You can narrow down the results using the filters
-
Isosorbide dinitrate and hydralazine in symptomatic systolic heart failure.
Isosorbide dinitrate and hydralazine have been shown in previous trials to be beneficial in heart failure patients. Previous haemodynamic based studies have been conducted with older forms of treatment of heart failure, and larger clinical studies have been largely focused on African Americans. The purpose of the study is to evaluate the effect of Isosorbide dinitrate and hydralazine on Pulmonary and left heart pressures in patients with symptomatic heart failure with documented pulmonary hypertension on comtemporary treatment. indirect assessemt of improvement will be evaluated with functional scores, and exercise distance. Patients meeting the study (inclusion and exclusion) criteria will be recruited via the cardiomyopathy service (outpatient)and inpatient ward at the Royal Melbourne Hopsital. Informed consent will be obtained. Screening phase of the study will include baseline investigations and the right heart study. Stabilisation phase takes place in next 2-4 weeks till stable doses of study medication achieved. Treatment phase will commence and parameters reassessed at end of study period.
-
Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?
The null hypothesis is: Women with pelvic pain and or dysmenorrhoea who undergo laparoscopy and insertion of Mirena IUS will have a reduction in symptoms of at least 50% at 12 months follow-up (primary point).
-
The acceptability, safety and tolerability of combined methadone-naloxone in methadone maintained individuals aged between 18 - 65
The acceptability, safety and tolerability of combined methadone-naloxone: Is oral methadone-naloxone indistinguishable from mono-methadone? Does injection of methadone-naloxone precipitate withdrawal? Robert Graham, Suzanne Rizzo, Kristy Korompay, James Bell Introduction: Daily methadone and buprenorphine dosing is associated with high costs and rigidity. Maintenance models that predominantly employ dispensed medication (i.e. unsupervised dosing) may be more cost effective and preferable to clients and health departments. However, takeaway doses are often used in unintended ways including being injected by the client or other persons. The addition of naloxone to methadone has the potential to discourage the diversion of takeaway doses. Aims: To ascertain the safety and tolerability of oral methadone-naloxone in a 50:1 ratio by investigating aspects of its pharmacokinetic and pharmacodynamic properties, and in a second study, to investigate the effectiveness of the combination in precipitating withdrawal when administered intramuscularly. Methods: A randomised phase II study, double-blind, crossover design was used for the oral study. 10 subjects attending methadone clinics who were on a stable dose of least 20mg methadone volunteered and were given either methadone-naloxone or methadone alone for 14 days and then switched to the alternative for a total of 28 day study period. The second study was a Phase II, single group before-after design. Five of the subjects from the first study were administered IM saline solution followed by IM 10mg methadone/0.2mg naloxone prior to their scheduled methadone dose and were observed for 60 minutes. In the absence of objective signs of withdrawal at 30 minutes, participants were administered an additional 20mg methadone/0.4mg naloxone intramuscularly and observed for a further 60 minutes. Findings: Oral methadone naloxone in a 50:1 ratio appeared to be well tolerated. The same preparation reliably precipitated opioid withdrawal upon injection among methadone maintained individuals.
-
A randomised study of a Nurse-led Intervention for Less Chronic Heart Failure: The NIL-CHF Study
The primary aim of this study is to develop a cost-effective health care program to prevent the development of Chronic Heart Failure (CHF). This unique and innovative study will examine the impact of a specialist nurse-led, multidisciplinary, home and clinic-based intervention for patients at high risk of developing CHF relative to usual post-discharge and community care. It will target patients aged > 50 years discharged from hospital with a broad range of cardiovascular disease states (including diabetes) in order to optimise their cardiovascular health. An appropriately powered randomised study will compare the composite primary end-point of incident CHF-related admission or all-cause mortality during 5-year follow-up.
-
Malnutrition, fuel utilisation and nocturnal carbohydrate supplementation in cirrhosis.
We aim to increase the understanding of how nutrition supplements interact with metabolism and fuel usage in advanced liver disease. The objective of this study is to investigate the impact of three different nutrition supplements on metabolic rate and fuel usage in people with cirrhosis. It is hypothesised that a cornflour supplement taken in the evening will improve fuel usage, as measured by indirect calorimetry, for cirrhotic patients compared to an evening snack that is nutritionally similar but without cornflour.
-
An evidence based assessment of rehabilitation strategies appropriate to persons with macular vision loss: functional outcomes and comparaitve cost analysis.
Vision impairment which affects macular vision has a severe impact upon a person’s ability to perform skills relating to activities of daily living. This ranges from ability to perform simple tasks such as self-grooming, to more complex skills such as reading or writing. The traditional method of vision rehabilitation for these patients has been the use of magnifiers. This intervention is widely used and is considered very successful. Nevertheless, it does have some limitations and is not necessarily appropriate for use in all situations. Another method of vision rehabilitation and one that can be used in conjunction with magnification is eccentric viewing strategy. Although there has been some research into the efficacy of this technique, it has not been widely studied. This study is unique in that it has investigated the impact of magnification intervention, eccentric viewing strategy and a combination of the two strategies, upon clinical measures. A non-intervention control group has been incorporated in this study. Use of a control group has not been reported in previous studies of vision rehabilitation interventions. A repeated measures random control investigation of 48 participants was undertaken. The participants were divided equally among 4 study groups. The Magnification group received assessment and instruction in the use of magnification, the Eccentric Viewing group received training in eccentric viewing strategy, the Combination group received both interventions and the Non-intervention group received no intervention for the 8-week study period. Outcome measures included reading print size, reading speed, comprehension, performance of activities of daily living and self-reported goal achievement measures. Whilst economic studies into the costs of medical treatments, screening programs and costs of vision impairment have been reported, no study to date has investigated the direct cost of providing vision rehabilitation in the form of magnification or eccentric viewing intervention. A comparative cost analysis was conducted as a component of this study in order to measure the direct costs involved with each rehabilitation strategy. Results indicate that, whilst both magnification intervention and eccentric viewing training are effective rehabilitation strategies, a combination of both techniques is the most effective and cost efficient.
-
Laparoscopic Approach to Cervical Carcinoma
We are conducting a Phase III Randomized Clinical Trial Comparing Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer. The primary objective of this study is to compare disease-free survival amongst patients who undergo a total laparoscopic or robotic radical hysterectomy (TLRH/TRRH) versus those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer. Method 1 is the standard approach worldwide and consists of a laparotomy where the abdomen is opened through a vertical incision or a lower transverse incision and the uterus, the upper one to two centimetres of the vagina and soft tissue around the cervix are removed. Method 2 is a relatively new method where the operation is performed laparoscopically. The rationale for the study design is that Total abdominal radical hysterectomy (TARH) and pelvic lymph node dissection (± aortic lymph node dissection ± postoperative [chemo-] radiotherapy) is the current standard treatment for early cervical cancer. While this is an accepted effective treatment, a laparotomy is highly invasive, visibly scarring and is associated with tissue trauma, blood loss and a significant risk of wound and infectious adverse events. Additionally, radical hysterectomy by laparotomy is associated with an average hospital stay of approximately 5 to 7 days and an average recovery period (from surgery) of 5 to 6 weeks. Laparoscopic/Robotic techniques have been demonstrated to be feasible and safe with previous retrospective studies on Total Laparoscopic/Robotic Hysterectomies showing encouraging results. In a number of retrospective and prospective, non-controlled series the incidence of treatment-related morbidity was less in patients who had a laparoscopic/robotic hysterectomy compared to patients who underwent a Total Abdominal Hysterectomy. Retrospective data suggest that the recurrence rate and patterns of recurrence are similar in patients who had a laparoscopic/robotic or an open approach. Treatment recommendations ideally are based on prospective, randomized trials comparing the current standard technique (TARH) with the proposed better technique (TLRH/TRRH). However, there are currently no prospective studies available which directly compare Total Laparoscopic/Robotic Radical Hysterectomy against the standard treatment of Total Abdominal Radical Hysterectomy in regards to disease-free or overall survival.
-
Anticholinergic and sedative drug use and functional status among older Australians.
The proposed study will provide important insight for identifying medications that may contribute to functional impairments and age related disability in older Australians. This study aims to describe the exposure of older Australians to medications with sedative and anticholinergic effects using the Drug Burden Index. It will investigate the role of the drug burden index as a tool to guide prescribing in older Australians and whether changes drug burden are associated with changes in the physical and cognitive functional status.
-
Increasing resilience and physical activity for heart health
Depression and poor social support are significant risk factors for coronary heart disease (CHD), and acute life-event stressors can trigger coronary events. People experiencing such psychosocial difficulties are also more likely to be physically inactive, which is itself an independent risk factor for CHD. It is important therefore, to trial innovative heart health programs that promote both psychosocial functioning and physical activity. Resilience training programs offer a means by which to enhance resistance to stressors and improve psychosocial functioning, but do not directly address physical activity. In this study we propose to investigate (i) whether a resilience program designed for adults in the general population can improve psychosocial functioning and lower CHD risk indicators, and (ii) the added value of including a component to promote physical activity. If successful, the results from this trial will demonstrate an innovative means by which to prevent CHD in the general population.
-
Ascorbate Supplementation in Kidney Failure
The primary aim of this study is to discover if giving patients with severe kidney failure ascorbate (vitamin C) reduces symptoms that are common to both renal failure and ascorbate deficiency. It is known that low ascorbate levels are common in patients with severe kidney failure, and that symptoms of scurvy (ascorbate deficiency) and of kidney failure (uraemic syndrome) overlap. There is however no consensus on whether ascorbate supplementation is beneficial in patients with severe kidney disease and there are concerns that supplementation may cause adverse effects. This study would significantly improve clinical care, by examining the benefits and adverse outcomes of supplementation.