ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

You can narrow down the results using the filters

33073 results sorted by trial registration date.
  • Haemodynamic Effects Of Intravenous Paracetamol In Healthy Volunteers

    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

  • Pain Management in the Aged Care Population: The Impact of Light Therapy.

    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.

  • Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of ALD403

    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.

  • Care After Lymphoma (CALy) Trial: A phase II pilot randomised controlled trial of a lymphoma nurse-led model of survivorship care

    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.

  • Light Therapy and Depression in Residential Aged-Care Clients: A Treatment Approach

    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.

  • A comparison of preoxygenation methods for prehospital intubation in patients with a simulated mask leak

    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.

  • A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults

    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.

  • Physiotherapists prescribing medications to manage pain in emergency departments and outpatient clinics

    This study aims to investigate the safety and patient experience of prescribing by credentialed physiotherapists. Patients attending emergency departments and outpatient clinics with musculoskeletal conditions will be prescribed medications from a limited list to manage pain and support physiotherapy treatment.

  • Treatment of clozapine associated obesity and diabetes with exenatide in people with schizophrenia

    Schizophrenia has a lifetime risk of 7.2 per 1000 persons with 25-50% of people with schizophrenia failing to respond to typical and atypical antipsychotics. For these people clozapine is the gold standard treatment, however, clozapine greatly increases the risk of weight gain and type 2 diabetes (T2DM) which contribute to cardiovascular disease and premature mortality. Current interventions against antipsychotic-associated metabolic dysregulation are limited and insufficient. The mechanism of action for metabolic abnormalities associated with clz is not completely understood; however, recent pre-clinical models have shown that clozapine causes acute deficits in glucose metabolism. This occurred via suppression of glucagon-like-peptide-1 (GLP-1) levels and these defects could be overcome by treatment with a GLP-1 agonist. Exenatide, a GLP-1 agonist, is available in a once weekly injectable formulation which is practical for this population with poor adherence. Therefore, in consideration of the promising preclinical data, the use of exenatide, which is already known to improve glycaemic control and reduce body weight in subjects with and without T2DM, may represent an effective therapeutic intervention for clozapine-associated obesity and T2DM. Therefore, the present study is a 24-week investigator-initiated, parallel group, randomised, open-label pilot study designed to evaluate the acceptability of exenatide weekly and determine the preliminary clinical efficacy and tolerability of exenatide for weight loss and glycaemic control in clozapine-associated obesity and T2DM. This study also has exploratory objectives to examine the feasibility of recruitment, retention, assessment methods and implementation of this intervention for subsequent larger scale, multicenter studies.

  • The Motherhood Choices Decision Aid for Women with Rheumatoid Arthritis Increases Knowledge and Reduces Decisional Conflict: A Randomized Controlled Study

    Arthritis NSW has identified that there is a need for more information and support for women faced with family decisions in the context of their RA. Therefore the aim of this project was to develop a Decision Aid (DA) resource (printed booklet and an online version) for women with Rheumatoid Arthritis (RA) who were contemplating pregnancy. In order to evaluate the effectiveness of the DA, a randomised control trial (n = 200) was conducted with women diagnosed with RA, aged between 20-45 and who may be contemplating pregnancy.

Tags:
  • Finding clinical trials