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Effect of investigative laparoscopy on bladder pain syndrome: a prospective cohort trial
Expand descriptionChronic pelvic pain is a frustrating condition for many women, having a variety of potential causes including endometriosis, adenomyosis, pelvic inflammatory disease, adhesions, irritable bowel syndrome and bladder pain syndrome (BPS). Endometriosis is considered the main cause with a prevalence of 70-90% in women with chronic pelvic pain. A number of recent trials have found that bladder pain syndrome also is an important differential diagnosis to consider with studies showing 53-89% of women with chronic pelvic pain have bladder pain syndrome. Similarly studies have also reported the high prevalence of having concomitant bladder pain syndrome and endometriosis with a study by Cheng et el in 2011, finding 60% of women with BPS also had endometriosis. This study aims to assess the impact of laparoscopy and more specifically surgical treatment of endometriosis on bladder pain syndrome. The study will use questionnaires preoperatively which will be compared at three, six and twelve months post procedure. The primary outcome measure will be bladder pain reduction at 12 months following endometriosis surgery with bladder pain reduction being defined as a >/=50% bladder pain reduction by the Visual Analogue Scale (VAS).
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Prospective analysis of the nutritional status of chemoradiotherapy patients
Expand descriptionThe study aims to evaluate the nutritional status of chemo-radiotherapy patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing curative intent chemo-radiotherapy at the Alan Walker Cancer Care Centre in Darwin, Northern Territory. Trial details All participants in this study will have their nutritional status assessed at baseline, first week of treatment, then final week of treatment, and finally at 1-month post treatment using the Patient Generated-Subjective Global Assessment. This is a validated malnutrition assessment tool for cancer patients. This study aims to baseline the nutritional status of chemo-radiotherapy patients undergoing treatment at the Alan Walker Cancer Care Centre (Darwin), identify contributors to nutritional deterioration and determine if there is a difference between Indigenous and non-Indigenous patients. This study will provide a prospective analysis of malnutrition and a clear insight of nutritional status of cancer patients. This study will be the first of its kind to address the nutritional status of cancer patients in Indigenous Australians.
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An evaluation of school-based sleep education programs: Does reducing barriers to change and increasing supports improve outcomes?
Expand descriptionThis study will evaluate the effectiveness of sleep education classes for high school students. As teenagers typically have a sleep pattern where they fall asleep late and wake up late, and which conflicts with getting up for school, this study will test 3 versions of sleep education classes against a control group (normal classes). These are: sleep education classes plus parent sleep education (SEC + P), sleep education classes plus light therapy (SEC + L) and sleep education classes plus parent sleep education plus light therapy (SEC + P + L). We expect that compared to the control classes that improvements in sleep and mood will occur in all 3 versions of the sleep education classes. We expect that the SEC + P + L will show the greatest improvements.
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A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia.
Expand descriptionThe main purpose of this study is to assess how safe and how well a topical solution, which is applied to the scalp of male participants who have a condition called male pattern baldness is tolerated. The secondary purpose is to assess how effective the topical solution is and also to assess the way the body absorbs, distributes and gets rid of the drug SM04554. .
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Evaluation of the Pharmacokinetics of IPX231 (L0007, C0001) in Healthy Subjects
Expand descriptionTo compare the pharmacokinetics of three IPX231 formulations administered subcutaneously as well as a single IPX231 formulation (IPX231-L0007) administered sublingually by two different methods: instillation via syringe versus spray in healthy adults.
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Improving Vitamin D status and related health in young women: The Safe-D study – Part B
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A study in healthy males to assess the safety and tolerability of two different formulations of the study drug, (MSP-2017), administered intranasally.
Expand descriptionThe primary purpose of this study on healthy volunteers is to determine the safety and tolerability of two different formulations of study drug when administered via the intranasal route. There will be four study treatments: two active formulations and two placebos, or dummy treatments. Neither the study staff or the participants will know which treatment they are on. All formulations will be administered by the intranasal route using a single use nasal spray syringe. Each participant in each dose level group will receive two single doses of either both active drugs or both placebos, with the doses administered 48 hours apart via the nasal spray, in alternating nostrils.
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Melatonin and Cognitive-Behaviour Therapy for the treatment of insomnia in individuals with schizophrenia
Expand descriptionThe study is to evaluate the effectiveness of (i) Cognitive-behavioural therapy for insomnia in schizophrenia [CBT-I(S)] (ii) melatonin, (iii) a combination of CBT-I(S) and melatonin, and (iv) placebo, on insomnia symptoms, clinical symptoms, cognition, and functional health, in individuals with schizophrenia.
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Study of F03 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease
Expand descriptionThe purpose of this study is to assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of F03 in subjects with mild cognitive impairment.
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Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids (Chronic Study)
Expand descriptionConsumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is deficient in n-3 PUFA. If the same is true for humans, this research will have important implications for the prevention of cardiovascular and other chronic diseases. Therefore we hypothesise that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in omega-3 polyunsaturated fatty acids. We also hypothesise that the benefits of n-3 PUFA can be optimised when consumed in combination with saturated fats. This is a randomised controlled, dietary intervention trial, in parallel design with healthy adults. Blood samples will be collected at baseline and after 6 weeks of dietary intervention with omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation either in combination with saturated fat or omega-6 Polyunsaturated fatty acids (n-6 PUFA). The saturated fat group will consume butter (24g, which can be spread on bread, muffins or crackers), white chocolate (40g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods containing saturated fat for cooking. The n-6 PUFA group will consume margarine (20g, which can be spread on bread, muffins or crackers), sunflower seeds (42g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods and oils containing n-6PUFA for cooking. Participants will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken in each of their visits. Subjects will also complete a 3 day food record.