ANZCTR search results

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

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31611 results sorted by trial registration date.
  • FirstCPR - an intervention targeting clubs and organisations to increase training and willingness to respond to cardiac arrest in the community

    Good quality bystander cardiopulmonary resuscitation (CPR) significantly increases the chances of survival for a person who suffers a cardiac arrest in the community. Yet not everyone in the community is trained, confident and willing to provide this life saving skill. FirstCPR is a targeted health education intervention designed to reach out to members in the community via organisations and clubs to upskill them in the knowledge and skills necessary to respond to a cardiac arrest and build their confidence and willingness to provide CPR and use a defibrillator in an emergency. Training will include digital material plus face-to-face information sessions.

  • The mobile food record: A pilot study using images to assess dietary intake in children and adolescents with type 1 diabetes

    The purpose of the study is to assess the usability and acceptability of using the Mobile Food record (mFR) App to measure dietary intake, by assessing the number and quality (ability to assess food contents) of images captured using the mFR. Children and adolescents aged between 9-18 years who access the Diabetes Service at Perth Children’s Hospital will be invited to take part in the study. Participants will be asked to take ‘before’ and ‘after’ eating images of all foods and beverages consumed for four consequative days using the mFR App and continue using their continuous glucose monitor (CGM). The images are automatically time and date stamped, which will allow dietitians to compare time and content of meals and snacks against a continuous glucose monitor trace as well as Australian Dietary Guidelines. We hypothesis that children and adolescents with Type 1 Diabetes will be able to use the Mobile Food Record App to capture images of their dietary intake, which will be clear enough for estimation of their macro- and micronutrient intake.

  • TEDI-Prem: Telehealth for Early Developmental Intervention in babies born very preterm

    We have developed an intervention called TEDI-Prem (Telehealth for Early Developmental Intervention in babies born very preterm) that focuses on early motor, cognitive and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving neurodevelopment outcomes and parental well-being in children born preterm. It involves direct physiotherapy/occupational therapy collaborating with parents to provided developmentally appropriate activities, with 4 sessions delivered in the neonatal nursery, and 9 via telehealth, until 12 months’ corrected age. In addition, parent/s can access psychosocial education content to promote parental well-being and support parental mental health developed by our multidisciplinary team. We will test the efficacy of TEDI-Prem compared with usual care, in a multi-centre pragmatic superiority randomised controlled trial in 466 very preterm (VPT) infants.

  • A randomised control trial comparing the timing of the removal of the laryngeal mask airway (LMA) after tonsillectomies in children and the likelihood of delirium occurring on emergence in the post anaesthesia care unit (PACU).

    Emergence delirium is a very common occurrence, typically presenting in young children, after waking up from anaesthesia. Emergence delirium poses risks for the child as they are likely to harm themselves by removing intravenous drips, catheters etc It also poses significant stress on the nurses and can cause dissatisfaction among the parents in regards to the care their child is receiving. Tonsillectomies are common surgical procedures performed on children so trying to minimize emergence delirium will be beneficial for all involved. Previous studies and research have shown the benefits of a laryngeal mask airway over an endotracheal tube but research is limited in terms of when the laryngeal mask airway should be removed. We hypothesize that the removal of the laryngeal mask airway whilst anaesthetized (deep) at the end of surgery for tonsillectomy in children aged 2-7 years results in a lower incidence of emergence delirium in the post-anaesthesia care unit compared to awake removal of the laryngeal mask airway. Patients will be recruited after consent is gained by the student or the student's supervisor from the child's parents. The student will then observe the child before the surgery and then for 5 minutes and 20 minutes after the child awakens from surgery. If the child or parents feel uncomfortable with their child's participation during the study then they are able to sign a withdrawal form (attached to the consent form) at any time stating a reason for withdrawal.

  • Fractional CO2 laser for postmenopausal vaginal symptoms - a follow-up study

    We have performed a double blind placebo-controlled randomised trial investigating the efficacy of fractional CO2 laser for postmenopausal vaginal symptoms. At completion of study (data collection and analysis), participants have been contacted individually to unblind and reveal their randomisation allocation, and as offered at recruitment, participants from both the laser and sham groups will be offered the opportunity to undergo one laser treatment course (three treatments, four weeks apart). Participants who opt for the treatment course will attend the clinic for treatment which will be performed at the laser treatment settings as aforementioned. Prior to each of their three treatments, participants will complete the same questionnaires as during the study assessing symptom severity. Participants will be asked to report adverse events at every visit. The aim of the study is to further evaluate the efficacy of this treatment and investigate the role of placebo effect.

  • The PRoCESS Trial: Pancreatic cancer Relatives Counselling and Education Support Service trial.

    Relatives or friends who care for a person diagnosed with pancreatic cancer have a high need for support themselves. The purpose of this study is to determine if it is helpful and cost-effective for carers to regularly talk to an experienced nurse-counsellor via video conferencing or over the telephone. Who is it for? You may be eligible for this study if you care for someone who has been diagnosed with pancreatic cancer, you and the person you care for live in Australia, you are over 18 years old and can speak and write in English. Study Details Carers of people who have been recently diagnosed with Pancreatic Cancer will be randomly allocated by chance to one of two groups. One group will be offered ten 60 minute counselling sessions with a trained oncology nurse-counsellor over 4 months. The other group will be offered written information only. Both groups will be asked to complete questionnaires about how they are feeling at enrolment and at 2, 4 and 6 months after joining the study. In addition, each person will be interviewed over the telephone each month for other relevant health event information and, with consent, de-identified data will be matched with Medicare and the Queensland Hospital Admitted Patient Data Collection in order to measure if each group has used hospital and medical services differently. It is optional for the person with cancer that participating carers look after to also complete 4 surveys and/or give permission to access their medical records too. Our aim is to determine whether taking part in our support service reduces carers’ anxiety, depression, tiredness, and need for help. We will also see if the service makes carers feel better able to cope and improves their overall quality of life. We will also investigate whether supporting carers reduces the number of times patients with pancreatic cancer have to go to the hospital emergency department and the length of time in hospital. We will see if our service for carers improves patients’ quality of life. Finally, we will determine if the service is cost-effective. Ultimately, it is hoped this research will improve the standard of care, education and support for people affected by pancreatic cancer and their carers in the future.

  • A Comparison of patient assessment of comfort, comparing bronchoscopy with conscious sedation or anaesthetist controlled sedation; a randomised prospective trial.

    As part of any bronchoscopic procedure, patients are administered sedation. This is in order to make the procedure as comfortable as possible for them, as well as making the procedure technically easier by reducing movement and suppressing cough. We currently use two methods of sedation: 1) Conscious Sedation: this is the use of 2 medications (Midazolam and Fentanyl); administered by one of the treating doctors, whilst the other doctor performs the bronchoscopy. The dose of medication is adjusted to the desired effect during the procedure. The effect is that the patient will be in a sleep like state, whilst still breathing, but with a poor recollection of events once the effect has resolved. 2) Anaesthetist Controlled Anaesthetic: This involves the use of general anaesthetic agents to induce a state of unconsciousness. In most instances this will require the use of an airway device (Laryngeal mask airway or endotracheal tube) to ensure the airway stays open and there is clear flow of oxygen to the lungs. This anaesthesia is given by an Anaesthetist whilst the treating doctor performs the bronchoscopy. Currently the method of sedation is determined by the treating doctor and generally depends on the technical difficulty of the procedure as well as the likelihood of the patient coughing. General anaesthesia being favoured for these cases. In the majority of cases the mode of sedation is decided upon by chance. As we have 2 conscious sedation lists a week and 2 anaesthetic lists per week, whichever list the patient fits into will decide the mode of sedation. Neither of these methods has been shown to be more effective, or shown to be safer than the other. Information regarding patient comfort and satisfaction with either sedation technique has not been collected. We aim to assess comfort and satisfaction during the procedure, so we can determine which is the more favourable for patients, when we offer it in the future. We plan a randomised prospective cohort comparison survey of patients undergoing sedation for a bronchoscopic procedure. Two groups will be compared. Those undergoing conscious sedation versus those undergoing anaesthetist controlled sedation. Patients in both groups will be undergoing both therapeutic and diagnostic procedures. Data collection would involve a short survey prior to the procedure to get an idea of patient expectations, as well as a survey 24-48 hours following the procedure (when the sedation has worn off), to get an idea of what the experience was like. This would involve a phone call from the treating doctor. Other secondary endpoints such as complications and medical staff perception of sedation will also be assessed. In no way will this impact on the procedure the patient would otherwise be having.

  • Predicting absence of endometriosis in people with pelvic pain

    Endometriosis is an important and common cause for pelvic pain for which laparoscopy provides definitive diagnosis and often symptom relief. There are however many people with pelvic pain who do not have endometriosis in whom laparoscopy poses potential risks and costs without the same possibility for symptom benefit. As yet, there are no validated, symptom-based, patient-reported questionnaires for endometriosis screening. We plan to make a predictive tool that uses questions about a person’s symptoms and medical history and their anogenital distance (AGD – the distance from the vagina to the anus which is associated with chance of endometriosis), to better predict pre-operatively the absence of endometriosis. This could hopefully be used as a tool that women could use to help decide if they want to go on and have a laparoscopy or not. It might result in fewer women having unnecessary surgery and getting more appropriate treatment for their pain instead. In this study we will look at people already planning to have a laparoscopy for investigation of their pelvic pain. We will ask them to fill in a questionnaire about their symptoms and medical history before their operation and then we will check if they had endometriosis at surgery or not. We will also measure their anogenital distance while they are asleep under the anaesthetic for their surgery. We will use this information to develop and validate a predictive tool for absence of endometriosis.

  • Randomised trial of Empagliflozin and Left ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)

    Sodium-glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce heart failure hospitalisation in patients with type 2 diabetes (T2D) at high cardiovascular risk and in patients with heart failure (HF) with reduced ejection fraction without or without diabetes. However, the mechanisms by which SGLT2 inhibitors reduce the risk of HF remains unclear. Previous studies have demonstrated that SGLT2 inhibitors can reduce left ventricular (LV) mass and improve LV diastolic function in stable outpatients with T2D and in patients with HF with reduced ejection fraction. We recently performed the first study to assess the effects of empagliflozin (an SGLT2 inhibitor) on LV function following an acute coronary syndrome (ACS) in patients with T2D. The observational study found that empagliflozin reduces LV mass and improves LV diastolic function in this cohort, which means that empagliflozin could potentially improve the heart’s pumping function after a heart attack or an angina episode. This had led to the design of the Randomised trial of Empagliflozin and Left Ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D). Following an ACS, 80 participants with T2D at Fiona Stanley Hospital (FSH) will be randomised 1:1 in this open-label trial to either 1) Empagliflozin or 2) no SGLT2 inhibitor therapy. Diastolic stress echocardiography (DSE) using supine bicycle will be performed at baseline and at 6 months follow-up. Echocardiography will be performed by certified sonographers and reported by a consultant Cardiologist who are both blinded to treatment allocation. Results at follow-up will be compared to baseline by a blinded investigator to assess for significant changes in LV function between groups. Non-fasting blood samples will be collected at baseline and follow-up and analysed to detect significant associations. We hypothesise that empagliflozin treatment can reduce adverse LV remodelling and improve LV diastolic function following an ACS in patients with T2D.

  • Reducing operative birth for fetal distress in women with small or suboptimally grown infants - The RidStress 2 Randomised Controlled Trial

    This is a 4-year Phase 3 RCT to re-purpose sildenafil citrate - a widely available, off-patent drug that dilates pelvic blood vessels and improves placental blood flow. The trial will evaluate whether, compared to Placebo, sildenafil citrate safely reduces emergency caesarean sections for fetal distress in small or suboptimally grown babies.

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