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A Phase I Study of AV-1959R, an Amyloid Beta Vaccine in Healthy Participants
Expand descriptionThe key neuropathological findings of Alzheimer’s Disease are the accumulation of diffuse and neuritic amyloid plaques. In AD, it has become increasingly recognized that amyloid accumulation in the brain occurs decades before such symptoms as memory loss and personality change begin. AV-1959R vaccine is designed to induce production of anti-amyloid antibodies, that can prevent plaques formation. In this Phase I trial, the Sponsor will seek to determine the safety, tolerability, and immunogenicity of an active preventive vaccine, AV-1959R, targeting amyloid beta in healthy participants.
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A Randomized Controlled Trial to Evaluate the Effect of Tailored Behavioral Sleep Interventions for Non-Respiratory Sleep Disorders in Children with Neurodisability Compared to Routine Care
Expand descriptionThe primary purpose of this study to evaluate the effectiveness of behavioural sleep interventions for treatment of non-respiratory sleep disorders in children with ND. Alongside this, we hope to determine the optimal mode of delivery of treatment for non-respiratory sleep disorders in children with ND. Therefore, we developed the following two hypothesis: (i) A structured behavioural sleep intervention program will be more effective than standard clinical treatment for the management of non-respiratory sleep problems in children with ND. and (ii) Group telehealth and app delivery of a behavioural sleep intervention program will be as effective as standard clinical care for the management of non-respiratory sleep problems in children with ND.
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The GPS Parenting Program. Navigating parenting trans and gender diverse young people with a group-based program: A single-blind randomised controlled trial of efficacy and acceptability.
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Not just a walk in the park: Implementing nature walking groups in rural mental health services as a transdiagnostic approach on mental health recovery.
Expand descriptionThis study aims to 1) evaluate the implementation of structured Nature Walking Groups (NWG) in mental health services, 2) identify the impact of facilitated nature contact for people living with severe and persistent mental health conditions, and 3) deliver evidence-based guidelines for service providers to implement and evaluate NWGs supporting future implementation and research. The study hypothesis is that participation in structured Nature Walking Groups (NWG) within mental health services will lead to significant improvements in mental health outcomes for individuals living with severe and persistent mental health conditions, as evidenced by measured reductions in symptoms of anxiety, depression, and overall psychological distress.
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Safety, Feasibility, and Dose Study of Aethlon Hemopurifier in Solid Tumor Patients on Pembrolizumab or Nivolumab
Expand descriptionThe primary purpose of the study is to assess the safety and feasibility of using the Aethlon Hemopurifier in combination with anti-PD-1 therapy (pembrolizumab or nivolumab) for cancer patients with solid tumors. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with non-small cell lung cancer, melanoma, bladder/urinary tract cancer (urothelial cancer), renal cancer, colorectal cancer, gastric or gastroesophageal junction or esophageal cancer, head and neck cancer, cervical cancer or mesothelioma; and are determined by the treating physician to have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab. Study details Participants who choose to enrol in this study will all receive the Aethlon Hemopurifier (HP) treatment, however depending upon the timing of your enrolment you may receive a different dose of the HP treatment. The maximum number of doses you may receive is one 4-hour treatment per day, on alternating days, for a total of up to three doses. You will continue to receive your scheduled pembrolizumab or nivolumab treatment during your participation in this study. It is hoped this research will determine the optimal dosing interval for the Aethlon Hemopurifier treatment and demonstrate that this treatment can decrease the levels of exosoms associated with cancer progression. It is also hoped that the HP treatment may improve cancer patients response to anti-PD-1 therapy (pembrolizumab or nivolumab).
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An examination into the safety and efficacy of Khaya senegalensis on pain, physical and emotional wellbeing in women experiencing menstrual distress: a randomised, double-blind, placebo-controlled trial
Expand descriptionIn this randomised, double-blind, placebo-controlled study, 90 women aged 18 to 50 years experiencing psychological and physical symptoms associated with menstruation will be randomly assigned to receive a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark Khapregesic (3 grams daily) or a placebo for one menstrual cycle. Pain, mood, and physical wellbeing changes will be assessed before, during, and after the intake of the investigational product. Moreover, changes in the intake of pain-relieving medication will be examined, along with changes in blood measures of C-reactive protein, liver function, renal function, and complete blood count.
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Testing the effectiveness and cost-effectiveness of Bounce Back, a tailored action-oriented discharge planning intervention for older hip fracture patients: A randomised controlled trial
Expand descriptionThis study will rigorously test the effectiveness and cost-effectiveness of an action-oriented discharge intervention. This intervention aims to increase the number of days elderly hip fracture patients spend living well in the community during the first 30 days post-discharge. It will overcome barriers to best practice by promoting active involvement of patients and their support persons in discharge planning, as well as collaboration with hospital and community care providers.
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FRONTIER-AP Vision: Randomized controlled trial of endovascular versus standard medical therapy for stroke with occlusion of posterior cerebral artery.
Expand descriptionThe posterior cerebral artery (PCA) is an important artery which supplies the visual cortex in the occipital lobe and is key to visual function in the contralateral hemifield (loss of half visual field on side opposite to the stroke). Preservation of vision is essential in reading, return to work and driving post-stroke (deficit less than quarter of visual field). Unfortunately, spontaneous complete recovery of visual field occurs in 18.4% of cases and visual rehabilitation does not reduce hemifield deficit. The aim of this trial is to determine if clot extraction versus best medical therapy is the optimal treatment.
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A First-in-Human Safety Trial of MTX-474
Expand descriptionThis study is intended to study the safety and tolerability of a new investigational medication, MTX-474 in healthy adults. The study is "randomized", meaning that the study drug will be compared against a placebo comparator. MTX-474 as well as Placebo will be administered intravenously to study volunteers over the course of 1 hour, and safety assessments (Clinical Labs, ECG, Physical Examinations) will be performed at various timepoints throughout the study.
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The effect of a tailored dance program on health and wellbeing in people aged 65+: a pilot trial
Expand descriptionFalls are a major health issue for people aged 65+. Participating in regular physical activity which focuses on balance and strength training can reduce the risk of falling, however existing fall prevention exercise programs are not always popular. Tailored dance programs designed for wellbeing and fall prevention are well attended and highly engaging, but as yet there is no evidence that dance prevents falls. We will conduct a pilot RCT of tailored dance classes for people aged 65+, with a waitlist control group, to assess the acceptability, feasibility and impact of a tailored dance intervention. The results will inform the design and methods for a planned large trial of tailored dance classes for older people, with falls as the primary outcome.