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One significant complication of hepatitis B virus includes reactivation (HBVr) in the context of the use of immunosuppressive agents, such as corticosteroids and rituximab, among others. Limited data exist on the topic of HBVr risk in the context of tyrosine kinase inhibitors for which there is no strong guidance recommendation. We describe the clinical characteristics, diagnostic challenges, and the clinical course of a single patient with recurrent mantle cell lymphoma who developed HBVr after treatment with acalabrutinib, a Bruton tyrosine kinase inhibitor.
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BACKGROUND: Current treatment guidelines for moderate to severe colitis (IMC) secondary to immune checkpoint inhibitors (ICI) recommend systemic corticosteroids as the primary therapy in conjunction with biologics, namely infliximab and/or vedolizumab. We aimed to explore the efficacy and safety of oral budesonide in the treatment of IMC. METHODS: We performed a retrospective analysis at MD Anderson Cancer Center of adult cancer patients with a confirmed (based on clinical, radiographic and laboratory assessment) diagnosis of IMC between 1 January 2015 and 31 November 2022, treated with budesonide. Data collection included demographics, oncologic history, IMC-related information and outcomes up to 6 months after the last dose of ICI. RESULTS: Our sample (n = 69) comprised primarily of Caucasian (76.8%) females (55.1%). The majority of patients received combination therapy with anti-PD-1/L1 and anti-CTLA-4 (49.3%), and the most common malignancy treated was melanoma (37.6%). The median grade of diarrhea was 3 and of colitis was 2. Of the 50 patients who underwent endoscopic evaluation, a majority had non-ulcerative inflammation (64%) and active colitis on histology (78%). Budesonide was used as primary treatment at onset of IMC in 56.5% patients, as well as a bridging therapy from systemic corticosteroids in 33.3%. Less than half of the patients (44.9%) required additional therapies such as biologics or fecal microbiota transplant. Additionally, 75.3% of patients achieved full remission of IMC and 24.6% had a recurrence of IMC. ICI was resumed in 31.9% of patients and 17.4% received other forms of cancer therapies. CONCLUSIONS: Budesonide may be an effective strategy to treat and prevent the recurrence of IMC. The remission rates observed in our analysis with budesonide alone are comparable to systemic corticosteroids. Patients that require an extended duration of steroid exposure and those with moderate to severe colitis may benefit from budesonide given its lower risk of infection and complications. Furthermore, we observe that budesonide may serve as a successful bridge from systemic corticosteroids with subsequent biologic treatment. Larger prospective studies are necessary to determine the role of budesonide as well as its safety profile.
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OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.
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Anticoagulantes , Veia Femoral , Veia Ilíaca , Síndrome Pós-Trombótica , Trombectomia , Trombose Venosa , Humanos , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Feminino , Masculino , Pessoa de Meia-Idade , Veia Femoral/diagnóstico por imagem , Veia Femoral/cirurgia , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/terapia , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Resultado do Tratamento , Trombectomia/efeitos adversos , Fatores de Tempo , Idoso , Fatores de Risco , Sistema de Registros , Adulto , Incidência , Modelos Logísticos , Pontuação de Propensão , Terapia Trombolítica/efeitos adversosRESUMO
In-stent thrombosis (IST) is a common venous stent complication. Acute IST warranting intervention can generally be treated with catheter-directed thrombolysis or aspiration thrombectomy. However, thrombosed stents often have chronic-appearing components that pose a significant treatment challenge as the thrombus firmly adheres to the stent and vessel wall and becomes resistant to thrombolytics and aspiration thrombectomy. Alternate treatment options such as venoplasty, stent relining, and medical management do not remove existing IST but rather remodel the lumen with limited long-term efficacy. This report details 2 cases of chronic-appearing IST successfully debulked with the novel RevCore Thrombectomy System. RevCore, designed to mechanically liberate acute to chronic IST via an expandable nitinol coring element, achieved substantial luminal gain and sustained patency in both patients.
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INTRODUCTION: This study analyzes the optimal biliary stenting strategy for palliation in cholangiocarcinoma (CCA). METHODS: This is a retrospective study of patients with CCA who underwent biliary drainage from 1997-2023. A per-patient analysis of percutaneous biliary drainage (PTBD) rates, the median number of ERCPs, overall survival (OS), and a per-procedure analysis of clinical success (CS), stent-specific Adverse Events (AEs), and mean time to reintervention by stent type and laterality (unilateral(u) & bilateral(b)) is presented. RESULTS: A total of 333 patients underwent 1,050 ERCPs; 85% with plastic stents (PS). PTBD was eventually done in 23% of PS patients, 35% of whom had PS removed prior to PTBD. ERCPs with SEMS/uniSEMS use had higher CS (89%/91%) vs PS/uPS (85% both) and PS within SEMS (PS-SEMS)/uPS-SEMS (71%/74%;p=0.013/p=0.054). Compared to PS, SEMS and PS-SEMS were associated with higher stent-specific AEs (OR SEMS 4.85; 3.23-7.27; PS-SEMS 9.99; 5.33-18.71;p<0.001). Straight PS were associated with more stent-specific AEs compared to double-pigtail stents (OR 6.74; 3.95-11.45;p<0.001). More 7 Fr stents were used in cases with balloon dilation (BD, 109 vs. 88 with no BD; p<0.001). BD had 79% CS rate vs 87% without BD (p<0.001). Cases with pus on ERCP and those with BD had a shorter mean time to reintervention. On regression analyses, higher Bismuth class, PS use, and PS-SEMS use were associated with a shorter mean time to repeat ERCP. 52% of patients in the bSEMS arm died from cholangitis (p=0.005). CONCLUSION: The relatively higher clinical success of SEMS is countered by the higher stent-specific complication rate. PS can be removed and may better facilitate PTBD. Within PS types, DPTs may have fewer stent-specific AEs. Cases requiring balloon dilation and with endoscopic evidence of pus may benefit from earlier reintervention.
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The human voice is an essential communication tool, but various disorders and habits can disrupt it. Diagnosis of pathological and abnormal voices is very important. Conventional diagnosis of these voice pathologies can be invasive and costly. Voice pathology disorders can be effectively detected using Artificial Intelligence and computer-aided voice pathology classification tools. Previous studies focused primarily on binary classification, leaving limited attention to multi-class classification. This study proposes three different neural network architectures to investigate the feature characteristics of three voice pathologies-Hyperkinetic Dysphonia, Hypokinetic Dysphonia, Reflux Laryngitis, and healthy voices using multi-class classification and the Voice ICar fEDerico II (VOICED) dataset. The study proposes UNet++ autoencoder-based denoiser techniques for accurate feature extraction to overcome noisy data. The architectures include a Multi-Layer Perceptron (MLP) trained on structured feature sets, a Short-Time Fourier Transform (STFT) model, and a Mel-Frequency Cepstral Coefficients (MFCC) model. The MLP model on 143 features achieved 97.1% accuracy, while the STFT model showed similar performance with increased sensitivity of 99.8%. The MFCC model maintained 97.1% accuracy but with a smaller model size and improved accuracy on the Reflux Laryngitis class. The study identifies crucial features through saliency analysis and reveals that detecting voice abnormalities requires the identification of regions of inaudible high-pitch sounds. Additionally, the study highlights the challenges posed by limited and disjointed pathological voice databases and proposes solutions for enhancing the performance of voice abnormality classification. Overall, the study's findings have potential applications in clinical applications and specialized audio-capturing tools.
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Most gastric cancers are adenocarcinomas, but other malignancies can arise in the stomach. Patients with leukemia may develop myeloid sarcoma (MS) in the gastrointestinal tract. Our patient was a 68-year-old woman who was initially diagnosed with acute myeloid leukemia and underwent a matched unrelated stem cell transplantation. She was in remission for 10 years before developing a rare case of gastric MS without acute myeloid leukemia. She had partial response to chemotherapy but ultimately died because of infection. Gastric MS has an incidence of less than 1%. Gastrointestinal involvement usually involves the small intestine and rarely the stomach.
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Background and Objective Respiratory Diseases are one of the leading chronic illnesses in the world according to the reports by World Health Organization. Diagnosing these respiratory diseases is done through auscultation where a medical professional listens to sounds of air in the lungs for anomalies through a stethoscope. This method necessitates extensive experience and can also be misinterpreted by the medical professional. To address this issue, we introduce an AI-based solution that listens to the lung sounds and classifies the respiratory disease detected. Since the research work deals with medical data that is tightly under wraps due to privacy concerns in the medical field, we introduce a Deep learning solution to classify the diseases and a custom Federated learning (FL) approach to further improve the accuracy of the deep learning model and simultaneously maintain data privacy. Federated Learning architecture maintains data privacy and facilitates a distributed learning system for medical infrastructures. Methods The approach utilizes Generative Adversarial Networks (GAN) based Federated learning approach to ensure data privacy. Generative Adversarial Networks generate new data by synthesizing new lung sounds. This new synthesized data is then converted to spectrograms and trained on a neural network to classify four lung diseases, Heart Attack and Normal breathing patterns. Furthermore, to address performance loss during FL, we also propose a new "Weighted Aggregation through Probability-based Ranking (FedWAPR)" algorithm for optimizing the FL aggregation process. The FedWAPR aggregation takes inspiration from exponential distribution function and ranks better performing clients according to it. Results and Conclusion A test accuracy of about 92% was achieved by the trained model while classifying various respiratory diseases and heart failure. Additionally, we developed a novel FedWAPR approach that significantly outperformed the FedAVG approach for the FL aggregate function. A patient can be checked for respiratory diseases using this improved learning approach without the need for extensive sensitive data recording or for making sure the data sample obtained is secure. In a decentralized training runtime, the trained model successfully classifies various respiratory diseases and heart failure using lung sounds with a test accuracy on par with a centralized model.
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Insuficiência Cardíaca , Doenças Respiratórias , Humanos , Sons Respiratórios , Algoritmos , ProbabilidadeRESUMO
PURPOSE: Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein. MATERIALS AND METHODS: The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated. RESULTS: All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs (P < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements. CONCLUSION: Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.
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Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Trombectomia/efeitos adversos , Veia Femoral , Seguimentos , Qualidade de Vida , Veia Ilíaca , Resultado do Tratamento , Grau de Desobstrução Vascular , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Terapia Trombolítica/efeitos adversosRESUMO
PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.
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Trombectomia , Trombose Venosa , Humanos , Trombectomia/efeitos adversos , Resultado do Tratamento , Estudos Prospectivos , Qualidade de Vida , Terapia Trombolítica , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Trombose Venosa/etiologia , Sistema de Registros , Veia Ilíaca , Estudos RetrospectivosRESUMO
Background: We report in-hospital outcomes from the multicenter, prospective, single-arm ClotTriever Outcomes (CLOUT) registry, which enrolled up to 500 patients with proximal lower extremity deep vein thrombosis (DVT) treated with percutaneous mechanical thrombectomy using the ClotTriever System (Inari Medical). Methods: The CLOUT registry enrolled all-comer patients with DVT, irrespective of symptom duration, thrombus age, prior treatment of the current DVT, or bilateral thrombus. The primary effectiveness end point was defined as complete or near complete (≥75%) reduction in Marder score. Thrombus burden was assessed by an independent core laboratory. Mortality and serious adverse events, including device-relatedness, were adjudicated by an independent medical monitor. Here, safety and outcomes are evaluated through discharge. Results: The median age was 61.9 years (IQR, 48.0-70.8), 50.5% were women, 24.9% had a history of DVT, and 23.2% had previously failed treatment of the current DVT. Nearly all procedures (99.4%) were performed in a single session with negligible procedural blood loss (median 40.0 mL; IQR, 20.0-50.0), and most patients (97.8%) required no subsequent intensive care unit monitoring. The primary effectiveness end point was achieved in 91.2% of limbs. Through discharge, 1 device-related serious adverse event (0.2%) occurred. Health status, as assessed by self-reported pain and circumferential measurements of limb edema, were significantly improved at discharge. Conclusions: Thrombectomy with the ClotTriever System is a safe and effective treatment for proximal lower extremity DVT, while also avoiding the need of intensive care. Early patient improvements are demonstrated, and follow-up is ongoing to 2 years.
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OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.
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Síndrome Pós-Flebítica , Síndrome Pós-Trombótica , Trombose Venosa , Fibrinolíticos , Humanos , Veia Ilíaca , Pessoa de Meia-Idade , Dor/etiologia , Síndrome Pós-Flebítica/etiologia , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Estudos Prospectivos , Qualidade de Vida , Sistema de Registros , Estudos Retrospectivos , Trombectomia/efeitos adversos , Trombectomia/métodos , Terapia Trombolítica , Resultado do Tratamento , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/cirurgiaRESUMO
This paper first explores spatial distributions and patterns of COVID-19 case rates (cases/100,000 people) and mortality rates (deaths/100,000 people) and their disparities between urban and rural counties in the contiguous US. A county-level social vulnerability index was created using principal component analysis. Social vulnerability components were regressed against both county case and mortality rates. Results suggest that hotspots of case and mortality rates are clustered in Midwest and Upper-Midwest US. We found substantial disparities in case and mortality rates between urban and rural counties. County social vulnerability was positively correlated with both case and mortality rates suggesting counties with higher social vulnerability had higher case and mortality rates. Relationships between social vulnerability components and case and mortality rates vary across the conterminous US. Additionally, counties with increased racial and ethnic minorities, higher percentages of minors, and lower median household income are associated with higher COVID-19 case and mortality rates.
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COVID-19 , Pandemias , Estados Unidos/epidemiologia , Humanos , COVID-19/epidemiologia , População Urbana , Vulnerabilidade Social , População RuralRESUMO
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in diabetics. However, it is not the sole cause of chronic liver disease in diabetics. We present a case of an 18-year-old male with poorly controlled type I diabetes mellitus who presented for evaluation of asymptomatic elevated liver chemistries. An extensive autoimmune, metabolic, and infectious workup was unrevealing. Liver biopsy was consistent with glycogenic hepatopathy without evidence of steatosis or fibrosis. Increased glycemic control led to his liver enzymes trending down. In conclusion, glycogenic hepatopathy should be considered in poorly controlled type 1 diabetics with elevated liver chemistries.
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INTRODUCTION: Although opioids are widely used for pain management in acute pancreatitis, the impact of opioid use disorder (OUD) on outcomes in patients with acute pancreatitis remains unknown. In the current study, we aimed to evaluate the impact of the OUD on outcomes in patients hospitalized with acute pancreatitis and delineate the trends associated with OUD and acute pancreatitis using a nationally representative sample. METHODS: This is a retrospective cohort study of patients with acute pancreatitis using the combined releases of the year 2005-2014 of the National (Nationwide) Inpatient Sample (NIS) database. Patients over the age of 18 years with a principal diagnosis of acute pancreatitis were divided into cohorts of patients with opioid use disorders and those without. The primary measured outcome was in-hospital mortality and secondary outcomes were healthcare utilization measures, including length of stay (LOS) and hospitalization costs. RESULTS: A total of 2 593 831 hospitalizations of acute pancreatitis were included; of which, 37 849 (1.46%) had a secondary diagnosis of OUD. Total acute pancreatitis-related hospitalizations increased from 237 882 in 2005 to 274 006 in 2014. At the same time prevalence of OUD in acute pancreatitis patients also increased from 1 to 2.1%. Patients with OUD had significantly increased mortality as compared to patients without OUD (aOR: 1.4; P < 0.001). At the same time, acute pancreatitis patients with OUD were associated with 1.3 days longer LOS as compared to other acute pancreatitis patients (P < 0.001]. The mean adjusted difference in total hospitalization costs was $2353 (P < 0.001). CONCLUSION: OUD is associated with a significant increase in LOS, healthcare utilization cost and in-hospital mortality in patients admitted for acute pancreatitis. Therefore, clinicians should exercise caution in prescribing opioid medications to this high-risk patient population and other modalities such as nonopioid pain medications should be tried as alternatives to opioid analgesics.
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Transtornos Relacionados ao Uso de Opioides , Pancreatite , Doença Aguda , Adulto , Analgésicos Opioides/efeitos adversos , Humanos , Pessoa de Meia-Idade , Pancreatite/diagnóstico , Pancreatite/epidemiologia , Estudos RetrospectivosRESUMO
Approximately 20% of patients with newly diagnosed colorectal cancer present with distant metastatic disease. Brain metastasis from colorectal cancer is uncommon and usually associated with metachronous metastases in other organs. We describe a rare case of a 49-year-old patient presenting with headaches and left-sided weakness found to have a solitary brain metastasis from primary rectal cancer. Primary rectal cancer, young age, lung and liver metastases, and KRAS mutation are risk factors associated with brain metastases in patients with colorectal cancer. Intracranial imaging should be considered as part of the workup in the staging of colorectal cancer in patients who are at high risk of brain metastasis.
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INTRODUCTION: Anxious patients can cause unexpected increases in healthcare costs that are often overlooked. There are no studies examining the use of an educational pamphlet and its effects on secondary outcomes at colonoscopy. The goal of this study was to determine if the use of an educational pamphlet lowers the anxiety levels before colonoscopy, and if its use has any effect on the quality of the prep or medication or the amount of medication use during the procedure. METHODS: We prospectively enrolled 121 patients having a first-time screening colonoscopy. Patients were blinded and randomized into two groups. One group received standard prep instructions only (group P), and the other group received the American Gastroenterological Association colonoscopy educational pamphlet along with their prep instructions (group I). All information was sent by mail 3 weeks before the procedure. The endoscopists were blinded as to which of their patients were in the study and of those, which were in the standard prep group or the intervention group. Anxiety was measured immediately before endoscopy using the State portion of the 'State Trait Anxiety Index'. Procedure-related information was recorded and analyzed at the end of the study using a statistical package looking at primary and secondary endpoints. RESULTS: Fifteen patients did not show their examination or were otherwise lost to follow-up. Of the 106 patients who completed the study, there were 55 patients in the P group and 51 in the I group. The average State Anxiety score of the P group was 45.18, and of the I group was 40.54 (P=0.014). The use of Midazolam was significantly less in the group. The use of Meperidine was lower in the I group but the difference was not statistically significant. Both the groups took the same amount of time to complete the prep, but the I group fasted longer. The I group also completed or drank more of the prep more often than the P group. The prep quality was found to be superior with less frequency of a poor prep in the I group. Most important, the I group was more likely to have a complete colonoscopy. The I group tended to have fewer questions on the day of the procedure, and less fear about what to expect on the basis of their lower anxiety scores. CONCLUSION: We found that providing the American Gastroenterological Association educational pamphlet to patients before colonoscopy lowers the overall anxiety level, provides a reduction in sedative use during the procedure, and leads to better colon preparation when given in addition to standard instructions.