ANZCTR search results

The proposed project involves conduction of a randomised double-blind placebo-controlled clinical trial to test the efficacy and safety of oral ingestion of Chinese herbal medicine granules, PTQX for children with moderate to severe atopic eczema. The primary objective of this trial is to evaluate whether the oral ingestion of PTQX can reduce severity of the condition and improve the quality of life in children with moderate to severe AE. It will also assess the safety of PTQX for AE. The 16-week trial includes 12 weeks of treatment and a 4-week follow-up period.

The study is comparing two different techniques to diagnose acute pulmonary embolism in patients referred to the Peter MacCallum Cancer Institute. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for suspicion of acute pulmonary embolism. What is the purpose of this research? Lung scan (also known as lung scintigraphy, ventilation/perfusion scan or V/Q scan) and CT pulmonary angiogram (called CTPA) are imaging tests that are used to diagnose pulmonary embolism (clots in the blood vessels supplying the lungs). This research project is assessing the diagnostic value of a new imaging test called lung PET/CT. PET/CT stands for Positron Emission Tomography/Computed Tomography. The conventional lung scan uses a different technology called SPECT/CT (Single Photon Emission Tomography/Computed Tomography). PET/CT produces images of better quality than the conventional SPECT/CT scan, which may improve diagnosis of pulmonary embolism. The research project is designed to compare the diagnostic value of lung PET/CT and CTPA for the diagnosis of pulmonary embolism. Our hypotheses are that V/Q PET/CT is an alternative modality to CTPA for diagnosis of PE and that the combination of both imaging may improve PE diagnosis. What does participation in this research involve? You will undergo both CTPA and lung PET/CT scans. For the lung PET/CT scan, a small quantity of a substance called Galligas, which are particles labelled with a radioactive substance called Ga-68, is breathed in and thereby deposited into your lungs. After this, you will be required to lay still on the PET/CT camera bed for about 10 minutes whilst images are obtained. Whilst you are in the PET/CT scanner, you are then injected with a substance called Ga-MAA via the intravenous catheter. Ga-MAA stands for Ga-68 macroaggregated albumin (MAA) and is radioactive substance that localises in your lungs’ blood vessels. You will then be imaged again for a further 10 minutes. Lung PET/CT is a diagnostic procedure only, not a treatment. Lung PET/CT and CTPA will be initially interpreted separately. CTPA and V/Q PET/CT images will then be interpreted together by a consensus reading. It is anticipated that 50 patients will participate in this project.

The Victorian WorkCover Authority (VWA) is an injury compensation system in the state of Victoria, Australia which provides financial, as well as health and related support, to Victorian workers who have sustained an occupational injury. In 2014, VWA introduced a compensation claims process change for key elective surgical procedures. The aim of the proposed research is to determine whether the compensation claims process change improved injured workers' perception of the service quality of the compensation claims process, as well as whether the compensation claims process change reduced injured workers' time away from work and compensation claims costs, and improved injured workers' ratings of health-related quality of life.

When patients suffer infections or have damaged organs they may develop an excessive inflammatory response called the systemic inflammatory syndrome (SIRS). This SIRS manifests as changes in heart rate, breathing, white cells release into blood, fever and carbon dioxide production. While a small amount of SIRS may be helpful for the healing process, uncontrolled SIRS may contribute to making intensive care unit (ICU) patients unwell, leading to a low blood pressure, organ failure, need for artificial life support and, in some cases prolonged time in ICU and hospital and even death. Finding safe, effective and inexpensive ways to decrease the severity of SIRS is an important goal of modern ICU medicine. Unfortunately, no medications have been shown to do this. Recently, however, a safe drug used by millions of people every day has been shown to have unexpected properties that might reduce the severity of SIRS. This drug is Aspirin. Every day, Aspirin is given to millions of patients at low dose because it protects from heart attacks and strokes through its ability to block clotting. Over the last three to four years, however, multiple studies in animals and observational studies in man have shown that low-dose Aspirin (as given to patients with heart attacks and strokes) also inhibits excessive inflammation. Aspirin does this by stimulating the production of newly discovered helpful molecules called resolvins, protectins and maresins. These molecules combat inflammation and help the body to recover. Observational studies have reported that SIRS patients treated with Aspirin were more likely to live than similar untreated patients. In addition, patients who were on Aspirin before admission to ICU were similarly more likely to survive. On the other hand, it is also known that Aspirin therapy may increase the risk of bleeding, stomach inflammation and maybe even kidney impairment. How the risks and benefits of aspirin therapy balance each other in patients with SIRS is unknown because no controlled studies have been done so far. Because of this, we plan to conduct a pilot randomized controlled trial to study whether Aspirin treatment in patients with SIRS is safe, feasible, and shows preliminary evidence of beneficial effects. The primary outcome is the concentration of a substance which indicates severe inflammation, called interleukin 6 (IL-6) in the blood 48 hours after randomisation. We wish to test the hypothesis that Aspirin improves the resolution of high levels of IL-6. If our findings support the feasibility, safety and possible benficial effect of aspirin when used in this way, we will be able to conduct larger studies to asses its benefits in terms of patient-centred outcomes.

Patellofemoral pain is common in people who participate in activities and sports that involve running. Improved treatment outcomes in patellofemoral pain are required as recent research has established a link between patellofemoral pain and future osteoarthritis of the knee. Common interventions such as quadriceps strengthening exercises are effective at reducing pain for many people with patellofemoral pain. Quadriceps strengthening is likely to have an effect in improving patellofemoral pain because of resultant increases in quadriceps size and strength. However some people with patellofemoral pain are unable to perform exercises with a resistance that significantly strengthens the quadriceps because pain limits their ability to perform the exercises. Blood flow restricted training can increase muscle size and strength at lower resistance than typical strengthening programs, and may therefore be a suitable method of improving quadriceps size and strength in those unable to perform traditional quadriceps strengthening exercises effectively. Blood flow restricted training involves placing an inflatable cuff around a limb before performing strengthening exercises. The placement of the cuff reduces blood flow within the limb during the exercise. It is hypothesised that limited blood flow causes the muscle to work harder than in normal blood flow conditions, and therefore improvements in muscle size and strength can be obtained at lower resistance than conventional exercises. This study will compare 8 weeks of low resistance quadriceps strengthening with blood flow restriction to the current gold standard treatment of 8 weeks of quadriceps strengthening. Participants will be assessed at 0, 4, 8, 24 and 52 weeks.

Glucose sensor technology has been evolving with an ultimate goal of achieving a level of accuracy required to replace finger prick glucose testing, together with a level of reliability for use in an artificial pancreas. While there have been recent advances in glucose sensing technology, further improvements relating to sensor accuracy and reliability are required. A glucose sensor based on a novel technology platform has been developed. Studies in animals and humans during development of this sensor have shown positive results, and this will be the first study in humans to formally compare the novel glucose sensor to a glucose sensor based on the traditional sensing platform.

The primary aim of this study is to investigate whether five weeks of up to one hour daily of early, active, repetitive motor training in addition to usual upper limb therapy can prevent upper limb contractures after stroke or other types of ABI. Secondary aims are to determine the effect of this intervention on upper limb function and upper limb pain, and to investigate patients’ perspectives of the intervention. The study will be a parallel group, randomized controlled trial, with blinding of assessors and concealed randomization. Pre-intervention outcome measures will be taken prior to participants being randomized into either the experimental or the control group. Participants in the experimental group will receive a maximum of 1 hour a day of early active repetitive motor training using the SMART Arm device plus usual upper limb therapy, five days a week, for five weeks, in addition to the usual upper limb therapy. Participants in the control group will receive usual upper limb therapy only. The intervention will cease at the end of 5 weeks and outcome measures for both groups will be collected at that time. Follow-up outcome measures will be collected at 7 weeks. Qualitative interviews with ten participants from the experimental group will be undertaken at the end of the intervention period.

This study investigates the analgesic effect of intraperitoneal injection of a long acting local anaesthetic agent (Ropivacaine) during laparoscopic (keyhole) appendicectomy. Trial participants will be randomly divided into two groups. One group will receive intraperitoneal Ropivacaine during laparoscopic appendicectomy while the other will receive normal saline. The consumption quantity of total Fentanyl analgesia, the presence of shoulder tip pain and post surgery nausea or vomiting will be recorded up to 16 hours post surgery. The study aims to determine whether the use of Ropivacaine during laparoscopic appendectomy is an useful analgesic adjunct. The primary aim of this study will be to determine whether using Ropivacaine will reduce total amount of analgesia used, hence reducing post-operative pain, and its effect on the incidence of post laparoscopic appendicectomy shoulder tip pain and nausea or vomiting.

This is a two arm parallel group randomised controlled trial to determine if substantial weight loss is superior to modest weight loss in reducing maternal glucose at 26-28 weeks gestation and therefore preventing adverse maternal and neonatal pregnancy outcomes.

Greater trochanteric pain syndrome (GTPS) causes severely debilitating pain on the outside of the hip, resulting in limited activity, employment and decreased capacity to exercise. The pain of GTPS has been shown to be as severe and debilitating as osteoarthritis of the hip in those waiting for hip replacement. It most commonly affects post-menopausal women and limits capacity for physical activity that is critical for older women to achieve healthy ageing. In addition to tendon injury, ageing women suffer a myriad of conditions and diseases that burden both the individual and society, all of which can be ameliorated by physical activity (cardiovascular disease, obesity and osteoporosis). Conservative management is the first line treatment, although evidence is limited and the condition can be resistant to treatment. Thus, the aim of this study is to investigate the effect of menopausal hormone therapy and exercise on pain and function in post-menopausal women with GTPS. Eighty women will be recruited and randomised to one of four groups: (i) Exercise therapy, placebo MHT cream; (ii) Sham exercise, MHT cream; (iii) Sham exercise, placebo MHT cream or (iv) Exercise therapy, MHT cream. Interventions will be 12 weeks in duration and outcomes (6 questionnaires) will be examined at baseline, 3 months, and 12 months. We hypothesise that as tendon cells contain hormone-specific receptors, supplemental hormones may be beneficial for reducing pain and dysfunction measured by a clinical significant change in VISA-G scores (using responder analysis).