You can narrow down the results using the filters
-
A study of aminophylline for infants less than 12 months of age with bronchiolitis, requiring admission to intensive care
Expand descriptionBronchiolitis is a common, acute, viral infection of the lower respiratory tract. It is mostly seen in children less than 1 year of age, but does affect children up to 2 years of age. Each year, several children with severe bronchiolitis need admission to the intensive care unit. These children experience significant breathing difficulty and around 50% are ill enough to need help with breathing through a breathing machine called a mechanical ventilator. The normal treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. Aminophylline is a medicine we know from previous research that improves the function of the diaphragm, the major breathing muscle. Aminophylline also stimulates the respiratory centre in the brain, which stimulates the body to breathe. This tells us that aminophylline might be a helpful drug to use when treating children with severe bronchiolitis. Some doctors use this medicine because they believe it works. Others do not use this medicine because they do not believe it works. The purpose of this research project is to see whether aminophylline makes a difference in the treatment of children with bronchiolitis. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment and aminophylline. We will compare the duration of mechanical ventilation and the length of intensive care and hospital stay in both groups.
-
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects with Acute Decompensated Heart Failure and Renal Insufficiency
Expand descriptionThe Trident-1 study is an International multi-center, randomized, double-blind, placebo controlled phase 3 clinical trial with plans to randomise a total of 900 patients. The purpose of the study is to determine the effects and safety on the body weight of 3 different doses of BG9928 (0.03 mg/kg, 0.15 mg/kg, or 0.3 mg/kg) and placebo given up to a maximum 5 days to subjects hospitalized due to Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency. BG9928 is a A1 receptor antagonist, which from previous studies have demonstrated ability to preserve renal function and promote urine production. The effect of BG9928 on body weight is thus related to the urine output. The study drug will be given in addition to the medication that would normally be given to ADHF patients. This means that patients on placebo still receive normal standard care. The primary objective of the study is to determine the effect of BG9928, when added to standard therapy, on the change in body weight at 24 hours following the first dose in these subjects. The secondary efficacy objectives of this study are to determine the effect of BG9928, when added to standard therapy, on worsening renal function during the treatment period, the number of days of hospital-free survival (DHFS), the improvement in Dyspnea Symptom and Edema Score, Subject Global Clinical Assessments and Physician Global Clinical Assessment. Additionally the secondary efficacy objectives are measuring the use of concomitant medications to treat heart failure, length of hospital stay, cardiovascular and all-cause mortality and re-hospitalization up to 180 days after the initial dose. The safety objective of the study is to assess the safety and tolerability of BG9928. Upon screening patients will be randomized evenly into either of the 4 treatment arms and will receive IV study drug infusions twice daily for a maximum treatment period of 5 days 910 doses). Prior to and during hospitalisation period, for a maximum of 7 days, the patients will be monitored via physical exam, vital signs, body weight, ECG diagram, questionnaires, blood samples (including pregnancy test for women of childbearing potential, haematology, chemistry, special kidney tests (BNP, Cystatin C), bone markers ,genetic and PK testing. Safety monitoring and concomitant medication monitoring will be conducted from screening and up to day 30 . Telephone follow-up done at 2, 3 and 6 months after the first study dose.
-
Observational study comparing the safety and tolerability of Somatuline (Registered trade mark) Autogel (Registered trade mark) injected by Health Care Professionals and patients who inject at home for the treatment of acromegaly.
Expand descriptionThis study will compare the safety and tolerability of a treatment for acromegaly in two groups: one group is injected by a health care professional the other group will inject themselves or have a carer/partner inject.
-
A phase 1 trial of exercise for patients admitted to hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD)
Expand descriptionThe effects of the exercise programme in the pulmonary rehabilitation has been thoroughly evaluated on people who are in their stable stage of COPD and the training has been proven to be very beneficial to this population (Lacasse et al.2003, (Nicki et al., 2006), (Carter & Nicotra, 1996; Mink, 1997). Benefits of exercise training include improved sense of well-being, increase in muscle metabolic capacity, reduction in lactic acid and increase in cross section of muscle fibres (Nicki et al., 2006). However, there are no trial investigating the possibility of implementing the exercise programme for patients who have been admitted for acute exacerbation of COPD. The primary aims of study is to investigate the safety and feasibility of implementing an exercise programme for patients with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) and also aim to establish the optimal intensity of exercise for in-patient exercise programme An estimated number of 30 participants will be recruited and assessed on the 1st or 2nd day following admission with the intention of commencing intervention from 2nd day of admission up to day of discharge. Out of the three groups, one will be the control group that received standard care and the other two will participate in a twice-daily 15 minutes exercise sessions during the trial duration in addition of standard physiotherapy treatment that the control group will be receiving. The two exercise groups will be exercising at either 40% or 70% maximal output intensity.
-
Aboriginal Smoking Cessation: Randomised trial of support strategies in Aboriginal health services. Be our Ally Beat Smoking (BOABS) Study
Expand descriptionAboriginal people smoke at much higher rates than non-Aboriginal people and smoking is an important contributor to increased disease, hospital admissions and deaths in Aboriginal populations. Quit smoking programs in Australia have not had the same impact on Aboriginal smokers as on non-Aboriginal smokers and Aboriginal people are twice as likely to smoke as non-Aboriginal people. It is important that improved techniques for assisting Aboriginal people to quit be developed and implemented as part of comprehensive strategies to improve Aboriginal health. A range of strategies have been used to encourage Aboriginal people to quit smoking however there have been few good quality studies that show what approaches work best. More evidence of strategies that could work more widely in Aboriginal primary health care settings is needed if good policy is to be developed and implemented. This trial will be based in two major Aboriginal health services in the Kimberley region of Western Australia and run over three years. Participants who agree to participate will be randomly allocated to either a program following current Australian recommended primary care smoking cessation strategies or a more intensive supported quit smoking intervention.
-
A study to evaluate the safety of a single dose of increasing amounts of PF0713 given via a vein to healthy adult male volunteers
Expand descriptionThe purpose of this study is to test the safety and the effect on the body of a drug called PF0713. PF0713 is being developed for commencement and maintenance of anaesthesia and sedation. The hypothesis is that PF0713 will produce anaesthetic effects and be well tolerated.
-
A randomised controlled blinded trial to investigate the effect of hyoscine butylbromide during colonoscopy on rates of polyp detection.
Expand descriptionSome colonic polyps are not seen during colonoscopy, and new therapies are frequently tested to decrease the 'miss-rate' of around 15-20 %. The aim of this study is to test the hypothesis that using an antispasmodic drug (hyoscine butylbromide - also known as buscopan), given as a single intravenous dose during colonoscopy, that polyp detection rates may be improved. The study population will be all patients (who agree to participate)booked in for routine colonoscopy for any indication at a university hospital centre.
-
A pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a short stretch compression bandaging system in the management of people with venous ulceration.
Expand descriptionVenous disease is the most common cause of leg ulcers. The refractory nature of venous ulcers affects the quality of life and work productivity of those persons afflicted. This, in combination with the high costs of long-term therapy, makes venous ulcers a major health problem in developed countries. Management of venous leg ulcers is based on understanding pathophysiologic abnormalities. In recent years, identifying prognostic factors for healing and developing novel therapeutic approaches for venous ulcers have offered valuable tools for the management of patients with this disorder. Compression increases ulcer healing rates compared with no compression. Multi-layered systems are more effective than single-layered systems. High compression is more effective than low compression but there are no clear differences in the effectiveness of different types of high compression(1). The aim of this study is to evaluate the efficacy and safety of graduated three layer straight tubular bandaging when compared to 4 layer compression bandaging in healing venous ulcers in patients with chronic venous ulceration.
-
Fish oil treatment for depression in cardiovascular disease
Expand descriptionThe aim of this project is to evaluate the potential for supplementation with long-chain omega-3 fatty acids to relieve depressive symptoms and improve health status in cardiac patients suffering from depression. The study will explore potential mechanisms mediating these benefits, with a particular focus on the role of serotonin transporter gene polymorphisms and changes in cerebral blood flow. It is anticipated that depressive symptoms will be greatest in people who have reduced cerebral blood flow and a particular form of serotonin transporter gene. However, it is expected that omega-3 supplementation will increase serotonin receptor expression and cerebral blood flow, thereby improving depressive symptoms, but that these improvements will be less in people who carry the 5HTT-S gene. It is also expected that omega-3 supplementation will improve peripheral blood vessel function, which will be associated with improvements in depressive symptoms and angina scores.
-
Prospective Double Blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on post operative voiding difficulties.
Expand descriptionThe Tension Free Vaginal Tape Procedure (TVT) is the most commonly used procedure for women with stress incontinence worldwide. The cough-test (involving asking the patient to cough during TVT placement until no further leakage is seen) was originally described as being integral to the TVT procedure to improve outcomes and reduce post-operative voiding difficulties. Many gynaecologists now perform TVT insertion without the cough-test claiming similar outcomes, The proposed study is the first randomised trial comparing the differences in post-operative outcome between the TVT performed with an intra-operative cough-test and the same procedure without a cough test