bluuebunny/crossref_metadata_2025_split huggingface dataset:
Expectations for overall survival in mRCC patients who were selected for upfront cytoreductive nephrectomy in the targeted therapy era.
Authors: Abel E. Jason , Karam Jose A. , Spiess Philippe E. , Raman Jay D. , Sexton Wade J. , Zemp Logan , Bilotta Alyssa , Patil Dattatraya , Allen Glenn O. , Lauer Kate V. , Shapiro Daniel D. , Matin Surena F. , Wood Christopher G. 
Published: February 2020

646 Background: Surgical selection is critical to obtain the best outcomes for mRCC patients treated with cytoreductive nephrectomy (CN). Prior studies suggest that international metastatic disease consortium (IMDC) poor risk patients should not be considered for upfront CN because of expectation for short overall survival (OS). The purpose of this study is to evaluate OS among IMDC risk categories for patients treated with upfront cytoreductive nephrectomy during the targeted therapy era at five independent institutions. Methods: After IRB approval, data for consecutive mRCC patients treated with CN at 5 institutions from 2006-2017 was analyzed. Kaplan-Meier method was used to estimate survival from date of surgery and univariate/multivariable Cox models were used to evaluate associations with OS. Results: Of 1163 patients who were treated with CN at 5 institutions, 914 (79%) patients were treated without neoadjuvant systemic therapies. Preoperative IMDC risk category for upfront CN patients was favorable in 71 (8%), intermediate in 598 (65%), and poor in 245 (27%) patients. Median age was 61 (53-68) and median Charlson co-morbidity index was 1 (0-2). Median (IQR) patient follow-up for patients alive at last follow-up was 42.7 months (23, 69). The median OS (IQR) following upfront nephrectomy was 115.4 months (33,NR) for favorable risk patients, 28.6 months (9-65) for intermediate risk patients and 21.8 months (10-47) for poor risk patients. No differences were identified in OS among 5 different institutions (p=0.11) Of 245 poor risk patients, OS was not associated with co-morbidity status or age were not associated with OS (p=0.77, 0.92). Percentage survival at 1, 2, 3 and 5 years was 69%, 48%, 34%, and 20% in the poor risk cohort. Conclusions: Conclusions: After stratification by the IMDC model, observed survival following upfront cytoreductive nephrectomy in this multi-institutional cohort was longer than expected from prior studies, which may be partially attributed to surgical selection bias.
SHR3680, a novel antiandrogen, for the treatment of metastatic castration-resistant prostate cancer (mCRPC): A phase I/II study.
Authors: Qin Xiaojian , Han Weiqing , Luo Hong , Du Chuanjun , Zou Qing , Sun Zhongquan , He Chaohong , Zhu Shaoxing , Chong Tie , Yao Xin , Wan Ben , Gu Weijie , Ye Dingwei 
Published: February 2020

90 Background: SHR3680 is a novel and pure androgen-receptor (AR) antagonist that shows a potent antitumor activity against CRPC but with much less brain distribution than enzalutamide in preclinical study. In this first-in-human phase 1/2 study, the safety and efficacy of SHR3680 were assessed in patients with mCRPC. Methods: This phase 1/2 study was conducted in 11 hospitals in China. Patients with progressive mCRPC that was not previously treated with novel AR-targeted agents were eligible for this study. In the phase 1 part, patients received oral SHR3680 at a starting daily dose of 40 mg, which was subsequently escalated to 80 mg, 160 mg, 240 mg, 360 mg, and 480 mg. In phase 2, patients were randomized to receive one of three daily doses of SHR3680 (80 mg, 160 mg, and 240 mg). The primary endpoint in phase 1 was safety and tolerability, and in phase 2 was the proportion of patients with a PSA response (≥50% decrease of PSA level at week 12). Results: From Apr 2016 to Sep 2018, a total of 197 patients (median age 67 years, range 45−80; visceral metastases in 29 patients; previous chemotherapy history in 80 patients) were enrolled (phase 1, n = 18; phase 2, n = 179). No dose-limiting toxicities were reported and the maximum tolerated dose was not reached. Most adverse events were grade 1/2 (87.3%). The most common adverse events were anemia (22.8%), back pain (16.2%), and proteinuria (13.2%). The antitumor activity was observed at all doses, including PSA response in 134 (68.7%) of 195 evaluable patients, stabilized bone disease in 169 (86.7%) of 195 patients at week 12, and responses in soft tissue lesions in 22 (36.7%) of 60 patients. No obvious dose-related activity benefits were found. As of Sep 26, 2019, the median time to PSA progression was 36 weeks (95% CI 24−47), while that to radiological progression was 73 weeks (95% CI 49−96). As expected, patients without previous chemotherapy showed relatively longer time to PSA and radiological progression than those with previous chemotherapy. Conclusions: SHR3680 is safe and well tolerated, and exhibits high efficacy in mCRPC patients. Clinical trial information: NCT02691975.
A phase Ib/II open-label study of tazemetostat (TAZ) plus enzalutamide (E) or abiraterone/prednisone (A/P) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
Authors: Abida Wassim , Bradley Thomas Paul , Rezazadeh Arash , Karsh Lawrence Ivan , Ross Ashley , Saltzstein Daniel , Argon Evren Kocabas , Hamlett Anthony , Tang Jeanie , Adib Deyaa 
Published: February 2020

TPS255 Background: The histone methyltransferase EZH2 is overexpressed in many cancers. In prostate cancer (PC), EZH2 inhibition may reverse acquired resistance to androgen inhibitors (AIs). Pts may initially respond to AIs, but pts who progress have limited treatment options. In phase 2 trials, TAZ, a selective, orally bioavailable, investigative small molecule EZH2 inhibitor, has demonstrated encouraging objective responses in B-cell lymphomas and molecularly defined solid tumors and a favorable safety profile. In PC preclinical models, TAZ + E or A/P showed a greater reduction in tumor growth than either drug alone. This study will evaluate the safety and efficacy of TAZ + E or A/P vs E or A/P alone in mCRPC. Methods: This phase 1b/2 study will enroll pts ≥18 years with progressive mCRPC, with or without prior second-generation AI treatment, and no prior chemotherapy. Phase 1b will identify the recommended phase 2 dose (RP2D) of TAZ when combined with E (160 mg/day) or A/P (A: 1000 mg/day; P: 5 mg twice-daily [BID]) and evaluate the safety and tolerability of each combination in treatment-naïve pts and pts previously treated with a second-generation AI. Using a modified 3+3 design (up to 48 pts: 18 for TAZ+A/P and 30 for TAZ+E), TAZ dosing will start at 400 mg BID, escalating to 800 mg BID in the TAZ+A/P group or 1600 mg BID in the TAZ + E group, if no dose-limiting toxicities are observed. Phase 2 will begin once the RP2D for each combination is determined. Efficacy and safety results from phase 1b will inform the final design for phase 2. Phase 2 will be an open label study where pts will be randomized to either E or A/P alone or in combination with TAZ. TAZ will be administered at the RP2D in continuous 28-day cycles for as long as pts tolerate treatment and continue AI therapy. Tumor assessments will be performed every 9 weeks for 6 months and every 12 weeks thereafter. Efficacy assessments include radiographic progression-free survival (primary endpoint), prostate-specific antigen (PSA) ≥50% response rate, time to PSA progression, time to subsequent systemic therapy, and objective response rate. Safety is a secondary endpoint.
A phase II pilot study of the efficacy and safety of nivolumab and ipilimumab in T1aN0M0 renal cell carcinoma patients ineligible for surgical treatment.
Authors: Tsimafeyeu Ilya , Volkova Maria , Gafanov Rustem Airatovich , Nosov Dmitry , Bex Axel 
Published: February 2020

TPS769 Background: Surgery remains the standard curative-intent therapy for localized renal cell carcinoma (RCC). Thus, systemic therapy for RCC should only be considered in patients who have contraindications to surgery. The phase 3 CheckMate 214 trial showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic RCC patients with a complete response rate of 11%. Median time to objective response was 2.8 months. Among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan. We hypothesize that this combination could eliminate the primary tumor in T1aN0M0 patients ineligible for surgical treatment. Methods: This is a prospective, multicenter, non-randomized phase 2 pilot study. Patients with biopsy-proven clear-cell RCC of ≤4 cm (cT1a), no evidence of any metastases, and unable to have surgery or other nephron-sparing interventions (ablation) for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or with preference to have no surgery or intervention for any reason will receive combination of ipilimumab (1 mg/kg intravenously) every 3 weeks for four doses, and nivolumab (240 mg intravenously) every 2 weeks during 16 weeks. The primary endpoint is complete response rate. Simon's two-stage design (Simon, 1989) is used. The null hypothesis that the true complete response rate is 11% will be tested against a one-sided alternative. This design yields a type I error rate of 0.05 and power of 0.9 when the true complete response rate is 60% (alternative hypothesis). In the first stage, 3 patients will be accrued. If there are no complete responses in these 3 patients, the study will be stopped. Otherwise, 5 additional patients will be accrued for a total of 8. The null hypothesis will be rejected if 3 or more responses are observed in 8 patients. Clinical trial information: NCT04134182.
Utility of Circulating Tumor DNA in the Management of Patients With GI Stromal Tumor: Analysis of 243 Patients
Authors: Arshad Junaid , Roberts Ali , Ahmed Jibran , Cotta Jared , Pico Brian A. , Kwon Deukoo , Trent Jonathan C. 
Published: February 2020

PURPOSE GI stromal tumor (GIST) is the most common sarcoma of the GI tract. Management of patients with GIST is determined by KIT, PDGFRA, or other genomic alterations. Tissue-based next-generation sequencing (NGS) analysis is the standard approach for diagnosis, prognosis, and treatment selection. However, circulating tumor DNA (ctDNA)–based NGS is a novel and noninvasive alternative. METHODS ctDNA sequencing results were evaluated in blood samples from 243 de-identified patients within the Guardant360 database. Under an approved institutional review board protocol, a retrospective analysis was performed on 45 single-institution patients. RESULTS Of 243 patients, 114 (47%) were women, and the median age was 59 years (range, 17-90 years). Patients with no alterations and variations of uncertain significance were excluded. Of the 162 patients with known pathogenic mutations, KIT was the most common (56%), followed by NF (7%), PDGFRA (6%), PI3KCA (6%), KRAS (5%), and others (6%). Most tumors harbored an actionable KIT or PDGFRA mutation. Our institutional cohort (n = 45) had 16 (35%) KIT exon 11 mutations, 3 (6%) KIT exon 9 mutations, and 1 (2%) PDGFRA mutation detected on ctDNA. Resistance mutations were observed in KIT exon 17 (8 patients), exon 13 (3 patients), and in both (3 patients). Our comparison of ctDNA with tissue NGS revealed a positive predictive value (PPV) of 100%. Failure of concordance was observed in patients with localized or low disease burden. From the time of ctDNA testing, the median overall survival was not reached, whereas the median progression-free survival was 7 months. CONCLUSION ctDNA provides a rapid, noninvasive analysis of current mutations with a high PPV for patients with metastatic GIST. ctDNA-based testing may help to define the optimal choice of therapy on the basis of resistance mutations and should be studied prospectively.
Dithiazolylthienothiophene Bisimide-Based π-Conjugated Polymers: Improved Synthesis and Application to Organic Photovoltaics as P-Type Semiconductor
Authors: Teshima Yoshikazu , Saito Masahiko , Mikie Tsubasa , Komeyama Kimihiro , Yoshida Hiroto , Osaka Itaru 
Published: February 2020

Abstract
Dithiazolylthienothiophene bisimide (TzBI) is a promising building unit for donor-acceptor π-conjugated polymers due to its strong electron-deficiency and high coplanarity. We previously reported a TzBI-based π-conjugated polymer functioned as n-type semiconductor in organic photovoltaic cells. However, a critical deficiency was that the molecular weight of the polymer was not sufficiently high. It is also important to investigate the possibility of TzBI-based polymers as a p-type semiconductor. In this study, we show that a new synthetic approach gave a new TzBI-based polymer with an improved molecular weight relative to the previously reported polymer. Further, having a co-building unit with a more electron-rich nature, the polymer functioned as p-type semiconductor in organic photovoltaic cells when the PC61BM was used as n-type material. This study shows that TzBI is a versatile building unit for π-conjugated polymers that can be used in organic electronic devices.
Effects of rehabilitation training of core muscle stability on stroke patients with hemiplegia
Authors: Chen Xiaofeng , Gan Zhuohui , Tian Wuchao , Lv Yongkai 
Published: February 2020

Objective: To evaluate the effects of rehabilitation training of core muscle stability on stroke patients with hemiplegia.
Methods: A total of 180 stroke patients who were hospitalized from December 2017 to December 2018 were enrolled. They were randomly divided into an observation group and a control group (n=90) that both received conventional hemiplegia rehabilitation therapy. On this basis, the observation group was subjected to training for core muscle stability, five times a week for a total of eight weeks. The balance functions before and after training were assessed using the Berg Balance Scale (BBS). The functions of hemiplegic lower limbs were evaluated by Brunnstrom staging and the Fugl-Meyer motor assessment (FMA) scale. The walking speed was estimated using the 10 m walking test. Musculoskeletal ultrasonography was performed to measure the thicknesses of three abdominal muscles of the paralytic side, i.e. transverse abdominis, internal oblique and external oblique muscles.
Results: After treatment, the BBS scores of the two groups were significantly higher than those before treatment, with significant differences (P<0.05). The BBS score of the observation group was significantly higher than that of the control group (P<0.05). After treatment, the Brunnstrom stage and FMA scale score, and standing and stepping scores were significantly higher than those before treatment (P<0.05). The Brunnstrom stage, FMA scale score, stepping score and walking speed of the observation group significantly exceeded those of the control group (P<0.05). After treatment, the thicknesses all increased compared with those before treatment, but the thicknesses of internal oblique and external oblique muscles were not significantly different (P>0.05). The thickness of transverse abdominis muscle of the observation group significantly surpassed that before treatment (P<0.05), whereas the thicknesses of the control group were similar (P>0.05). The thickness of transverse abdominis muscle of the observation group was significantly higher than that of the control group (P<0.05).
Conclusion: Rehabilitation training of core muscle stability can effectively improve the balance function and walking speed of stroke patients, probably by increasing the thickness of transverse abdominis muscle.
doi: https://doi.org/10.12669/pjms.36.3.1466
How to cite this:Chen X, Gan Z, Tian W, Lv Y. Effects of rehabilitation training of core muscle stability on stroke patients with hemiplegia. Pak J Med Sci. 2020;36(3):461-466. doi: https://doi.org/10.12669/pjms.36.3.1466
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Correlation between changes in intraocular pressure and refractive error indices post Cataract Surgery
Authors: Bodla Muhammad Afzal , Bodla Ali Afzal , Moazzam Ayema , Tariq Noor 
Published: February 2020

Objective: To evaluate the correlation between refractive errors and change in intraocular pressure in patients undergoing cataract surgery.
Methods: This interventional retrospective case study was carried out from September 2018 to April 2019 at Bodla Eye Care and Multan Medical and Dental College, Multan. A total of 127 eyes were recruited in the study among which six were excluded. Out of remaining 121, 53 eyes were emmetropes, 41 were mild myopes and 27 were high myopes. Single surgeon performed the procedure. Pre-operative investigations of IOP and refractive error were done by goldmann tonometry and auto refractometry. IOP was reviewed at day 1, 7, 14 and 28 post cataract surgeries.
Results: Out of 121 eyes, 53 eyes were emmetropes, 41 were mild myopes and 27 were high myopes, who underwent phacoemulsification. There was an elevation of 2-3mm Hg at Day-1, in emmetropes and mild myopes, and further on, a constant drop was noticed on follow ups. In high myopes a significant fluctuation of IOP was noted in first fourteen days followed by an unremarkable gradual decline afterwards.
Conclusion: Cataract surgery helps lowering the IOP in patients with refractive errors. Mild myopic and emmetropic patients showed a linear swift pattern while high myopes presented instable and gradual reduction in IOP. A total decrease of 1-2mm Hg was seen at the end of the study depicting that relation between IOP and cataract surgery is insignificant.
doi: https://doi.org/10.12669/pjms.36.3.1597
How to cite this:Bodla MA, Bodla AA, Moazzam A, Tariq N. Correlation between changes in intraocular pressure and refractive error indices post Cataract Surgery. Pak J Med Sci. 2020;36(3):574-577. doi: https://doi.org/10.12669/pjms.36.3.1597
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Discriminatory power of Stroke Specific Quality of Life questionnaire items to evaluate the participation component of the International Classification of Functioning, Disability and Health
Authors: Silva Soraia Micaela , Corrêa Fernanda Ishida , de Morais Faria Christina Danielli Coelho , Corrêa João Carlos Ferrari 
Published: February 2020

Background/aims This study aimed to estimate the discriminatory power of 26 items on the Stroke Specific Quality of Life Scale questionnaire to evaluate the participation component of the International Classification of Functioning, Disability and Health. Methods A prospective study was conducted using accuracy procedures based on the Standards for Reporting Diagnostic Accuracy Studies to evaluate individuals with hemiparesis stemming from a stroke. Discriminatory power was estimated based on the area under the receiver operating characteristic curve with a 95% confidence interval. Two groups were defined for the analysis: community-dwelling and institutionalised individuals. A 5% level of significance (α=0.05) was considered for all analyses. Results The area under the receiver operating characteristic curve was 0.888 (95% confidence interval: 0.794–0.949; P=0.001). Analysis indicated a cut-off point of ≥80 with 73.9% sensitivity and 100% specificity. Conclusions The 26 items of the Stroke Specific Quality of Life questionnaire that evaluate the participation component of the International Classification of Functioning, Disability and Health demonstrate adequate discriminatory power. A cut-off point of ≥80 seems to best discriminate the perception of participation between community-dwelling and institutionalised stroke survivors.
Ultra-compact non-volatile Mach–Zehnder switch enabled by a high-mobility transparent conducting oxide
Authors: Parra Jorge , Olivares Irene , Ramos Francisco , Sanchis Pablo 
Published: February 2020

Compact and broadband non-volatile silicon devices are mainly absorption based. Hence, access to low-loss non-volatile phase shifters is still a challenge. Here, this problem is addressed by using a high-mobility transparent conducting oxide such as cadmium oxide as a floating gate in a flash-like structure. This structure is integrated in a Mach–Zehnder interferometer switch. Results show an active length of only 30 µm to achieve a

π

phase shift. Furthermore, an extinction ratio of 20 dB and insertion loss as low as 1 dB may be attained. The device shows an optical broadband response and can be controlled with low-power pulses in the nanosecond range. These results open a new, to the best of our knowledge, way for enabling compact silicon-based phase shifters with non-volatile performance.
Should the Talk be Cheap in Contribution Games?
Authors: Chang Jen-Wen 
Published: February 2020

AbstractThis paper studies the equilibria of contribution games with commitment and with cheap talk under incomplete information. When agents contribute to a club good, we find that with commitment, high types contribute early to induce low types to contribute in later rounds. With cheap talk, low types signal to contribute early but may drop out later if they find the total contributions are low. When there are sufficiently many rounds, we construct a cheap talk equilibrium that implements the ex-post efficient and ex-post individually rational allocation. In contrast, every equilibrium of the commitment game is inefficient. When the good is a public good, the cheap-talk game admits no informative equilibria. In this case, the equilibria of the commitment game may be more efficient.