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First In Human Feasibility Clinical Study Evaluating the Safety of the XPD System for Periosteal Distraction
Chronic, non-healing foot and leg ulcers are often a result of reduced blood flow due to Peripheral Artery Disease (PAD) or other ischemic (reduced blood flow) conditions in patients with chronic diseases, including diabetes. These ulcers can compromise quality of life and increase the risk of serious infection and tissues necrosis (injury and death of the tissue). Periosteal distraction (PD) is a medical technique used to increased blood flow to the affected area of tissue (peripheral perfusion). It works by gently pulling on the thin tissue covering the tibia (periosteum). This tissue plays a key role in encouraging blood flow to the feet and ankles. The XPD system is a new medical device designed to facilitate PD. It consists of both external fixation and implanted components which are surgically fixated to the tibia to apply controlled stress to the periosteum in order to promote blood vessel formation and tissue regeneration. This is a multi-centre, open label, single arm study to evaluate the safety of the XPD System for PD in participants with hard to heal ulcers in the peripheral lower extremities (ankle and below). Chronic ulcers will be graded using the Wound, Ischemia, and foot Infection (WIFi) scale (W)1-2, (I)1-3, (fI)0-1 based on physician judgement. All patients will have a procedure for sharp debridement and installation of the XPD System to perform PD for 3 weeks. The patients will return at 4 weeks for removal of the device and begin an observation period for 16 additional weeks for a total of 20-week follow-up period.
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A two-phase study investigating the quality of life benefit of additional 0.5% cocaine mouthwash to institutional standard of care mucositis management in head and neck cancer patients undergoing radiotherapy or chemoradiotherapy.
Aim of the study This study aims to investigate the quality of life benefit of additional 0.5% cocaine mouthwash to institutional standard of care mucositis management in head and neck cancer patients undergoing radiotherapy or chemoradiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older and had a histologically confirmed head and neck cancer receiving radiotherapy or chemoradiotherapy with curative intent. Study details Eligible patients received standard of care mucositis management as per the established guidelines +/- cocaine mouthwash. During and after completion of the treatment participants will be assessed for quality of life, rate of analgesic prescription, physician assessed mucositis score, pain, number of hospital admissions, need for feeding tube and weight. It is hoped that this study will establish the benefit (or lack of) of cocaine mouthwash in the treatment of mucositis in head and neck cancer patients undergoing radiotherapy or chemoradiotherapy. Study Ethics The study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Human Research Ethics Committee of the Sir Charles Gairdner Group (application number 12573). Written informed consent was obtained from all individual participants included in the study.
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Effect of chronic curcumin supplementation on performance and recovery during a four-week off-season training program for team-sport athletes.
The effects of a chronic curcumin supplementation on team sport athletes performance and recovery. The study involves team sport athletes, aged 18-35. This is a randomized, double-blinded, cross-over study where participants will consume either a curcumin supplement or a placebo at a time, without knowing which one they were given. They will be tested on their athletic performance and recovery over five sessions, with a break between the supplements to ensure any effects of the supplements have worn off. The study will measure performance through a battery of field tests and recovery through blood sample collection and questionnaires. The hypothesis of this study an acute dose of curcumin supplementation will reduce the detriment in exercise performance post-fatiguing exercise. Additionally, muscle damage markers and inflammation will be reduced, and the participants’ perceived recovery will be improved.
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Evaluating an online quality improvement tool developed for family day care to promote healthier nutrition and physical activity practices - phase 2.
The aim of this study is to explore the effects of an online quality improvement tool developed for service providers and educators in family day care to promote healthier nutrition and physical activity practices. it is hypothesised that using the online tool will improve the quality of the service provider's revised quality improvement plan (QIP) compared to the service provider's previous QIP.
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Evaluating the impact of a community-led, trauma-informed psychosocial intervention on health outcomes of children and young people with Type 1 Diabetes: Wellbeing-T1D
Provision of psychotherapy to children with T1D has been associated with improved mental health and improved management of diabetes symptoms. These promising findings for the role of psychological interventions in the management of diabetes have led to international guidelines which recommend that they be easily accessible for children and young people with T1D and their families. Despite this international consensus, there is not yet a widely accepted and employed psychosocial intervention for management of diabetes distress and other mental health symptoms. Further, there are no trauma-informed interventions that address traumatic stress in this population. Thus, we intend to address these gaps by co-designing an intervention with community stake holders to support the psychological needs of children and young people with T1D using a trauma-informed framework. We hypothesise that the Wellbeing project will show efficacy in improving the wellbeing, resilience and coping skills of adolescents with T1D.
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Rethinking Models of Outpatient Type 2 Diabetes care using eHealth (REMODeL) – in General Practice
This prospective pilot study will assess various implementation factors associated with integration of a digitally enabled model of care for individuals with type 2 diabetes (T2D) from regional areas into primary care using a digital health intervention. The comprehensive assessment of implementation factors will inform strategies to optimize the implementation process and maximize the effectiveness of future Digital Health interventions.
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The impact of dance movement therapy on women with an experience of family and domestic violence: A controlled feasibility study
The main aim will be to test the effectiveness of dance therapy on reducing symptoms of trauma in women with experience of family and domestic violence. The secondary aim will be to investigate the influence of dance movement therapy on overall wellbeing domains on women with an experience of family and domestic violence. Finally, as this is a new trial, the last aim will be to test acceptability and feasibility of implementing this intervention.
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An open-label study to evaluate the safety and efficacy of modified-release calcium formate in adult patients with homocystinuria
The aim of this study is to evaluate the efficacy and long-term safety of modified-release calcium formate to reduce elevated plasma homocysteine (Hcy) levels in adults patients with homocystinuria. The hypothesis, seen in preclinical models, is that modified-release formate can rapidly (within weeks), sustainably, and safely lower plasma homocysteine levels. This outcome would improve long-term outcomes in patients with homocystinuria
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Gastro-intestinal transit and safety of tirzepatide in people with Prader-Willi Syndrome
The primary aim of this 12-week open-labelled trial is to determine stomach emptying and both small intestinal and colonic transit before and after 1 month and 3 months’ exposure to tirzepatide to evaluate its effect on gastrointestinal function and safety in people with PWS. Secondary outcomes of this study will be the effect of tirzepatide on body weight, food-seeking behaviour, metabolism, and sleep apnoea. This study will quantify transit in the stomach, small intestine and large intestine at baseline and following treatment with tirzepatide. It will improve our understanding of gastrointestinal function, including the prevalence of delayed gastric emptying, small intestinal transit and colorectal transit in PWS and also provide information concerning the safety and tolerability of tirzepatide. A secondary aim is to validate the gas-sensing capsule in measuring gastric emptying and caecal arrival time against scintigraphy. This has not yet been done. If it is shown to be accurate, this capsule is a much less invasive way of assessing gastric emptying and will help to provide data to support its use for this measurement.
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Surgery-related Heart Injury Evaluation: Limiting Damage (SHIELD) Pilot
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