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Outcomes of a therapeutic program with children and adolescents with Autism using trained assistance dogs
Expand descriptionThis project will explore the use of assistance dogs as the primary therapeutic tool in occupational therapy sessions for children and young persons with autism spectrum disorder (ASD). Five individual therapy sessions with an occupational therapist, an assistance dog and an assistance dog trainer will be conducted with 75 individuals with ASD. The content of the therapy sessions will be analysed to investigate the assistance dog as a tool to facilitate social engagement, communication and play in children and young persons with ASD. Interviews will be conducted with parents and caregivers of those involved in the sessions to understand their perceptions of their child’s experiences and outcomes of the sessions. This process will develop a shared understanding of the role of assistance dogs in supporting individuals to engage in the social and practical tasks that they want to, and are expected to, achieve. Enhanced insight into the unique role of assistance dogs will enable the development of occupational therapy sessions targeting the specific needs of children and young persons with ASD.
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Examining the effects of Ionix Supreme on stress, mood, energy and anxiety.
Expand descriptionThis research project is aiming to determine the effects of Ionix Supreme on stress, mood, energy and anxiety. Despite the widespread use of vitamins to compensate for the busy lifestyle and irregular eating patterns that often accompany busy modern lifestyles, there are few controlled trials directly investigating the relationship between dietary supplements on stress, mood, energy and anxiety. We will be measuring the effects Ionix Supreme compared to a placebo using assessments of mental performance, mood and stress measures, along with the collection of blood samples. A smaller group of participants will be invited to participate in a brain imaging component using Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS). These scans will allow us to assess the effects the supplement may have on the brain.
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Macrosomia rates in women with diet-controlled gestational diabetes
Expand descriptionBackground: Current data on the rates of macrosomia in women with gestational diabetes mellitus (GDM) are heterogenous. No study has specifically examined macrosomia rates in women with diet-controlled gestational diabetes. Aims: To compare the rates of macrosomia between mothers with diet-controlled GDM to mothers without diabetes mellitus. Methods: A retrospective case-control study in which all patients with diet-controlled GDM and singleton pregnancies in a single calendar year were considered for inclusion in the study. These cases were individually matched to controls without GDM and without type 1 or 2 diabetes. Cases were matched to parity, age and BMI. Controls were selected from the same year and as close as possible to the date of delivery of the case. Primary outcomes were macrosomia, defined by estimated fetal weight >90th centile and >95th centile (separately). Results: 217 cases were identified with diet-controlled gestational diabetes, out of a total of 7185 births. 15 cases were excluded, leaving 202 cases in total. A total of 16 babies were >90th% and 10 were >95th% in the diet-controlled GDM group. 21 babies were >90th% and 11 were 95th% in the control group. Conclusions: Our findings suggest that macrosomia is not increased in women with diet-controlled GDM, so women with diet-controlled GDM may not require extra surveillance for fetal growth beyond that of the normal obstetric population. Provided women attend appropriate initial consultations with a diabetes educator and a dietician, are linked in with an experienced maternity centre and care-givers are familiar with blood-glucose targets, serious consideration should be given to new guidelines allowing women with diet-controlled diabetes to have obstetric care within lower risk pathways.
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Prophylactic post-operative high flow nasal oxygen therapy versus conventional oxygen therapy in obese patients undergoing bariatric surgery: a randomised controlled pilot study
Expand descriptionObesity, defined as a body mass index (BMI) > 30 kg/m2, has almost doubled since 1980, with more than 671 million people worldwide now classified as obese. Health problems associated with obesity impact on quality of life and impose a significant cost burden to the health service. The total financial cost of obesity is estimated to be $8.3 billion. Obesity is difficult to treat. Diet, exercise and medications being only modestly effective in aiding weight loss. In selected individual’s, bariatric surgery may offer a means of achieving long-term weight loss, improved health and cost reduction. The physiological and pathological changes that arise from obesity predispose to post-operative respiratory complications. Excess pressure exerted by an increased amount of fat tissue on the chest wall and in the abdomen, leads to collapse and closure of small airways within the lungs. This collapse of the small airways is worsened still by general anaesthesia and lying flat both of which are a requirement for surgery. This collapse persists longer into the postoperative period in the obese when compared to the non-obese population. High flow nasal oxygen therapy (HFN02) has been established as treatment for respiratory failure in infants and neonates. Its use has also become more prevalent in the adult population over the last decade, with an expanding list of clinical applications. High flow nasal cannula (HFNC) are designed to deliver a predetermined amount of heated and humidified oxygen to a patient. HFNC deliver oxygen at a much higher flow rate than a conventional face mask or nasal cannula, up to 70L/min vs 6L/min. The use of high flow nasal oxygen (HFN02) has been shown to improve the clearance of mucus from the airways, reduce the amount of energy used to breath, deliver a more accurate and reliable amount of oxygen to the lungs, and provide a degree of positive pressure into the lungs. The provision of positive pressure has been shown to increase the lung volume, this suggests that small airways that were previously closed are splinted open by the pressure provided. All of the positive effects of HFN02 outlined above are of potential benefit to obese patients in the postoperative period. Of particular interest is the provision of positive pressure which helps open up collapsed small airways. By carrying out our proposed study we hope to determine the impact that HFN02 has on postoperative lung volumes when compared to standard oxygen therapy. Lung volumes, specifically end expiratory lung volume (EELV) can be measured using electrical impedance tomography (EIT). EIT is a radiation free functional imaging modality invented over 30 years ago. It is non-invasive and can be used in real time at the patient’s bedside to assess lung volume changes. EIT has been successful validated against a number of other imagining and measurement modalities. It consists of 16 paired electrodes attached to a belt that is placed around the patient’s chest usually between the 4th/5th or 5th/6th rib. It then feeds back information about the patient’s volumes lungs as they breath to a computer for analysis. Both numerical measurements and images are produced. Hypotheses In obese, adult patients, undergoing laparoscopic surgery for weight reduction, prophylactic post-operative HFN02 therapy will increase EELV, improve respiratory function and reduce respiratory morbidity in the post-operative period
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Investigating the impact of treating adverse memories on individuals with depression and anxiety
Expand descriptionResearch has repeatedly identified that stressful life events and childhood adversities are associated with increased risk of psychological disorders. For example, individuals who were maltreated as children are approximately twice as likely to develop recurrent or persistent depression than individuals who had not experienced maltreatment. Additional studies have also found a high association between childhood maltreatment and anxiety disorders. Eye Movement Desensitisation and Reprocessing (EMDR) is an evidence based psychological intervention utilised to treat symptoms of post traumatic stress disorder (PTSD). EMDR also has empirical support for treating comorbid symptoms of depression and anxiety in individuals with PTSD. By targeting early adverse experiences, therapists can work with clients, with a primary diagnosis other than post-traumatic stress disorder, to significantly improve treatment outcomes. Exploratory studies examining the impact of EMDR for clients experiencing depression and/or anxiety, indicate emerging evidence regarding the utility of these methods in improving treatment outcomes and decreasing relapse rates. However, studies in this area are scarce and the majority of studies identified have limitations including small sample sizes and lacking other key aspects of experimental design. The aim of this study is to build on the evidence to improve treatment outcomes for people with depression and anxiety. All participants will be partaking in a two week, outpatient group CBT based intervention for depression and anxiety. Participants will be randomly allocated to one of three treatment conditions, receiving either three 90 minute individual EMDR sessions; three 90 minute individual CBT sessions or treatment as usual (TAU)/delayed treatment. Psychological symptoms will be measured prior to treatment, at the completion of treatment, and at six and twelve week follow up sessions. The TAU group will be offered individual therapy following their six-week assessment. It is proposed that the addition of a EMDR targeting adverse childhood experiences will increase positive outcomes of treatment post treatment and at follow up.
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A study of the safety of a novel treatment (PVX108) for peanut allergy, conducted in peanut-allergic adults
Expand descriptionPVX108 is a novel treatment being developed to treat the underlying cause of peanut allergy. It is anticipated that PVX108 administered by intradermal injection every 2 or 4 weeks will produce immune tolerance to peanut proteins in patients with peanut allergy. The product has been designed to have little or no capacity to induce acute allergic reactions, which is a significant risk with most, if not all other forms of allergen immunotherapy. Clinical trial AVX-001 is the first study of PVX108 to be conducted in humans. Its objectives are to determine the maximum dose that can be safely administered as a single injection, and then also to assess the safety of 9 repeat, escalating doses, administered once every 2 weeks. The study will therefore be conducted in 2 stages. In Stage 1, up to 48 peanut-allergic subjects will receive a single dose of PVX108. The first cohort of 6 subjects will receive the lowest dose of PVX108 (or placebo) and be monitored for 24 hours in clinic for adverse events and other clinical effects. A safety review committee will review the results obtained in this cohort. If the committee judges that it is safe to do so, dosing in the next cohort will progress at the next dose level. Dose will be escalated in each cohort until the safety review committee determines that the maximum safe dose of PVX108 has been determined. In Stage 2, up to 18 peanut-allergic subjects will commence the study at the maximum safe starting dose of PVX108. If the dose is well tolerated, an increased dose will be administered 2 weeks later. Subjects will receive a maximum of 6 administrations over a 16 week period. Adverse events and other clinical effects will be monitored periodically during treatment and for 4 weeks after the last dose. A range of blood samples will be collected from subjects prior to, during and after treatment to address an exploratory objective to investigate potential biomarkers of disease and the effects of PVX108 therapy.
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The Melanoma Genomics Managing Your Risk Study: examining the impact of personal melanoma genomic risk information on prevention behaviours in the general population
Expand descriptionThe primary purpose of the Managing Your Risk Study is to evaluate the efficacy of personal genetic risk of melanoma information, compared to standard prevention advice, in motivating preventative behaviours in the general population. Who is it for? You may be eligible to enroll in this trial if you are aged between 18 and 69 years, have European ancestry, and have never had a melanoma. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive personalised genetic risk of melanoma information and an educational booklet on melanoma preventive behaviours, or to receive the educational booklet only. Participants allocated to the group receiving their genetic risk information will provide a saliva sample using the kit sent via postal mail. This will be used for genetic testing and 2-3 months later, these participants will receive a booklet in the mail containing information on their personal genetic risk of melanoma. With their genetic risk information, participants will be given an educational booklet on melanoma preventive behaviours including sun exposure, sun protection and skin examinations. Within 2 weeks of receiving the mailed booklets, participants will receive a phone call from a genetic counsellor to answer any questions about the information. The other group of participants will receive the educational booklet only, and no genetic risk information information or phone call. All participants will have be able to contact a study-dedicated genetic counsellor at the time of consent to ask any questions they may have. All participants will be asked to complete questionnaires and to wear a specialised wrist-worn device (similar in appearance to a watch or a fitbit) which measures sun exposure for 10 days. All participants will be asked to complete a questionnaire and wear a UV dosimeter at baseline, complete a questionnaire at 1-month after they are sent their booklet(s) and complete a questionnaire and wear a UV dosimeter at 12 months after baseline. A subgroup of ~240 participants will also be asked to wear a UV dosimeter at 1-month after they are sent their booklet(s). It is hoped that the findings from this trial will provide information on whether providing information on personalised genetic risk of melanoma motivates people to undertake preventative and early detection behaviours.
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The Duchenne Registry Australia
Expand descriptionThe Duchenne Registry Australia is an online, patient-report registry for individuals with Duchenne and Becker muscular dystrophy and carrier females. The purpose of The Duchenne Registry Australia is to connect Duchenne and Becker patients with actively recruiting clinical trials and research studies, and to educate patients and families about Duchenne and Becker care and research. At the same time, the registry is a valuable resource for clinicians and researchers in academia and industry, allowing access to a de-identified, aggregate dataset provided by patients and their families—information that is vital to advances in the care and treatment of Duchenne.
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A Phase 1, Randomized, Double-Blind, Two-Arm, Placebo-Controlled, Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of LJPC-401 in Healthy Adults
Expand descriptionA single- and multiple-dose Phase I study of LJPC-401 in healthy adult volunteers. LJPC-401 is being developed to treat conditions characterized by iron overload, such as hemochromatosis and beta thalassemia.
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Improving mental health outcomes following mild to moderate traumatic brain injury.
Expand descriptionOver 7000 individuals sustain a Traumatic Brain Injury (TBI) each year in Queensland with minimal rehabilitation services available after injury, particularly in regional areas. Individuals with TBI are at increased risk for the development of depression, anxiety, alcohol misuse and suicide. The diagnosis of psychiatric disorders is estimated to occur in approximately 75% of TBI survivors within five years post-injury, with the highest increase of mental illness recorded in the first twelve months. Currently, there are limited resources or services in regional Queensland to address the mental health needs of TBI survivors. This pilot project will use a prospective randomised controlled trial design to compare the efficacy of short psychology treatment interventions after mild to moderate traumatic brain injury. Participants will be recruited at 1-2 weeks post-injury, and complete a short one hour assessment that will consist of a clinical interview and self-report measures of health and wellbeing. They will then be allocated into one of three treatment arms: (1) treatment as usual (TAU): bibliotherapy intervention or (3) brief positive psychology intervention. Follow-up interviews will occur at the end of the one week intervention, and again at 3 months and 6 months post-injury. The findings from this study may assist in the development of short practical interventions that may prevent the onset of novel mental illness in the first 12 months following a TBI.