ANZCTR search results

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

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31196 results sorted by trial registration date.
  • Reversing malnutrition with targeted enteral feeding in patients awaiting liver transplantation: a randomized controlled trial

    Malnutrition is a common problem in patients waiting for a liver transplant and can impact their health both before and after transplantation. Malnutrition prior to transplant can be caused by poor dietary intake due to the symptoms of chronic liver disease, altered metabolism of nutrients, or malabsorption. Poor nutritional status can be identified by weight loss, muscle wasting, poor appetite, and/or blood tests. Patients with malnutrition who are waiting for liver transplant are encouraged to eat a high calorie and protein diet with additional supplement drinks, to help meet their extra nutritional needs. However, most patients are not able to consume enough of their usual meals and extra supplements to meet these needs, which can worsen malnutrition and influence recovery after surgery. Many studies have shown that malnourished patients undergoing liver transplant have a longer hospital length of stay, have an increased number of infections, increased incidence of rejection, and are more likely to be readmitted to hospital in the early months after transplant. Patients with malnutrition awaiting liver transplant who aren’t able to eat or drink enough may therefore need a different way to meet their nutrition needs. Enteral nutrition (nutrition fed by a ‘nasogastric’ tube (NGT) directly into the stomach) is the preferred way for these patients to receive all the energy, protein and nutrition they need, and can be undertaken in both hospital and at home. The aim of this study is to determine if NGT feeding before liver transplant helps improve outcomes for patients with malnutrition. Patients will be randomised to either NGT feeding while awaiting transplant, or standard high energy and protein diet (current practice). Patients in the NGT group will have a NG feeding tube inserted and receive feeds overnight to meet 75% of their nutrition needs. They will also be allowed to eat and drink throughout the day (to meet the other 25%). Patients in the diet group will be advised by the dietitian to eat high energy and protein foods and fluids (target 100%), which is the current standard practice for patients before liver transplant. If NG feeding is effective, it may minimise the loss of weight and muscle strength that commonly occurs before transplant; and has the potential to reduce patient length of stay, and reduce episodes of infection and rejection after transplant.

  • Compare and contrast of two prostate-specific membrane antigen (PSMA) PET tracer aids for detecting and staging prostate cancers.

    The purpose of this study is to determine if the radio-tracer 18F-PSMA-1007 has similar diagnostic accuracy to the radio-tracer 68Ga-PSMA-11 in patients with prostate cancer metastasis. Who is it for? You may be eligible for this study if you are aged 60 and above and currently have prostate cancer. Study details. Participants will receive a PET scan using the radio-tracer 68Ga-PSMA-11 as normal standard-of-care. Participants will be asked to return for a second PET scan within two weeks of the first PET scan. This second PET scan will be performed using the radio-tracer 18F-PSMA-1007. The only tests involved with this study will be PET scans. By comparing the two radio-tracers (68Ga-PSMA and 18F-PSMA) we hope to validate the use of 18F-PSMA for diagnostic use in screening and staging prostate cancers. 18F-PSMA has slightly different properties to 68Ga-PSMA that will make it a more versatile tool for diagnosing prostate cancer. Its longer half-life means that 18F-PSMA will be able to be shipped to regional centres to be used instead of cancer patients having to travel to a large metropolitan hospital.

  • The effect of using a peanut ball with women having epidurals during labour.

    The aims of this pilot study are three-fold: the practicality of conducting a formal trial and information needed including recruitment rates, to determine whether using a peanut ball for pregnant women who have an epidural during labour makes clinically significant different outcomes and inform whether to conduct a larger randomised controlled trial (RCT) to establish clinical and statistical significance. The assessment of endpoints is to determine if the peanut ball makes clinically significant different outcomes by comparing the intervention group that uses the peanut ball and the control group that does not use the peanut ball. Specifically it asks: Is there a difference between women using the peanut ball and those who do not in the rate of vaginal births? Is there a difference between women using the peanut ball and those who do not in the length of labour? Is there a difference in health service usage between arms, regarding staff time, medications, procedures and length of stay in hospital. Is there a difference in experience in labour, including health related quality of life? We hypothesise that placing the peanut ball between the labouring woman’s legs who has an epidural may facilitate the progress of labour (Tussey et al., 2015) and would be more likely to have a vaginal birth as opposed to a caesarean birth. We also hypothesise that women’s views about their own experience and health related quality of life will be more positive. Evidence of these outcomes will be evaluated more closely in the larger randomised control trial.

  • A phase I study investigating the mean circulation time, biodistribution and safety of an infusion of cultured red cells (CRC) in patients with myelodysplastic syndrome (MDS) or patients in remission from haematologic malignancy

    This is a phase I study investigating the mean circulation time, biodistribution and safety of an infusion of cultured red cells (CRC) in patients with MDS or patients in remission from haematologic malignancies CRCs are enucleated red cells (reticulocytes) that are grown in culture from donor human haematopoietic stem cells. The collection, manufacturing and administration process used for CRC reduces the risks of infection and immune mediated transfusion reactions associated with traditional blood product administration. This trial will be conducted in patients with very low and low-risk MDS or previous haematologic malignancy in remission and not on active treatment and who are able to undergo infusion of CRC and who fulfil all of the other protocol-defined eligibility criteria. This is a single centre, Peter MacCallum Cancer Centre (PMCC) Study outline: The study will recruit four patients in the initial treatment phase. These patients will have a single infusion labelled cultured red cells at a dose of 0.7-1.5 x10^10 cells. They will be labelled with chromium and a cell surface marker called biotin. Following infusion the patients will undergo blood sampling, surface scanning, clinical review and physical examination at predefined intervals to determine mean circulation time of the red cells and evidence of distribution throughout the body. The Data Safety Monitoring Board will review the safety data, circulation times and biodistribution after the fourth patient’s day 27 post infusion assessment has been completed and make a recommendation on safety to proceed to expansion phase. The Principal Investigator and the Clinical Study Oversight Group will determine need to pursue the expansion phase in which up to six additional patients may be recruited. Patients in the expansion phase will be treated and evaluated in the same way as those in the initial phase. Up to 10 patients in total may be treated on this protocol. Mean CRC circulation time (mCCT) and biodistribution will be determined from data collected in the first 27 days post infusion using the 51Cr label. Patients will be monitored until 120 post infusion to monitor for mCCT, alloantibody development and delayed transfusion associated reactions. This Phase 1 study aims to determine the mean circulation time, biodistribution, safety and tolerability of CRCs in these patient groups. It is anticipated that the technology in this study will be used in the development of Red-Cell Therapeutics that will act as a protein/drug delivery mechanism in the treatment of a wide range of diseases.

  • Natural products to lower cholesterol

    This project will investigate the role of natural plant and food-derived compounds (nutraceuticals) and their ability to lower cholesterol levels in high-risk patients who are unable to take standard statin therapy due to side effects. It is expected that a combination of natural compounds with known cholesterol lowering ability will reduce cholesterol levels in this high-risk population. When taken in conjunction with non-statin pharmacotherapy, these natural compounds will offer additional benefits, including additive reduction in cholesterol levels. In addition to helping these patients achieve cholesterol targets, these natural compounds will prevent the development of side effects associated with statin use, leading to greater adherence to their medication regime and an overall reduction in the risk of heart disease. Given the prevelance of heart disease within the Australian population and the need to identify alternative treatment options to lower cholesterol, the findings of this study will have enormous significance and translation potential for clinical practice.

  • Myeloma and Related Diseases Registry

  • Dexmedetomidine in delirium at the end of life

    Patients near the end of life may suffer from delirium that can be difficult to control; with up to 88% of inpatients in palliative care units suffering from a terminal delirium. The current practice within the Illawarra Shoalhaven Local Health District (ISLHD) for patients suffering from a terminal delirium is to first attempt to reverse or treat any causes found, such as urinary retention and pain. If delirium proves to be irreversible, patients are typically given a continuous subcutaneous infusion (CSCI) of a benzodiazepine (midazolam), often in combination with an antipsychotic medication (haloperidol), with the aim of providing sedation to alleviate distress. If these medications are unable to alleviate a terminal delirium, the medication can be altered to include an infusion of levomepromazine, an antipsychotic, or phenobarbital, a barbiturate. With the above regimen, the majority of patients with terminal agitation will find symptom relief but will often become unable to eat, drink or interact with their loved ones. Patients who currently suffer with terminal delirium admitted to the Port Kembla palliative care unit are provided with symptom relief via CSCI of midazolam infusion, with escalation to other agents per the European Association of Palliative Care (EAPC) framework for sedation in palliative medicine. Prognosis for patients with a terminal delirium is measured in a number of days to a week, and rarely extends beyond that timeframe. Patients suffering from worsening delirium and agitation, however, are often still verbal but the intractable nature of their suffering means that deeper sedation is the only current way available to provide them peace and dignity. Access to an option that may provide some resolution of the delirium without as deep a sedation so that the patient could interact with family and friends would be of benefit in these circumstances. Dexmedetomidine is a novel agent for managing intractable symptoms in palliative medicine towards the end of life. It has the attribute of decreasing the frequency and severity of delirium, as well as analgesic benefits to assist in the management of pain and delirium. Of particular interest to patients towards the end of life who would like to continue to communicate with loved ones and be involved in decision-making is the potential ability to be woken when dexmedetomidine is utilised for sedation instead of midazolam, levomepromazine or phenobarbital. These features have been well studied in anaesthesia and in the ICU, with only case reports in palliative medicine. Given the gap in knowledge we propose a Phase 2 trial for the utilisation of dexmedetomidine via CSCI in patients with a terminal delirium in an inpatient palliative care unit. The goal of this study is to answer the following question: does dexmedetomidine provide effective relief from confusion and delirium at the end of life, with rousability, as assessed on standardised delirium and rousability scores

  • A comparison of high versus low intensity exercise for symptoms of knee and hip osteoarthritis

    Osteoarthritis (OA) of the knee and the hip is an important health issue in the senior population since it causes chronic pain, reduces physical functioning and has a negative effect on quality of life. Different types of exercise intervention programs have shown a beneficial effect on OA symptoms. However, only few studies tested the effect of high load resistance training in OA patients. Observational data from The Bone Clinic suggests that our bone exercise program, consisting of high load resistance training plus impact weight bearing is not only beneficial for bone but also for OA symptoms. This study aims to formally test the effect of our bone exercise program in combination with balance exercises on pain, physical function and quality of life in people with knee or hip OA.

  • Examining the helpfulness of an internet-delivered program for stress, anxiety, low mood and depression among University of Queensland (UQ) students.

    The proposed project builds on a program of research that has resulted in a highly acceptable and effective internet-delivered treatment program, the UniWellbeing Course, for university students experiencing symptoms of stress, anxiety, low mood and depression. The proposed project seeks to examine the acceptability, effectiveness and feasibility of the UniWellbeing Course when offered by the University of Queensland (UQ) Counselling Service to their students. Students will be supported through the program by staff at the UQ Counselling Service with training, support and supervision provided by the eCentreClinic, Macquarie University. The eCentreClinic Team will be responsible for providing training around the use of the course, and the scientific evaluation of the program within the service.

  • Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.

    Background Uncemented stems in primary total hip replacement (THR) are increasingly popular. The purported benefits of uncemented primary THR relate to improved stability and less side effects of cement implantation. However, concerns remain with the use of uncemented press-fit stems in primary THR. Methods From 2013-15, a total of 98 consecutive participants (100 primary THR procedures) were inducted into a single-institution, single-blinded, randomised clinical trial assessing, with radiostereometric analysis, whether autologous impaction bone grafting in uncemented primary THR reduced femoral component migration compared with traditional uncemented primary THR technique. Secondary outcomes comparing the two techniques were postoperative proximal femoral bone density (using dual-energy X-ray absorptiometry), function and quality of life (using Oxford Hip Score and Short Form-12 Health Survey), patient satisfaction, and hip pain (using visual rating scale). Results There was no difference in femoral component stability between the Graft and No Graft Groups at 2-years (p>0.5). There was no difference in calcar resorption between the Graft and No Graft Groups at 2-years (p>0.16), with both groups experiencing calcar bone loss. There was no difference in patient-reported pain, quality of life, function, or satisfaction postoperatively between the Graft and No Graft Groups at 2-years (p>0.3), with both groups improving in all measures. Conclusion Autologous impaction bone grafting in uncemented primary THR has shown its short-term postoperative outcomes to be on par with traditional uncemented technique. The next phase of research regarding this autologous impaction bone grafting technique will be to expand its application from Type-B femora into the elderly population with Type-C femora.

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