ANZCTR search results

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

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31420 results sorted by trial registration date.
  • Effectiveness of an online bulletin board for depression

    This project is a randomised controlled trial of an established online bulletin board for depression. It has been estimated that millions of people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs) for health conditions. However, little is known about the effectiveness of these groups in terms of symptom reduction or improvement in quality of life. To our knowledge, this is the first randomised controlled trial of the effectiveness of a pre-existing, well-established online bulletin board for depression in the community. The aims of the project are to determine whether BlueBoard, an established online bulletin board for depression, improves mental health, quality of life, and related outcomes among members of the community with high levels of self-reported psychological distress and previous history or current experience of depression.

  • Dose Optimisation for Spinal treatment Effectiveness (The DOSE Study): A randomised controlled pilot trial investigating the effects of high and low mobilisation forces in patients with neck pain

    Around 30-50% of adults will experience neck pain over a 12 month period, and many are treated with manual therapy. Although evidence supports manual therapy treatment when combined with exercise, the dose is not defined. Up until now, there were few methods for objectively quantifying a manual technique to establish its optimal dose. This pilot randomised controlled trial will investigate two specific doses of posterior-to-anterior (PA) mobilisation, the most common manual technique therapists use when treating the cervical spine. Sixty patients will be randomised to receive either a high force or low force PA mobilisation, or sham treatment, with patients’ pressure pain threshold, resting pain, cervical range and stiffness measured before, immediately after and 3-5 days post-treatment. We will utilise innovative equipment we developed to standardise the manually applied forces, conducting the trial using demonstrable methods from our previous research. Determining dose-response relationships for manual therapy is essential for establishing optimal treatment strategies for patients with neck pain. The cost of neck pain is increasing, and many patients do not achieve symptom resolution. Therefore there is an urgent need for physiotherapists to provide effective treatment dosages with demonstrated patient outcomes, impacting spinal pain and advancing physiotherapy as the preferred treatment choice.

  • Placebo-Controlled, Single and Multiple Ascending Dose Study of BMS-919373 in Healthy Subjects.

    The purpose of this study is to assess the safety and tolerability of BMS-919373 in healthy subjects.

  • The use of oral steroid tablets to help with the treatment of otitis externa (an inflammatory/infective swelling of the ear canal, also known as a 'swimmer's ear')

    Otitis externa is a common ear condition. Also known as a ‘swimmer’s ear’, it often causes painful swelling of the external ear canal and may lead to sensation of blockage as well as hearing loss. It is primarily an inflammatory disease with infective component which can be bacterial or fungal in nature. Risk factors include compulsive scratching of the ear, swimming, hearing aid use and use of cotton buds. Otitis externa is typically treated with antibiotic/steroid ear drops but it is common for patients to experience symptoms of otitis externa such as pain for many days. Given that otitis externa is primarily inflammatory in nature, we propose that if patients are given a 3 day course of oral steroid tablets (anti-inflammtory drugs commonly used in many medical conditions) in addition to ear drops, it may speed up the recovery and reduce the total number of days during which patients would experience symptoms especially pain. This study would be a double-blinded and randomised-control trial in nature, meaning that both treating doctors and participating patients will not know which treatment has been given (i.e. treatment drug vs. placebo), thereby increasing the validity of the trial outcome.

  • Can the placement of ear canal wick (medical sponge) prevent the flow of antibiotic ear drops into the middle ear space (where it can cause side-effects) in patients with known or suspected perforation in their ear drum?

    Otitis externa causes swelling of the ear canal which makes visualisation of ear drum very difficult or often impossible. Primary care physicians regularly use ear drop known as Ciloxan or Ciproxin HC to treat otitis externa when ear drums are not visualised as these drops are indicated in the presence of actual or suspected ear drum perfortion. More broad spectrum, cheaper alternatives such as Sofradex, Otodex, Kenacomb/Otocomb Otic drops are not regularly used for the fear of introducing these to the middle ear space where these drugs can potentially be ototoxic. We, however, believe that by placing an otowick (self-expanding sponge) in the ear canal and then using these drops, they can be safely delivered to the external ear without risking the potential entry of these drops into the middle ear in presence of a perforated ear drum. By staining these drops with fluorescein, we will know if standard instillation (3 drops 3 times a day) of these drops will be limiting the drug presence within the external ear canal only when an otowick is placed in the ear canal by looking at whether staining of the ear drum occurs. If ear drums are stainined then we can assume that drugs can reach middle ear if ear drum is perforated even if there is a otowick in place.

  • Deprescribing in frail older people: a randomised controlled trial

    Older people are at high risk of adverse drug reactions and many medications cause confusion and falls in older patients. In addition, evidence for the benefit of preventative and symptomatic therapies in frail older people is limited, as most clinical trials specifically exclude these patients. Although polypharmacy is widely recognised as a serious problem in frail older people, data on the effects of active medication withdrawal ("deprescribing") are scarce. Our primary aim is to determine whether we can safely reduce the total number of medications prescribed to older people living in residential aged care facilities (RACF). Secondary aims are to estimate the effect of deprescribing on mortality, falls and fractures, sleep quality, cognitive function, and independence.

  • Physical Activity Levels During and After an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

    Obtain current physical activity levels during hospital admission and post hospital discharge in COPD patients admitted to an Australian hospital with an acute exacerbation of COPD. If activity levels are shown to be reduced, this provides evidence for the need to investigate options to improve physical activity levels in hospital and once home in this group. The hypothesis is that in people admitted to hospital with an acute exacerbation of COPD, physical activity will be lower during hospitalisation and will improve in the first week after discharge and improve further six weeks after hospitalisation admission.

  • To predict a breakdown in the joint of the two ends of the bowel after bowel resection surgery.

    Colorectal anastomosis /joins in the colon following surgery leak around 2%. From previous studies we are aware that the most important reason being decreased blood supply. To this date there are lots of studies looking at how to detect anastomotic leaks, But very few studies in predicting anastomotic leak. We believe a prospective study which involves measuring blood flow with the help of rectal laser doppler probe used preoperatively and then post operatively will help us in predicting which anastomosis are more prone to leak. The proposed study is a non-randomised study.All participants who are considered for bowel anastomosis at the participating hospital will comprise the study sample. After obtaining an informed consent from the participants the study will be conducted. The laser doppler flowmetry is a well established method for providing non-invasive real time measurements of blood flow within local tissue

  • Placement of LMA Supreme versus GuardianCPV – a randomized controlled trial assessing leak pressure, cuff pressure and fibreoptic grading of airway placement.

    The research project aims to compare 2 different Laryngeal Mask Airways, and to establish which is superior of the two. The main interest of our trial is to determine which LMA is easier to insert properly, and how well they both maintain a good seal. To date we have seen that there is occasionally some difficulty in placing the LMA, with consequent suboptimal airway control. Device manufacturers are always presenting us with new and improved versions of these devices, and we feel that it is the place of research projects such as this to help us decide if the new devices are worth employing. This sort of research may also aid in the development of future airway devices, leading to safer delivery of anaesthesia to the community. 80 patients will be enrolled in this project which will only be run at the Princess Alexandra Hospital. All patients enrolled in this project will have either one of these “LMAs” inserted after the anaesthetic has started. We will only be trialing 2 types of “LMA”, namely the LMA Supreme and the GuardianCPV, as previously mentioned. All the researchers involved will be from the Princess Alexandra Hospital. This research will be used by the principal researcher Dr Colin Brodie (currently in training in the specialty of anaesthesia) as part of a requirement of his training to become a specialist anaesthetist. This project is not funded by any sponsorship or grant, and all funding for this project will come from the Anaesthetic Department at the Princess Alexandra Hospital.

  • Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections

    Posaconazole (POS) is a systemic antifungal oral suspension approved for use as a treatment of refractory invasive fungal infection (rIFI), treatment of oro-pharyngeal thrush (candidiasis) and prevention (prophylaxis) of invasive fungal infection (IFI) in high-risk patients as a result of severe immuno-suppression. This includes those with neutropenia (low white blood cell count) after chemotherapy or patients who have had a bone marrow or stem cell transplant (HSCT) and are having treatment for graft-versus-host (GVHD) condition. It is recommended that Posaconazole (POS) oral liquid suspension is taken several times a day and/or with a high fat meal or nutritional supplement to ensure that the medication is absorbed into the body. Such food intake is difficult to achieve in immuno-compromised, acutely ill patients, particularly patients with active Graft-Versus-Host Disease or patients with leukaemia undergoing acute chemotherapy. A new solid oral formulation of Posaconazole (POS), SCH 056592, has been developed to optimize absorption in patients with limited food intake. It has been designed to release Posaconazole (POS) in the small intestine. This maximises its systemic absorption and overcomes the food-effect limitations of the oral suspension formulation. The purpose of this study is to evaluate the amount of drug absorption and safety of SCH 056592 in a broad population of subjects who would benefit from antifungal prophylaxis and 2) compare these findings with results from other studies to support the selection of a dose for registration of the solid oral formulation.

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