bluuebunny/crossref_metadata_2025_split huggingface dataset:
Guideline-directed medical therapy in heart failure patients: impact of focused care provided by a heart failure clinic in comparison to general cardiology out-patient department
Authors: Joseph Jeeva , P S Stephy , James Jude , Abraham Suja , Abdullakutty Jabir 
Published: August 2020

AbstractBackgroundThe usage of guideline-directed medical therapy (GDMT) in the treatment of heart failure (HF) has shown to reduce morbidity and mortality. However, majority of the HF patients do not receive GDMT or do not achieve the target dose. Literature has shown that the patients who are managed in HF clinics receive GDMT and target doses of disease-modifying drugs (DMD) when compared to those treated in other general cardiology outpatient departments (OPD’s). It was a retrospective hospital-based study in which patients treated in HF clinic and other cardiology OPD in the year of 2017 were included (200 patients in each arm). The aim of this study was to assess the impact of heart failure clinics in medication therapy management including usage of guideline-directed medical therapy, if target dose specified by the guideline is achieved and time to reach target dose in comparison to other general cardiology OPD’s. IRB and IEC approval were obtained before the commencement of the study. Data relevant to the study were obtained from the electronic medical record (EMR) and were compared between the study groups to see for the adherence to guideline and achievement of target doses. Data storage and analysis were performed using SPSS Version 24. A significance level of 5% was used.ResultsThe usage of GDMT was higher in HF clinic when compared to other cardiology OPD (81% vs 55%,P= 0.001). A significantly higher number of patients in HF clinic achieved target dose when compared to other cardiology OPD (58% vs 29% -betablockers, 45% vs 9% -ACEI/ARB/ARNI,P= 0.000). Moreover, the number of eligible patients receiving DMD was found to be higher in HF clinic (98% vs 85% -betablockers, 69% vs 44% -ACEI/ARB/ARNI, 76% vs 44% -MRA). Also, the patients in HF clinic attained the target doses faster when compared to other cardiology OPD. In addition, there was better improvement in ejection fraction, as well as decreased rate of rehospitalisation and mortality in patients managed in HF clinic.ConclusionHF clinics were compared with other cardiology OPD for various parameters and it was observed that HF clinics were better than other cardiology OPD in maintaining the medication therapy management.
Correlation between quantitative multi-detector computed tomography lung analysis and pulmonary function tests in chronic obstructive pulmonary disease patients
Authors: Abd elsalam Sahar Mahmoud , Hafez Mai , Mohmed Maha Fathy , Said Ahmed Hesham 
Published: August 2020

Abstract
Background
Chronic obstructive pulmonary disease [COPD] is a very common disease in developing as well as in developed countries. Using CT has a growing interest to give a phenotypic classification helping the clinical characterization of COPD patients. So, the aim of the present study was to evaluate whether there was a significant correlation between quantitative computed tomography lung analysis and pulmonary function tests in chronic obstructive pulmonary disease patients.

Results
The study included 50 male patients with a mean age of 62.82 years ± 8.65 years standard deviation [SD]. Significant correlation was found between the pulmonary function tests [FEV1 and FEV1/FVC ratio], and all parameters of quantitative assessment with – 950 HU [the percentage of low-attenuation areas (% LAA)]. Pulmonary function tests according to GOLD [Global Initiative for Chronic Obstructive Lung Disease] guidelines revealed that 4% had normal pulmonary function, 8% had mild obstructive defect, 32% had moderate obstructive defect, 26% had severe obstructive defect, and 30% had very severe obstructive defect.

Conclusion
Automated CT densitometry defining the emphysema severity was significantly correlated with the parameters of pulmonary function tests and providing an alternative, quick, simple, non-invasive study for evaluation of emphysema severity. Its main importance was the determination of the extent and distribution of affected emphysematous parts of the lungs especially for selecting the patients suitable for the lung volume reduction surgery.
Value of using adaptive statistical iterative reconstruction-V (ASIR-V) technology in pediatric head CT dose reduction
Authors: Sherif Fatma Mohamed , Said Ayman Mokhtar , Elsayed Yara Nagi , Elmogy Sabry Alameldeen 
Published: August 2020

Abstract
Background
With widespread use of pediatric head CT, it is critically important to protect patients from radiation hazards, using reduced dose CT techniques. In this regard, adaptive statistical iterative reconstruction-V (ASIR-V) algorithm can decrease image noise, generating CT images of reasonable diagnostic quality with less radiation. The objective of this study was radiation dose assessment, quantitative and qualitative evaluation of reduced dose pediatric head CT using ASIR-V 60% and 80% reconstruction.

Results
Retrospective analysis was performed on two groups of pediatric head CT examinations, a reduced dose CT examination group with ASIR-V reconstruction (ASIR group) (n = 27) and a standard dose CT examination group without ASIR reconstruction (non-ASIR group) (n = 14). The average effective dose (ED) of ASIR group was significantly lower than that of the non-ASIR group (1.04 ± 0.1 mS vs 3.48 ± 0.45 mS; p = 0.001). Quantitative analysis revealed comparable results of signal to noise ratio (SNR) and contrast to noise ratio (CNR) of ASIR and non-ASIR groups (p > 0.05). Qualitative evaluation of resulting images by two readers revealed comparable results of both ASIR and non-ASIR groups (p > 0.05) with excellent inter-reader agreement (κ = 0.97). Both quantitative and qualitative assessment demonstrated better ASIR-V 80% than ASIR-V 60% reconstructed images.

Conclusion
ASIR-V algorithm is a promising technology for effective dose reduction of pediatric head CT with preservation of diagnostic image quality.
Compulsory admissions of patients with mental disorders: State of the art on ethical and legislative aspects in 40 European countries
Authors: Wasserman D. , Apter G. , Baeken C. , Bailey S. , Balazs J. , Bec C. , Bienkowski P. , Bobes J. , Ortiz M. F. Bravo , Brunn H. , Bôke Ö. , Camilleri N. , Carpiniello B. , Chihai J. , Chkonia E. , Courtet P. , Cozman D. , David M. , Dom G. , Esanu A. , Falkai P. , Flannery W. , Gasparyan K. , Gerlinger G. , Gorwood P. , Gudmundsson O. , Hanon C. , Heinz A. , Dos Santos M. J. Heitor , Hedlund A. , Ismayilov F. , Ismayilov N. , Isometsä E. T. , Izakova L. , Kleinberg A. , Kurimay T. , Reitan S. Klæbo , Lecic-Tosevski D. , Lehmets A. , Lindberg N. , Lundblad K. A. , Lynch G. , Maddock C. , Malt U.F. , Martin L. , Martynikhin I. , Maruta N. O. , Matthys F. , Mazaliauskiene R. , Mihajlovic G. , Peles A. Mihaljevic , Miklavic V. , Mohr P. , Ferrandis M. Munarriz , Musalek M. , Neznanov N. , Ostorharics-Horvath G. , Pajević I. , Popova A. , Pregelj P. , Prinsen E. , Rados C. , Roig A. , Kuzman M. Rojnic , Samochowiec J. , Sartorius N. , Savenko Y. , Skugarevsky O. , Slodecki E. , Soghoyan A. , Stone D. S. , Taylor-East R. , Terauds E. , Tsopelas C. , Tudose C. , Tyano S. , Vallon P. , Van der Gaag R. J. , Varandas P. , Vavrusova L. , Voloshyn P. , Wancata J. , Wise J. , Zemishlany Z. , Öncü F. , Vahip S. 
Published: August 2020

AbstractBackground.Compulsory admission procedures of patients with mental disorders vary between countries in Europe. The Ethics Committee of the European Psychiatric Association (EPA) launched a survey on involuntary admission procedures of patients with mental disorders in 40 countries to gather information from all National Psychiatric Associations that are members of the EPA to develop recommendations for improving involuntary admission processes and promote voluntary care.Methods.The survey focused on legislation of involuntary admissions and key actors involved in the admission procedure as well as most common reasons for involuntary admissions.Results.We analyzed the survey categorical data in themes, which highlight that both medical and legal actors are involved in involuntary admission procedures.Conclusions.We conclude that legal reasons for compulsory admission should be reworded in order to remove stigmatization of the patient, that raising awareness about involuntary admission procedures and patient rights with both patients and family advocacy groups is paramount, that communication about procedures should be widely available in lay-language for the general population, and that training sessions and guidance should be available for legal and medical practitioners. Finally, people working in the field need to be constantly aware about the ethical challenges surrounding compulsory admissions.
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results
Authors: Schuster S. J. , Neelapu S. S. , Gause B. L. , Muggia F. M. , Gockerman J. P. , Sotomayor E. M. , Winter J. N. , Flowers C. R. , Stergiou A. M. , Kwak L. W. 
Published: August 2020

2 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]
Preferential pathologic complete response (pCR) in HER-2 positive and triple-negative breast cancer to sequential FEC 100- docetaxel (T) neoadjuvant chemotherapy (NCT) in stage II-III operable breast cancer
Authors: Dubray P. , Durando X. , Abrial C. , Mouret-Reynier M. , Nayl B. , Thivat E. , Gimbergues P. , Achard J. , Chollet P. , Penault-Llorca F. 
Published: August 2020

e11502 Background: NCT is increasingly used for operable breast cancer to allow breast conservation. Our objective was to evaluate clinical and pathological response after sequential NCT of FEC 100-T. This chemotherapy is currently the reference in the adjuvant setting in France.In PACS 01 trial (Roche et al. J Clin Oncol, 2006) FEC followed by T significantly improved 5 years overall survival rates (90.7%) compared to 6 FEC 100 in node-positive breast cancer. However this combination has not yet been evaluated in NCT. Methods: 101 patients (pts) from February 2005 to September 2008 with stage II-III operable breast cancer received 3 cycles (c) of FEC 100 (epirubicin 100 mg/m2 + 5-fluorouracil and cyclophosphamide 500mg/m2) followed by 3 c of T (100mg/m2) every 3 weeks. pCR was defined according to Chevallier's (Am J Clin Oncol, 1993) as level 1 and 2 and to Sataloff's classification (J Am Coll Surg, 1995) as grade A. A clinical, mammography and ultrasound breast evaluation was performed at baseline, after 3 or 4 c and before surgery. Results: Median age was 52.3 years [32–71]. Median diameter of the tumor was 42 mm [15–100]. 83 pts had a ductal, 14 a lobular, 3 ductal and lobular, 1 another carcinoma. 8.9% were grade I SBR, 58.4% grade II SBR, 28.7% grade III SBR and 4% unspecified. 74 (73.3%) tumors were HR+, 9(8.9%) Her-2 + and 18(17.8%) triple negative. Ultrasound objective response rate (ORR) was 66.3%: 6 pts had a complete response and 53 pts had a partial response. 77pts (76.2%) underwent breast-conserving surgery After the completion of NCT, complete histologic data were available for 92 pts. 10 (10.8%) achieved pCR using Chevallier's classification and 9 (9.8%) using Sataloff's classification. The pCR rate was superior in triple negative (4/12) and Her2+ (2/6) tumors than in patients with HR+/Her-2- according to Chevallier's classification (p=0.034) and to Sataloff's classification (p=0.014). Conclusions: Sequential NCT with FEC followed by T was active and significantly improved pCR in patients with triple negative and Her-2+ tumors without an anti-Her2 specific biological agent. Breast-conserving rate appeared satisfactory. No significant financial relationships to disclose.
Who benefits from taxanes?
Authors: Piccart-Gebhart M. J. , Bedard P. L. 
Published: August 2020

e11503 Over the last fifteen years, 21 clinical trials randomized nearly 36,000 women with early-stage breast cancer to taxane-based versus non-taxane-based adjuvant chemotherapy regimens to establish the role of taxanes in early breast cancer therapy. Preliminary results from the Oxford Overview –pooling individual patient data from some of these studies –suggest that the inclusion of a taxane to an anthracycline-based regimen reduces 10-year breast cancer related mortality by an absolute value of 5% over anthracycline therapy alone. In spite of this enormous global research effort, there remains considerable uncertainty regarding which patients benefit from taxane therapy. Three recent meta-analyses indicate that taxanes are beneficial irrespective of age, lymph node involvement, and hormonal receptor expression. Unfortunately, differences in trial design, pathological evaluation, and outcome reporting limit the robustness of these findings. Individual studies have suggested that patients with HER-2 positive disease derive greater benefit from taxane therapy, although the methods used to assess HER-2 status have been heterogeneous and there is no clear biological rationale to account for differential benefit in this subset. A number of promising predictive molecular markers related to taxane metabolism, microtubule dynamics, and intracellular signaling warrant further evaluation using biospecimens collected from the first-generation taxane trials. Future clinical trials should account for the molecular heterogeneity of breast cancer, by excluding the chemotherapy insensitive luminal A subset and mandating upfront central pathological assessment to further optimize the role of taxane therapy in early-stage disease. No significant financial relationships to disclose.
Preliminary safety results from a multicenter phase II trial of nanoparticle albumin-bound paclitaxel/cyclophosphamide in early stage breast cancer plus trastuzumab in HER-2+ patients (pts)
Authors: Raefsky E. , Inhorn R. , Lange M. , Peacock N. , Shastry M. , Vazquez E. , Priego V. , Franco L. , Hainsworth J. D. , Yardley D. A. 
Published: August 2020

e11509 Background: Docetaxel/cyclophosphamide has demonstrated superior disease free and overall survival compared to doxorubicin/cyclophosphamide in the treatment of early stage breast cancer with an acceptable safety profile, with grade (G) 3/4 neutropenia of 61% and no cardiotoxicity. Nanoparticle albumin-bound (nabtm)-paclitaxel (nab-P) is a novel formulation with demonstrated superior efficacy to conventional paclitaxel (P) in treatment of metastatic breast cancer with a comparable safety profile. We therefore conducted a multicenter phase II pilot trial of weekly nab-P/cyclophosphamide to assess the safety and tolerability of this combination in early stage breast cancer. Methods: Eligibility: T1–4pN0–3M0, ECOG PS 0–2, normal organ function, normal LVEF for pts receiving trastuzumab (T). Treatment consisted of nab-P 100 mg/m2 day (D) 1, 8, 15 with cyclophosphamide (C) 600 mg/m2 D1 q 21 days x 4 cycles. T was given in IHC 3+ or FISH HER2+ pts with an 8 mg/kg loading dose followed by 6mg/kg q21D x 52 weeks. Results: 63 pts enrolled from April 2008 through September 2008; 33 pts are evaluable for safety with a median of 2 cycles. Baseline characteristics: median age 57 years (range 33–76); ECOG PS 0–94%, T1-T2 tumors - 100%, node negative 61%, hormone receptor negative 33%, HER 2+ 15%, triple negative 27%, ductal histology 73%, premenopausal 37 %. nab-P dose modifications occurred in 10 of 33 pts with nab-P reductions in 2 pts: 1 each due to G3 neutropenia- cycle 2 and G3 neuropathy- cycle 4. All 8 nab-P treatment delays were due to G3 neutropenia at D15. G3/4 neutropenia was present in 30% with only 1 G4 episode. 1 pt utilized myeloid colony stimulating factors. There were no G3/4 non-heme toxicities present in > 5 % of pts and no LVEF declines in pts receiving T. 17 pts remain on study with 3 pts receiving T. Conclusions: The combination of weekly nab-P with cyclophosphamide is feasible and well tolerated with an acceptable safety profile as adjuvant therapy for early stage breast cancer. The addition of T to this combination did not create any safety concerns. Full safety data for the 63 pts will be updated at the time of the meeting. [Table: see text]
Interim analysis of the multicenter phase II HEDON trial evaluating pathological response to pre-operative docetaxel and docetaxel+trastuzumab (T) in locally advanced breast cancer (BR) stratified by HER2-status
Authors: Paepke S. , Kiechle M. , Paepke D. , Klein E. , Warm M. , Augustin D. , Camara O. , Nährig J. , Kates R. , Harbeck N. 
Published: August 2020

e11512 Background: Docetaxel is the most effective mono-substance in metastatic BC and highly effective in adjuvant chemotherapy. Early docetaxel-monotherapy data in primary systemic therapy (PST) showed a pCR of 18% (Amat et al; 2003), comparable with pCR-rates of standard PST combination chemotherapy. HEDON was conducted to evaluate efficacy of docetaxel ± T with regard to pCR (defined as absence of invasive and non-invasive BC in breast and lymph nodes) as primary endpoint; secondary endpoints were safety, breast conservation rate and 5-yr DFS. Additionally Trans-HEDON includes a translational research program to identify molecular RNA and methylation (DNA) based markers of response to docetaxel-monotherapy. Methods: From 2006 until 2008, the multicenter phase II HEDON trial fully recruited 93 pts, with therapy still ongoing; tumor stages: T2 (23), T3 (11), T4 (5); nodal status: N0 (16), N1–2 (23). Arm A: Docetaxel (100 mg/m2x6) in HER2-negative (n=60) and Arm B: Docetaxel (100 mg/m2x6) in combination with T (18x2mg/kg KG) preoperatively in HER2-overexpressed BC (n=33), followed by surgery and then by adjuvant epirubicin/cyclophosphamide (E90Cx4), radiotherapy if indicated, T for altogether one year, and endocrine therapy in ER+ and/or PgR+ BC. Pre-planned interim analysis (safety and efficacy) was performed after recruitment of 39 pts (Arm A 26, Arm B 13). Results: In Arm A, 7 pts. (26.9%) achieved pCR and 9 pts. (34.6%) pPR. In Arm B, 7 pts. (53.8%) achieved pCR and all 6 others (46.2%) pPR. Neutropenia occurred in 11 pts. (8 with grade 3). Moderate (25%) dose reduction was necessary in 13 pts., and 50% dose reduction in one patient. Conclusion: According to interim analysis of the HEDON trial, docetaxel-monotherapy of 6 cycles at 100mg/m2 q21 (plus T in HER2-positive BC) is an effective and safely administrable PST. There were no unexpected toxicities, and preliminary pCR rates in HER2-neg (26.9%) and HER2-pos (53.8%) pts. were comparable to those of combination chemotherapy. These interim results will be completed by final analysis on the full collective, with molecular predictors from TransHEDON hopefully identifying patients who derive extensive benefit. [Table: see text]
HER-2 central confirmatory testing using ASCO/CAP guidelines for trastuzumab/lapatinib trial MCCR RC0639
Authors: McCullough A. , Dueck A. , Chen B. , Reinholz M. , Wiktor A. , Lingle W. , Jenkins R. , Perez E. 
Published: August 2020

e11527 Background: 118 Her2 positive invasive carcinomas were retested centrally at the Mayo Clinic for Her2 status confirmation prior to inclusion in Mayo Clinic Cancer Research Consortium study RC0639 phase II study of cardiac safety and tolerability of adjuvant chemotherapy plus trastuzumab with lapatinib for resected Her2+ breast cancer (MCCRC RC0639). Methods: Central confirmatory methods were immunohistochemical (IHC) Dako HercepTest on a Dako Autostainer using the manufacturer's recommendations and HercepTest kit epitrope retrieval kit and fluorescent in situ hybridization (FISH) using Vysis PathVysion probe kit. Test results are interpreted using ASCO/CAP guidelines (IHC >30%, Her2:CEP 17 ratio >2.2). Results: There is local and central test 3+ IHC concordance in 48 of 53 tumors (agreement 90.6%) and FISH amplification in 29 of 33 tumors (agreement 87.9%), improved or similar results using identical methods to results in NCCTG N9831 adjuvant trial (n=1063, 81.6% IHC; n=813, 88.1% FISH). Of 92 centrally tested 3+ IHC positive tumors, 88 (95.7%) were FISH amplified. 5 centrally tested patients interpreted as Her2 positive by pre-ASCO/CAP guidelines (IHC >10%; HER2:CEP17 ratio >2) are Her2 ineligible using ASCO/CAP guidelines. IHC not confirmed centrally was reviewed by a second pathologist in 16 of 118 specimens. IHC concordance between two central pathologists was 10/16 (62.5%) in negative or equivocal (≤30% IHC staining) specimens; 7/10 (70%) with two reader agreement were FISH amplified and 4/6 (66%) with disagreement were FISH amplified. Conclusions: Concordance in IHC and FISH results between local and central labs is similar or improved since N9831. New ASCO/CAP Her2 testing guidelines change eligibility based on Her2 status in 4.2 % of patients. Equivocal IHC results falling between pre- and post- ASCO/CAP IHC positive thresholds (>10% and <30% IHC strong staining) are only partially resolved by repeat IHC review and/or FISH testing. No significant financial relationships to disclose.
Current status of treatment of local recurrence and distant metastasis of triple negative breast cancer in Japanese population
Authors: Osako T. , Nishimura R. , Okumura Y. , Hayashi M. 
Published: August 2020

e11548 Background: Triple-negative breast cancers have an aggressive clinical history such as high incidence of visceral metastases, high rate of cerebral metastases, high rate of local recurrence, and early age of onset. However, there are limited long-term clinical data evaluating outcomes of locoregional and systemic therapy. The purpose of this study was to evaluate the clinical outcome of current therapy with TNBC retrospectively. Methods: From the medical records of our hospital, we retrospectively reviewed breast cancer patients whose three markers were available and describe the relationship between current therapy and clinical outcome. Results: Between 1998 and 2007, 1967 breast cancer patients were treated in Kumamoto City Hospital. Of 1967 patients, 264 (13.4%) were classified as TNBC by immunohistochemical technique. As of December 2008, with a median follow-up time of 31months, 53 patients (20.0%) with TNBC had locoregional recurrences or distant metastases (17 local recurrences, 15 nodal recurrences, 44 distant metastases). Forty out of 53 patients with recurrent TNBCs had adjuvant or neoadjuvant chemotherapy around surgery. Of 53 patients with recurrences, 31 had initial locoregional recurrence and 19 had initial distant metastases. Forty two patients had already been dead and common causes of death were lung metastases (19 patients), liver metastases (11 patients), and brain metastases (8 patients). Patients with TNBCs had a poorer 5 year-survival compared with those with non-TNBCs. Furthermore, patients with initial distant metastases had significantly poorer survival than those with initial locoregional recurrence (p=0.015). Focusing on chemotherapy, no specific cytotoxic agent had high effectiveness for recurrent TNBCs. However, patients who had responded to first regimens had a tendency to respond to the next regimens. Conclusions: TNBC had an aggressive behavior and poorer prognosis. However, TNBC with locoregional recurrence and benefits from the first regimen had favorable prognosis. Therefore, to distinguish the subgroup that respond to chemotherapy might contribute to the prolongation of survival of in TNBC. No significant financial relationships to disclose.