ANZCTR search results

This study investigates the effectiveness and safety of the combination of Brentuximab vedotin and donor lymphocyte infusions for Hodgkin lymphoma that has relapsed or persists after an allogeneic stem cell transplant. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with CD30+ Hodgkin lymphoma in any remission status, for which you are undergoing allogeneic hematopoietic cell transplantation (alloHCT) OR are less than or equal to 60 days post-alloHCT from a matched related or unrelated adult donor. Study details All participants in this study will be monitored for relapse of Hodgkin lymphoma by positron emission tomography (PET) scans commencing 60 days after allogeneic transplant, and then 3 monthly thereafter. Upon identification of relapse of Hodgkin lymphoma, patients will receive treatment with brentuximab 1.8mg/kg every 3 weeks intravenously. After 3 doses of brentuximab, patients will also commence donor lymphocyte infusions at an initial dose of 1x10^6 T cells/kg intravenously, escalating to a maximum of 1x10^8 T cells/kg in a graded fashion. Donor lymphocyte infusions will be administered once every 3 weeks for a total of up to 5 infusions. Participants will undergo PET scans to assess response every 3 months for 24 months. This research will examine the effectiveness of treatment with the combination of brentuximab vedotin and donor lymphocyte infusions, which may be an important strategy for patients with Hodgkin lymphoma that relapses after allogeneic transplant.

Mental health during and after pregnancy is important for the well-being of mother and infant. Perinatal depression and anxiety are common problems, particularly for Aboriginal and Torres Strait Islander women, and can have significant short and long-term impacts on both mother and child. Aboriginal and Torres Strait Islander women in remote areas are at particular risk and the available screening instrument, the Edinburgh Postnatal Depression Scale is not seen as appropriate for this population. The locally developed, validated, culturally appropriate and user friendly KMMS was developed to accurately assess risk of anxiety and depression, improve screening rates and help provide better care for Aboriginal women during the perinatal period. The KMMS has been piloted on 91 women in the Kimberley. It was found to be an effective screening instrument for anxiety and depression in Aboriginal perinatal women, improved relationships between health care providers and their patients, and was a useful tool for providing psycho social support and, where necessary developing pathways for specialised mental health/social and emotional wellbeing follow up. The KMMS is accepted for use across the Kimberley and is included in regional guidelines. The KMMS has not been fully evaluated in a real world setting and has not been trialed in other remote settings. In partnership with health services and Aboriginal communities in northern Western Australia and Far North Queensland, this study aims to: * adapt the KMMS and develop locally appropriate versions for participating partners as required; * evaluate the real-world performance of the KMMS in the Kimberley and other remote regions in northern Australia; and * evaluate the process of implementation.

Despite several studies recommending surf therapy as a relevant form of holistic treatment for youth with clinical and subclinical mental health concerns, there is a paucity of research examining the efficacy of surf therapy programs, particularly in youth, and a lack of understanding of the mechanisms underpinning positive change. Published studies to date have largely been descriptive in design, lack control groups, and display other methodological limitations, such as study-designed questionnaires and potential for bias by the researchers. Nonetheless, preliminary evidence, indicating that surf therapy may be effective for improving a range of mental health indicators in vulnerable young people, provides the justification for further methodologically sound evaluation of such programs. The main objective of this research study is to evaluate the effectiveness of the Ocean Mind surf therapy intervention in a controlled design, for improving indicators of youth mental health. In particular, it is thought that the combination of mentorship and social connection, surf practice and the benefits of contact with nature within a therapeutic environment may be helpful for reducing risk factors for common mental health conditions like anxiety and depression, and behavioural problems for the young people involved. Demonstrating the efficacy of this intervention through rigorous scientific evaluation is important for the shared interest in promoting the wellbeing of young people and further surf therapy programs within the community. Therefore, we seek to answer the research question: Can surf therapy have a positive effect on indicators of youth mental health? It is hypothesised that: 1) Young people receiving the surf therapy program will have lower anxiety and depressive symptoms and fewer behavioural problems (conduct and hyperactivity) compared to the wait-list control group. 2) Young people receiving the surf therapy program will have higher self-esteem and social support compared to the wait-list control group 3) Young people will maintain improvements in social contentedness and group identification at 2- and 4-week follow-up 4) Young people will maintain improvements in anxiety and depressive symptoms at 2- and 4-week follow-up 5) Young people will maintain improvements in self-esteem at 2- and 4-week follow-up

This is a prospective study seeking to investigate the post-operative clinical and radiographic outcomes of meniscal repair surgery in the knee in paediatric patients, with or without concomitant knee surgery if indicated. Patient outcomes will be collected over a 24 month post-operative period, and will include a range of subjective and functional outcomes, radiographic measures and patient satisfaction.

This is a clinical trial of PRAX-114 to assess the safety, tolerability, PK, and efficacy in participants with moderate to severe MDD. Each participant will complete 3 study periods: Screening, Treatment Period (14 days) and Safety Follow-up.

This research project is being conducted to investigate the safety and tolerability of a single application of a transdermal drug delivery system containing memantine when administered to healthy volunteers.

Chronic physical illness (e.g. diabetes, epilepsy, asthma, autoimmune disease) affects 10-20% of Australian youth and can involve frequent pain, intensive treatment, and major limitations in daily activities. This can have serious impacts on well-being and mental health. In order to address this, we need engaging and accessible interventions to improve well-being and mental health among young people with chronic conditions. We aim to find out whether online self-compassion training improves mental health and well-being in adolescents and young adults with chronic illness. Self-compassion involves treating yourself with the same kindness and understanding as you would a good friend. In self-compassion training, people learn to skills to be kinder to themselves and soothe themselves when they are distressed. This helps them to recover from difficult experiences more quickly. Online programs may be preferable for people with a chronic illness as they are accessible and flexible. We have developed a four-week online program to help people learn self-compassion skills. A We will trial the program with young people (16-25 years) with chronic conditions. We will test whether people doing the program have significant improvements in psychological distress and well-being, compared to people on a waitlist. We will also explore whether any improvements in these outcomes are driven by increases in self-compassion or emotion regulation skills.

To assess the pharmacokinetics of memantine and donepezil in LYN-157 extended release capsules. To evaluate the safety of LYN-157 extended release capsules containing memantine HCl and donepezil HCl in healthy volunteers

This is a pilot study for a new application of robotic assisted surgery for removal of urogynaecological mesh from the vagina or pelvis aiming to reduce incision size and therefore surgical harm.This study will examine the use of this approach in improving visualisation and access in order to remove mesh completely via smaller incisions. Our aim is to confirm that this it is techincally possible to completely remove implanted pelvic mesh with a robot-assisted laparoscopic surgical approach.

This study will evaluate the effects of virtual reality on pain intensity in people with cancer-related pain Who is it for? You may be eligible to join this study if you are aged 18 and above, have a current or previous cancer diagnosis and are experiencing pain for at least a month Study details Participants in this study will receive both immersive and non-immersive virtual reality (VR) experiences but in a random sequence. Participants will attend once only where they undergo two 15-minute VR sessions with a one-hour washout period between sessions. The immersive session will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The non-immersive session will comprise viewing the same scene but directly watching the laptop screen. After each session, participants will be asked to answer questionnaires regarding pain intensity. A subset of participants will also undergo linear and non-linear electroencephalogram (EEG) analyses using a wireless EEG during the VR sessions to analyse regions of the brain that may be involved with pain. It is hoped that this research will contribute to the management of cancer-related pain using commercially available, non-pharmacological treatment applications that may improve health outcomes giving patients more control over their symptoms.