ANZCTR search results

The primary aim of this project is to test the feasibility of recruitment, retention, data collection and analysis for a fully-powered randomised controlled trial (RCT). This is to evaluate the effectiveness of the rebozo technique in improving birth experiences and outcomes in first time mothers utilising epidural analgesia. As the rebozo technique is an under-researched method to optimise fetal position for labour and birth, a pilot RCT is needed to determine feasibility to a fully-powered RCT. The study participants will be low risk first time mothers using an epidural. The intervention will be the rebozo technique, and the comparison group will be standard care provided by midwives. Primary outcomes are proportion of women who meet inclusion criteria give consent to participate; proportion of women who give consent are randomised; proportion of women who receive allocated intervention; proportion of participants who withdraw from the study; proposition of participant data collection sheets completed; and number and nature of adverse events.

This project will determine whether atrophy of the quadriceps muscles in previously ACL injured limbs is due to an inability to activate key molecular signalling pathways that govern maintenance of muscle mass and the ability to regenerate new muscle tissue. We will provide both functional and mechanistic evidence regarding how ACL injured limbs have a reduced capacity to build muscle. The findings from this work will assist in the development of interventions aimed at improving muscle building capacity in the quadriceps in individuals following ACL injury. Hypothesis: Following exposure to strength/rehabilitation (resistance-based) exercise, limbs with a history of ACL injury will demonstrate impaired activation of key molecular pathways underlying muscle growth, compared to non-injured limbs. Study design: A within-participant cross-sectional study will permit investigation of differences in exercise-induced molecular pathway within the same participant between his/her limbs (with/without a prior ACL injury) at rest and immediately following a single bout of strength/rehabilitation exercise.

This study aims to test if it is practical to conduct a one-off multi-disciplinary team (MDT) consultation for patients with advanced non-small cell lung cancer, focussing on survivorship care needs. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have advanced non-small cell lung cancer, and have been receiving your current cancer treatment for at least 6 months without the disease getting worse on scans. Study details All patients who enrol in this study will be invited to participate in a single, 30-minute, multi-disciplinary team (MDT) meeting via a secure, online video-conferencing platform. The meeting will focus on any unmet needs and concerns the participating patient may have related to survivorship, with discussion led by a lung cancer specialist nurse from the hospital. The MDT will include the patient (+/- a family member), hospital doctor, allied health professional, and a member of the patient’s primary care team (ideally the patient’s GP). Prior to the MDT meeting, all patients will be asked to complete a survey to identify survivorship concerns in order to guide the MDT discussion, and they will receive a 15-minute call by a member of the study team prior to the MDT meeting. The patient’s GP will also be asked to complete a 5-minute questionnaire prior to the MDT. After the MDT meeting a survivorship care plan will be produced summarising the discussion at the MDT meeting, and a copy made available to the patient, the patient’s GP and placed in the patient’s hospital record. Three months after the MDT meeting, participating patients and GPs will be asked to complete a short follow-up questionnaire about how acceptable the MDT meeting process was. Later on (4-4.5 months post participating in the MDT meeting) some patients and their GPs will also be invited to participate in an interview to discuss their impressions of participating in the MDT meeting. Rationale It is hoped that this study will show that a MDT consultation is both feasible and acceptable to patients, hospital and community-based health-care providers, and enable further implementation of these consultations to improve the survivorship care for patients living with advanced non-small cell lung cancer.

The purpose of this study is to assess the effect of adding perforations to scleral contact lenses upon; 1) corneal tissue swelling, 2) tear flow behind the contact lens, and 3) build up of debris behind the contact lens in young healthy adults during short-term lens wear (3.5 hours). The null hypothesis is that the incorporation of scleral lens perforations will have no significant effect upon the primary outcome measures (1,2,3 listed above).

The purpose of this study is to investigate the long-term impact of wearing minimalist school shoes on a child’s (9 – 12 yrs) foot muscles and balance. The hypothesis, based on previous research is that over time, with no externally imposed shoe movement restrictions (such as with normal stiff school shoes) the child’s balance will improve and their foot muscles will increase in size and strength.

The Kinephonics app is a new technology to support people with communication difficulties using speech entrainment intervention technique. It is hypothesised the app, with the support from a support worker or allied health assistant, can help adults with a range of backgrounds (including stroke, developmental disorder, autism, brain injury) with improving their speech and language skills. The current study is a pilot study, which will inform the development of a future large clinical trial. The primary objectives of the study are to a) determine the acceptability and feasibility of conducting the study for a large clinical trial in the future using the Kinephonics app with support workers and allied health assistants implementing the intervention; and b) to determine the effect of the Kinephonics app on various speech and language outcomes. Following an assessment visit to capture communication outcomes, participants will be randomised to immediate intervention group or waitlist control group. Each group will receive Kinephonics® speech entrainment sessions 20-30 minutes 1-2 weekly for a total of 12 sessions within 6 weeks. Outcomes will be assessed after each intervention/usual care phase, and 1 month after all phases. fMRI neuroimaging on 20 participants with a background of a stroke before and after the intervention to identify neurological changes with Kinephonics® use is an optional component of the study. Outcomes which will be measured include: * Number of intervention sessions participants attend * Support worker and allied health assistants following the Kinephonics training and intervention requirements * Receptive and expressive language skills before and after the intervention * Speech skills before and after the intervention * Fatigue ratings after participating in the intervention * Optional functional MRI for stroke participants to measure neurological changes * Optional interview to discuss participant and family experience with being in the study

This clinical trial aims to assess the effect of a combination therapy with Venetoclax, Iberdomide and Dexamethasone for the treatment of patients with first or second relapse of Multiple Myeloma t(11;14). 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 receive cycles of combination treatment. Each cycle is 28 days in length. The treatment is 3 products that will be used in combination. The first product, Venetoclax is an oral treatment and participants will take this from day 1 to day 28 of each cycle. The second product, Iberdomide is also an oral treatment and participants will take this from day 1 to day 21. The third product is Dexamethasone which participants have most likely had before. Dexamethasone will be taken on days 1, 8, 15 and 22. Participant will continue on the treatment combination until they are no longer responding to the therapy, or if the treatment causes too many adverse events. Safety assessments will be carried out by the Chief Investigator and trial committee. It is hoped this research will determine whether the combination of Venetoclax, Iberdomide and Dexamethasone is successful at treating people with relapsed or refractory multiple myeloma. 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.

Osteoarthritis (OA) is a chronic and progressive condition affecting 1 in 8 Australians. Recent advancement suggests that there is a vascular (formation of new vessels) and inflammatory component associated with OA. Osteoarthritis of the knee is the most common form of OA. The risk of functional limitations from knee osteoarthritis is greater than that from any other medical condition for those aged 65 and above. Blockage (embolisation) of these newly developed blood vessels in knee OA represents a method to reduce a patient's symptoms but also delay the progression of their condition. Across Japan, USA and UK, many researchers have looked at the safety and efficacy in carrying out embolisation of geniculate arteries. These studies have shown a reduction in patient’s pain and nil adverse outcomes associated with the procedure itself. This procedure represents a potential intermediate management tool with reduction in the costs associated with total knee replacements as well as increasing economic productivity for patients and the community. This study hypothesises that patients who undergo blockage of the newly developed vessels will result in a reduction in analgesic consumption and an increase in quality of life for patients in comparison to the placebo. This study aims to compare geniculate artery embolisation with non-procedural intervention to ascertain further data and aid the growing literature in the global community for the use of this procedure as a method to manage patients with osteoarthritis. Participants will be assessed prior with a thorough clinical/medication history, physical examination and a questionnaire (visual analogue scale and Knee injury and osteoarthritis severity score) related to the patient’s experience with regards to their knee issues. Once the participant has consented and enrolled in the study. The study will randomise participants into an intervention group (those that receive the blockage of vessels) and those that do not. Both participants will be followed up post procedure at the 1 day, 1 week, 1 month, 3-month, 6 month and 12-month mark for functional and subjective assessment of the knee.

Patients admitted to the Intensive care Unit (ICU) are the sickest in hospital, and those that survive experience significant muscle wasting and poor functional outcomes. Nutrition therapy is a fundamental part of clinical care that is thought important to optimise recovery. Historically, invasive mechanical ventilation (IMV) – the insertion of a tube into the trachea to support or replace spontaneous breathing – has been a key strategy in respiratory management; however, for certain causes of respiratory failure there has been increasing use of non-invasive techniques. Current international critical care nutrition guidelines largely focus on those patients that are receiving IMV, and guidance in the setting of non-invasive ventilation (NIV) is lacking. This is partly due to limited high-quality nutritional and functional outcome data in this population group. We propose undertaking a prospective observational study to quantify both nutrition intake and physical and functional outcomes in critically ill patients receiving non-invasive respiratory support.

Following childbirth tears to the perineum (area between the vaginal and bowel) and vagina are common occurring in 80 to 90% of women. Tears to the anus (bottom muscle) known as 3rd or 4th degree tears and occur in 3.5% of women giving birth in Australia. To promote healing of these tears, medications are given to soften the stool (poo). Currently all women following childbirth who have sustained a tear to the bowel muscles (3rd or 4th degree tear) would have laxatives ordered. Several types of medications known as laxatives are prescribed however we do not know which one is the best. If you choose to be involved in the research, you will be allocated one of two laxatives that are prescribed for women following birth. The research team contact you and ask you about how easy it was to open your bowels (Poo), if you had any bowel incontinence (accidental loss of poo, gas or need to rush to the toilet for a Poo) or any concerns with healing of the wound (stitches). Information from this research will help guide development of a larger trial in the future. The research project aims to see how several types of laxatives affect 1. How easy or hard it was to use your bowels (Poo) after birth and until 3 months following the birth of your baby. 2. If you have accidental leakage of (Poo), called anal incontinence following birth until 3 months post birth. 3. Any concerns about healing of the stitches (3rd and 4th degree tear) following birth until 3 months post birth. ? The Continence Nursing team routinely provide follow up care to women following 3rd and 4th degree tears. As part of the research, and on discharge from hospital, you will only be required to provide verbal feedback to questions on three occasions, about how easy or difficult it was to use your bowels (do a poo) if you have accidental loss of poo (anal incontinence) and how the