There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The three purposes of this study are the following: - To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk; - To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment; - To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.
Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.
Stubbing of the finger-tip is a common injury in sports such as basketball, volleyball, cricket and football. This can result in a Mallet finger deformity, where the end joint of a finger cannot be actively straightened out. In most mallet finger cases seen at The Alfred, the skin remains intact, and the impairment results from a tear of the extensor tendon or an avulsion (a small fracture where the tendon attaches to the bone). Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved. This study aims to compare two different types of splintage (the commonly used thermoplastic thimble splint and the aluminium-foam “Mexican hat” splint which is in use in Britain) with a control splint (thermoplastic prefabricated “stack splint” with tape). Outcome measures will include patient compliance with the splint, degree of extensor lag, active movement of the joint, and any complications. The null hypothesis is that there are no differences in outcome between different methods of conservative splinting treatment for mallet finger.
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control vaccine for the birth dose. The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups. Each mother and infant will be followed from pregnancy until the baby is seven months of age. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule. The primary outcome will be prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.
Colonoscopy and sedation are frequently accompanied by hypotension, which reduces the amount of sedation able to be employed. Blood pressure is restored by the infusion of intravenous normal saline. Prophylactic infusion of normal saline may enhance the colonoscopy completion rate, and patient comfort during colonoscopy and during the recovery from colonoscopy. The investigators propose randomising consenting adult patients attending outpatient colonoscopy to one of two treatment arms: (i) A control arm (ii) A treatment arm, with pre-hydration with an infusion of 1.0 litre of normal saline immediately prior to colonoscopy. Outcome measures include colonoscopy completion rates, hypotension during or after colonoscopy, and patient ratings of comfort and satisfaction.
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
Currently patients thought to have anxiety or depression by their GPs are referred to the Primary Mental Health Team (PMHEIT) for psychiatric assessment. This assessment consists of a one-hour interview with a senior psychiatry registrar or psychiatrist, who then writes a letter to the referring GP. The letter contains diagnostic information and management recommendations. It is not current practice to send a copy of this letter to the patient. We hypothesize that patients who receive a copy of the psychiatric assessment letter that is sent to GPs will improve adherence to treatment recommendations; and that patients who receive a copy of the letter will have improved outcomes. GPs will be asked to agree to the participation of their patients. Participants will be persons over the age of 18 years who are referred to the PMHEIT for assessment and who receive primary diagnoses of depression or anxiety. After the assessment interview, the patient will be given an explanatory letter and a consent form. Consenting patients will complete the Depression and Anxiety Stress Scales (DASS) and a SF12 questionnaire to measure the level of disability they are experiencing due to their mental condition. Participants will be randomly allocated into two groups: a control group who will not receive a copy of the assessment letter, and an experimental group who will be mailed a copy of the same information that their GP receives. The registrar who conducts the assessment and writes the report will not know to which group each participant has been assigned. Thus, the content of the letter will not be affected by knowledge that the patient will or will not see it. The letter will be sent simultaneously to the referring GP and to experimental group participants. To ensure confidentiality, the letter will be sent by registered mail. Three weeks later, participants will be mailed a copy of the DASS. After a week, they will be contacted by phone and asked for their DASS responses. They will also be asked a brief series of questions regarding their adherence to the treatment recommendations given in their assessment letter. When adherence is partial or absent, the interviewer will attempt to ascertain the reason. This procedure will be repeated at 3 months, except that assessment on the SF12 will also take place.