ANZCTR search results

The objective of the study is to assess the safety and feasibility of using the Millipede System to remove occlusive thrombus and improve blood flow in subjects experiencing an ischemic stroke due to large vessel occlusion.

This study aims to pilot an intervention (SIBS-ONLINE) for siblings of children with chronic illness to ensure it: 1) addresses the ongoing realities of siblings’ potential caregiving responsibilities; 2) addresses issues unique to being a sibling of a child with chronic illness; 3) allows siblings to meet and interact with other siblings; 4) improves family communication and family functioning. The original intervention (called SIBS) was developed by Prof Fjermestad and Dr Vatne and their team in Norway. We are working with consumer representatives from Canteen Australia to modify the intervention for an Australian audience. Part of the modification has been to deliver the intervention via video-conferencing. This new, updated version of the intervention for Australian families is called SIBS-ONLINE. Who is it for? Eligible participants will be adolescents aged at least 12 years and at most 18 years of age, who live with at least one brother or sister with a chronic illness who has been diagnosed greater than or equal to 6 months prior to the study. One of the siblings’ parents will also be eligible to participate. Participants must be able to give informed consent and speak/read conversational English. All participants will be required to have access to the internet and a computer/smartphone/tablet with web-cam and microphone. Details of the study The SIBS-ONLINE intervention consists of four sessions delivered via video-conferencing (e.g. Skype) by group leaders (two with only parents and two with only siblings) and two homework and feedback sessions at home. The sibling sessions will focus on discussing emotions, thoughts, and feelings about their siblings’ chronic illnesses and questions they might ask of parents. The parent sessions focus on learning about challenges common to siblings and encouraging open-exploratory communication with their children. The homework and feedback sessions will be conducted with siblings and their parents together. Clinical staff and psychosocial researchers from BSU and Canteen will be trained and act as group leaders for the parent and sibling groups.

This study tests patient-led surveillance which is a new way of following up people who have had an early melanoma (in situ melanoma or stage I or II invasive melanoma). Patient-led surveillance combines skin self-examination and teledermatology, which involves taking pictures of skin lesions on your body with a device attached to your smartphone and uploading these images for a dermatologist to review remotely. This study will investigate if this type of follow-up can diagnose new or recurrent melanoma earlier than if regular clinic visits with the patient’s doctor is used alone. Who is it for? You may be eligible for this study if you are 18+ years old, have previously had surgery to remove a melanoma in-situ or early invasive melanoma (stage I or II), own a smartphone, are being followed up at a recruiting dermatology clinic, skin cancer specialist clinic or general practice clinic, and have a suitable study partner (spouse, partner, family member, friend) to help with skin self-examination. Study details Participants will be screened via questionnaire, asked to view videos on skin self-examination and to upload test photos via the secure web-based platform. On satisfactory completion of these tasks they will be randomly allocated to either a patient-led surveillance or clinician-led surveillance arm. Clinician-led surveillance: Educational booklet, regular scheduled appointments with treating clinician, access to unscheduled appointments as required. Patient-led surveillance: All components of clinician-led surveillance as well as a mobile dermatoscope and smartphone app for taking detailed photos of skin lesions, training in skin self-examination and in using the dermatoscope, and access to timely remote dermatology review of any concerning lesions. Participants will be asked to complete online questionnaires and patient diaries. Their clinical data and any relevant diagnoses will also be collected. Information from this study will allow investigators to document the efficacy of patient-led surveillance in terms of melanoma diagnoses and resource use.

MEMOIR aims to evaluate the efficacy of oral memantine and the effectiveness of Graded Motor Imagery (GMI) on pain intensity and pain interference at 16 weeks in people with chronic Complex Regional Pain Syndrome, in a 2 x 2 factorial RCT. Participants will be randomised to one of 4 groups: memantine plus GMI; memantine plus usual care; placebo memantine plus GMI; placebo memantine plus usual care. We hypothesise that memantine and GMI will produce clinically meaningful reductions in pain intensity and pain interference.

The aim of this study is to determine the feasibility and efficacy of an AI-supported intervention that comprises automated phone calls (interactive voice response), and emails or text-message (SMS) delivered according to an algorithm, as well as an educational website. Participants interact with the automated phone calls via voice and the system interprets participant responses using natural language processing (AI component). The intervention incorporates periodic assessments of overall health status, AF symptoms and impact on daily life, General Practice (GP) access, and medication confidence and adherence, along with providing education content related to AF. We hypothesize that a AI supported technology platform for patients with AF can help identify higher-risk patients needing closer follow-up from the healthcare team, provide behaviour support for AF self-management, and identify and address barriers to AF management (attendance at regular GP and specialist appointments), leading to improved outcomes and care experience. We aim to evaluate the effect of the intervention on quality of life, behavioural and self-management outcomes (e.g. medication adherence), patient knowledge, health outcomes (stroke, myocardial infarction, mortality), healthcare service utilisation, feasibility outcomes (acceptability, usability, program engagement) and patient care experience.

Chronic pouchitis is a common complication after a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Although antibiotics have been the mainstay of treatment for acute pouchitis, a proportion of patients become antibiotic-dependent or develop antibiotic-refractory pouchitis. There are few effective therapeutic options for these patients, and few prospective trials assessing their effectiveness. Tofacitinib was recently approved by Therapeutic Goods Administration (TGA) for treatment of ulcerative colitis (UC). It was found to be effective for induction and maintenance therapy in patients with moderate to severe UC. Chronic pouchitis is associated with similar inflammatory pathway activation as UC, therefore this study aims to investigate whether tofacitinib is effective for the treatment of chronic pouchitis.

Recovery following current treatment for methamphetamine use disorder (MUD) is poor. Only 14% of individuals report continued abstinence at one-year follow-up, which decreases again to 6% after three years. One of the critical limitations of existing treatment approaches is that they do not address the cognitive deficits that result from long-term methamphetamine use, which is critical to recovery from methamphetamine addiction. Goal Management Training (GMT), originally designed for individuals with brain injury, is a well-validated evidence-based intervention for executive dysfunction (i.e. impulsivity, working memory and decision-making deficits). Proof of concept studies conducted in Europe have shown that GMT improves cognition in stimulant (cocaine/amphetamine) users. However, we do not know if GMT is a feasible intervention in the context of methamphetamine treatment in Australia, or if it can improve clinical outcomes such as treatment retention and abstinence rates. We have modified this program (now GMT+) to reduce the content to four weeks (so that it is better aligned with average treatment duration for MUD in Australia) and improve relevance and engagement for consumers with MUD. We intend to conduct a proof of concept trial to test GMT+ within a residential addiction rehabilitation setting for individuals with MUD. Participants will receive follow-up testing immediately after the intervention (cognitive performance, acceptability), 4-weeks after the intervention (treatment retention, quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence), and 12-weeks after the intervention (quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence) to assess the benefit of GMT+ compared to psychoeducation-control.

The ImmunoPET study aims to assess whether it is feasible to use 89Zr-durvalumab (89Zr-durva) as a PET tracer of PD-L1 (a cancer related protein) in patients with cancer. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive an injection in the arm containing the 89Zr-durva tracer 30 minutes prior to completing a PET scan on Day 0. A further 3 PET scans will be taken 24 hours, 3 days and 5 days after the injection of the 89Zr-durva tracer. Each PET scan will take approximately 30-45 minutes. Blood tests will be taken at each of these PET scans. About 15-20ml of blood will be taken at each PET scan. It is hoped that this study will help determine if 89Zr-durvalumab (89Zr-durva) is a feasible option for use as a tracer of PD-L1.

The purpose of this protocol is to allow for patients on current AP01 studies to continue therapy and for patients with progressive, fibrosing ILD, including IPF without treatment options and who are unable to enroll in an AP01 study to be treated with AP01. The primary objective is to allow patients to continue or start AP01 therapy. A screening visit will be performed if the patient has not previously been on an Avalyn sponsored AP01 study. If a patient has been previously enrolled on an Avalyn sponsored AP01 study, a modified screening visit will occur. If the patient stops treatment for any reason an end of treatment visit will take place. Patients will have an in clinic visit every 12 weeks to collect any safety and lung function tests that are performed as standard care. AP01 treatment within the realm of this study will continue if patient can tolerate the drug or regulatory approval is granted or the study is terminated. Study may be terminated by the sponsor at any time for any reason. The data in this study will be used to assess the safety of patients on AP01 therapy.

The purpose is to determine if it is better (or worse) to include the carpometacarpal joint in total wrist fusion. The carpometacarpal joint (CMC) doesn’t move much in a normal wrist. It is located at the base of the metacarpals which are bones located between the wrist bones and fingers. If the carpometacarpal joint is fused in total wrist fusion, the third carpometacarpal joint (at the base of the long finger metacarpal) is usually fused. Sometimes the second carpometacarpal joint (base of the index finger) is fused if a slightly different position of the wrist is required. We do not yet know if fusing the CMC joint (or not) during wrist fusion leads to better patient outcomes. Currently, some surgeons prefer to fuse this joint as they think it may become painful later and that motion at this joint may cause the metal plates used in wrist fusion to break. Previous research on this question has shown there is no difference in outcome in patients who have or have not have this joint fused during total wrist fusion. However, these studies were small and were not properly designed to answer this question. For this reason, we would like to complete a properly designed study to determine what approach leads to the best outcomes. We seek to compared the two 'gold standards' of wrist arthrodesis in a randomised way - wrist fusion with inclusion of the CMCJ with a plate that goes across this joint to wrist fusion without CMCJ fusion with a plate that does not cross this joint. The results of this study will inform future patients and surgeons of the best option.