Adverse event (Total 313678 Papers Found)

The efficacy and tolerability of Lu AA21004 at 5 mg/day, a novel multimodal antidepressant, were assessed in elderly patients with recurrent major depressive disorder. Patients were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60 mg/day (reference) or to placebo in an 8-week double-blind study. The primary efficacy measure was the 24-item Hamilton Depression Scale (HAM-D(24)) total score (analysis of covariance, last observation carried forward). Patients (mean age 70.6 years) ha ...
BACKGROUND The independent effects of diet- or exercise-induced weight loss on the reduction of obesity and related comorbid conditions are not known. The effects of exercise without weight loss on fat distribution and other risk factors are also unclear. OBJECTIVE To determine the effects of equivalent diet- or exercise-induced weight loss and exercise without weight loss on subcutaneous fat, visceral fat skeletal muscle mass, and insulin sensitivity in obese men. DESIGN Randomized, control ...
Hospitals now have the responsibility to implement strategies to prevent adverse outcomes after discharge. This systematic review addressed the effectiveness of hospital-initiated care transition strategies aimed at preventing clinical adverse events (AEs), emergency department (ED) visits, and readmissions after discharge in general medical patients. MEDLINE, CINAHL, EMBASE, and Cochrane Database of Clinical Trials (January 1990 to September 2012) were searched, and 47 controlled studies of fai ...
PURPOSE Chimeric antigen receptor-modified T cells (CAR-T) have demonstrated encouraging results in early-phase clinical trials. Successful adaptation of CAR-T technology for CEA-expressing adenocarcinoma liver metastases, a major cause of death in patients with gastrointestinal cancers, has yet to be achieved. We sought to test intrahepatic delivery of anti-CEA CAR-T through percutaneous hepatic artery infusions (HAIs). EXPERIMENTAL DESIGN We conducted a phase I trial to test HAI of CAR-T in ...
OBJECTIVE To determine the efficacy of botulinum toxin type A (BTX-A) in treating neck and upper-back pain of myofascial origin. DESIGN A randomized, double-blind, placebo-controlled pilot study. SETTING Outpatient physical medicine and rehabilitation clinic of a university-affiliated tertiary hospital. PARTICIPANTS A total of 29 subjects enrolled from among 45 screened patients. No subject withdrawal due to serious adverse events occurred. INTERVENTION Subjects were evaluated at baselin ...
BACKGROUND The Internet is changing the way people learn about health and illness. Over the previous decade, the oral antineoplastic (OAN) agents have changed patient management allowing more ambulatory care. In this regard, websites could be an interesting source of data about OAN-induced adverse events (AEs). OBJECTIVE The aim of the study was to describe the characteristics of AEs, as reported on websites by patients exposed to OAN agents, and to compare these to those recorded in the Frenc ...
BACKGROUND Oxymorphone extended release (ER) is a tablet formulation of the mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymorphone ER given every 12 hours with those of placebo in patients with pain related to osteoarthritis (OA) of the hip or knee. METHODS This was a 2-week, multicenter, randomized, ...
Sudden unexpected death in epilepsy (SUDEP) is the most frequent cause of epilepsy-related death [1–3]. Sudden unexpected death in epilepsy is responsible for 7.5% to 17% of all deaths in people with epilepsy with incidence rates among adults between 1:500 and 1:1000 patientyears [4,5]. The main risk factors related to SUDEP include the presence or number of generalized tonic–clonic seizures (GTCS) and nocturnal seizures, young age at epilepsy onset, longer duration of epilepsy, dementia, ab ...
8524 Background: Novel therapies are needed to improve outcomes in T-cell lymphomas. We report the interim results of a prospective multicenter trial evaluating lenalidomide in T-cell lymphomas. METHODS Patients with relapsed and refractory T-cell lymphomas other than mycosis fungoides were prescribed oral lenalidomide (25mg daily) on days 1 to 21 of each 28 day cycle, with standardized dose reductions for toxicity. Treatment continued until disease progression, death or unacceptable toxicity. ...
BACKGROUND Fully efficient vaccines against malaria pre-erythrocytic stage are still lacking. The objective of this dose/adjuvant-finding study was to evaluate the safety, reactogenicity and immunogenicity of a vaccine candidate based on a peptide spanning the C-terminal region of Plasmodium falciparum circumsporozoite protein (PfCS102) in malaria naive adults. METHODOLOGY AND PRINCIPAL FINDINGS Thirty-six healthy malaria-naive adults were randomly distributed into three dose blocks (10, 30 an ...
One of the most important scientific discoveries of the last century was that persistent infection by some types of HPV is a precondition for the development of cervical cancer. The oncogenic types of HPV are also associated with other tumours (vaginal, vulvar and anal carcinomas, tumours of the head and neck, urethra and penis). Two preventive vaccines are currently available (Cervarix and Gardasil). Both have shown very good efficacy, safety and tolerability profiles. Nonetheless, extensive va ...
AIMS AND OBJECTIVES To develop and validate a modified Situation-Background-Assessment-Recommendation communication tool incorporating components of the Cape Town modified early warning score vital signs chart for reporting early signs of clinical deterioration. BACKGROUND Reporting early signs of physiological and clinical deterioration could prevent "failure to rescue" or unexpected intensive care admission, cardiac arrest or death. A structured communication tool incorporating physiological ...
Dear editor, A systematic review of studies mostly evaluating the role of fully covered selfexpandable metal stents (FCSEMS) for drainage of pancreatic fluid collections (PFCs) reported a pooled adverse event rate of 23%. To overcome the limitations of FCSEMS and to minimise adverse events, a lumen-apposing metal stent (LAMS) was recently developed. The new stent is a single-step drainage device that is very different in design and mechanics from FCSEMS and hence warranted a change in the termin ...
The aim of this study is to estimate the willingness of multiple sclerosis (MS) patients to accept life-threatening adverse event risks in exchange for improvements in their MS related health outcomes. MS patients completed a survey questionnaire that included a series of choice-format conjoint tradeoff tasks. Patients chose hypothetical treatments from pairs of treatment alternatives with varying levels of clinical efficacy and associated risks. Among the 651 patients who completed the survey, ...
Phase III clinical trials using radiotherapy for esophageal cancer are reviewed. Concerning preoperative radiotherapy, results of 6 of 7 clinical trials failed to show its usefulness. Two randomized trials evaluating postoperative radiotherapy were performed. Both of them, however, proved negative. Chemoradiation has been used for inoperable esophageal cancer instead of radiotherapy alone. Combined modality therapy with radiation and Bleomycin was found to be useless. In early 1980, multiple dru ...
OBJECTIVE To evaluate the safety of coadministering tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines during pregnancy by comparing adverse events after concomitant and sequential vaccination. METHODS We conducted a retrospective cohort study of pregnant women aged 14-49 years in the Vaccine Safety Datalink from January 1, 2007, to November 15, 2013. We compared medically attended acute events (fever, any acute reaction) and adverse birth outcomes ...
Evaluating new rare serious vaccine safety signals is difficult and complex work. To further assess the observed increase in narcolepsy cases seen in Europe with the 2009 pandemic H1N1 influenza vaccine, the International Alliance for Biological Standardization (IABS) invited a wide range of experts to a one day meeting in Geneva in October 2015 to present data and to discuss the implications. The presentations covered the following topics: clinical picture of childhood narcolepsy following the ...
To the Editor, We have previously reported in the Nephrology journal the results of a clinical trial which showed therapeutic equivalence between a biogeneric epoetin, GerEPO and Eprex with respect to haemoglobin (Hb) response among patients on dialysis. The duration of the trial treatment was only 3 months, which was insufficient for safety evaluation. Following demonstration of equivalent efficacy, we have initiated an observational cohort study in late 2005 to evaluate the long-term safety of ...
The aim of this study was to evaluate the efficacy and safety of telbivudine 600 mg/day compared with lamivudine 100 mg/day for 48 weeks of treatment in patients with hepatitis B-related cirrhosis. Data were reviewed retrospectively from 165 hepatitis B-related cirrhotic patients (55 compensated patients and 110 decompensated) who received antiviral therapy with telbivudine or lamivudine. Serum alanine aminotransferase (ALT) and hepatitis B virus (HBV) DNA levels, hepatitis B e antigen (HBeAg) l ...
Priming of leukemic cells with cytokines may enhance the efficacy of cell-cycle chemotherapy. In this study, we utilized these synergistic effects of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim [Leukine]), hydroxyurea, and low-dose cytosine arabinoside to treat elderly patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). In a single-institution, retrospective study, we evaluated 94 treatments with concomitant hydroxyurea, cytosine arabinosi ...
Review of perioperative activity including adverse events, throughput and compliance with 'best practice', can theoretically be used to optimise healthcare delivery. Computer-based analysis of electronic patient records could provide a practical means to manage quality improvement. This pilot study examined the effectiveness of such a system in practice. All intraoperative patient notes and physiological data were collected over 17 months in a rural hospital using data from an electronic record- ...
PURPOSE Because highmyopia causes severe visual impairment, it is important to prevent the progression of myopia. Recently, the prevention of myopia progression by low dose atropine was reported from Singapore. We started the study of low dose atropine in Japanese children, with the aim of investigating the side effects of low dose atropine. SUBJECT AND METHODS The participants were 16 children between the age of 6 and 12. They receive 0.01% atropine once nightly in both eyes. Refractive error ...
Semantic Scholar extracted view of "Entering the second decade of the patient safety movement: the field matures: comment on "disclosure of hospital adverse events and its association with patients' ratings of the quality of care"." by Robert M. Wachter ...
The aim of this retrospective study was to determine the rate of nonadherence to disease-modifying therapies (DMTs) among multiple sclerosis (MS) patients in Kuwait and to identify reasons for patient discontinuation of long-term therapy. Using a newly established MS registry at our institution, we collected data on MS patients' demographics, clinical characteristics, disability measures, and continuation or discontinuation of first-line DMTs. Reasons for nonadherence were divided into four cate ...
We here describe a case of Stage IV breast and gastric cancer in which S-1/paclitaxel therapy was effective in maintaining the patient's QOL. A 50-year-old woman visited our hospital with complaints of her right breast tumor and right brachialgia. She was diagnosed with breast cancer with multiple bone metastases including cervical vertebrae. Accordingly, local radiation therapy and tamoxifen(TAM)administration was started immediately. Gastrointestinal endoscopy revealed gastric cancer, but lapa ...
The Institute of Medicine has recommended a change in culture from "name and blame" to patient safety. This will require system redesign to identify and address errors, establish performance standards, and set safety expectations. This approach, however, is at odds with the present medical malpractice (tort) system. The current system is outcomes-based, meaning that health care providers and institutions are often sued despite providing appropriate care. Nevertheless, the focus should remain to ...
OBJECTIVES The HISTORIC-AF trial is a prospective, multicentre, single-arm study designed to evaluate the outcomes of a staged endoscopic and transcatheter ablation in patients with stand-alone, persistent or long-standing persistent atrial fibrillation (AF). METHODS From 2012 to 2015, 100 consecutive patients were enrolled and underwent thoracoscopic left atrial epicardial isolation ('box lesion') followed by transcatheter ablation in case of AF recurrency. The safety end point was the compos ...
BACKGROUND Entecavir (ETV) has been shown to be safe and efficacious in randomised controlled trials in highly selected patients with hepatitis B virus (HBV) infection. AIM To determine the safety and effectiveness of ETV in 'real-world' HBV patients in the United States (US). METHODS Treatment-naïve HBV patients ≥18 years old who received ETV for ≥12 months between 2005 and 2013 were included in a retrospective, cohort study. Rates of ALT normalisation, undetectable HBV DNA, HBeAg and ...
OBJECTIVE To study the effect of risperidone treatment on behavioral disorders in children with autism. METHODS Forty children with behavioral disorders (aged from 5 to 12 years) were treated with risperidone for 8 weeks. The behavioral symptoms were evaluated by the Clinical Global Impression (CGI) and the Autism Treatment Evaluation Checklist (ATEC) before and after the treatment. The adverse events related to risperidone treatment were observed. RESULTS The score of severity of illness an ...
Objective The use of early colonoscopy in the management of acute lower gastrointestinal bleeding (LGIB) is controversial, with disparate evidence. We aim to formally characterize the utility of early colonoscopy (within 24 h) in managing acute LGIB. Design A systematic literature search to August 2016 identified fully published and abstracts of randomized controlled trials (RCTs) and observational studies assessing early colonoscopy in acute LGIB. Single-arm studies were also included to defi ...
PURPOSE The objective of the study was to compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004%/timolol 0.5% ophthalmic solution (Trav/Tim) to latanoprost 0.005%/timolol 0.5% ophthalmic solution (Lat/Tim), dosed once daily in the morning, in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). METHODS This was a randomized, double-masked, multicenter, parallel group, active-controlled study conducted at 41 sites. At the eligibility visit the p ...
INTRODUCTION Cutaneous warts are highly prevalent lesions caused by the infection of keratinocytes by different types of human papillomaviruses. Although cutaneous warts are capable of resolving spontaneously, these infections can persist for long periods of time by evading the host immune system, and, as a result, many patients choose to seek treatment. Imiquimod is an immune response modifier that is approved as a topical cream for the treatment of anogenital warts by the US Food and Drug Admi ...
The area of drug information is broad and of increasing importance to all pharmacy practitioners. The efficient and effective use of the literature should not be limited to those individuals with specialized drug information education and training. Pharmacists must be familiar with the many sources of information available to them, including the expanding line of CD-ROM products and on-line databases. Drug information specialists should serve as consultants and facilitators in the appropriate us ...
AIM Randomized, controlled trials have demonstrated the efficacy and safety of injectable bulking agents for the treatment of faecal incontinence (FI), although the long-term outcome has not been assessed. NASHA/Dx gel, a biocompatible, nonallergenic bulking agent consisting of nonanimal stabilized hyaluronic acid and dextranomer microspheres, has demonstrated efficacy and safety for up to 12 months after treatment. The objective of this study was to evaluate the long-term efficacy and safety of ...
The collection of information about events in the healthcare sector has been documented internationally for more than 25 years. Incident reporting is used for the structured acquisition of information about adverse events to improve patient and healthcare staff safety, prepare corrective action, and prevent event recurrence in the future. The establishment of an incident reporting system requires that the staff involved should be capable of recognizing events which require reporting. The aim of ...
Antrectomy with Roux-en-Y gastrojejunostomy was performed in 83 patients with “complicated” forms of peptic esophagitis. The esophagitis was considered complicated either because of the severity of the lesions (stricture, brachyesophagus, or endobrachyesophagus) or because of postoperative conditions after one or more previous operations (Heller's myotomy, esophagogastric resections, or hiatal hernia repair). A standard procedure was performed in 56 patients while technical adjustments were ...
BACKGROUND Dolutegravir (S/GSK1349572) is a once-daily HIV integrase inhibitor with potent antiviral activity and a favourable safety profile. We compared dolutegravir with HIV integrase inhibitor raltegravir, as initial treatment for adults with HIV-1. METHODS SPRING-2 is a 96 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began on Oct 19, 2010, at 100 sites in Canada, USA, Australia, and Europe. Treatment-naive adults (aged ≥ 18 years) with HIV-1 inf ...
OBJECTIVE The aim of this study was to evaluate the efficacy and safety of two dose ranges of risperidone in adolescents with schizophrenia. METHODS In a 6-week, randomized, double-blind, placebo-controlled study, adolescents aged 13-17 years with acute exacerbation of schizophrenia were randomized to placebo, flexible doses of risperidone 1-3 mg/day, or risperidone 4-6 mg/day. Assessments included the Positive and Negative Syndrome Scale (PANSS), clinical response (> or =20% reduction in P ...
Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective was ...
BACKGROUND More than 5 million US stroke survivors require comprehensive care for risk factor modification and secondary prevention. Younger stroke survivors may have reduced access to physician care and medications because they are more frequently uninsured. OBJECTIVE To assess age-related differences in access to physician care and medications among stroke survivors (aged 45-64 years vs > or = 65 years). DESIGN National Health Interview Survey from years 1998 to 2002. SETTING A US pop ...
UNLABELLED BACKGGROUND: everyone has a personal story of an incident in which the healthcare system has caused harm to a family member, friend, or work colleague. In 2004, one in three Americans (34%) said that they or a family member had experienced a preventable medical error; among them, 21% said the error caused "serious health consequences" such as death (8%), long-term disability (11%) or severe pain (16%). DISCUSSION the information patients give is important and can be part of a strate ...
OBJECTIVE Based on the results of the X-ACT study, capecitabine has become one of the standard postoperative adjuvant chemotherapies for colon cancer. However, few studies of tolerability have been conducted in Japan. METHOD In this study, we retrospectively examined treatment continuation, and the adverse events that occurred during eight courses of postoperative adjuvant chemotherapy with capecitabine, in 34 patients with colon cancer who had undergone curative resection. RESULT The comple ...
STUDY OBJECTIVE To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging (fMRI) in patients with obstructive sleep apnea (OSA) and excessive sleepiness despite continuous positive airway pressure (CPAP) therapy. METHODS This 2-week, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United Sta ...
OBJECTIVE To compare the efficacy and tolerability of duloxetine 60mg/day versus placebo in treating elderly patients with major depressive disorder (MDD) and concurrent anxiety symptoms. METHODS Patients (>/=65) were randomized to eight weeks of treatment with duloxetine 60mg/day (n=207) or placebo (n=104). Anxiety measures were analyzed for all patients, by age (<75 and >/=75), and in patients having concurrent high anxiety (HAMD(17), item 10; Psychic Anxiety baseline score of 2, 3, ...
INTRODUCTION General practitioners are sometimes faced with adverse events, which we define here as "all untoward or unfortunate events occurring unintentionally during the provision of health care services, but also all such events related to any kind of intervention during care." While their social, economic, and health repercussions are often studied, little is known about their effects on general practitioners, except perhaps for their legal consequences. Our principal objectives here were t ...
PURPOSE To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) when added to one to three concomitant antiepileptic drugs (AEDs) in patients with uncontrolled partial-onset seizures. METHODS This multicenter, double-blind, placebo-controlled trial randomized patients (age 16-70 years) with partial-onset seizures with or without secondary generalization to placebo, lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week baseline, a 4-week titration, and a 12-w ...
OBJECTIVE To study the effect of weight loss in response to a lifestyle modification program on the circulating levels of adipose tissue derived cytokines (adipokines) in obese individuals with insulin resistance. RESEARCH METHODS AND PROCEDURES Twenty-four insulin-resistant obese subjects with varying degrees of glucose tolerance completed a 6-month program consisting of combined hypocaloric diet and moderate physical activity. Adipokines [leptin, adiponectin, resistin, tumor necrosis factor- ...
Background To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials. Objective To determine the efficacy and safety of FMT for treatment of recurrent CDI. Design Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494). Setting Two academic medical centers. Patients 46 patients who had 3 or more recurrences of CDI and received ...
Triapine® is a novel small molecule ribonucleotide reductase inhibitor that showed activity in renal cell carcinoma (RCC) cell lines. Evaluating new agents with novel mechanisms remains of interest for patients with incurable RCC. This was a single-arm, multicentre phase II trial where Triapine was given at a schedule of 96 mg/m2 2-h infusion daily × 4 repeated every 2 weeks in patients with recurrent RCC. A median of four cycles of Triapine was administered to 19 eligible patients. One ...