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A pilot randomised controlled trial to determine the effect of a physiological (step) versus a standard action (slope) labour progress lines on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time
This project aims to test the feasbility of a trial into a new type of partograph for measuring progress in labour with the goal of increasing rates of spontaneous vaginal birth (SVB), improving maternal and infant health outcomes and reducing maternity costs. The partograph is a paper based tool recommended by the World Health Organisation (WHO), and universally used to measure progress in labour and to assist in the diagnosis and management of prolonged labour. Research suggests that a newly designed partograph could be more appropriate to the high resource setting and may result in increased SVB rates without harmful effects on mother or baby. We hypothesise that such a partograph will result in fewer women requiring augmentation (medical acceleration of labour) and increase the rate of SVBs. This trial will also determine the effect of the new partograph on analgesic use, operative birth (caesarean section and instrumental), maternal and infant outcomes. Appropriate management in labour is critical to achieving optimal SVB rates
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Pain Management for Older Infants During Immunisation: A pilot randomised, controlled trial (The MINDI Trial Pilot Study)
Immunisation is regarded as one of the most significant preventive health measures of all time. Since the implementation of immunisation programs worldwide, there has been a substantial reduction in both morbidity and mortality caused by infectious diseases. Most vaccines, however, require a needle puncture and infants receive up to 14 separate injections within the first 18 months of life. Up to four separate injections may be required on the one occasion in high risk infants. Sucrose 25% is now a widely used strategy for the management of needle related pain in Australian neonatal intensive care units, special care nurseries and postnatal units in newborn infants. However, the results from a recent Cochrane systematic review concluded that there is a lack of evidence to recommend sucrose for the management of needle-related pain in older infants. The authors recommended that further research is required to determine the effectiveness of sucrose, and also determine the most effective concentration in older, larger infants beyond the newborn period.
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Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study
The study aims to evaluate the applicability of Multiparametric Magnetic Resonance Imaging (MP MRI) and Positron Emission Tomography (PET) with [68Ga]Gallium-labelled prostate-specific membrane antigen (PSMA) ligand (68Ga-HBED-CC) for the detection of cancer foci in localised prostate cancer patients. You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with localised prostate cancer, and are awaiting prostatectomy. All participants in this study will undergo Multiparametric (MP) Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with [68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (68Ga-HBED-CC) and whole-mount pathology analysis. For MP MRI the participants will be lying flat on the back on a bed that moves through a scanner. In order to get the best pictures, the participants will be injected with a contrast agent (or “dye”). The whole scan would take about 30 to 40 minutes. A medication called Buscopan or Glucagon is injected into the blood stream to slow bowel movement, since a moving bowel can reduce the quality of the image. For PET, the [68Ga]Gallium-labelled Prostate-specific membrane antigen (PSMA) ligand will be injected into the blood stream. After 90 minutes, the participants will be placed in the PET scanner and the scan will begin (scanning takes ~30 minutes). A low dose whole-body computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. For whole-mount pathology, the participants do not need to do anything. The prostate tissue will be collected after surgery as part of their clinical management. A standard pathology report will be reported to the surgeon as a standard clinical management. Results will be compared and analysed once we have the results from PET scan, multiparametric MRI scan and wholemount pathology review.
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A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects.
A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects
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Pilot study to look at the feasibility of using remote vital sign monitoring app to improve the care of patients being treated at home with highly myelosuppressive chemotherapy.
This is a study to determine whether using a remote vital sign monitoring application improves the care in patients being treated with highly myelosuppressive chemotherapy at home. Who is it for? You may be eligible to join this study if you aged 18 years or above and are being treated with highly myelosuppressive chemotherapy. Study details Participants in this study will be using the remote vital sign application device at home for during the time when their white cell count is low (usually day 8-14 of the chemotherapy cycle). The remote vital sign application will be attached to the skin by a patch adhesive and it will monitor vital signs such as body temperature and heart rate. During this time, oral thermometer measurements will also be taken manually and recorded on a data sheet. Information from the device and the manual oral measurements will be collated after the white cell count has recovered, and the patch is removed.
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A randomised controlled trial evaluating a workshop for divorced or separated parents with children aged between 2 and 12 years.
The aim of the project is to evaluate the impact of a brief, intensive seminar on positive parenting for parents who are divorced. The seminar is specifically developed to address risk factors and enhance protective factors for parents who are divorced. It aims to enhance parental coping, communication, and conflict management skills as well as reduce dysfunctional parenting styles and parental adjustment issues. The seminar also aims to encourage parents to build skills and competencies in their child that will enable the child to successfully negotiate high-risk environments, and enhancing their child’s resilience.
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The effects of hypnosis on bleeding
The planned study is a pilot study performed in order to obtain baseline data for a larger randomised study in which we plan to compare bleeding time, amount of bleeding, local temperature and blood flow over the puncture sites between a hypnotised and non hypnotised arm of the same volunteer.
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Visual performance of prototype contact lens designs.
To assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens.
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A Clinical Validation Study to Determine Whether Whole Genome Sequencing (WGS) can Assist with Autopsy Findings for Families who have Experienced a Perinatal Death Without any Definitive Cause
Approximately one percent of pregnancies result in a death during the perinatal period, which extends from 20 completed weeks of gestation until 28 days after birth. The causes of unexpected death during this period range from obvious gross structural abnormalities, placental dysfunction and transplacentally-acquired infections, to cases where there is no apparent reason for the early demise of the fetus or neonate. A percentage of these perinatal deaths that have no detectable gross structural abnormalities may, for example, occur due to underlying cardiac channelopathies, cardiomyopathies and potentially, some forms of epilepsy. Such conditions at a development stage may not leave any clinically significant characteristics at autopsy such as histological abnormalities detectable with light microscopy or anatomical changes normally observed with MRI. In essence, this study is an extension to the usual genetic analysis component of our perinatal autopsy protocol, enabled by a new technology that is currently maturing. Thus, the rationale of this trial is to provide more information on the cause of perinatal death and improve the clinical management of families whose babies have died during the perinatal period.
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IMPACT Youth Study - Physical activity for young people with depression: A cluster randomised controlled trial to test the effectiveness of incorporating a brief intervention into routine clinical care.
Depressive disorders are highly prevalent and are the leading cause of disability in young people worldwide. While there is an increasing evidence base regarding effective treatments for youth depression, interventions that are recommended by the Australian clinical practice guidelines, such as cognitive behavioural therapy (CBT), are only modestly effective in this age group. There is an urgent need for additional treatment strategies to treat current problems as well as prevent the onset of secondary or comorbid mental disorders and disability. One such strategy that has an emerging evidence-base is physical activity as an augmentation or adjunct treatment. Physical activity is a low-stigma intervention with few side effects, factors that are important to help-seeking young people. This project aims to evaluate the effectiveness of a brief physical activity intervention that is integrated into usual clinical care in reducing depression and increasing engagement in physical activity in help-seeking young people. All allied health professionals at selected headspace centres (enhanced primary care youth mental health services) will be invited to take part in the project and those who participate will be offered training in the delivery of the intervention and a treatment manual. All help-seeking young people aged 12-25 years who present to the selected headspace centres will be screened for eligibility to participate in a cluster randomised controlled trial (RCT). Clinicians will be randomised to be trained in and to deliver either the physical activity intervention (active condition) or the psychoeducation (control condition) in addition to routine clinical care. Young people who consent to take part will be allocated to receive treatment from a clinician who has been randomised to deliver either the physical activity intervention or psychoeducation on physical activity in addition to treatment as usual. The primary hypothesis is that the physical activity intervention will lead to greater reductions in depressive symptoms compared to treatment as usual. The secondary hypothesis is, a) that the physical activity intervention will lead to: i) reduction in anxiety symptoms; and ii) improvements in functioning, when compared to treatment as usual; b) that changes in depressive symptoms will be mediated by increased physical activity.