA will have significantly lower disordered eating compared to gradual responders in CBT-T at end of treatment and that these gains will be maintained at the 3- and 6-month follow-up. We also hypothesise that remission will be higher in the former than latter group. We also hypothesise the same advantages for the rapid responder group in CBT-TA over rapid responders in CBT-T. We will also explore (1) change in health service utilisation, (2) engagement and completion data between the two conditions to establish the relative acceptability of the interventions, and (3) client’s experiences of therapy in the form of qualitative feedback.

This study aims to assess the clinical utility of a previously validated collection of geriatric assessment tools and its impact on clinicians’ treatment recommendations for first-line therapy. Who is it for? You may be eligible for this study if you are aged 70 years or over, of any gender and performance status diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2-breast cancer. Decisions about first-line therapy not yet made at this time of consent. Study details Your study doctor will assess whether this research project is appropriate for you. If you are suitable and agree to take part in this research project, you will be asked to sign a consent form. You will undergo a geriatric assessment (questionnaires, quick bedside tests assessing falls risk and cognition) to help your study doctor make decisions about your treatment. You will also complete a survey within 6 weeks of your initial appointment with the doctor about what factors influenced your treatment decisions and how helpful the geriatric assessments were. You will have a follow-up appointment in 4-6 weeks to determine if you stay on the same treatment or if any changes are needed. It is hoped the finding from this study will determine the usefulness of geriatric assessment tools and its impact on clinical decision and patient outcomes.

The research questions this project seeks to answer are whether the optical power designs developed by Johnson and Johnson Vision Care (JJVC) for use in contact lenses have the ability to shorten the eye and how much those same designs affect vision levels. This will be a prospective, interventional data collection study comparing the relative effectiveness of the various designs that are tested. It is hypothesized that by varying the optical design and the amount of blur imposed on the eye, small temporary changes in the length of the eye can be measured. Short-term changes in eye length (30 minutes) are thought to be a biomarker for the longer-term growth of the eye and can therefore be used as a predictive tool for whether the specific design will slow or increase myopia progression in longer term clinical trials (over years).

The Health4Life Parents & Teens study aims to test a new digital intervention designed to support parents experiencing socioeconomic disadvantage to encourage healthy habits among their adolescent children. The intervention targets six key lifestyle risk factors for chronic disease: physical inactivity, poor nutrition, alcohol use, smoking/vaping, screen time, and poor sleep. Using the Multiphase Optimisation Strategy, this study will test the individual and combined effects of five parent-based intervention components in improving parental encouragement of adolescent health habits. The five components are: online modules, tailored feedback, stress management, text messages, and health coaching. Findings will be used to build a maximally effective and efficient intervention for parents, to improve youth health outcomes.