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A comparison of LightForce vs conventional orthodontic brackets in initial lower arch alignment efficiency and discomfort: a randomised clinical trial
Expand descriptionThe purpose of this trial is to compare the improvement of lower dental crowding and patient discomfort in the initial stages orthodontic treatment using conventional preadjusted orthodontic brackets (3M Victory and Clarity, MBT Prescription 022 slot) vs custom LightForce brackets (LightForce Orthodontics, Custom Prescription 022 slot). The primary outcome measured will be change in mandibular Little’s Irregularity Index (LII ) which assesses crowding over a set time period of 12 weeks. The null hypothesis is that there is no difference in the rate of change of lower incisor crowding in the first 12 weeks when using LightForce or conventional preadjusted brackets. The secondary outcomes will include time to reach the first rectangular nickel titanium (NiTi) archwire and evaluation of patient discomfort.
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Randomised, double-blinded, placebo-controlled trial assessing the efficacy of Mi-Gel® in the treatment of women with vulval pain / entry dyspareunia.
Expand descriptionThis research study is for women with a diagnosis of vulval pain / entry dyspareunia (pain at the level of the vaginal entry). Entry dyspareunia has a variety of causes and can be linked to pudendal neuralgia, hypoestrogenism or vulvodynia. Vulvodynia is described as vulvar pain of at least 3 months duration, without clear identifiable cause. Pudendal neuralgia, like vulvodynia, is a nerve pain condition diagnosed in the absence of other causes. Amitriptyline is an effective pain medication that is often used orally (in a tablet) for the treatment of nerve pain. However, this is sometimes not well tolerated due to side effects. When applied topically (directly onto the affected area) instead of orally, amitriptyline works locally, on nerves where it is applied, and there is evidence that it is better tolerated. Oestriol is one of the three main oestrogens produced naturally by the body. We have found that many of our patients with entry dyspareunia, pudendal neuralgia and vulvodynia have skin changes suggestive of low oestrogen levels. Treatment with topical oestrogen improves skin health and can reduce pain. This study will assess the effectiveness of a topical gel containing both amitriptyline and oestriol in the treatment of this pain. The study is designed to measure the effect the treatment has on pain as a result of entry dyspareunia; bladder function; sexual function; and whether it causes any adverse effects. The study hypothesis is that the use of Mi-Gel will result in a statistically significant reduction in vulval pain, as measured by the Numeric Rating Scale (NRS) change from baseline at Week 12, compared to placebo.
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Liver Transplantation for Unresectable ColoRectal Liver Metastases
Expand descriptionThis study will assess long term survival after Liver Transplantation for Unresectable ColoRectal Liver Metastases Who is it for? You may be eligible to join this study if you are aged between 18 and 60 years old and have been diagnosed with primary colorectal cancer and liver metastases Study details All participants in this study will receive a liver transplant if no extrahepatic disease and the primary cancer has been removed. Participants will be followed up at 1, 3 and 5 years post-transplantation to determine overall survival, and tumour recurrence. This research will contribute to the field of transplant oncology by better understanding which patient may benefit from a liver transplant.
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A randomised controlled trial of an online digital cognitive behavioural therapy (CBT) intervention for adults with insomnia
Expand descriptionThe purpose of this research is to further examine the efficacy of the Sleep Course, a brief, cognitive behavioural therapy intervention for insomnia (CBT-I). In previous research, the Sleep Course and similar interventions have shown they are safe and effective for diverse groups of people with insomnia. However, we do not know which components are associated with the most benefit, or how people's symptoms improve during the course of treatment. The aim of this study is to examine participants' symptoms more closely as they take part in treatment, to understand when they experience benefit. We expect that participants will demonstrate significant improvement in their insomnia and associated symptoms, and that much of this improvement will be experienced in early weeks of the treatment. Participants (adults with insomnia symptoms) will be randomised to receive either the Sleep Course (digital CBT-I intervention) or a brief sleep hygiene waitlist control. While in the intervention, participants will have access to the Sleep Course along with clinical support from a psychologist. Both groups will complete measures of their symptoms during the treatment phase.
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Effectiveness of Zinc Supplementation in Respiratory Infections in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Randomised Controlled Trial
Expand descriptionCOPD is an incurable disease with high morbidity and mortality rates, due to hospitalisations from the condition and antibiotic-resistant respiratory infections. Zinc deficiency could increase the risk of recurrent airway infections. Incorporating zinc therapy into COPD treatment could be a significant breakthrough, particularly in light of our previous findings of low zinc levels in the airways of COPD patients.
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Detection of Kidney Transplant Medication Toxicity
Expand descriptionThis is an observational study to discover and assess new markers in the blood or urine that detect early stages of kidney damage from the toxic effects of transplant anti-rejection medications (tacrolimus). Patients undergoing kidney transplantation with no prior exposure to tacrolimus are enrolled and daily blood and urine samples are collected for the first 30 days after the transplant. The hypothesis is that we can better detect kidney toxicity caused by tacrolimus by using the new biomarkers studied here than by the standard clinical measurement of serum creatinine. This will allow our team to develop better protocols to determine tacrolimus dosage in clinical care within the first 30 days after kidney transplantation.
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An Open Label Extension of the double-blind randomised, placebo-controlled clinical trial to test the treatment of amyotrophic lateral sclerosis with ambroxol.
Expand descriptionAmbroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study is the open label extension (OLE) of the parent study, which aims to investigate if ambroxol in high doses is effective in treating ALS. This OLE study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where ALS patients whole have successfully completed the randomised phase of the parent study, will be asked to participate in the OLE phase. Participation will be over a 52-week period, where they will come in for a an OLE baseline, followed by 48-week treatment, and 4-week end of study safety follow-up period. All participants will active drug that they will take three times a day, Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.
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The availability of drinking water on postural sway following a simulated military march in the heat
Expand descriptionThe purpose of the study is to evaluate the effect that hydration and fluid restriction might have on postural stability, aiming and shooting targets during and after a simulated march in the heat. The expected outcomes are that participants will show greater signs of fatigue by measure of postural stability and target accuracy when dehydrated in the heat.
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Clinical Outcomes following Acute Shock in Trauma - The Sydney COAST Study
Expand descriptionThe Sydney COAST study will create a clinician-defined, meaningful dataset containing both prehospital and in-hospital data. The study will examine this for the identification of physiological, mechanistic, or biochemical risk factors that influence in-hospital mortality for major trauma patients with shock, across the greater Sydney area.
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Treatment of steroid-sensitive nephrotic syndrome in children – the OPtimising dosE in Nephrotic syndrome (OPEN) trial.
Expand descriptionNephrotic syndrome (NS) affects around 1 in 50,000 children. Nephrotic syndrome causes the kidneys to leak too much protein into the urine leading to a drop in protein levels in the blood. This causes swelling in the body, especially in the face, legs and feet. The treatment of NS is steroid therapy. Most children with NS get better with steroid therapy but for many children, the disease comes back (relapses). NS often continues to relapse for many years. Steroids can help in treating relapses but they come with many side effects like changes in behaviour and sleep, appetite, weight and growth.