ANZCTR search results

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

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31198 results sorted by trial registration date.
  • Comparing a 'wait and watch' approach vs medical treatment with misoprostol for first trimester retained products of pregnancy and using ultrasound to predict success

    Study hypothesis - This study hypothesizes that non surgical management of first trimester retained products of conception has a high success rate and various ultrasound parameters can help in more accurate treatment selection with either expectant or medical management. Brief summary Retained products of conception ( RPOC) is a common occurrence after first trimester expectantly, medically or surgically managed miscarriage or termination of pregnancy. However, there is lack of evidence on the most ideal way to manage these patients, Surgical management has been the fall-back due to immediate results but comes with a high rate of complications such as intra-uterine adhesions which can lead to sub-fertility. On the other hand, non-surgical methods, not known to cause such complications, have shown promise but lack robust evidence. Hence, the purpose of our study is to determine the efficacy of non-surgical options in successfully managing RPOC. Participants aged 16-45 years presenting to the early pregnancy assessment unit and Emergency department (ED) with symptoms and ultrasound diagnosis of retained products of conception in first trimester of pregnancy will be consented, recruited and randomized to either expectant management or medical management with misoprostol. They will be followed up at 4 and 8 weeks for symptom review and progress ultrasounds to note successful management of RPOC. Success rates, ultrasound factors influencing success, short- and long-term complications will be noted.

  • Sexual and Reproductive Health Screening in a Child and Youth Mental Health Service

    This study aims to implement standardised sexual and reproductive health (SRH) screening into the Children’s Health Queensland (CHQ) Child and Youth Mental Health Service (CYMHS). CYMHS provides specialist outpatient mental health services to those up to 18 years of age with complex mental health needs. The intervention involves development and delivery of a brief training and education module designed to equip clinicians with the knowledge and confidence required to engage young people aged 12-17-years in consultations around their SRH and facilitate referrals for nurse-led SRH consultations where indicated, through which further SRH information, more advanced screening, and/or other care can be provided.

  • Influence of the clear aligner trimline on incisor tooth movement, and patient experiences during orthodontic treatment

    The intervention involves the use of clear aligners with a straight trimline, with control being aligners of a scalloped design. Participants are randomly assigned to start in aligners of either design. The predictability of the achieved tooth movement, according to each aligner design, will be assessed on a monthly basis. Tooth position data will be captured and superimposed to assess the predicted vs achieved tooth movements. The comfort and acceptability of each aligner type will be assess using a online questionnaire, using the validated tools of the OHIP-14 Questionnaide (Slade, Spencer, 1994) and the Visual Analogue scale. We hypothesise that using a straight trimline aligner may increase the predictability of orthodontic treatment with clear aligners.

  • Can peer-workers help those leaving residential addiction treatment improve their recovery by planning and setting goals based on recovery strengths and weaknesses?

    Most people who receive alcohol and/or other drug (AOD) treatment in Australia are not provided with continuing care; however, those who are, have improved outcomes (Manning et al., 2017). In Australia, the employment of AOD Lived Experience Workers (LEW) is growing with most jurisdictions committing to building this workforce. LEWs have their own experience in building recovery resources and are ideally placed to provide cost-effective continuing care. However, the LEW workforce is still developing and LEWs describe a lack of structure and standardisation in their roles (Eddie et al., 2019). This project will test a peer-supported recovery planning intervention to assist people leaving AOD residential inpatient treatment to receive structured peer support, identify their recovery skills and assets, improve engagement with services, and access additional care and support. The study aims to compare the effectiveness of this peer-led continuing care intervention compared to treatment as usual using a randomised trial design. It is hypothesised that those who receive this continuing care intervention will have a greater growth in recovery capital compared to those who receive treatment as usual.

  • This is the first study in humans to test the safety, effectiveness, and practicality of ADAM™ 2.0, a biocompatible contraceptive implant. This implant is designed to be tested in men with normal fertility levels who are considering a vasectomy as a contraceptive option.

    This study will test the safety and effectiveness of ADAM™ 2.0, a new contraceptive device for men, in a group of 30 healthy males aged 25 to 55 who are considering a vasectomy. Researchers believe that ADAM™ 2.0 can block sperm flow safely and could offer a reliable, non-hormonal, non-permanent alternative to traditional vasectomy. Participants will be closely monitored to assess how well the device works and to ensure their safety. The study aims to gather valuable information on the potential of ADAM™ 2.0 as a long-term contraceptive solution for men. The study hypothesis is that implanting a pre-formed, water-soluble hydrogel into the vas deferens will effectively block sperm flow into the ejaculate, thereby reducing sperm counts to near zero and preventing pregnancies.

  • A study of opaganib in addition to darolutamide in participants with metastatic hormone resistant prostate cancer, selected for the presence of a specific biomarker.

    This study is taking a novel approach to using predictive biomarkers to select people for lipid (fat) targeted treatments, to attempt to overcome hormone resistance in people with metastatic hormone resistant prostate cancer. There is increasing evidence that abnormal lipid (fat) metabolism promotes the growth of prostate cancer cells. We have previously shown that abnormal patterns of blood-borne lipids (called ceramides) can identify a group of people with metastatic hormone resistant prostate cancer who are likely to be resistant to the usual hormone treatments: abiraterone and enzalutamide. In the DARO-LIPID study, we will first identify which participants with metastatic hormone resistant prostate cancer have the high ceramide lipid signature through a blood test. Participants who do not have this lipid signature will receive usual care by their oncologist. Participants with this lipid signature who consent to the study will all receive darolutamide as standard of care. Participants will then be randomly split into two groups with one group also receiving the lipid drug called Opaganib to target the abnormal lipid changes and the second group receiving a placebo. The study is designed to see if Opaganib can increase the number of people who respond to darolutamide, and increase the time that they get benefit from the treatment. We will also look at how the Opaganib is affecting lipid/fat metabolism in the body/tumour.

  • Personalised pair-based physical activity promotion intervention for autistic adults: A trial evaluating feasibility and acceptability.

    This pilot trial will evaluate the feasibility and acceptability of a 12-week co-designed, dyadic physical activity intervention for autistic adults. Participants will invite a partner (e.g., a family member, carer, friend, mentor, or trainer) to co-plan, schedule, and engage in chosen physical activities. The partner acts as a supporter, and the pair has full autonomy to set goals and plan activities. The research team will provide workshops on the benefits of physical activity, the risks of sedentary behavior, daily personalized prompts, reminders, and fortnightly feedback. Autistic participants will also receive Fitbit and Sens devices to monitor their physical activity and sedentary behavior throughout the program. The intervention’s impact will be measured by changes in physical activity levels (measured in minutes per week), sedentary behavior (measured in minutes per week), and motivation for physical activity (measured by self-reported physical activity motivation scales). It is hypothesized that the intervention will lead to increased physical activity, reduced sedentary behavior, and improved motivation for physical activity at the end of the intervention compared to baseline measures.

  • BREATHE SMART- Breathlessness Rapid Evaluation And THErapy- Screening, Management And IntegRated Technology: Screening adults in Australian GP clinics

    The BREATHE SMART study aims to test a computerised system to screen for breathlessness among patients presenting to primary care in Australia. All patients with a scheduled GP appointment will complete a screening questionnaire via their SmartPhone prior to their GP consultation. The patient's screening results will be automatically transferred to the patient's electronic medical record and will be available to the GP prior to the patient's scheduled appointment. Each patient identified as having chronic breathlessness and consents to the BREATHE CDSS project will participate for 12 months. In this study we will assess the benefits of these tools for patients and GPs in reaching a diagnosis, commencing evidence-based management and achieving relief of breathlessness.

  • The Breathlessness Rapid Evaluation and Therapy Study Clinical decision support system (BREATHE CDSS): The effect of a clinical decision support tool for shortness of breath on disease control and symptoms

    BREATHE CDSS study, which is an open label, cluster-randomised controlled trial of standard of care compared to a CDSS intervention. It will recruit for 12 months, and the will follow-up patients for 12 months. General practices in urban, regional and rural settings will be recruited to the trial. BREATHE CDSS is a stud that uses an clinical decision system to guide GPs with managing and diagnosing breathlessness, Patients will be followed up for 12 months from time of commencing study and the study will be conducted across a number of practices in ACT, NSW, TAS.

  • PANDA Trial - Physical activity in Nature for Cardiometabolic Diseases in People Aged 45y+

    The PANDA study aims to explore whether a personalised nature prescription can encourage physically inactive adults aged 45 and older, who have cardiometabolic diseases, to increase their physical activity over 12 months. The study compares two groups: one that receives standard advice on physical activity, and another that gets tailored encouragement to spend time in nature through personalised text messages. We hypothesise that participants who receive the nature prescription will engage in more physical activity compared to those who only receive standard guidance. By examining changes in activity levels and health outcomes, we hope to determine if spending more time in natural environments can lead to improved health and well-being in this population. Additionally, we will evaluate the cost-effectiveness of the intervention and its impact on various psychological and social factors.

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