ANZCTR search results

Aims/Objectives To evaluate the effect of an existing standardized Quality Improvement (Q.I.) process of “Delta Therapy Dogs” in the Canberra Hospital Intensive Care Unit (ICU) on patient and family member’s anxiety. Summary Data regarding Animal Assisted Therapy in the ICU are scant, with narratives suggesting that animal presence is beneficial to patients. To date, there are no Australian studies that have examined the use of therapy dogs in an ICU. Further research is required to adequately assess the potential benefits of dog therapy in this specialised environment. Given the absence of research to support therapy dogs in the ICU setting, this study will provide evidence that could demonstrate the effects of dog therapy on anxiety in ICU patients and their family members. The data collected could assist with scientific evidence to support this as a non-pharmacological intervention to reduce anxiety in the ICU environment. Hypothesis Delta Therapy dogs in the ICU setting will assist in reducing anxiety for the patient and family members who meet the inclusion criteria for this study. Outcome Primary Outcome: • To compare anxiety levels in ICU patients and their families prior to and after the therapy dog visit. Secondary Outcomes: • To assess whether the change in level of anxiety experienced is sustained in long term patients and their relatives/immediate families who have received multiple therapy dog visits throughout their ICU stay. • To assess physiological change in patients before and after therapy dog visit (e.g. pain levels, vital signs, minute ventilation, etc.)

This purpose of this study is to evaluate the efficacy of asciminib in newly diagnosed patients with chronic phase chronic myeloid leukaemia. Who is it for? You may be eligible for this study if you are an adult who has been newly diagnosed with chronic phase chronic myeloid leukaemia. Study details Eligible participants in this study will receive asciminb 40mg (oral) twice a day for up to five years. Dose reduction or increase may occur depending on the patients tolerability and blood results. The investigator will review every 3 months. During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment. It is hoped that this research will help determine the efficacy of this treatment, and what kinds of side effects/complications may occur with this treatment.

This study will investigate the effectiveness of a short-term ketogenic diet before and during chemotherapy in patients with acute myeloid leukaemia Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with acute myeloid leukaemia and will undergo 4 or more cycles of chemotherapy Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will follow a standard hospital diet daily for 5 to 7 days for each round of chemotherapy. Participants in the other group will follow a ketogenic diet daily for 5 to 7 days before and during each round of chemotherapy. What is required Blood, bone marrow, urine and stool samples will be collected throughout the study to assess the effect of the diets on the body. Acceptability of the diets will also be assessed using questionnaires. Outcomes It is hoped that this research will provide a dietary intervention that will protect normal, non-cancer cells from chemotherapy, which will be used for leukaemia and other types of cancer.

This purpose of this study is to determine the safety, tolerability and efficacy of MG010 in combination with sorafenib in patients with solid tumors who have failed existing treatments Who is it for? You may be eligible to join this study if you are aged between 18 years and above, and have histologically confirmed diagnosis of advanced or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable Study details All participants in this study will receive MG010 and sorafenib. This study will have 2 stages: the dose escalation stage and the dose expansion stage. In the dose escalation stage, there will be 3 groups of participants who each receive different doses of each drug. The drug will be given orally once every day of a 28-day cycle. In the dose expansion stage, participants will receive once/twice a day MG010 and once daily sorafenib (at a dose determined from the dose escalation stage) for up to 6 28-day cycles. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis. Medical imaging, e.g. PET and/or CAT scans for stage I will be performed at the beginning and the end. For stage II 5 images will be taken throughout the study; at screening, days, 56, 112, 168 and 210. It is hoped this trial will provide information on the treatment of solid tumours by demonstrating a benefit in the proposed combination treatment, by improving the tolerability and expand the usage of sorafenib in cancer treatment.

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.