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Imaging Tau in Patients with Progressive Supra-Nuclear Palsy with [18F]PI-2620 PET
Expand descriptionThe study will investigate a new PET radiotracer PI-2620 to see if it can visual the tau protein which is observed in the brains of patients with progressive supranuclear palsy (PSP). The tau protein builds up in certain brain areas in patients with PSP, such as the basal ganglia. We hypothesise that PI-2620 will show high levels of uptake in the basal ganglia, indicating the presence of tau. Patients will undergo a single PET scan, whereby we inject a small amount of the radiotracer. The patient will then be scanned for 60 minutes. The resulting image will then show whether or not the radiotracer binds in the basal ganglia (indicating tau accumulation). The amount of tau in the basal ganglia can be measured from these images and we will then establish whether the levels of tau increase with increasing severity of PSP symptoms. If successful this radiotracer could be used in the future to help diagnose PSP.
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OPAL: Combining Peanut Oral Immunotherapy and Omalizumab in Adults with Peanut Allergy
Expand descriptionThis is a prospective, single-arm study of adults who react at blinded challenge to less than 300mg of peanut protein (approx. one peanut kernel) that will evaluate the utility of omalizumab as an adjunctive therapy to improve safety, as indicated by severity and frequency of reactions due to immunotherapy, and patient acceptability, as indicated by improved completion of the full course of oral immunotherapy, when compared to existing literature. Treatment in the study will consist of three phases. For the first phase, all participants will receive omalizumab injections every 4 weeks for 12 weeks. In the second 12 weeks, all participants will commence peanut oral immunotherapy and will continue omalizumab injections every 4 weeks. In the third phase, from week 24, omalizumab will cease and a maintenance dose of peanut will continue until the final study visit at 48 weeks. DBPCFC will be performed at screening, Week 24 and Week 48. Peanut protein doses of up to 100mg will be in the form of roast peanut fines or flour. Doses of 150mg and above will be taken in the form of whole roast peanut or smooth peanut butter according to patient preference. At Baseline, Week 12, Week 24 and Week 48 blood will be collected and tested for specific IgE, IgG4 and basophil activation tests to total peanut protein and protein components to assess for changes in peanut-specific immunity in response to trial interventions, and to evaluate the utility of such tests in predicting outcomes to therapy in adults
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What is the effect of passive movements on joint stiffness in intensive care unit patients?
Expand descriptionThe main purpose of this study is to investigate whether passive movements prevent or reduce joint stiffness in intensive care unit (ICU) patients. It is believed that ICU patients, particularly longer-term patients, are at risk of developing joint stiffness because of their critical illness, and the management thereof, and immobility which prevents them from moving their limbs in a normal way. The development of joint stiffness has the potential to adversely affect functional ability and health-related quality of life. For this reason, physiotherapists often carry out passive movements on ICU patients, particularly longer-term ICU patients, with the aim of preventing or reducing joint stiffness. However, to date, there is little evidence to support or refute this practice. The primary aim of this within-participant study is to measure the effect of passive movements on joint range of motion (ROM) for longer-term ICU patients. The within-participant design of the study means that each participant will act as their own control, with one side of their body randomly allocated to receive the intervention (i.e. passive movements) and the other side to receive no intervention (i.e. control).
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Assessing change in Anti-Mullerian Hormone associated with surgical excision vs conservative management of endometrioma
Expand descriptionEndometriomas are a type of endometriosis consisting of fluid filled benign cysts of the ovary. Endometriomas are associated with an increased risk of infertility and may require medical interventions to conceive. Management of these cysts prior to fertility treatment is controversial. On the one hand, leaving them has the potential for the cyst to get bigger and further damage ovarian tissue including eggs, as well as the very rare risks of malignancy and serious infection due to egg collection from the ovaries during fertility treatment. On the other hand, surgically removing the cyst has been shown to decrease the ovarian reserve, or the number of eggs left in the ovary and puts the patient through the risks of surgery. This study aims to investigate how the ovarian reserve changes over time in patients with endometriomas left alone compared to those patients who have endometriomas surgically removed. This will help clinicians to decide the best way to manage these cysts in the future where fertility is desired. We plan to assess the ovarian reserve using a blood test to measure anti-mullerian hormone (AMH), which is secreted by the ovary and correlates with the number of available follicles (hosting future eggs). Participants in this study will already have a management plan for their endometrioma and we will observe the change in the ovarian reserve over time by taking blood samples at 7 time points: at recruitment, 6 months post-surgery or recruitment, 12 months post- surgery or recruitment and then again at 2, 3, 4 and 5 years. These time points will be similar for both groups (cyst removal or not) to ensure comparable times between recruitment and follow-up in both study arms. The results will be available to the participants and any abnormal results will be discussed with them by the investigative team and appropriate referrals made. The initial management plan will not be affected by this study.
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Sonidegib (Odomzo) neo-adjuvant therapy for participants with Gorlin syndrome – A pilot study
Expand descriptionOne characteristic of Gorlin syndrome is that individuals typically develop numerous basal cell carcinomas over multiple areas of the body, with many occurring on the face and neck. The purpose of this study is to determine whether the drug Sonidegib is effective in reducing the size and number of tumours in patients with Gorlin syndrome. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with Gorlin syndrome (Basal Cell Nevus Syndrome). Study details All participants in this study will receive the study drug (Sonidegib), however participants will receive this drug for either 4, 6 or 8 weeks. The duration of treatment will be based upon enrolment which will occur by 1:1:1 allocation, into the three groups; 4 weeks, 6 weeks or 8 weeks of treatment. This means that you have a 1 in 3 chance of being in one these groups. All patients will receive treatment and standard practice of care. At each clinic visit your treating dermatologist will assess your skin and perform safety assessments (such as blood and urine samples). Participants will then be followed up for up to one year. During this time there are two phases. In the primary (first) treatment phase, you will be taking the study drug (Sonidegib) and a secondary phase where your lesions will be treated. During the secondary treatment phase, you will have 12 lesions treated; 3 lesions surgically excised, 3 lesions treated with cryosurgery and 3 lesions treated with topical Imiquimod cream. For lesions treated with topical Imiquimod cream, your study doctor will give you instructions on how to apply. It is hoped that this study will determine if Sonidegib can be used to decrease the excessive growth of tumours in patients with Gorlin Sydnrome.
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DREAM3R: A phase 3 trial of durvalumab with chemotherapy as first line treatment in mesothelioma
Expand descriptionThe purpose of this study is to see whether adding durvalumab, a type of immunotherapy, to standard chemotherapy will improve overall survival in patients with pleural mesothelioma (PM). Who is it for? Participants may be eligible to join this study if they are aged 18 years or above, and have had a diagnosis of PM that cannot be surgically removed. Study details: The study involves allocating participants to receive treatment with standard chemotherapy given with durvalumab (experimental arm), or physician's choice of: chemotherapy alone OR Ipilimumab and Nivolumab immunotherapy (control arm) . These treatments are allocated by chance. Treatment will be given by infusion until disease worsens or you experience unmanageable side effects. Study treatment: Chemotherapy and durvalumab (experimental group): This group will receive standard chemotherapy for mesothelioma (cisplatin or carboplatin and pemetrexed) every 3 weeks (one cycle) for a maximum of 6 cycles (about 18 weeks) plus the experimental treatment durvalumab every 3 weeks on the same day as the chemotherapy. After combination treatment has been completed, participants will continue treatment with durvalumab alone every 4 weeks for as long as they are tolerating the treatment well and the mesothelioma is under control. Physician's choice of (control group): Chemotherapy alone: This group will receive standard chemotherapy for mesothelioma (cisplatin or carboplatin and pemetrexed) every 3 weeks (one cycle) for a maximum of 6 cycles (about 18 weeks). OR Ipilumumab and Nivolumab immunotherapy: This group will receive Ipilimumab every 6 weeks and Nivolumab every 3 weeks or 2 weeks until disease progression, unacceptable toxicity, or up to 2 years. After treatment has been completed, participants will receive the same care as they would if they were not on a clinical trial. After stopping treatment, we would like to follow participants up every 6 weeks for the rest of their life. Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma. We plan to enrol 480 participants in this study from hospitals and clinics throughout Australia, New Zealand and the United States of America (USA). Durvalumab is not approved in Australia or any other country for treatment of advanced mesothelioma. Durvalumab is approved for locally advanced lung cancer and advanced bladder cancer in Australia and USA. It is hoped this research will demonstrate that durvalumab is safe and effective for the treatment of advanced mesothelioma, and that the results of this study will lead to improved outcomes for future mesothelioma patients.
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Moderately Hypofractionated Chemoradiation and Immunotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (MODERN-LUNG)
Expand descriptionThe purpose of this study is to determine if larger doses of radiation given over a shorter period of time, as compared to standard radiation therapy, given with chemotherapy and followed by immunotherapy is safe for participants. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive radiation daily with chemotherapy weekly for 4 weeks. They will then receive immunotherapy either fortnightly or monthly for up to 12 months. It is hoped that this study will then determine if further research into this treatment method is necessary.
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Combined gut-brain therapy for children with autism
Expand descriptionThe overall research aim is to reduce the burden of functional gastrointestinal disorders (FGIDs) in children with Autism Spectrum Disorder (ASD) with possible amelioration of ASD-associated behaviours and anxiety disorders. Children diagnosed with ASD and comorbid FGIDs aged 5.00-10.99 years (n=40) will be recruited through community and clinical settings and randomised (1:1) to one of two 12-week treatment groups: 1) synbiotic or 2) synbiotic + gut-directed hypnotherapy. The primary outcome will be changes in GI symptom severity as measured by the 6-item gastrointestinal severity index (6-GSI). Secondary measures include changes to ASD severity (ATEC questionnaire) and anxiety scores (PRAS-ASD questionnaire) and biological measures to characterise the gut microbiome (metagenomic DNA sequencing) among participants. It is hypothesised that a combined treatment approach (synbiotic + GDH) will be more effective than a synbiotic alone at reducing GI symptoms in the target population.
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Evaluating the impact on in-hospital orthopaedic waitlists after introducing community-based advanced physiotherapy assessments for patients with chronic musculoskeletal conditions
Expand descriptionPatients referred to orthopaedics outpatients commonly face long wait times for outpatient appointments and surgery. This study intervention supports advanced physios- funded through Cairns Hospital - to offer assessments to referred chronic musculoskeletal patients within community Queensland Health (QH) facilities. they will collaborate with other QH allied professionals and create an individual Plan for patient management- which will be sent to the patient's GP for discussion on how to access existing community allied health services to complete the recommended planned sessions.
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An open, naturalistic trial of the Inroads program, an internet-delivered early intervention to reduce anxiety and alcohol use among young people
Expand descriptionThis project builds on a previous randomised controlled trial (RCT), which demonstrated beneficial alcohol and anxiety outcomes compared to control following delivery of the therapist-supported "Inroads" CBT-based early intervention program. This study seeks to extend those findings to evaluate the acceptability and preliminary efficacy of a self-guided version of the Inroads program, which provides automated, personalised eHealth features in place of therapist support. The present study will conduct a large, single-group naturalistic trial (i.e., a noncontrolled clinical trial) of a 5-session cognitive behavioural therapy (CBT)-based self-guided early intervention for anxiety and alcohol use. The self-guided version of the Inroads program incorporates additional eHealth features to provide troubleshooting, accountability and motivational support via customised, responsive auto-messaging in place of therapist involvement. In view of increasing rates of anxiety and concerning levels of binge-drinking among young Australians (AIHW 2017; Dooley et al., 2018), it is critical that we provide young people with effective tools to help them manage anxiety and alcohol use, when problematic symptoms first emerge. This is particularly important at present, as experts predict there will be further increases in the incidence and severity of anxiety and hazardous alcohol use as the result of recent and ongoing global crises, such as bushfires, droughts and the COVID-19 pandemic. Benefits associated with the self-guided Inroads program will be measured immediately post-intervention (2-months post-baseline) to assess short-term intervention effects and at 6-months post-baseline to examine the durability of the intervention effects. Primary outcomes will include symptoms of anxiety (social anxiety, generalised anxiety) and alcohol use (frequency of binge drinking and hazardous consumption). Secondary outcomes will include alcohol consumption and negative consequences from drinking, existential anxiety and anxiety about global threats (e.g. COVID-19), depression, and functional impairment. We hypothesise that: 1. Participants will show significant reductions in primary anxiety and alcohol use outcomes from baseline to 2-months post-baseline; 2. Participants will show sustained improvements in these outcomes until 6-month follow-up (primary end point); 3. These changes will be reflected in clinically significant improvements on alcohol and anxiety symptom measures; and 4. Participants will rate the Inroads program as acceptable.