ANZCTR search results

The focus of this project is on improving mental health outcomes among Australian young adults (18-25 years) who are lesbian, gay, bisexual, trans and gender diverse, and questioning or queer (LGBTQ). The main aim of the project is to determine whether participants in an 8 week self-compassion group program (MSC) report improved mental health outcomes compared to a group of participants on a waiting list. We expect that participants in the MSC group will show improvements in self-compassion and emotion regulation as well as reductions in self-stigma and symptoms of depression, anxiety, stress. A second aim of the project is to look at the relationship between those health outcomes to see whether the changes in self-compassion and emotion regulation lead to changes in depression, anxiety and stress. Finally, we will determine whether the program is acceptable to participants and the people delivering the program. To do this, we will conduct interviews with participants, program facilitators and peer facilitators.

This study will investigate the effect of topical polaprezinc mouthwash on the incidence of oral mucositis in cancer patients undergoing haematopoietic stem cell transplantation Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with blood cancer and will receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic haematopoietic stem cell transplantation Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive polaprezinc mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Participants in the other group will receive sodium bicarbonate mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Daily oral assessment will be conducted by nurses and oral mucositis severity will be graded according to the WHO mucositis scale. Patients will be asked to complete an oral mucositis daily questionnaire that evaluates their oral pain and functional difficulties. Patients’ compliance, acceptability of the mouthwashes, total opioid and patient controlled analgesia (PCA) use, enteral nutrition (EN) and total parenteral nutrition (TPN) use will be collected. If polaprezinc lower the incidence and severity of oral mucositis, it may be used in the future as an effective, inexpensive and safe prevention of oral mucositis.

Lyndra Therapeutics is currently developing extended release (ER) capsules for weekly administration across therapeutic areas with certain medications for which consistent pharmacokinetics (PK) or enhanced adherence may translate to improved efficacy, and possibly better safety. LYN-045 (Lyndra code for dapagliflozin) ER capsules are intended to provide comparable dapagliflozin exposure to daily treatment affording better accessibility and tolerability for the treatment of type 2 diabetes mellitus (T2DM). This Phase 1 study is intended for execution in healthy individuals due to its exploratory nature. Data from this study will be a key indicator of feasibility of the product concept and will inform formulation optimization and dose selection for further development. This study will be conducted in up to 10 healthy volunteers (including 2 sentinels) who meet all of the inclusion criteria and none of the exclusion criteria. This is a single-center, open-label study of dapagliflozin 70 mg ER capsules (LYN-045) to evaluate its safety, tolerability, and PK administered as 2 weekly doses in healthy male and female volunteers. All subjects will receive 3 doses of IR dapagliflozin 10 mg in the inpatient unit, Dose 1 on Day -3, Dose 2 on Day -2, and Dose 3 on Day -1. Following that, all subjects will receive 2 doses of LYN-045 70 mg; on Day 1 and Day 8. After completion of Day 10 assessments, subjects will be discharged from the inpatient unit. Thereafter, subjects will attend study center visits on an outpatient basis on Days 14 and 15. All subjects will attend an End-of-Study (EOS) visit on Day 21 for final study assessments.

This study aims to assess the cardiovascular risk in people with acute gout treated with anakinra through performing imaging the heart at baseline and at 9 months. We will determine the impact of having an acute flare of gout on the scans, which is a surrogate of cardiovascular risk. We will also determine the impact of a drug (anakinra), which is increasingly being used in acute gout, on its effect on these heart scans. This will help us understand the effect of acute inflammation on cardiovascular risk in gout. The use of anakinra for acute gout will also be assessed in terms of its effectiveness, safety and tolerability.

Respiratory distress syndrome (RDS) is a condition found commonly in babies born prematurely, which results in breathing difficulty soon after birth, due to immaturity of the lungs. Many babies will be managed successfully with breathing support alone, but some require additional treatment with surfactant. Surfactant is a liquid that is applied directly into the baby’s airway, which helps open the lungs to make breathing easier Currently, the standard method to administer surfactant requires laryngoscopy. This is where a doctor looks directly into the baby’s airway using a laryngoscope (a metal device that holds the airway open) and then inserts a tube into the airway to deliver the surfactant treatment. This method is very effective, but is challenging to learn, and may take more than one attempt even for experienced doctors. Also, during laryngoscopy, some babies may briefly have a drop in their heart rate or oxygen levels. ‘Supraglottic airways’ are a different type of device, made from a soft plastic, shaped to fit into the mouth and form a seal over the airway opening. They can be inserted without using a metal laryngoscope, and are easier to use for doctors and more comfortable for babies. Previous research suggests that surfactant treatment can be given through a supraglottic airway, but we do not yet know if this method is as effective as using direct laryngoscopy in helping the baby’s breathing. This research study will compare the new method, supraglottic airway surfactant treatment, with the current standard method, laryngoscopy. We will measure how stable babies are during surfactant treatment, including their oxygen levels and heart rate. We will also record how many babies need a higher level of breathing support (ventilation by a breathing tube), to determine how effective the treatment is in helping babies with RDS. If supraglottic airway surfactant treatment can be used safely and effectively, and is more comfortable and easy to use, it could become the preferred method of surfactant treatment for babies with RDS.

The study aims to assess the impact of a nature therapy program for adults with mental illness living in the community. The program will include 10 weekly 90-minutes sessions of ‘Forest Therapy’, conducted in groups of 6-10 people. Forest Therapy involves a slow, mindful walk in nature with a focus on feeling totally immersed in the natural environment. Forest Therapy also involves activities like breathing exercises, and working as a team to make an artwork out of objects in the natural environment such as leaves or bark. It is hypothesised that participants will feel calmer after each Forest Therapy session, and experience longer-term improvements in quality of life, social support, and mental illness at the end of all 10 sessions.

Persistent pelvic pain is often associated with endometriosis. Treatment for endometriosis has previously focused on surgery and hormonal medications. Some women continue to experience pain despite this treatment. Tenderness and increased contraction/ tightness in the pelvic floor muscles is thought to be related to pelvic pain. It is unknown how many women with endometriosis also have tenderness and tightness in the pelvic floor muscles. A larger observational study is planned to address this question. This study will investigate how well gynaecologists and physiotherapists are able to detect pelvic floor muscle tenderness and tension, so that clinicians can better identify which women may have these pelvic floor muscle problems and receive appropriate treatment. Women who agree to participate in this study will fill out a questionnaire and attend one of the hospitals involved in this study. They will see a gynaecologist and a physiotherapist who will both assess their pelvic floor muscles to see if they have any tenderness or tension in the muscles. Pelvic floor muscle assessment is measured with an internal vaginal examination. The tests are common clinical procedures for any type of pelvic floor problem and best practice guidelines to ensure comfort and safety will be followed. The questionnaire and assessments are done before the woman has surgery. The findings of the examination from the gynaecologist and the physiotherapist will be compared to assess the reliability of the examination.

The aim of this study is to investigate the effects different terminology for depression on hypothetical help-seeking intentions and psychosocial outcomes by presenting workplace stress and mental illness scenarios. We will also examine the impact of the different terminologies on self-stigma, perceived stigma from others, perceived severity and cognitive illness perceptions. Additionally, we will examine the impact of different terms used to describe therapist providing psychological support (clinical psychologist vs mind coach) on help-seeking intentions and psychosocial outcomes.

During pregnancy, one modality of ensuring the well-being of the fetus is by measuring the heart rate. At present, the mainstay of such fetal surveillance is carried out by utilising cardiotocography (CTG). The CTG utilises Doppler ultrasound to approximate the FHR by detecting the movement of cardiac structures, which requires signal modulation and auto correlation to provide accurate quality recordings of FHR (Smith et al. 2018). Some of the main limitations with CTG are its inability to support mobile, ambulatory and accurate FHR monitoring. This is particularly worse in women with obesity, where there is the need for clinician oversight during its placement so as to ensure that the maternal heart rate (MHR) is not wrongly monitored over the FHR and that an interpretable trace is obtained. The limitations of CTG use prompted a Singapore based medical technology company, Biorithm, to investigate new methods of fetal monitoring using fetal ECG. This subsequently led to the prototyping of a new device, Femom, which can obtain and analyse fetal heart rate patterns in an outpatient setting. The output from the device will mirror available CTG technology and will therefore be interpreted in line with pre-existing available CTG guidelines. Femom utilises trans-abdominal electrocardiogram (ECG) to measure the fetal and maternal heart rates. Routine data collection at the National University Hospital in Singapore and Monash Medical Centre in Melbourne supports the ability of Femom to collect FHR patterns and contractions. No adverse effects were reported. This study will pilot a clinical trial aiming to examine the efficacy of Femom. Similar technology has also been previously used to monitor the fetus of women in clinical populations with no documented adverse effects (Reinhard et al., 2012). The device presently comprises of 5 electrodes which will be attached to the woman’s abdomen. Our primary research focus encompasses pilot testing the efficacy of Femom in comparison to traditional CTG monitoring to evaluate the quality of tracing obtained. The aims of the project are: 1. to assess the similarity between fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA) measured by Femom vs CTG, and 2. to assess whether there are any differences in fetal heart short term variation (STV) measured by Femom versus CTG 3. to pilot and inform the design of a future confirmatory study

A double-blind randomised controlled study to evaluate the effectiveness of a fermented red ginseng extract supplement (FermenGIN) compared to placebo on blood circulation parameters in an adult population. The aim of this study is to assess the effectiveness of FRG for improving peripheral blood circulation compared to a placebo.