ANZCTR search results

Hearing voices (auditory verbal hallucination) is a potentially distressing and disabling experience which often persists in spite of treatment with medication. This pilot study examines whether it is helpful for people who hear voices to receive assistance in coping with this experience from someone else who hears voices and has adapted to living with this experience.

The purpose of this study is to investigate the effects of family supervised therapist-devised physical rehabilitation programs for adults with acquired brain injury (ABI) in an inpatient rehabilitation setting. The specific aims are to compare therapist-devised physical rehabilitation programs conducted by the family members to usual care for the following outcomes: Physical function for clients with ABI; satisfaction with the health care provided for the family members; mood for family members.

This study evaluates the effectiveness of a nurse-led educational clinic offered to patients within 5-7 days after having a procedure on their heart. The main aim of the clinic is to reduce patient anxiety after discharge from hospital. This study also aims to reinforce education on post-operative cares, risk and lifestyle modification, and encouraging medication adherence whilst improving access to secondary prevention programs. Through the provision of nurse-led clinical follow-up, support and education in the early post-discharge period, it is hoped that patients can achieve confidence and independence in their health-management, resulting in improvements in psychosocial and physical well-being.

This is a 2-stage, Phase I/II (3 + 3 dose escalation with an expansion phase), open label, single centre study to determine the safety, tolerability and preliminary efficacy of escalating doses of the experimental drug VAL-1000. Enrolled patients will have a bone marrow aspirate to determine the baseline blast count and to collect samples for correlative laboratory studies by the Investigator. This study is open to Male and Female subjects aged 18 years of age or over with Acute Myeloid Leukaemia, Acute Lymphoblastic Leukemia (ALL) or high-risk Myelodysplastic Syndromes (MDS), who are unsuitable for treatment with standard chemotherapy regimens. Further details on the inclusion and exclusion criteria for this study can be found in the relevant section of this form. Trial details In this study, you will be assigned to receive an ascending dose of 100mg, 150mg, 200mg up to 250mg of VAL-1000 daily via oral administration for 12 months, with three patients enrolled in each of these cohorts (study groups). The maximum dose you will receive may vary depending on the safety, tolerability and efficacy of the earlier doses of oral VAL-1000. Patients experiencing a Dose Limiting Toxicity (DLT) or disease progression will be taken off the study; other patients will continue to be treated daily with 50mg oral twice a day (100mg/day) VAL-1000. Further details of this treatment can be found in the Description of intervention(s)/ exposure field in this form, and may be discussed further with your treating clinician.

Distal radius fractures are among the most common fractures seen in the hospital emergency department. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating systems have better clinical and radiological outcomes following surgery, and also the lowest complication rates. Few studies have compared different types of plates, which may have different plate and screw designs, features or may be manufactured from different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures: one made from stainless steel (Trimed Volar Plate) and the other made from titanium (Medartis Volar Plate). This study will use a two group (intervention) blinded (blinded outcome assessor, blinded data analysis, concealed randomisation, blinded participant) randomised trial in an adult population. A suite of outcome measures recommended for this patient group will be used. These measures include an assessment of range of movement, strength, function (quickDASH and Patient Rated Wrist Evaluation), pain(VAS) , complications (medical chart and self-report), quality of life (EQ5D), radiological outcome (XRay) and patient satisfaction (VAS). These outcomes will be administered by a blinded assessor at seven time points: baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

Overall this research aims to determine whether or not CLEAR SPEECH is a viable treatment option for patients with non-progressive dysarthria. Specifically, this research project aims to: 1. Determine the efficacy of CLEAR SPEECH as a treatment for non-progressive dysarthria following stroke and TBI across a range of perceptual, acoustic and everyday communication outcome measures. 2. To compare the effects of CLEAR SPEECH with the outcomes of traditional dysarthria therapy (TRAD) in individuals with non- progressive dysarthria. It is hypothesized that CLEAR SPEECH will result in short and long term improvements to perceptual and acoustic measures of speech function, and ratings of everyday communication in individuals with non-progressive dysarthria. Also, the degree of improvement in speech and communication parameters will be greater following CLEAR SPEECH compared to the effects achieved following TRAD.

A randomised trial to determine whether using a sprayable adhesion barrier onto the operative field during removal of a gastric band will make a future laparoscopic sleeve gastrectomy quicker and safer due to reduced scar formation where the gastric band used to be.

To determine if a purpose built evidenced-based internet-based program called Getreal is effective in reducing the frequency and distress associated with psychotic like experinces in young people.

Omega-3s in fish oil are important for brain function and Australian children are not consuming enough in their diet. The purpose of this study is to give primary school children fish oil capsules or placebo capsules to determine whether the fish oil capsules assist them with their learning and behaviour, specifically literacy, attention, cognitive development, and parent/teacher reports of learning and behaviour as well as quality of life.

Laparoscopic surgery continues to cause specific pathophysiological changes particularly due to intraabdominal pressure (IAP) and positioning. Cardiovascular changes include hyperand hypotension, prolonged QT dispersion, arrhythmias and rarely cardiac arrest. Splanchnic perfusion changes with changes in organ function are mainly due to the increased intraabdominal pressures and the resultant reduction in abdominal perfusion pressure. Pulmonary changes like hypercarbia, hypoxemia and barotraumas are usually avoided through adaptations in ventilation settings. Although other causes like CO2 absorption, ventilation strategy, surgical technique, the nature and duration of the procedure, and intrinsic patient factors (intravascular volume, preexisting cardiopulmonary status and neurohormonal status) have been identified, the intraabdominal pressure caused by the CO2 pneumoperitoneum combined with the patient’s position remain the main drivers behind these pathophysiological change. Commonly IAP is around 12 mm Hg for most laparoscopic procedures. Pressures above 15 mm Hg lead to increased systemic and pulmonary vascular resistance and a reduction in cardiac index. Lowering insufflation pressures even more leads to a further reduction in postoperative pain and a better quality of life 5 days after surgery. The primary reason for insufflation is to create good view of the surgical field and enough room to manoeuvre with the surgical instrumentation. Determining factors will be the proceduretype dependent extent of the relevant surgical field, the patient habitus, and the abdominal wall elasticity. One would assume that a neuromuscular block (NMB) would facilitate the extension of the abdominal wall and produce more space at lower insufflation pressures. However, only very limited evidence exists, both suggesting that ongoing NMB may or may not provide any benefit. Clinical practice varies between ongoing NMB, intermittent NMB or no NMB at all after induction. With the advent of the reliable NMB reversal agent Sugammadex, we are now in a position to offer continuous deep NMB (CDNMB) until the end of the procedure without compromising our ability to timely and fully reverse the NMB. This enabled us to design this prospective observational pilot study to investigate if the IAP can be reduced to lower values with a CDNMB with Rocuronium compared to no ongoing neuromuscular block under a standardized anaesthetic technique. The outcome of this study will help us determine the power and study size requirements for a randomized controlled trial looking at the lowest IAP in patients with and without continuous deep NMB.