ANZCTR search results

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.

This observational study is collecting information from patients to form the Myeloma and Related Diseases Registry (MRDR) Who is it for? You may be eligible for this study if you have a diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of undetermined significance (MGUS). Study details Medical information including diagnostic tests, therapy and demographics will be provided by medical records. Participants can also provide information regarding their quality of life using a questionnaire. It is hoped this registry will enable clinicians and hospitals to provide the best possible care to people with the included conditions and allow the evaluations of new therapies.

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

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.

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.

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.

This study is to assess whether photobiomodulation is beneficial in treating Retinitis Pigmentosa (RP). Photobiomodulation is a low level laser therapy that is used to treat varying conditions by stimulating cell functioning. Lasers are routinely used and are approved in Australia for treating differing eye conditions. These lasers are called Thermal Lasers and are usually green in colour. They are applied to the retina through a special type of microscope and many laser spots are individually placed over the affected area. In all cases, these lasers work by burning small areas of the retina in order to trigger the required healing response for the affected cells. We are trying to assess the effectiveness of a new type of Near Infrared (NIR) laser that is about 100 times lower in power density than a Thermal Laser. The NIR laser causes no burn; however, it appears to stimulate a healing response to injured cells, including blood vessels and neurons in the retina, resulting in a protective effect on cone cells. This treatment is not yet approved for use in Australia, although it has been tested in research studies overseas. The purpose of the trial is to determine if NIR laser has an acceptable safety profile to treat patients with RP. The study will last for approximately 6 months with up to 11 study visits. Each visit will take up to 1 hour depending on the assessments involved. There will be a total of 2 laser treatments within a 1 week period for 4 weeks. After the completion of the laser treatment there will be a visit 4 weeks later to repeat the same checks as the baseline visit, and again at 6 months. This is a research study, and NIR Laser therapy is not registered for use in patients with RP in Australia at the present time and may never be registered. If this treatment becomes registered, then it may not be subsidised by the Medicare Benefit Scheme (PMBS) in Australia. The Investigators cannot commit at this stage to provide this as ongoing treatment after the study is over.

The study is a phase 1, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacokinetics of multiple-ascending doses of PRAX-114 in healthy subjects. In addition, potential metabolites of PRAX-114 will also be evaluated.

The aim of this study is to identify and categorize barriers and facilitators to the use of guidelines in the management of bronchiectasis and to clarify current bronchiectasis care. Objectives: 1.To examine sample populations of health professionals and patients working or living with bronchiectasis to determine their attitudes to bronchiectasis management and the use of guidelines. 2.To examine opinions to bronchiectasis guideline specific areas of patient management including action plan/ emergency pack use, vaccination, sputum clearance, use of antibiotics, impact of co-morbid disease, clinical assessment and documentation of review. 3.To explore patterns and common themes in attitudes to bronchiectasis management and use of guidelines Study design: Questionnaires and semi moderated guided interviews will be conducted to obtain quantitative, semi quantitative, and qualitative data from participants. Participants will be health professionals (Respiratory physicians, respiratory nurses and respiratory physiotherapists) and bronchiectasis patients. It is expected recruitment will be between 12-18 people from each of these 2 groups. If data saturation is not reached more participants will be recruited. Study procedure At interview participants will bring consent form and sign, answer the questionnaire and then take part in the semi structured interview. Bronchiectasis patients will complete an additional Quality of life assessment using the quality of life bronchiectasis questionnaire. A eFACED severity score will also be calculated for patients to allow grouping of patients responses with like disease severity/ impact. Data Analysis Transcribed interviews will be coded by 2 researchers using deductive thematic analysis to categorise the responses into the 18 Domains of the Theoretical Domains Framework. Date will be analyses using IBM Statistical Package for Social Science (SPSS) Statistics Version 24.0. for quantitative data and coded responses will be entered and analysed in NViVo software version 11.0. Data collected will be safely and securely managed. Audio recordings will be kept for 15 yrs, data will be de-identified through use of a study code. All data will be stored securely with password protection on secure network or locked filling cabinet accessible by trial researchers only.

The purpose of this study is to evaluate the effectiveness of paraesthesia-free (sub-perception) waveform patterns for patients with chronic neuropathic low back pain.