bluuebunny/crossref_metadata_2025_split huggingface dataset:
Defining a Distinct Immunotherapy Eligible Subset of Patients with Cancer of Unknown Primary Using Gene Expression Profiling with the 92-Gene Assay
Authors: Raghav Kanwal , Overman Michael , Poage Graham M. , Soifer Harris S. , Schnabel Catherine A. , Varadhachary Gauri R. 
Published: September 2020

Abstract

Background
Although recent advances in immunotherapy have transformed the treatment landscape for many anatomically defined cancers, these therapies are currently not approved for patients diagnosed with cancer of unknown primary (CUP). Molecular cancer classification using gene expression profiling (GEP) assays has the potential to identify tumor type and putative primary cancers and thereby may allow consideration of immune checkpoint inhibitor (ICI) therapy options for a subset of patients with CUP. Herein, we evaluated and characterized the ability of a 92-gene assay (CancerTYPE ID) to provide a molecular diagnosis and identify putative tumor types that are known to be sensitive to ICI therapies in patients with CUP or uncertain diagnosis.

Findings
A total of 24,426 cases from a large-scale research database of 92-gene assay clinical cases were classified, of which 9,350 (38%) were predicted to have an ICI-eligible tumor type. All ICIs with approved indications as of March 2020 were included in the analysis. Non-small cell lung cancer (NSCLC) was the most frequent molecular diagnosis and accounted for 33% of the ICI-eligible tumor types identified and 13% of the overall reportable results. In addition to NSCLC, the assay also frequently identified urothelial carcinomas, gastric cancer, and head and neck squamous cell carcinoma. The distributions of identified tumor types with indications for ICI therapy were similar across age and gender.

Conclusions
Results suggest that molecular profiling with the 92-gene assay identifies a subset of ICI-eligible putative primary cancers in patients with CUP. We propose a treatment strategy based on available tests, including clinicopathologic features, GEP, and ICI biomarkers of response.
Disease Flare During Temporary Interruption of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia
Authors: Hampel Paul J. , Call Timothy G. , Rabe Kari G. , Ding Wei , Muchtar Eli , Kenderian Saad S. , Wang Yucai , Leis Jose F. , Witzig Thomas E. , Koehler Amber B. , Fonder Amie L. , Schwager Susan M. , Van Dyke Daniel L. , Braggio Esteban , Slager Susan L. , Kay Neil E. , Parikh Sameer A. 
Published: September 2020

Abstract

Background
Approximately 25% of patients with chronic lymphocytic leukemia (CLL) experience a flare of disease following ibrutinib discontinuation. A critical question is whether this phenomenon may also occur when ibrutinib is temporarily held. This study aimed to determine the frequency and characteristics of disease flares in this setting and assess risk factors and clinical outcomes.

Materials and Methods
We identified all patients with CLL seen at Mayo Clinic between October 2012 and March 2019 who received ibrutinib. Temporary interruptions in treatment and associated clinical findings were ascertained.

Results
Among the 372 patients identified, 143 (38%) had at least one temporary interruption (median 1 hold, range 1–7 holds) in treatment. The median duration of interruption was 8 days (range 1–59 days) and the most common indication was periprocedural. Among the 143 patients with ≥1 hold, an associated disease flare was seen in 35 (25%) patients: mild (constitutional symptoms only) in 21 patients and severe (constitutional symptoms with exam/radiographic findings or laboratory changes) in 14 patients. Disease flare resolved with resuming ibrutinib in all patients. Predictive factors of disease flare included progressive disease at time of hold and ≥ 24 months of ibrutinib exposure. The occurrence of disease flare with an ibrutinib hold was associated with shorter event-free survival (hazard ratio 2.3; 95% confidence interval 1.3–4.1; p = .007) but not overall survival.

Conclusion
Temporary interruptions in ibrutinib treatment of patients with CLL are common, and one quarter of patients who held ibrutinib in this study experienced a disease flare. Resolution with resuming ibrutinib underscores the importance of awareness of this phenomenon for optimal management.

Implications for Practice
Ibrutinib is a very effective treatment for chronic lymphocytic leukemia (CLL) but needs to be taken continuously. Side effects, such as increased bleeding risk with procedures, require temporary interruptions in this continuous treatment. Rapid CLL progression following ibrutinib discontinuation has been increasingly recognized. This study demonstrates that similar flares in disease signs or symptoms may occur during ibrutinib holds as well. Importantly, management with restarting ibrutinib led to quick clinical improvement. Awareness of this phenomenon among clinicians is critical to avoid associated patient morbidity and premature cessation of effective treatment with ibrutinib if the flare is misidentified as true progression of disease.
Professional Medical Writer Assistance in Oncology Clinical Trials
Authors: Kouzy Ramez , Abi Jaoude Joseph , Mainwaring Walker , Lin Timothy A. , Miller Austin B. , Jethanandani Amit , Espinoza Andres F. , Verma Vivek , Fuller Clifton D. , Minsky Bruce D. , Rödel Claus , Taniguchi Cullen M. , Ludmir Ethan B. 
Published: September 2020

Abstract

Background
The use of professional medical writers (PMWs) has been historically low, but contemporary data regarding PMW usage are scarce. In this study, we sought to quantify PMW use in oncologic phase III randomized controlled trials (RCTs).

Methods
We performed a database query through ClinicalTrials.gov to identify cancer-specific phase III RCTs; we then identified whether a PMW was involved in writing the associated trial manuscript reporting primary endpoint results.

Results
Two-hundred sixty trials of 600 (43.3%) used a PMW. Industry-funded trials used PMWs more often than nonindustry trials (54.9% vs. 3.0%, p &lt; .001). Increased PMW usage was further noted among trials meeting their primary endpoint (53.4% vs. 32.9%, p &lt; .001) and trials that led to subsequent Food and Drug Administration approval (63.1% vs. 36.3%, p &lt; .001). By treatment interventions, PMW use was highest among systemic therapy trials (50.2%). Lastly, the use of PMWs increased significantly over time (odds ratio: 1.11/year, p = .001).

Conclusion
PMW use rates are high among industry-funded trials. We urge continued and increased transparency in reporting the funding and use of PMWs.
Cladribine with Granulocyte Colony-Stimulating Factor, Cytarabine, and Aclarubicin Regimen in Refractory/Relapsed Acute Myeloid Leukemia: A Phase II Multicenter Study
Authors: Wang Hua , Wang Liang , Li Chun , Wuxiao Zhijun , Shao Ruonan , Wang Huizhong , Lu Yue 
Published: September 2020

Abstract

Trial Information
Click here to access other published clinical trials.

Lessons Learned
Studies targeting cladribine in combination with granulocyte colony-stimulating factor, low-dose cytarabine, and aclarubicin (C-CAG) regimen in relapsed and refractory acute myeloid leukemia (R/R AML) are limited. The complete remission rate after two cycles of C-CAG regimen was 67.6%, and 1-year overall survival and disease-free survival rates were 59.7% and 72.9%, respectively. The C-CAG regimen is significantly effective against R/R AML with a low hematological toxicity and thus serves as an alternative treatment for R/R AML.

Background
The optimal salvage chemotherapy regimen for relapsed and refractory acute myeloid leukemia (R/R AML) remains uncertain. Therefore, a phase II study was conducted for the prospective evaluation of the efficacy and safety of the purine analog cladribine in combination with granulocyte colony-stimulating factor (G-CSF), low-dose cytarabine, and aclarubicin (C-CAG) regimen for patients with R/R AML.

Methods
A total of 34 patients received C-CAG regimen for salvage treatment as follows: cladribine 5 mg/m2, days 1–5; G-CSF 300 μg, days 0–9; aclarubicin 10 mg, days 3–6; cytarabine 10 mg/m2 every 12 hours, subcutaneously, days 3–9; 4 weeks per cycle. Patients were allowed to withdraw from the study if complete remission (CR) was not achieved after two courses of chemotherapy. If conditions were right, the patients achieving CR were recommended to receive allogeneic hematopoietic stem cell transplantation. Otherwise, they were treated for a total of six cycles unless disease progression or unacceptable side effects were observed or they withdrew their consent.

Results
All patients received at least two cycles of C-CAG regimen chemotherapy. After two cycles of C-CAG, 23 patients (67.6%) achieved CR, and 5 patients had partial remission (14.7%). At a median follow-up of 15 months (range, 3–38 months), the 1-year overall survival (OS) and disease-free survival (DFS) rates were 59.7% (95% confidence interval [CI], 42.6%–76.8%) and 72.9% (95% CI, 54.3%–91.5%), respectively. The most common adverse effect was myelosuppression. Nonhematological toxicities were mild, and no treatment-related deaths occurred.

Conclusion
Preliminary data indicate that the C-CAG regimen chemotherapy is significantly effective against R/R AML with a high remission rate and a low hematological toxicity. Thus, it may serve as an alternative treatment for R/R AML.
PENGARUH IRADIASI TERHADAP KUALITAS FUNGSIONAL ANEKA SAYUR KERING SKALA SEMI-PILOT
Authors: Kadir Idrus , Darwis Darmawan 
Published: September 2020

PENGARUH IRADIASI TERHADAP KUALITAS FUNGSIONAL ANEKA SAYUR KERING SKALA SEMI-PILOT. Teknologi iradiasi merupakan salah satu teknologi pilihan unggul dalam penanganan pascapanen aneka sayur. Tujuan penelitian ini untuk mengetahui pengaruh iradiasi dosis sedang terhadap kualitas nilai fungsional bahan pangan berbasis aneka-sayur kering pada skala semi-pilot. Selain itu juga dilakukan pengujian tingkat kesukaan (hedonik) dan kandungan logam berat terhadap aneka sayur iradiasi. Hasilnya pengujian menunjukkan bahwa iradiasi dapat mempertahankan aktivitas antioksidan aneka sayur, kecuali terhadap jamur kuping yang mengalami penurunan yang cukup signifikan. Begitu juga dengan kandungan mikronutrisi mineral, hasil pengujian menunjukkan bahwa iradiasi dosis sedang dapat mempertahankan kualitas mikronutrisi mineral aneka sayur, bahkan cenderung meningkat. Kandungan logam berat pada aneka sayur umumnya tidak terdeteksi. Dari pengujian kesukaan (hedonik), aneka sayur yang diiradiasi tetap disukai konsumen.
PENERAPAN TEKNIK ANALISIS NUKLIR DALAM MENGKAJI KUALITAS UDARA DI SEKITAR PLTU CILACAP
Authors: Murniasih Sri , Prabasiwi Devi Swasti , Ariany Dewi Puspa , Sukirno Sukirno 
Published: September 2020

PENERAPAN TEKNIK ANALISIS NUKLIR DALAM MENGKAJI KUALITAS UDARA DI SEKITAR PLTU CILACAP. Kandungan zat berbahaya dalam partikulat udara dapat menimbulkan permasalahan kesehatan bagi masyarakat. Tujuan utama dari penelitian ini adalah mengkaji kualitas udara di daerah sekitar PLTU Adipala Cilacap melalui penilaian konsentrasi zat partikel tersuspensi, kandungan logam berat berbahaya dan metaloid lainnya menggunakan metode AAN, serta mengidentifikasi radionuklida menggunakan metoda spektrometri gamma, yang terkandung dalam PM2.5 dan PM10. Pengambilan sampel dilakukan pada Juli 2018 di tiga lokasi sampling, selama 24 jam secara simultan. Karakteristik konsentrasi rata-rata keseluruhan PM2.5 dan PM10 masing-masing adalah 16,76 μg/m3 dan 37,61 μg/m3. Sekitar 45 % partikel berasal dari fraksi halus (PM2.5) dan 55 % berasal dari fraksi kasar (PM10). Nilai radioaktivitas dalam PM2.5 dan PM10 yang yang terendah adalah radionuklida Pb-210 berkisar 0,134 µBq/m3 dan tertinggi adalah K-40 mempunyai nilai 6,407 µBq/m3. Berdasarkan Perka BAPETEN Nomor 7 Tahun 2017 dijelaskan bahwa baku tingkat radioaktivitas di lingkungan udara dinyatakan di bawah baku mutu yang diijinkan. Kandungan logam berat (As, Cd, Cr, Cu, Sb dan Zn) dalam sampel PM10 dengan konsentrasi tertinggi adalah seng (0,394 ng/m3) dan terendah adalah kadmium (0,0008 ng/m3). Kandungan logam berat pada sampel PM2.5 teridentifikasi bahwa konsentrasi terkecil adalah Cd (0,0006 ng/m3) dan yang tertinggi adalah Zn (0,223 ng/m3) dengan rerata 0,114 ng/m3. Standar ambang batas rata-rata PM2.5 dan PM10 yang ditetapkan WHO berturut-turut adalah 25 μg/m3 dan 50 μg/m3, hal ini menujukkan logam berat di udara disekitar PLTU Adipala Cilacap dengan jarak sekitar 2 km sampai 3 km masih dalam batas terkendali.
Changes in Motor Unit Number Estimate and Forced Vital Capacity as Predictors of ALS Progression
Authors: Olney Nicholas , Lomen Hoerth Catherine , Kohn Michael , Olney Richard 
Published: September 2020

Background: An independent measure of lower motor neuron function that can be monitored over time is essential to evaluating the effect of drugs or stem cell transplantation and to determining prognosis in amyotrophic lateral sclerosis (ALS). Longitudinal changes in forced vital capacity-percent of predicted (FVC%) and motor unit number estimate (MUNE) may identify patient groups with more rapid disease progression.
Objective: We attempted to define cutoff values for 3-month changes in FVC% and MUNE that identify ALS patients with rapidly progressive disease defined as survival of 30 months or less from symptom onset.
Design: Cohort study.
Subjects: We report data from 26 ALS patients, 10 patients reported previously and 16 patients not reported previously, except for the reproducibility of their MUNE data.
Results: Of the 26 patients, 7 had rapid progression. Either a 40% decrease in statistical MUNE or a 20% decrease in FVC% over 3 months identified 6 of 7 rapid progressors (Sensitivity=86% 95% confidence interval [CI] 42.1% - 99.6%). Of the 19 patients without rapid progression, 18 met neither the FVC or MUNE criterion (Specificity = 94.7% CI 95% 74.0% - 99.9%). In a proportional hazards model, 3 month change in both FVC and MUNE were significantly predictive of decreased survival.
Conclusion: We suggest the use of a three-month change in MUNE or FVC% as a secondary enrollment criterion in therapeutic trials or to identify a subgroup of rapid progressors that may respond differently to treatments.
Soil radon gas emission on the Sivrice (Elazığ, Turkey) fault zone between 2007-2008 years
Authors: ŞAHİN BAL Sultan , DOGRU Mahmut 
Published: September 2020

Soil radon gas measurements were made via a sensing system embedded in soil at radon monitoring station, which was established in Sivrice Fault Zone of Eastern Anatolia Fault Systems (DAFS) being one of the active fault system of Turkey. The occurrence times and magnitude of earthquakes at this zone were compared with the radon gas diffusion obtained online from the mentioned station and the results were interpreted in the light of data in the literature.
In this study, it was seen that there is a relationship between the changes in soil radon gas emission and earthquakes. Additionally, according to the analyses on graphs which present the changes in soil radon gas outlet taken from stations and earthquake lists taken from AFAD (Republic of Turkey Prime Ministry Disaster and Emergency Management Presidency), it was seen that almost all of the earthquakes occur in a decreasing period following the increase in radon emission.
Spatial modelling of PM2.5 concentrations in Tehran using Kriging and inverse distance weighting (IDW) methods
Authors: Masroor Kazhal , Fanaei Farzad , Yousefi Somayeh , Raeesi Mohammad , Abbaslou Hossein , Shahsavani Abbas , Hadei Mostafa 
Published: September 2020

Introduction: Estimating air pollution levels in areas with no measurements is a major concern in health-related studies. Therefore, the aim of this study was to investigate the amount of exposure to particulate matter below 2.5 µ (PM2.5) in the metropolis of Tehran.
Materials and methods: The hourly concentrations of PM2.5 during 2017-2018 period were acquired from the Department of Environment (DOE) and Air Quality Control Company of Tehran (AQCC). The hourly concentrations were validated and 24-h concentrations were calculated. Inverse distance weighting (IDW), Universal Kriging, and Ordinary Kriging were used to spa- tially model the PM2.5 over Tehran metropolis area. Root Mean Square Error (RMSE) and Mean Error (ME) were used to measure and control for the ac- curacy of the methods.
Results: The results of this study showed that RMSE and MENA values in Kriging method was less than the IDW, which indicates that the Kriging was the best method to estimate PM2.5 concentrations. According to the final map, the highest annual concentrations of PM2.5 were observed in the southern and southwestern areas of Tehran (districts 10, 15, 16, 17, and 18). The lowest exposure to PM2.5 was found to be in districts 1, 2, 3, 6, and 8.
Conclusion: It can be concluded that Kriging method can predict spatial vari- ations of PM2.5 more accurately than IDW method.
Sulfur dioxide adsorption by Iron Oxide Nanoparticles@Clinoptilolite/HCl
Authors: Mahmoodi Meimand Mina , Jonidi Jafari Ahmad , Nasiri Alireza , Malakootian Mohammad 
Published: September 2020

Introduction: The purpose of this study was to investigate and compare the effect of iron oxide nanoparticles on the adsorption of sulfur dioxide by modified zeolite with hydrochloric acid. In this investigation was used modi- fied zeolite with HCl with and without iron oxide nanoparticles (Iron Oxide Nanoparticles@Clinoptilolite/HCl) as adsorbent.
Materials and methods: Structural characteristics, chemical composition and specific surface area of adsorbent were determined using the FTIR, FE- SEM, EDX, Mapping, XRD, XRF and BET techniques. Glass cylinder filled with zeolite seeds and SO2 cylinder balanced with N2 gas was used for experi- ments. It was evaluated factors affecting SO2 uptake process including tem- perature and contact time, also thermodynamics and kinetics of adsorption. Sulfur dioxide adsorption of real sample was taken with both adsorbents.
Results: Adsorption efficiency of SO2 in the synthetic and actual sample were %82.8±5.5 and %67.2±7.21 respectively, by modified zeolite with HCl and iron oxide nanoparticles in the optimum conditions of temperature of 25 °C and duration 28.5 min. As well as, removal percentage average was obtained in the synthetic and actual sample %46.1±4.34 and %35.8±5.85 respectively, by modified zeolite with HCl without nanoparticles in optimum condition of temperature of 25 °C and contact time of 20.5 min.The results showed that SO2 adsorption is an exothermic and spontaneous process and adsorption ki- netics of sulfur dioxide by both adsorbent is more consistent Pseudo-second order kinetics model.
Conclusion: The use of iron oxide nanoparticles on the zeolite can increase SO2 removal efficiency from the gas phase.
Prevalence and Mechanism of Injuries in Male Beach Soccer Players
Authors: Sharifatpour Reza , Akochakian Mahdieh , Alizadeh Mohammad Hossein , Abbassi Hamid 
Published: September 2020

Introduction: One of the preventing injuries methods is recognizing common injuries in sports and causative factors of injury. The aims of this study was to investigate the injuries of beach soccer players in terms of prevalence and mechanism.
Methods: The present study is a Cross-sectional and descriptive research that was conducted as a field study. Forty players were selected randomly from two teams of the Yazd province in premier country league that took place in 2019. For recording prevalence and mechanism of injuries, the modified injury report form by Fuller et al. (2006) was used. The SPSS software version 25 and the chi-square test at a significance level P < 0.05 were used for statistical analysis.
Results: In total, the most common injuries of beach soccer were in lower extremities (%69.84), and for injury severity, %31.75 were severed injury, and in terms of the type of injuries, the strain was the most of the injuries occurred (%33.33). The amount of injury during the match (%60.26) was higher than the time of training (%39.68). The degree of contact injuries %73.02 was significantly higher than non-contact injuries %26.98 (p <0.05).
Conclusion: Most of the injuries in beach soccer are caused by playing bare foot and lack of shoes and guards on the legs and feet, and then on the knee. Contact of players is one of the main sources of injury in beach soccer, which is likely to be effective in preventing injury by changing training, implementing proper techniques, and improving performance factors by using injuries preventive programs.
The Perspective of Nurses Concerning the Characteristics and Competencies of a Change Manager in Healthcare System
Authors: Beigzadeh A , Dehghani MR , Daryazadeh S , Heydari S , Ebrahimi S 
Published: September 2020

Introduction: Nowadays “change” in all aspects of human's life and organizations is rapidly increasing. By knowing the characteristics of change managers as the main pillars of change in healthcare organizations we can implement effective changes in healthcare systems. Therefore, the aim of this study was to determine the characteristics and competencies of change managers in healthcare system.
Methods: This descriptive cross-sectional study was conducted on nurses in educational hospitals of Kerman University of Medical Sciences in 2016. In this study 280 nurses entered the study based on stratified random sampling. To collect data, a valid and reliable questionnaire was used. Data were analyzed using cluster analysis by SPSS software version 16.
Result: The highest mean score regarding the characteristics of a change manager was related to "evaluation system and feedback" (9.22 ± 1.17), and "counselor and guider" in the process of change (9.31 ± 1.10). Conversely, "creating an amicable atmosphere in the workplace" (7.35 ± 2.45) and "thinking to reduce resistance" (8.04 ± 1.07) achieved the lowest scores. Totally, 4 roles as futurist and planner; coordinator and information provider; facilitator; and strategist were identified for a change manager in healthcare system.
Conclusion: Characteristics such as futurist, information provider, facilitator and strategist are the main traits of a change manager. Emphasizing these characteristics and making managers ready in this regard can enhance their performance in the process of change and makes the change easier.
A Systematic Review of the Instruments Used for Evaluating Causal Beliefs and Perceived Heart Risk Factors
Authors: Saeidi Mozhgan , Komasi Saeid , Compare Angelo 
Published: September 2020

Background: The etiologies and causal beliefs of heart disease are considered one of the 5 dimensions of health selfregulatory model. Thus, the present study aimed to review the literature and screen the appropriate tools for evaluating the causal beliefs and perceived heart risk factors (PHRFs).
Methods: The review samples encompassed all published articles from 1992 to March 2017. A systematic search was conducted across 6 databases: the Web of Science, Scopus, Medline, EBSCO, ProQuest, PsycINFO, and Google Scholar. The qualitative evaluation of the articles was examined using the checklists of the Critical Appraisal Skills Programme (CASP) by 2 independent investigators. After the application of the criteria for inclusion in the study, 22 studies were obtained according to the PRISMA guidelines.
Results: A total of 10 504 (50.5% male) patients at an average age of 57.85±10.75 years participated in 22 studies under review. The results of the systematic review showed that 22 tools were available to measure PHRFs. The instruments were categorized into 4 groups of valid scales (6 studies), invalid questionnaires (6 studies), checklists (3 studies), and open-ended single items (7 studies). Only 23.2% of the measuring instruments were sufficiently valid.
Conclusion: The results of this systematic review showed that a limited number of valid tools were available to measure PHRFs. Considering the importance of studying cardiac patients’ perception of the etiology of disease and the paucity of standards and valid grading scales, it seems necessary to design and provide tools with broader content that can cover all aspects of patients’ beliefs.