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Australasian Oncofertility Registry: uptake and utilisation of fertility preservation, reproductive health after cancer treatment, and future use and complications of assisted reproductive technologies in cancer survivors
Expand descriptionThis study will establish the first web-based, multi-site Australasian Oncofertility Registry (AOFR) collecting data from cancer and fertility specialists. This study is for cancer patients who are diagnosed with cancer who are aged under 45 years old. Who is it for? You may be eligible to join this study if you are aged 13 years or above and have been diagnosed with cancer or aged 0-12 years diagnosed with cancer who have been referred for fertility preservation only. Study Details This study will collect data regarding uptake and utilisation of fertility preservation, future use and complications of assisted reproductive technologies as well as the potential for infertility following treatment for cancer survivors will be collected. Patients will be asked to consent to the research team collecting the results of fertility tests following cancer treatment. In males (semen analysis and fertility hormone blood tests in years 1,3,5). In females fertility hormone blood tests and ultrasound scans looking at the number of follicles in the ovaries. The research study will be undertaken under five broad and interlinked themes. These themes include: Themes 1: Awareness and referral for fertility preservation Theme 2: Strategies, uptake, complications and quality of fertility preservation in cancer patients Theme 3: Reproductive health following cancer treatment Theme 4: Family planning and use of assisted reproductive technologies with pregnancy and birth outcomes The data from the registry and patient Medicare records will be used to perform a cost modeling health economics study for theme. Patients who consent to being part of the AOFR study wil be asked to supply data at diagnosis, end of treatment and then annually for 20 years. Eligible patients or their parents/guardians/carers on behalf of the patient no longer being treated for their cancer at their cancer centre will be contacted retrospectively (2 years retrospectively from diagnosis) by the International FUTuRE Fertility Research Manager to explain the study and to determine whether eligible patients or parent/guardian/carer on behalf of their child would be interested in having their/their child's details stored on the registry. If a patient or parent/carer/guardian on behalf of the patient, is interested in having their/their child's Medical records reviewed in order to ascertain personal, cancer and fertility history then an information pack will be sent out to the patient/patient's family. The information pack will include study information details and patient consent forms.
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Does the patient's position whilst undergoing ERCP (Endoscopic Retrograde Cholangiopancreatography) affect ease of the procedure and complication rates
Expand descriptionPatients having an ERCP may have the procedure lying on their left side or on their stomach. Currently, the position chosen is decided by the doctor performing the procedure. We do not know if one position is better than another. This project aims to assess whether the position a patient is in affects the ease and time taken to perform the procedure as well as any affect this may have on the rate of potential complications.
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Comparison study of PF530 and Betaferon in healthy subjects
Expand descriptionThe purpose of this study is to test the safety and tolerability of new interferon beta-1b product called PF530. Who is it for? You may be eligible to join this study if you are aged between 18 to 50 years and are in good general health. Females must not be pregnant or breastfeeding. Study details The study will consist of two parts (Part I and Part II). Twelve participants will be enrolled in Part I, and the results of this part will determine how many participants will be enrolled in Part II. The study is divided into a screening phase lasting about 4 weeks and an on-study phase. The on-study phase will be broken into 2 periods with at least a 14 day gap (called a wash-out) between each period to ensure that the study drug is completely gone from your body before the next period starts. Doses will be administered subcutaneously (under the skin), with participants receiving PF530 in one period and BETAFERON in the other period. The order in which you receive those doses (i.e. in period 1 or period 2) will be random. The chance of receiving PF530 first compared to BETAFERON is 1:1. Which treatment you receive first (PF530 or BETAFERON) will not be known by the study staff or yourself. The study dose will be given to you by a clinical unit staff member. Study doses will be administered in the abdomen. Initially in Part I, the first 2 participants will receive a randomised dose – one with PF530 and one with BETAFERON - on the morning of Day 1 and will complete 48 hours of monitoring by site staff before the remaining participants receive their dose. This is referred to as a sentinel dosing. Dosing of the remaining participants will depend on safety information obtained from the 2 sentinel participants. Each of the two study periods will include a confinement period of 5 days and 4 nights, commencing the day before your dosing each period. After leaving the clinical unit on Day 4, you will be required to attend the unit at the same time each morning on Days 5, 6 & 7 for a brief appointment. Your total involvement in the study will be approximately 8 weeks. It is anticipated that each visit will last from 1-2 hours depending on the procedures required. These will include: blood and urine sampling; physical examination; vital signs; medical history, concomitant medications and adverse events (AE) assessment; completion of questionnaires.
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Randomised controlled trial of Cool Little Kids Online: A parenting program to increase young children’s confidence and prevent anxiety problems
Expand descriptionThis study evaluates an online parenting program that aims to help shy/sensitive young children become more confident and prevent them developing anxiety problems. Parents will receive access to the website program immediately or after a 24-week delay, and will complete questionnaires at baseline, 12 weeks, and 24 weeks later.
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An audit of the impact of a change in the blood glucose targets protocol on intensive care mortality for diabetic patients admitted to the intensive care unit
Expand descriptionMany people with type-1 and type-2 diabetes develop critical illness, which inevitably leads to deterioration in glycaemic control. However, most critically ill patients with hyperglycaemia are not diabetic, but develop disordered glucose metabolism that normalises once the acute illness resolves – so-called critical-illness induced hyperglycaemia (CIIH). While a number of studies have evaluated the effects of modulating glycaemia, using insulin, on outcomes in the critically ill, a major limitation of these studies, given recent information, is that critically ill patients with hyperglycaemia have been considered a homogenous cohort, rather than classifying hyperglycaemia in the critically ill according to pre-morbid glycaemia or presence of diabetes. Recent data indicate that a paradigm shift is required, and that patients with CIIH should be considered separately to those critically ill patients known to have diabetes, particularly those patients with ‘chronic’ hyperglycaemia, or ‘poorly controlled’ diabetes. Given these data (and that it intuitively makes sense) the medical staff at Austin Hospital Intensive Care Unit believe we should be personalising blood glucose targets and that, in diabetic patients, the target glucose level in ICU should simulate the sort of glycemic levels these patients are likely to commonly experience in their daily lives, especially during situations of physiological stress (between 10-14 mmol/L). Such target glucose level would also be expected to prevent any episodes of even mild hypoglycaemia, which have been associated with increased risk of death. However, allowing slightly increased blood glucose concentrations in critically ill patients known to have diabetes is a slight change from current practice, and evidence to support this change, although logical and strong, is from observational studies only. Accordingly, we wish to collect data after the implementation of the new protocol to audit the effects of glycaemia on outcomes and ensure that this protocol proves safe and does indeed prevent hypoglycemic episodes as expected. This audit represents a formal assessment of a quality improvement initiative dedicated at increasing the quality of glycaemic care in critically ill diabetic patients.
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Mindfulness Based Cognitive Therapy for Fear of Recurrence in Ovarian Cancer Survivors. (FROCS)
Expand descriptionThis study will determine the effect of mindfulness based cognitive therapy on the fear of recurrence in ovarian cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with ovarian cancer, have completed all hospital based adjuvant treatment and are now disease free. Study details All participants will receive the same intervention and will involve intensive training and practice in mindfulness based cognitive therapy. Treatment is designed as an 8 week course of 2-2.5 hour small group sessions once weekly with approximately 8-15 individuals in each group. Sessions are run at locations in Shenton Park, Duncraig and East Fremantle by the Cancer Council WA, or by SolarisCare Foundation, at Sir Charles Gardner Hospital in Nedlands. Courses take place during the day and are free of charge. The groups will be run by experienced clinicians in psychotherapy, counselling and meditation and will have a clinician manual and a participant workbook outlining the themes and exercises for each week. Group members will be expected to practice skills between sessions. Participants will be asked to answer questionnaires before, during and after the group sessions to collect information on how participants are feeling.
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The Exterior Interior Can pseudo-natural environments, produced through video projections, improve dementia related symptoms and behaviours?
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A randomized controlled trial of daily aerobic exercise for inpatient cannabis withdrawal
Expand descriptionThe study is a prospective, parallel-group randomized controlled trial comparing an exercise versus control intervention across a range of cannabis detoxification outcome measures during a 7-day inpatient admission, with follow-up at 28 days post-discharge. Specifically, the study will compare severity of cannabis withdrawal and cannabis cravings, detoxification completion rates, and adverse events between the two conditions in an intention-to-treat analysis. Mechanisms by which exercise affects cannabis withdrawal will be assessed through the analysis of markers of endogenous cannabinoids, and plasma and urine THC levels.
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Sexual Healing: A randomised, controlled trial on the effect of pre-operative sexual counselling on sexuality and quality of life after risk-reducing salpingo-oophorectomy.
Expand descriptionThis study will determine the effect of pre-operative sexual counselling on sexuality and quality of life after risk reducing salpingo-oophorectomy (RRSO) in women at high risk of ovarian cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, at high risk of ovarian cancer and have decided to undergo risk-reducing salpingo-oophorectomy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a single pre-operative counselling session with a sexologist to discuss the potential effects of surgery on sexual function and physical changes, potential changes to intimacy, loss of sexual self-esteem related to body image changes, menopausal symptoms and confidence, changes to sexual response such as reduced arousal, loss of libido, difficulty reaching orgasm, menopausal symptoms related to treatment including hot flushes/night sweats, disturbed sleep, poor memory and weight gain, all of which may impact on one’s sexual self esteem, sexual functioning and general wellbeing (quality of life). While participants in the other group will receive routine care which is the initial consultation with your gynaecologic oncology specialist who may or may not discuss such issues with you. Participants will be followed-up for up to 12 months post-surgery to determine the effect on sexual function, the prevalence and severity of sexual difficulties after RRSO, and any other factors that significantly affect sexual function and quality of life. Serum testosterone levels will also be tested to determine whether there is a correlation with sexual function after RRSO.
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High Flow Nasal Oxygenation for General Thoracic Patients during Diagnostic Bronchoscopy. Comparison of conventional methods of respiratory support during bronchoscopy vs. High Flow Nasal Cannula.
Expand descriptionHigh flow oxygen therapy has been successfully trialled in a multitude of clinical scenarios. High flow oxygen therapy is known to provide more support than standard methods of oxygen delivery. This study aims to trial and assess the use of high flow as respiratory support during bronchoscopy as an alternative method to standard practice. We aim to establish whether high flow maintains end expiratory lung volume and improves other physiological parameters.