ANZCTR search results

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

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1534 results sorted by trial registration date.
  • Efficacy of tREating aSymptomatic infEctions To resTore fERtility: The RESETTER Study

    The current study aims to reduce the rate of unexplained infertility in couples who test positive for Genital Mycoplasmas by using antibiotic and probiotic treatments. It will recruit couples attending Concept Fertility and City Fertility clinics for investigation of unexplained infertility. Couples will submit semen and vaginal swab samples for analysis; Semen samples will subsequently undergo routine analysis as per World Health Organisation (WHO) guidelines and Lactobacillus and Bifidobacterium spp. will be quantified in vaginal swabs using quantitative PCR (qPCR). Both sample types will undergo qPCR analysis for the presence of Genital Mycoplasmas and where one or more are identified in at least one partner, couples will be treated with either doxycycline (M. hominis and U. urealyticum) and/or azithromycin (M. genitalium) as per standard treatment guidelines. Women will receive a vaginal Lactobacillus sp. probiotic for seven weeks post-treatment and then both partners will provide follow-up semen and vaginal swab samples for repeat analysis to assess treatment efficacy in terms of semen parameters and removal or reduction in Genital Mycoplasma DNA titres.

  • Early allied health assessment for frail older adults.

    Those living with frailty are at greater risk of adverse events when attending the Emergency Department (ED). Gold standard practice for frail older patients is a multidimensional multidisciplinary comprehensive geriatric assessment (CGA). However, routine completion is difficult in the ED setting due to increasing demand, overcrowding and patient flow issues, but has shown positive outcomes when used selectively with patients at high risk of adverse events. Allied health professionals often contribute to the multidisciplinary process providing comprehensive care to ED patients, However, referrals are traditionally received after medical intervention which can cause delays in decision making and discharge. The project aims to implement an early allied health assessment for frail older adults presenting to the ED. They will provide individualised interventions to priority patients, minimising the risk of adverse events and gathering valuable information regarding social complexities and function earlier to assist discharge decision making, facilitating patient flow through the ED and improve patient outcomes and experience.

  • PAUSEMATTERS Study: Exploring the impact of natural pauses in childbirth on the mother's and newborn's health

    The PAUSEMATTERS Study investigates natural pauses during childbirth, so-called physiological plateaus. This study seeks to generate high-quality data on the prevalence (how often), timing (when) and duration (how long) of physiological plateaus in healthy labour, including how such plateaus may affect the mother’s and newborn’s health. This study applies a cohort design, meaning that data is collected in a group of women, during and soon after birth. Participants in this study include women who plan a homebirth in Western Australia with the support of a midwife.

  • Effect of acute curcumin supplementation on recovery from a match-play simulation in team-sport athletes.

    The effects of an acute curcumin supplementation on team sport athletes performance and recovery. The study involves team sport athletes, aged 18-35. This is a randiomised, double-blinded, cross-over study where participants will consume either a curcumin supplement or a placebo at a time, without knowing which one they were given. They will be tested on their athletic performance and recovery over five sessions, with a break between the supplements to ensure any effects of the supplements have worn off. The study will measure performance through a battery of field tests and recovery through blood sample collection and questionnaires. The hypothesis of this study an acute dose of curcumin supplementation will reduce the detriment in exercise performance post-fatiguing exercise. Additionally, muscle damage markers and inflammation will be reduced, and the participants’ perceived recovery will be improved.

  • An implementation-effectiveness trial to evaluate physiotherapy guideline care in practice and determine whether a course of protocolised physiotherapy ventilator lung hyperinflation treatment, added to guideline care, is feasible, safe, cost-effective and improves patient-important outcomes for ICU patients with severe pneumonia requiring invasive mechanical ventilation.

    The aims of this study are: 1. To determine the feasibility (acceptability and fidelity) of implementing the physiotherapy guideline in patients with pneumonia, incorporating a set dosage of ventilator hyperinflation (VHI) treatment, with target volume determined for each patient according to their estimated inspiratory reserve volume, based on height as per Jacob et al (2021). 2. To explore pneumonia phenotypes which demonstrate treatable traits that are amenable to respiratory physiotherapy intervention commenced during the acute period of invasive mechanical ventilation. 3. To determine the effect of a course of VHI treatment method], at a set dosage and frequency of three times daily for the duration of the period that patients are on the mechanical ventilator on symptomatology and patient-centred outcomes. 4. To determine the cost-effectiveness of physiotherapy guideline care incorporating a course of new VHI treatment for pneumonia requiring invasive ventilation in ICU. It is hypothesised that best practice physiotherapy guideline care, with incorporation of protocolised VHI treatment is safe, feasible and effective in improving patient-important outcomes for critically ill adults requiring invasive mechanical ventilation for pneumonia.

  • Assessing the Impact Cardiac Rehabilitation has on Functional Status after Cardiac Surgery using a questionnaire

    We are conducting a pilot study to see how well a cardiac rehabilitation program helps patients recover after open heart surgery. We will use the Duke Activity Status Index (DASI) tool to measure how much the program improves your ability to perform daily activities. This study aims to gather early information to understand how cardiac rehabilitation might help patients get better after their surgery. We are also interested in learning about the recovery of patients who choose not to participate in a cardiac rehabilitation program. This will help us compare the outcomes of those who do and do not participate in the rehabilitation program.

  • Patient Initiated Follow Up (PIFU) in Endometrial Cancer (PECAN) – a Randomised Pilot Feasibility Study

    This study aims to investigate the feasibility and acceptability of patient initiated follow-up (PIFU) following surgery for low risk endometrial cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or over who has completed definitive primary surgical treatment for endometrial endometrioid adenocarcinoma, and has been assessed by a gynaecological oncology multidisciplinary team as having low risk disease in whom adjuvant therapy is not indicated. Study details Participants will be randomly allocated to PIFU, or standard of care follow up 6-monthly with the patient's General Practitioner. In the PIFU group, participants will receive an education session at baseline regarding when and how to contact the gynaecologic oncology service. Data will be collected on how many women on PIFU refer themselves back to the clinic. All participants will be followed up at 12 months post-baseline to conduct quality of life measures and cancer recurrence rates will be assessed. It is hoped that findings from this study inform a larger trial in future to assess healthcare costs and long term cancer outcomes associated with PIFU in endometrial cancer.

  • Can virtual pharmacist-led prescribing help improve medication safety among hospital inpatients?

    Partnered pharmacist medication charting (PPMC) is a safe and effective model of care which significantly reduces medication errors and length of stay in hospital, ultimately improving patient flow. This study aims to assess whether virtual delivery of this model (VPPMC) in rural/remote NSW can reduce length of stay, among other measures of effectiveness and feasibility, including an economic analysis using incremental cost-effectiveness ratios. Hospitals within Western NSW Local Health District will be approached for recruitment, then randomised to either the intervention (VPPMC) or control (best usual care). Eligible patients must be aged 18 years or over, admitted to a recruited hospital and, for those admitted to intervention sites, clinically reviewed by a pharmacist prior to partnered charting of regular medications and venous thromboembolism prophylaxis. Data generated from this project would provide evidence to support the VPPMC model as a new standard of care, enabling the expansion of clinical pharmacy services to geographically isolated patients. Therefore, the research team is uniquely placed to be the first to examine and evaluate the unique challenges associated with a VPPMC model.

  • Visual clarity using the Fisher and Paykel Laparoscopic Vision System – A Prospective Randomised Controlled Trial

    Loss of visual clarity during laparoscopic surgery remains a major challenge for surgeons as this can contribute to the safety and outcomes of patients. Typically, a suboptimal display of surgical field can occur due to fogging on the front of the laparoscope lens, smoke generated during tissue cutting, and/or splatter of blood, bodily fluids, fat droplets or tissue etc. When the visual clarity is suboptimal, the surgical procedure will be disrupted or prolonged. Currently there are a number of products for restoring laparoscopic visual clarity. Multiple products are often needed in a surgery to tackle the visual clarity challenge. The frequent practice is still to remove the laparoscope from the abdomen for lens cleaning outside of the body. The F&P Laparoscopic Vision System is designed to remove smoke from the field of view of surgeons, enabling surgeons to continue with their work with better visual clarity and less interruption. Better visual clarity has been demonstrated in bench model and uses in patients. The aim of this prospective randomized study is to evaluate whether laparoscopic visual clarity can be improved by using the F&P Vision System compared to other available visual clarity products. Participants will be recruited and randomized to the intervention (where surgeons will use the F&P Laparoscopic Vision System during the surgery) or control group (where surgeons will use the off-the-shelf smoke filter plus other available visual clarity products during the surgery). All other aspects of the surgery are to be carried out as per standard of care and hospital practice. Study participation ends at the end of surgery.

  • Evaluating Early Initiation of Hybrid Closed Loop Therapy in Newly Diagnosed Type 1 Diabetes

    Automated insulin delivery via an advanced hybrid closed loop (AHCL) system is accepted as the most effective management strategy, proven in clinical trials and real-world studies, wherein a continuous glucose monitor (CGM) provides glucose information to an insulin pump which can then adjust insulin delivery via an algorithm (housed in an application or in the pump). Due to the established glycaemic benefits, access to AHCL therapy is recommended for all children with T1D according to the latest international guidelines. However, despite national subsidy for CGM, AHCL access in Australia is limited as insulin pumps are primarily self-funded or accessed via health insurance funds or philanthropic programs. This has led to significant inequity in accessing AHCL. The Department of Endocrinology and Diabetes at Perth Children’s Hospital is implementing a new clinical model of care that will provide early access to AHCL to all children with a new diagnosis of T1D. This study aims to evaluate the impact of the new model of care through a combination of routinely collected clinical information and prospectively collected survey data. The overall objective is to comprehensively evaluate a model of care providing early access to AHCL following diagnosis of T1D.

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