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Randomized, Placebo-Controlled Clinical Trial of Transdermal dihydrotestosterone Gel to Improve In Vitro Fertilization Outcomes In Women With Poor Ovarian Response
Despite the advances in assisted reproduction techniques, suboptimal In Vitro Fertilization(IVF) outcomes in women with Poor Ovarian Response(POR) still remains a challenge. Older women seeking IVF have suboptimal utcomes, at least partly due to inadequate number of eggs on conventional stimulation. This suboptimal response relates mainly to inadequate ovarian response but there is often also reduced live birth rates, increased risk cycle cancellation and a need larger doses of gonadotrophins, which increases both cost and risk of ovarian hyperstimulation syndrome (OHSS) risk. There is now growing evidence that androgens (or male hormones) may improve egg quality and numbers in women with POR. So far the androgens used in women with POR include testosterone and the pro-androgen hormone Dehydroepiandrosterone(DHEA) as well as aromatase inhibitor drugs, which increase the body’s own testosterone levels by blocking its conversion to estradiol. For each of these drugs, their multiple levels of action mean that it is not clear whether they produce any benefits by acting as an androgen (or male hormone). For this reason, this study is using dihydrotestosterone (DHT), the natural product of testosterone in the body of men and women, and which acts only as a pure androgen in the body. As a result, the study will determine for the first time whether these drugs do work as androgens or not and may refine and improve the treatment for POR. In this study we will temporarily increase the circulating levels of DHT during the time when oocyte (egg) development and maturation is occurring. This will be achieved by applying the DHT gel onto the skin once a day for 21 days prior to the start of IVF ovarian stimulation. Aims: To investigate the efficacy of DHT gel treatment applied onto the skin before an IVF stimulation cycle in women with poor ovarian response. Research Hypothesis DHT pre-treatment prior to an IVF cycle will improve the number of healthy, fertilisable eggs retrieved.
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Testing the Relevance of Acupuncture Channel Theory in the Treatment of Myofascial Pain in the Upper Trapezius Muscle: A Randomised Controlled Trial
The design of this study is a prospective single-blind parallel four arm randomised placebo controlled trial with repeated measures. The purpose of this study is to investigate various methods of acupuncture therapy in the treatment of myofascial pain in the upper trapezius muscle. This study is designed to test the following hypotheses; 1) There is no significant difference between needling locally and needling relevant distal points only in the treatment of myofascial pain; and 2) Needling a combination of both local and distal points is superior to needling either local points or relevant distal points alone in the treatment of myofascial pain; 3) Acupuncture is superior to placebo in the treatment of myofascial pain. Participants will be randomly allocated to one of four groups that will receive one of three types of acupuncture therapy, with the remaining group acting as a control group.
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The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised control trial
The use of music in the operating theatre has been longstanding with reports of its potential therapeutic effects dating back to the 1940s. Music therapy prior to and during an operation have been shown to reduce anaesthetic requirement, patient anxiety, and improve overall satisfaction. There is also evidence that proceduralist-selected music improves surgical skill acquisition. In gastrointestinal endoscopy, music has shown benefits for patients, however, there is no data on the effects of music on improving the performance of endoscopists and whether a specific style of music would lead to optimal performance. This is particularly relevant in an era where high volumes of endoscopic procedures are performed in an often stressful clinical environment and procedural outcomes, such as adenoma detection rate (ADR) in colonoscopy, are reported as validated benchmarks of quality endoscopy. The appropriate style of music to use and avoid in the operating theatre has been previously proposed, but there was an absence of music from epic movies on this list. Thesoundtracks from these movies often contain uplifting musical tracks associated with glory,success, and large scale victory We hypothesise that music from the epic movie Star Wars would be superior to endoscopist-selected popular music when measuring quality outcomes in colonoscopy.
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Effects of night eating during simulated shift work on metabolism, cognitive performance and mood in healthy adult males
The prevalence of type 2 diabetes and obesity are rising at alarming rates. Across Australia, these chronic diseases account for billions in health care costs and lost productivity. Rates of type 2 diabetes and obesity are high among shift workers, even after controlling for lifestyle and socioeconomic status. Shift workers experience poor timing of their body clocks to the daily light/dark cycle, and they show abnormal metabolic responses, including insulin resistance and glucose intolerance. Simulated shift work studies in rodents provide a link between timing of meals and metabolic processes: withholding feeding during 'night-shift' prevents the adverse metabolic effects of simulated shift work. Whether this strategy is effective in humans remains to be demonstrated. Our preliminary data from humans in several laboratory studies indicate that meal timing does play an important role in metabolic disturbance. Indeed eating at night, when the body is primed for sleep, seems to underlie an increase in metabolic disturbance that could predispose them to chronic disease. To test this, we will measure metabolic markers in healthy men studied under simulated shift work conditions, where we will keep daily energy intake constant but vary meal times. We propose that by simply altering the timing of meals we will be able to mitigate the negative metabolic consequences of shift work. These results could be readily translated to existing dietary guidelines, industry recommendations and workplace policy reducing the significant and increasing burden of metabolic disease in shift workers and the wider community.
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Chemotherapy-induced alopecia (CIA) in breast cancer patients: effectiveness of two temperature levels of scalp cooling on reducing rates of CIA.
The primary purpose of this study is to gather more scientific data on the efficacy of scalp cooling to prevent chemotherapy-induced hair loss and to assess the effect of specific temperature used on the efficacy of scalp cooling. Who is it for? You may be eligible to join this study if you are 18 or over and have histologically confirmed invasive breast cancer, and a planned course of one of the approved chemotherapy regimens. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive scalp-cooling at 3 degrees Celsius or 5 degrees Celsius. Scalp-cooling involves wearing a cap connected to a cooling device that will lower the temperature of your scalp. The cap is to be worn at each chemotherapy treatment 30 minutes before, during and 90 minutes after the chemotherapy treatment. Patient outcomes will then be assessed through patient-reported level of hair loss at the end of planned chemotherapy and monitoring of short-term and long-term side effects of scalp-cooling for 10 years after the end of planned chemotherapy. It is hoped that the findings of this trial will enhance our knowledge of the efficacy and long-term safety of using scalp-cooling to prevent chemotherapy-induced alopecia in breast cancer patients.
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A clinical research study that is testing whether Penthrox (methoxyflurane) plus local anaesthetic reduces pain and discomfort for men having their first transrectal ultrasound-guided prostate biopsy compared to local anaesthetic alone
The purpose of this study is to see if the discomfort of a prostate biopsy can be reduced by a drug called methoxyflurane (Penthrox) given with a simple inhaler, popularly known as the ‘green whistle’, and widely used by ambulance officers and first aid services. Methoxyflurane is already approved in Australia for the relief of pain in patients having surgical procedures. Who is it for? You may be eligible to participate in this study if you are a male, aged 18 or over, who has been scheduled for your first transrectal ultrasound-guided prostate biopsy. Study Details All participants have injections of a local anaesthetic (lignocaine) around their prostate before the biopsy. This is the standard way of reducing the discomfort of a prostate biopsy. Before having the local anaesthetic, all participants are given the study treatment which is a ‘green whistle’ inhaler after being shown how to use it. After their biopsy, participants fill out short, simple forms to let us know how they felt. In this study, one half of the participants are given inhalers loaded with methoxyflurane (the active inhaler group). The other half are given inhalers that look and smell the same, but are loaded with saline solution alone (the placebo inhaler group). Comparing the results in these two groups at the end of the study will show how good methoxyflurane is at reducing the discomfort of a prostate biopsy. It is hoped that this study will improve understanding of drugs which may be used to reduce discomfort of prostate biopsies for future patients.
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Effect of ongoing feedback on compliance with physical activity following an exercise intervention in chronic disease
The project aims to determine the effect of different types of ongoing feedback regarding maintenance of physical activity levels post completion of the 12-week strength2strength exercise treatment program. It is hypothesised that activity trackers will be as effective as telephone counselling for assisting participants to maintain their activity, however will be a more cost effective method.
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The effect of probiotic supplementation on symptoms and quality of life of individuals suffering Allergic rhinitis
The symptoms of Allergic rhinitis, such as nasal congestion and itching, are a burden for an estimated 3.2 million Australians and its prevalence is increasing. There is growing evidence to suggest that probiotic supplementation elicits beneficial health effects on the host through modulation of the immune system and thereby can improve symptoms associated with Allergic rhinitis. The aim of this research is to examine the effect of probiotic supplementation on symptoms and quality of life in individuals suffering from Allergic rhinitis
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Can intervention for perfectionism reduce the onset of postnatal depression?
This study aims to investigate the potential impact of a perfectionism self-help intervention on maternal mental health outcomes. In particular, the potential benefits of a brief self-help intervention for new mothers with high levels of perfectionism. The study is designed to investigate if mothers who make use of a perfectionism self-help booklet during their third trimester score differently than waitlist controls on measures of perfectionism, rumination and symptoms of anxiety and depression. It is hypothesized that perfectionism and rumination will be positively correlated with postnatal depression and anxiety, and that rumination will mediate the relationship between perfectionism and symptoms of postnatal depression and anxiety. It is also hypothesized that scores on measures of perfectionism, rumination, and symptoms of anxiety and postnatal depression will change significantly more from pre to post intervention for new mothers in the self-help group than for the waitlist control group, and this will be maintained at 3 month follow-up.
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Haemodynamic Effect of Intravenous Paracetamol during and after Cardiac Surgery
There are currently no double-blinded, randomised controlled trials that assess the haemodynamic effects of paracetamol in patients undergoing cardiac surgery. The effects of cardiopulmonary bypass (CPB) on paracetamol pharmacokinetic are also poorly understood. This study will add to a growing body of evidence evaluating the safety and efficacy of paracetamol use in patients undergoing cardiac surgery. Hypothesis: Paracetamol (1g IV) has adverse effects on blood pressure in patients undergoing cardiac surgery. No of patients: 50 No of recruiting hospitals: 1 Randomisation: Patients will be randomised in a 1:1 fashion via a computer generated randomisation program to either paracetamol IV formulation (N=25) or control treatment (normal saline 0.9%) (N=25). Blinding: This is a double-blinded clinical trial. Surgical teams, intraoperative and postoperative nursing staff, and patients will be blinded to assignment of treatment.