ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies (P-EASY PLUS)

    Prostate artery embolisation (PAE) is an emerging, minimally invasive treatment for lower urinary tract symptoms caused by benign prostate enlargement. The first prospective trial of PAE in Australia was performed at The Wesley Hospital, and this project builds on those successful results. Whilst PAE was shown to be very effective at shrinking the prostate and relieving urinary tract symptoms during short-term follow-up, its impact on urodynamics, and the complex interplay between prostate obstruction and bladder function, is yet to be studied. This project aims to be the first study to comprehensively assess the impact of PAE on bladder function (urodynamics), as well as improvements in urinary symptoms and quality of life. The study will also compare the responses of patients with differing severity of prostate enlargement, and those with recurrent symptoms after a surgical resection. This information will be used to hopefully predict which patients are likely to best respond to a PAE, and can therefore be considered as an alternative to medical therapy or as an effective medium term precursor to more invasive surgical resection.

  • Medical Therapy versus Prostate Artery Embolisation in treatment naïve men with symptomatic benign prostate hyperplasia (MEDS vs PAE)

    Prostate artery embolisation (PAE) is a minimally invasive technique that has proven effective in decreasing lower urinary tract symptoms (LUTS) in men with medically refractive benign prostatic hyperplasia (BPH). BPH, or an enlarging prostate, affects more than 50% of males older than 60 years. LUTS include multiple night-time urination, urgency, hesitancy initiating urination, weak or interrupted urinary stream and post-urination dribble. The primary goals of BPH therapy are to decrease LUTS, improve quality of life (QoL) and prevent disease progression. For men with mild-to-moderate symptoms, sequential step-up therapy starting with watchful waiting and escalating to single or multiple medical therapies and, in some cases surgery, constitutes common clinical practice. A common combined medical therapy is Duodart, a fixed-dose combination of 0.5 mg Dutasteride and 0.4 mg Tamsulosin, that is usually prescribed for men with more severe prostate enlargement. The benefits of combined therapy can be explained by the synergistic mechanisms of action of the component drugs. Tamsulosin, an a-blocker, relaxes the smooth muscle tissue in the prostate and bladder neck, allowing urine to flow more freely. Treatment with Tamsulosin provides improvement of LUTS but has no effect on prostate growth. Dutasteride, a 5-alpha reductase inhibitor, blocks the production of dihydrotestosterone, the metabolic driver of prostate growth. Thus Dutasteride treatment reduces prostate size and impedes disease progression related to prostatic overgrowth. Adverse side effects associated with these medication include retrograde ejaculation, urinary incontinence and impotence. Overall, medications are generally ineffective for long-term control of LUTS, and medical therapies are often abandoned because of poor tolerance and inefficacy. PAE is emerging as a viable alternative to medication and invasive surgery for patients with LUTS. PAE has already shown promise as a short to medium-term treatment in patients who are not willing, or not able to undergo surgery. Medium-term follow-up in patients who have undergone PAE demonstrates that: • Improved symptoms and increased quality of life persist for at least 5 years in a majority of patients, • PAE is more efficacious than medical therapy alone, • PAE causes fewer side-effects than surgical resection, • PAE can be repeated if required, and does not preclude future surgical options. To date, a direct comparison between PAE and medical therapy in a randomised controlled trial has not been performed. The study proposed here will extend knowledge in this area by investigating whether PAE is a suitable intervention in treatment-naive men who would otherwise be prescribed medications as a first-line treatment.

  • Does triggering an Autonomic Sensory Meridian Response (ASMR) reduce pre-operative anxiety?

    The purpose of this study is to test whether a video designed to trigger the Autonomous Sensory Meridian Response (ASMR) will have an effect on preoperative anxiety. Preoperative anxiety is a significant phenomenon that negatively impacts patients that are preparing to undergo a procedure. In this study, we showed preoperative patients an informational video that told them about the anesthetic procedure that they were going to undergo. This video was either one specially designed to trigger an ASMR, or a normal video with the same information. ASMR is an alternative approach to relaxation and is currently very popular. You-Tube channels dedicated to producing ASMR videos have large followings and achieves significant viewership. Despite its rising popularity in society, only a few studies have been conducted to scientifically evaluate the effects of ASMR. We measured preoperative anxiety using standardized questionnaires that have been proven to be effective in many other studies. The questionnaires that we chose are the Visual Analogue Scale (VAS), the State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). We compared the results from the patients that watched the ASMR video with the results from patients that watched a normal video. Our aim is to assess the effects of ASMR on preoperative anxiety and determine if it yielded any clinically significant effects.

  • Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) using a 19-gauge needle for solid lesions: a multicenter prospective randomized controlled study

    The aim of this study is to evaluate the quantity and quality of tissue obtained through macroscopic on-site evaluation (MOSE) and the diagnostic ability of the procedure when compared with the conventional combined histologic-cytologic analysis. Who is it for? You may be eligible to join this study if you aged 18 years or over are referred for Endoscopic ultrasound (EUS) - guided tissue acquisition for intestinal or extra- intestinal solid lesions more than 2cm in the largest diameter. Study details Patients will be assigned on a 'chance' basis to receive standard care or an intervention. All participants will undergo endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) using a 19-gauge needle which is standard care when obtaining solid lesion specimens. Intervention group specimens will be subjected to the macroscopic on-site evaluation (MOSE) prior to being pathologically evaluated. We hypothesis that MOSE during EUS-FNA could improve the diagnostic yield of the procedure.

  • Using scripts to improve the state-wide delivery of simulated resuscitation education

    Paediatric patients are a vulnerable population who can deteriorate rapidly. Teaching medical and nursing staff across the state to recognise this in a learning environment that simulates this is crucial in maintaining their skills. Simulation and appropriate debriefing has been well-documented as an ideal tool to prepare for these real-life situations. It is currently unknown the impact that the introduction of a script will have on the quality of the debriefing, particularly by novice instructors. This proposal aims to improve the quality of the delivery of a paediatric resuscitation course that is delivered state-wide, including rural and remote centres, by introduction of pre-scripted debriefing. The ability to utilise an approved team with access to train clinicians each year will directly improve the care delivery at the bedside for children across the state. Furthermore, the findings may be applicable to how large scale simulation courses are taught and delivered.

  • The Promoting Introduction to Prevent Peanut Allergy (PIPPA) Project - testing a new service to support the early feeding of peanut to infants aged between 4 and 11 months at risk of allergy.

    Peanut allergy is the most common cause of severe food allergic reactions in children, and rates of peanut allergy appear to be rising. Some infants are at an increased risk of developing a peanut allergy due to the presence of eczema, other food allergies or a family history of allergy. For these high-risk infants, early introduction of peanut with regular consumption starting before 12 months of age significantly decreases the incidence of peanut allergy. However, parental apprehension to introduce peanut early leads to only 1 in 5 high risk infants starting peanut within the recommended window. Recent guidelines released by the Australasian Society of Clinical Immunology and Allergy suggest at risk infants should see their doctor for advice on introducing peanut, however uncertainty remains amongst health care professionals about how and where high risk infants should introduce peanut. The aim of the Promoting Introduction to Prevent Peanut Allergy (PIPPA) project is to develop a safe and efficient parent-led, clinician-supported model that promotes early introduction of peanut. This intervention study will examine the efficacy of a new model of care, where parents with high risk infants will introduce peanut in a supported environment. The primary outcome of the PIPPA project will be to compare the number of high risk infants consuming peanut before 12 months of age, between families who attend the PIPPA clinic (intervention group) and families who receive the current standard of care, and the proportion of infants who have an allergic reaction to first consumption of peanut in the PIPPA clinic. Secondary outcomes will examine whether there is any difference in the incidence of peanut allergy between the intervention and standard care group. The PIPPA project will provide evidence for the safety and efficacy of a new model of care to be implemented in a wide range of settings across Australia. The key components of the PIPPA project can be replicated in almost any healthcare environment, including primary care and rural/regional hospitals, ultimately reducing the incidence of peanut allergy in the community.

  • Online planning tool for reducing unhealthy snacking

    Snacks are important because they keep us going until the next meal. Sometimes though, we eat too many, or choose snacks that are unhealthy. Even though each snack is usually small, over time these snacks can add up. This can make us gain weight. Smart snacking means choosing nutritious, healthy snacks that give you energy until the next meal. While many of us want to change the way we snack, this can be very hard to do. Often we make plans but have trouble sticking to them over long periods of time. This study is testing a ‘smart snacking’ tool that will make sure that plans to snack healthily are high quality and easy to follow in the long term. To test the effect of this tool on snacking behaviour, we randomised participants to receive one of three planning tools: 1. Volitional help sheet (the online smart snacking planning tool) 2. Directions to create a detailed plan 3. Hints and tips to snack healthily

  • A phase I/IIa study to assess safety, tolerability, pharmacokinetic, pharmacodynamic effects and exploratory efficacy of two doses of AGMG0201 in patients with essential hypertension.

    The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic effects, and exploratory efficacy of AGMG0201 vaccine administered as an intramuscular injection in male and female participants with essential hypertension at two dose levels (low dose; high dose) compared with placebo. You may be eligible to join this study if you are of non-childbearing potential, between 18 and 79 years of age, and have mild to moderate hypertension This is a placebo controlled, dose escalation study. Each participant will receive a single injection to the deltoid muscle, followed by a second injection to the deltoid muscle, in the same arm, 30 days later. A vaccine for hypertension could potentially reduce or halt the use of antihypertensive drugs and reduce long-term medical expenses. Although current antihypertensive drugs appear to fulfill the unmet medical needs of hypertensive patients, there are still serious issues (e.g., daily dosage of the medication, often for life) that may be a significant financial burden, particularly in developing countries.

  • Reducing urinary catheter use: a randomised controlled study on the efficacy of an electronic reminder system in hospitalized patients

    Indwelling urinary catheters are commonly used in healthcare facilities, with foundation work by two investigators indicating that 26% of patients admitted to an Australian hospital receive an indwelling urinary catheter and 1% of these patients develop catheter-associated urinary tract infections (CAUTIs). Healthcare associated urinary tract infections (HAUTIs), including CAUTIs have been associated with increased morbidity, mortality, higher hospital costs for patients and health systems. In Australia, an estimated 380,000 bed days are lost each year due to HAUTIs, a large proportion of which are CAUTIs. Urinary tract infections (UTIs), specifically CAUTIs are associated with higher risk of antimicrobial resistance (AMR), making the treatment of patients difficult and compounding the effects of AMR when treatment is provided. A recent high-level meeting of the United Nations General Assembly addressed the issue of increasing AMR. This further emphasises the need to develop interventions to reduce the incidence of CAUTIs. Despite advances in infection prevention and control, CAUTIs remain problematic, hence further research is needed to identify ways to reduce the burden they create. The greatest risk factor for CAUTIs is prolonged catheterisation, with catheters often placed unnecessarily, lacking documented reasons for insertion, and catheters remaining in place too long and not being promptly removed. Interventions that prompt removal of unnecessary catheters may therefore enhance patient safety. A reminder intervention is a mechanism used to remind either a physician or nurse that the catheter is still in place and that removal may be warranted if the catheter is no longer required. The current study aims to evaluate the effectiveness of an electronic reminder system – the CATH TAG – to reduce urinary catheter use.

  • An open label dose-finding, safety and tolerability study of Panitumumab, Irinotecan, Trifluridine/Tipiracil in RAS wild-type patients with metastatic colorectal cancer.

    This study aims to determine the maximum tolerated dose (MTD) and assess the efficacy of panitumumab, irinotecan and trifluridine/tipiracil when given in combination for participants with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a confirmed diagnosis of metastatic colorectal cancer that is RAS/BRAF wild type. Study details This study will be conducted in two parts: phase Ib and phase II. The study will commence with a phase Ib dose escalation phase, during which participants will be administered Irinotecan (180mg/m2) and Panitumumab (6mg/Kg) intravenously (IV) on Day 1 of every 14 day cycle, in combination with oral Trifluridine/tipiracil twice a day on Days 1-5 of every 14 day cycle. Dosing of trifluridine/Tipiracil will commence at 25 mg/m2 orally twice a day in the first group. If tolerated, the dose will be elevated for subsequent groups up to a maximum of 35 mg/m2 orally twice a day. Phase II of the study will enrol a separate group of participants who will receive the maximum tolerated dose determined in phase Ib. Treatment in both phases will continue until disease progression, unacceptable toxicity or participant withdrawal. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Follow-up visits will occur every 12 weeks after the end of treatment visit until death or study closure. It is hoped that this study will provide evidence for further research into this combination, and improve health outcomes for patients with this disease.

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