ANZCTR search results

This study aims to evaluate the efficacy and safety of an enhanced influenza vaccination schedule in immunocompromised children undergoing treatment for cancer. Who is it for? You may be eligible to join the study if you are aged between 6 months and 18 years, and undergoing therapy for cancer or within 6 months of completion of treatment. Study details All participants in this study will receive an influenza vaccine: 3 doses given at least 4 weeks apart for children younger than 9 years and 2 doses given at least 4 weeks apart for children aged 9 years or older. Blood samples will be collected throughout the study to determine immune response to the vaccine. Safety of the enhanced vaccine schedule will be closely monitored in each participant throughout the study. Overall, we aim to establish an optimised and safe influenza immunisation schedule for children and adolescents undergoing treatment for cancer.

To conduct a proof-of-concept trial to determine whether an ‘after delivery’ community care (education & physical activity) program impacts physical activity levels, diet quality, health behaviour and attitudes, and reduces risk factors for and incidence of Type 2 Diabetes in the 10 years post-delivery in mothers with a history of or risk factors for GDM, compared to control no=intervention.

If you agree to participate you will be enrolled into either of two groups. One group will receive A prescribed course of narrow band UVB and the second will trial the combination of the trial lotion with natural sunlight. If you are enrolled in the trial group and fail to respond by 12 weeks or 6 months in the case of vitiligo you will receive a prescribed course of narrowband UVB. The purpose of this study is to ascertain whether natural sunlight used in combination with the trial lotion produces a similar benefit to narrow band UVB.

The purpose of this study was to see if there is a role for intravenous (IV) fluids in improving patient outcomes during routine colonoscopies. Who is it for? You may be eligible for this study if you are aged 18 to 80, and are scheduled for a colonoscopy. Study details Participants in this study were randomised by chance (like flipping a coin) into two groups. One group received intravenous fluids through a needle in the arm while they have their colonoscopy. The other group did not receive the needle in the arm and had no fluids during the procedure. As part of this study, participants had additional blood tests (to see if they were adequately hydrated) as well as completed some questionnaires. It was believed this research will demonstrate there is no significant difference between the groups, which could reduce the unnecessary use of intravenous fluids during colonoscopy.

Wearing compression stockings is the best treatment to heal venous leg ulcers and prevent new ones, but adherence to wearing these stockings is low. Ulcers are very costly to patients and health care systems. Multiple known reasons (barriers) exist to explain why patients don’t wear their stockings and most patients have several barriers at once. The study aims to investigate whether a new clinical decision-aid can improve adherence with wearing compression stockings by using a new questionnaire to inform on each patient’s specific barriers and a decision tree (or algorithm) which will then instruct the clinician how to address each of those barriers. The intent is to guide both novice and experienced clinicians to the next level of care delivery. This questionnaire and algorithm are combined into the Personalised and Multidimensional Compression Assessment and Intervention (PAMCAI) tool. The study will take place within the Gold Coast Hospital and Health Service across two Occupational Therapy Vascular outpatient clinics. The study will also investigate if there are any economic benefits from using this tool. A pilot study will investigate if the study design is feasible and shows potential to improve adherence. Completion of this phase will allow for any changes to the tool or the research design before the next phase commences (a randomised controlled trial which includes a health economics study and a series of qualitative interviews is planned to explore participant’s experiences and perceptions of the intervention and how they influenced adherence, if they did). The predicted benefits of conducting this pilot study include opportunity to trial the PAMCAI tool in practice, gaining feedback on usability and potential benefit in influencing adherence to wearing compression stockings. Further, it will provide information on feasibility of recruitment, data gathering, clinician acceptability while allowing for alternations as required prior to conducting a full research design. The predicted benefits of the overall research design, include health care savings, improved patient outcomes, with the potential to use this tool in multiple settings and by different health disciplines.

This study aims to collect data on the efficacy of clinically prescribed cannabis products from a large-scale cohort to examine the relationships between cannabis treatment and concomitant medication use, pain, symptoms, quality of life, mood and sleep measures in a patient population that includes, but is not limited to, cancer patients. Who is it for? You may be eligible to join this study if you have been prescribed medicinal cannabis through the Special Access Scheme B via Cannvalate and their medical practitioner for any condition including, but not limited to, cancer. If you are under 18 years of age your parents must also consent to your participation in the project. Study details All eligible participants will be emailed a link to an online survey. An automated email will be sent at set intervals (2 weeks, 1 month, 3 months, 6 months, 12 months) from the date of first completion asking patients to complete the survey again. In addition, participants will be asked whether they consent to the investigators accessing their medical records in order to store data in a research database for this and future projects. Participants may choose to participate in one component of the study without the other (e.g. complete survey but not consent to medical records access or vice versa). The survey will take approximately 45 minutes to complete and will be a compilation of the following questions and questionnaires: Demographics, Medical Condition that cannabis is prescribed, dosage, duration and administration of cannabis treatment, general health, pain, symptoms, quality of life, mood and sleep measures. It is hoped that this research will contribute to the knowledge of the safety and efficacy of medicinal cannabis products for different medical conditions.

The purpose of this study is to assess the safety of one course of a chemotherapy drug named blinatumomab when added to the Interfant-06 backbone in infants with newly diagnosed acute lymphoblastic leukaemia. Who is it for? Your infant may be eligible if they are less than 12 months of age and have been dignosed with acute lymphoblastic leukemia. Study details All participants in this study will receive the chemotherapy drug blinatumomab every day for 4 weeks via a needle in the arm. Some of the tests required for this study are routinely performed as part of standard treatment in children with Infant ALL, such as the bone marrow aspirates, lumbar punctures and most blood tests. Some additional tests and procedures are required. It is hoped that this research will help determine if blinatumomab is safe for use in infants newly diagnosed with acute lymphoblastic leukemia.

Introduction As you are going to be treated with chemoradiation therapy for your head and neck cancer, you will most likely develop oral mucositis. As such this study is testing an experimental treatment for oral mucositis. This experimental treatment is called ST-617. Oral mucositis involves painful ulcers or lesions developing in the lining of your mouth. There are currently no approved medicines to successfully prevent and/or treat oral mucositis for head and neck cancer patients. Most patients are treated with best supportive care (BSC) which includes such things as making sure you are taking care of your mouth properly, providing ice chips or lozenges to suck on, or swishing with a mouthwash. This study aims to test the safety and tolerability of ST-617 on patients and their oral cavities while they are being treated with chemoradiation for head and neck cancer. There are two arms to this study, Phase 1b and Phase 2. It is hoped that the Phase 1 arm will help determine the recommended dose of ST-617 that will be used in head and neck cancer patients in the Phase 2 study. ST-617 is a medication that has been widely studied in multiple human clinical trials and belongs to a group of medications that have been shown to help protect cells from damage. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with head and neck cancer who is planning to undergo chemoradiation. Study details In the Phase 1b part of the study participants will receive either Best Supportive Care (BSC) alone, or BSC plus an oral suspension of ST-617 administered daily for 3 days prior to the start of radiation, and then daily during radiation treatment. Participants will attend hospital visits for approximately 4 months. After the last visit, their study doctor will check on the status of their cancer every 3 months for up to 1 year after they started radiation. Most of the exams, tests, and procedures that will be done during this study are part of regular medical care, but will be done multiple times so more information can be gathered. Participation in this study will be divided into different visits: Screening Period, Treatment Period, End of Treatment, 30-Day Safety Follow-Up and Response Follow-Up Visits. Blood will be taken from a vein in the participants’ arm for testing of their general health and to check their medical condition.

As you are going to be treated with chemoradiation therapy for your head and neck cancer, you will most likely develop oral mucositis. As such this study is testing an experimental treatment for oral mucositis. This experimental treatment is called ST-617. Oral mucositis involves painful ulcers or lesions developing in the lining of your mouth. There are currently no approved medicines to successfully prevent and/or treat oral mucositis for head and neck cancer patients. Most patients are treated with best supportive care (BSC) which includes such things as making sure you are taking care of your mouth properly, providing ice chips or lozenges to suck on, or swishing with a mouthwash. This study aims to test the safety and tolerability of ST-617 on patients and their oral cavities while they are being treated with chemoradiation for head and neck cancer. There are two arms to this study, Phase 1b and Phase 2. It is hoped that the Phase 1 arm will help determine the recommended dose of ST-617 that will be used in head and neck cancer patients in the Phase 2 part of the study. ST-617 is a medication that has been widely studied in multiple human clinical trials and belongs to a group of medications that have been shown to help protect cells from damage. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with head and neck cancer who is planning to undergo chemoradiation. Study details In the Phase 2 part of the study, participants randomised to the Treatment Arm will receive ST-617 at the RP2D doses as determined in Phase 1b. Patients in the Control Arm will receive a placebo in equivalent volume to the active drug. Participants will attend hospital visits for approximately 4 months. After the last visit, their study doctor will check on the status of their cancer every 3 months for up to 1 year after they started radiation. Most of the exams, tests, and procedures that will be done during this study are part of regular medical care, but will be done multiple times so more information can be gathered. Participation in this study will be divided into different visits: Screening Period, Treatment Period, End of Treatment, 30-Day Safety Follow-Up and Response Follow-Up Visits. Blood will be taken from a vein in the participants’ arm for testing of their general health and to check their medical condition.

The objective of this study is to examine the diagnostic accuracy of ultrasound (US) scanning of the nasogastric tube (NGT) in mechanically ventilated patients by non radiologist. The study design is a dual centre prospective, single blind study assessing US of the NGT with positive placement verification being a captured hyperechoic image of an NGT in the oesophagus and epigastrium. This is compared to the chest radiograph. The setting will consist of patients admitted to the intensive care unit (ICU) who were mechanically ventilated and required a nasogastric tube for either the treatment or diagnosis of their admitting illness.