ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Re-frame the pain: Using attention and language to reduce needle pain and distress in children

    Many people are terrified of and avoid needles. This fear often stems from bad experiences with receiving needles as a child. For many children getting a needle can be a painful, distressing experience. This fear can have devastating consequences, leading to vaccine hesitancy and outbreaks of preventable diseases. Our research aims to reduce the negative impact of needle procedures in children. We aim to test 2 different strategies – using attention and using positive language to reframe memory – for their ability to reduce needle pain and fear in children aged 8-12 years of age undergoing flu vaccination in South Australia. Importantly, we will also test if these strategies, when combined together, have even greater effects. Children’s memories of needle-related pain are a powerful predictor of future pain experiences. Memory of pain can be distorted (recalling higher levels of pain than initial pain reports) and this is associated with higher subsequent pain, distress and worse medical compliance. Children’s memories for pain can be changed through use of positive language to reframe memory of past painful experiences. These interventions involve talking to children for a few minutes to emphasise the positive aspects of a past painful experience, correct exaggerations in recall, and increase their self-efficacy in their pain coping. We want to test the effect of such an intervention for flu vaccination related pain intensity and pain-related fear. We can also reduce the pain and fear associated with needles by reducing how much the needle hurts. Attention and expectation can impact how much something hurts. Recent work has shown that even small shifts in attention can reduce pain. For example, when you expect to feel something in one of two locations on your skin (so you have to pay attention to both locations), a stimulus provided between those two locations hurts less than when your attention is not divided. Because you feel needle pain in one small area of skin, dividing attention may be useful to reduce the pain felt from a needle merely by taking advantage of the way our nervous system works. We will recruit a minimum of 40 children that have consented to undergo flu vaccination. They will be randomly assigned to 1 of 4 groups – using positive language, dividing attention, both, or neither (usual standard care). An experienced paediatric nurse will provide the flu vaccinations and we will measure how much pain (intensity) and fear (pain-related) that children expect at baseline, how much pain/fear they experienced during the vaccination, how much pain/fear they remember experiencing (measured 2 weeks after the vaccination), and how much pain/fear they expect for a future vaccination. We will also explore feasibility in terms of : recruitment rate, retention rate, feasibility/acceptability of the interventions (based upon parent, child, nurse experiences) and fidelity of the intervention provision.

  • Study evaluating the efficacy of: 1. Olaparib and cyclophosphamide followed by olaparib and durvalumab, or 2. Olaparib followed by olaparib and durvalumab, or 3. Olaparib in ovarian cancer patients.

    Study purpose The purpose of this study is to test new combinations of drugs for ovarian cancer that has come back after first-line treatment. The new combinations of treatment include olaparib given by itself, olaparib given with an antibody (durvalumab), or olaparib given with chemotherapy (cyclophosphamide) and then with an antibody (durvalumab). These new combinations may slow the progression of the cancer and delay the time until chemotherapy treatment is needed. Who is it for? You may be eligible for this study if you are a female aged over 18 years and have a histologically proven diagnosis of high-grade serous or carcinoma of the ovary, fallopian tube or peritoneum, at first asymptomatic CA125 progression which responded to platinum-based chemotherapy. Study details Participants will be randomly assigned (by chance) to one of three treatment groups. One group will receive two medications, olaparib taken by mouth twice a day, followed by durvalumab given into a vein and at the same time olaparib, then olaparib only. The second group will receive three medications, olaparib taken by mouth twice a day and at the same time cyclophosphamide taken by mouth once daily for 5 days of every week, followed by durvalumab given into a vein and at the same time olaparib, then olaparib only. The third group will receive one medication, olaparib taken by mouth twice a day. Participants will attend a number of hospital visits to give blood and answer questionnaires about their quality of life. It is hoped that this research may help people in the future who have the same kind of cancer as you have.

  • DCD 1010 (PILOT STUDY): Validation Of A Spontaneous Breathing Test To Better Predict Time To Circulatory Death In Organ Donation Candidates (Safety And Feasibility Study)

    This study aims to establish a simple, safe, bedside test to better determine which patients are most suitable for organ donation following circulatory death. The DCD 10-10 test is a 10 minute spontaneous breathing trial which aims to determine respiratory drive in these patients, it is hypothesised that this test will be predictive of which patients will die within 90 minutes post withdrawal of cardiorespiratory support. This 90 minute time frame is essential for ensuring organ viability for donation. The DCD 10-10 Pilot Study is a safety and feasibility trial on a small sample of patients, it aims to ensure the DCD 10-10 test is safe and can be easily performed in the organ donation setting. It will also test software used for data collection and gather some early descriptive statistics on the sensitivity and specificity of the test and patient factors that correlate to time of death.

  • The Centralised Specialist Cancer SurvivOrship (CISCO) Assessment Unit - an implementation study for transition to primary care

    This study is evaluating a Centralised Specialist Cancer SurvivOrship (CISCO) Assessment Unit for people who have completed curative therapy. Who is it for? You may be eligible for this study if you have a histologically confirmed diagnosis of early breast cancer or ductal carcinoma and are completing or have recently completed chemotherapy and/or radiotherapy. Study details All participants will complete a series of questionnaires and have a consultation with a survivorship specialist team, who will provide information for ongoing cancer care and symptom management. Participants and their general practitioner will receive a care plan (called a survivorship care plan (SCP)) to easily manage their follow up care together. Supportive resources will be reviewed and pathways for contacting the oncology service will be established. Participants will be followed-up 6-12 months later and complete some questionnaires to evaluate the CISCO assessment unit. It is hoped this study will establish the feasibility and acceptability of the CISCO model and improve the transition from cancer care to primary care for patients who have completed treatment.

  • Exploring physiological and metabolomic changes with sauna and exercise in healthy young volunteers

    The purpose of this research study is to investigate the changes in cardiovascular function and contents of sweat and urine in healthy young adults after a single session of Finnish-style sauna, far infrared sauna and exercise in comparison to a control resting activity.

  • Improving the cardiometabolic health of people with psychosis: The Physical Health Nurse Consultant service

    Individuals experiencing psychosis are 2-3 times more likely to have comorbid cardiometabolic illness, and die 10-25 years prematurely compared to the general population. Despite this, consumers receive rates of cardiometabolic care as low as 3%. There remains a critical implementation gap around delivering a high standard of cardiometabolic care within Australia’s current health service and policy landscape. Based on the best available evidence and preliminary studies, our team developed the Physical Health Nurse Consultant (PHNC) service that is offered alongside usual mental health care. The PHNC service offers cardiometabolic assessment, risk management and care coordination, and overcomes barriers including stigma, consumer disempowerment and lack of specialist health knowledge. The objective of this project is to evaluate whether the PHNC role alongside usual care (compared to usual care alone) results in improvements in Burden of Disease risk factors, consumer experience of care, and cost-effectiveness in an 24 month, 2 group RCT. Evaluating consumer experience is a key innovative feature of the methodology that addresses a critical knowledge gap around the influence of consumer experience and participation in care on Burden of Disease risk factors. Outcomes are expected to result in a significant advance in knowledge on implementing and delivering physical health care within mental health services. Outcomes will also have a substantial impact on health policy given the National Mental Health Commission is seeking solutions for this priority issue. Our experienced project team includes highly influential senior members and an outstanding early career researcher with a depth and breadth of expertise that includes mental health nursing, psychiatry, consumer participation, health economics, statistics, health services and physical health research.

  • Mirena for treatment of polyps

    Objective – To test the hypothesis that the LNG-IUD can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women. Design - We designed a case control study, in which premenopausal women who had a polyp diagnosed at outpatient hysteroscopy and had a LNG-IUD inserted were booked for GA hysteroscopy and polypectomy through the standard booking process. A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case. Results - A total of 39 patients were included in the study, with 19 in the exposed group and 20 in the control group. The mean age was 43.6 (SD = 5.6) and 43.2 (SD = 8.1) in the two groups, respectively. No difference was found in time interval between the two procedures in the intervention and control groups (mean 92 vs 84 days, p=0.73). However, the proportion of polyps present at second procedure was significantly higher in the control group (80% vs 37%; relative risk (RR) 2.17; 95% CI [1.16, 4.07]; p=0.0062). Conclusion – Our case control study found that the LNG-IUD can have a role in the treatment of polyps for women who have heavy menstrual bleeding. This is the first study to show regression of endometrial polyps post treatment with LNG-IUD by direct visualisation at hysteroscopy.

  • A Participant Rotation Magnetic Resonance Imaging Study

    Background: Current radiation therapy requires a radiation beam to be rotated around a patient. An alternative approach is to rotate a patient while the radiation beam remains stationary. Such a system may greatly reduce the costs of radiation therapy and would simplify the incorporation of radiation therapy with Magnetic Resonance Imaging (MRI), which would allow therapists to deliver treatment with greater precision. Since this approach has never been utilised for either radiation therapy or in combination with MRI, the acceptance of the rotation to cancer patients is not known. It is also unclear how this rotation will impact the position and shape of the body’s internal organs and subsequently on the radiation therapy. The rotation will have no impact on the organ functions. This study aims to bring patient rotation in MRI closer to reality, which would reduce the costs and complexity of radiation therapy. The participant rotation device used for this study is not a medically approved device. All other devices used in the study, including the MRI, are medically approved. Who is this for? You may be eligible for this study if you have a current or previous diagnosis of cancer. Study Details: The study will be discussed with you at the time of your clinic appointment or prior to the MRI imaging session. You will have the opportunity to discuss the study with a qualified physician. Written informed consent will be obtained prior to registration on the study and before any assessments are performed. Prior to the MRI imaging, you will be asked to complete a questionnaire, where you will be required to rate your current levels of anxiety, claustrophobia and motion sickness. The questionnaire will take approximately 5 minutes to complete. During the imaging session, you will be asked to lie down on the couch on your back, supported by cushions under your back, head and knees. You will then be fastened with belts around the legs, across the chest and across the forehead and will be made as secure as possible without causing discomfort. Once you are comfortable, three inflatable air-cushions will be placed around you, the air cushions will then be inflated to support the weight of your body and restrict movement during the rotation. You will then be inserted into the MRI by the clinical investigators. They will then manually rotate the device to 45 degrees, and reposition you back in the MRI bore for each scan. The device will not rotate during the imaging.The whole imaging session should last approximately 40 minutes. You will be monitored constantly during the study in addition to holding a distress buzzer. Following the imaging, you will again be asked to complete the questionnaire to assess any change in your levels of anxiety and motion sickness. At the end of the session you will be asked a series of open ended questions relating to your experience. The full session will take 2 hours.

  • INB03 for patients with metastatic cancer with increased inflammatory biomarkers in peripheral blood

    The purpose of this study is to determine the safety and tolerability of INB03 in patients with metastatic cancer. Who is it for? You may be eligible for this study if you have epithelial cancer of the lung, breast, upper or lower gastrointestinal tract, kidney, or skin (melanoma only). Study details. All participants will receive INB03 subcutaneously once a week for up to 9 months. There will be three groups who each receive a different dose. As a part of the clinical research study patients will have regular blood tests, physical examinations, will have to complete short questionnaires on their depression, sleep and fatigue. This is first in the human clinical research study and its results will help to determine if INB03 is safe and is tolerated well. Dose of INB03 selected in this study will be used in future study intended for patients with metastatic cancer.

  • Airway collapsibility as an indicator of perioperative adverse event risk and obstructive sleep apnoea

    This project is an observational study assessing upper airway collapsibility and peri- and post-operative adverse events in patients undergoing surgery not related to the head, neck, airways or chest. Demographic and anthropometric (height, weight, neck circumference, Mallampati) information will be recorded and a STOP-Bang assessment performed prior to surgery in all consenting patients. Following surgery, prior to transfer to the recovery room, assessment of airway collapsibility will be performed using the Pclose technique. In addition, all adverse events including respiratory adverse events (respiratory depression (rate & depth), desaturation events, requirement for re-intubation or other medical intervention including unplanned initiation of positive airway pressure therapy) will be documented as well as length of stay in hospital and planned and unplanned intensive care unit or high dependency unit admissions. Within 3 weeks of surgery, sleep apnoea severity will be ascertained in a subgroup of consenting participants with a reliable home monitoring device (ApneaLink). The expected outcome of this research is to demonstrate that Pclose is a suitable method for quickly identifying the presence of abnormal airway collapsibility in surgical patients and that airway collapsibility, as measured by Pclose, is greater in those people who experience post-operative adverse events. This will then potentially enable high-risk patients to be stratified to the appropriate level of care and improve post-operative patient safety. It is hypothesised that more adverse respiratory events will occur in those patients with the greatest airway collapsibility. In addition, a measure of airway collapsibility in the early post-operative period may provide a useful tool for identifying patients at high risk of OSA beyond the perioperative period. In those patients, it is hypothesised that airway collapsibility will be greatest in those with the most severe OSA and lowest in those patients without OSA.

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