ANZCTR search results

The purpose of this study is to compare the efficacy of administering the drugs, EPI-7386 and Darolutamide, in combination versus Darolutamide alone, as treatment for patients with prostate cancer, before they undergo standard surgery to remove the prostate gland. Who is it for? You may be eligible for this study if you have been diagnosed with localized prostate cancer and have been referred for radical prostatectomy surgery. Study details Participants will be randomly allocated to either doublet therapy consisting of EPI-7386 and Darolutamide (Arm A) or Darolutamide alone (Arm B) for a treatment duration of 12 weeks. Treatment will be in the form of oral tablets. Prostatectomy will occur the day after completing neoadjuvant therapy, and specimens removed during surgery will then be examined to determine treatment efficacy. It is hoped that information collected in this study will help inform treatment options for patients with localized prostate cancer undergoing removal of their prostate.

This study involves the testing for eight weeks of a regulatory listed supplement targeting fatigue symptoms. This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences using the TGA-listed and marketed Swisse Body Activator product to generate advertisement claims within the regulatory permitted indications/label. Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey. The Swisse Body Activator product (ARTG ID: 391453, June 2022) is a hard oral capsule with a comprehensive formulation that targets physical fatigue, energy management and inflammation. It has several permitted indications – Maintain/support energy levels and vitality, relieve weariness, tiredness, fatigue and the feeling of weakness and decrease, reduce, and relieve mild joint inflammation, swelling, pain and soreness, among others.

This is a one-time cross-sectional, online study, consisting in a patient survey and a patient caregiver survey. Adult and adolescent patients with AA, and the caregivers of adolescent AA patients (dyadic and non-dyadic caregivers), will be recruited to participate in the survey. The surveys will assess the psychosocial and life impacts and disease burden associated with AA. In order to increase sample size for the caregiver survey, caregivers will be allowed to participate in the survey even if their dependant adolescent with AA refuses or is unable to participate (ie, non-dyadic caregiver). Additional information about the adolescent with AA will be provided by the non-dyadic caregiver compared to the dyadic caregiver. The survey will use online screening questions to verify participants’ eligibility and invite potential participants to take part in the study. After consenting, data will be collected in the patient survey via a bespoke questionnaire on patient/caregiver characteristics (e.g., age, sex, socioeconomic status, race, and ethnicity), self-reported medical and treatment history, satisfaction with treatment, and validated instruments on disease severity and impact, psychosocial disorders, disease specific quality of life, and work and classroom productivity and impairment. IQVIA will collaborate with the Alopecia Areata Australia Foundation (AAAF) to recruit eligible patients with AA and caregivers, defined by inclusion and exclusion criteria below. The AAAF has nationally representative sample of AA patients and caregivers in their network. Participants will be invited to participate online via the AAAF’s closed Facebook page via post and via the AAAF newsletter distributed by email among AAAF registrants. until the sample size is met. AAAF was founded in 2010 with the purpose of improving the lives of people living with AA and their families in Australia. Recruitment is expected to last 8 weeks or until recruitment target is reached.

In this study we are trying to find out whether 2 different types of knee joint prostheses have the same clinical and functional outcomes for patients 60 years or over at the time of surgery. Once patient and surgeon decide that the patient will undergo total knee replacement with a B.Braun knee replacement prosthesis; depending on the structural features of the joint, the patient may be receiving either a B.Braun Enduro if additional stability is required, or a B.Braun Columbus prosthesis. The purpose of this study is to compare the outcomes of these two variations of the B.Braun prosthesis when considering patient related factors and the complexity of surgery. This study will analyse outcomes, satisfaction, survival, complication, and revision rates of patients 60 years or over who receive the B.Braun Enduro hinged prosthesis, as compared to an age-matched standard care group who receive the B.Braun Columbus prosthesis. This study will collect data at baseline, day 3, day 14, 6 weeks, 6 months and 12 months post-operative. These devices are both used as standard care globally and are not experimental. All components of these devices can be found on the Australian Register of Therapeutic Goods (ARTG) under B.Braun Australia Pty Ltd EnduRo or Columbus.

While continuous positive airway pressure (CPAP) and high flow nasal cannulae (HFNC) are commonly used for treatment of infants with respiratory distress, the optimum level of CPAP/HFNC remains somewhat uncertain. Due to leaks occurring at the nostrils, the mouth and into the stomach, not all of the pressure generated by CPAP/HFNC is transmitted to the airway. Real-time information of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a proof-of-concept observational study to measure the pharyngeal pressure in a convenience sample of 50 infants receiving CPAP/HFNC for the purpose of developing a novel airway pressure monitoring device. TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the deep oropharynx using a new airway pressure device (under development). The modified gastric tube will be inserted nasally or orally, similar to regular gastric tubes, and pressures recorded over a one-hour period .

This clinical study is an uncontrolled, non-randomised, open-mask, pilot study aiming to test the feasibility of a single microdose of ayahuasca alkaloids on neurotransmitters and inflammation blood pathology markers. This pilot study will recruit four healthy adult volunteers with strict exclusion criteria. This study will test whether an ayahuasca microdose has any measurable biological effects outside of the subjective mood self-efficacy effects. This study will also measure safety observations such as blood pressure, heart rate, pain and oxygen saturation (SPO2). The study hypotheses is that a single microdose of ayahuasca alkaloids will increase neurotransmitters, decrease or have no effect on inflammation markers, have no effect on safety observations, and may enhance mood.

This is a longitudinal proof-of-concept study of benzalkonium chloride (BAC) wound gel in conjunction with standard of care (SOC), We plan to enroll 20 individuals presenting to the Liverpool Hospital High Risk Foot Service (Sydney, Australia) with a diabetes-related foot ulcer (DRFU) suspected of having a local chronic biofilm infection. "Biofilm" is a term given to microorganisms, typically bacteria, that demonstrate alterations in behaviour, such as slow growth, multi-drug resistance, virulence, pathogenicity and aggregation. They are not visible to the naked eye and hence clinicians cannot see which tissue to target during sharps debridement, therefore debridement alone may not be enough to remove biofilms. This study has been designed to provide proof of concept regarding a wound dressing's ability to impact biofilm and may assist in building an evidence base for their continued use in wounds with chronic biofilm infection. We plan to assess the total microbial microbial load before, during and after therapy. We will use a combination of molecular and microscopy techniques to determine the number of bacteria and to better understand the effects of the wound gel on biofilms in real study participants, living with a DRFU with chronic biofilm infection.

In people with Cystic Fibrosis (CF) those who have higher numbers of lung (pulmonary) exacerbations (increased cough, sputum, shortness of breath) live shorter lives than those who have fewer exacerbations. We think that a delay in managing lung exacerbations can lead to worse results. In the past two years more people with CF have been interested in digital ways of getting CF healthcare. The COVID-19 pandemic meant more people got healthcare at home or in the local community rather than in hospitals. People with CF have said they want this to continue post pandemic. This research study will look at new ways of providing care for people with CF using an online system, which is connected to our hospital medical record, that can pick up lung exacerbations in people with CF by examining symptoms (cough, sputum, breathing) that they enter into the system. If the system identifies a lung exacerbation, it will send out an action plan to the person with CF, explaining what they can do to help them get better from their lung exacerbation. The research study will run for 12 months and will compare the online detection system to normal CF care to understand if the new system is easy to use, liked and supported for ongoing use by people with CF and the CF team compared to the current system.

This study aims to evaluate and develop the topic of conflict management in medical student education. This will be addressed through the following objectives: 1. Explore the experiences of final year medical students with conflict whilst on placement 2. Quantify the extent to which medical students encounter conflict whilst on placement 3. Assess the baseline individual skills and individual characteristics of the student cohort to identify gaps that could be addressed through education 4. Use the experiences of medical students combined with gaps in baseline skills to develop an educational intervention (workshop) on conflict management 5. Assess the effectiveness of this intervention in terms of student self-assessed confidence and competence in managing conflict, amount of conflict experienced, and individual skills.

The purpose of this study is to investigate the safety, tolerability and effectiveness of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions using data reported by patients during treatment over a 12 month period.