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Diagnostic Yield and Safety of Bronchoscopic Lung Cryobiopsy in Evaluation of Lung Mass.

Background A mass lesion in the lung is a common finding seen on chest radiology. The prognosis of patients with mass lesions in the lung is … defined as a positive tissue diagnosis after the histopathological examination (HPE) along with the safety of the procedure. Results During the above period, we evaluated 70 patients who were diagnosed radiologically with mass lesions of the lung and underwent BLC. We obtained tissue diagnoses for 66 cases and the result of four cases was inconclusive. T …

A Narrative Review of Pharmacologic Treatments for COVID-19: Safety Considerations and Ototoxicity.

OBJECTIVE/HYPOTHESIS: The purpose of this review is to summarize evidence-based data regarding the ototoxic effects of potential COVID-19 therapeutics to treat patients suffering from SARS-CoV-2. METHODS: Medications under investigation as novel therapeutics to treat COVID-19 were identified using the search term coronavirus therapeutics, COVID therapeutics, and SARS-CoV-2 therapeutics on ClinicalTrials.gov and the PubMed Database. A literature review was performed using the PubMed Database for each proposed COVID-19 therapeutic to identify relevant articles. Search criteria included Medical

Evaluation of the safety and efficacy of AdvaxTM as an adjuvant: A systematic review and meta-analysis.

PURPOSE: Developing a vaccine with improved immunogenicity is still a growing priority for many diseases. Different types of adjuvants may be beneficial to initiate and maintain the long-lasting immunogenicity of vaccines. Evidence has shown that polysaccharide adjuvants are efficient in improving immunological mechanisms with their biocompatibility and biodegradability characteristics. In this study, we aimed to investigate the safety and efficacy of AdvaxTM an adjuvant derived from delta inulin. METHODS: A systematic research was performed in Pubmed, Web of Science, and Scopus databases for…

Re-evaluation of the Cardiovascular Safety Profile of Tegaserod: A Review of the Clinical Data.

BACKGROUND AND AIMS: Tegaserod is a 5-HT4 receptor agonist approved for irritable bowel syndrome with constipation in women <65 years of age without a history of cardiovascular ischemic events. Safety data are presented from 2 external adjudications from the 2018 Gastrointestinal Drugs Advisory Committee meeting supporting tegaserod's reintroduction after its voluntary 2007 withdrawal. Withdrawal was based on an internal adjudication using pooled placebo-controlled tegaserod data to identify potential cardiovascular ischemic signals. METHODS: An independent committee conducted an external adj…

Characterization of a hepatitis a outbreak in underserved urban tertiary safety net hospitals.

Outbreaks of Hepatitis A, caused by the Hepatitis A Virus (HAV), remain a worldwide health concern. We conducted a retrospective chart review to characterize patients with acute HAV during an outbreak at our urban tertiary care center to better characterize patients infected with HAV. We searched our electronic records for patients with positive HAV IgM antibodies during a period of outbreak in Philadelphia, May 2017-December 2019. Characteristics of patients were recorded. We searched an equal period of time prior to the outbreak, September 2014-April 2017, to compare the two patient populati

Safety and Feasibility of Home Transfusions in Pediatric Palliative Care: A Preliminary Report.

BACKGROUND: While hematological symptoms are considered difficult to manage in a Pediatric Palliative Care setting, home may still represent a safe and convenient place for transfusions in patients with advanced malignancy or chronic conditions. This research focuses on the safety and feasibility of a home transfusion program. METHODS: This is a case series of patients between 0 and 18 years diagnosed with advanced malignancy or incurable chronic conditions and eligible to Pediatric Palliative Care who received home platelet or packed red cell transfusions. For all patients, we recorded adver…

Evaluation of an Interprofessional Training Program to Improve Cancer Drug Therapy Safety.

PURPOSE: Drug therapy for cancer is a high-risk, high-volume clinical intervention that requires interprofessional teams. Given the complexity of anticancer drug therapy and safety concerns, an interdisciplinary team developed a novel training program for oncology registered nurses and pharmacists to improve cancer drug safety. METHODS: Participants completed preworkshop learning assessments and received access to web-based modules on six topics: hazardous drug handling, drug extravasation, hypersensitivity reaction management, sepsis recognition, immune checkpoint inhibitor toxicities, and o…

Radiation safety and knowledge: an international survey of 708 interventional pain physicians.

INTRODUCTION: Interventional pain procedures have increased in complexity, often requiring longer radiation exposure times and subsequently higher doses. The practicing physician requires an in-depth knowledge and evidence-based knowledge of radiation safety to limit the health risks to themselves, patients and healthcare staff. The objective of this study was to examine current radiation safety practices and knowledge among interventional pain physicians and compare them to evidence-based recommendations. MATERIALS AND METHODS: A 49-question survey was developed based on an extensive review …

Country-based report: the safety of omalizumab treatment in pregnant patients with asthma.

BACKGROUND/AIM: We aimed to report outcomes of pregnant patients with asthma under omalizumab treatment and their infants in our country. MATERIALS AND METHODS: Patients with asthma who received omalizumab for at least 6 months and at least one dose during their pregnancy were retrospectively evaluated using a questionnaire regarding their disease and therapy and the health of their infants. RESULTS: Twenty pregnant patients and their 23 infant’s data were analyzed. The mean delivery age was 31.8 ± 7.4 years. They received omalizumab for 28.9 ± 21.8 months. Eight (36.4%) patients showed exac

Belantamab Mafodotin for the Treatment of Multiple Myeloma: An Overview of the Clinical Efficacy and Safety.

Despite the introduction of immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), and, more recently, monoclonal antibodies (mAbs), in the chemotherapy regimens for newly diagnosed (NDMM) and relapsed/refractory MM (RRMM), the occurrence of drug resistance remains a challenge in MM patients. This is mainly in the advanced stage of the disease when treatments are limited, and the prognosis is abysmal. Nevertheless, novel molecules and therapeutic approaches are rapidly moving through the several phases of drug development and could address the need for new treatment options. The recent i

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… This review will focus on Belamaf, describing its mechanism of action, pharmacokinetics, and available clinical data on their safety and efficacy. … This international study comprised a Part 1, a dose-escalation phase assessing the safety and tolerability of Belamaf and recommended phase II dose (RP2D) and a Part 2, dose-expansion phase, evaluating safety and tolerability pharmacokinetics, and clinical activity. …

A data mining approach to deriving safety policy implications for taxi drivers.

INTRODUCTION: Traffic safety issues associated with taxis are important because the frequency of taxi crashes is significantly higher than that of other vehicle types. The purpose of this study is to derive safety implications to be used for developing policies to enhance taxi safety based on analyzing intrinsic characteristics underlying the cause of traffic accidents. METHOD: An in-depth questionnaire survey was conducted to collect a set of useful data representing the intrinsic characteristics. A total of 781 corporate taxi drivers participated in the survey in Korea. The proposed analysi…

The Cost Burden of Safety Risk Incidents on Construction: A Probabilistic Quantification Method.

The construction sector is vulnerable to safety risk incidents due to its dynamic nature. Although numerous research efforts and technological advancements have focused on addressing workplace injuries, most of the studies perform empirical and deterministic postimpact evaluations on construction project performance. The effective modeling of the safety risk impacts on project performance provides decisionmakers with a valuable tool toward incidents prevention and proper safety risk management. Therefore, this study collected Australian incident records from the construction industry from 2016…

[Efficacy and safety of bulevirtide in patients with chronic hepatitis D and compensated cirrhosis].

AIM: To study the efficacy and safety of bulevirtide, the HBV and HDV entry inhibitor. MATERIALS AND METHODS: Analysis of the results of using bulevirtide in randomized controlled open-label comparative studies MYR202 and MYR203 in 56 patients with chronic hepatitis D and compensated cirrhosis, in monotherapy and combination with pegylated interferon alpha-2a (PEG-IFN). RESULTS: Monotherapy with bulevirtide for 24 weeks in the MYR202 study in 46 patients with compensated liver cirrhosis demonstrated: 1) a high rate of virological (100%) and biochemical response (alanine aminotransferase norm…

Efficacy and safety of clozapine in psychotic disorders-a systematic quantitative meta-review.

A recent increase in the literature regarding the evidence base for clozapine has made it increasingly difficult for clinicians to judge "best evidence" for clozapine use. As such, we aimed at elucidating the state-of-the-art for clozapine with regard to efficacy, effectiveness, tolerability, and management of clozapine and clozapine-related adverse events in neuropsychiatric disorders. We conducted a systematic PRISMA-conforming quantitative meta-review of available meta-analytic evidence regarding clozapine use. Primary outcome effect sizes were extracted and transformed into relative risk r

The Safety Factor for Neuromuscular Transmission: Effects of Dimethylsulphoxide, Cannabinoids and Synaptic Homeostasis.

BackgroundIn myasthenia gravis, impaired postsynaptic sensitivity to acetylcholine results in failure of neuromuscular transmission and fatiguing muscle weakness.ObjectiveDevelop an ex vivo muscle contraction assay to test cannabinoids and other substances that might act on the myasthenic neuromuscular junction to restore control of the muscle.MethodsTubocurarine was added to an ex vivo, mouse phrenic nerve-hemidiaphragm muscle preparation to reduce acetylcholine sensitivity. This produced a myasthenia-like decrement in twitch force during a train of 10 nerve impulses (3 / sec). Endplate poten

A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss.

INTRODUCTION: The Orbera365 is a new balloon that can stay in the stomach for up to 12 months. The aim of this study is to investigate the safety and effect of Orbera365. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of Orbera365 in the period between September 2019 and August 2020. The patients were followed up to assess, pain, nausea, and vomiting after procedure, weight loss, and the complication rate. RESULTS: A total of 97 patients underwent Orbera365 placement. Mean weight and BMI before the procedure were 93.8 ± 15…

Natural history of postpartum hematocrit recovery in an urban, safety-net population.

BACKGROUND: Postpartum anemia is common after delivery, and postpartum blood transfusion is the leading indicator of severe maternal morbidi … stpartum follow-up. Our population was composed of a predominantly Hispanic population at an urban, safety-net hospital. All women received a complete blood count on postpartum day 1 and a spun hematocrit at their postpartum follow-up visit in our hospital system. All women were scheduled for a routine postpartum visit 2 to 3 weeks after delivery. All de …

Safety and Success of Lumbar Puncture in Young Infants: A Prospective Observational Study.

Objective: This study aims to evaluate safety and success rates of lumbar puncture (LP) and to identify factors associated with adverse events or failure of LP in infants. Methods: This two-center prospective observational study investigated infants younger than 90 days of age who underwent LP. Need for resuscitation oxygen desaturation (SpO2 < 90%), bradycardia and intraventricular hemorrhage were considered adverse events. LP failed if cerebrospinal spinal fluid was not collected or had traces of blood. Logistic regression analysis was used to evaluate whether corrected gestational age (GA),…

Safety and Outcomes of Dentate Nucleus Deep Brain Stimulation for Cerebellar Ataxia.

Cerebellar symptoms remain orphan of treatment options despite being prevalent and incapacitating. Investigate whether dentate nucleus deep … of Ataxia (SARA) after the active compared to the sham period. Secondary outcome measures included safety and tolerability, the Fahn-Tolosa-Marin Tremor Rating Scale (FTMRS), quality of life measurements, and patients' global impression of change. The effects on ataxia were numerically better in four out of five patients after active versus sham stimula …

Safety and heart rate changes in Covid-19 patients treated with Remdesivir.

OBJECTIVES: Limited data are available regarding the occurrence and the extent of cardiac rhythm disturbances in patients with COVID-19 treated with Remdesivir. METHODS: We present a case series of 52 patients who underwent daily electrocardiogram (ECG) examination after Remdesivir administration. RESULTS: Compared to baseline, a significant heart rate reduction was observed after initiation of Remdesivir; however, no case of severe bradycardia or arrhythmias leading to significant clinical complications or Remdesivir discontinuation occurred. Heart rate reduction was proportional to baselin