ANZCTR search results

The proportion of older Australians is increasing, in parallel to increasing multimorbidity, polypharmacy and an increased risk of Adverse Drug Events (ADEs). The Drug Burden Index (DBI) is a pharmacologic risk assessment tool that measures an individual’s total exposure to anticholinergic and sedative medications. A high DBI score is associated with poor clinical outcomes in older adults. Home Medicines Review (HMR) is a comprehensive medication review service involving a pharmacist, general practitioner (GP) and the patient with the aim of enhancing quality use of medicines and reducing ADEs. To date, the DBI has not been tested in the HMR setting. AIMS: (1) To assess if the DBI report is feasible as a risk assessment tool in this setting; (2) To establish whether the DBI together with HMR service can reduce use of anticholinergic and sedative medications in older adults; (3) To assess changes in clinical outcomes in older adults following reduction of anticholinergic and sedative medications. Methods: An interventional feasibility study with two arms will be conducted: 10-20 pharmacists, who regularly conduct HMRs in the community, will be recruited to participate in the study. Each pharmacist will undergo an education program and be provided access to the Drug Burden Index Calculator 'Copyright'. Each pharmacist will also provide anonymous data on HMRs conducted for 10 patients to serve as historical controls. The intervention will involve pharmacists providing a DBI report to GPs with the HMR service for 10 patients. Patients will be asked to fill in a questionnaire, and be contacted by telephone for an interview at 0 and 3 months (post-HMR) by lead investigator to assess cognition and physical function. Discussion: Results from this study will provide an evaluation of the utility of the DBI as a risk assessment tool for reducing inappropriate prescribing in older adults during a HMR; and set the groundwork for a larger randomised control study.

This is a multi-centre trial to investigate the effects of the pneumococcal vaccination in the primary prevention of heart attacks and strokes. People aged 55 to 60 from 6 sites around Australia will be invited to participate in the study. The selected participants will attend a clinic in their area and will be randomly given the pneumococcal vaccine or a placebo vaccine. Outcomes on the expected 6000 participants will be ascertained by health record linkage with government databases after 6 years.

The purpose of this study is to examine the effects of the medication prazosin on: 1) the quantity and quality of Rapid Eye Movement (REM) sleep; and 2) emotional memory. This is so we can learn more about the basic effects of the medication in healthy adults as a step towards better understanding how the medication might help those with Posttraumatic Stress Disorder. The hypotheses are: 1. Increasing doses of prazosin will lead to greater quantity of REM sleep and fewer disruptions of REM sleep (e.g., fewer awakenings during REM sleep) 2. Increasing quality of REM sleep, resulting from increasing doses of prazosin, will lead to improved overnight memory for emotional pictures.

Intravenous paracetamol is ubiquitously used in hospitals as an antipyretic and analgesic worldwide. It is administered to a wide array of patients including those undergoing major surgeries and the critically ill due to its minimal side effect profile. However, recent studies have provided compelling evidence for a re-evaluation of paracetamol use in this setting as it has been found to cause hypotension in intensive care patients. Importantly, there is a paucity of guidance regarding its haemodynamic safety in surgical and critically ill patients. This may be due to a lack of double-blinded, randomised controlled trials in these settings as well as in healthy patient cohorts for comparative studies. In addition, a previous study found that oral effervescent paracetamol tablets produced hypertension in patients which study investigators linked to the high sodium content in the effervescent formulation. It is therefore important to acknowledge that excipients (pharmacologically inactive compounds that act as vehicles for the active compound in the drug) may affect blood pressure. There is no existing literature that has addressed the potential for the high mannitol content of intravenous paracetamol to produce haemodynamic effects. Hypothesis: Paracetamol (1g IV) and mannitol (3.91g mannitol IV) will have adverse effects on blood pressure in healthy volunteers compared to 0.9% normal saline. No of participants: 24 No of recruiting hospitals: 1 Randomization: In this triple-cross over study, participants will be randomized in a 1:1:1 fashion via a computer generated randomization program to receive 1 treatment from each of the treatment arms. The treatment arms include: 1) Control (100mL 0.9% normal saline) 2) IV paracetamol (100mL paracetamol and mannitol 3.91g) 3) IV Mannitol treatment (100ml mannitol 3.91g) Blinding: This is a double-blinded clinical trial. This study requires the use of 100mL blinded fluid vials. These vials will look identical in all treatment groups. Depending on randomization, IV paracetamol, 0.9% normal saline or mannitol will be transferred into the blinded vials just prior to IV infusion. Preparation of the blinded vials will be conducted by an anaesthesia nurse who will not be involved in the data collection. The participants, sampling anaesthetist and data analyst will be blinded to the assignment of treatment. Primary endpoint: Changes in haemodynamics: Mean, systolic and diastolic blood pressure Secondary endpoints: Cardiac output and cardiac index, stroke volume, systemic vascular resistance, plasma osmolality Other data collected: Patient characteristics and adverse events

This study is looking at the impact of light therapy on pain levels in an older population. There will be two participant groups, group 1 will receive bright light therapy using light therapy glasses, and group 2 will receive natural light therapy. Both groups will receive their specified light therapy for 10 days (2 weeks, Monday to Friday), and will also have two weeks with care as usual before and after receiving light therapy. Group 1 will receive care as usual for the first 2 weeks, then bright light therapy first for 2 weeks, followed by another 2 weeks of care as usual. Group 2 will also receive 2 weeks of care as usual for the first 2 weeks, and will then receive 2 weeks of natural light therapy. This will be followed by another 2 weeks of care as usual. It is hypothesised that light therapy will reduce reported pain levels in an older population. The Brief Pain Inventory will be administered at baseline, 2 weeks, 4 weeks and 6 weeks of the study. A daily Sleep Diary will be kept by all participants, and an Actiwatch2 will be worn for the duration of the study.

To determine the safety and tolerability of ALD403 via injection and infusion in healthy participants. To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 via injection and infusion in healthy participants.

This project aims to develop and test a nurse-led model of survivorship care for lymphoma survivors. You may be eligible to join this study if you are over 18 years, have completed first line chemotherapy treatment for new Hodgkin or non-Hodgkin lymphoma or second line curative intent autologous transplant and have no evidence of lymphoma on PET scan. Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will continue to receive usual follow-up care with their haematologist. Participants in the other group will take part in an evidenced-based survivorship clinic that will provide tailored care to meet the informational and practical needs of lymphoma cancer patients who have completed active treatment. The nurse-led lymphoma survivorship clinic intervention will involve three 1 hour face-to-face structured interviews that will occur over a 6 month period. These will involve discussion and delivery of a survivorship care plan, treatment summary and resource pack. Participants in both groups will be asked to complete a number of questionnaires at baseline, 3 months and 6 months in order to evaluate unmet informational and practical needs, depression, anxiety, stress, coping and self-empowerment. The findings from this study will add to a limited body of knowledge in this cancer survivor group and make a significant contribution to the planning and delivery of survivorship care.

The older population often presented with changes in mood, such as depression. Biological changes in the body can contribute to depression. These changes can be altered by strategic management of light exposure. It is believed that exposing older people to light in the early morning will lead to biological shifts, which will reduce depressive symptoms. The purpose of the study is to see whether exposing older people to artificial light and natural sunlight can improve their symptoms of depression, with the aim of improving treatment opportunities for the older population.

We aim to measure the adequacy of preoxygenation by NRB and BVM in the abscence and presence of a simulated mask leak, and whether the addition of oxygen via NP significantly improves preoxygenation in these conditions, as measured by ETO2. We propose to perform a four-period crossover study (repeated measures design) with two arms, using healthy volunteers. There will be a NRB arm and BVM arm. After informed consent participants with be randomised to NRB and BVM. They will then be randomised to a sequence of 3minutes preoxygenation using the NRB, NRB+NP, NRB and simulated leak, NRB+NP and simulated leak in the NRB arm; or BVM, BVM+NP, BVM and simulated leak, BVM+NP and simulated leak in the BVM arm. ETO2 and endtidal carbon dioxide (ETCO2) will be measured using the gas sample analyser on an anaesthetic machine. Participants will also be asked to rate their comfort with each preoxygenation method.

This pilot trial aims to evaluate if a structured exercise intervention improves fitness, lowers fatigue and improves quality of life in adolescents and young adults after the completion of cancer treatment. Who is it for? You may be eligible to join this study if you are aged between 15 and 25 years of age, are diagnosed with a haematological malignancy or solid tumour and have completed a systemic cancer treatment (ie chemotherapy and/or radiotherapy). Study details: Participants in this study will be assigned to either an intervention group or the control group by chance. Participants in the intervention group will receive 10 weeks of structured, individually tailored exercise intervention performed twice a week for 60 min per session. The control group will not receive exercise physiology input and will not be offered an exercise intervention during the study period; however no restrictions will be imposed on their activities. (Once the study is over, control patients will be offered participation in an exercise intervention if they want, but this will not be part of the study). Participants in both groups will have a blinded assessment of physical fitness, fatigue, and quality of life at baseline, 10 weeks, and 6 months. These measures will be compared between the group undertaking the programme and the control arm to determine whether the programme is associated with initial improvements, and whether these improvements are sustained at 6 months. It is hoped that this study will help determine whether a structured exercise programme speeds up recovery of physical fitness, reduces fatigue, and improves quality of life in adolescent and young adult patients who have been treated for cancer.