ANZCTR search results

There is emerging that the medication, Quetiapine (trade name: Seroquel) is clinically useful in treating clinically significant depression (major depressive disorder) and in the augmentation of antidepressant medication in this condition and depression that occurs in bipolar disorder (manic-depression). Quetiapine is currently approved for the treatment of schizophrenia and bipolar disorder. This study will look at whether the addition of the medication Quetiapine XR (trade name: Seroquel XR) to standard antidepressant medication is better than antidepressant medication alone in keeping symptoms of depression to a minimum after a clinically beneficial course of electroconvulsive therapy (ECT) within the previous 3 weeks for clinical depression (major depressive disorder). Participation in the study will occur after remission (disappearance) of clinically significant depression has occurred after treatment with ECT, when there has been failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will be invited to participate in the study if they: are aged 18-65 years ;have been diagnosed as experiencing major depressive disorder; have had a course of ECT completed within the previous 3 weeks, which has led to remission of depression sustained over the last 2 ECT treatments of the ECT course, after failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will not be able to participate in the study if they are: at immediate risk to themselves or others; dependent on alcohol or other substances, apart from caffeine or nicotine; or have diabetes mellitus that is not stable or well controlled. Women who are pregnant, or may become pregnant, or are lactating during the course of the study, will also not be able to participate in the study. There will be 2 groups of 20 participants, each, in the study. One group will be treated with the medication Quetiapine XR in combination with an antidepressant medication. Another group will be treated with an antidepressant medication alone. The antidepressant medications, either a selective serotonin reuptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) that has not been previously prescribed, or previously not helpful in preventing relapse of clinically significant depression, will be prescribed by treating doctors. The addition of Quetiapine XR to the antidepressant medication will be randomly determined, so that the study doctors or treating doctors will have no prior knowledge nor influence on whether this medication is added to prescribed antidepressant medication. The dose of Quetiapine XR will range from 50 milligrams to a maximum of 300 milligrams per day, with doses adjusted according to clinical response to, and tolerability of this medication. Psychiatric medications other than the prescribed antidepressant medication or Quetiapine XR, will not be prescribed or permitted during the course of the study. The duration of the study is 6 months, with weekly study visits for the first month and monthly, thereafter for the remaining 5 months. Participants will be asked questions about the presence of depressive symptoms and how they are tolerating their medication, as well as a physical examination as part of each study visit. Participants will have blood tests (clinical chemistry, haematology) prior to commencing the study, and at 1,2,3 and 6 months. Participants will also have a fasting (not having eaten, or drunk anything other than water since midnight) prior to commencing the study, and at 3 and 6 months. Participants will also have a urine drug test and electrocardiogram (ECG) prior to commencement. Participants will be free to withdraw their consent at any stage without affecting or prejudicing their clinical care in any way. In the event of depressive relapse (recurrence of clinically significant depression), participants will be discontinued from study, with alternative treatment arrangements made in consultation with their primary treating medical practitioner.

This study looks at whether a new imaging technique, referred to as optical coherence tomography (OCT), is as accurate as histology (examining cells under a microscope) in identifying cancerous tissue in people with breast cancer. Who is it for? You can join this study if you are a woman or man with breast cancer and are about to undergo surgery. Trial details In this preliminary study, OCT images of tissue samples removed during surgery will be compared to standard histology, to see whether OCT can reliably distinguish cancerous and healthy tissue. OCT is an imaging technique which acquires high resolution images of tissue. It is similar to ultrasound, but uses reflections of near infrared light waves instead of sound waves. OCT could potentially be used on tissue before it is cut out of the patient, which would avoid the unnecessary removal of healthy tissue during breast cancer surgery. Results from this trial will form the basis for future trials which will be performed on human tissue prior to removal of the tissue from the patient.

Patients experience a period of altered bowel function after the reversal of a temporary loop ileostomy. This study aimed to assess whether a probiotic preparation, VSL#3, improved bowel function during the first month after loop ileostomy reversal.

The longitudinal birth cohort study Environments for Healthy Living (EFHL) is designed to collect information from before birth through to 25 years of age across a spectrum of eco-epidemiological factors, including but not limited to, genetic material from cord-blood samples at birth, individual and familial factors to spatial data on the living environment. The EFHL study has had an annual four month recruitment of mothers since 2006. Detailed information on each participant is obtained at birth, 12-months, 3 years, five years and at subsequent three to five yearly intervals. Data collected is centred on both mother and child and includes questions about nutrition, parenting style, psychological factors, child behaviour, physical activity, attachment behaviours, quality of life, illnesses and injuries, health outcomes, utilisation of health care services, and socioeconomic factors (e.g. income, education, family structure and cultural identity). Findings will be used to identify where improvements can be made within the community to make health and lifestyle choices easier for families. The study will assist in discovering the best ways to reduce the major health problems facing Australians today, such as obesity, asthma, cardiovascular disease, cancer, diabetes, injury, mental health and musculoskeletal disorders.

This study looks at the effectiveness of using fluoro-deoxy-glucose positron emission tomography (FDG-PET) imaging to guide therapy in people with newly diagnosed, advanced Hodgkin lymphoma. Who is it for? You may be able to join this study if you have previously untreated advanced Hodgkin lymphoma and are over 18 years of age. Trial details Participants receive 2 cycles of the standard chemotherapy regimen (ABVD) and then have a FDG-PET scan, which provides a 3 dimensional image of the lymphoma. Depending on the results of this and future scans, participants are assigned different courses of chemotherapy at various stages during the trial. The trial aims to see how the different treatments, which are guided by the results of FDG-PET imaging, affect survival rates, and also monitors any toxic effects of treatment.

This project has been designed to investigate whether one particular method of administering local anaesthetic around the knee in order to provide pain relief for patients undergoing foot surgery is better than the other. A routine part of anaesthesia for foot surgery performed in our unit is to perform a popliteal block. This involves injecting local anaesthetic around the nerves behind the knee to numb the foot and provide pain relief both during and after the operation. This block is performed either using an ultrasound machine to visualise the nerves or a nerve stimulator which stimulates the nerve. Both allow the anaesthetist to know the correct position to inject the local anaesthetic. We are planning to randomly allocate patients undergoing foot surgery to receive the block either with the ultrasound machine or with the nerve stimulator. We will then use a form to collect information about pain and pain relief requirements whilst the patient is in hospital to assess the efficacy of the block. We will also collect information about the length time to perform each block and patient satisfaction. Patients will be seen at routine follow up at 8 weeks and assessed to see if there are any ongoing problems related to the nerve block. We will analyse the data to see if one technique is superior to the other and modify our practise as appropriate.

This study looks at the effectiveness of the drug panobinostat in combination with 5-azacytidine in treating people who have recently been diagnosed with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Who is it for? You can join this study if you are aged 55 or greater and have recently been diagnosed with high risk myelodysplastic syndrome or acute myeloid leukaemia, and you are unsuitable for or unwilling to undergo standard therapy. Trial details Participants will receive treatment with the anti-cancer drugs panobinostat (taken orally) and 5-azazytidine (administered via injection) over six 28 day cycles, On completion of this initial treatment, all patients not experiencing disease progression will receive further combination therapy with panobinostat and 5-azazytidine based on their degree of disease response. This will be followed by maintenance therapy with panobinostat alone. The study aims to determine the safety, tolerability and efficacy of treatment.

Currently knee replacement surgery is performed using alignment rods that correctly position the cutting blocks which guide bone cuts necessary to implant the metal and plastic total knee joint. Using a computer navigation system during surgery is considered the "gold standard" for guiding the cuts. Many surgeons however find this extends the time of the surgery for what is considered only a marginally better aligned knee and for much of the time the alignment is the same. These surgeons feel that the accuracy of the alignment of the total knee replacement without computer navigation is very good anyway and it is quicker to do. There is however new technology that has been developed that allows patient-specific cutting blocks, which are said to guide the cuts more accurately, to be manufactured based on a an MRI scan and x-ray of the affected knee taken before surgery. In this way it may be possible to have the accuracy of computer navigation in addtion to decreasing surgical time. This would be potentially good for the patients for a number of reasons including shorter operation time resulting in less chance of complications. In addition to this, less instuments will need to be used during surgery because the surgeon will already know the size of the knee replacement needed. This will reduce the cost of surgery while potentially increasing the accuracy. The current study will include 50 patients that have met the criteria for total knee replacement on the waiting list. The patients will require a pre-operative MRI and full-leg x-rays. Their surgery will be performed with the custom instrumentation. All bone cuts will be measured during surgery and compared to the bone cuts the MRI scan predicted. The surgeon can override the custom made blocks at any time and continue surgery in the conventional way if they feel the blocks are in any way inaccurate. The surgery time will vary but on average it should require approximately 80 minutes. The patients will require a post-operative computer tomography [CT] scan to evaluate the limb and implant alignment and information will be collected including pain levels, how far a person can walk and the affected knee's range of motion. This scan will be performed at least 6 weeks after surgery and the other information will be gathered before surgery and also at 3,6 and 12 months after surgery. Otherwise, the recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery. Our hypothesis is that the patient-matched instrumentation will align the bone cuts, implants, and the mechanical axis of the limb at least as well as would be expected using the conventional alignment rods, will cost less and on average speed up the surgery.

The primary study objective is to verify that under normal conditions of use the Coherex Left Atrial Appendage Occlusion System is a safe and effective LAA occlusion device. This investigation will be accomplished by: 1) implanting the device in patients with non-valvular paroxysmal, persistent, or permanent atrial fibrillation when anticoagulation is indicated for potential thrombus formation in the left atrium; 2) assessing LAA occlusion; and 3) monitoring adverse events at 45 days and/or up to one year post procedure. The study will also be designed to demonstrate the safety of the Coherex Left Atrial Appendage Occlusion System by assessing: 1) ease of successful device insertion; 2) positioning accuracy; 3) placement stability; and 4) post-procedure adverse events. To achieve this objective, data will be collected before, during, and after the procedure.

The primary objective of this study is to evaluate migration of the Hyperion uncemented femoral stem in primary total hip replacement using Radiostereometric Analysis (RSA). RSA will be performed at discharge, 6 months, 1 year, 2 years and 5 years following surgery