ANZCTR search results

Birthing women experience perineal tears and episiotomy (cutting the vaginal opening during childbirth) that may impact upon a woman's physical, emotional and sexual well being. This study began after the author (who is both a Midwife and an acupuncturist) observed acupressure that she offered to birthing women on the perineal acupuncture point Conception Vessel 1 (CV1) facilitated normal vaginal birth and women were less likely to have severe perineal tears and did not require an episiotomy.

Parental acceptance and insightfulness has been found to be important to the attachment security and social and emotional development of autistic children. However, no research exists relating to developing parental insightfulness and acceptance in parents of autistic children. This study tests the effectiveness, feasibility and acceptability of a novel consumer-informed parent support program through a pilot randomised controlled trial (RCT) of the AutInsight program: a program developed based on insights from autistic adults and what they wanted from their own parents. The program seeks to help parents i) develop greater insight and understanding of autism from the inside out, drawing on the perspectives of autistic adults; ii) strengthen their relationship with their child; and iii) develop practical strategies for parents’ self-care. It is expected that at the end of the program, parents will develop in insightfulness and acceptance of their autistic children, report a better relationship with their child as well as develop greater strategies for self-care.

This study aims to assess the feasibility of making virtual reality (VR) experiences available to palliative care inpatients in a large tertiary hospital. Who is it for? You may be eligible for this study if you are a hospital inpatient admitted directly by the palliative care team, and have a life expectancy of less than 12 months. Study details Patients will be offered a one-off VR experience with a head mounted device (HMD), where they are immersed in different VR environments of their choice. Choices include indoor or outdoor scenes and urban or natural environments. There will be a brief interview afterwards to discuss what they thought about the experience. It is hoped that patients will find this experience enjoyable and that the findings from this study will help elicit the preferences of this patient population with regards to the types of VR experiences they would be interested in, to guide the provision of future VR product offerings.

This study will assess the potential of neurologist videoconferencing to improve the accuracy of paramedic-led transport decisions for hyper-acute stroke. We anticipate that when appropriate the video assessment of patients by a neurologist, at the point of first contact will improve the accuracy of transport decisions. We will introduce this process and support the effort using virtual reality training, which guide paramedics through detailed stroke assessment and transport decision-making workflow. The overarching aim is to enhance paramedic identification of treatment-eligible stroke patients, to support decision-making regarding the most appropriate hospital destination, and thereby reduce treatment times and improve patient outcomes. To achieve this we have co-designed a clinical pathway, protocols and processes to facilitate paramedic point-of-care video conferencing with stroke neurologists. In the current study we will 1) Develop, test and evaluate a new Virtual Reality training platform, to enhance paramedic detection of stroke signs and pre-morbid status, and use of optimal workflow procedures (including videoconferencing) and 2) Determine the impact of i) training on local paramedic staff and their use of the new workflow approach via implementation outcomes and ii) the training platform on accuracy of stroke patient transport destination decisions in a pre-/post-analysis.

This study aims to determine the efficacy and safety of low-dose cannabidiol for anxiety. Cannabidiol or CBD is a major component originally derived from the Cannabis plant and works on cannabinoid receptors. There are two types of cannabinoid receptors, CB1 mainly in the brain and CB2 mainly in the immune system. These two receptors help regulate things like sleep, mood, pain and more. This study will be investigating if low-dose CBD will improve anxiety when compared to a placebo or inactive drug. CBD has been used for a number of conditions but there are limited clinical studies for individual products and conditions. There is evidence that low-dose CBD is safe to use and the Therapeutic Goods Administration (TGA) has scheduled low-dose CBD (maximum of 150mg per day) as Schedule 3 or pharmacist only due to the acceptable safety and tolerability profile. There is evidence to suggest CBD is effective for anxiety but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for anxiety compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for anxiety then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.

This study aims to determine the efficacy and safety of low-dose cannabidiol for sleep disturbances. Cannabidiol or CBD is a major component originally derived from the Cannabis plant and works on cannabinoid receptors. There are two types of cannabinoid receptors, CB1 mainly in the brain and CB2 mainly in the immune system. These two receptors help regulate things like sleep, mood, pain and more. This study will be investigating if low-dose CBD will improve sleep disturbances when compared to a placebo or inactive drug. CBD has been used for a number of conditions but there are limited clinical studies for individual products and conditions. There is evidence that low-dose CBD is safe to use and the Therapeutic Goods Administration (TGA) has scheduled low-dose CBD (maximum of 150mg per day) as Schedule 3 or pharmacist only due to the acceptable safety and tolerability profile. There is evidence to suggest CBD is effective for sleep disturbances but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for sleep disturbances compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for sleep disturbances then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.

Resistance training safely improves a range of outcomes in older adults, with high-velocity resistance training (HVRT) the most effective at improving power and function in this group. Improving power generation with training such as HVRT is critical for older adults because muscle power is more important than muscle strength for physical function, dynamic balance and reacting to a loss of balance to prevent a fall. While HVRT is effective, the benefit of such training is partly dependent on maximising movement velocity. Providing augmented feedback during resistance training is effective at improving movement velocity, motivation, and functional performance in young adults, but the use of feedback during resistance training in older adults has not been studied. Feedback is an integral component of a physiotherapist’s tool kit to optimise interventions (e.g., providing verbal feedback during task practice) but evidence to support the efficacy of feedback during HVRT in older adults does not yet exist. The proposed study will be the first to identify whether providing augmented feedback during resistance training enhances movement velocity in older adults. Based on the established benefits of adding targeted instruction or feedback to other physiotherapy interventions, and the identified benefits of velocity-based feedback in young adults, it is hypothesised that augmented feedback will improve movement velocity during training. Improved movement velocity should translate to greater power adaptations and functional improvements. If feedback is effective at improving within session performance in older adults, the benefits may be transferrable to other physiotherapy settings such as rehabilitation where improving muscle power and function is a priority for most patients. Importantly, if feedback influences perceived exertion/motivation, this has positive implications for exercise adherence. The objectives of this study are to identify whether: a. providing augmented feedback during a resistance training session increases barbell velocity in older adults b. different types of augmented feedback (e.g., visual) optimise barbell velocity c. provision of feedback influences motivation and perceived exertion in older adults

This research project is testing the effectiveness of using pressurised fluid during flexible cystoscopy insertion in reducing pain. We know that the most significant pain is experienced during camera insertion. There is some evidence that a ‘bag squeeze’, which temporarily generates an increase in fluid pressure that can reduce a participant’s pain, it is unclear how much pressure during the ‘squeeze’ is ideal and it is not easily reproducible. Hence, we also will use pressurised fluid bags with a standardised pressure level to make this more reproducible for participants. Whilst fluid-pressure bags are commonly utilised other areas of Urology such as ureteroscopy, it would represent an experimental intervention for pain-reduction in Flexible Cystoscopy.

This is a Phase 1/2, open label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and clinical activity of escalating doses of BOS-342 monotherapy in patients with Hepatocellular Carcinoma (HCC) or other Glypican 3 (GPC3)-expressing tumors. Who is it for? You may be eligible for this study if you are aged 18 years or older, have histologically confirmed diagnosis of locally advanced, unresectable or metastatic HCC for which no standard curative therapy is available or other Glypican 3 (GPC3)-expressing tumors. Study details There are 2 Phases in this study. In Phase 1, all participants will be enrolled into small groups. Each group will receive a dose of BOS-342 administered intravenously (IV) every 2 weeks until radiologically documented progressive disease (PD), unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the study treatment. There will be up to six different dose levels tested to identify the highest tolerated dose of BOS-342. In Phase 2, participants will receive a dose level and schedule that is deemed safe and tolerable as determined in discussion among the Sponsor, Medical Monitor, and Safety Review Team (SRT) in Phase 1. Observations related to safety including TEAEs occurring within and beyond the DLT window, tolerability, compliance, PK, pharmacodynamic, ADA and preliminary efficacy will be included in the rationale supporting the selection of the Recommended Phase 2 dose (RP2D). Safety, tolerability, PK and clinical activity evaluations will be assessed in both phases. After completion of the Safety Follow-up visit, patients will be contacted every 3 months for survival status following the last dose of study drug. It is hoped that the information obtained from this study may help treat and improve the survival of future patients with HCC and other tumors

Research question: Is it effective, feasible, and acceptable to deliver FEP (CRAFT) online? The primary aims of this study are to a.) evaluate the effectiveness of an online delivery of FEP to family members with a loved one experiencing substance problems and mental health conditions; and b.) Feasibility - extent of exposure to FEP by participants (number& length of sessions attended). The secondary aims are to identify the factors associated with successful implementation as perceived by a.) participants, b.) clinicians & c.) referral agents; and 2. whether the person with substance dependence a.) engaged with health or substance dependence services in the period during which FEP was delivered and b.) reduced their substance use as reported by a participating family member.