ANZCTR search results

SIIPL Tdap-IPV, manufactured by Serum Institute of India Pvt. Ltd. (SIIPL), is a combined vaccine for active immunization against tetanus, diphtheria, pertussis and poliomyelitis. The formulation contains reduced amounts of the tetanus, diphtheria and acellular pertussis antigens in comparison to paediatric vaccines; it is indicated for booster immunization of children, adolescents and adults. The study is aimed at comparing the reactogenicity and safety of SIIPL Tdap-IPV to comparator Boostrix®-IPV (GlaxoSmithKline). A comparison of immunogenicity in terms of seroprotection rates of tetanus, diphtheria and inactivated poliomyelitis components and the booster response rates to the acellular pertussis antigens will also be assessed. The study will be conducted in two combined phases: phase I and phase II. Phase I will include healthy adults, whilst Phase II will also include adolescents and adults aged 4 years and above.

The primary objective of this open-label matched control trial is to examine the safety and efficacy of enriched CBD oil for reducing relapse among people accessing treatment for methamphetamine use disorder. The effect of enriched CBD oil on depression, anxiety and sleep will also be evaluated.

Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper respiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of PEA for reducing incidence and severity of URTI symptoms compared to a placebo in otherwise healthy adults aged 18-65 years old.

This exploratory single-centre study will be conducted at the Royal Adelaide Hospital, South Australia. Patients will be recruited from two locations; the intensive care and general medical units. Healthy volunteers will be recruited from existing pools or through advertisements as required. This study will recruit: 1. 25 ICU patients 2. 25 general medical patients 3. 25 healthy volunteers The primary aim of this study is to determine whether energy intake as measured from a weighed, soft diet, energy buffet is reduced in adult survivors of critical illness when compared to general hospitalised patients and healthy controls. This study will also aim to determine if there are impairments in the following mechanisms or psychological factors that regulate nutrient intake in survivors of critical illness when compared to general hospitalised patients and healthy controls: a. Fasting and post-prandial gastrointestinal hormone response b. Antral area c. Self-perceived appetite d. Gastrointestinal symptoms e. Taste threshold f. Quality of life

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 4) is evaluating the effect of Lenzilumab on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, and are hospitalised with a severe COVID-19 infection Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive intravenous Lenzilumab over 24 hours while the other group will receive placebo intravenously over 24 hours. Participants will be followed for 60 days to assess effectiveness and safety. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 1) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, have a negative COVID-19 test and without known positive contact with COVID-19 Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intransal spray for 3 months while the other group will receive a daily placebo intranasal spray for 3 months. Participants will be followed during the 3-month treatment for incidence of COVID-19 and other respiratory infections. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 2) is evaluating the effect of interferon-alpha on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, and have had recent exposure to a known COVID-19 case Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive daily interferon-alpha intransal spray for 7 days while the other group will receive a daily placebo intranasal spray for 7 days Participants will be followed for 28 days for incidence of COVID-19 and other respiratory infections. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 3) is evaluating the effect of Selinexor on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, and are hospitalised with a moderate COVID-19 infection Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive oral Selinexor 3 times a week for 2 weeks while the other group will receive oral placebo 3 times a week for 2 weeks Participants will be followed for 60 days to assess effectiveness and safety. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

The cytokine storm, resulting from the extreme immune response to COVID-19 virus, has been identified as the key event that leads to the acute respiratory distress and multiple organ damage, eventually leading to death in COVID-19 infection. The cell therapy, mesenchymal stromal cells (MSC), secrete anti-inflammatory factors that can prevent the cytokine storm. The first published report of 7 patients with severe COVID-19 pneumonia showed that MSC therapy was able to change the inflammatory status of severely ill patients and significantly improve pulmonary function. The small study demonstrated that MSC therapy was safe and effective in severe COVID-19 pneumonia. Our centre manufactures an allogeneic MSC product, under licence from Isopogen Pty Ltd, that is cryopreserved for off-the-shelf use. No donor matching is required and the MSC have natural immunity to COVID-19. The objective of this study is to identify and treat deteriorating COVID-19 patients with MSC therapy to attenuate the cytokine storm response to the COVID-19 virus and thus prevent acute respiratory distress and multi organ damage, improving chance of survival. This is an open label trial, planned to recruit and consent 10 high risk patients on admission. Patients will receive MSC infusions if they are COVID-19 positive and have increasing oxygen requirements to maintain O2 sat of >92%. The primary study endpoint is safety, with secondary endpoints of clinical parameter assessment, including oxygen requirements, ventilatory support, ICU admission, length of stay, survival and the effect of treatment on inflammatory markers.

The present study seeks to evaluate a brief online intervention, Managing Emotion, which has been developed by the present investigators for the purpose of supporting the psychological and emotional well-being of university students. Participants will be randomly assigned to either the Managing Emotion intervention or a wait-list control. The intervention content seeks to increase understanding of the relationship between thoughts, emotions, and behaviour, and discusses a number of evidence-based strategies for managing one’s emotions, particularly during times of stress. The intervention content is divided into five self-paced modules, to be completed over the course of one week. Each module includes a number of brief engaging videos, light reading material, and take-home activities. A set of questionnaire measures will be administered immediately before and after completion of the Managing Emotion program to provide an evaluation of the efficacy, acceptability and feasibility of this intervention. We predict that completion of the Managing Emotion program will be associated with an increase in participants' ability to regulate their own emotions, an increase in participants' perceived self-efficacy and resilience, and reductions in reported depressed mood, anxiety and stress.