ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33673 results sorted by trial registration date.
  • Evaluating methods for effective decontamination of needleless connectors in adult patients: A pilot randomised control trial

    The large number of patients require a central venous access device (CVAD) for the administration of intravenous fluids, medications, blood products and specialised treatments. These intravenous fluid lines will be accessed by nurses via a needleless connector (NC) multiple times every shift; however these connectors have also been linked with the development of CVAD associated bloodstream infection (CLABSI). The two most common causes of CLABSI are: the colonisation of the outer surface of the catheter during insertion from bacteria originating from the skin; and colonisation of the inner surface of the catheter through contamination of the hub or NC, often from poor non-touch technique practices from healthcare workers. These complications can be minimised, however while practice is variable, with little evidence to guide clinicians, research is required to reduce the gaps in this area. The importance of decontaminating the needleless connectors (NC) has been highlighted prior to accessing the central venous access device (CVAD) by many of the current CVAD guidelines. However, the standard for the scrub time and the decontamination solution is still lacking, with some studies showing the time required for decontamination to be from 10 to 30 seconds using friction and 70% isopropyl alcohol swab. The Centre for Disease Control and Prevention (CDC) guidelines for the prevention of intravascular catheter-related infections suggest decontamination with a chlorhexidine/alcohol preparation. However, they do not mention a specific time for this procedure, other than stating that using a 70% alcohol solution for 3 to 5 seconds is not adequate (O'Grady, 2011). The national evidence based guidelines for preventing healthcare associated infections in National Health Service hospitals in England (Epic3) recommend disinfecting the connector for a minimum of 15 seconds with chlorhexidine gluconate in 70% isopropyl alcohol, then allowing it to dry prior to accessing the system. The Queensland Health I-Care Guideline for Tunnelled Central Venous Catheters recommends a 5 second scrub with a 70% alcohol solution and allowing the connector to dry before accessing the CVAD system. With each guideline having differing recommendations, clinicians may have difficulty deciding which method will reduce the risk of CLABSI.

  • Target Temperature Management for Traumatic Brain Injury: A Feasibility Study of Pyrexia Control

    Injuries to the brain that occur after an accident, such as a car crash or after a fall, can be serious and have lasting negative consequences. Estimates suggest that at least 10 million people globally are affected by this type of brain injury every year, known as traumatic brain injury. Those that survive are often left with significant physical and or mental disabilities that are challenging to manage for the patients, their families and the health care system. Prevention of the accidents are important, but it is also important to find treatments that can help the recovery of patients affected by traumatic brain injury. At present there are a limited number of treatments that improve the recovery of these patients. One important area that has promising evidence is temperature control. Our group has contributed to evidence in this area of study. Preliminary evidence suggests that a raised temperature is a very common occurrence and that it may be harmful after traumatic brain injury. Yet, there still remains substantial uncertainty about this finding and whether reducing the patients temperature will help in their recovery. In clinical practice in Australia, cooling treatments are used with substantial variability by doctors, without certainty that the treatment will help the patient recover. Additionally, From our prior research, we know that often the temperature of patients still remains above the normal range, despite the use of cooling treatments. Therefore, we propose a study to work out if it is possible to maintain patient temperature in a targeted low normal range and avoid any elevation of temperature. From our prior work, maintaining temperature in a low normal range is an approach that is used in some centres in Australia. If we are able to maintain temperature in a low normal range successfully, then our plan is to apply for a larger grant to work out if this approach helps with the recovery after traumatic brain injury a study that would help inform the way patients are treated. This larger type of study would require about 1000 patients, but the study that we are seeking to do now only involves 50 patients and is designed to provide practical, preliminary information to enable us to proceed to the next stage.

  • Flinders Chronic Condition Self-managment Program for Weight Loss in Obstructive Sleep Apnoea study

    The primary study hypothesis is that use of the Flinders chronic condition self-management program (FP) intervention will result in weight loss in patients with moderate to severe obstructive sleep apnoea (OSA) over a 6 month period compared to a cohort of historical patients matched for age, sex and baseline BMI with moderate-severe OSA. INTERVENTION: The Flinders Chronic Condition Management Program will be delivered to all participants. The Flinders Program was developed by the Flinders Human Behaviour & Health Research Unit (FHBHRU) and is used widely to enable patients to self-manage their chronic disease. Patients will also be offered a weight management Impromy program developed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) at no cost in addition to intensive support using behavioural techniques. The pharmacy-supervised Impromy program uses nutritious and highly accepted meal replacements as a means to weight loss. DESIGN: A prospective cohort of 40 patients will be compared to a historical control cohort. DURATION: Participants will be followed-up over a 6 month period to assist them to achieve their goals.

  • An observational study of first yearuniversity students’ body weight and lifestyle.

    This study aims to identify what the impact of young adults in their first year of university has on behaviours and choices made around diet and exercise, and how this may impact on nutritional intake, physical activity and anthropometric measures. This concept has been fuelled by longitudinal studies from the US which have consistently demonstrated an increase in weight during the first year of university with the rate of weight gain in university students determined to be 5.5 times greater than the general community. To date there has been no study in Australia documenting dietary and physical activity levels in first year undergraduate students and the impact on weight. As obesity is a growing health concern in young adults in Australia, it is important to identify how the influences involved in the transition period from high school to university, as well as observing changes in overall health and lifestyle patterns, may guide universities and health practitioners in providing advice and strategies on healthy and sustainable choices that can be made around diet and exercise to prevent further weight gain as a result of a new environment.

  • Randomized, Placebo-Controlled Clinical Trial of Transdermal dihydrotestosterone Gel to Improve In Vitro Fertilization Outcomes In Women With Poor Ovarian Response

    Despite the advances in assisted reproduction techniques, suboptimal In Vitro Fertilization(IVF) outcomes in women with Poor Ovarian Response(POR) still remains a challenge. Older women seeking IVF have suboptimal utcomes, at least partly due to inadequate number of eggs on conventional stimulation. This suboptimal response relates mainly to inadequate ovarian response but there is often also reduced live birth rates, increased risk cycle cancellation and a need larger doses of gonadotrophins, which increases both cost and risk of ovarian hyperstimulation syndrome (OHSS) risk. There is now growing evidence that androgens (or male hormones) may improve egg quality and numbers in women with POR. So far the androgens used in women with POR include testosterone and the pro-androgen hormone Dehydroepiandrosterone(DHEA) as well as aromatase inhibitor drugs, which increase the body’s own testosterone levels by blocking its conversion to estradiol. For each of these drugs, their multiple levels of action mean that it is not clear whether they produce any benefits by acting as an androgen (or male hormone). For this reason, this study is using dihydrotestosterone (DHT), the natural product of testosterone in the body of men and women, and which acts only as a pure androgen in the body. As a result, the study will determine for the first time whether these drugs do work as androgens or not and may refine and improve the treatment for POR. In this study we will temporarily increase the circulating levels of DHT during the time when oocyte (egg) development and maturation is occurring. This will be achieved by applying the DHT gel onto the skin once a day for 21 days prior to the start of IVF ovarian stimulation. Aims: To investigate the efficacy of DHT gel treatment applied onto the skin before an IVF stimulation cycle in women with poor ovarian response. Research Hypothesis DHT pre-treatment prior to an IVF cycle will improve the number of healthy, fertilisable eggs retrieved.

  • Testing the Relevance of Acupuncture Channel Theory in the Treatment of Myofascial Pain in the Upper Trapezius Muscle: A Randomised Controlled Trial

    The design of this study is a prospective single-blind parallel four arm randomised placebo controlled trial with repeated measures. The purpose of this study is to investigate various methods of acupuncture therapy in the treatment of myofascial pain in the upper trapezius muscle. This study is designed to test the following hypotheses; 1) There is no significant difference between needling locally and needling relevant distal points only in the treatment of myofascial pain; and 2) Needling a combination of both local and distal points is superior to needling either local points or relevant distal points alone in the treatment of myofascial pain; 3) Acupuncture is superior to placebo in the treatment of myofascial pain. Participants will be randomly allocated to one of four groups that will receive one of three types of acupuncture therapy, with the remaining group acting as a control group.

  • The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised control trial

    The use of music in the operating theatre has been longstanding with reports of its potential therapeutic effects dating back to the 1940s. Music therapy prior to and during an operation have been shown to reduce anaesthetic requirement, patient anxiety, and improve overall satisfaction. There is also evidence that proceduralist-selected music improves surgical skill acquisition. In gastrointestinal endoscopy, music has shown benefits for patients, however, there is no data on the effects of music on improving the performance of endoscopists and whether a specific style of music would lead to optimal performance. This is particularly relevant in an era where high volumes of endoscopic procedures are performed in an often stressful clinical environment and procedural outcomes, such as adenoma detection rate (ADR) in colonoscopy, are reported as validated benchmarks of quality endoscopy. The appropriate style of music to use and avoid in the operating theatre has been previously proposed, but there was an absence of music from epic movies on this list. Thesoundtracks from these movies often contain uplifting musical tracks associated with glory,success, and large scale victory We hypothesise that music from the epic movie Star Wars would be superior to endoscopist-selected popular music when measuring quality outcomes in colonoscopy.

  • Effects of night eating during simulated shift work on metabolism, cognitive performance and mood in healthy adult males

    The prevalence of type 2 diabetes and obesity are rising at alarming rates. Across Australia, these chronic diseases account for billions in health care costs and lost productivity. Rates of type 2 diabetes and obesity are high among shift workers, even after controlling for lifestyle and socioeconomic status. Shift workers experience poor timing of their body clocks to the daily light/dark cycle, and they show abnormal metabolic responses, including insulin resistance and glucose intolerance. Simulated shift work studies in rodents provide a link between timing of meals and metabolic processes: withholding feeding during 'night-shift' prevents the adverse metabolic effects of simulated shift work. Whether this strategy is effective in humans remains to be demonstrated. Our preliminary data from humans in several laboratory studies indicate that meal timing does play an important role in metabolic disturbance. Indeed eating at night, when the body is primed for sleep, seems to underlie an increase in metabolic disturbance that could predispose them to chronic disease. To test this, we will measure metabolic markers in healthy men studied under simulated shift work conditions, where we will keep daily energy intake constant but vary meal times. We propose that by simply altering the timing of meals we will be able to mitigate the negative metabolic consequences of shift work. These results could be readily translated to existing dietary guidelines, industry recommendations and workplace policy reducing the significant and increasing burden of metabolic disease in shift workers and the wider community.

  • Chemotherapy-induced alopecia (CIA) in breast cancer patients: effectiveness of two temperature levels of scalp cooling on reducing rates of CIA.

    The primary purpose of this study is to gather more scientific data on the efficacy of scalp cooling to prevent chemotherapy-induced hair loss and to assess the effect of specific temperature used on the efficacy of scalp cooling. Who is it for? You may be eligible to join this study if you are 18 or over and have histologically confirmed invasive breast cancer, and a planned course of one of the approved chemotherapy regimens. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive scalp-cooling at 3 degrees Celsius or 5 degrees Celsius. Scalp-cooling involves wearing a cap connected to a cooling device that will lower the temperature of your scalp. The cap is to be worn at each chemotherapy treatment 30 minutes before, during and 90 minutes after the chemotherapy treatment. Patient outcomes will then be assessed through patient-reported level of hair loss at the end of planned chemotherapy and monitoring of short-term and long-term side effects of scalp-cooling for 10 years after the end of planned chemotherapy. It is hoped that the findings of this trial will enhance our knowledge of the efficacy and long-term safety of using scalp-cooling to prevent chemotherapy-induced alopecia in breast cancer patients.

  • A clinical research study that is testing whether Penthrox (methoxyflurane) plus local anaesthetic reduces pain and discomfort for men having their first transrectal ultrasound-guided prostate biopsy compared to local anaesthetic alone

    The purpose of this study is to see if the discomfort of a prostate biopsy can be reduced by a drug called methoxyflurane (Penthrox) given with a simple inhaler, popularly known as the ‘green whistle’, and widely used by ambulance officers and first aid services. Methoxyflurane is already approved in Australia for the relief of pain in patients having surgical procedures. Who is it for? You may be eligible to participate in this study if you are a male, aged 18 or over, who has been scheduled for your first transrectal ultrasound-guided prostate biopsy. Study Details All participants have injections of a local anaesthetic (lignocaine) around their prostate before the biopsy. This is the standard way of reducing the discomfort of a prostate biopsy. Before having the local anaesthetic, all participants are given the study treatment which is a ‘green whistle’ inhaler after being shown how to use it. After their biopsy, participants fill out short, simple forms to let us know how they felt. In this study, one half of the participants are given inhalers loaded with methoxyflurane (the active inhaler group). The other half are given inhalers that look and smell the same, but are loaded with saline solution alone (the placebo inhaler group). Comparing the results in these two groups at the end of the study will show how good methoxyflurane is at reducing the discomfort of a prostate biopsy. It is hoped that this study will improve understanding of drugs which may be used to reduce discomfort of prostate biopsies for future patients.

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