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Safety Issues clinical trials

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NCT ID: NCT03038126 Completed - Clinical trials for Chronic Kidney Disease

Care Coordination/Home Telehealth to Safeguard Care in CKD

CCHT in CKD
Start date: May 2014
Phase: N/A
Study type: Interventional

Home telehealth monitoring of veterans with chronic kidney disease, with a disease management protocol and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for urgent health resource utilization and associated poor outcomes.

NCT ID: NCT03035721 Completed - Safety Issues Clinical Trials

Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

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

This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

NCT ID: NCT03011125 Completed - Safety Issues Clinical Trials

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.

NCT ID: NCT03006549 Completed - Safety Issues Clinical Trials

Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?

EM
Start date: January 10, 2015
Phase: N/A
Study type: Interventional

Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.

NCT ID: NCT03000361 Completed - Colonoscopy Clinical Trials

Motorized Spiral Colonoscopy Trial: A First Feasibility Trial

MSCT
Start date: December 2016
Phase: N/A
Study type: Interventional

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

NCT ID: NCT00845052 Completed - Safety Issues Clinical Trials

Survey of Housestaff Attitudes Toward Patient Care and Safety

Start date: July 2008
Phase: N/A
Study type: Observational

Background: The occurrence of medical errors and their deleterious effects on quality of care delivered are widely recognized phenomena in healthcare today. This has spurned an aggressive nationwide campaign to improve the quality of care all hospitals throughout the country. Currently, there are numerous reports of quality improvement initiatives across medical centers in the United States. However, a review of the literature failed to identify any publications regarding targeted resident/housestaff involvement in hospital quality improvement and safety related activities. Purpose: To investigate and track housestaff attitudes on patient care, patient safety, communication and overall quality within the institution. Objective: To investigate, analyze and publish the results of this prospective study. The information obtained will help us and others understand whether proactive attempts to change housestaff culture can indeed change attitudes towards the better with regards to patient care and safety. It is assumed that improved attitudes ultimately translates into improved care and safety. Methods: Each residency coordinator in each clinical department will be asked to distribute a survey, which has already been validated for this type of investigation, to each resident in the respective program (see attachment). The Vice-President of Medical Affairs will provide a cover letter to help with the process. After a week, a reminder will be distributed by the coordinators to each resident asking them to fill out the survey. The surveys will be filled out anonymously. However, each participant will be asked to note their sex, department and year of postgraduate training. This process will be repeated every eight months until June of 2010. The Housestaff Quality council (HQC) has already distributed and collected this survey. The results of those surveys will be used in a retrospective part of this study. The results of (HQC) survey will be used to establish a baseline of the housestaff attitudes at the New York Presbyterian Hospital-Weill Cornell. Data will be stored on a password protected computer. The Institutional Review Board (IRB), Office of Human Research Protection and Food and Drug Administration and all appropriate federal oversight agencies may have access to those files.