ANZCTR search results

To describe the prevalence of cancerous growths in the small bowel as assessed by capsule endoscopy in a group of patients previously diagnosed with Familial Adenomatous Polyposis (FAP). These patients are known to have previously identified cancerous growths and this study aims to compare the findings of capsule endoscopy to correlate this with the findings by other investigative techniques. These techniques are abdominal Magnetic Resonance Imaging (MRI) scanning, barium follow through examination(SBFT), and gastrointestinal side-viewing endoscopy.

Finger prick blood tests are a widely accepted method of small blood volume collection. Blood collection via finger prick is painful. A reduction in pain and anxiety from finger prick may assist subjects who require numerous procedures. The aim of this study is to assess whether amethocaine reduces the pain and anxiety of finger prick blood sampling

The primary purpose of the study is to determine whether or not acute administration of amphetamine produces schizophrenic-like brain function and cognitive effects.

Lipids form an outer layer of the tear film, which is essential in retarding evaporation of the aqueous layer of the tears. Contact lenses, after being inserted onto the eye, adsorb tear lipids. Analysis of tear lipid changes before and after contact lens wear may reveal which lipid component causes problems (in terms of ocular discomfort and inflammatory responses) with contact lens wear. The study hypothesis is that contact lens wear and/or lens care solutions change the tear lipid profile and thereby influence lens performance.

Bronchiolitis 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.

The 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.

This 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.

The 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 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.

The 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.