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Adverse Effects clinical trials

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NCT ID: NCT01602250 Completed - Adverse Effects Clinical Trials

Local Anaesthetics Toxicity and Intralipid®

TOXALIP
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The systemic toxicity of local anaesthetics may be treated using lipid emulsions ("lipid rescue"). However, there is no evidence-based proof of the efficacy of the treatment. The aim of the intended protocol is to study the effect of the emulsion Intralipid® on the toxicity prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a sensitization session with lidocaine, subjects will receive in a double blind, crossover manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be performed in order to evaluate the changes in pharmacokinetics induced by the emulsion.

NCT ID: NCT01553383 Completed - Clinical trials for Obstructive Sleep Apnea

Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea

Start date: February 2012
Phase: N/A
Study type: Interventional

Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve "Provent" in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.

NCT ID: NCT01533792 Completed - Clinical trials for Periodontal Diseases

Effect of Non-surgical Periodontal Treatment

EONSPT
Start date: March 2010
Phase: Phase 2
Study type: Interventional

Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling. Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.

NCT ID: NCT01471366 Completed - Adverse Effects Clinical Trials

Method of Fish Oil Administration on Patient Compliance

Start date: November 2011
Phase: N/A
Study type: Interventional

Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.

NCT ID: NCT01318928 Unknown status - Adverse Effects Clinical Trials

The Treatment of Periodontal Diseases

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine if the correct use of antibiotics, as well as the application of one-day-treatment, in the therapy of periodontal diseases. The population of treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3: Metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21 End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all sites at 3 months, 1 -, 3 -, and 5 years post-treatment

NCT ID: NCT01172626 Not yet recruiting - Epilepsy Clinical Trials

Exploration of Genotype Based Personalized Prescription of Valproate Sodium in Anti-epileptic Treatment

EGBPPVPA
Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the relationship between the side effects of valproate sodium in the treatment of epilepsy in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of valproate sodium.

NCT ID: NCT01116323 Completed - Adverse Effects Clinical Trials

Emergency Department Crowding in Relation to In-hospital Adverse Medical Events

Start date: June 2010
Phase:
Study type: Observational

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 measurably safer. Health care is one of the few risk-prone areas in which public demand limits the use of common-sense safety-enhancing solutions, such as limiting the flow and choosing the type of incoming patients. The latter is especially true for emergency departments (EDs) since they deliver an important public service by providing emergency care 24 hours a day, 365 days per year, without discrimination by social or economic status. One of the key expectations of EDs is the ability to provide immediate access and stabilization for those patients who have an emergency medical condition. However, emergency department (ED) crowding is recognized to be a major, international problem that affects patients and providers. A recent report from the IOM noted that the increasing strain caused by crowding is creating a deficit in quality of emergency care. Crowding has been associated with reduced access to emergency medical services, delays in care for cardiac patients, increased patient mortality, inadequate pain management, increased costs of patient care, and delays in administration of antibiotic therapy. Several issues remain concerning ED crowding and it's relation to adverse events. First, the existing evidence on adverse event occurrence during ED crowding is largely anecdotal and inconclusive. Secondly, although a few studies showed a relationship between ED crowding and mortality, neither of these examined the causes of excess mortality. Finally, although a significant increase in the average length of hospital stay was shown during ED crowding the reasons for this are open to speculation. The purpose of this study therefore is to identify six explicit adverse events and mortality for patients who were admitted through ED and to compare these results in relation to ED crowding. This will provide us novel insight into the reasons for the hypothesized increased mortality during ED crowding.

NCT ID: NCT01060410 Completed - Clinical trials for Lupus Erythematosus, Systemic

Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

Start date: May 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the relationship between the side effects of cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of cyclophosphamide.

NCT ID: NCT01041352 Completed - Anaesthesia Clinical Trials

Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position

Start date: October 2009
Phase: N/A
Study type: Interventional

The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours. Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.

NCT ID: NCT00925353 Completed - Adverse Effects Clinical Trials

The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).