ANZCTR search results

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.

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.

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.

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.

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.

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).

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.

Ulcerative colitis (UC) is a chronic and relapsing inflammatory bowel disease (IBD) characterised by inflammation in the lining of the large bowel. Recent studies of the bacterial populations that normally reside in the large bowel (gut microbiota) have shown abnormalities (i.e., dysbiosis) in the faeces of patients with UC. Our research group has found evidence that the ability of the gut microbiota to ferment carbohydrates may be markedly defective and this cannot be corrected by simply providing more dietary fibre. Such fermentation is an important function of the microbiota as it delivers breakdown products that include short-chain fatty acids such as butyrate to the lining cells of the colon. Butyrate is the major source of nutrition for those cells and also has anti-inflammatory and anti-tumour-producing effects. This observation has potentially large implications for how we manage UC. If it is true, then manipulation of the bacteria and of the specific carbohydrate substrates they see by, for example, dietary manipulation of the types of carbohydrates they eat might have therapeutic benefit. Furthermore, such fermentation lowers acidity (pH) in the bowel and this lowering is utilised for the activation of some drugs commonly used in UC (e.g. mesalazine). Defective fermentation might lead to poor activation of those drugs and lack of effectiveness. The major problem with studying fermentation in the large bowel is that most occurs in the proximal part of the large bowel – i.e., the part furthest away from the anus - and we have only been able to study it indirectly. Using swallowed capsule technology that transmits information to a transmitter worn by the patient (as used by the ‘pill-camera’), a new wireless pH-motility device, has been developed. This device is able to capture measurements for transit (speed of passage through the gut) and pH in real time and in a non-invasive manner as it travels along the entire gut. It is the pH measurement that provides our first way of examining fermentation in the intact colon. We propose to measure the pH profiles in the gut of 10 healthy volunteers and of 20 patients with UC who do not have active disease after both a large and a minimal load of indigestible, fermentable carbohydrates. This will be achieved by controlled food intake over the 12 hours prior to the capsule being swallowed. This will give us a range of pH profiles related to high and low levels of fermentation in the gut. We will then be able to determine if the fermentation capability of patients with UC is truly deficient. The pH-motility device will also permit us to examine transit through the regions of the gut and provide mechanistic information on the role of gut transit in any abnormalities found. We anticipate variation in responses of patients (but not in healthy volunteers). In order to be able to identify patients with abnormal fermentation, we will also collect, prior to the investigations with a wireless pH-motility device, dietary intake information and faeces to determine if these indices provide the correlations with the pH profile.

Constipation is highly prevalent among users of antipsychotic medication and is linked to physical issues such as bowel obstruction and paralytic ileus as well as psychological issues such as greater distress, poor mental health and low quality of life. Aside from the prescription of laxatives, the standard approach to reducing the symptoms of constipation is with increasing fibre into the diet, increasing fluid intake, and encouraging physical activity. It can be difficult to increase the amount of fibre and fluid in the diet in patients residing in a psychiatric hospital due to limited dietary options. Only one clinical trial assessing constipation in antipsychotic medication users could be found, while most studies exclude participants where medication is the likely cause of the constipation. The objectives of this study are to evaluate the effectiveness of regular exercise on constipation in patients prescribed antipsychotic medication within a psychiatric setting and to compare this treatment against receiving written and verbal information on constipation.

Age-related macular degeneration (AMD) is a very common problem in the elderly. The treatment is given by intraocular injection, and there are two TGA approved medications (Lucentis and Eylea) which are in common use in Australia for AMD. Both have been shown to be equivalent. The investigators have shown in previous studies that a novel tool for visual testing known as multifocal objective pupil perimetry (mfPOP) is sensitive at picking up the loss of retinal function observed with AMD, and also the recovery in function following Lucentis therapy. The investigators plan to randomise 60 patients with new onset wet AMD to either Lucentis or Eylea therapy and to manage them according to standard, accepted clinical practice. They will be followed using both the standard testing and also mfPOP to see if mfPOP is an effective tool at monitoring disease progress on therapy, and also to see if mfPOP can detect any subtle differences between the two medications.