Clinical Trials About "Australia Proposes Mandatory Reporting Major Failings Medicines Shortages" RSS

23:20 EST 16th November 2018 | BioPortfolio

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Showing "Australia Proposes Mandatory Reporting Major Failings Medicines Shortages" Clinical Trials 1–25 of 6,600+


Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

Despite all prevention efforts, many people in Australia continue to be infected with HIV. The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination of HIV transmission by the year 2020. This project will evaluate a new additional way to lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to people who are at high risk for HIV and evaluate what impact this new prevention approach will have on HIV in WA at th...

Comparison of Active vs. Passive Surveillance to Collect Adverse Events

This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will b...

Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH

This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) 7 days prior to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by mandatory q16 weeks IAI for 52 wee...

Modified Reporting From Indwelling Catheters

Positive urine cultures collected from indwelling catheters from inpatients will be randomized to standard reporting or modified reporting. Physician antibiotic treatment decisions will be prospectively observed and determined to be appropriate or inappropriate. The hypothesis is that modified reporting will lead to an increase in the percentage of appropriate therapy without an increase in pyelonephritis or sepsis.

Xpert Omni Performance Evaluation

The study proposes to conduct a pragmatic, parallel cluster-randomized trial with nested mixed methods, health economic and modeling studies to evaluate the effectiveness, implementation and costs of the intervention strategy relative to standard TB diagnostic evaluation at community health centers that are part of Xpert referral networks in Uganda. The effectiveness of the intervention strategy will be assessed using routine data collected as part of mandatory reporting to the...

A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

This study will consist of 2 randomized controlled trials in which we test the feasibility and effectiveness of mandatory nap programs for physicians in training. One site will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The other will be the oncology service of the Hospital of the University of Pennsylvania. The primary outcome will be the amount slept while on call.

Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.

Post-Marketing Study to Evaluate the Efficacy of Influenza Vaccine

As a result of the recent supply shortages in the U.S., as well as an anticipated increase in demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a single dose of...

The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12

In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.

Tuberculosis Treatment Shortening Trial

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...

Web-based Tool to Improve the Assessment of Reporting (COBPeer)

The peer review process is a cornerstone of biomedical research publication. Despite being essential, the assessment of the completeness of the reporting and the identification of switched outcomes are not appropriately performed. Furthermore, these tasks do not suppose a high level of expertise and could be performed by junior researchers. To assess the completeness of reporting and identified switched outcome(s), junior peer reviewers could use a simple online tool (COBPeer)...

Medicines Reconciliation at an Intensive Care Unit

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 Clinical Impact of Isolation of Two Different Bacteria in Urinary Cultures

The purpose of this study is to determine whether identification of two different bacteria in urine culture of patients with indwelling catheter has a clinical impact - change in antibiotic, duration of antibiotic, days to clinical resolution and length of stay in hospital. The microbiology laboratory will randomized urine cultures with two bacteria from indwelling catheter to either reporting identity and susceptibility of the bacteria or reporting "mixed growth".

E-reporting of Adverse Drug Reactions by Patients in Relapsing-remitting Multiple Sclerosis

Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients popula...

Drug Interaction Study Between Antimalarial and Anti-HIV Medications

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...

Carefully seLected and Easily Accessible at No Charge Medications Randomized Controlled Trial

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.

Development of the Medicines Optimisation Assessment Tool

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.

The Effectiveness of a Nationwide Mandatory Accreditation in General Practice in Denmark

Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence of the effectiveness of accreditation. The overall aim of this study is to evaluate the effectiveness of a mandatory accreditation in general practice.

Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.

Differences Between Essential Medicines Lists in 135 Countries and Model List of Essential 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...

Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety

The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.

Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine. The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment ...

Strategic Timing of Antiretroviral Treatment

Objectives: - To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their CD4+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level recommended by the guidelines. - To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resist...

Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease

Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. The side effects of these medicines include fast heart rates and increasing the amount of work the heart has to do. Corticosteroids are made by the body and help to use the energy in the food people eat, control the chemicals in their blood a...

Patient Retention in HIV Medical Care in a Primary Care Practice in Australia

The purpose of this study is to determine linkage and retention in care in patients with HIV infection and reasons for loss to follow up Care in a High HIV-caseload Inner City Primary Care Practice in Sydney, Australia. The investigators hypothesise that patients attending HHMP will have higher rates of linkage and retention in care than the US HIV-infected population, and equivalent to Australian modelling.

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