ANZCTR search results

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

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32707 results sorted by trial registration date.
  • A phase III multi-centre randomised controlled trial to evaluate the ability of slightly higher than normal carbon dioxide levels, compared to normal carbon dioxide levels, to reduce brain damage in resuscitated cardiac arrest patients admitted to the intensive care unit.

    The TAME Cardiac Arrest trial will study the ability of higher carbon dioxide (CO2) levels to reduce brain damage, comparing giving patients ‘normal’ to ‘slightly higher than normal’ blood CO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the ICU. This therapy is cost free and, if shown to be effective, will improve thousands of Australian lives, transform clinical practice, and yield major savings.

  • focal radiotherapy for previously treated prostate cancer patients

    The aim of the study is to examine the feasibility, safety and toxicity of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer following definitive external beam radiotherapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with biopsy proven locally recurrent prostate cancer. Study details All participants in this study will first receive two different types of scans to locate the suspected regions of recurrence – these scans are called prostate-specific membrane antigen positron emission tomography (PSMA-PET) and magnetic resonance imaging (MRI). They will then proceed to receive six treatment sessions of Stereotactic Body Radiation Therapy (SBRT). The first 12 participants will receive a radiation dose of 36 grays (radiation dose unit). If this is tolerated, then the next 12 participants will receive a dose of 38 grays. Again if this is tolerated, then the final 12 participants will be treated at a dose of 40 grays. After treatment, all participants will have follow-up every 4 months for the first two years, After two years patients will have routine follow-up (6 monthly for one year, then yearly thereafter until 10 years). During the follow-up period, Patients will have PSA and toxicity assessments. PSMA-PET scans will be repeated at 12 and 24 months post treatment. Study related outcomes will be collected for 2 years. After 2 years outcomes will be collected as per departmental protocol. The study aims to combine the non-invasive advantages of SBRT re-irradiation using functional MRI plus PSMA-PET scans to define and treat the area of recurrence rather than the whole prostate gland.

  • Assessing the influence of chewing gum on the gastric volume in patients fasting for surgery

    The need for a period of fasting (not eating or drinking) before having a general anaesthetic is well known and accepted by the community. This measure is necessary to prevent patients from regurgitating and inhaling stomach contents, a phenomenon known as pulmonary aspiration. Many people find fasting an unpleasant experience with hunger, thirst and dry mouth common complaints. Some individuals find chewing gum while fasting helps with these symptoms, however, currently there is no significant medical evidence to either support or refute the safety of chewing gum in this period. Our group proposes to conduct a study in patients who are booked by their gastroenterologist for a gastroscopy (an inspection of the inside of their stomach with a telescope). We intend to randomly divide people into two groups, the first group will fast before their procedure as per the current normal instructions. The second group will also fast, but will be asked to chew gum during their period of fasting before the endoscopy. Both groups of patients will undergo their gastroscopy under a general anaesthetic. After insertion of the telescope the stomach will be inspected and then drained of any fluid by sucking it out through the suction channel of the telescope under direct vision by the gastroenterologist. It is normal for all people to a have a small volume (usually 20-30ml) of fluid in their stomach despite not eating or drinking due to swallowing saliva and the stomach producing its own secretions. The volume of the fluid sucked is then measured and recorded for each patient. The data collected during the course of the study will be collated and analysed statistically looking for any differences between the two study groups. Once completed, the results of the study will be published in the medical literature. The investigators postulate that chewing gum will make no significant difference in the amount of fluid in the stomach of a patient fasting before an operation. In fact, the action of chewing gum may actually be beneficial in stimulating the stomach to empty its normal residual volume of fluid. The information gained from this study will be valuable to all anaesthetists in streamlining pre-operative fasting guidelines for their patients to ensure safety as well as potentially improving comfort while they are fasting.

  • Pharmacokinetic and safety study of HTD1801 and its components

    This will be a single-blind, randomized, single-dose, triple-cross over (a Latin square design), single-centre study. 24 Subjects will be enrolled. Each subject will receive all three treatments in random order. At each administration day approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C and this will switch around on the second administration day and then again on third administration day until all participants have been administered all three treatments. Screening: Subjects will be screened for the study. Eligible subjects will return for the admission to the Unit within four (4) weeks following screening. All subjects will be instructed to maintain their lifestyle and background medications, if any. Baseline: Subjects will be admitted to the Unit in the evening of Day -1. Blood draw to establish the baseline for all measured endpoints will be drawn in the morning of Day 0. Randomisation: Following the completion of all baseline assessments and draws on Day 0, eligible subjects will be randomized so that approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C. The first dose of study medication will be then promptly administered. Drug administration and assessment periods: Each subject will receive a drug three times in random pre-determined order, single dose, separated by at least 14 days of washout. Following each administration, blood for PK and safety will be drawn and safety and tolerability assessments will be conducted over the ensuing 36 hours. Final tolerability/safety assessment: Approximately seven (7) days following the administration of the last medication, the site will follow up over the phone with the subjects regarding any tolerability or safety issue; if clinically necessary, they could be invited back to the Unit for follow up tests or evaluation.

  • Effects of a brief meta-cognitive intervention on pre-event rumination in social anxiety

    Negative rumination is a key maintaining factor in social anxiety disorder and the current study seeks to advance the limited literature on pre-event rumination in social anxiety. Given the lack of research investigating the effects of specific interventions on pre-event rumination, it is imperative to trial strategies that may reduce the frequency of pre-event rumination in individuals with social anxiety. This will have the positive benefit of assisting an individual with social anxiety to not enter a social situation in a negative self-focused processing mode and anticipating failure. One such strategy that has previously been suggested, but yet to be determined as efficacious, is instructing individuals with social anxiety to ban rumination as it serves no adaptive purpose for them. Additionally, the temporal pattern of pre-event rumination is unclear and determining this will assist in understanding this process for individuals with social anxiety and also make clearer when future interventions should be trialled. Specially this study aims are to investigate: 1. The effects of a brief intervention that instructs individuals to not engage in negative pre-event rumination. 2. The temporal pattern of pre-event rumination and determine optimal time points for future interventions to be delivered. The present study hypothesises that: 1. Individuals with social anxiety disorder whom receive the brief intervention will report reduced negative pre-event rumination before a planned speech task, compared to a control group, and thus will report reduce state anxiety in relation to a speech task. 2. While it is suggested that frequency, uncontrollability, severity, and distress of pre-event rumination will increase in linear fashion in the days before the planned speech task, the lack of research regarding the experience of pre-event rumination for individuals with social anxiety precludes a firm hypothesis.

  • 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.

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