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Adverse Events clinical trials

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NCT ID: NCT04012320 Completed - Children Clinical Trials

Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

Bisphosphonate
Start date: October 31, 2018
Phase:
Study type: Observational

The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.

NCT ID: NCT02928705 Completed - Analgesia Clinical Trials

Quality of Telemedically Guided Prehospital Analgesia

Start date: January 2014
Phase: N/A
Study type: Observational

The purpose of this retrospective study is to analyze quality and adverse events of analgesia by telemedically supported paramedics in comparison to conventional treatment by on-scene emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.

NCT ID: NCT02725073 Recruiting - Feasibility Clinical Trials

Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

PDT
Start date: January 2016
Phase: Phase 2
Study type: Interventional

To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

NCT ID: NCT02310815 Completed - Adverse Events Clinical Trials

ReSure Sealant Post Approval Study

Clinical PAS
Start date: December 2014
Phase: N/A
Study type: Observational

This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.

NCT ID: NCT02268331 Completed - Adverse Events Clinical Trials

Comparison of Active vs. Passive Surveillance to Collect Adverse Events

Start date: October 2014
Phase: N/A
Study type: Interventional

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 be utilized in this study for the passive reporting and learning arm. Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.

NCT ID: NCT02130570 Completed - Patient Engagement Clinical Trials

Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions

Start date: June 2013
Phase: N/A
Study type: Interventional

The objective of this study is to design and implement a set of procedures (the intervention) to improve patients' experiences when they are discharged home from the hospital. Second, this study aims to look at how the intervention affects problems that are known to occur after discharge, including medication issues, worsening medical problems, or readmission to the hospital. The investigators will study how well patients recover the ability to do the things they could before they were admitted to the hospital and their opinions of the discharge process. Lastly, this study will look to understand the best way to implement the intervention into different hospitals and practices, and which types of patients benefit from it most.

NCT ID: NCT02011607 Terminated - Adverse Events Clinical Trials

Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

SEDLine
Start date: January 2013
Phase:
Study type: Observational

We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.

NCT ID: NCT01291667 Completed - Adverse Events Clinical Trials

Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE

HOPES
Start date: May 2009
Phase: Phase 3
Study type: Observational

Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.

NCT ID: NCT01128127 Withdrawn - Adverse Events Clinical Trials

Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Start date: January 2013
Phase: N/A
Study type: Interventional

Background Despite the low prevalence of serious complications associated with non-steroidal anti-inflammatory drugs (NSAIDs) use, there is a widespread use of gastroprotective proton pump inhibitors (PPIs) in order to prevent adverse effects. Inappropriate prescribing of PPIs includes overprescribing for inappropriate indications and the misuse of first choice in their class in terms of efficacy, safety and cost. A series of recommendations, based on the best available scientific evidence, has been established to justify prophylaxis with PPIs associated to NSAIDs. Therefore, there is the need to encourage the incorporation of this knowledge to guide decisions of physicians with the objective of improving patient health and sustainability of the Public Health Service. Although since long ago there is a great concern regarding rational use of drugs, the available evidence for the most appropriate strategies to improve prescribing is scarce. Passive dissemination of research findings are generally ineffective and at best result in small changes in practice. Multifaceted intervention targeting different barriers to change are more likely to be effective than single intervention. Objectives The objective of this study is to evaluate the effectiveness of two educational multifaceted strategies aimed at improving PPIs prescription associated to NSAIDs use in primary care. We will also compare the cost-effectiveness of such strategies. Hypothesis It is hypothesized that a quality improvement intervention directed to primary care physicians will decrease inappropriate PPIs prescriptions associated to NSAIDs prescription. Methodology A three-arm prospective quasi-randomized controlled trial will test the effectiveness of two strategies for improving PPI prescription associated to NSAID in primary care context. Three of the Canary Islands will be selected and randomized to either a experimental multifaceted intervention (group education+audit-feedback+CCDSS) group, a experimental multifaceted intervention (audit-feedback+CCDSS) group, or a control group (usual intervention). From each of these islands, 6-8 primary care centers will be randomly selected to received the intervention practices. All family physicians working at each randomly selected primary care center were mandatorily included. Primary outcome measure is reduction of inappropriate PPI prescription. The efficacy of the intervention will be examined within a 3, 6 and a 12 month follow up.

NCT ID: NCT00728780 Completed - Adverse Events Clinical Trials

Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

Start date: August 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.