ANZCTR search results

The purpose of the study is to determine the efficacy and safety of a Marinova seaweed supplement in improving symptoms in participants with diagnosed osteoarthritis of the knee. The primary hypothesis is that the oral administration of the study medication over 12 weeks will result in a statistically significant decrease in osteoarthritis symptoms in comparison with a placebo.

The primary focus of this study is dizziness in the community dwelling elderly. Neck pain and dysfunction can cause dizziness and may be an important under-investigated risk factor for falls in the elderly. Neck manipulation is known to be effective for neck pain. There is also preliminary evidence that physical treatments administered to the neck (including manipulation) may improve dizziness. This study will use clinical rigorous research methods to determine whether chiropractic manipulation can be used to successfully treat dizziness, thereby lowering the likelihood of falls in the elderly. Falls in the elderly are a significant public health problem in need of new and innovative management strategies.

Pain is a common presenting symptom in the emergency department patient population with opioids being the cornerstone of treatment for moderate to severe pain. Fentanyl is a safe and effective opioid drug which is commonly used in adults and children for this indication. Rapid analgesia is usually effected in emergency patients by administering an opioid via the intravenous route but this can be associated with pain, inconvenience and delay as it requires the insertion of an intravenous cannula. The intranasal route of administration of opioids offers an attractive alternative as it is non invasive and does not require intravenous access. It also provides an alternative where intravenous access is difficult or not required and where nausea and vomiting prevent oral drug administration. In a number of patients intravenous access may then be completely avoided. The intranasal (IN) route has increasingly been viewed as an alternative route for drug administration. It is commonly used in the paediatric population where more invasive methods of drug delivery (intravenous or intramuscular) may result in significant discomfort, anxiety and increased stress during a hospital visit. The effective treatment of acute pain in children with intranasal opioids such as fentanyl is well documented. There is also evidence in adult acute and chronic pain settings that fentanyl in analgesic doses by the intranasal route provides effective analgesia. A significant limitation of using IN fentanyl in the adult population in the hospital setting is the inability to access the concentrated formulation (300mcg/ml). This preparation is more expensive than the widely available standard formulation (50mcg/ml) fentanyl and so is not widely accessible for use. Effective IN analgesia in adults requires the more concentrated formulation of fentanyl due nasal absorption considerations. This is a non-randomised single group study of IN fentanyl in 150 adult patients with moderate to severe pain from all causes. Patients presenting with pain greater or equal to 6 out of 10 will be given a dose of concentrated (300mcg/ml) IN fentanyl. Pain scores will be taken at regular intervals over 60 minutes. If there is no response by 15 minutes a second dose of fentanyl will be given. If no appreciable pain relief occurs by 30 minutes, standard IV opioid analgesia will be given. The results of this study will provide information on the effectiveness of fentanyl in the treatment of moderate to severe pain in adult ED patients and will allow us to determine future sample sizes for prospective comparative studies of fentanyl to other pain relievers used in the ED.

This study is evaluating the safety, tolerability and pharmacokinetics of RPH-203 following a single dose in health male volunteers as a potential treatment for secondary cancer of the bone. Who is it for? You may be eligible to join this study if you are aged between 18 and 45 years old, have a body mass index between 19kg/m2 and 30kg/m2, have a negative Quantiferon (Registered Trademark) test, male and healthy. Trial details Participants in this study will be randomly (by chance) divided into 6 sequential dose cohorts to receive 10.0mg, 30.0mg, 60.0mg, 120.0mg, 180.0mg of RPH-203 or matching placebo. Cohorts will receive a single dose of 10.0mg, 30.0mg or 60.0mg of RPH-203 subcutaneously, or a single dose of 60.0mg, 120.0mg or 180.0mg intravenously. As this is a dose escalation study, the first group will receive the lowest dose and when it is determined safe, the second group will receive a higher dose. Participants will be told which group they will take part in and what the dose level will be. As this is the first time this drug is being given in humans, 2 participants from the first dosing group will be given the drug first. 1 will be receiving the active drug and the other will receive the placebo. The assignment will be done at random. The remaining 6 participants will be given the drug at least 48 hours later when the drug is deemed safe. Participants will be advised if they are intended to be the first 2 participants before they come to the unit for dosing. All 8 participants will be dosed together for all other dosing groups. Participants will be admitted and be required to stay in the study unit for 3 days and be required to attend outpatient visits on 5 occasions for monitoring and assessment. This study is being conducted at the Centre for Clinical Studies.

The primary aim of the study is to test in a randomised, double ­blind, placebo­ controlled trial the efficacy of melatonin in patients with REM sleep behaviour disorder over 8 weeks of treatment Specifically, we will test the hypothesis that, compared to placebo, melatonin treatment will result in a reduction in the frequency of patients' self reported events

The primary aim of the study is to test in a randomised, double ­blind, placebo­ controlled trial the efficacy of melatonin in patients with REM sleep behaviour disorder over 8 weeks of treatment Specifically, we will test the hypothesis that, compared to placebo, melatonin treatment will result in a reduction in the frequency of patients' self reported events.

The study is evaluating whether premedication can prevent or delay the onset of carboplatin hypersensitivity reactions in women win gynaecological malignancy. 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 a gynaecological malignancy, for which you will be commencing a carboplatin containing chemotherapy regime. Eligible patients will have already undergone at least one prior line of carboplatin containing therapy. Trial details All participants in this study will be given premedication with Dexamethasone, Loratadine and Ranitidine the night before chemotherapy, the morning of chemotherapy and about 30 minutes prior to chemotherapy. These will be administered orally (by mouth) the night before and the morning of chemotherapy, and intravenously (directly into the vein) about 30 minutes prior to chemotherapy. All participants will be asked to complete a symptom diary, and will be clinically assessed in order to evaluate whether the study premedication can prevent or delay the onset of hypersensitivity reactions following chemotherapy with carboplatin. If it does (compared to a control group who receive their care in the past), then a subsequent larger randomised trial will be developed.

Aims / Objectives To compare the results from a Laser Doppler Flowmetry -based test against the current gold standard protocols for skin testing in patients suspected of severe allergic reaction. Hypothesis LDF-based testing is as accurate as conventional skin testing protocols in assessing anaesthetic allergy. Significance of project LDF-based testing is objective, inexpensive and non-invasive. This may prove to be a valid alternative to conventional skin testing and may facilitate the identification of an allergic agent in patient’s that have proven to be difficult using previous testing protocols. It may present a faster, more efficient and reliable method of undertaking skin testing with the potential to discriminate between two main causes of serious allergic reaction (currently indistinguishable); Anaphylactic (IgE mediated allergy) versus anaphylactoid (direct histamine amplification).

This study aims to explore 3 key themes: 1.What are the perspectives of podiatrists on the utilization of Complimentary and Alternative Medicine and its effectiveness? 2.Which specific Complimentary and Alternative Medicine therapies should be classified as Complimentary and Alternative Medicine in podiatry and why? 3.Is there a need to integrate Complimentary and Alternative Medicine into the podiatric medicine education system?

With increasing rates of food allergy in countries such as Australia, there is a growing need to understand the role and effects of early food allergen exposure in the development of tolerance to food allergens. Egg allergy is now the most common food allergy in babies in Australia, with almost 1 in 10 babies at 1 year of age in the community now having an egg allergy. Previous recommendations to prevent food allergy through early allergen avoidance of certain foods have failed and now have instead been associated with increased risk of allergy development. With rates of food allergies increasing in our young Australian children, prevention is therefore the key to reduce allergies and the associated burden on the individual, the family and the health care system. In recent studies we have found a significant number of babies to have food allergy reactions the first time they eat a solid food (for example, egg) at 4-6 months of age. This indicates that earlier strategies may be needed in some babies to prevent food allergy. To develop tolerance (and not have a food allergy reaction) to a food it is currently thought that regular eating of that food is needed. However the ideal age to eat the food and amount of the food is unknown. Foods proteins are known to pass from the breastfeeding mother’s diet into breast milk. Current thinking is that the regular presence of food proteins in breast milk will help babies to develop tolerance and hence prevent allergies to foods. The primary aim of the study is to investigate the effect of a breastfeeding mother’s dietary egg intake on egg levels in breast milk during the first six weeks of breastfeeding. We will recruit women with singleton pregnancies who have a history of allergic disease, and ask the women to eat "high egg" (4-6 eggs per week), "low egg" (1-3 eggs per week) or "egg-free" diet during the first 6 weeks of breastfeeding. Differences in egg levels in breast milk samples will be measured. The study will not interfere in any way with breastfeeding or the mother’s or the baby’s nutrition. With expanding the research in this area, recommendations of what women should eat while breastfeeding can be more evidence based, especially with the goal to reduce the current rising problem of food allergy in Australia.