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Evaluation of Response Adapted Stereotactic ablative body radiotherapy (SABR) in advanced mElanoma receiving immunotherapy (ERASE part 1: pilot trial)
Pilots Part A and B of the ERASE study aim to develop a method for using Stereotactic Ablative Radiation Therapy (SABR) that accounts for both the anatomy (the shape and position of the cancer) and the biological response to immunotherapy. These pilot studies will establish and test the planning and treatment workflow for delivering response- and anatomical-adapted SABR. Successful treatment of participants in these pilot studies will help to demonstrate that this treatment approach can be delivered. Who is it for? You may be eligible for this study if you are an adult receiving first line programmed death (PD)-1 backbone immunotherapy for metastatic melanoma and showing an incomplete metabolic response to this immunotherapy 3 months after commencement. You will have a maximum of 5 metastases which are not showing complete metabolic response to immunotherapy and are radiologically defined targets which are suitable for treatment with SABR. Study details Participants will either receive standard of care (immunotherapy with immune checkpoint inhibitors) without SABR or one to three rounds of SABR to up to 5 new or SABR-naïve lesions. Your response to immunotherapy at 3 months after commencement will help to determine whether you will receive SABR. If you do not receive SABR at 3 months you may still receive SABR at 6 and/or 9 months after commencement of immunotherapy based on your responses at those times. Lesions will only be treated once with SABR. Data on participant response to treatment and any adverse events will be collected. It is hoped that findings from these pilot studies can support the use of response- and anatomical-adapted SABR in the treatment of metastatic melanoma and thereby minimise the radiation dose delivered to the important nearby organs, whilst potentially increasing the doses of radiation delivered to metastatic lesions. This personalised approach could avoid over-treating patients who respond well to immunotherapy and allow for higher doses for patients who don't respond as well.
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Evaluation of Response Adapted and Anatomical Adapted Stereotactic ablative body radiotherapy (SABR) in advanced mElanoma receiving immunotherapy (ERASE phase 2 trial)
The ERASE study aims to develop a method for using Stereotactic Ablative Radiation Therapy (SABR) that accounts for both the anatomy (the shape and position of the cancer) and the biological response to immunotherapy and demonstrate that this approach is effective in treating metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult receiving first line programmed death (PD)-1 backbone immunotherapy for metastatic melanoma and showing an incomplete metabolic response to this immunotherapy 3 months after commencement. You will have a maximum of 5 metastases which are not showing complete metabolic response to immunotherapy and are radiologically defined targets which are suitable for treatment with SABR. Study details Participants will either receive standard of care (immunotherapy with immune checkpoint inhibitors) without SABR or one to three rounds of SABR to up to 5 new or SABR-naïve lesions. Your response to immunotherapy at 3 months after commencement will help to determine whether you will receive SABR. If you do not receive SABR at 3 months you may still receive SABR at 6 and/or 9 months after commencement of immunotherapy based on your responses at those times. Lesions will only be treated once with SABR. Data on participant response to treatment and any adverse events will be collected. It is hoped that findings from this study can support the use of response- and anatomical-adapted SABR in the treatment of metastatic melanoma and thereby minimise the radiation dose delivered to the important nearby organs, whilst potentially increasing the doses of radiation delivered to metastatic lesions. This personalised approach could avoid over-treating patients who respond well to immunotherapy and allow for higher doses for patients who don't respond as well.
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The observation of radiotherapy doses achieved when planning on an empty bladder versus a full Bladder for prostate radiotherapy treatment.
Aim: The aim of this study is to improve the patient experience in the future, whilst lowering the risk of planning errors, treatment errors, and the need for replanning. Who is it for: You may be eligible for this study if you are male or female age 18 or older with confirmd prostate only or prostate with SVs. Study details: Participants will receive one radiotherapy planning scan session as per the current standard of care. The extra Computed Tomography scan will be completed on the same day if the patient agrees to participate in the study. the extra scan will take approximately 20 minutes and will deliver an extra 7.6 mSv of dose. It is hoped that findings from this study will be a lower risk of patients having to miss their treatment due to the inability to reproduce the bladder size from initial planning scan. Patients will be in the department for a smaller amount of time, and it will have less of a knock-on effect to other patients receiving treatment.
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Effect of implementing a treatable traits approach on care of high risk chronic respiratory disease (the TAPPET trial)
Patients with chronic respiratory diseases are frequently hospitalised despite receiving the best available drug treatments. Systemic inflammation and frequent chest infections represent clinical signs (treatable traits) across multiple chronic respiratory diseases. These treatable traits are known to predict high risk of hospitalisations but are not routinely targeted by treatments. Non-drug treatments such as pulmonary rehabilitation and self-management are effective in reducing hospitalisations, but their potential to transform outcomes for high risk patients is unrealised, due to limited access and lack of guidance on optimal implementation. In this clinical trial we will implement a treatable traits approach that identifies patients at highest risk of hospitalisation, and targets personalised, safe, low-cost model of home pulmonary rehabilitation and self-management.
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Physiotherapy management options for women who experience separation of their abdominal muscles in the first 6 months after giving birth
The aim of this study is to determine if treatments administered by a physiotherapist are effective at reducing the gap between abdominal muscles in the first 12 weeks after giving birth in people with a separation of >28mm at the level of the belly button compared with natural recovery. Secondarily, this study aims to determine if there is a difference between participant-reported pelvic floor function, body satisfaction, back pain, pelvic girdle pain, satisfaction with outcome, and abdominal pain and/or discomfort between the three groups across the first 6 months postpartum. Force transfer across the front of the trunk will also be measured and compared between and within groups to see if improved transfer of forces across the front of the trunk is related to the width of the gap, body image, pelvic floor dysfunction, or treatment group.
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A 2-part Phase I study to evaluate the safety, tolerability, pharmacokinetics and food effects of AXN-027
This study in healthy volunteers aims to identify the range of safe single and multiple doses of AXN-027 Salt administered by mouth; to assess how the body handles AXN-027 Salt; how AXN-027 Salt contained in capsules compares to AXN-027 Salt contained in a tablet, what effect a high fat meal has on how the body handles AXN-027 absorption and to evaluate the safety of AXN-027 Salt compared to placebo. The results of this study will help identify appropriate doses of AXN-027 Salt to evaluate in future clinical trials.
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A randomised controlled trial of online self-reported clinical information followed by clinical interview in mental health triaging via phone.
The study aimed to test whether the online mental health self-report by patients at home (or anywhere with internet and phone access) without necessarily presenting to an emergency department, to inform subsequent clinical triage contributed to reduction in the time required to complete triaging e and whether this novel approach was acceptable. Study hypotheses: 1) The intervention (online mental health self-report by patients prior to triage phone interview) reduces triage time compared to the usual triaging process; 2) The intervention is acceptable to clinicians and clients.
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Dads Tuning in to Kids: Real-world evaluation
Dads Tuning in to Kids (Dads TIK) is an evidence-based parenting program that helps fathers to understand and regulate their own emotions and to use emotion coaching with their children to promote children’s competence. Dads TIK has been selected as one of several programs to be delivered as part of the Movember 'Scaling What Works' project, with a focus on improving men's mental health outcomes. As part of the ‘Scaling What Works’ project, 40 facilitators are trained to deliver Dads TIK to approximately 800 ‘hard to reach’ fathers. This research specifically aims to explore the acceptability, effectiveness, and adaptability of Dads TIK in this ‘real world’ context. Outcomes of interest include the impact of Dads TIK on men’s health by strengthening connections between fathers and their children, supporting emotional competence, improving fathers' responses to their children's emotions and improving father’s wellbeing in order to reduce mental health problems. More broadly, the project aims to contribute to cultural change where emotions become more acceptable for men.
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A phase 1 safety trial of CANN001, a hydrogel patch containing 2-deoxy-D-Ribose, in diabetic foot ulcers
Diabetic foot ulcers are a chronic wound and the pathophysiology is linked to neuropathy, infection and peripheral vascular disease. This peripheral vascular disease, linked to diabetes, prevents ulcer closure and leads to susceptibility to infection. 2-deoxy-D-ribose (2dDr) is known to promote vascularisation and may therefore increase angiogenesis when administered to a DFU and through this mechanism promote wound closure. The planned study will investigate if CANN001 (2dDr containing hydrogel) is safe in patients with diabetic foot ulcers and whether 2dDr may promote DFU healing and localised wound angiogenesis/neovascularisation through increasing local expression of VEGF.
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Helping Women Overcome Infertility Distress: The Impact of Eye Movement Desensitization and Reprocessing (EMDR) Therapy
This study aims to investigate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in reducing infertility-related distress in women undergoing infertility treatments. The research will compare the emotional and psychological outcomes of women receiving EMDR therapy with those on a waitlist control group. It is hypothesised there will be differences between the groups in terms of distress, anxiety, depression, trauma-related symptoms, psychological well-being, and coping strategies. Participants will be assessed before, after, and three months post-treatment. The study hopes to provide insights into how EMDR can help women cope with the emotional challenges of infertility.