ANZCTR search results

Infliximab is the mainstay of treatment in perianal fistulising Crohn’s disease. It has previously only been administered via infusions for perianal fistulising Crohn’s disease. Subcutaneously delivered infliximab has recently been approved by the Therapeutic Goods Administration for perianal fistulising Crohn’s disease. Real-world data has demonstrated that switching from intravenous to subcutaneous infliximab in patients with disease of their bowel is safe and effective. However, there is currently a lack of data regarding the efficacy or treatment persistence in patients switched from intravenous to subcutaneous infliximab in perianal fistulising Crohn’s disease. Our study involves switching patients from intravenous to subcutaneous infliximab and evaluating how many patients continue to take this medication at 12 months. Secondarily, we will look at how effective this drug is at treating perianal fistulising Crohn’s disease with a variety of measures

The effect of screen use on children’s health and development is now considered a public health issue. National Child Health Polls consistently report excessive screen use as Australian parents’ top-ranked child health concern, and over half of Australian parents are concerned about their own children’s screen use. Parents report that children’s screen use contributes to family conflict, oppositional child behaviour, lack of physical activity, and sleep problems, and data show that high screen use is associated with poorer physical, psychological and developmental health outcomes for children, including in early childhood—relationships which appear to be at least partially mediated by parenting behaviour (e.g., reduced parent-child interaction). Parents report that difficulties with implementing screen use limits, difficult child behaviour when limits are imposed, and parenting practices which encourage screen use are barriers to healthy screen use. Indeed, our own data suggest that difficult child behaviour is a key predictor of low parental self-efficacy for managing children’s screen use which, in turn, predicts greater screen use. This project will evaluate a brief online parenting support intervention designed to help parents develop the skills and confidence to implement healthy screen use practices with children from the earliest years. It will generate essential data to inform study design and applications for funding for a larger scale, fully powered RCT to establish intervention efficacy.

Multiple myeloma is a plasma cell malignancy that remains incurable. In multiple myeloma, patients with non-measurable disease, poor kidney function, extramedullary relapse, or Central nervous system myeloma are frequently excluded from clinical trials. Considering this, none of the available treatments have been adequately studied in these populations, and these patients represent a group with an unmet clinical need. We plan to establish a platform trial to look at these orphan groups (strata) of patients who have previously had no prospect of enrolment in clinical trials and in groups of patients who have not been explored before. Therefore, this clinical trial aims to assess the effectiveness of different treatment regimens for patients with first or second relapse of Multiple Myeloma. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with Multiple myeloma and have had 1-2 prior lines of treatment. Study details Participants who choose to participate in this trial will undergo screening assessments to see if they meet one of the four following disease criterions described as stratums: •Stratum A: Poor kidney function, defined by a laboratory value of creatinine clearance (CrCl) less than 30mls per minute. •Stratum B: Non-measurable disease (defined by specific levels for blood and urine tests collected at screening) •Stratum C: presence of a plasma cell tumour that develops outside the bone marrow (extramedullary plasmacytoma) •Stratum D: Central Nervous System (CNS) myeloma Once the participant has met one of the four disease criteria described above, they will be assigned to the corresponding platform clinical trial (called appendixes) based of the four stratums described above. Once it is determined which platform trial they should be assigned to, the participant will be screened and consented again for the platform trial and go on to receive treatment if they meet the eligibility for the specific platform trial. This will continue until the participant experiences either unacceptable toxicity, or disease progression. Participants will be monitored for adverse effects for the duration of treatment, as well as the start of every cycle for assessment of their response to treatment through blood and urine samples and/or bone marrow biopsies, and assessment of quality of life through completion of a questionnaire. It is hoped this research will determine whether the combination of different treatments in treating a specific population of participants with relapsed or refractory myeloma is successful. If this combination treatment is found to be effective, it may be used to improve the health outcomes of future patients with refractory and relapsed multiple myeloma.

Stoma formation in the neonatal period is necessary in many surgical conditions. There remains debate surrounding a number of factors (such as indications, type, timing of closure) and a paucity of quality literature to inform these decisions. The study aims to give an accurate reflection of practice and outcomes in Australia and New Zealand. Results will be used to aid and improve decision-making for this vulnerable group of patients

Background: Anorexia Nervosa (AN) has one of the highest mortality rates of any mental illness and very low treatment success rates. AN is characterised by high anxiety around food and weight gain. There are no pharmacotherapies approved for the treatment of anorexia nervosa (AN) and a need to find novel interventions to improve outcomes. Cannabidiol (CBD) has shown promising anxiolytic therapeutic effects in young people (12-25 years) with severe anxiety as well as young adults with social anxiety disorder. Anxiety is both a major feature of AN and highly prevalent during active treatment of the disorder, providing a strong incentive to explore CBD in people with AN. In an open label design, CBD capsules will be administered as an adjunctive intervention alongside an outpatient psychological intervention for 12 weeks. Safety and preliminary efficacy will be determined in people with AN. Study Aim: To determine if CBD treatment is a safe and a well-tolerated intervention in persons with AN. Moreover, to elucidate whether CBD is effective to reduce anxiety Hypothesis: We hypothesise that CBD is highly tolerable with a high safety profile, with no associated serious adverse events reported in relation to the investigational product. We hypothesise that CBD will reduce anxiety scores throughout the study and at follow-up. Furthermore we hypothesise that CBD will improve eating disorder psychopathology, depression, obsessive and compulsive symptoms and quality of life.

The aim of this study is to explore the long-term pain relieving effect after receiving ketamine infusions. There is a need to monitor the psychological, social and functional outcomes of patients receiving this treatment. We hypothesise that ketamine infusions will improve the pain experience for those with chronic refractory pain. Your pain specialist will determine if you are eligible to participate based on your symptoms. You will need to sign a consent form prior to any further information being collected. After this you will need to complete a baseline questionnaire asking about your history with ketamine infusions as well as some common pain, psychological and social measures. You will receive three burst ketamine infusions lasting 4 hours, 2-3 weeks apart. At the end of the infusion you will be asked to complete several questionnaires about your pain as well as some information regarding any side effects experienced. At two months and three months after your course of burst ketamine treatments you will need to complete a set of questionnaires again on pain and psychosocial measures. At each point the questionnaires will take you about 30 minutes and you have the option to complete the majority of them online via email in order to make the process more convenient.

This is an open label, Phase Ib/II trial with a randomized platform design study for treatment of myelodysplasia. The purpose of this trial is to determine the safety and efficacy of treatment by adding SRA515 to ASTX727 in intermediate and high risk MDS. This multi-centre trial will recruit participants across Australia and New Zealand. Up to 26 subjects will be recruited for the dose-determining phase (Phase Ib) and at least a further 60 patients in the dose expansion phase. Who is it for? You may be eligible to join this study if you are aged 16 years or above and have a diagnosis of MDS or acute myeloid leukaemia (AML) with <30% blasts. Study Details This study will be conducted in two phases with cycles of 28 days. Phase Ib (Safety and Dose-Determination) will determine safety, tolerability and Recommended Phase II Dose (RP2D). Subjects will receive 35mg of ASTX727 by oral capsule on Days 1-5 of each cycle followed by a starting dose of 10mg of SRA515 by oral capsule on days 6-15. Phase II (Dose-Expansion) will assess preliminary signs of efficacy by monitoring overall response rates in participants for a minimum of 6 cycles. Patients will continue receiving therapy until experiencing an event as detailed in the MDS05 Master Protocol. During treatment participants will be assessed routinely for treatment-related toxicity events and investigators will modify treatment dosage or, if necessary, discontinue treatment. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option. It is hoped that the results of this trial will help determine if, and what dosage of, SRA515 in combination with ASTX727 is a safe and effective treatment option for patients with MDS or AML.

Uterine Artery Embolisation (UAE) is accepted in Australia to treat uterine leiomyomas (fibroids). There is also growing literature to support UAE for the treatment of symptomatic adenomyosis (a condition when the tissue that lines the uterus grows into the muscular wall of the uterus). Adenomyosis and endometriosis are both disorders of the endometrial tissue that lines the uterus. UAE is a procedure where an embolic agent (a gel or glue) is placed in the uterine artery to limit the blood flow to areas of the uterus. It is a minimally invasive procedure performed by an Interventional Radiologist under image guidance. A small incision is made in the groin or the arm and a catheter (a long narrow tube) is placed in the artery and, under image guidance the catheter is directed to the artery to be treated. Once the catheter is in place the embolic agent is placed in the artery and the catheter is removed. UAE is not approved to treat endometriosis. Therefore, it is an experimental treatment for endometriosis. This means that it must be tested to see if it is an effective treatment for endometriosis. In this trial, the researcher would like validate that embolisation is a safe procedure and will provide improvement in the symptoms of endometriosis for patients with endometriosis.

This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1b clinical study to evaluate the safety, tolerability, PK, and PD of oral multiple-ascending doses (MAD) of iN1011-N17 after Oral Administration in Healthy Volunteers and OsteoarthritisPost-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers. The study will be conducted with approximately in 3 parts. 56 healthy volunteers and 8 PHP patients will enrolled in up to 8 sequential MAD dose cohorts (Cohorts 1 to 8), each cohort can commence after the corresponding dose cohort has been completed and after Safety Review Committee (SRC) approval.

BACKGROUND Micromotion analysis supports effective cemented tibial component fixation in Total Knee Replacement (TKR) but a paucity of literature exists for medial pivot designs. This clinical study examined the tibial component micromotion and clinical scores in a second-generation medial pivot TKR. METHODS This prospective single-center clinical cohort trial involved 35 patients with a mean patient age of 71 years. Operations were performed by one experienced arthroplasty surgeon using the SAIPH implant (MatOrtho). All patients received fully cemented fixation with patella resurfacing. Other variables were standardized. Radiostereometric Analysis was performed at 6 weeks and 12 months to monitor tibial component behavior. The working hypothesis of this study is that the SAIPH tibial baseplate achieves stable fixation using bone cement in subjects undergoing TKR