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

32707 results sorted by trial registration date.
  • Efficacy of Lithium versus Lamotrigine for the treatment of bipolar II disorder

    While experts in the field are increasingly recommending Lamotrigine for bipolar II, there has been very little research comparing pharmacological treatment options for bipolar II disorder specifically. Therefore, the objective of the current study is to examine the comparative effectiveness of Lamotrigine and Lithium – both as monotherapies – in a sample of newly diagnosed bipolar II patients, employing a single blind RCT design. We hypothesise that patients will report improvements in mood when trialling Lamotrigine or Lithium medication, and specifically that the Lamotrigine group will report greater improvement and maintenance benefits over the 28-week trial period when compared to the Lithium group. The Lamotrigine group is also expected to report fewer side-effects then the Lithium group.

  • Agreement and clinical interchangeability of a coagulation monitoring analyser between devices, operators, and across multiple time points.

    TEG6S (Haemonetics Corp, USA) is a novel haemostasis analyser that measures viscoelasticity properties of blood using resonance technology. We assessed agreement of the TEG6S analyser between devices, operators, and across multiple time points. We collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). Measurements were performed by one operator on two TEG6S devices (“Interdevice” agreement). Then, 5 different operators performed sample analysis from 5 healthy volunteers, using 5 TEG6S devices (“Interoperator” agreement). Finally, a single operator performed 15 measurements on 4 TEG6S devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) was examined. “Interdevice” agreement was estimated using Lin’s condordance coefficient and further validated using intraclass correlation coefficients and reduced major axis regression. “Interoperator” and “Timepoint” agreement was assessed using the Intraclass correlation coefficient estimated by a random effect regression model.

  • Stereotactic ablative body radiotherapy (SABR) for Liver Cancer After Radiology treatment (TACE)

    The primary purpose of this trial is to assess the safety and efficacy of stereotactic ablative body radiotherapy (SABR) for liver cancer which has re-occurred or not responded to radiology treatment (TACE). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with hepatocellular carcinoma (liver cancer), which has been pre-treated with TACE with incomplete response or re-occurrence, and is deemed suitable for SABR therapy by your treating clinicians. Study details All participants enrolled in this trial will receive SABR therapy. The treating team of clinicians may determine that it would be useful to insert fiducial markers in some participants, which are small gold markers, inserted around the tumour to act as a reference point across different images. Within 5 days of fiducial marker insertion (where applicable), all participants will undergo a CT scan simulating the body immobilisation procedure. This will take approximately 45 minutes to one hour. A full body immobilisation system is utilised to create an impression of the body. The CT scan is more in depth than a regular CT and takes multiple images. Small tattoos are drawn onto the patient to act as a guide to allow the lasers to line up during treatment. In order to help the patient stay still and breathe regularly, they are asked to breathe in time with a metronome (typically 30 bpm). Participants will then undergo three SABR treatment sessions over the next two to three weeks, which involves delivery of radiotherapy to the tumour. The treatment takes approximately one hour and consists of using the full body immobilisation system and the tattoo guides to ensure the patient is in the correct position and alignment for the precise delivery of radiation to the tumour. A quick scan is then done to check the positioning, followed by a more in depth CT scan to verify this. When the treating team are happy with the positioning, the treatment radiation dose will be delivered, followed by a pause mid treatment to verify and confirm the positioning once again. Post treatment all participants will be followed up every few months for up to 24 months following completion of SABR treatment. This will involve blood tests, CT/MRI scans to assess tumour progression, and monitoring of the side effects related to SABR treatment. It is hoped that the findings from this trial will provide information on whether SABR, with or without fiducial maker insertion, is safe and effective for the treatment of liver cancer, where the tumours have not responded or re-occurred following treatment with TACE.

  • Can contrast enhanced spectral mammography (CESM) play a clinically useful role in the pre-operative assessment of women with Ductal Carcinoma in Situ (DCIS), the ‘CESM D’ study

    This study aims to evaluate the accuracy of an imaging technique called contrast enhanced spectral mammography (CESM) for assessing the extent of Ductal Carcinoma in Situ (DCIS). Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer where abnormal cells are contained within the milk ducts, on core biopsy, for which you are undergoing pre-surgical assessment at Royal Perth Hospital in Western Australia. Study details All participants in this study will undergo contrast enhanced spectral mammography (CESM) in addition to standard imaging and histopathology. CESM is a special type of mammogram performed after injection of intravenous x-ray dye (contrast). The CESM images will be independently read by two radiologists, and compared to standard imaging. If there are additional findings on the CESM images, these may be used to change subsequent surgical treatment. All participants will be followed up 12 months following their treatment as per standard of care for patients who have had breast conserving surgery. Cost effectiveness of the addition of CESM to standard imaging will also be evaluated. It is hoped that CESM will be more accurate than standard imaging at demonstrating the extent of DCIS – this may improve surgical planning and reduce the need for re-excision.

  • Can we prevent recurrent severe low blood glucose reactions using a new glucose sensing device?

    This study will determine whether a new relatively non-invasive glucose monitoring system (Flash Libre) helps adults with diabetes who have a severe glucose reaction to avoid further such episodes. The hypothesis is that the non-invasive system will be superior to usual care in preventing both severe and non-severe hypoglycaemia after the index severe hypoglcyaemic event.

  • Studies of Glucocorticoid Induced Hyperglycaemia - Part 1: effects of commonly prescribed Glucocorticoid (GC) regimens on blood sugar levels

    To use continuous glucose monitoring (CGM) to profile the glycemic impact of commonly prescribed GC regimens.

  • High Flow Nasal Oxygen during Endobronchial Ultrasound to prevent low oxygen levels.

    Endobronchial ultrasound (EBUS) is a procedure performed to extract tissue from the lung to aid diagnosis of lung cancer, infections and sarcoidosis. To tolerate this procedure, which involves a camera on a tube being inserted into the lung, patients require sedation. The sedative medications commonly cause patients to hypoventilate, and a reduction in oxygen saturation and increase in carbon dioxide level is commonly seen, necessitating the interruption of the procedure, and occasionally putting patient’s lives at risk. An intervention to reduce the rates of these problems may make the procedure safer. The OptiFlow THRIVE device delivers high flow oxygen via the nose, and may reduce the rate of desaturation and limit the rate of increase in CO2 level. The device has been trialed in anaesthesia in morbid obesity surgery, difficult airways in ENT and during awake fibreoptic intubation, which is a conceptually similar procedure to EBUS. The device has been used safely for many years to assist intubation in the emergency department and intensive care unit. There is no data currently using the device during EUBS, or any endoscopic procedure for that matter. This study will randomize participants to either oxygen therapy during sedation with standard care (being a gutter mask) or OptiFlow THRIVE. The research question is: In adults undergoing endobronchial ultrasound, does oxygen therapy provided using the OptiFlow THRIVE device reduce the frequency of desaturation and hypercarbia compared to standard oxygen therapy using a gutter mask?

  • Multi-parametric MRI for Therapeutic Response Prediction in Rectal Cancer

    The main purpose of this study is to assess whether MRI (including MRI with contrast) and PET can predict response to treatment in patients with locally advanced rectal cancer. 'Who is it for?' You may be eligible to join this study if you have been diagnosed with rectal cancer and are undergoing treatment consisting of chemoradiotherapy followed by surgery. 'Study details' Participants will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to treatment by participating in this study. Patients participating in this study will have multi-parametric MRI (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE)) and PET/CT at the following 3 time-points: 1. Prior to chemoradiotherapy 2. During the third week of chemoradiotherapy and 3. Post chemoradiotherapy, within 1 week prior to surgery. Patients will be followed up for 2 years. Correlations between MRI and PET biomarkers with tumour response and survival outcomes will determine whether multi-parametric MRI and PET can predict treatment response.

  • SupportMe: Text messaging support for patients with chronic disease

    The SupportME is a pragmatic, multicentre, single-blinded, parallel-group, randomised controlled trial to determine the effect of mobile phone text messaging intervention on blood pressure for patients with diabetes and cardiovascular diseases. This study was funded by NSW Translational Research Grant. It aims to recruit 1000 patients with coronary heart diseases and/or type 2 diabetes. Patients will be randomised to text messaging intervention or standard-of-care. The primary outcome is the difference between groups in systolic blood pressure at 6 months.

  • a Coach based Motivation and Anti-Doping Education program (CoachMADE)

    Aim and hypothesis: This project aims to support the principles and aims of the Olympic Charter by developing and testing a preventative motivation theory informed and evidence-based intervention. Methods: The intervention will deliver anti-doping education and psychological training to support coaches’ in communicating with athletes in a needs supportive manner. The intervention will be compared against ‘usual practice’ (i.e., education programs run by National Anti-Doping Organizations). This is a multi-centre research project with sites in Western Australia, the UK, and Greece. The project is a cluster randomised control trial (2 arms; total across 3 countries: 60 coaches and 600 athletes in each arm). Athletes will be asked to complete a questionnaire package of psychological measures. The constructs of the questionnaire will include rating their willingness to take prohibited performance enhancing substances, their anti-doping attitudes, efficacy to resist doping-related temptations, and perceptions of coach behaviours. Similarly coaches will be asked to complete a separate package of psychological constructs and measures. The measures will ask coaches to rate their efficacy to foster anti-doping attitudes and deliver anti-doping information, and their efficacy to confront athletes about doping. Data collection and analysis: Baseline data (0 week) (video-recording of coaches, athlete/coach questionnaire packages) will be collected prior to the first workshop (control/intervention). Questionnaire packages will be repeated at the end of the intervention (12 week) and again at a follow-up (20 week). Interviews with coaches in the intervention arm will take place after the second workshop. We will use advanced statistical analysis (multilevel growth models) to account for both the longitudinal and nested (athletes within coaches) nature of the data. We will implement: 1) a process evaluation of the intervention, via coach interviews, coach questionnaires on ease and usefulness of the training material, and 2) fidelity to the protocol assessments, via coach observations, and 3) we will analyse the data and disseminate the results of the intervention via coach information sessions, printed material, policy briefings, media interviews, and social media engagement.

Tags:
  • Finding clinical trials