ANZCTR search results

Patients with persistent pelvic pain (PPP), including those with endometriosis associated pelvic pain, often have pelvic floor muscle tenderness and tension. These problems may be related to their pelvic pain continuing, despite medical or surgical treatments for endometriosis. Prior to a patient’s first laparoscopy for the investigation of PPP, we will investigate if they experience tenderness and tension in their pelvic floor muscles and whether this is associated with their pelvic pain. We will also investigate whether the pelvic floor muscle tenderness and tension, and pelvic pain, change following the laparoscopy, in the short term (3 months) and the medium term (1 year). This study will also test how well gynaecologists and physiotherapists are able to detect pelvic floor muscle tenderness and tension to ensure patients with pelvic floor muscle problems receive appropriate treatment.

This study aims to evaluate the impact of an online low health literacy fertility-related decision aid (DA) for young women with early breast cancer among women of all health literacy levels. The primary hypothesis is that the Intervention (DA website) is superior to the control (DA booklet), as measured by a greater reduction in decisional conflict at 12 months via the Decisional Conflict Scale. Who is it for? You may be eligible to take part in this study if you are a pre-menopausal woman aged between 18-40 years, have recently been diagnosed with early stage breast cancer, have not had an advanced cancer, have not undergone adjuvant therapy for breast cancer, want to find out more about fertility and/or fertility preservation at the time of diagnosis, and have easy access to the internet. Study details Participants will be randomly allocated (by chance) to receive either the new decision aid website or the existing decision aid booklet. The decision aid website contains easy-to-understand information about the side effects of cancer treatments on women's fertility, and options for preserving fertility to increase the chances of having a baby in the future. Participants will be asked to complete surveys at 4 timepoints: baseline (before viewing the DA), 1-month, 6-months, and 12-months after recruitment. We will then assess how effective the new DA is in supporting women to make decisions about breast cancer treatment and fertility. It is hoped that the DA will lead to better understanding of fertility-related issues and educated involvement in decision-making among women with diverse levels of health literacy.

This study is a FIH, open label, SAD and MAD study to determine the safety and PK characteristics of mEphA4-Fc in HVs and patients with ALS. Measurements of clinical endpoints associated with ALS will also be assessed. All potential subjects will be required to provide written informed consent prior to any study specific Screening procedures being performed. Subjects eligible to participate in the study will be assigned to receive their first IMP administration no later than 28 days after Screening. Part 1 (SAD): Total of 20 healthy volunteers (HVs) in five cohorts Part 2 (MAD): Total of 8 ALS patients in two cohorts Part 3 (Extended Access Study): Total of 8 ALS patients in two cohorts. The study patients will receive 5 cycles of 4 weekly infusions.

Does four weeks of malt extract supplementation in individuals with IBS reduce IBS symptoms, improve gut health and improve quality of life?

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This study follows the mothers and infants that have participated in the SUMMIT randomized controlled trial, and aims to compare the impact of two doses of domperidone on long-term breastfeeding, child growth and neurodevelopment up to 24-36 months infant corrected age. Eligibility participants will be mothers of preterm infants (< 34 weeks' gestation at birth), with insufficient breast milk (<300 mL/day or < 500 mL/day depending on postnatal age), who are expressing an average of six times a day or more, between 7 to 28 days postpartum, and who participated in the SUMMIT trial. Eligible women were randomised to receive high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days.

The aim of this two-arm cluster-randomised controlled trial is to determine whether the less resource- and cost-intensive version of the PACE program (i.e., ePACE) is non-inferior with regards to increasing teachers’ implementation of classroom physical activity via Energisers, relative to the original PACE program. Eighty primary schools will be recruited to examine this. In each of the two arms, teachers will receive support to increase the amount of physical activity time, in particular Energisers, they deliver across the school week. Schools in the ePACE program will receive executive support, access to an online portal, equipment pack vouchers and ongoing project officer support. The comparator (i.e., PACE) condition will include the original face-to-face in-school champion training, an educational session delivered to teachers by in-school champions as well as executive support, and information and resources to support implementation. Eighty primary schools will be randomly allocated to one of two intervention groups. The final trial endpoint is defined as 12 months after baseline.

This project aims to extend research conducted by Alt and colleagues in the United States in 2014 and 2020 which found preliminary efficacy of a speech pathology treatment for children who are late to talk (late language emergence). This treatment was based on theories of statistical word learning where a speech pathologist spoke to the child in language containing target words spoken a large number of times (high dose), within different types of sentences (linguistic variability) and referencing a number of different physical objects (physical variability). This treatment was found to result in children speaking more target words and in a quicker timeframe than established treatments. This treatment was administered by speech pathologists however, which is not traditional for this young population (commonly parent-administered) or cost effective. This project aims to examine if this treatment can be trained to a group of parents, to be administered at home. The specific research questions are: 1 - Can parents be successfully trained in administering an intervention to their children which presents target words with high dosage and variability? 2 - Will the parent group training program be acceptable to parents, children and study personnel? 3 - Will children with late language emergence (LLE) receiving the parent intervention learn a significantly higher number of treated words relative to control words? 4 - Will children with LLE receiving the intervention protocol acquire untreated words at a rate exceeding that of typical language acquisition in late talking toddlers?

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will resolve the issue of whether a higher dose of domperidone (60 mg/day) leads to greater improvements in maternal breast milk supply compared to a lower dose (30 mg/day), while also evaluating differences in adverse events, impacts on breast milk composition, and identifying predictors of treatment response to domperidone. Eligible women will be randomised to a high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days. All women will initially commence on the low dose for 2-days before continuing with their assigned treatment dose for a further 19 days. The primary outcome will be assessed at day 21 following treatment initiation. After this point in time, women will be provided with the option to taper their dose to twice daily for four days and then once daily for three days, before stopping. All participants will undertake regular study assessments including at baseline (study enrolment), day 7, 14, 21 of treatment, one-week following intervention, and at infant discharge to home or term corrected (whichever comes first). Women will undergo a breast assessment by a lactation consultant or nurse/midwife, and complete a breast milk diary throughout the study. Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will provide breast milk, blood, urine, stool and buccal cell swab samples.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the clinical activity of the combination of durvalumab and acalabrutinib in participants with high grade B cell lymphoma. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with high grade B cell lymphoma. Study details: Participants will receive 2 drugs: 1/ durvalumab, to be administered via intravenous infusion at a dose of 1500mg every 4 weeks, and 2/ acalabrutinib, to be administered orally at a dose of 100mg twice daily. Both drugs will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo clinical assessments at 4 weekly intervals from first treatment until end of treatment, then 8 weekly intervals until disease progression. Imaging will be at 8 weekly intervals until disease progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who have limited treatment options available to them. It is hoped that the combination of durvalumab and acalabrutinib will be well tolerated and will improve outcomes for future patients, however there may be no clear benefit from participation in this study.

Non-ambulant children with cerebral palsy experience more sedentary behaviour, spending up to 96% of their waking day sitting. With limited evidence-based interventions available, this can have a devastating impact on health and well-being. CPMovetime aims to develop new interventions that reduce sedentary behaviour to improve health outcomes.