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Exploring first time mothers' knowledge and experience of induction of labour
This will be a mixed-method, observational study and will be undertaken at the Royal Prince Alfred Hospital, Women and Babies Department. The study hypothesis is: Women feel more prepared for the induction of labour process when they access antenatal education, receive adequate clinical information and feel part of a shared-decision making process in the antenatal period. Women who feel prepared and satisfied with their decision to proceed with induction of labour feel more supported and greater contentment with their birth outcomes. The study will be conducted via a participant questionnaire (quantitative) and an audio-recorded interview with women at 6 to 8 weeks postpartum (qualitative). Electronic medical notes will also be reviewed to measure pregnancy and birth outcome data. The purpose of this design is to review the association between women who access antenatal education services, the reason given for induction of labour, women’s perspectives and experiences with the induction of labour process and delivery outcomes. The sample size calculation is approximately 100 participants for the survey and 15 participants for the interview, or until saturation with themes has been reached.
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The effects of different types and intensities of exercise on arterial stiffness and blood pressure throughout pregnancy.
In this study we will be looking at the effects of vigorous intensity exercise during each trimester of pregnancy on blood pressure and blood vessels, as well as foetal heart rate. More specifically we want to see if exercising at a higher intensity may be more beneficial to vascular function during pregnancy. During pregnancy adaptations occur to the circulatory system to support the growing foetus. Sometimes these changes can result in negative health outcomes for the mother and the baby, e.g. gestational hypertension and pre-eclampsia. Exercise during pregnancy has been shown to have a range of benefits, including reducing blood pressure and the risk of pre-eclampsia. Higher intensity exercise has been shown to have more benefits on blood pressure in non-pregnant populations, however research on the effects during pregnancy is currently lacking.
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Role of pupil in myopia
Excessive near work is considered to play a role in the development of refractive errors of the eye, especially myopia (also known as short-sightedness). Studies have shown that myopia onset is associated with the education. Our modern education commonly involves reading, writing, arithmetic (problem solving etc). During near work, the pupil (aperture that allows light into the eye) normally constricts (reduces in size) and in addition, the lens inside the eye (crystalline lens) changes shape to increase in power (accommodation). These changes allow the image to focus on the retina (photosensitive layer responsible for sending signals from eye to brain). Although it is commonly considered that pupil constricts (reduces in size) while doing near work, surprisingly, performing a cognitive task at near (solving mathematical problems) dilates the pupil. In a previous study conducted as part of our research, we have demonstrated that whilst doing near tasks, the accommodative system is engaged for both reading and cognitive tasks but not for gratings. In comparison, the pupil is constricted for reading, dilated for cognitive tasks, and remains unaltered for grating tasks. A smaller pupil will improve the depth of field and improve resolution whereas a larger pupil is likely to decrease retinal image quality due to increased aberrations. This in turn may play a role in development of myopia. Optical correction such as myopia control contact lenses and spectacle lenses, which were specifically designed with desired power profiles to reduce the optical defocus and enhance the retinal image quality were found effective in slowing myopia. It is important to determine if the pupillary and accommodative responses are altered with such treatment modalities. Other than optical correction, it has been thought that exposure of the eye to short wavelength light (blue light 440nm – 480nm) may influence myopia progression. Therefore, it is of interest to determine the accommodative and pupillary responses of the eye with habitual and myopia control strategies under normal light and blue light.
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SGLT2 Inhibition with Empagliflozin on Metabolic, Cardiac and Renal Outcomes in Recent Cardiac Transplant Recipients
Heart failure occurs when the heart muscle becomes too weak to pump blood to vital organs in the body. Common causes include prior heart attacks, cardiomyopathy (genetic or acquired), high blood pressure and diabetes. The long-term prognosis of heart failure is poor and multiple medications are required to treat it. Cardiac transplantation is a lifesaving procedure that can prolong the life of a person with heart failure. It requires lifelong immunosuppression to prevent rejection of the transplanted heart. Heart transplant survival rates have improved with modern immunosuppression medications. However, these medications can cause complications that eventuate in transplant-related illness and death. Prevention of medication-related complications, including diabetes, kidney impairment, and stiffening of the transplanted heart will improve health outcomes and financial costs associated with managing these complications. Excitingly, a new class of diabetes medications, the sodium glucose cotransporter-2 (SGLT2) inhibitors, have recently been shown, in large numbers of human subjects, to have major benefits for the heart. Not only do they reduce the risk of death from heart disease in people with type 2 diabetes, but they also improve heart function and reduce the likelihood of admission to hospital for heart failure. Interestingly, they also appear to exert this benefit in people without diabetes. In light of this evidence, it is possible that the SGLT2 inhibitors could improve the functionality of transplanted hearts. We will undertake a 12-month study of SGLT2 inhibitors in 100 patients who have undergone a heart transplant, to determine whether diabetes and other complications of immunosuppression medications can be prevented, and whether the efficacy of the transplanted heart, and the lives of the recipients, can be improved.
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Evaluating the acceptability of a therapist-assisted, online parenting program (‘PiP-Education’) to support parents of adolescents who refuse school in the context of anxiety and/or depression.
This study aims to evaluate the acceptability of a coach-supported, individually-tailored online parenting program for parents of adolescents who refuse school in the context of clinical-level anxiety or depression. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to school refusal, anxiety and depression. The intervention is delivered online and comprised of up to 12 parent-led, online modules covering different topics. Online modules are supplemented by up to 8 one-on-one videoconferencing sessions with a therapist-coach to support parents in making changes in their parenting. In this study we aim to understand how acceptable the program was to receive, and how the acceptability of the program could be enhanced. We also aim to gather preliminary indications of how effective the program was in improving 1) parental self-efficacy to respond to school refusal, 2) parenting behaviours to reduce teen anxiety and/or depression, 3) carer burden, and 4) teen school attendance. Due to the exploratory and mixed-methods nature of the study, no hypotheses have been specified.
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A dietitian and physiotherapy approach to the management of bowel disorders.
We want to assess the value of having physiotherapists and dietitians involved early and routinely when treating patients with constipation, obstructed defecation and/or faecal incontinence. It will help us to know the best way to care for people and may reduce the need for surgery. All participants will be gathered over a period of 2 years from a specialist colorectal pelvic floor waiting list. Participants will be a randomised into one of three groups; A, B and C, The study design was chosen to enable participants to be randomised to the groups whilst minimising the impact to outpatient services for other patients. • Group A: will receive physiotherapy and dietetics treatment concurrently for 6 months (research component). • Group B: will receive 6 months of physiotherapy treatment. After six months, participants have the option of continuing physiotherapy and adding dietetic treatment when they have progressed on the dietetic waiting list (standard care). • Group C: will receive 6 months of dietetic treatment. After six months, participants have the option of continuing dietetics and adding physiotherapy treatment when they have progressed on the physiotherapy waiting list (research component). The outcome measures are participant answered questionnaires on their experience of severity of symptoms and quality of life before and after intervention with dietetics &/or physiotherapy.
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Assessing the ability to detect tetrahydrocannabinol (THC) from cannabidiol (CBD) dominant medicinal cannabis products in patient samples of saliva, blood, and urine
Medicinal cannabis predominantly containing cannabidiol (CBD) is often prescribed for the relief of cancer symptoms. However, it is illegal to drive in Queensland while taking tetrahydrocannabinol (THC) irrespective of whether it is for recreational or medicinal use. Unfortunately, very few CBD dominant products are completely free of THC, with most products containing traces of THC. Whether a CBD-dominant preparation with trace THC taken as an oil preparation would return a positive result on a roadside screening test is an important gap in the literature. Therefore, the aim of this study is to assess whether THC is detectable in saliva, blood, and urine after administration of CBD-dominant medicinal cannabinoid preparations in cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with cancer, are known to the Cancer Care Service, and are experiencing cancer-related symptoms. Study details Participants will be allocated to one of three treatment groups based upon doctor/patient preference and product availability, involving either LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL), LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL), or LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) administered as an oral solution. Treatment will be administered for a total of 27 days, starting at a dose of 0.25ml daily and increasing every 3 days for the first 14 days, reaching a max dose of 1ml twice a day. The day 14 dose is then continued for days 15 - 27. If the participant experiences adverse effects, the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants will be asked to return for study visits on days 7, 14, and 28 after commencing the treatment to collect saliva, urine, and blood samples for the detection of THC. During these visits, questionnaires regarding cancer symptoms will also be completed, as well as an assessment of any adverse effects experienced as a result of treatment. It is hoped that this study may show that CBD-dominant preparations do not produce a detectable level of THC in clinical samples, while showing an improvement in cancer symptoms with minimal side effects. This may help to inform advice given to patients taking medicinal cannabinoid preparations in future.
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SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancer with KRAS G12C mutation
The purpose of the study is to test the effectiveness of a new treatment combination for patients with non-small cell lung cancer (NSCLC) whose tumour has a specific type of gene mutation called KRAS G12C. This mutation is believed to cause the tumour to grow and spread. Who is it for? You may be eligible for this study if you are aged 18 years and older, with either: a) newly diagnosed, treatment naïve metastatic (Stage IV) non-squamous NSCLC, or b) recurrent non-squamous NSCLC with no disease progression for at least 6 months following prior curative lung surgery and (neo)adjuvant chemotherapy, or prior curative concurrent chemoradiotherapy and immunotherapy maintenance, for non-resectable stage III cancer. Study details The new drug, sotorasib, is a tablet treatment which is targeted against the KRAS G12C gene mutation. Early results show that sotorasib is moderately active when given alone. The effectiveness of sotorasib might be increased when given in combination with other anti-cancer drugs. This study will investigate whether sotorasib used in combination with two chemotherapy drugs (called carboplatin and pemetrexed) and bevacizumab (which improves anti-cancer drug delivery), can result in better outcomes. The combination of carboplatin-pemetrexed-bevacizumab is a proven treatment for NSCLC.
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Procalcitonin in the Febrile Paediatric Population
The majority of paediatric infections are benign and viral in origin, more serious infections - particularly of bacterial causes - are important to diagnosis and treat promptly. So the purpose of this study is to look at a investigation called procalcitonin and see if it can be accurately used as a prediction of bacterial infection. Then to look at the level of procalcitonin, in patients with bacterial infections, and compare it to other inflammatory markers, assess it against a timeline from fever onset, and look at it in comparison of different age groups. In order to do this we will have clinicians in the paediatric emergency department fill in a form of relevant patients to highlight those suitable for the study. Then after diagnosis and discharge we will look at data (that is investigations performed) pertaining to procalcitonin and infections and use this information to come to conclusions. The hypothesis is that procalcitonin is a sensitive and specific marker of bacterial infections, superior in both its sensitivity and specificity, as well as its rise in relation to fever onset, to other inflammatory markers and will be a useful marker in diagnosing bacterial infections.
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A study to evaluate the Safety, Tolerability, and Pharmacokinetics of SBI-100 Ophthalmic Emulsion in Healthy Adult Participants
This is a randomised, double-masked, placebo-controlled, single and multiple Ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of SBI-100 Ophthalmic Emulsion in healthy adult participants. The study will enroll 48 healthy volunteers who will receive either study drug or placebo at the stay-in centre where they will be observed for any changes during the course of study period.