ANZCTR search results

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.

The aim of the Smarter, Safer Homes project is to investigate the feasibility, acceptance, usage and impact of providing cutting edge technology into the homes of elderly people and providing a number of services informed by the technology to: 1. A resident or aged/disabled person 2. Their family 3. Their health care providers To this end we have created the SSH platform, which is made up of a collection of hardware (sensors, computers, iPad) and software (iPad app and portals) which will be provided to participants for a period of twelve months for the purpose of a pilot study of a series of “Smart Homes”. The SSH platform is a web based monitoring and communication system which can a) collectively present health and well-being information of independently living aged/disabled people in a way useful to care providers; b) collectively present health and well-being information of independently living aged/disabled people in a way useful to interested adult children of the elderly person or family members of the disabled people, without compromising the privacy of the aged/disabled person; c) enhance and promote interactions by care providers and family members through the use of the video conferencing module. The primary outcomes of the study are: * Independent living scales or Activities of Daily Living (ADL) (Mobility, Meal, Hygiene, Transfer, Dress) assessed through tools e.g. Katz index, Barthel Index The secondary outcomes of the study are: * Develop methods to recognise and identify individual activity profile(s) in multi-resident homes through sensors, which will be assessed by comparing against routine activity data collected through wearable sensors (such as mobile phones) and simple daily routine questionnaires.

The purpose of the study is to reduce the symptoms of mild to moderate obstructive sleep apnoea (OSA) and snoring using the Oventus oral appliance. Sleep apnoea is assigned an apnoea hypopnoea index (AHI) number which indicates the severity of OSA. The aim of the study is to reduce AHI by at least 50% in at least 20% of the participants in the study.

Tooth extraction or loss results in resorption of bone volume in the jaw. This is a natural phenomenon which occurs mainly during the first 3 months following removal of the tooth. Preservation of bone volume facilitates subsequent placement of dental implants and leads to improved functional and aesthetic outcomes for patients. Guided bone regeneration (GBR) is a commonly used technique where a bone substrate (autologous or de-proteinised bovine bone matrix) is packed around the exposed implant to fill the defect, and covered with a membrane. The membrane promotes the growth of new bone by occluding infiltration of competing soft tissue, but permitting fluid and nutrient transfer to the newly forming bone. Native collagen membranes of porcine origin are commonly used as they have been proven to significantly enhance periodontal and bone regeneration in animal and human clinical studies. Celgro(tm) is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin. Celgro(tm) is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of Celgro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type. This study proposes to use Celgro(tm) in a standardised dental implantation procedure to assess its suitability for use in GBR.

The Coronary Angiogram Database of South Australia (CADOSA) was established in 2011 to establish a clinical quality registry of cardiac catheterisation procedures and is know as CADOSA-Registry. The registry captures detailed clinical, angiographic and outcomes data on every South Australia public hospital patient undergoing coronary angiography/PCI. The purpose of the registry is multifold and includes monitoring patient safety, defining natural history of coronary heart disease, assessing performance measures, and evaluating appropriateness of procedures. Furthermore, the CADOSA Registry offers opportunity to address research question if the appropriate ethical and scientific requirements are meet. The CADOSA Registry is compatible with the American College of Cardiology (Registered Trademark) CathPCI (Registered Trademark) Registry, sharing common data elements and data specifications. The CADOSA-Registry captures all the in-hospital data by prospective data collection. MACE at 12 months is assessed via data linkage linkage with hospital administration datasets, no patient contact is required. Attached is the CADOSA Data Collection form, which details all of the data that is collected for each procedure.

Venous cannulation via peripheral intravenous catheters (PIVC) is the simplest and most frequently used method for drug, fluid and blood product administration. Researchers estimate that up to 70% of patients in acute care hospitals require a PIVC. However, PIVC are associated with inherent complications which can be mechanical or infectious. Failure rates of these devices is unacceptably high, affecting up to 40% of patients receiving this therapy. Of these, 30% failed due to occlusion and infiltration (fluids into surrounding tissues) meaning patients had to have the PIVC replaced, which has implications for patient comfort, therapy and health care costs.There have been a range of strategies developed to prevent or reduce PIVC related complications including flushing regimes to maintain PIVC patency. However, current flushing practice is widely varied, with poor outcomes. There is little evidence that flushing of PIVC is actually happening in practice. To achieve best and evidence based practice it imperative that trial research is conducted to establish the best regime for maintaining PIVC patency. The study aims to establish the feasibility of conducting a four arm, factorial, randomized trial evaluating the efficacy and cost effectiveness of different flushing frequencies and volumes.