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 pharmacokinetics of intranasal droperidol in healthy volunteers.

    The intranasal (IN) route of drug administration has many advantages. It has the potential to eliminate the pain, anxiety, and distress that can be associated with the use of needles for IV or IMI drug delivery. The risk of needle-stick injury and blood-borne infection is also minimized by the use of needleless systems. In addition, drug administration can occur more quickly than intravenous administration as there is no need to spend time siting a cannula and there is reduced resource utilisation. Recent observational research in the ED setting has revealed that more than 50% of inserted intravenous cannulae are never used for therapeutic purposes and pose a significant risk for skin infection and septicaemia if left in-situ. There is currently no data examining the pharmacokinetic profile of intranasal droperidol. However, based upon results with intranasal haloperidol, it is likely that droperidol, having similar pharmacokinetic properties, may display a comparable intranasal absorption profile. Currently, there are no anti-emetics or antipsychotic medications being administered intranasally in the clinical setting. As a result, if the pharmacokinetic profile is favourable, droperidol may be a useful drug to consider for clinical trials of intranasal treatment of acute behavioural disturbance and anti-emesis.

  • ASCOLT Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers.

    This study will evaluate the safety and efficacy of adjuvant Aspirin 200mg versus Placebo 200mg for patients with Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or above, and have confirmed Dukes C colon cancer, high risk Dukes B rectal cancer or Dukes C rectal cancer for which you have had surgery to remove the primary tumour and completed at least 3 months of chemotherapy. Study details Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will be provided with Aspirin 200mg daily for 3 years and the other group will be provided with a matching Placebo 200mg daily for 3 years. Participants will be asked to attend clinic visits every 3 months for a period of 3 years and thereafter every 6 months for 2 years to determine disease free survival, overall survival and quality of life.

  • Albany Physical Activity & Nutrition Project: A home-based physical activity and nutrition program targeting middle-aged adults at risk of metabolic syndrome in a disadvantaged rural community

    Older Australians are now heavier than they were a generation ago, with 75% of this age group classified as either overweight or obese. Much of this overweight/obesity is likely to have resulted from poor diet and/or low levels of physical activity, which in the long-term contributes to chronic disease and related conditions. This intervention research will actively promote improvements in levels of physical activity, strength exercises and healthy diet via a home-based intervention that will educate, support and motivate participants through a range of strategies. Specifically, this intervention will target adults aged 50 to 69 years at risk of metabolic syndrome, residing in regional Australia (Albany). Participants will be required to be insufficiently active (< 150 minutes of moderate physical activity per week), and satisfy the diagnostic criteria for the metabolic syndrome (a predictor of type 2 diabetes mellitus and cardiovascular disease). It is hypothesised that by the end of the intervention, the intervention group participants compared to the control group will show significant improvements in: metabolic syndrome parameters; blood pressure; body weight; physical activity level; fat intake; fruit and vegetable consumption; sugar and fibre intake. The study will provide information on the impact of the physical activity and nutrition intervention on a range of physical and clinical variables in the older population in a regional setting.

  • Predictive Low Glucose Management (PLGM) Trial : Comparing insulin pump therapy with predictive low glucose suspend feature versus standard sensor augmented pump therapy in patients with type 1 diabetes.

    This study will compare the new insulin pump with predictive low glucose suspend feature with current pump therapy with the aim to reduce the time spent hypoglycaemic.

  • Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia.

    To compare Usual Care (UC) with an innovative interactive therapeutic robot (PARO) and with a look-alike Plush Toy (PT - without the artificial intelligent aspects of the robot) in terms of reducing emotional and behavioural (agitation) symptoms of dementia.

  • Cognitive behavioural therapy for the sensation of breathlessness : A pilot study

    In people with chronic obstructive pulmonary disease, psychological interventions usually target generalised anxiety and depression rather than the sensation of breathlessness. The objectives of this pilot study were to develop and implement a cognitive behaviour therapy (CBT) program specific to the perceptual experience of breathlessness, estimate any beneficial effect of combining the CBT program with comprehensive pulmonary rehabilitation and identify any practical issues in the study protocol.

  • Clinical evaluation of the Thumbwheel Delivery Zilver PTX Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

    The purpose of this study is to evaluate the performance and safety of a new delivery system for the Zilver PTX Drug-Eluting Peripheral Stent in the treatment of peripheral arterial disease.

  • Differences in gut bacteria of patients with Clostridium difficile infection and patients with ulcerative colitis before and after faecal microbiota transplantation

    Faecal microbiota transplantation (FMT) is a highly successful treatment for Clostridium difficile infection (CDI) with success rates of over 90%. Success rates of FMT treatment for ulcerative colitis (UC) are lower. The success of FMT in CDI treatment is believed to be in part due to the implantation of the full complement of bacteria from the FMT into the patient's bowel. It is unclear if this implantation occurs with FMT in UC patients. The lower success rate of FMT treatment for UC may be due to a failure of the bacteria from the FMT to implant in the bowel's of UC patients. This study will compare the composition and changes in the gut bacteria before and after FMT in patients with CDI and in patients with UC.

  • Combined Local Infiltration Analgesia and Femoral Nerve Blocks in Total Knee Replacements. A Prospective Randomised Controlled Trial

    Total knee replacements (TKRs) are one of the most painful orthopaedic procedures and are associated with a protracted recovery period. Multiple techniques are utilised for pain relief and these include femoral nerve blocks (FNBs) and high volume local infiltration analgesia (LIA), the superiority of either is largely contentious. This study aims to assess the differences in several outcomes for patients undergoing total knee replacement using single shot FNBs and LIA. This is a prospective, blinded, single centre randomised controlled trial at Nambour General Hospital, in Queensland, Australia. Ninety (90) patients having TKRs will be sought during their visit to the Pre-Anaesthetic Evaluation Unit (PAEU) and assessed against the eligibility criteria. Inclusion criteria are patients who consent to participate in the study; ability to comprehend pain scoring and ability to use PCA machine; elective primary unilateral TKR performed at NGH; American Society of Anesthesiologists (ASA) Physical Status I-III; and patients aged 18-85 years. The exclusion Criteria are patients who lack capacity, or are unwilling, to consent to the study; patients with pre-existing chronic pain syndromes; patients with opioid tolerance (opioid consumption >30mg oral morphine or equivalent per day; chronic gabapentin or pregabalin analgesic therapy; patients with known contraindication, allergy, intolerance or previous reaction to any of the drugs being administered; inability to walk independently prior to TKR; Body Mass Index >40 kg/m2; patients <18 years of age; patients who are pregnant; and patients who have dementia. Participants will be randomly selected using a blocked permuted randomisation method for Arm 1 – Single Shot FNB and placebo LIA, Arm 2 – LIA and placebo FNB, or Arm 3 – Single Shot FNB and LIA. The trial will be double-blinded. The trial looks to determine how explanatory variables (FNB, LIA) relate to total opiate consumption and highest pain scores in the immediate post-operative recovery period and at 4/12/24/48 hours (4/24/48 hours for pain scores) post-operatively and at hospital discharge, time to Post-Anaesthesia Care Unit (PACU) and hospital discharge, and time to mobilisation (outcome variables).

  • Number of clots found in the arms of high risk surgical patients with a drip

    Aim: To investigate the relationship between dorsal hand/forearm cannulas and the development of an upper limb DVT in high risk surgical patients. Our sample size population will include 75 high risk patients (sample size of 62 + 10% for attrition) . Inclusion criteria are patients with an underlying malignancy, thrombophilias, previous surgery/trauma and over 65 years of age. As part of the inclusion criteria all patients will receive standard DVT prophylaxis surgery and have baseline bloods performed including a FBC,LFT, U+E and INR.Patients with a previous upper limb DVT, previous neck surgery/mastectomy/axillary clearance and thoracic outlet syndrome were excluded. Ultrasounds will be performed at enrolment (which is part of normal patient care) and at discharge to identify an upper limb DVT. Patients found to have an upper limb DVT will be placed on DVT protocol for treatment and will be followed up for 30 days for continuing management and monitoring of complications.

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