ANZCTR search results

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

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31252 results sorted by trial registration date.
  • The Sinus microbiome: a comparison between the healthy sinus and Chronic Rhinosinusitis

    The study aims to determine which bacteria, fungi, and viruses normally exist in the health sinus and chronic rhinosinusitis. Persons with healthy sinuses will be invited to participate in the study (Group 1) as well as individuals with chronic rhinosinusitis (group 2). A number of swabs will be taken from the sinuses of participants as well as a biopsy of the anterior aspect of the middle turbinate for sinus patients and analysed by laboratory techniques (microbiology and immunology).

  • Association between Physical Activity levels and Acute hospital Discharge destination in patients referred to physiotherapy and admitted under General Medical units at the Royal Melbourne Hospital (The PAAD Study)

    Medical patients often present to hospital with both medical and functional problems, including social dependency, reduced mobility and cognitive impairment. As such, discharge planning forms an important part of a patient's hospital stay. At present, an allied health team - consisting mainly of physiotherapist, occupational therapists, social workers, dieticians and speech pathologists - make recommendations for discharge destination based on clinical experience. If the patient is not for discharge home, the treating medical team makes a referral to the Consultant Liaison Rehabilitation and Aged Care team for a Geriatrician opinion. This process is potentially problematic when clinicians disagree on discharge destination. This can delay discharge and increase the patient's length of hospital stay. It can also detrimentally impact on the patient and family experience. We hypothesise that one factor effecting discharge destination may be physical activity levels, that is, patients who are less physically active prior to their admission and patients who are less physically active on the ward during an admission are more likely to need further subacute intervention on discharge from the acute setting. Thus, this study aims to investigate if pre-admission physical activity levels and / or in hospital physical activity levels are associated with discharge destination.

  • Vitamin C levels in hospitalised patients

    It is well known that severe Vitamin C deficiency can lead to gum disease, bleeding and poor wound healing but the effect of mild to moderately low levels in hospitalised patients is less known. This research endeavours to review the effect of Vitamin C deficiency in the unwell person and how it affects recovery. The aims of the present study is to examine Vitamin C levels in hospitalised patients and determine possible correlation with cognition, severity of illness and clinical course in hospital. This study will involve addition of Vitamin C levels in blood samples after informed consent from the patients, admitted in General Medicine Department of Flinders Medical Centre. The nutrition status of the participants will be determined using Malnutirition Universal Screening Tool (MUST) and quality of life will be assessed using European Quality of life Questionnaire (EQ5D). The patients will be followed onto the discharge for development of complications during hospital stay and hospital lenght of stay will be recorded.

  • The ADP-TRAUMA Trial A randomised controlled clinical trial of Augmented Dosing of Piperacillin-tazobactam in TRAUMA patients with suspected or confirmed infection

    This research is testing different methods for how an antibiotic can be delivered intravenously (into a vein). In this case, intermittent administration of the antibiotic (20-30 minute infusion every 6-8 hours), is being compared with continuous delivery (over 24-hours). Treatment of infection in the intensive care unit (ICU) represents an ongoing challenge for doctors. Successful therapy relies on early recognition of infection, and the timely application of antibiotics. Antibiotic dosing (how much and how often we give the drug) should aim to rapidly achieve adequate antibiotic levels through out the body. This is in order to ensure the causative pathogen (the ‘bug’ causing the infection), is eradicated quickly. This tends to be more difficult in ICU patients due to their underlying illness, and the requirement for other therapies (such as breathing support machines, ‘fluid drips’, and surgical procedures). The optimum method of delivering antibiotics is unknown, and current dosing strategies are generally based on those used outside the ICU, where patients are not as sick. Previous research has shown that trauma patients admitted to the ICU are at high risk of developing hospital-acquired infections. Unfortunately, these can often negatively impact patient outcomes (such as length of stay in hospital). Achieving better antibiotic levels in the body, by using alternative dosing strategies, may be one way to improve these outcomes. This is particularly the case for trauma patients being cared for in the ICU, where we know that antibiotic prescription is more difficult. However, before simply changing prescribing habits, we need to measure how effective these new dosing methods are, in comparison to what is done routinely. The purpose of this research is therefore to test a new method of administering the antibiotic piperacillin-tazobactam, which will hopefully result in better levels of the drug in the bloodstream. An ICU patient is eligible to be involved in this project, because they have suffered trauma, and their doctor has prescribed this drug, as they believe your the patient has an infection.

  • Basic life support training for patients and their family members at cardiac rehabilitation: a feasibility study.

    A cardiac arrest is a life threatening condition that occurs when a victims’ heart stops suddenly and breathing becomes abnormal. To prevent death, someone nearby must start basic life support (BLS) measures. This includes; 1) recognising the person is in cardiac arrest, 2) calling for help and 3) commencing cardiopulmonary resuscitation (CPR). CPR involves compressing the chest, and if able and willing, providing mouth to mouth breaths. Up to 75% of cardiac arrests will happen in the home environment and nearly half of these will be witnessed by someone at home. This person is usually the spouse or a family member of the victim. Therefore it is important that family members of people who are more at risk of having a cardiac arrest are trained in BLS skills. People who have had a prior heart attack, or other heart conditions are at higher risk of repeat events, including the risk of having a cardiac arrest. Therefore the relatives of these people should be targeted for BLS training. Approximately four to six weeks after hospitalisation for a heart attack or cardiac event, most patients attend cardiac rehabilitation. Cardiac rehabilitation is a six to eight week outpatient program, usually run at a hospital by trained cardiac rehabilitation nurses and other health staff. These programs include both exercise and education sessions. Family members are encouraged to attend the education sessions along with the patients. Cardiac rehabilitation programs may provide the ideal catchment and environment to provide BLS training to both cardiac patients and their family members. In recent years, the way we teach and perform BLS has changed significantly. BLS training can now be undertaken in 30 minutes and without a formal instructor. This training can be done via a self-training kit that includes a training video and a reusable, inflatable manikin to practice CPR skills. The most important part of CPR is the chest compressions, with the mouth to mouth being optional. Therefore learning and performing BLS is much easier than it used to be. In this study we will train patients and family members attending the Cabrini cardiac rehabilitation program using self-instructional BLS video training kits. The primary aim of this research is to assess whether it is feasible to conduct BLS training to patients and their family members at a cardiac rehabilitation program. Our secondary objectives are: 1) to assess whether this group can perform BLS adequately; 2) to assess willingness to utilise and maintain BLS skills; 3) to determine the level of secondary training (sharing of training kit) that is undertaken by participants; 4) to assess levels of anxiety and confidence pre and post training. In order to assess the feasibility of running the program at cardic rehabilitation, cardiac rehabilitation staff will complete a brief survey at the completion of the study.

  • Evaluation of the usefulness of a new method for predicting the outcome of critical illness in patients admitted to intensive care.

    It has been postulated that as a result of critical illness, patients leak particular chemicals from their cells with subsequent movement of these chemicals into the blood stream where they may be detected. Disappearance of these chemicals from the blood has been linked to resolution of the process that triggered the episode of critical illness and ultimately, to recovery of the patient. Currently and with few exceptions, direct measurement of these chemicals is not possible and their effect has to be inferred indirectly as part of another commonly performed measurement - the standard base excess (SBE). The SBE also responds to alterations in the concentrations of the major blood chemicals which are normally present in health. The changes in the normal chemistry of the blood occurs as a result of either the underlying critical illness or the fluids used during resuscitation and unfortunately, they also have a major effect on the SBE, The result is that the SBE becomes more of a general indicator of the presence of critical illness rather than a specific and sensitive predictor. It also can remain abnormal even when the patient has returned to health. A recent method for splitting the SBE into its components that permits the estimation of the specific effect of the unmeasured chemicals has been developed, published and experimentally validated - the Unmeasured Ion eXcess (UIX) algorithm. The utility of this algorithm needs to be formally tested in the clinical environment and it is this requirement that drives the need to conduct an audit that involves mapping the results of the routinely collected daily bloods in a population of critically ill patients to their eventual outcome and length of ICU and hospital stay.

  • Does empagliflozin preserve pancreas function in recently-diagnosed type 1 diabetes?

    Empagliflozin is used to treat type 2 diabetes. It works by promoting loss of glucose in the urine. Recent evidence suggests this drug might help preserve pancreas function in people with diabetes. This study will assess the feasibility and safety of this approach in people who are within 100 days of being diagnosed with type 1 diabetes.

  • Consumer Choice of Pre-Packaged Foods that Vary by Nutrition Information and Price

    The non communicable diseases associated with poor diet (e.g., high blood pressure, high blood cholesterol, obesity and poor metabolic outcomes) are increasing in prevalence but are also preventable. Nutrition labels on the front of food packs is one public health intervention designed to assist people to consume a healthy diet. A variety of other information (health related and otherwise) is available on food packs for consumers to incorporate into their purchase decisions. (such as the Nutrition Information Panel, health claims, price, etc). These sources of information often occur together on food packs, yet past research has generally look at the isolated effects of individual forms of nutrition information without consideration of how these pieces of information interact. The primary aim of this study is to investigate how nutrition information format, healthiness and price interact to affect consumer product choice.

  • A pilot study of tongue stimulation to improve balance and gait in stroke survivors

    Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.

  • Western Australian Illicit Substance Evaluation

    Recreational drug use is becoming an increasing public health issue in our society. Methamphetamine usage in Australia has been described as an ‘epidemic’ that is ‘tearing our country apart’, and has recently been the subject of a Prime Ministerial National Ice Task Force. The average purity of methamphetamine seized by police in Western Australia has increased from 10% to 75% in just six years. In addition to this, there are a huge new range of synthetic drugs entering circulation, which are collectively termed novel psychoactive substances. These include many novel stimulants and hallucinogens, such as cathinones, NBOMe type drugs, and synthetic cannabinoid receptor antagonists. There were seven unrelated deaths in Australia over the 2015-2016 summer festival season related to synthetic drug use, as publicised in the ABC Four Corners investigation “Dying to Dance” (February 2016). This project is a novel study, based in the emergency department (ED), where patients suspected of being under the influence of recreational drugs have a single blood sample taken to identify the causative agent. The analysis will be undertaken by ChemCentre WA, with whom we have an established collaboration, using liquid chromatography-mass spectrometry analytical techniques. Prior to analysis, the sample is permanently de-identified. We aim to identify the agent (or agents), determine its concentration, and relate it to the clinical picture and complications. We will also compare the analytic result with what the patient believed they had taken. Where novel drugs are identified, repeat analytical work can be undertaken to aim to develop new assays and reference standards for future analysis. Samples will be stored frozen for five years to enable this work. We will be able to identify trends in recreational drug use in patients presenting to the ED, which is vitally important from a public health perspective. Should information of early interest to clinicians or the general public be identified, this would be released in the interest of public safety.

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