ANZCTR search results

This study aims to investigate the effectiveness and safety of twice daily ZYN002, for 12 weeks in 320 (300 randomized) adults with knee pain due to osteoarthritis of the knee. This will be done by analysing a daily pain score and skin check, knee pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical and neurological exams, vital signs (including oral temperature), 12-lead ECGs, clinical laboratory tests and side effect monitoring. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 40 and 75 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a 1 week washout period, a 1 week baseline period; a 12 week study treatment period; and an end of study (EOS) visit at Week 12. During the washout period, participants will be asked to discontinue their anti-inflammatory agents (e.g., NSAIDs) and other analgesics prior to the Baseline Period. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. During the Baseline Period, participants will use a 0 to 10 point numeric rating scale to capture their worst pain severity every day. Only paracetemol (not more than 3 grams per day) will be allowed as rescue medication. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants will record rescue pain medication in a daily diary (Skin Check, Knee Pain, Rescue Medication Diary. Participants will apply all study drug to clean, dry, intact skin, thoroughly massaging it into both the right and left shoulders and/or upper arms until the area is dry.

Patients with liver cirrhosis are at risk of having varices (dilated vessels) in their oesophagus and stomach. These varices can bleed and bleeding is associated with serious complications. It is recommended that all patients have their oesophagus examined with an endoscopy (flexible telescope / camera) to detect these varices. Currently these endoscopies are performed in the Gastrointestinal Investigation Unit using sedation (medication to make you drowsy). The purpose of this study is to evaluate the accuracy of a new endoscope in detecting dilated vessel in the oesophagus and stomach compared to standard the endoscopy. The newer scope is very thin, disposable and can be performed in a consultation room. The thinness of the scope allows the examination to be performed without sedation, using only local sedation.

This study will be a randomised trial investigating whether changes in sensitivity to pressure pain are different when comparing spinal manipulation (a manual therapy technique) of the neck and the low back. It will measure any changes in pain sensitivity over 1 hour, and will measure pain sensitivity in 4 different areas of the body to study how widespread any changes are.

Increased intestinal permeability, often referred to as ‘leaky gut’, is a measure of integrity and functioning of the mucosal (innermost) lining of the gastrointestinal tract. Increased levels have been found to correlate with the development of sepsis in the Intensive Care Unit. The location of increased intestinal permeability (gastroduodenal, small bowel and whole gut permeability) has not been adequately explored in the Intensive Care Unit. The aim of the study is to determine the location and degree of changes in intestinal permeability in mechanically ventilated critically ill adult patients. Additionally, this study aims to investigate the association between intestinal permeability, inflammation and clinical outcomes. Findings will be compared to data from healthy subjects being recruited in a separate study at La Trobe University (Request ID: 371028).

Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently no definitive high quality evidence is available for the effectiveness, impact on health-related quality of life, health service costs, adherence and treatment satisfaction of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Therefore evidence of the effectiveness of these treatments is required in children. A randomised controlled trial will be conducted. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following burns scar reconstruction surgery. Participants will be randomised to one of three groups: Strataderm topical silicone gel only, pressure garment therapy only, or combined Strataderm topical silicone gel and pressure garment therapy. Primary outcomes are scar thickness and scar itch intensity. Secondary outcomes include subjective scar severity (e.g. colour, pigmentation, pliability, pain, overall opinion), objective scar colour, health service costs, adherence, health-related quality of life, treatment satisfaction, and adverse effects. Measures will be completed up to 12-months post-burn or post-burn scar reconstruction. Data will be analysed using descriptive, univariate and multivariate statistics including regression analyses. The results of this study will determine the effectiveness of three non-invasive scar prevention interventions in children at risk of scarring post-burn or post-burn scar reconstruction.

The aim of this study is to determine if a course of ketamine is an effective therapy for depression. The study will also determine if repeated ketamine doses: 1) are safe, tolerable and feasible in outpatient settings; 2) provide sustained antidepressant benefits; 3) improve anxiety, suicidal ideation and health related quality of life; 4) are a cost effective treatment. 200 participants will be recruited across 6 sites in Australia (Black Dog Institute, Sydney; Royal Prince Alfred Hospital, Sydney; Monash Alfred Psychiatry Research Centre, Melbourne; South Eastern Private Hospital, Noble Park; Royal Adelaide Hospital, Adelaide; Gold Coast University Hospital, Gold Coast) and 1 in New Zealand (Dunedin, Otago). The study is a randomised controlled trial. Participants will be randomised to receive repeated doses of ketamine or a comparator treatment. For all participants, a follow-up assessment after finishing the randomised controlled phase will assess eligibility for an open label extension phase. All participants will be followed up after exiting the trial to assess treatment effects.

There has never been a more sedentary population than the 21st century western society, with physical inactivity accounting for a similar number of deaths per annum as tobacco. Physical inactivity is a modifiable risk factor for chronic disease, especially cardiovascular diseases, and no other intervention possesses the broad spectrum of health impacts that can be attributed to exercise. However, the cardiovascular response of an individual to exercise is idiosyncratic and, whilst most individuals incur favourable effects, a sizeable proportion (~30%) of individuals either do not respond or respond “adversely” to exercise. The current research study aims to answer two fundamental questions. Firstly, is non-response to one exercise modality universal across all modalities? Secondly, to what extent is non-response to exercise environmentally versus genetically determined?

Chronically transfused patients receive multiple units of blood products over the course of their treatment. Multiple red blood cell (RBC) unit transfusions may lead to adverse transfusion related outcomes including the production of antibodies directed against RBC surface markers (antigens), haemolytic diseases and potential long-term donor cell survival, which is termed ‘microchimerism’. Patients requiring transfusion are routinely typed for ABO and Rh (D) blood group antigens via serological methods since these antigens are immunogenic and its incompatibility with donor RBCs can lead to severe and fatal transfusion outcomes. Patients are also screened for the presence of clinically significant RBC antibodies that are either immunoglobulin (Ig) G or IgM isotypes. Antibodies against RBC antigens are either alloantibodies that are formed in response to foreign RBC antigens acquired during transfusion and pregnancy, or autoantibodies that are directed against an individual’s own RBC antigens observed in patients with haemolytic anaemias and autoimmune disorders. Haemolytic anaemia is a condition where circulating immunoglobulins and/or complement bind to the surface of RBCs leading to their destruction. Direct antiglobulin testing (DAT) is used in clinical investigations to confirm and diagnose the cause of haemolytic anaemia. It detects the presence of IgG or various activated complement components attached to RBC surface membrane when haemolysis or haemolytic anaemia is present. In patients diagnosed with haemolytic anaemia, a ‘pan-reactive’ autoantibody (antibodies indiscriminately reacting with all RBCs) coupled with a positive DAT result can cause difficulty in pre-transfusion testing, since the patient’s serum reacts to multiple donor RBC units. Furthermore, a strongly positive auto agglutinin may mask the presence of concurrent alloantibodies if present. The detection of patient alloantibodies via the auto- and allo- adsorption procedures are prolonged, labour intensive, complex and can often have no clear result. In these situations, a least incompatible but best matched donor RBC unit against the patient’s known phenotype becomes the only option available for transfusion. This project will determine whether the use of RBC genotyping can be a useful integration into routine laboratory transfusion practice in Australia. Information on the patient’s blood group genotype can be used to predict the patient’s blood group phenotype and allow clinical staff managing chronically transfused patients to provide more appropriately matched donor RBC units. The ability to closely match a donor RBC unit to the patient could also prevent several rounds of manual serological laboratory investigations and reduce the risk of alloimmunisation in patients requiring long-term chronic transfusion regimes.

We intend to test the hypothesis that consuming gelatin (a food derivative of collagen) and Vitamin C combined with exercise may increase collagen synthesis. To test this hypothesis, eight healthy males will complete a randomized cross-over design protocol where they will consume either a drink containing a isocaloric placebo, 5, or 15 grams of gelatin at a constant level of Vitamin C. Measurements of amino acid appearance in the blood over the first 3 hours will be measured in each condition and a larger blood draw will be taken at 1 hour to determine the effect of the nutritional supplement on engineered ligament collagen and mechanics. The subjects will perform six minutes of rope-skipping to stimulate collagen synthesis. This short bout of exercise will be repeated every six hours for the next three days and will be preceded by one hour with the appropriate drink containing placebo, 5, or 15 grams of gelatin. Over the 3-day training period, blood will be taken for the analysis of the amino-terminal propeptide of collagen 1 (PINP), a byproduct of collagen synthesis.

Obesity is one of the most prevalent and challenging diseases affecting our community. According to the latest census figures, 63.4% of Australians aged 18 years and over were overweight or obese, namely, 35.0% overweight and 28.3% obese. Along with the increase in our community BMI has been a burgeoning of obesity related diseases including type II diabetes, cardiovascular disease, osteoarthritis, hypertension, liver disease, depression and infertility. Weight loss leads to a significant improvement in these conditions. Currently the only durably effective treatment for the most severe grades of obesity is bariatric surgery. Conservative programs are effective in the short-term, however, only 3% of successful weight losers are able to maintain a meaningful weight loss beyond 2 years. Pre-operative weight loss with a short term very low calorie diet (VLCD) has been shown to improve surgical access by reducing liver volume as well as the metabolic status of the patient, reducing the number of postoperative complications. For this reason, most clinicians request their patients to undertake a preoperative weight loss programme for a minimum of two weeks. Whilst clinicians perceive a benefit for preoperative weight loss, patients often struggle to comply. One reason for this is the difficulty complying with the currently available VLCD. Most are based on liquid formulations and patients struggle with the taste and texture of the product. Patients regularly report bloating, abdominal discomfort and constipation. In addition, the nutritional construct is often based around a large amount of sugar, and lacks high quality protein and fibre. Formulite (Trademark) is a new VLCD that the manufacturers claim retains the benefit of traditional VLCD, inducing Ketosis thereby avoiding hunger, whist reducing the unwanted GI side effects by combining high quality proteins with soluble fibre, less sugar and probiotics. These changes are supposed to improve patient compliance. We wish to confirm potential benefits of Formulite in patients undergoing bariatric surgery. We hypothesised that patient satisfaction would be higher and therefore compliance with the preoperative weight loss programme would be improved when compared with traditional VLCD. HYPOTHESIS: Compliance with Formulite is better than traditional VLCD prior to bariatric surgery in obese adults. AIMS: - To measure patient compliance with Formulite compared to traditional VLCD - To determine if there are improved gastrointestinal symptoms with Formulite compared to traditional VLCD - To assess patient satisfaction with Formulite compared to traditional VLCD - TO measure peri-operative liver volume and weight loss following 2 weeks of Formulite when compared to traditional VLCD