ANZCTR search results

This randomised controlled trial of 120 pregnant people aims to evaluate the efficacy of a gut health-focused, smartphone-delivered, prenatal dietary program (Bugs & Bumps), compared to a smartphone-delivered program focused on the Australian Dietary Guidelines, for: (1) improving diet quality during pregnancy, (2) altering microbial or inflammatory biological pathways that may underpin neurodevelopment, and (3) influencing mental health-related outcomes in children.

Steroid-Reducing Options for ReLapsING PMR (STERLING-PMR): a pragmatic, randomised trial to compare the clinical and cost-effectiveness of adding immunomodulation to steroid-tapering treatment for patients with relapsing PMR, versus steroid-tapering alone. This is a Multi-centre, Phase III, parallel-group, open-label, randomised controlled trial with internal pilot. Internal Pilot: A 12-month internal feasibility phase will determine the likelihood of achieving i) opening of centres, ii) planned recruitment rate, and iii) achieving the recruitment target of 200 participants (41). An internal review will also be conducted after 8 months, corresponding to one-third of the total recruitment phase (42). At the end of the internal pilot phase, if Amend (amber) criteria are met, then a recovery plan detailing remedial actions will be submitted to the funder. If this is approved, the trial will proceed with caution This study aims to determine the clinical and cost-effectiveness of adding a disease-modifying anti-rheumatic drugs (DMARDs) to prednisolone-tapering treatment in relapsed PMR patients. The primary objective to test whether adding a DMARD to usual-care prednisolone reduces patient-reported cumulative steroid dose requirements over 18 months, compared with usual-care alone; within a pragmatic RCT design. The secondary objectives will be assessment of PMR symptom severity and disease activity; time to stopping steroids and to steroid-free remission; cumulative steroid dose; AE; quality of life; work participation; diagnosis of adrenal insufficiency or GCA; and the impact of increased referrals on Rheumatology service capacity.

The primary aim of this study is to test the effectiveness of an online Cognitive Behavioural Therapy (iCBT) intervention (called CarersCanADAPT) for carers of people with cancer in reducing symptoms of anxiety and depression compared to carers in the wait list control condition. Who is it for? You may be eligible for this study if you are an adult who is a primary carer for an adult diagnosed with cancer. Study details Participants will be asked to complete the CarersCanADAPT 6 week online cognitive behavioural therapy program. You will be randomly allocated to join either the immediate access group or the waitlist group. Either way you will receive access to the CarersCanADAPT program, however those people in the waitlist group will get access to the program in 14 weeks’ time. You will also be asked to complete an online initial (baseline) questionnaire, and 2 more questionnaires at 6 and 14 weeks after beginning the trial. If you are allocated to the waitlist group, you will also be asked to complete an additional 2 questionnaires at 20 and 28 weeks after beginning the trial. This research offers an opportunity to test the effectiveness and implementation of an evidence-based online support module for carers, which if found to be effective can be broadly disseminated and potentially implemented into routine care.

Missing a diagnosis of primary aldosteronism (PA) leads to adverse patient outcomes above and beyond hypertension. A simple blood test is available to screen for this common and potentially curable condition, but is severely under-utilised. Interventions including education and clinical decision support are likely to increase PA screening in primary care where the vast majority of hypertensive patients are managed. A well-powered trial that incorporates strong implementation strategies and health economic analyses is what we are proposing to address the issue.

The purpose of this trial is to assess efficacy of an induction phase of combination therapy with asciminib plus low dose dasatinib in newly diagnosed chronic phase CML (CP-CML) with high-risk genetics, with respect to achievement of major and deep molecular response. CML14 (ASCENDANCE) is a successor trial to the ALLG-sponsored CML13 (ASCEND-CML, ACTRN12620000851965). CML14 aims to further improve outcomes through the use of our NGS panel to identify AGAs, and offer these patients with AGAs frontline treatment with combination asciminib / dasatinib therapy. Who is it for? You may be eligible for this study if you are aged 18 and above and have been newly diagnosed with CP-CML. Study details Participants who choose to participate in this trial will receive treatment with asciminib monotherapy at 80mg daily for the first 4 weeks. At the end of this period, New Generation Sequencing (NGS) and cytogenetic results will be available from the central and local labs. The presence of additional genomic abnormalities (AGA) will be defined by the central lab for each case as per predefined criteria. Patients with evidence of AGAs and high risk ACAs will be assigned to the high risk cohort, and will receive combination treatment of asciminib 80mg plus dasatinib 50mg daily - All patients with high risk will receive combination therapy between months 2 to 12. - Patients who achieved Molecular Response 4 (MR4), and confirmed at a timepoint 3 months afterwards, will de-escalate to asciminib monotherapy. - Patients without MR4 at month 12 will de-escalate to asciminib monotherapy. An extension of combination therapy to the 18th month timepoint is permitted at the discretion of the investigator - Patients with intolerance to combination therapy, despite maximal supportive therapy for the same, will deescalate to asciminib monotherapy at any time All other patients (without evidence of AGAs and high risk ACAs) will be assigned to the standard risk cohort and will continue to receive asciminib 80mg daily monotherapy. - AGA negative patients will then have to achieve predetermined targets: BCR::ABL1 of less than or equal to 10 percent, at 3 & 6 months, and less than or equal to 1percent, at 12 and 18 months to continue with asciminib 80mg daily. - Patients failing to achieve these responses will have dasatinib 50mg daily added to asciminib 80mg daily. - Patients with “warning” under ELN2020 will be offered, at investigator discretion, asciminib dose escalation to 80mg twice a day. Overall treatment duration is 2 years post-enrolment. All treatment will be administered by the study team. Drug accountability will be performed by the administering institutions to assess compliance. It is hoped this research will improve overall survival and molecular response achievement and minimise treatment related morbidity and mortality for CP-CML patients.

The aim of the CUBIC Clinical Trial is to find better treatment options for Chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder that results in slowly progressive weakness and loss of feeling in the legs and arms. CIDP is commonly treated with immunoglobulin, which must be given every 3-4 weeks and patients may need to continue treatment for the rest of their lives. The purpose of this study is to see if we can use other medication to manage the symptoms of CIDP and reduce the amount of immunoglobulin needed. This could mean that CIDP patients could be treated with a lower dose of immunoglobulin or could potentially no longer need immunoglobulin. The results of this study will help to inform the medical community of the best treatment to give to people who have CIDP in the future.

CTCAs have become increasingly utilised non-invasive modality to assess the presence of coronary artery disease for patients with stable coronary syndromes. Despite this, patients who undergo optimal medical therapy based on CTCA will require invasive management 1/3 of the time, meaning that the parameters used in CTCA assessment currently fail to accurately predict patients who need invasive angiograms and subsequent pressure wire investigations. Pressure wire studies are linked to cardiovascular outcomes. This study aims to apply novel measurements, including aggregated plaque volume, to predict the hemodynamic (and therefore ischaemic) burden of coronary disease based on pressure wire studies.

Parkinson's disease (PD) is the second most common neurodegenerative condition globally and its prevalence is increasing exponentially due to ageing and industrialisation. There is no cure but there is preliminary evidence to suggest high-intensity aerobic exercise may help slow down PD progression. To benefit, people with PD need to perform regular, high intensity aerobic exercise for the long term. The primary aim of this study is to examine the feasibility, acceptability, and sustainability of a pragmatic, individualised, high intensity aerobic exercise program. Secondary aims are to quantify effects of high intensity aerobic exercise on clinical, physiological, and neuroimaging outcomes, including potential disease modifying effects. People with PD will perform high intensity aerobic exercise 3 times per week for 6 to 12 months. The type (e.g., continuous and/or interval training, e.g., fast walking/jogging/running, elliptical cross-training, rowing, stairs climbing) and location (e.g., home, gym, local park) of exercise will be tailored to meet individual needs and preferences. Participants will also receive health coaching via regular phone/video calls to support them to exercise. At the end of the study, participants will be interviewed to explore their experiences of their program.

This study is looking to perform a double blinded randomised controlled trial for patients with primary colon adenocarcinoma (cancer) with the use of a monoclonal antibody (Labetuzumab) targeting receptors in the liver which may form liver metastases. Who is it for? You may be eligible for this study if you are an adult with suspected or confirmed colon adenocarcinoma (on histopathology) who is undergoing surgical resection at St George Hospital, Sydney. Study details Participants will undergo blood and tissue testing to determine if they are at low or high risk for developing liver metastases of their colon adenocarcinoma. Patients in the high-risk group will be randomly allocated to either an active treatment group, who will receive an intravenous infusion of Labetuzumab every other day during the month following their surgical resection, or a placebo group who will receive infusions of normal saline only. Data regarding the development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer will be collected from all patients in this study. It is hoped that findings from this study will help inform a multicentric, multinational trial investigating this treatment for patients affected by colon cancer that are at risk of it spreading to their liver and causing unresectable or terminal disease to follow.

This research study aims to evaluate the effectiveness, (including cost-effectiveness), maintenance and scalability of a novel youth specific aftercare service designed to reduce self-harm and suicide in young people aged 12-25. The program being evaluated is a brand-new youth suicide prevention service – the HOPE aftercare. The aftercare provides intensive, person-centred psychological, psychosocial, family and peer support tailored to the young persons’ unique needs and circumstances using the Relational Clinical Care model. The aftercare is delivered weekly, for up to three months, by a multi-disciplinary team of health professionals, peer support workers. Psychological interventions include, but are not limited to: safety planning, behavioural activation, emotion regulation, substance use interventions, problem solving and relapse prevention. Psychosocial interventions include housing and employment assistance, or referral to support services (e.g., education and training).