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We list hundreds of Clinical Trials about "Human medicines European public assessment report EPAR ellaOne" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.
We have published hundreds of Human medicines European public assessment report EPAR ellaOne news stories on BioPortfolio along with dozens of Human medicines European public assessment report EPAR ellaOne Clinical Trials and PubMed Articles about Human medicines European public assessment report EPAR ellaOne for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Human medicines European public assessment report EPAR ellaOne Companies in our database. You can also find out about relevant Human medicines European public assessment report EPAR ellaOne Drugs and Medications on this site too.
The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.
Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events we...
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.
Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this study is to see if taking 4 months of TB medicines is as effective in curing some TB patients as taking 6 months of TB medicines. Study participants will include 758 human immunodeficiency virus (HIV)-non-i...
The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal dominant, associated with a duplication of the chromosome 17p11.2 region which leads to overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major component of peripheral myelin. In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A ...
This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety Update Report", which is to be regularly sent to the European Medicines Agency (EMEA) and the responsible German Higher Federal Authority (BfArM).
The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain). This study may help to inform decisions regarding future influenza vacci...
Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures fo...
This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.
Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In developing countries, medicines to treat NCDs are often difficult to access or too expensive for many households. Novartis/Sandoz has recently launched Novartis Access, an initiative to subsidize a basket of NCD medicines sold to purchasers in program countries and delivered through the public and non-profit health sectors. This study will evaluate the impact of Novartis Access on the ...
This randomized clinical trial is a multicentre study conducted at 4 community-based pharmacies within the Brazilian public health service, which freely distributes standardized medicines. The group coordinator is located at the Universidade Federal do Rio Grande do Sul, a public university at Porto Alegre.
Findings in neuroscientific research show that the environment one lives in has measurable effects on brain morphology and functioning. Human exposure to airborne infra- and ultrasound has been constantly increasing during the last decades. For instance, the European Renewable Energy Directive, established in 2009, lead to an increased use of wind turbines, generating infrasound. The EU Directive states that until 2020 a 20% of the EUs' total energy needs is to be generated wit...
In both symptomatic and asymptomatic disease, only about half of medicines are taken as prescribed1. Relatively little is known about how patients with Parkinson's disease take their medication. One of the challenges in the management of Parkinson's disease is the prevention and treatment of involuntary movements2,3 and wild fluctuations between being mobile and able to function against being slow, stiff and unable to move which recurs as a delayed (several years) effect of t...
This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow European parents and likewise for the Chinese participants).
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
A crucial factor in evaluating the risk of dioxins, and related endocrine disruptor compounds (dioxins for short) in the human population is the accumulation of these chemicals in the human body. Human data on tissue background levels is extremely limited, and there are no studies in UK populations, although there are several European studies looking at blood levels of dioxins. Adipose tissue concentrations were 139 ng of TEQ (total dioxin-like compounds) per kg lipid weight (5...
Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology. Anxiety levels have never been reported before and after sessions. Indeed, the present study wants...
Randomized cluster trial of cardiac report cards for AMI and CHF. 103 acute care Ontario hospitals/85 hospital corporations participating, randomized to two groups: Group A Early Feedback and Group B Delayed Feedback. Two phases of retrospective chart review of AMI and CHF separations to assess the impact of the public release of hospital specific performance on a set of Canadian quality indicators.
In France, patients with benign viral infections (ie: gastro enteritis and/or rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although there is evidence that these medicines are not efficient. We hypothesize that patients could be reassured by health advices, especially if they are written. In addition, we believe that doctors would feel less guilty for not prescribing drugs if they could hand written consultation reports to patients, in these s...
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.
This study evaluates the effect of performing medicines reconciliation on patients admitted to an intensive care unit. Half of the patients will receive a medicines reconciliation at the intensive care unit. The other half will not. All included patients will receive medicines reconciliation after transfer to the ward.
The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood. The study medicines that will be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for ma...
Since the report "To Err is Human" by the Institute of Medicine (IOM) in 1999, attention was brought to the general public that adverse events in medicine are common and are one of the leading causes of morbidity and mortality within the United States. The report estimates that 44,000 - 98,000 patients hospitalized in the United States die each year as a result of medical errors. In spite of the growing patient safety movement worldwide, health care has not become measur...
This trial evaluates the effect of providing primary care patients with free and convenient access to a set of essential medicines. Half of the participants will receive free and convenient access to these essential medicines, while the other half will have usual access to medicines.
The World Health Organization (WHO) has developed a model list of more than 400 medicines and recommends that each country adapt the list to its own circumstances. More than 100 countries have developed essential medicines lists. Some countries have essential medicines lists that are very similar to the WHO's model list and other countries have lists that are very different from the WHO's model list. Differences between the WHO list and country lists could be explained by feat...