ANZCTR search results

Postoperative nausea and vomiting (PONV) is a common complication that may cause significant morbidity. It is usually treated with anti-emetics. Recently, Chewing Gum (GC) showed similar level of efficacy to ondansetron in a pilot controlled trial of surgical patients. Moreover, CG has bee shown to reduce postoperative gut malfunction and vomiting after colorectal surgery However, to date, CG has not bee studied in the prevention of PONV in patients admitted to the intensive care unit (ICU). Thus we aim to perform a study to evaluate the comparative effect of CG compared with the effects of taking a 20 ml sip of water in the prevention of PONV in patients admitted to the ICU after major surgery. Patients will be randomly allocated to be given sugarless plain CG or a 20 ml sip of water 4 hourly for 24 hours. The nurse looking after the patient will record the effects of the intervention on the presence of nausea, its duration, and severity using a visual analogue scale every 4 hours. The number of episodes of vomiting and retching will be recorded. Rescue anti-emetic therapy if the nausea is rated > 5, or if vomiting has occurred. Nausea and vomiting assessments will be made 30 minutes after the patient had been given rescue medication. If the CG intervention proves effective, it will represent an important and easily deployed, safe step towards making the patient's post-operative period less distressing.

Despite advances in management, falls continue to be a major problem for people with Parkinson’s disease (PD). Most falls prevention research excludes people with PD with cognitive impairment; however these are the people most at risk of falls. The objective of this study is to determine the feasibility and acceptability of a multifactorial fall prevention program and assessment for people with PD, including people with impaired cognition and freezing of gait. A mixed methods study with a single group trial of a 4 to 6 month multifactorial home-based fall prevention intervention will be conducted. The intervention will consist of behavioural modification, environmental modification and exercise. The intervention will be delivered by physiotherapists and occupational therapists. Semi-structured interviews will be conducted with participants before and after the intervention. Before the intervention the interview will explore participant’s perceptions of risk and their response to this perceived risk, and after the intervention questions will explore intervention acceptability.

Wernicke-Korsakoff syndrome (WKS) is a neurological disorder caused by thiamine deficiency associated with alcohol dependence or other causes of malnutrition. Although WKS is a common condition, there are currently no universally accepted, national or international, evidence-based guidelines for thiamine dosing for the treatment of either acute symptomatic WKS or for prevention of subclinical WKS-related brain damage in at-risk people. WKS is most commonly seen in alcohol dependent people who therefore constitute a major at-risk population. In the absence of agreed treatment guidelines, different clinical groups or hospital settings tend to maintain their own protocols based on experience or tradition, and in general the dosage levels of thiamine prescribed in Australia for symptomatic WKS varies from lower doses (100-300mg daily) to higher doses (1000mg daily). Australian Department of Health and Aging treatment guidelines recommend 300mg per day for at risk patients (DoHA, 2009). The main aim of this study is to evaluate whether high dose (1000mg daily) thiamine is more effective than Australian standard dose (300mg daily) thiamine for treating subclinical WKS-related brain damage in at-risk alcohol dependent patients admitted for management of their alcohol dependence. The study has direct implications for how this common condition should be treated in the future. In this study, patients will not have acute symptomatic WKS, rather, they will be alcohol dependent patients at risk of subclinical WKS-related brain damage. Patients will be treated as per usual hospital protocols, except that they will be randomly allocated to one of two treatment groups that differ only on dosage amount of thiamine (300mg or 1000mg per day for 3 days) administered via intravenous (IV) infusion. All patients admitted to Depaul House and receiving “treatment as usual” for alcohol withdrawal would routinely have received at least 3 days of thiamine (200mg x two times per day administered intramuscularly) as part of that treatment. Baseline measures, to be obtained before treatment on day 1 and outcome measures obtained after treatment on day 3, include structured examinations of mental health and neurological symptoms, particularly signs associated with WKS such as lack of coordination and irregularity of muscle movement (ataxia) and abnormal eye movements (nystagmus, ophthalmoplegia). Cognitive function will be assessed via standardised tests of working memory and anterograde memory. All participants will receive full hospital care during and after data collection, as per usual hospital protocols for such patients. It was hypothesised that higher doses of parenteral thiamine (1000 mg daily) will lead to greater improvements in specific aspects of cognition and neurological function than lower doses (300mg) in alcohol dependent patients undergoing alcohol withdrawal who are at risk for subclinical WKS-related brain damage.

The primary purpose of this trial is to evaluate the safety and tolerability of A-337, the rate that the drug is processed by the body, and the best dose for treatment in patients with solid tumours. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced malignant solid tumor known to express EpCAM, that does not respond to standard therapy or for which no standard therapy is available. Study details All participants enrolled in this trial will receive eight doses of A-337, delivered twice per week over four weeks. The dose received by each participant depends on the time of their enrolment and the safety of previous doses. A-337 is an antibody designed to target a specific cancer marker, found in some cancers. Researchers will assess patients for side effects of the medication, and take blood samples until 6 weeks after the first dose. It is hoped that the findings from this trial will determined the optimal dose of A-337 to administer for treatment, and to determine whether A-337 is safe and well tolerated by cancer patients.

The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can prevent abdominal muscle atrophy during mechanical ventilation in critically ill patients. If feasible, data will be used to design a second, larger trial on clinically relevant endpoints. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of the diaphragm, (2) respiratory function, (3) ventilation duration, (4) markers for systemic inflammation, (5) Intensive Care Unit (ICU) length of stay, (6) ICU and hospital representations, (7) re-intubations, (8) mortality and (9) quality of life.

Psoriasis is an auto-immune disease of the skin, characterised by inflammation and thick patches of abnormal skin that are red, itchy, and scaly. In an effort to address the need for effective treatments for psoriasis, Samumed has developed a small molecule inhibitor of the Wnt pathway, SM04755. In addition to the critical role the Wnt pathway plays in tissue repair and regeneration, the Wnt pathway has been associated with inflammation and inflammatory diseases. SM04755 may play a role in attenuating acute inflammation and may have potential benefit in a variety of disease states such as psoriasis following topical administration. This new study is a Phase I, randomised double-blind placebo controlled, multiple ascending-dose (MAD) safety study of topical SM04755 in subjects with mild to moderate plaque psoriasis. SM04755 will be administered daily using a single-use topical solution formulation. Dose levels will be 15, 45 and 90 mg SM04755 per mL. Some subjects at each dose level will also receive placebo. Subjects will receive 28 days of daily drug administration and will be followed for approximately 28 days after last treatment. Samumed is conducting this trial to evaluate the safety, tolerability and systemic exposure of multiple doses of SM04755 topical solution in subjects who have mild to moderate plaque psoriasis. Safety monitoring throughout the study will allow for the estimation of the maximum recommended dose to be used for future studies conducted in individuals with psoriasis.

The objective of the study is to explore the perceived ease of swallowing whole tablets, when using different pill-swallowing aids, by people who self-report disliking swallowing them. This study consists of two parts: a questionnaire and a tablet swallowing task. Participants will be enrolled into the study once they meet the inclusion and exclusion criteria.

The primary purpose of this trial is to evaluate the efficacy of using parent donors for bone marrow transplants in children, using a particular processing method of the donor blood cells (TCR a+ß+/CD19+ cell depletion) compared to those receiving a standard bone marrow transplant from another donor, We also want to compare cost to the health system of TCR a+ß+/CD19+ cell depletion with that of standard bone marrow transplant procedures, Who is it for? Patients may be eligible to enrol in this trial if they are aged 3 months to 18 years of age, have been diagnosed with haematological malignancies or non malignant disorders requiring a bone marrow transplant, and have an eligible parent donor. Study details Patients who have no fully matched brothers or sisters, and no well matched volunteer donors or umbilical cord blood units available will receive a TCR a+ß+/CD19+ cell depleted graft from a parent donor. Control patients will receive a standard bone marrow transplant from another donor (e.g., volunteer donor) as per institutional practice. Patients will undergo clinical assessments at regular intervals for two years following the transplant to evaluate the efficacy of the treatment. Further information, such as quality of life and carer burden, will be collected for up to 5 years following the transplant. It is hoped that the findings from this trial will provide information on whether parent donor cells undergoing specialised cell processing can be effectively used for bone marrow transplants in children with haematological malignancies or non malignant disorders.

We know that patients with serious illness undergoing surgery are at risk of major complications after surgery and benefit from treatment by specialists in Intensive Care and High Dependency Units. It is more recently recognised that patients with less serious medical illnesses (such as diabetes, obesity, and hypertension) undergoing certain surgery also have a high risk of life-threatening complications in general postoperative wards in the early hours after elective surgery. Recent evidence suggests that providing these patients with advanced treatment in the early hours after surgery may benefit their recovery from surgery in terms of the risk of serious complications and time to return to home and that overall health care costs may fall. It is also possible that there is a positive impact on post-discharge return to normal living, which may also positively impact on health care costs. We already have skilled medical and nursing teams in place in recovery rooms to provide very short-term advanced care for these patients, but often there is no option to continue this beyond a few hours. We propose that an anaesthesia led advanced care service based in operating suite recovery rooms can care for both the sicker patients currently being sent to the wards after surgery and the less sick of the higher risk patients currently being admitted the high dependency beds. We call this combined group of patients “medium risk” for early and late complications. To fully test this proposal we will need to conduct a large multi-million dollar randomized trial at over 20 hospitals. Before we can do that trial we need to conduct a study of the feasibility of elements of the trial. This feasibility study will examine the impact on patients and the health care system of providing advanced post-anaesthesia care with the skilled staff and facilities in recovery rooms. Formal screening of patients preoperatively, including using computer risk-assessment tools to assist clinical judgment will be tested to identify the patient group at risk. A group of these patients will receive advanced postanaesthesia care in a small number of hospitals around Australia, with careful measurement of the effect on their recovery from surgery. If the results of this feasibility study show a potential benefit to patient and the health care system, and that we can expect to complete the large randomised trial.

The purpose of the proposed study is to evaluate whether a self-compassion-focused writing exercise, (“My Changed Body”), can decrease levels of distress among women with lymphoedema Who is it for? You may be eligible to join this study if you are a woman aged 18 years or over and have cancer related lymphoedema. Study details Study participants will be allocated by chance to one of the two groups. One group will receive general lymphoedema information as per usual care. This contains information about lymphoedema prevalence, reducing the risk, and self management strategies . The second group will receive a writing exercise. The writing exercise consists of 6 steps (total 30 minutes) with structured prompts that will encourage the writer to be kind; to consider how they would support a friend in the same circumstances; and to look at their feelings from a broader perspective Study questionnaires will be completed up to six months past intervention completion to assess self-compassion and sexual functioning. This is a significant project because lymphoedema is a prevalent side-effect of cancer treatment, is incurable and leads to concerning levels of psychological morbidity, which may be alleviated by a simple, low-cost writing exercise.