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A Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of BG00012 when given with methotrexate to subjects with active rheumatoid arthritis who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy.
Expand descriptionBG00012 has been shown to be effective in reducing signs and symptoms of psoriasis and multiple sclerosis. BG00012 may be effective in the treatment of rheumatoid arthritis (RA) as well. The present study will test this concept in subjects with RA who have not responded adequately to methotrexate (MTX), the standard first-line oral agent for this disease.
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Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent transfusions for women with red cell alloimmunisation: A randomised trial
Expand descriptionThe aim of this study is to assess in the fetus where one intrauterine fetal transfusion has been performed for anaemia due to red cell alloimmunisation, whether fetal middle cerebral artery (MCA) Doppler can be safely used to determine the timing of second and subsequent fetal blood transfusions, without increasing the risk of adverse fetal and neonatal health outcomes. Red cell alloimmunisation is estimated to affect 0.1 to 0.6% of all live births. Treatment of the resultant fetal anaemia with intrauterine fetal blood transfusion has been associated with survival rates in excess of 90%. However, intrauterine fetal blood sampling and transfusion is an invasive procedure, with recognised complications, which may result in the need for early birth, and rarely mortality. More recently, reports have emerged utilising Doppler ultrasound to measure the fetal middle cerebral artery (MCA) peak systolic velocity (PSV) to determine the presence of fetal anaemia.
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Communication of genetic information in families: A randomised trial of a genetic counselling intervention.
Expand descriptionAdvances in genetics research, including the Human Genome Project, have led to the availability of an increasing number of genetic tests that can give people information about their risk of developing specific genetic conditions. Genetic information given to an individual when diagnosed with a genetic condition is likely to have important health implications for their family members as well as themselves. However, the task of talking to family members about genetic information and what it means for family members can be difficult. Research has shown that commonly genetic information does not get passed on to all relevant family members and that this process is influenced by factors such as family dynamics and the complexity of the information. Despite this, current practice in genetic counselling, in keeping with Privacy laws, is for health care providers to discuss with patients attending genetic testing services the implications of their genetic information for their relatives, and the importance of the patient relaying that information to family members who have been identified as potentially at risk. Letters or information sheets for family members may be offered to the patient if they believe it would be helpful. There is much discussion about ways to improve communication of genetic information in families but very little evidence to guide practice. This study aims to evaluate a specific genetic counselling intervention to aid communication, using a robust randomised study design. Participants will be recruited from genetics clinics at several sites. Individuals who are presenting for the first time at a genetics clinic for the diagnosis of a genetic condition in themselves or their children, that has implications for family members, will be eligible to participate. They will also need to have at least one living relative who could benefit from being told the genetic information. Once participants are recruited into the study they will be randomly assigned to one of two groups. The control group will receive usual care which involves the current practice of discussing the implications of the genetic information for family members, identifying relatives who might be at risk and offering a letter for the individual to give to family members, if that would be helpful. The intervention group will receive an enhanced genetic counselling intervention where a research genetic counsellor will contact the person by phone at 3, 6 and 9 month intervals. The intervention comprises 15-20 minute telephone genetic counselling addressing family communication of genetic information. The effectiveness of the intervention will be assessed 18 months after enrolment into the study. Participants from both groups will be asked to complete a survey and the number of at-risk relatives who have attended a genetics service and/or had a genetic test will be ascertained from genetic health records. This is the first ever scientifically robust study to test an intervention to aid family communication of genetic information. It will provide evidence to guide genetic counselling practice in this important area of family communication.
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Utility of 18F-fluorocholine positron emission tomography in prostate cancer.
Expand descriptionProstate cancer can extend beyond the prostate, most commonly to lymph nodes or bones. Determination of its extent is crucial to determining best treatment options for patients. Currently, the conventional tests that are most commonly used for this purpose are a bone scan and computed tomography but these are not very accurate and may result in inappropriate treatment. Positron emission tomography with fluorocholine (FCH-PET/CT) is a promising new test for diagnosing the extent of prostate cancer since it can detect disease in the prostate itself, lymph nodes, and bones. This project proposes to compare the utility of FCH-PET/CT with that of conventional tests for guiding treatment decisions. Patients who have a newly diagnosed prostate cancer, or in whom a relapse of prostate cancer is suspected will be randomly assigned to undergo either conventional tests or FCH-PET/CT as the initial investigation. If these show no distant spread, patients will undergo the alternative test strategy. The usefulness of each test strategy will be assessed by its influence on treatment planning. It is anticipated that FCH-PET/CT will better identify the patients who are amenable to a curative treatment and avoid futile treatments in some other patients. If FCH-PET/CT, a new and non-invasive test, proves successful, it is likely to become more widely available to patients with prostate cancer.
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A multi-modality approach to prevent and treat contracture after traumatic brain injury: a randomised controlled trial
Expand descriptionThe primary objective of the project is to determine the benefit of using multiple physical modalities for treating and preventing contracture in adults with traumatic brain injury. An assessor blinded, multi-centre, randomised controlled study will be conducted. In this study, the ankle is selected as a model to asess if a multi-modality programme (tilt table standing combined with ankle splinting and electrical stimulation) is more effective than usual care (tilt table standing alone). The participants are people with traumatic brain injury admitted to the brain injury rehabilitation units of the Royal Rehabilitation Centre Sydney, Liverpool Hospital and Westmead Hospital.
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Reduction of shoulder pain in obese patients undergoing laparoscopic adjustable gastric banding.
Expand descriptionThe process of laparoscopy can result in shoulder pain post-operatively, apart from what is performed surgically. This pain is thought to be from the gas used to inflate the abdomen. We propose to test a manoeuvre, recently reported to be successful for reducing this pain in another patient group, in our obesity surgery patients. The manoeuvre is a series of five manual "breaths" near the end of surgery which may help to expel the inflating gas from the abdomen, and leave less of the gas to irritate the abdominal lining post operatively, which is felt as shoulder pain.
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Electrical stimulation to assist standing in paraplegia
Expand descriptionThe purpose of this research is to investigate the use of electrical stimulation to support a muscle strengthening program aimed at increasing standing function in individuals with incomplete spinal cord injury (SCI). Specifically, this project will establish whether there are any differences in outcome using a conventional stimulation pattern (low frequency) or a new, higher frequency stimulation pattern. The project will test the hypotheses that, following training using a combined FES-voluntary muscle strengthening program, motor-incomplete SCI individuals will be able: 1. to stand for longer; 2. to perform significantly more repetitions of the sit-to-stand/stand-to-sit activity ; 3. to achieve significantly greater upper limb reach.
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Women who cannot contract their pelvic floor muscles- avulsion or denervation? The Pelvic Floor Neuroanatomy Study
Expand descriptionThis study is an observational study looking at women who cannot contract their pelvic floor muscles. This study applies to all women who have had a pregnancy and includes those delivered by caesarean section.
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Australasian Antenatal Study To Evaluate the Role Of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability – a randomised controlled trial
Expand descriptionThe primary aim of this randomised controlled trial is to determine whether giving antenatal dexamethasone to women at risk of preterm birth at less than 34 weeks gestation increases the chance of their children surviving free of neurosensory disability at 2 years’ corrected age, compared with women given antenatal betamethasone. The primary hypothesis of the study is that, compared with betamethasone, antenatal dexamethasone given to women at risk of preterm birth (less than 34 weeks gestation) reduces the risk of death or any neurosensory disability, caused by impairments such as cerebral palsy, blindness, deafness or developmental delay, in their children at 2 years’ corrected age. Specific aims are to assess whether dexamethasone has greater short-term benefits than betamethasone (a greater reduction in the risk of intraventricular haemorrhage as suggested by a new systematic review) and whether there are longer-term effects on childhood neurological function, including motor function, cognition and behaviour, as well as body size, blood pressure and general health.
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Chinese herbal medicine for Primary Dysmenorrhea.
Expand descriptionThis is a randomised, double-blind placebo controlled trial in the use of Chinese herbal medicine in the management of primary dysmenorrhea in Australia. This investigation seeks to establish whether Chinese herbs offer any beneficial effect in the management of this disorder. Dysmenorrhea is a common gynaecological complaint among adolescent girls and women of reproductive age and refers to the occurrence of painful menstrual cramps of lower abdominal origin. This trial will include the assessment of Chinese herbs in standard and individual formulas against placebo.