ANZCTR search results

This study looks at the effectiveness of chemotherapy with the drug Omacetaxine in people with chronic myeloid leukemia (CML). Who is it for? You can join this study if you have chronic myeloid leukemia (CML) (cancer of blood cells) which is in chronic, accelerated, or blast phase and you have have had no success with or have been intolerant to therapy with tyrosine kinase inhibitors (iminitab - Glivec). Trial details All participants will be treated with induction course cycles consisting of subcutaneous (SC) Omacetaxine administered twice daily for 14 consecutive days every 28 days. During this induction therapy, participants will be evaluated every 7 days with complete blood and platelet counts; the number of consecutive dose s of Omacetaxine or intervals between subsequent cycles may be adjusted as necessary, according to guidelines provided in the treatment plan. Omacetaxine causes programmed cell death in myeloid cancer cells. Patients will be monitored from the beginning of treatment until any return of the disease or until they die. The study aims to measure the effectiveness of treatment, and investigates the tolerance to and toxicity of Omacetaxine.

Kidney stones [renal colic] can be a very painful condition. Current recommendations suggest non-steroidal anti-inflammatory agents [e.g. ketorolac, indomethacin] as first line treatment, although it is recognised that many patients also need strong painkillers such as morphine. A recent report has suggested that anti-histamine drugs [such as promethazine] may also be effective. The aim of this study is to compare the combination of promethazine/ indomethacin/ morphine against indomethacin/ morphine on the amount of pain reported and total dose of morphine needed for patients with kidney stone pain.

Dietary fibre and protein are thought to attenuate postprandial blood glucose levels. This study in 33 participants with type 2 diabetes, will compare glucose and insulin responses following consumption of drinks containing glucose with and without protein and fibre from two different sources: lupin and soy. It is proposed that: 1. Fibre and protein-enriched drinks (lupin and soy) will be associated with lower postprandial levels of glucose and insulin compared with the carbohydrate-matched control; and 2. The lupin-enriched drink will be associated with lower levels of glucose and insulin compared with the soy-enriched drink.

This is a two stage project: (1) independent microbiological studies to confirm the identity of the probiotic bacteria and the safety (contaminants, unspecified contents, osmolarity) of the probiotic product followed by (2) a pilot clinical trial to test the hypothesis that routine supplementation with this probiotic product will result in colonisation of the gut (primary hypothesis) and reduction in all cause deaths, and diseases like NEC, and late onset sepsis (secondary hypotheses) in premature babies.

This study looks at the effectiveness of chemotherapy with the drug Omacetaxine in people with chronic myeloid leukemia (CML) who have the Philadelphia chromosome (T315I bcr-abl gene) mutation. Who is it for? You can join this study if you have: - chronic myeloid leukemia (CML) (cancer of blood cells) which is in chronic, accelerated, or blast phase - tested positive for the T315I bcr-abl point mutation - had no success with tyrosine kinase inhibitor (iminitab - Glivec) treatment. Trial details All participants will be treated with induction course cycles consisting of subcutaneous Omacetaxine administered twice daily for 14 consecutive days every 28 days. Participants who demonstrate a response may receive maintenance therapy for up to 24 months, consisting of subcutaneous Omacetaxine twice daily for 7 days every 28 days. Participants will be evaluated every 7 days with complete blood and platelet counts while undergoing therapy; the number of consecutive doses of Omacetaxine or intervals between subsequent cycles may be adjusted as necessary, according to guidelines provided in the treatment plan. Omacetaxine causes programmed cell death in myeloid cancer cells. Patients will be monitored from the beginning of treatment until any return of the disease or until they die. The study aims to measure the effectiveness of treatment, and investigates the tolerance to and toxicity of Omacetaxine.

The primary aim of this project is to prospectively evaluate and improve an interactive model for predicting outcomes for individual patients following endovascular aortic aneurysm repair (EVAR). The model was developed to allow clinicians to preoperatively predict the likelihood of individual failure based on the following outcomes: perioperative and aneurysm-related mortality, need for reintervention, type I & III endoleaks and 3 year survival. The secondary aim is to assess whether specific biomarkers are able to predict the incidence of postoperative EVAR failure and hence contribute to the predictive model. This study will include 1000 patients who require elective, non-urgent EVAR repair, recruited at multiple sites over a 2 year period. Data will be collected for a minimum of 3 years from the time a patient is enrolled into the study. Active endovascular surgeons at participating hospitals will be responsible for ensuring the data submission forms are completed for the duration of patient involvement in the study. The University of Adelaide, Department of Surgery in Adelaide, will administer the study and assign a team of data coordinators, researchers, statisticians, and programmers to undertake this study. Data will be collected preoperatively, immediately post-operatively and at follow up. Patients will be reviewed at 30-days and at six months post-operatively, and then annually for three years. Biomarkers will also be collected pre-operatively and at each follow up vsit for the duration of the study.

This research aims to provide preliminary data on a randomised controlled treatment trial for treatment refractory childhood obsessive-compulsive disorder (OCD) – that is, children and adolescents with OCD who continue to suffer disability even after first-line evidence-based treatment. Treatment evaluated in this study will be 5 (+3) sessions augmented behaviour therapy, specifically intensive exposure and response prevention, with D-Cycloserine – an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NMDA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia or fear of heights, and OCD in adult samples. This drug is yet to be investigated in a sample of children and youth with OCD.

This study compares radiation plus chemotherapy with radiation alone in treating women with endometrial cancer that is classified as high risk or advanced stage. Who is it for? You can join this study if you are a woman who has endometrial cancer that is classified as high risk or is at an advanced stage. Trial details Participants will be divided into two groups. Both groups will receive radiation treatment in the pelvic region, while one group will also receive chemotherapy at the same time as radiation, followed by adjuvant chemotherapy. The chemotherapy given at the same time as radiation treatment is called cisplatin and is administered by intravenous drip on days 1 and 22. The adjuvant chemotherapy is a combination of carboplatin and paclitaxel and is administered in 4 cycles at 3 week intervals. For the group receiving radiation and chemotherapy, the treatment extends over 5 months. For the group receiving radiation alone, treatment goes for 6 weeks. All participants are monitored for 10 years. The study aims to see whether combining chemotherapy with radiotherapy treatment, compared with radiotherapy alone, improves overall survival rates, and also looks at quality of life.

This study tests whether Oxytocin improves the social communication problems in young people with Autism. It is predicted that individuals from the community diagnosed with autism or asperger's disorder who receive a single dose of oxytocin nasal spray will show improved performance on social cognition tests in comparison to performance on these tests under a placebo. Two single session assessment sessions within a two week period are conducted using a crossover design. All subjects, therapists, assessors, and data entry staff are blind to condition.

There is no good evidence to support any particular level of protein input in critical illness. Some studies have indicated a level above which there is no additional benefit to short-term indicators (such as nitrogen balance), but none of the studies have looked at the effects on concrete outcomes such as time in the intensive care unit, or functional measures after discharge. The aim of this study is to look at such concrete measures after administering two different levels of protein to patients who are fed intravenously. The hypothesis is that a higher level of protein will improve outcomes.