bluuebunny/crossref_metadata_2025_split huggingface dataset:
Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5
Authors: Huang Feng , Sun Fei , Wan Wei-Guo , Wu Li-Jun , Dong Ling-Li , Zhang Xiao , Kim Tae-Hwan , Sengupta Raj , Šenolt Ladislav , Wang Yi , Qiu Hao-Min , Porter Brian , Haemmerle Sibylle 
Published: September 2020

Abstract

Background
Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study.

Methods
MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China).

Results
Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52.

Conclusions
Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations.

Trial registration
ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1.
Multi-center investigation of the clinical and pathological characteristics of inflammatory breast cancer based on Chinese Society of Breast Surgery (CSBrs-007)
Authors: Zhou Qi , Zhang Hai-Ping , Zhao Ya-Ting , Wang Xiao-Hong , Xiong Wei , Liu Yun-Jiang , Zhang Jing-Hua 
Published: September 2020

AbstractBackgroundInflammatory breast cancer (IBC) is an aggressive type of cancer with poor prognosis and outcomes. This study aimed to investigate clinicopathological features, molecular characteristics, and treatments among Chinese patients diagnosed with IBC.MethodsWe collected data of 95 patients with IBC who were treated by members of the Chinese Society of Breast Surgery, from January 2017 to December 2018. The data, including demographic characteristics, pathological findings, surgical methods, systemic treatment plans, and follow-up, were obtained using a uniform electronic questionnaire. The clinicopathological features of different molecular types in patients without distant metastases were compared using the Kruskal-Wallis (H) test followed bypost hocanalyses.ResultsLymph node metastasis was noted in 75.8% of all patients, while distant metastasis was noted in 21.4%. Pathological findings indicated invasive ductal and lobular carcinomas in 86.8% and 5.3% of cases, respectively. Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) (41.5%) and HR−/HER2+ (20.1%) were the most common biologic subtypes, followed by HR+/HER2+ (19.1%) and HR−/HER2− (19.1%). Stage III IBC was treated via pre-operative neoadjuvant chemotherapy in 87.7% of the cases, predominantly using anthracycline and taxanes. A total of 91.9% of patients underwent surgical treatment. Among them, 77.0% of the patients underwent modified radical mastectomy, 8.1% of whom also underwent immediate breast reconstruction. The Kruskal-Wallis test revealed that the efficacy of chemotherapy significantly differed among those with HR+/HER2− and HR−/HER2− tumors (adjustedP = 0.008), and Ki-67 expression significantly differed in HR−/HER2+ and HR+/HER2+ molecular subtypes (adjustedP = 0.008).ConclusionOur study provides novel insight into clinicopathological characteristics and treatment status among patients with IBC in China, and might provide a direction and basis for further studies.Trial registrationchictr.org.cn, No. ChiCTR1900027179; http://www.chictr.org.cn/showprojen.aspx?proj=45030
Incidental Coronary Artery Calcium on Breast Radiation Therapy Planning Scans Identifies Patients for Cardiac Preventive Therapy
Authors: Amin Neha P. , Kim Samuel M. , Lasio Giovanni , Zhou Jinghao , Romar Linda , Shipman Kalin , Dukes Kelly , Amin Nivee P. 
Published: September 2020

Purpose/Objective(s):
The presence of coronary artery calcium (CAC>0) is associated with increased cardiac-related mortality and is a common indication to initiate statin therapy to prevent future long-term cardiac-related adverse events. CAC is also well visualized on noncontrast chest computed tomography simulation (CT sim) scans used for breast radiation planning. We hypothesize that by screening for incidental CAC on CT sims, radiation oncologists could help identify patients who may benefit from additional preventive medical interventions with their primary care physician or cardiologist.

Methods:
A retrospective analysis of 126 consecutive patients with breast cancer treated with external beam radiation therapy at a single institution was performed. Noncontrast CT sim scans were reviewed for the presence of CAC and the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) was calculated to identify patients who may benefit from initiating statin therapy. Patients with CAC>0 and/or ASCVD risk >20% were identified as those who may benefit from statin therapy.

Results:
Out of 72 patients with CAC>0, only 12(16%) had reported pre-existing coronary artery disease and 32(44%) were not already on recommended statin therapy. CAC>0 visualized on CT sim was able to identify 29 additional patients who would benefit from statin beyond what the ASCVD risk calculator could identify.

Conclusion:
Observation of incidental CAC on breast radiation-planning CT scans identified patients who could benefit from cardiac-related preventive strategies. By increasing attention, awareness, and reporting of incidental CAC visible on CT sims, radiation oncologists may fulfill a unique role to bridge a potential gap in cardiovascular preventive medicine.
Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an Intensive Care Units Admission for COVID-19 (OPTImAL)—A Protocol for a Single Center Prospective Study
Authors: Mayer Kirby P. , Steele Angela K. , Joshi Rajan R. , Soper Melissa K. , Dupont-Versteegden Esther E. , Morris Peter E. , Montgomery Ashley A. , Parry Selina M. 
Published: September 2020

Purpose:
Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance leading to limited physical function. Early data from the COVID-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Patients with COVID-19 that survive an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to prehospital level of function. The primary aim of this study is to evaluate the safety and feasibility of providing combined ICU aftercare (ICU Recovery Clinic) and 8 weeks of physical therapy treatment for patients surviving an admission to ICU for COVID-19. The secondary aims will be to explore trends of effect on physical, mental, and cognitive recovery as well as the impact on return to work, readmission rates, and mortality.

Methods:
This is a protocol to describe a single-center, prospective phase I feasibility study in patients surviving ICU admission for COVID-19. We hypothesize that this novel combination is (1) feasible to provide for patients surviving COVID-19, will (2) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical Battery, and (3) reduce incidence of anxiety, depression, and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised. Safety will be assessed based on occurrence of adverse events and feasibility will be measured by adherence and attrition. Repeated measures analysis of variance will be used to assess change in outcomes from baseline to 3- and 6-months after institutional discharge.

Results:
We present the protocol of this study that has already received ethics approval at the University of Kentucky with enrollment commenced on May 1, 2020. Conclusions: The results of this study will support the feasibility of providing ICU follow-up treatment and physical therapy treatment for patients surviving critical illness for COVID-19 and will assess the effectiveness. We plan to disseminate study results in peer-reviewed journals as well as presentation at physical therapy and critical care national and international conferences.
Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function
Authors: Georgiadis Paige L. , Vlassakov Kamen V. , Patton Megan E. , Lirk Philipp B. , Janfaza David R. , Zeballos Jose L. , Quaye Aurora N. , Patel Vijay , Schreiber Kristin L. 
Published: September 2020

BACKGROUND
The ultrasound-guided retroclavicular block (RCB) is a recently described alternative approach to brachial plexus blockade at the level of the cords. Although more distal blockade of the brachial plexus is thought to be associated with a lower incidence of phrenic nerve block, the impact of RCB on ipsilateral diaphragmatic function has not been formally investigated.

OBJECTIVE
To compare the effects of supraclavicular and retroclavicular brachial plexus block on diaphragmatic function.

SETTING
A single tertiary hospital, study period from December 2017 to May 2019.

DESIGN
Double-blinded, randomised study.

PATIENTS
A total of 40 patients undergoing upper extremity surgery below the axilla. Exclusion criteria included significant pulmonary disease, BMI more than 40 and contra-indication to peripheral nerve block.

INTERVENTIONS
Patients were randomised to supraclavicular or retroclavicular brachial plexus block with ropivacaine 0.5%.

OUTCOME MEASURES
Phrenic block was assessed by measuring changes in diaphragmatic excursion using M-mode ultrasound, and maximum inspiratory volume on incentive spirometry from baseline, at 15 and 30 min postblock, and postoperatively. Comparative assessment of block characteristics included timing and distribution of sensory and motor block onset in the upper extremity, and scanning and block performance times.

RESULTS
The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001). There was no difference in timing and extent of distal arm block, but suprascapular and axillary nerves were more consistently blocked after SCB than after RCB.

CONCLUSION
The current study confirms the hypothesis that a RCB is significantly less likely to affect ipsilateral diaphragmatic function than a SCB.

TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT02631122.
Appropriateness of the Direct Oral Anticoagulants Dosing in the Middle East Gulf Region
Authors: Anouassi Zohour , Atallah Bassam , Alsoud Leen Oyoun , El Nekidy Wasim , Al Mahmeed Wael , AlJaabari Mohamed , Almuti Khalid 
Published: September 2020

Abstract:
Direct oral anticoagulants (DOACs) have proven efficacy to prevent cardioembolic strokes. Data are scarce about the appropriateness of DOAC dosing in the Middle East. We investigated the prevalence of inappropriate DOAC dosing in the region. A cross-sectional study was conducted at our hospital between April 2015 and February 2019 of patients receiving 1 of the 3 available DOACs. Patients with incomplete data sets, those prescribed DOACs for indications other than atrial fibrillation, on DOACs for <30 days, and dialysis patients were excluded. A total of 608 met the inclusion criteria. The mean age was 65.2 ± 13.9 years, and most were men (58.6%). The mean CHA2DS2-VASc score was 3.8 ± 2.0. There were 346 (56.9%) on apixaban, 123 (20.2%) on dabigatran, and 139 (22.9%) on rivaroxaban. The logistic regression model showed that for the 3 agents together, age, eGFR, major bleeding history, and history of prior stroke were significantly associated with the decision to inappropriately underdose (P < 0.05). Fifteen patients had an ischemic stroke after apixaban initiation (5 underdosed and 3 overdosed). Among patients with at least one follow-up encounter, major bleeding occurred in 13 patients (11.7%) with inappropriate dosing compared with 29 patients (6.0%) with appropriate dosing (P = 0.04). Ischemic stroke occurred in 11 patients (9.9%) with inappropriate dosing compared with 15 patients (3.1%) with appropriate dosing (P < 0.01). We concluded that inappropriate DOAC underdosing is common in our region, particularly with apixaban and rivaroxaban. It is associated with increased risk of stroke and bleeding. More education targeting prescribers is needed to encourage adherence to standard dosing criteria.
Body Surface Area Dosing of High-Dose Methotrexate Should Be Reconsidered, Particularly in Overweight, Adult Patients
Authors: Gallais Fanny , Oberic Lucie , Faguer Stanislas , Tavitian Suzanne , Lafont Thierry , Marsili Sabrina , Brice Aurélie , Chatelut Etienne , Puisset Florent 
Published: September 2020

Background:
High-dose methotrexate is used for treating several types of cancer. However, it is associated with a high risk of acute kidney injury (AKI), especially in patients with high MTX concentrations. Although therapeutic drug monitoring is performed to monitor MTX concentrations, it is unclear what concentration should be considered critical, thus requiring rescue protocols to prevent nephrotoxicity.

Methods:
Patients treated with high-dose methotrexate for lymphoma or acute lymphoblastic leukemia and those benefited from therapeutic drug monitoring were included. The relationship between MTX concentrations and the presence or absence of AKI was assessed. MTX concentrations were analyzed using a population pharmacokinetic approach. Specific attention was given to morphological covariates because MTX doses are individualized according to body surface area (BSA).

Results:
In total, 328 patients and 657 cycles of treatment were analyzed. Higher MTX concentrations were observed in the AKI+ group. For cycle 1, all patients showing an MTX concentration >6 µM at 36 hours or >2 µM at 48 hours after infusion developed nephrotoxicity. The final pharmacokinetic model had 2 compartments and included the effect of age on clearance (CL) and of body weight on peripheral distribution volume. None of the morphological covariates tested on CL led to significant improvement in the model. Higher MTX concentrations were observed in patients with extreme BSA values (≥2 m2) or body mass index (≥25 kg/m2). Patients with AKI who received at least 1 cycle had higher BSA and BMI.

Conclusions:
The results from this study provide additional information on the relationship between MTX concentration and nephrotoxicity. Patients with a plasma MTX concentration >6 µM at 36 hours were more likely to manifest AKI. In addition, the results suggest that overweight patients have a high AKI risk and that BSA-based adjustment of MTX dose is not appropriate.
Updates in treating fecal incontinence in women
Authors: Kim Youngwu , Ortega Marcus , Von Bargen Emily 
Published: September 2020

Purpose of review
Fecal incontinence is a chronic condition that can significantly affect a woman's quality of life. The pathogenesis of fecal incontinence is multifaceted and management ranges from supportive care, medical therapy to more invasive surgical procedures. This review will discuss the recent advancements in treating fecal incontinence.

Recent findings
The pelvic floor disorder consortium has created a consensus document with recommendations on pelvic floor symptom measurement tools, patient-reported instruments, and questionnaires that should be used when evaluating fecal incontinence. There is new robust data reinforcing the importance of conservative management prior to proceeding with more invasive treatment. Lastly, several novel therapies that were developed in the past decade now have longer term data on safety and efficacy.

Summary
Management of fecal incontinence is challenging, as no one therapy has been proven to be predominately effective. We should continue to first optimize patients with conservative therapy followed by induction of more advanced therapies. There needs to be continued efforts to develop and evaluate effective treatment guidelines and therapies for fecal incontinence.
Penetrating atherosclerotic ulcer
Authors: Evangelista Arturo , Moral Sergio 
Published: September 2020

Purpose of reviewPenetrating aortic ulcer (PAU) is defined as ulceration of an aortic atherosclerotic plaque penetrating through the internal elastic lamina into the media. With the advances in imaging techniques, the differential diagnosis between PAU and other aortic ulcers remains a challenge. This review aims to summarize the latest insight into PAU, based on clinical context and the newest imaging characteristics, to aid treatment decision-making.Recent findingsMost PAUs are asymptomatic and do not require urgent invasive treatment. Nevertheless, when PAU leads to an acute aortic syndrome, emergency invasive therapy is recommended. A differential diagnosis with other lesions, such as ulcerated plaques or intimal disruptions within the context of an aortic intramural hematoma, is required as the risk of complications and management differ. Imaging technique plays a pivotal role in the correct diagnosis of aortic ulcers.SummaryThe differential diagnosis of PAU with other aortic ulcers based on clinical and imaging technique information is mandatory as it may imply different prognosis and management. This diagnosis is particularly important when PAU is the cause of acute aortic syndromes as urgent invasive treatment should be recommended.
Generalizability of Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial in patients with a history of coronary artery bypass graft surgery
Authors: Kosmopoulos Andrew , Verma Subodh , Meglis Gus , Bhatt Deepak L. , Verma Raj , Mazer C. David , Voisine Pierre 
Published: September 2020

Purpose of review
Following coronary artery bypass grafting (CABG), there remains persistent risk of ischemic events despite secondary prevention strategies, including low-density lipoprotein cholesterol lowering. Although REDUCE-IT recently demonstrated the benefits of icosapent ethyl (IPE) on reducing ischemic events in a broad population of primary and secondary prevention patients, its generalizability to a contemporary CABG population is not known. This article aims to ascertain the proportion of patients with a history of CABG that would be eligible for IPE treatment.

Recent findings
A review of recent literature highlights the presence of residual ischemic following CABG. Using the Québec Heart Database, a repository of contemporary Canadian cardiac patient information, was searched between 1 January 2006 and 31 December 2016, to ascertain generalizability of IPE.

Summary
In a large (N = 12 641), contemporary, Canadian cohort of patients with a history of CABG and currently on statin therapy, 21.9, 33.6 and 26.4% would be eligible for IPE, according to REDUCE-IT, Health Canada, and Food and Drug Administration criteria, respectively. These analyses would support IPE as an adjunct to secondary prevention therapies post-CABG.
Social Smoking Environment and Associations With Cardiac Rehabilitation Attendance
Authors: Bolívar Hypatia A. , Elliott Rebecca J. , Middleton William , Yoon Jin H. , Okoli Chizimuzo T. C. , Haliwa Ilana , Miller Charles C. , Ades Philip A. , Gaalema Diann E. 
Published: September 2020

Purpose:
Continued cigarette smoking after a major cardiac event predicts worse health outcomes and leads to reduced participation in cardiac rehabilitation (CR). Understanding which characteristics of current smokers are associated with CR attendance and smoking cessation will help improve care for these high-risk patients. We examined whether smoking among social connections was associated with CR participation and continued smoking in cardiac patients.

Methods:
Participants included 149 patients hospitalized with an acute cardiac event who self-reported smoking prior to the hospitalization and were eligible for outpatient CR. Participants completed a survey on their smoking habits prior to hospitalization and 3 mo later. Participants were dichotomized into two groups by the proportion of friends or family currently smoking (“None-Few” vs “Some-Most”). Sociodemographic, health, secondhand smoke exposure, and smoking measures were compared using t tests and χ2 tests (P < .05). ORs were calculated to compare self-reported rates of CR attendance and smoking cessation at 3-mo follow-up.

Results:
Compared with the “None-Few” group, participants in the “Some-Most” group experienced more secondhand smoke exposure (P < .01) and were less likely to attend CR at follow-up (OR = 0.40; 95% CI, 0.17-0.93). Participants in the “Some-Most” group tended to be less likely to quit smoking, but this difference was not statistically significant.

Conclusion:
Social environments with more smokers predicted worse outpatient CR attendance. Clinicians should consider smoking within the social network of the patient as an important potential barrier to pro-health behavior change.
Oxygen Indications and Utilization in a Diverse, Urban Community Setting
Authors: Karki Apurwa , Morante Joaquin , Cervellione Kelly L. , Ullah Tofura , Patel Viral , Fein Alan M. 
Published: September 2020

Purpose:
Long-term oxygen therapy (LTOT) is widely used to treat chronic obstructive pulmonary disease (COPD) and other conditions with severe hypoxemia, imposing a large financial burden on the American health care system.

Methods:
To better understand oxygen prescription and its use in a multiethnic community hospital, we completed a prospective, observational study with a survey design in our multicultural population to better recognize patient understanding of oxygen indications and utilization.

Results:
The survey was conducted at three outpatient pulmonary clinics. Among the 94 respondents (42% men and 58% women; age 71.8 ± 13 yr), 64% were current or former smokers. Sixty-one percent had primary diagnoses other than COPD, most commonly interstitial lung disease and congestive heart failure. One-third used oxygen for <12 hr daily. Oxygen use was variable among those to whom it was prescribed. Thirty-two percent of patients described themselves as noncompliant with their prescribed therapy due to poor equipment ergonomics, burdensome machine weight, and negative self-image and social stigma when using oxygen.

Conclusions:
Chronic obstructive pulmonary disease represented <50% of LTOT patients who were surveyed. Our data suggest that more structured prescribing practices and patient education should be studied if compliance is to be increased.