ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31378 results sorted by trial registration date.
  • The use of biofeedback in the treatment of swallowing disorders following stroke: a randomised controlled trial.

    The aim of this project is to evaluate the use of biofeedback as an adjunct to traditional therapies in the treatment of swallowing disorders following stroke. (biofeedback is a technique using monitoring devices to provide feedback to the patient about the swallow). Participants in this proposed study will have swallowing difficulties persisting for more than 2 weeks as a result of stroke. Participants will undergo a Videofluoroscopic Swallowing Study prior to the commencement of therapy, to determine an appropriate rehabilitation plan. Participants will need to be able to follow at least 1 stage instructions to participate in a therapy program. For this project, two commonly used swallowing exercises will be used. This includes the effortful swallow, which, as the name suggests, encourages the patient to use increased effort to swallow. The second therapy is ‘mendelsohn manoeuvre’, which encourages the patient to have a longer swallow. Patients who are suitable for either of these therapies will then be randomly assigned into two groups. In one group, patients will receive one or both of these exercises, and in the other group, they will receive one or both of these exercises in addition to biofeedback. Patients will receive therapy twice a day for two working weeks (20 sessions total). After these two weeks, patients will complete another Videofluoroscopic swallowing study for comparison. Outcomes will be measured using the Videofluoroscopic swallowing study results and rating any changes in what the patient can eat and drink. Information collected will include demographic information and stroke pathology, food and fluid texture status, and swallowing severity. This information will be collected from the patients’ medical history and outcome measure tools. It is hypothesised that the use of surface electromyography biofeedback (sEMG) as an adjunct to traditional swallowing therapy will result in improved functional swallowing status. In particular: 1. Treatment with sEMG will decrease the time taken for patients to transition through food and/or fluid textures 2. Treatment with sEMG will result in reduced penetration and/or aspiration of food and/or fluid 3. Treatment with sEMG will result in an improvement in swallowing physiology

  • A Pilot Study of Community Jury for Prostate Cancer

    Healthy men who are tested for prostate cancer are usually not informed of the potential harms of the screening process, such as overdiagnosis and overtreatment. The balance of benefits and harms in screening depends on individual risks and values, and prior research suggested men currently appear inadequately informed. This pilot study will use a randomised controlled trial to investigate the use of Community Jury (a “jury” who undergo 2 days of expert information, discussion and reflection) compared with a standard information group to investigate men's knowledge and attitudes towards prostate cancer testing. In additiion the Community Jury will be asked to recommend hypothethical policy issues regarding testing for prostate cancer in healthy men.

  • The influence on blood clotting of the consumption of fish oils.

    There is strong evidence that the use of omega-3 fatty acids (O3FAs) reduces cardiovascular risk in certain populations. Major bodies such as the Australian National Heart Foundation (NHF), American Heart Association (AHA) and British Heart Foundation (BHF) have recommended their use which has lead to widespread uptake by the general population. As their use becomes more prevalent, increasing numbers of patients are presenting for surgery whilst taking O3FAs. Amongst the potential adverse effects of O3FAs, there is theoretical suspicion that these compounds may reduce blood coagulability. Both the AHA and BHF have issued cautionary statements regarding this. This is of clinical interest as it could increase both perioperative blood loss, and the risk of serious complications with certain anaesthetic techniques. Previous studies investigating this effect have used older laboratory measures of coagulation which show little correlation with clinical bleeding risk. In the absence of good evidence disproving their theoretical suspicions, many surgeons and anaesthetists may advise patients to discontinue fish oils for several days prior to surgery. Given that the perioperative period is a time of increased cardiovascular risk, this decision is not without risk to the patient. We plan to investigate the effects of two different doses of fish oils on blood coagulation as measured by several laboratory tests which have been shown to have a much stronger correlation with clinical bleeding risk than traditional tests used in earlier studies.

  • The effect of critical illness on fat absorption: comparative measurements in healthy volunteers

    The purpose of this study is to understand how healthy people absorb glucose (sugar) and lipids (fat) from their small intestine. This information can then be compared to information we are collecting about nutrient absorption in Intensive Care Unit patients. We hypothesize that absorption will be reduced in Intensive Care Unit patients compared to healthy volunteers.

  • The effect of clonidine on heart rate variability analysis in patients undergoing key-hole surgery to remove gallbladder

    Clonidine has been effectively used as a non-opioid (morphine-like) pain killer and sedative in a variety of clinical settings for many years. The Analgesia Nociceptive Index (ANI) monitor is a novel anaesthetic monitor that has been developed for use with opioid based pain killers. It works by assessing (primarily) heart rate variability to generate a score which gives an indication of nociceptive (painful) inputs. This study aims to examine the effects of clonidine on the ANI under general anaesthesia for laparoscopic cholecystectomy, as part of the pain relieving strategy

  • The Obsessive Compulsive Disorder (OCD) Program - A Randomised Controlled Trial comparing clinician-assisted Internet based treatment for OCD vs. a waitlist control condition on severity of symptoms of OCD.

    We have recently developed an online cognitive behavior therapy program involving exposure and response prevention for people with OCD. This study will examine the program’s effectiveness in reducing symptoms of OCD and related symptoms of anxiety, depression, distress, and disability. We will also assess how acceptable the program is to participants.

  • Pain processing in patients after severe burns versus a population of unaffected volunteers: a comparison

    Patients with previous burns injuries are subject to abnormal pain processing responses compared to people who have never been affected by severe burns. We propose to run a pilot study which will demonstrate whether patients have ongoing abnormal pain responses. This would be determined by using a form of quantitative sensory testing which evaluates the integrity of pain pathways.

  • A randomised study to compare the technical difficulty of retrieval between the Bard G2X and the Cook Celect Vena Cava Filter systems

    Patients with multiple fractures or whose blood has a tendency to clot easily have a risk of developing a pulmonary embolus. This occurs when a clot formed in the legs, called a deep vein thrombosis, is dislodged and travels in the blood circulation to the lungs, causing difficulty in breathing and potentially death. Patients who have a risk of developing a pulmonary embolus may have a filter called a vena cava filter placed in the large vein beneath the heart. The filter stops any clots from the legs reaching the lungs. The filters are designed to be removed once the risk period is over. In some cases the filters may be difficult to remove and in a few cases may not be able to be removed at all. The design of vena cava filters and the devices used to remove them are being continually improved. There are a number of good filters with good removal devices available. The purpose of the study is to help us determine which of two commercially available vena cava filters is best designed for ease of removal. Taking less time to place and remove the filters helps to reduce the procedure time and consequently the radiation dose, the volume of contrast dye and the discomfort to patients.

  • EMOTIV Trial - Enhancing Melanoma Outcomes using a Timed Immunotherapy Vaccine

    This study is evaluating the effect of timed vaccine and chemotherapy delivery in advanced melanoma patients. You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with advanced melanoma (Stage IV or IIIB/IIIC) that cannot be treated with surgery. Participants in this trial will be randomly allocated to one of two groups. Participants in groups one and two will both receive the VCML vaccine. Group one will receive regular, pre-determined vaccinations whereas Group two will have their vaccination times determined by blood test results. If disease progression occurs, then participants in group one will receive oral chemotherapy treatment on pre-determined dates, whereas participants in group 2 will receive oral chemotherapy at times determined by the results of blood tests. The treatment in group 1 will not be timed in this way. All participants will be assessed on a regular basis for a period of up to 5 years in order to determine whether treatment response and overall survival differ between groups. This will enable us to determine whether the timing of vaccine or chemotherapy administration can improve treatment response.

  • An evaluation of cognitive stimulation therapy for people with dementia in Australia

    Cognitive stimulation therapy (CST) is a structured group intervention for people with mild to moderate dementia aimed at improving cognition and social functioning. The initial course of CST involves 45-minute group sessions, held twice a week over seven weeks (or weekly with two 45 minute sessions and a 30 minute break). Maintenance CST (MCST) follows on from the initial course and is a weekly 45-minute 24-session group program. The content of the sessions is designed to stimulate mental function by focusing on the retained abilities of people with dementia and by doing so in a varied, interesting and fun way, through group interactions, games and puzzles, and by sights and sounds. This project aims to 1. To develop an Australian adaptation of the Cognitive Stimulation Therapy (CST) and the Maintenance Cognitive Stimulation Therapy (MCST) programs 2. To pilot and evaluate the adaptations in an Australian setting. The project will involve adapting the content to Australian conditions, piloting the CST and MCST programs and evaluation of both the CST and MCST programs. In addition family members and carers (support persons) will be ask for input and feedback regarding their perceptions of the program's efficacy as well as in the latter part of the maintenance program, being informed what was beneficial and/or enjoyed by their relative/friend.

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