There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of CF, it failed to improve FEV1 in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis. The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis. We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health. Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily against control.
This pilot study will examine one issue only in weight loss - food cravings in overweight (i.e. BMI between 25-29.9) or obese (BMI greater than 30) consumers. Food craving is hypothesized to be an important intervening causal variable and the development of obesity. This randomized clinical trial will explore whether a relatively under researched energy based therapeutic procedure, Emotional Freedom Techniques (EFT), can reduce food cravings in participants under laboratory-controlled conditions, and compare this to a waitlist group. The following foods will be tested: chocolate, salty foods (e.g. chips, crisps, salted nuts), sweet carbohydrate foods (eg. cakes, biscuits, soft/soda drinks), carbohydrate foods which are neither sweet nor salty such as white refined foods such as bread), and caffeinated items. Research examining energy based procedures (e.g. EFT) combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as "psychological acupuncture". Few adequately controlled studies have been conducted on EFT however acupuncture has been quite extensively studied, with hundreds of research reports published (see attached references). Screening will occur over the telephone with one of the chosen self report questionnaires - the Food Craving Inventory (FCI; White et al., 2002). The FCI is a reliable and valid measure for the assessment of cravings for specific types of foods: High Fats, Sweets, Carbohydrates/Starches, and Fast Food Fats, all of which comprise the higher order construct of "food craving" or the FCI Total score (White et al., 2002). Higher numbers for each of the subscales reflect greater cravings for that food type with the highest score being 185. Scores of 93 or higher during the screen will be used to admit subjects to the next diagnostic interview phase of the trial. In addition, subjects will be asked their weight and height in order to ascertain their BMI and this will be confirmed in the diagnostic interview with a standardized weight machine. The Structured Clinical Interview (SCID-II; Spitzer, Williams, Gibbon, & First, 1990) has 12 groups of questions corresponding to12 personality disorders and will be used as a diagnostic tool in a face-to-face interview with subjects who are suitable from the telephone screen. The aim is to exclude any active diagnoses from the DSM-IV in order to obtain the purest non clinic sample possible. All subjects will be notified by letter of the outcome of their diagnostic interview and those unsuitable for the trial will be told they did not meet selection criteria. Suitable practitioners who would be able to provide individual support for the food cravings will be provided in written format. Subjects who meet a diagnostic category will be informed of this and appropriate referral will be offered. Participants will be randomly assigned (using the NHMRC Clinical Trials Centre service) to a free group EFT treatment condition or a non treatment waitlist control condition of the same duration (4 weeks). This design ensures that potential treatment gains are neither due to the mere passage of time nor regression to the mean. To limit attrition from waitlist conditions, several contacts will be made with the waiting clients. Prescheduled phone contacts, for example, may maintain adherence to the waitlist condition. Prior to treatment all subjects will be weighed and height measured for their BMI status and food craving outcome measures (pre, post and follow-up) will be measured using: 1. SUDS rating (subjective) in daily food diaries (food diaries were chosen as a method that best measures real-life eating behaviour) 2. Power of Food Scale (Didie, 2003) 3. Food Craving Inventory (White et al., 2002) Three aspects of eating behaviour will be measured using the Revised Restraint Scale (Herman & Polivy, 1980). The items are summed for a total score that ranges from 0 to 40. High scores indicate chronic dieting in which the individual is constantly cycling on and off the diet, typically without any substantial weight loss. Dietary restraint appears to play a causal role in the development of eating disorders and obesity and loss of control over intake. Food cravings may trigger these eating behaviours. The Symptom Assessment 45 (SA-45, Strategic Advantage, 1998) will be used to assess symptomatology across nine psychiatric domains and as measures of the outcome of the psychological intervention. Demographic information will be collected in questionnaire format at the beginning of the study. The EFT intervention will consist of 4 sessions (2 hours duration) with homework and will be based on standard delivery of EFT, as per founder Gary Craig's training for level 1 EFT certification ( see http://www.emofree.com/WorkShop/workshop-guidelines.htm#Level%201).
The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts of the HER2/neu receptor is important for breast cancer to grow and spread. Women with previously untreated metastatic breast cancer (breast cancer that has spread to other organs) and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes") together with another approved drug called "trastuzumab". Chemotherapy drugs, such as paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although some of the patients who receive this taxane plus trastuzumab treatment feel better for some months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab, it also works by specifically "targeting" the HER2/neu receptor, but it does so in a different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth. Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However, this is not known. Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with HER2/neu positive breast cancer.
This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment