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Transdermal testosterone therapy: a potential treatment for selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction in women.
Expand descriptionThe Primary Aim of this study is to assess the efficacy of transdermal testosterone therapy on sexual function over 3 months in women at midlife being treated for depression with a selective serotonin re-uptake inhibitor (SSRI) who are experiencing at least one of: loss of sexual desire, sexual arousal disorder or delayed orgasm/anorgasmia for which they desire treatment Study hypothesis Transdermal testosterone, compared with placebo, will result in a clinically meaningful improvement in the total score of the Sabbatsberg Sexual Self Rating Scale indicating improvement in sexual dysfunction secondary to the use of SSRI/SNRI medication .
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The impact of continuity of care on weight gain in obese pregnant women
Expand descriptionObesity in pregnancy has increased to epidemic proportions in developed countries. It is associated with adverse outcomes for both mother and child. Maternal risks for hypertensive disorders, gestational diabetes, thrombo-embolism, haemorrhage, infections and death are increased in obese women and there are attendant risks and resourcing issues associated with obesity and childbirth. Compared to women who have a BMI between 20.1- 25, obese women are more likely to experience: increased rates of induction of labour and failed induction; anaesthetic difficulties; caesarean section; a stay in hospital of more than five days and obese women require specific equipment for accurate monitoring and safe maternity care. The risks of adverse outcomes for fetuses and neonates are also increased While there is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing excessive gestational weight gain, the American Institute of Medicine (IOM) published revised guidelines (2009) on how much weight a woman should gain during pregnancy and highlighted the importance of intervention in pregnancy to prevent both postpartum weight retention and childhood obesity. The American IOM recommends that pregnant women who are obese (BMI >/= 30 ) should gain 5 to 9 kg. Excessive gestational weight gain is defined as weight gain above this recommended guideline. Maternity reform at both Australian federal and state levels of government promote the benefits of continuity of care to women at low risk of complications and the expanded role of midwives working collaboratively in multidisciplinary teams. Continuity of care can be defined as care that is provided by the same clinician or small group of clinicians throughout pregnancy, birth and the postnatal period. Continuity of care can empower women and promotes participation in their care improve the sense of control women perceive, and improve satisfaction with care. However the impact of continuity of care as an intervention to improve outcomes for women who are obese has not been explored. The primary aim of this trial is to measure the impact of continuity of care in preventing excessive gestational weight gain in obese women. Following the calculation of their BMI at the booking in visit, women with a BMI>/=30 and meeting the additional selection criteria will be provided with written information about this project by the attending midwife or doctor (not members of the study group) and invited to participate. Women will be given time to answer questions and to provide written informed consent. Women agreeing to participate will be randomised to receive continuity of care (intervention) or routine care (control group). Women in both group will receive an information booklet on restricting gestation weight gain for women with a BMI>/= 30. A secondary aim of the study is to measure the impact of continuity of care on obese women receiving evidenced based care as defined by the 2010 guidelines for management of women with obesity in pregnancy developed by the Centre for Maternal and Child Enquires and the Royal College of Obstetricians and Gynaecologists. An audit of participants’ pregnancy records after birth will assess whether or not standards of care have been achieved. Information will also be obtained on participants’ demographics, previous pregnancies, medical problems, interventions for labour and birth, mode of birth and baby’s weight at birth. Another secondary aim is women’s satisfaction with care. Participants will complete two surveys, one at recruitment and another at 36 weeks gestation.
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Girls in Sport Action Research Project
Expand descriptionThe overarching aim of the project is to investigate the impact of a NSW Department of Education and Training (DET) initiated program designed to promote girls’ regular participation in sport and physical activity. The research will use both quantitative and qualitative methods to: assess changes in physical activity and sports participation over the duration of the Girls in Sport (GIS) project; measure the impact of the GIS intervention on the enjoyment of physical activity, social support and self-efficacy of female students; evaluate the impact of the professional learning and participation in the intervention on teachers involved in sport and physical education at the GIS intervention schools; and evaluate the impact of GIS interventions on functional links between schools and community sport, physical activity facilities and services.
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Repeat prostate evaluation and therapy pilot study in patients undergoing high dose rate brachytherapy for prostate cancer
Expand descriptiona preliminary study of the ability to obtain tissue before and after radiation therapy (using brachytherapy) for the purpose of studying the molecular and cellular response of the cancer.
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Cardiac function and cerebral blood flow in the beachchair surgical patient.
Expand descriptionDuring shoulder surgery patients are commonly positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may decrease and a concern of the anaesthetist is whether sufficient blood reaches the brain during such surgery. Even though this can be routinely treated with cardiac drugs, the exact effect of this treatment on the brain is unknown. This study plans to investigate the changes in cardiac function and flow to the brain when patients are anaesthetised and placed upright. The surgery will be performed using the anaesthetic technique that we use for the majority of the surgeon’s cases. The patient will receive a nerve block that will anaesthetise the arm receiving surgery. This will be combined with a general anaesthetic. Special monitoring of the heart and blood flow using sound waves, and brain function using reflected light waves will be used. These techniques are both non-invasive and present no harm to the patient. The study will investigate whether the administration of medication to gently increase blood pressure has an effect on hypotension and blood flow to the brain. In addition postoperative cognitive recovery will be assessed via a questionaire. By agreeing to the study patients will give us permission to make these extra measurements during anaesthesia, in order to understand whether we are protecting the brain during surgery.
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Can minocycline reverse morphine-induced respiratory depression in obstructive sleep apnea patients?- A pilot study
Expand descriptionOpioids are commonly used for a number of clinical settings, including treatment of acute pain, trauma, cancer, non-malignant chronic pain and in methadone maintenance treatment programs. In Australia, the number of PBS opioid prescriptions increased three-fold, from 2.4 million in 1992 to 7.0 million in 2007. Due to the rapid increase in opioid prescriptions, unintentional drug poisoning mortality rates have also increased substantially, with deaths attributed primarily to prescription opioid analgesics. A US study reported that more than 90% of unintentional medication poisoning deaths were caused by opioid analgesics. In Australia, the National Hospital Morbidity Database showed a three-fold increase in the number of separations from hospitals as a result of unintentional poisoning by opioids other than heroin or methadone from 1998/99 to 2006/07. Death from opioids is nearly always due to respiratory arrest.5,6 Acute opioid use can reduce vital ventilatory chemoreflexes and cause severe hypoventilation. The immediate cause of death is often pulmonary oedema secondary to prolonged hypoventilation. The sleep state is the most vulnerable time for patients using opioids. During sleep, respiration is naturally depressed and mainly under automatic neural-chemical control. Acute opioid use significantly reduces vital chemoreflexes, and patients have an increased risk of respiratory arrest during sleep. In addition, recent studies found that acute opioid use reduces upper airway patency during sleep. It is therefore not surprising that OSA is reported to be a major risk factor for postoperative morbidity and mortality. There are only two clinically available classes of drugs that can potentially reduce the respiratory depressant effect of opioids without reducing the analgesic effects. One is 5HT4a receptor agonists. Animal studies indicate that this drug class can reverse opioid-related respiratory depression without affecting sedation. However, the only clinical study found that it did not antagonize morphine-induced respiratory depression. In addition, the drug class was reported to cause the long QT syndrome and has been not registrated for clinical use in many countries, such as USA. In contrast, the tetracycline antibiotic Minocycline, a microglial inhibitor, is a commonly used antibiotic for many years particularly for acne. It is known to reduce opioid-induced glial activation which could enhance the analgesic effect of opioids and reduce the development of opioid tolerance. Dr Hutchinson from Prof Somogyi (AIB)’s laboratory found that in rats, Minocycline reversed morphine-induced respiratory depression while enhancing morphine-induced analgesia. However, the effect has not been tested in humans. If the findings can be verified in humans, the study may be a pivotal study in reducing the striking number of opioids-related deaths. The proposed double-blinded, cross-over study is a pilot study which may lead to a major NHMRC project grant application.
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A Pilot Study of a Steroid Sulphatase Inhibitor (BN83495) in Patients Receiving an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Expand descriptionPatients who have been diagnosed with non-small cell lung cancer may receive, or already be receiving treatment with a drug called Erlotinib or Gefitinib. Erlotinib and Gefitinib are similar drugs that belong to a class of drugs that inhibit a specific biological receptor, called the Epidermal Growth Factor Receptor (EGFR), which is over expressed in a number of different cancers. One of the potential side effects of Erlotinib and Gefitinib is skin rash, which occurs in up to 75% of patients. In this study, we will investigate whether treatment with a new drug, BN83495, can reduce the severity and/or frequency with which this rash occurs. BN83495 is an experimental drug, which is taken as a tablet, and is being tested as a possible anti-cancer treatment. The drug inhibits steroid production and is being developed by Ipsen Pty Ltd. Excess steroid production in the skin has also been linked to the development of acne and skin rashes. Therefore, it is our hypothesis that BN83495 pre-treatment may complement the use of erlotinib or gefitinib and reduce the severity of rash. This project will be performed at the Peter MacCallum Cancer Centre and will involve approximately 10 to 20 patients. The aim of this project is to measure the frequency and severity of skin rash, and other side-effects, for patients treated with Erlotinib or Gefitinib and BN83495. Changes in the drugs and hormones bllod levels will also be measured. Patients will be assessed at Peter MacCallum Cancer Centre weekly for a period of 12 weeks from the first day of treatment with BN83495.
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Prevention of bronchiectasis in infants with cystic fibrosis
Expand descriptionThe general aim of this project is to conduct a randomized, double-blind, placebo, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years of age. Safety and mechanistic evaluations will also be undertaken.
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Investigating predictors of response to Transcranial Magnetic Stimulation for the treatment of depression
Expand descriptionMajor depressive disorder (MDD) is common, associated with considerable disability and high morbidity and often resistant to treatment with standard approaches (~30% of patients meet standard definitions for treatment resistant depression (TRD)). There is currently an overwhelming need in the community for the development of better and novel treatments for depression. Despite the demand, there are relatively few treatment options available to patients with TRD. One of the only substantially new treatments developed in recent years has been repetitive transcranial magnetic stimulation (rTMS). Despite the considerable bulk of evidence demonstrating that rTMS can be effective in the treatment of depression, a major issue that limits its wider use is that only between 40-50% of patients respond to rTMS treatment. While this is a good response rate in a group of patients with significant depression who have failed to respond to other treatments, participation in rTMS treatment involves a considerable commitment of time and resources (stimulation is usually provided five days per week to outpatients who attend for up to six weeks). It is therefore essential to be able to identify patients who are more or less likely to respond to treatment. This research aims to provide a practical and clinically useful approach to predicting antidepressant response to rTMS treatment. In addition, by providing greater information about the underlying causes of depression and how these interact with treatments, this research may ultimately assist in developing more effective therapies for TRD. This would have a significant impact on the considerable numbers of Australians with depression who have tried standard therapies and yet remain significantly unwell. Therefore the current project aims to use both novel and more established neuroscience methodologies (namely electroencephalogy (EEG), TMS and near infra-red spectroscopy (NIRS)) to investigate whether such techniques can be used to predict response to rTMS treatment in depression.
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Topical timolol maleate gel for non-complicated superficial infantile haemangiomas
Expand descriptionNon-complicated infantile haemangiomas have been followed up with minimal intervention because of spontaneous involution. However the involution phase is slow and most children go to school with a disfiguring infantile haemangioma. Propranolol has been observed to accelerate the involution phase and a small retrospective chart review and a single case report have suggested that topical timolol maleate gel 0.5% may reduce the proliferative phase of smal and superficial infantile haemangiomas with reduced systemic complications.