ANZCTR search results

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

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31339 results sorted by trial registration date.
  • The analgesic efficacy, tolerability, safety and pharmacokinetics of a sublingual wafer formulation of ketamine in burns patients undergoing painful dressing changes

    The change of dressing in burns patients is a painful procedure; however, the pain is only short-lasting. Therefore pain relief requires a fast, but short acting method. Options widely used are inhalation of Entonox (a pain relieving gas mixture), short acting morphine-like tablets or administration of morphine-like drugs by patient-controlled analgesia pumps. In Royal Perth Hospital ketamine, a short-acting pain killer has been used successfully via patient controlled analgesia pumps for many years and, since the Bali disaster, by use of administration under the tongue (as liquid or lozenge made by hospital pharmacy). A new preparation of ketamine as a wafer, to be administered under the tongue, has been shown to have a rapid onset of effect with minimal adverse effects in volunteers. This could be a promising way to provide pain relief for dressing changes without the need for an intravenous line and with minimal adverse effects. The new medication will be tried in in-patients of the burns unit requiring painful dressing changes. The medication will be compared to placebo wafers, but patients can at any time ask for rescue analgesia, which will include the methods mentioned above. It is expected that ketamine wafers provide better analgesia than placebo with less need for rescue analgesia than placebo. The results of this trial will permit further development of this promising new form of pain relief.

  • Does melatonin help children with Attention Deficit Hyperactivity Disorder (ADHD) sleep better?

    Methodology Randomised, Double-Blind, Placebo-Controlled, Multi-Centre trial of aggregated N-of-1 Trials compared to parallel group RCT on the Effects of melatonin on SOL in children and adolescents with ADHD who are receiving stimulant medication. Study Duration 6 weeks (3 pairs over a six week period) for each individual participant Objectives Hypotheses: 1) Melatonin is effective for alleviating initial insomnia in ADHD children who are receiving stimulant medication; and 2) N-of-1 trials provide a similar estimate of treatment effect with less uncertainty than a parallel group RCT. Objectives: 1) To determine the efficacy of melatonin in shortening sleep latency times in children with ADHD treated with stimulants 2) To determine whether n-of-1 trials provide similar estimate of treatment effect with less uncertainty than a parallel group RCT Number of Participants 300 participants (children), 300 parent/guardians from Queensland and Canada

  • A pilot study to explore the safety of pyridostigmine in constipated palliative care patients

    Constipation is a common, distressing and serious problem, affecting between 50-90% of people referred to specialist palliative care services. Approximately half of these people do not achieve adequate management of their constipation. The number of people who do not achieve satisfactory symptom relief is not acceptable. So the researchers conducting this study are looking to see if there are more effective ways to treat constipation. The aim of this study is to explore whether people who are currently taking anticholinergic medications and suffer from constipation, will respond better to a cholinergic agent (pyridostigmine), without affecting other symptoms.

  • Healthy Living Program after Gestational Diabetes

    The study aims to determine if a comprehensive behavioural lifestyle intervention promoting physical activity and encouraging healthy diet can achieve short-term behaviour change in overweight/obese women with a recent history of gestational diabetes, in a real world setting.

  • A prospective study evaluating joint-line changes, patient outcomes and migration after Unity Total Knee Replacement.

    This research project is a prospective, randomised clinical study. The primary purpose of this study is to evaluate the change in medial joint-line position (JLP) of patients implanted with the Unity Total Knee System, in both flexion and extension, from preoperative to six months postoperative. A comparison of the change in JLP of patients having received the Posterior Stabilised versus the Cruciate Retaining surgical technique will be conducted. Secondary objectives are to track clinical outcomes, functional results and imaging assessments of patients implanted with the Unity Total Knee System over a 5-year follow-up period. The study will require 150 participants, equally randomised to receive either the Posterior Stabilised (PS) or Cruciate Retaining (CR) surgical technique. Both PS and CR techniques are reasonable standards of care employed on the basis of surgeon preference. RSA analysis will be performed on a randomised cohort 100 study participants (50 CR and 50 PS). Participants will be assessed preoperatively and postoperatively at discharge, 6 weeks, 6 months, 1 year, 2, 3 and 5 years. All Corin Unity Study procedures adhere to the standard operating procedures at the International Musculoskeletal Research Institute Inc.

  • Using New Technologies to Promote Weight Management.

    The primary purpose of this study is to identify a practical and cost-effective tool to assist overweight and obese people undergoing dietary and lifestyle changes to lose weight and sustain their weight loss.

  • Repair of Symptomatic Ear Drum Perforations: A Pilot Study Using Celgro Trademark Type I/III Collagen Bioscaffold

    More than 106,000 Australians suffer from hearing loss and chronic ear infections related to perforations of the ear drum. Closure of these perforations traditionally requires surgery lasting up to an hour or more under general anaesthesia. Conventional myringoplasty has closure rates of ~85% in non-Indigenous populations and 50-70% in Indigenous populations. This project validates a new approach for closure of perforations requiring minimal surgery. Adults are treated under local anaesthesia with a Celgro Trademark Type I/III Collagen Bioscaffold mixed with fibrin glue placed into the perforation, thereby promoting the self-healing capacity of the eardrum.

  • Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?

    The purpose of this research project is to study whether it is possible to use a lower total dose of fractionated stereotactic radiotherapy (FSRT) and small daily radiation treatments to treat choroidal melanoma, in order to increase the chance of keeping vision in the eye and to reduce the severity of radiation side-effects but without affecting the chance of cure. Who is it for? You may be eligible to join this study if you are aged less than or equal to 70 years and have been diagnosed with primary choroidal melanoma (small and medium sized) by an ophthalmologist. You should not have received previous treatment to the affected eye with radiation, laser or thermotherapy. Study details All participants in this study will receive reduced dose FSRT to a dose of 60Gy in 30 fractions, given 5 fractions per week over 6 weeks. It is known that small daily doses of radiation (2Gy) will protect normal tissues from radiation injury when compared with large daily doses. When small daily doses are used it is called full fractionation. Tissues such as the eye nerve and the blood vessels at the back of the eye are especially protected by full fractionation. FSRT is a technology that makes it possible to use full fractionation to treat choroidal melanoma, so this may make it possible to reduce side-effects and keep better vision in the eye. Participants will be followed for up to 10 years to evaluate disease response, vision and any radiation side-effects.

  • Effectiveness of Cognitive Behaviour Therapy in people with intellectual disability and anxiety: A pilot RCT

    Individuals with intellectual disability experience around twice the rate of mental health difficulties than typically-developing individuals. Anxiety is a common problem, however not only will the majority of people with intellectual disability not receive specialist psychological services, there is a paucity of research on evidence-based treatment approaches for this population. This study will adapt a well-validated psychological treatment (cognitive behavioural therapy; CBT) for use with adults with mild intellectual disability and anxiety. This new treatment program will be evaluated to investigate whether it is effective in treating anxiety in adults with mild intellectual disability.

  • Sedentary behaviour in people with cardiovascular disease: a pilot randomised controlled trial

    The purpose of this study is to investigate sedentary behaviour in people with cardiovascular disease undergoing a cardiac rehabilitation program at the Royal Adelaide Hospital. The aim of this study is to investigate the feasibility and impact of a goal-setting intervention at decreasing daily sedentary time in people with cardiovascular disease. A secondary aim of this study is to describe the sedentary behaviour (total duration and type of activities) of people with cardiovascular disease before and after undertaking a cardiac rehabilitation program.

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