ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Feasibility of Opioid Injectable Treatment

    Supervised Injectable Opioid Treatment (SIOT) is an evidence-based treatment for dependent opioid injectors who have not responded to conventional, oral treatment. This project will implement SIOT as an adjunct to oral methadone and explore whether benefits observed during injectable treatment are sustained after transfer to standard methadone treatment. The 2-year, open-label non-controlled study will be located in a methadone clinic. We will recruit 20-30 long-term injectors of street opioids, prescribe a combination of parenteral hydromorphone and oral methadone, then around 18 months gradually transfer to oral methadone only. The project will provide data to assess the acceptability (to staff and participants), safety, outcomes, and direct costs of SIOT. We will monitor non-prescribed drug use, health, psychological state and quality of life before, during, and after ceasing injectable treatment by performing qualitative interviews with participants, staff and policy makers.

  • To determine whether use of Technetium99m-labelled PSMA improves the sensitivity for detection and aids intra-operative localisation of lymph node metastases in men with intermediate or high-risk localised prostate cancer undergoing robotic-assisted radical prostatectomy.

    The purpose of this study is to determine whether it is feasible and safe to use Technetium99m-labelled PSMA as a tracer during prostate removal surgery (or a 'radical prostatectomy') for men with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with prostate cancer and is scheduled to receive a radical prostatectomy. Study details All participants will be asked to come into the hospital around 3-4pm the day before the surgery to receive an injection of the tracer and a scan. Once they have received the tracer, they will be observed for a while before going home. All participants will then proceed with the surgery as planned the next day. It is hoped that this study will be able to determine whether using Technetium99m-labelled PSMA as a tracer during radical prostatectomy is safe and results in better detection of any cancer that may have spread. Follow-up visits To determine the outcome of treatment, the participant will be asked to complete the self-reporting Expanded Prostate Cancer Index Composite (EPIC) survey. The EPIC survey has been extensively used to report on the physical, emotional and psychological outcomes of prostate cancer. The questionnaires will be completed at baseline (prior to surgery), at 6 weeks, 3 months, 6 months, 1 year and then yearly for a minimum of 3-5 years

  • A Study of AM-301 Nasal Spray in Seasonal Allergic Rhinitis

    A study to determine the safety and efficacy of treatment with AM-301 in subjects who suffer from seasonal AR. In this study, a saline nasal spray, ie, a drug free standard-of-care product commercially available in Australia will be used as a comparator After Screening, subjects will undergo a 7 day Run-in Period to establish Baseline, followed by a 2-week Treatment Period. The AM-301 medical nasal spray device is being developed as a nasal spray intended to treat Allergic Rhinitis by limiting exposure to airborne allergens and promoting alleviation of allergic symptoms triggered by the inhalation of airborne allergens. It is hoped that the AM-301 nasal spray device will be better than the standard of care saline spray nasal spray device (comparator) to help in improvement of Allergic Rhinitis symptoms.

  • Can muscle growth and strength gains from weight training in young, active, healthy adults be affected by supplementing with palmitoylethanolamide?

    Chronic analgesic use is widespread amongst active individuals and athletes. However, the most common over the counter analgesic options interfere with training adaptations and may therefore impact negatively on performance outcomes. This research project will investigate the effects of daily oral supplementation of palmitoylethanolamide (PEA - a nutraceutical analgesic) on improving muscle mass, power, strength, wellbeing and sleep in 18-35 year-old recreationally active adults while they undergo an 8-week program of whole-body, progressive resistance training. The project has been designed to test the hypothesis that supplementation with the nutraceutical compound palmitoylethanolamide (PEA) will improve muscle mass and strength/power when combined with resistance training, and that wellbeing, post exercise muscle soreness, menstrual pains and sleep quality will be improved during the study in participants taking PEA vs placebo.

  • Inter-organ cross talk in heart failure: A multisite biomarker sampling study

    This is a single centre, investigator-led study of the regional origins of biomarkers in patients with heart failure (heart failure with reduced ejection fraction: HFrEF, and heart failure with preserved ejection fraction: HFpEF) and in healthy control subjects, and of the relationship between biomarkers in cardiovascular function. The past studies have demonstrated the association between many biomarkers in the peripheral blood only and the regional blood is somewhat lack of information. This study is hypothesized to investigate the biomarkers at regional blood sampling to better understand the pathophysiology of heart failure

  • The effect of the Collaborative Optimisation and Ordering of Medications (COOM) on prescribing safety in hospitalised patients

    Patient harm from medications is common; 7% of patients (ie 1 in 14) will have a significant medication harm event in hospital, many due to prescribing errors. Direct pharmacist involvement in patient care improves safe medication management by reducing errors. Pharmacists are well known for identifying and rectifying prescribing errors, however, this is usually done after the error is made. We propose shifting from a reactive (waiting for a prescription) to a proactive model, where the pharmacist works collaboratively with the doctor at the point of care. This project will evaluate a pharmacist-physician team-based model compared to usual care in an adult general medical population at two hospital sites. This model will include extended scope roles (e.g. collaborative ordering of medications) and occur throughout the patients entire hospital stay (including at admission, on inpatient ward rounds and at discharge). After patients have discharged, we will retrospectively review patient's electronic medical records and hospital cost data. We hypothesise benefits in safety, medication appropriateness, continuity of care and cost.

  • Evaluating the safety and feasibility of the application of transcranial photobiomodulation therapy for the clinical signs and quality of life of Parkinson's disease patients

    The main aim of this study is to investigate the safety and feasibility of transcranial photobiomodulation intervention, using infrared LEDs, for patients diagnosed with Parkinson's disease. It is hypothesised that the application of transcranial photobiomodulation might produce clinically meaningful improvements in the quality of life for people living with Parkinson's disease. This feasibility study will inform on a larger, adequately powered randomised placebo-controlled clinical trial.

  • ImmuneCAP: Immune responses in severe community acquired pneumonia

    Community acquired pneumonia (CAP) is an infection of the lungs where the lungs become inflamed. CAP is most commonly caused by bacterial infections however during the seasonal ‘flu epidemics and novel pandemics such as COVID-19, viral infections may predominate. Severe CAP requires treatment in an intensive care unit (ICU) and often support of breathing with a ventilator. In Australia pneumonia is the most common infection treated in ICU and unfortunately often proves fatal. Additionally, there is a large economic cost and survivors are often left with significant reductions in their quality of life. The body’s immune responses in the lung is designed to kill and eliminate the bacteria or viruses causing the infection but can also cause collateral damage to the lung through inflammation and injury. the lung has specialised immune cells called Tissue Resident Memory T-cells, (TRM)that play a crucial role in protecting the lung against bacteria and viruses. As the name suggests this specialised type of immune cells are ‘resident’ in the lung tissues and are not detected in the circulating blood. In this preliminary study we will evaluate a system to collect and study TRM -cells in mechanically ventilated patients with severe CAP. We will compare the immune responses of patients with severe CAP caused by COVID-19, other viral infections and bacterial infections. We will also compare patients with severe CAP to two different control groups. The first control group will be mechanically ventilated patients with lung injury not caused by infection. The second control group will be mechanically ventilated patients without evidence of lung injury. Studying the local immune response in this way will offer insights into how severe CAP occurs, may help identify which patients are going to need to most support and may identify new treatments for this important condition.

  • Investigating the impact of text messages on contact lens wearers' hygiene, engagement and satisfaction.

    By conducting a double-blind randomised, controlled trial with 150 participants, we will evaluate the effect of behaviour change text messages over 6 months. The intervention involves sending contact lens (CL) wearers a sequence of text messages, similar to the ones that have been proven to be successful in other public health areas such as cardiovascular disease, breast cancer and obesity. The text messages have been carefully co-designed and constructed to be educational and persuasive with the aim to change the behaviour of participants. Participants will be recruited from online advertisements, including social media, and also from optometry clinics. A pre-determined sequence of up to four text messages per week will be sent to the test group by using an online platform. The control group will get a minimal sequence of administrative messages. Data collection will be through a series of self-report questionnaires which will occur at baseline, 3-months, and 6-months.

  • The effect of medical glue on bleeding after intravenous line insertion in babies: a clinical trial.

    Babies in intensive care nurseries often have long-term lines inserted into their veins. The insertion site can continue ooze blood and affect the integrity of the dressing. We are studying whether using medical glue when the line is inserted can reduce the rate of bleeding afterwards. Glue may also be able to reduce the rate of lines accidentally coming out, as well as helping prevent babies from developing line-related infections.

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