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 SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA) and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial. Double−blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate−to−severe OSA. A total number of 45 participants will be recruited from an OSA population, aged 18−65. Participants will consist of male and female patients diagnosed with moderate−severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the HREC, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to APAP or APAP with the addition of the SensAwake™ modification. The investigator and study staff will be blinded to the treatment of any participant.
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation). Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.
The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.
Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%. This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.
Electro convulsive therapy (ECT) remains the only established therapy for the large percentage of patients with depression who fail to respond to standard treatments. It is commonly used but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. The development of a new treatment with similar efficacy but which minimises these side effects would have great clinical value. One highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to produce similar clinical effects but without the disabling cognitive side effects related to ECT. However, substantive trials using the newest MST equipment are required. Due to the rarity of the equipment available so far, these are only being undertaken in a handful of places internationally and no research with MST has occurred in Australia. The investigators are fortunate to have been able to obtain one of the very limited number of MST devices available internationally and are proposing a pilot study of this technique. Conduct of a successful pilot study would be strong justification for an application for a large head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical practice throughout Australia and indeed internationally with substantial ongoing benefits to patients. These would include enhanced use of it as an outpatient therapy as well as the reduction in side-effects. The study will be an open label trial of MST in 15 patients with treatment resistant depression who have been referred for ECT. All patients will undergo a dose titration procedure to establish seizure threshold, six MST treatment sessions will then be provided at 120% of threshold. If the patients have not achieved a 50% reduction in their depressive symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients will receive another 12 sessions. MST will be administered three times a week. Patients will undergo a series of assessments to determine both the efficacy of MST and the cognitive outcomes. The primary outcome measure will be the MADRS measure of depression severity. The investigators will additionally measure patient rated depression severity and cognitive functioning The overall aim of the current project is to, via an open label pilot trial, investigate the clinical response to magnetic seizure therapy in patients with treatment resistant depression who have been referred for electroconvulsive therapy.
Theory of mind (ToM) refers to the ability to infer others mental states. It includes a recognition that other individuals experience thoughts, feelings, intentions, and desires that may be different to our own. ToM is often impaired among individuals with an autism spectrum disorder (such as autism and Asperger's disorder), and may underlie aspects of social dysfunction in this population. Indeed, it has been suggested that impaired ToM is the core deficit of autism and Asperger's disorder. Imaging studies suggest that the bilateral medial prefrontal cortex, the most important brain region in ToM processing, is underactive in autism. The current study examines whether repetitive transcranial magnetic stimulation (rTMS) to the bilateral medial prefrontal cortex can modulate ToM ability among healthy adults, and improve ToM ability among adults with autism or Asperger's disorder. With the prevalence of autism increasing, there is a clear need to develop appropriate therapeutic interventions to improve social functioning. This study involves a double-blind study using high-frequency rTMS in an attempt to improve ToM among adults with either autism or Asperger's disorder. Theory of mind will be measured using behavioural tasks that require the participant to infer what someone is thinking or feeling by observing their behaviour. These tasks will administered both before and after rTMS to determine whether any change in theory of mind has occurred. Thirty adults with either autism (n = 15) or Asperger's disorder (n = 15) will initially undergo functional and structural MRI to determine the site on the scalp that lies over the medial prefrontal cortex (to which rTMS will be administered). They will then attend our lab each consecutive weekday for a two-week period, during which they will 15 minutes high-frequency (5 Hz) rTMS (either active or sham) to the medial prefrontal cortex. ToM and clinical measures will be collected before the first session, soon after the last session, and one month after the last session. Based on prior imaging data, it is expected that high-frequency rTMS (compared with sham rTMS) to the medial prefrontal cortex will improve ToM ability and reduce social dysfunction among adults with autism or Asperger's disorder. Should these hypotheses be supported, it will indicate the suitability of rTMS as a neurobiological intervention designed to improve ToM and social function among individuals with autism and related disorders.
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.