ANZCTR search results

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

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31097 results sorted by trial registration date.
  • Safety and Efficacy of a single or multiple intra-articular injections of hyaluronic acid in osteoarthritis.

    The patients from which this data will be drawn were referred to the clinic by their general practitioner with symptomatic joint osteoarthritis for whom injection of hyaluronic acid (Durolane) was found to be the most appropriate treatment. This data is collected on all patients undergoing such injections as a routine pre and post injection measures of their pain and function. For those who had more than one injection, the time in days between injections will be analysed. Patient data will be included in the analyses if they were >18 years old with painful hip osteoarthritis and mild to moderate radiological changes on their imaging. There was no maximum age limit applied to the inclusion criteria. There were no specific inclusion or exclusion criteria in regards to race and gender. The current data set of the patient cohort intended for analysis was collected over 4 years.The data from these patients who have recieved Durolane injections in normal clinical practice will be analysed retrospectively.

  • Web-based low carbohydrate dietary intervention for adults with type 2 diabetes

    The purpose of this research is to assess the effectiveness of a 16-week web-based low carbohydrate diet program for adults with type 2 diabetes, toward facilitating improvements in glycaemic control, assessed on primary outcome HbA1c. In addition, dietary intake data and self-efficacy will be assessed, along with changes in weight, anti-diabetes medication and diabetes-related comorbidities. Study recruitment will occur online across Australia, with the aim of recruiting 100 adults with non-insulin dependent type 2 diabetes aged between 40-89 years. Participants will be randomised to standard care plus web-based intervention or standard care only. Participants will be provided with login details to the intervention website to access weekly structured behaviour change modules and on demand resources that assist participants to practically implement a low carbohydrate diet. An assessment of participants' experience of and engagement with the intervention will also be explored after the intervention.

  • A pilot study investigating the safety and feasibility of embolising the left gastric artery to aid rapid weight-loss in morbidly obese patients awaiting elective surgery.

    This pilot study will assess if blocking the blood supply to part of the stomach (known as a left gastric artery embolisation procedure) is feasible and can be performed safely in a small group of obese patients who are awaiting elective surgery. Blocking up the blood supply to a portion of the stomach reduces the production of the hormone that stimulates appetite (called ghrelin). Lower ghrelin levels in the blood stream have been shown to reduce the "hunger drive" and consequently reduce calories consumed, making dieting more effective and speeding up weight-loss. It is common for elective surgery in obese people to be delayed until they lose weight, and this procedure may help these patients to reach their weight-loss goals earlier. This study may provide information necessary to complete larger studies assessing the effectiveness of left gastric artery embolisaton as a complimentary weight loss technique.

  • A Phase 2 clinical trial to assess the safety and efficacy of ACT001 in combination with whole brain radiation therapy (WBRT) for participants with brain metastases from solid tumours.

    This study will evaluate the safety and tolerability of ACT001 in combination with standard of care whole brain radiation therapy for patients with metastatic brain cancer (cancer that has spread to the brain from another body part). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with secondary brain metastases (cancer lesions that have spread to the brain) from solid tumours including non-small cell lung cancer, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers, and you are eligible to undergo whole brain radiation therapy. Study details Participants will be asked to take 4 oral capsules of the study drug-ACT001 twice a day for up to 18 weeks. Standard care whole brain radiation therapy sessions will be scheduled to start 2 weeks after the first dose of ACT001, participants will continue to self-administer the daily doses of ACT001 until the end of the 18 week study period. During the study participants will be asked to attend a study clinic to report any unexpected side effects they experience during the study, and to complete quality of life questionnaires. Additional doses of ACT001 will be given to participants during these visits so that they can continue to self-administer the drug at home. All participants who are enrolled in this study will be asked to undergo a pre-treatment MRI, followed by two post-treatment MRIs at week 10 and week 18. It is hoped this research will demonstrate that ACT001 is safe and effective in treating patients with metastatic brain cancer, and is able to protect healthy cells during whole brain radiation therapy.

  • THE SCRIPT (Snp Cancer Risk Prediction) TRIAL: A STUDY OF DNA TESTING TO TAILOR BOWEL CANCER SCREENING IN PRIMARY CARE

    The SCRIPT Trial: A study of DNA testing to tailor bowel cancer screening in primary care. What is the purpose of this research? In Australia anyone aged 50-74 should have some sort of bowel cancer screening. People at increased rick of bowel cancer should start screening earlier. Screening is a highly effective way to diagnose bowel cancer earlier and save your life. There are two main ways you can be screened for bowel cancer, by FOBT (or poo test) or colonoscopy. Depending on your risk of getting bowel cancer, the age when you start and the type of bowel cancer screening will vary. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 70 years who have not previously been diagnosed with bowel cancer. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of bowel cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self collected mouth swab. After this the participant is placed at random into one of two groups. Randomisation means that you are put into a group by chance, like the toss of a coin. Neither the participant or their doctors can chose which group. If in the intervention group, after 2-3 weeks the participant will meet with the researcher at the GP practice or by phone to discuss the DNA test results. They will be given a report summarising their bowel cancer risk and screening recommendations to be discussed with their GP. For the control group, they will have a consultation with the researcher to discuss cancer risk, lifestyle factors and bowel cancer screening options. They will be given the option to receive their bowel cancer risk results after 12 months from recruitment. Follow up questionnaires will be sent to all participants at 1, 6 and 12 months after recruitment.

  • Early and intensive motor training (versus usual care) to enhance neurological recovery and function in people with spinal cord injury (SCI)

    A multi-centre pragmatic randomised controlled trial will be undertaken to compare 10 weeks of early and intensive motor training with usual care for people with recent SCI. The primary endpoint will be Total Motor Score (/100 points) at 10 weeks to reflect neurological recovery. Secondary endpoints will be other measures of neurological status, the Spinal Cord Independence Measure (SCIM), ability to walk, psychological status, time to discharge, improvement on self-selected goals and participants' impressions of therapeutic benefit/change at 10 weeks and 6 months.

  • Evaluation of a novel stress mitigation method on the effects of stress on clinician physiology and decision-making during resuscitation

    Team leading the resuscitation of a seriously injured or critical unwell patient can be stressful and this stress may affect the clinician’s ability to perform optimally, potentially adversely affecting patient care. Our recent systematic review of the literature revealed a paucity of studies looking at strategies for mitigating the effects of stress on clinician performance and this randomised controlled study will look at whether the deleterious effects of stress on clinician performance can be mitigated by a novel stress mitigation method. Our plain language research question: During a simulated stressful resuscitation can a novel stress mitigation method ameliorate the effects of stress on: 1. Objective physiological stress measures 2. Subjective stress assessment 3. Decision-making performance The primary outcome will be the ability of the intervention to ameliorate the change in physiological stress measures (based on real-time assessment of participants heart rate variability (HRV) during the simulated scenario as compared to their baseline). Secondary outcomes will be subjective measures of stress as well as an assessment of the effect of the intervention on the decision-making performance related to the scenario.

  • Efficacy and Cost Effectiveness of Remote Monitoring in Patients with Implantable Loop Recorders

    The study investigates the efficacy and cost-effectiveness of remote monitoring in patients with Implantable Loop Recorders, It is an observational study that collects data on time to detection of abnormal heart rhythms and clinical decision making in patients with and without remote monitoring attached to their devices. The utilization of health care resources (in-office visits) and cost-effectiveness of remote monitoring will be assessed.

  • Effects of a short burst of high-intensity exercise versus moderate-intensity exercise combined with restriction to blood flow to the exercising leg muscles on cardiovascular health in people with a combination of risk factors of cardiovascular disease (metabolic syndrome)

    Central arterial stiffness elevates one’s risk of developing hypertension and subsequent cardiovascular disease (CVD). There is also evidence to suggest that metabolic syndrome (MetS) may exacerbate central arterial stiffness (CAS). Alarmingly, MetS and arterial stiffness are both independent risk factors of cardiovascular events (CVEs) such as heart attack and stroke. Exercise-induced increase in cardiorespiratory fitness (CRF) has long been established as an effective antidote against both MetS and CAS, with its effect enhanced by higher exercise intensities. A more feasible modified version of the popular interval training known as reduced exertion high intensity interval training (REHIT), characterized by limited sprint durations and repetitions (2 x 20s sprints), has received much attention due to its health benefits yet time-efficient nature. Reports also show that BFR combined with lower exercise intensities can have favorable acute and chronic cardiometabolic adaptations. The aim of this study is to investigate the acute and chronic effects of REHIT compared to BFR moderate-intensity exercise on central arterial stiffness, metabolic severity, and other novel CVD risk factors in adults with MetS.

  • Do diagnostic x-rays for spinal pain in patients receiving chiropractic care change patient outcomes? A pilot randomised controlled trial.

    Many chiropractors believe that X-rays are needed to detect findings that will either contraindicate or change the application of spinal manipulative therapy. Without X-rays, these chiropractors believe that they may perform sub-optimal and potentially unsafe care. Although this belief is in contrast to recommendations in clinical practice guidelines, current evidence is unavailable to confirm or refute this belief. The limited research available indicates that X-rays do not improve outcomes in patients with acute low back pain when managed with usual medical care. No studies have assessed the effect of X-rays on patient outcomes when patient management includes spinal manipulative therapy. The effect of X-ray use on areas other than the low back, or on adverse events after spinal manipulative therapy have also not been examined. A large-scale fully powered effectiveness trial will provide important information to inform chiropractic clinical practice regarding the appropriate use of X-rays for spinal pain, to maximise patient outcomes and limit potential risks. This proposed pilot randomised controlled trial aims to provide critical feasibility data prior to performing a large-scale effectiveness trial. This study will inform the ability to recruit patients and chiropractors, the willingness of chiropractors to treat patients without X-ray, and the amount of patient loss to follow-up or cross-over rates.

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