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738 results for “Adverse events”
Supplementary file 20 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 20: Proportion of participants on methylphenidate with fingernail biting</p>
Supplementary file 73 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 73: Proportion of participants on methylphenidate with nasopharyngitis</p>
Supplementary file 28 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 28: Proportion of participants on methylphenidate with emotional lability</p>
Supplementary file 71 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 71: Proportion of participants on methylphenidate with gastroenteritis</p>
Supplementary file 34 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 34: Proportion of participants on methylphenidate with irritability </p>
Supplementary file 67 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 67: Proportion of participants on methylphenidate with nausea </p>
Outcomes and adverse events of pre- and extensively drug-resistant tuberculosis patients in Kinshasa, Democratique Republic of the Congo: retrospective cohort study
<p><strong>Abstract</strong></p> <p><strong>Background</strong>: Extensively drug-resistant tuberculosis (XDR TB) is a very serious form of tuberculosis that is burdened with a heavy mortality toll, especially before the advent of new TB drugs. The Democratic Republic of the Congo (DRC) is among the countries most affected by this new epidemic.</p> <p><strong>Methods:</strong> A retrospective analysis was performed of the records of all patients with pre- and extensively drug-resistant tuberculosis hospitalized from January 1, 2015 to December 31, 2017 and monitored for at least 6 months to one year after the end of their treatment in Kinshasa; an individualized therapeutic regimen with bedaquiline for 20 months was built for each patient. The adverse effects were systematically monitored.</p> <p><strong>Results:</strong> Of the 40 laboratory-confirmed patients, 32 (80%) patients started treatment, including 29 preXRB and 3 XDR TB patients. In the eligible group, 3 patients (9.4%) had HIV-TB coinfections. The therapeutic success rate was 53.2%, and the mortality rate was 46.8% (15/32); there were no relapses, failures or losses to follow-up. All coinfected HIV–TB patients died during treatment. The cumulative patient survival rate was 62.5% at 3 months, 53.1% at 6 months and 53.1% at 20 months. The most common adverse events were vomiting, Skin rash, anemia and peripheral neuropathy.</p> <p><strong>Conclusion: </strong>Bedaquiline based treatment improves patient survival in the DRC despite the still high mortality rate. The new anti-tuberculosis<br> drugs are a real hope for the management of Drug Resistant tuberculosis patient and other new therapeutic combinations may improve favorable outcomes.</p>
The Impacts of Increased Adverse Weather Events on Freight Movement
<p>Freight transportation is a major economic backbone of the United States and is vital to sustaining the nation’s economic growth. Ports, as one of the primary components of freight transportation and important means of integrating into the global economic system, have experienced significant growth and increased capacity during the past two decades. The study addresses an important national freight mobility goal to enhance the resilience of the port transportation operations in the event of extreme weather events. This study develops an adaptable resilience assessment framework that evaluates the impact of a disruptive event on transportation operations. The framework identifies dynamic performance levels over an extended period of an event including five distinct phases of responses- staging, reduction, peak, restoration, and overloading. This study applies the framework to the port complex in Houston, Texas, during a major hurricane event, Harvey, and two holiday events in 2017. The framework evaluates proactive and reactive responses of port truck activities during the disruptions and provides a comprehensive assessment of resilience and adaptability in port truck operations. Evaluating response systems and resilience of port truck activities during severe weather events such as Hurricane Harvey represents the first step for designing plans that support a fast system recovery that minimizes the economic, social, and human impacts.</p>
Content Validity and Reliability of the Italian Language Version of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
<p><strong>ABSTRACT </strong></p> <p><strong>Introduction: </strong>The US National Cancer Institute’s (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE<sup>®</sup>) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and evaluate content validity and reliability in a diverse sample of Italian-speaking patients.</p> <p><strong>Methods: </strong>All PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was examined and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was evaluated in a second sample (n=135).</p> <p><strong>Results: </strong>Four rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94).</p> <p><strong>Discussion: </strong>Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary evidence of content validity and reliability.</p>
Imaging mass cytometry analysis of brain tissues with CNS immune-related adverse events during anti-PD-1 cancer immunotherapy
<p><span>Dataset accompanying the manuscript "Anti-PD-1 cancer immunotherapy induces CNS immune-related adverse events by Spleen tyrosine kinase activation in microglia".</span></p> <p><span>The Metadata.xls file includes the metadata, the raw image data is saved as .txt file, the segmented cellular expression data is available as csv files. </span></p>
Supplementary file 15 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 15: Proportion of participants withdrawn from methylphenidate treatment due to hallucinations</p>
Supplementary file 45 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 45: Proportion of participants on methylphenidate with somnolence </p>
Supplementary file 53 in Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of possible adverse events in non-randomised studies
<p>Supplementary file 53: Proportion of participants on methylphenidate with cough</p>
Adverse childhood events and clinical manifestation of anxiety symptoms in Greek adolescents during COVID-19 pandemic
<p><strong>Background: </strong>Adverse Childhood Experiences (ACEs) are linked to the development of Anxiety in Adolescence. According to recent studies, the pandemic COVID-19 is a novel ACE that has increased Anxiety among adolescents. This study aims to investigate the relationship between Adverse Childhood Experiences (ACEs) and COVID-19 in the development of Anxiety in Adolescence. <strong>Methods: </strong>A cross-sectional study with a community sample of 248 boys and girls aged 12 to 15 years (Mean: 13.50 years) from five High Schools in Eastern Attica were conducted. A total of four questionnaires were used: 1) Demographic Questionnaire, 2) State-Trait-Anxiety-Inventory for Children – STAIC, 3) Adverse Childhood Experiences Scale, and 4) COVID-19 Impact Scale. <strong>Results: </strong>The results demonstrated a strong correlation between the total number of adverse childhood experiences (ACEs) and Anxiety (Trait and State) in adolescence (Trait Anxiety: rho=.37, p0.001; State Anxiety: rho=.29, p0.001). Girls scored substantially higher on Trait Anxiety (U = 4353, p 0.001) and State Anxiety (U = 5822.5, p = 0.014) than boys. Girls also demonstrated more significant Anxiety than boys. The number of adverse childhood experiences was found to be significantly related to the impact of COVID-19 (=0.025, p 0.001). <strong>Conclusions: </strong>The present study's findings can be used to design and implement future effective, preventive, and therapeutic programs for adolescents with anxiety symptoms who were exposed to a variety of Adverse Childhood Experiences and the COVID-19 pandemic during their adolescence.</p>
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overw
ClinicalTrials.gov study NCT02019264. IPD Sharing: Not stated. Countries: 8. Publications: 4.
Sertraline and the Risk of Serious Adverse Events
ClinicalTrials.gov study NCT07387120. IPD Sharing: NO. Countries: 1. Publications: 1.
Pramipexole and the Risk of Serious Adverse Events
ClinicalTrials.gov study NCT07382960. IPD Sharing: NO. Countries: 1. Publications: 4.
Surveillance for Adverse Events Following Influenza Immunization
ClinicalTrials.gov study NCT01318876. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
ClinicalTrials.gov study NCT05264129. IPD Sharing: YES. Countries: 1. Publications: 0.
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
ClinicalTrials.gov study NCT03518034. IPD Sharing: NO. Countries: 2. Publications: 6.
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