ANZCTR search results

Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with locally advanced pancreatic cancer (LAPC), Purpose of the study To investigate the safety of an active implantable (radiological) medical device called OncoSil, when implanted into patients with pancreatic cancer who are receiving standard chemotherapy, and to evaluate the response on the tumour after implantation. This will be compared to those who receive standard chemotherapy alone. Allocation to receive OncoSil treatment will be at the discretion of the investigator of the study, and your treating physician and oncologist. Study Details Participants that will receive the OncoSil treatment will undergo an Endoscopic Ultrasound, to accurately visualise the pancreas and assess tumour size. This will be performed under sedation and you are not likely to feel any pain during the process. The doctor guides the endoscope down the oesophagus, through the stomach and into the first part of the small intestine. The ultrasound is used to image the tumour in the pancreas. A fine needle is extended from the end of the endoscope into the pancreas and into the middle of the tumour. Once this needle is in an appropriate position within the tumour, a doctor will attach a syringe filled with OncoSil to the other end of the needle. The doctor will slowly depress the plunger of the syringe so that the contents of the syringe are implanted into the tumour, the OncoSil syringe is removed. Another syringe containing a small amount of saline (salt water solution) is attached to the needle. This will flush any remaining OncoSil from the needle into the tumour. The saline syringe is removed. The endoscope is removed by carefully pulling it back up the oesophagus and out of your mouth. Following implantation, you will be observed for a minimum of four hours and, if stable and pain-free, you may be discharged the same day. You will be required to attend two follow up visits with you study doctor, which will occur 4 weeks and 12 weeks after the OncoSil procedure. We hope this research will help provide further information on the safety and usefulness of this form of treatment for LAPC, and the results support further evaluation with larger trials.

The study aims to implement the ADAPT Portal and Clinical Pathway, which is a clinical pathway for managing anxiety and depression in cancer patients. This study also aims to evaluate the feasibility and acceptability of this pathway. Who is it for? If you are a cancer patient, you may be eligible for this study if you are aged 18 years or older, with any cancer, and are being treated at Lake Macquarie Private Hospital. If you are a cancer service staff member, you may be eligible for this study if you are aged 18 years or older, and employed on an ongoing or permanent basis at Lake Macquarie Private Hospital. Study details Cancer service staff will use the ADAPT Portal for patient registration, management and referral - including screening alerts. There will also be 5 x 45 minute Online Health Professional Education Modules, to be completed over a five week period. Patients will be able to log in to the ADAPT portal to complete screening, questionnaires, and access educational information at their discretion. There will also be online therapy treatment programs (involving 6-8 x 45 minute sessions over 10-12 weeks), available in the ADAPT Portal for patient self-referral or clinician referral. Cancer service staff will complete a survey before implementation and immediately after implementation to understand their experience with the ADAPT Portal. Immediately after implementation, cancer service staff and patients will also be interviewed on their experience with the ADAPT Portal. It is hoped that this study will provide evidence for how to effectively implement the ADAPT Portal and Clinical Pathway across private healthcare in Australia, and improve mental health for cancer patients.

The primary aim of this randomised controlled trial (RCT) is to compare the clinical and cost effectiveness of new generation peripheral intravenous catheter (PIVC) products with the standard care PIVCs. You may be eligible to participate in this trial if you are an emergency department patient more than the age of 18 and are requiring a peripheral venous catheter inserted as part of your therapy. All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two PIVC options. This will be either the standard PIVC, or a PIVC with a retractable coiled guidewire. The allocated device will be kept from device insertion until the time of device removal. Participants and families will be asked to rate the satisfaction of the device, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PIVC devices are most effective in preventing first insertion failure.

International consensus for the level of disinfection required of ultrasound transducers used in percutaneous needle guided procedures is lacking. This study aims to quantify and compare the measurable differences in bacterial colony forming units identified on linear ultrasound transducers following both high- and low-level disinfection. The hypothesis is that reprocessing using low-level disinfection will be non-inferior in the elimination of bacterial contamination compared to a high-level disinfection. This research will be the first to directly compare the effectiveness of these two disinfection processes in a pragmatic study design aiming to answer this clinically important question affecting patients, staff, and organisations.

In line with iterative improvement approaches, a successive implementation intervention will be delivered in the same maternity services that participated in an initial practice change intervention trial in 2018-2019. The trial has two aims: 1) to increase the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption; and 2) sustain the rate of care provision over time. A three-month implementation intervention will be delivered. Three strategies will be used to support increases in the proportion of pregnant women who receive the recommended model of antenatal care addressing alcohol consumption: remind clinicians; facilitation; and conduct educational meetings. Three strategies will be implemented to support sustain the rate of care provision over time: develop a formal implementation blueprint; purposely re-examine the implementation and conduct ongoing training. Cross-sectional data will be collected via telephone and online interviews with a random sample of women who attend the participating maternity services each week. The primary outcomes of the trial include: i) proportion of women that report being asked about alcohol consumption at subsequent antenatal visits; ii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at subsequent antenatal visits; and iii) proportion of women that report receiving complete care (advice and referral) relative to their level of alcohol risk at the initial antenatal visit. Intervention fidelity, penetration, acceptability and costs will be measured as secondary outcomes. A stepped-wedge controlled study design will be used to assess aim 1. It will determine whether the average proportion of women who received the recommended model of antenatal care for all three primary outcomes is higher post-intervention compared to pre-intervention. Aim 2 will use a multiple baseline design to assess whether the proportion of women who receive the recommended model of antenatal care increases and sustains following delivery of the implementation intervention.

The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in adult healthy volunteers of Chinese descent. Participants will be randomized in 1:1 ratio to 1 of 2 sequences. The ER tablet formulation will be used. Part C will enroll approximately 10 adult healthy volunteers of Chinese descent, defined as participants with both parents and both grandparents of Chinese ancestry.

The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in healthy volunteers. In Part B, participants will be randomized in 1:1:1 ratio to 1 of 3 sequences. The ER tablet formulation to be used in Part B will be selected from Part A. Part B will enroll up to approximately 12 adult healthy volunteers

This is a phase I clinical trial designed to assess the pharmacokinetics and safety and tolerability of IHL-675A compared to the reference listed drugs Epidiolex (CBD) and Plaquenil (HCQ). The trial will recruit at least 36 healthy subjects. Initially, 3 sentinels will be enrolled and randomised into Treatment 1, 2, and 3. Treatment 1 - Two IHL-675A softgel capsules (75mg CBD, 100 mg hydroxychloroquine sulfate per capsule, 150 mg CBD, 200 mg hydroxychloroquine sulfate total). Treatment 2: One 200mg hydroxychloroquine sulfate tablet (Plaquenil), Treatment 3: 1.5mL of 100 mg/mL (150 mg) CBD (Epidiolex) The sentinels will be dosed at least 24 hours prior to the remainder of the subjects. If there are serious adverse events associated with the dose the trial will be paused and the risk of further subjects receiving IHL-675A will be assessed. Each Treatment group will enrol at least 12 subjects each, for a total of at least 36 subjects. Subjects will be randomised into the treatment groups. The healthy subjects will be informed of the study and pre-screened. Screening will include blood and urine tests, screening for mental and cardiac health using a series of mental health questionnaires and 12-lead ECG in triplicate, respectively. Post screening, subjects will be admitted to the clinical unit, where they will undergo baseline assessments, including safety bloods and urine sampling to screen for pregnancy and drugs of abuse. On Day 1, subjects will be given a high-fat/high-calorie meal 30 minutes prior to dosing. At least 30 min before the time of dosing, the 24-hour telemetry period for cardiac monitoring will commence. Blood samples for plasma pharmacokinetic analysis, will be taken throughout the study. These samples will be assessed for the Active Pharmaceutical Ingredients as well as metabolites 7-OH-CBD and 7-COOH-CBD, and desethylhydroxychloroquine, desethylchloroquine, and bisdesethylhydroxychloroquine. Blood samples will also be taken for safety analysis. Subjects are discharged from the clinical unit on Day 2, at least 24 hours post dose, and will return to the clinical unit for outpatient visits on Days 3, 7, 14, 21, and 28 for blood sampling and/or to assess any existing or new Adverse Events, and concomitant medications. Subjects who have completed Cohort 1 and who continue to meet study entry criteria may be permitted to screen for participation in Cohort 3.

The study is testing the effectiveness of a new web-based intervention for mothers and their partners. The intervention is designed to provide parents with accurate and up-to-date information about their unborn child’s development during pregnancy and how to help manage problems with infant sleeping or crying, and how to best cope when parents are feeling stressed by the demands of caring for young infants. Parents who are allocated to the intervention group will meet online with our research psychologist at approximately 25 weeks of pregnancy to learn how their baby is growing and how to better get to know their baby during pregnancy. They will also have 4D ultrasounds at 28 and 34 weeks of pregnancy when they can view their baby in real time, and together with our psychologist observe what their baby is doing. After their baby is born, they will meet online with our psychologist when their baby is 2 weeks and 6 weeks old for support about how to care for themselves and their baby during stressful times, like when babies are having difficulty sleeping or settling. We hypothesise that parents undertaking the intervention will form a stronger attachment to their child, be able to better undertake health-promoting behaviors during pregnancy, and will be better equipped to manage personal distress, infant crying and sleep problems,

This study will compare three methods of relocating a dislocated shoulder. The three different methods being compared will use different positioning of the patient and their shoulder joint to relocate the shoulder. These methods are called the chair method, FARES method and Cunningham's method. The main purpose of the study is to determine which method is most effective at relocating the shoulder on first attempt.