ANZCTR search results

This is a 30 patient single-centre, open-labeled, randomised pilot study assessing the effectiveness of a cyclooxygenase (Cox)-II specific inhibitor, Celecoxib, in reducing perioperative inflammation associated with thoracic and major abdominal surgery as assessed by blood and urinary markers. Information regarding Celecoxib's capacity to reduce perioperative pain and morphine consumption will also be sought. Patients will receive standard dosing of Celecoxib in accordance with on-license use. Demonstration of effect and feasibility of inflammation suppression is intended to lead to a multi-centre study investigating the use of perioperative Celecoxib to delay cancer recurrence following Non-Small Cell Lung Cancer (NSCLC) resection surgery.

The elderly population in Australia is continuing to increase with the number of people over 65 years of age increasing from approximately 2.7 million in 2006 to 3 million in 2011. As people living longer they are exposed to a higher risk of trauma. Studies have shown that the elderly trauma population (over 65 years of age) have significantly higher mortality, increased ventilator days and longer ICU and hospital length of stay (LOS) compared to a younger population. Frailty is a widely used term to classify a multi-factorial syndrome comprising of physical and cognitive changes leading to increased vulnerability. Frailty is associated with increased risk of adverse events which are associated with higher cost of health care and care needs of patients. The prevalence of frailty amongst the critically ill population has been reported as 13% of all patients and 32.8% in patients over 50 years of age. Frail patients admitted to the intensive care unit (ICU) have been shown to have higher in-hospital mortality and lower quality of life at 6 month follow up. During the ICU admission, frail patients had more major adverse events and longer ICU and hospital LOS. There is no clear consensus on how to measure frailty, however two methods have been utilised in ICU research, the Phenotype Frailty (PF) and the Clinical frailty score (CFS). Historically elderly trauma patient outcomes have been investigated in relation to age and co-morbidities. This study aims to determine whether frailty is predictive of mortality and functional outcomes, which of two frailty measures is more effective at predicting mortality and functional outcomes and whether frailty is more effective at predicting mortality and functional outcomes compared to other patient measures (i.e. age, co-morbidities or injury severity score). METHODS: Prospective observational study, in 2 Australian ICUs (the Alfred Hospital and Royal Perth Hospital). We aim to recruit 200 patients admitted to ICU under the trauma unit, 50 years of age and over. Primary outcome measures include mortality (in ICU, hospital, 6 months and 12 months) and function using the GOS-E. Secondary outcome measure include (but not limited to) frailty, pre-morbid function, level of treatment in ICU, functional ability at ICU discharge.

This study involves measuring the blood levels of the medication, treosulfan, to improve the way we adjust the dose in children. Who is it for? Children and adolescents with either malignant or non malignant (genetic) diseases can join this study if they are receiving the medication, treosulfan, prior to undergoing blood or marrow transplantation. Trial details A series of blood levels will be collected after the treosulfan dose to see how well their body breaks down and gets rid of the medication. This study does not replace other studies, but simply investigates key medication widely used in the treatment of children's cancer. Participants will be studied for several years after the study to monitor their health. This study will define the best way to adjust the dose of the drug, treosulfan, a key medication in blood or marrow transplantation conditioning regimens. Too much causes toxicity and too little risks the disease being more likely to return.

Obstructive Sleep Apnoea is a common sleep-related breathing disorder and can be treated using a Mandibular Advancement Splint (MAS), an oral device worn during sleep which protrudes the mandible, improving airway calibre. Approximately two thirds of patients adequately resolve their sleep apnoea with this conventional therapy however; clinical trials have shown that the addition of a tongue restraining device significantly increases MAS effectiveness. This study will investigate the Tongue Tamer (TT) system, designed to be reversibly added to the conventional SomnoMed MAS to passively restrain the tongue. Safety, efficacy, tolerability and compliance of the TT MAS will be investigated in patients not demonstrating a complete response to conventional MAS treatment.

The primary purpose of the study is to develop and test a motivating communication/teaching style for Les Mills International instructors. More specifically the study will examine the feasibility and fidelity of delivering a motivation-based communication training intervention with Les Mills International instructors and test the effects of the intervention on clients’ perceptions of the instructors’ motivational style.

This study will evaluate the way we treat pre-cancerous lesions on the cervix. These lesions are commonly removed using a wire loop termed large loop excision of the transformation zone (LLETZ). The objective of this study is to compare different settings on the machine used to perform a LLETZ and compare the quality of the tissue obtained. All samples of tissue obtained from a LLETZ have a degree of tissue damage to the outer part of the tissue sample caused by the heat of the wire loop. This tissue damage is dependent on the settings used to obtain a LLETZ. Currently there are a wide range of different settings used to perform a LLETZ procedure. We wish to compare two settings, low vs high power, which are already used by surgeons in the hospital to see which setting gives the best quality sample of tissue. High quality samples help determine if all of the abnormal tissue was removed from the cervix. Each patient will have the procedure performed by the same surgeon who is a specialist in women’s cancers. The surgeon will not know which group the patient is allocated to, which is called blinding, to help improve the accuracy of the results. The doctor who will look at the tissue samples under the microscope, called a pathologist, will also be blinded. We will then measure how much tissue damage occurs between the two groups using a small ruler in a microscope.

A study utilizing a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.

Medications, drugs and devices have to be approved for use by the Australian Federal Government. Truvada (tenofovir and emtricitabine) is approved in Australia for HIV management in people who are HIV-positive. Truvada has been recently approved by the FDA in the United States for PrEP in people who are HIV-negative, however it has not yet been approved in Australia for use as PrEP. New HIV prevention strategies are necessary in Australia because HIV infection rates continue to rise. HIV pre-exposure prophylaxis (PrEP), when given as a daily pill and coupled with the consistent use of condoms and regular checks for sexually transmitted infections including HIV, is effective in preventing HIV infection. Several overseas studies have shown that daily tenofovir, or daily Truvada (tenofovir and emtricitabine) reduces HIV transmission by about 44% in men who have sex with men (MSM) and by about 70% in heterosexual people at risk of becoming HIV positive. There has been further evidence to show that in MSM who take their Truvada PrEP medication in the prescribed manner, that is one pill every day, that their risk of HIV infection is reduced by 96%. So taking PrEP every day according to the instructions along with using other HIV prevention measures like condoms and regular HIV and sexually transmitted infection (STI) screening is the best way to reduce your chances of becoming infected with HIV. It is now important to examine the results of these PrEP clinical trials in the “real world” setting to show that PrEP is a feasible, safe and effective method for reducing the risk of HIV acquisition in the Queensland community. The QPrEP demonstration project will address this need.

Hypotheses: The choice of fluid resuscitation preparations selected by clinicians is determined by short term considerations such as time to haemodynamic benefit and fluid volume required rather than by level of evidence, risk of adverse events or cost. Objectives: The primary objective of this study is to identify the attributes that have the largest influence on the choice of fluid used for resuscitation. The secondary objective is to describe a “willingness to spend” threshold (by international region) where clinicians will switch from less expensive preparations to more expensive preparations.

Hidradenitis Suppurativa (HS) is a chronic skin disease that appears as pea-sized to marble-sized lumps under the skin. The lumps form most often in the armpits, under the breasts, inner thighs, groin and buttocks. HS can be painful and cause scarring and pus in affected areas. Flare-ups may be triggered by perspiration, hormonal changes (such as monthly cycles in women), humidity and heat, and friction from clothing. The current standard for diagnosing and assessing your condition is called the Hurley Stage Method. This involves a physical assessment of your skin by your doctor. Recently a new tool has been developed to diagnose Hidradentitis Suppurativa called a ‘self administered questionnaire’. The purpose of this research is to investigate the predictive ability, sensitivity and specificity of this self-administered questionnaire against the gold-standard clinical assessment of Hidradentitis Suppurativa severity using the Hurley stage method. The ability of self-administered questionnaires to assess disease severity has not been assessed. A self-administered questionnaire offers advantages over physical assessment, particularly for epidemiologic research into HS where it is important to be able to determine both the prevalence and severity of disease.