tbuckley/cabot-search huggingface dataset:
Financial interests of patient organisations contributing to technology assessment at England’s National Institute for Health and Care Excellence: policy review
Authors: Kate L Mandeville, Rosie Barker, Alice Packham, Charlotte Sowerby, Kielan Yarrow, Hannah Patrick
Journal: BMJ (2019)

To investigate the prevalence of financial interests among patient organisations contributing to health technology assessment at the National Institute for Health and Care Excellence (NICE) in England and the extent to which NICE's disclosure policy ensures that decision making committees are aware of these interests.Policy review using accounts, annual reports, and websites of patient organisations; payments declared by pharmaceutical manufacturers on their websites and a centralised database (Disclosure UK); declarations of interests by nominated representatives of patient organisations; and responses from patient organisations.Appraisals of medicines and treatments (technologies) for use in the English and Welsh National Health Service.53 patient organisations contributing to 41 NICE technology appraisals published in 2015 and 2016, with 117 separate occasions that a patient organisation contributed to the appraisal of a technology.Prevalence of specific interests (that is, funding from manufacturer(s) of a technology under appraisal or competitor products); proportion of specific interests of which NICE's decision making committees were aware; proportion of unknown specific interests for which disclosure was not required by NICE's policy RESULTS: 38/53 (72%) patient organisations had accepted funding from the manufacturer(s) of a technology or a competitor product in the same year that they had contributed to the appraisal of that technology or the previous year. Specific interests were present on 92/117 (79%) occasions that patient organisations contributed to appraisals in 2015 and 2016. NICE's decision making committees were aware of less than a quarter of specific interests (30/144; 21%). For nearly two thirds of the specific interests not known to committees (71/114; 62%), disclosure by patient organisations was not required by NICE's policy.Financial interests are highly prevalent among patient organisations contributing to health technology assessment. NICE should review its disclosure policy to ensure that decision making committees are aware of all relevant interests.
Sofosbuvir and Ribavirin Eradication of Refractory Hepatitis E in an Immunosuppressed Kidney Transplant Recipient
Authors: Mary Drinane, Xiao Jing Wang, Kymberly Watt
Journal: Hepatology (2018)

1Division of Gastroenterology and HepatologyDartmouth‐Hitchcock Medical CenterLebanonNH 2Division of Gastroenterology and HepatologyMayo ClinicRochesterMN *Address Correspondence and Reprint Requests to: Mary Drinane, M.B.B.Ch., Division of Gastroenetology and Hepatology, Dartmouth‐Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756. E‐mail: [email protected]. Tel: +1‐603‐650‐5261, Fax: +1‐603‐650‐5225
O-GlcNAc Transferase Links Glucose Metabolism to MAVS-Mediated Antiviral Innate Immunity
Authors: Tianliang Li, Xinghui Li, Kuldeep S. Attri, Changhong Liu, Lupeng Li, Laura E. Herring, John M. Asara, Yu L. Lei, Pankaj K. Singh, Chengjiang Gao, Haitao Wen
Journal: Cell Host & Microbe (2018)
Strategies of Combination Drug Delivery for Immune Checkpoint Blockades
Authors: Huitong Ruan, Linlin Bu, Quanyin Hu, Hao Cheng, Weiyue Lu, Zhen Gu
Journal: Advanced Healthcare Materials (2018)

Abstract The past few years have witnessed vast clinical accomplishments of immune checkpoint blockades (ICB), which block the regulatory receptor expressed on immune cells or tumor cells to prevent the suppression of antitumor cytotoxic T‐cell responses. Despite this, limitations still exist, such as low objective response rate (ORR) and the risk of immune‐related side effects. To address these issues, combination treatment strategies are vastly explored and recommended. This review summarizes recent advances in combination of ICB with therapies that participate in different stages of cancer immune cycle, including tumor antigen release, tumor antigen presentation, T‐cell activation, recognition of cancer cells by T‐cells, and tumor‐killing activity. Challenges and potential opportunities of combination approaches in this field are also discussed.
Fast-track Radioiodine Ablation Therapy After Thyroidectomy Reduces Sick Leave in Patients With Differentiated Thyroid Cancer (FASTHYNA Trial)
Authors: Farahnaz Waissi, Jakob W. Kist, Lutske Lodewijk, Ardine G. de Wit, Jos A. van der Hage, Thijs van Dalen, Bart de Keizer, Gerlof D. Valk, Inne H. M. Borel Rinkes, Menno R. Vriens
Journal: Clinical Nuclear Medicine (2018)

Recombinant human thyroid stimulating hormone (RhTSH) aided radioiodine ablative therapy (RIT) is current-day practice in the treatment of differentiated thyroid cancer (DTC). It is often planned 4 to 6 weeks after surgery or sometimes even longer (standard protocol). The RhTSH-aided RIT, however, has the advantage that it can be planned shortly after thyroidectomy. The FASTHYNA trial was designed to test the hypothesis that RIT 1 week after thyroidectomy (fast-track protocol) results in a significant reduction of sick leave with lower societal costs and with a better quality of life (QOL) compared with the current standard treatment.In a randomized, multicenter trial, we included patients with differentiated thyroid cancer, stage T1-3 N0-1 M0-x, who were treated with a total or completion thyroidectomy, with a paid job of at least 12 hours per week. The primary study end point was days of sick leave reported from time of surgery. Secondary end points were QOL and societal costs associated with absence from work.Twenty patients were eligible for inclusion between November 2013 and May 2016. Significant decreases in mean duration of sick leave in the fast-track group versus the standard care group (115 and 280 hours, respectively, P = 0.02) and in costs associated with productivity losses (&OV0556;4070.77 vs &OV0556;9202.90, P = 0.02) were found. There were no significant differences in QOL between both groups.The trial showed a significant reduction in sick leave and in societal costs in the fast-track group without a deterioration of QOL. Therefore, fast-track ablation is desirable.Netherlands trial register: NTR 3933.
KEYNOTE-177: Phase 3, open-label, randomized study of first-line pembrolizumab (Pembro) versus investigator-choice chemotherapy for mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal carcinoma (mCRC).
Authors: Luis A. Diaz, Dung T. Le, Takayuki Yoshino, Thierry André, Johanna C. Bendell, Minori Rosales, S. Peter Kang, Bao Lam, Dirk Jäger
Journal: Journal of Clinical Oncology (2018)

TPS877 Background: Approximately 5% of mCRCs are dMMR, leading to high levels of MSI. CRCs with MSI-H have abundant lymphocyte infiltrates and strong expression of immune checkpoints. In the phase 2 KEYNOTE-016 study, the anti–programmed death 1 (PD-1) antibody pembro provided an ORR of 40% in patients (pts) with progressive dMMR mCRC vs 0% in pts with MMR-proficient mCRC. KEYNOTE-177 (ClinicalTrials.gov, NCT02563002) is an international, randomized, open-label, phase 3 study to evaluate the efficacy and safety of pembro vs standard-of-care (SOC) chemotherapy as first-line therapy for dMMR or MSI-H mCRC. Methods: Pts aged ≥18 years with locally confirmed dMMR or MSI-H stage IV CRC, measurable disease per RECIST v1.1 by local site assessment, ECOG performance status 0-1, adequate organ function, no active autoimmune disease or brain metastases, and no prior systemic therapy for mCRC are eligible. Pts will be randomized 1:1 to receive pembro 200 mg every 3 weeks (Q3W) or investigator’s choice of SOC chemotherapy (options include mFOLFOX6 or FOLFIRI alone or in combination with bevacizumab or cetuximab; must be chosen prior to randomization). Treatment will continue until disease progression, unacceptable toxicity, pt/investigator decision to withdrawal, or completion of 35 cycles (pembro only). Response will be evaluated Q9W per RECIST v1.1 by central imaging vendor review and per immune-related RECIST. Pts in the SOC arm who have disease progression and meet crossover criteria may be eligible to receive pembro for up to 17 treatment cycles. Eligible pts may continue pembro after initial RECIST-defined progression. AEs will be assessed throughout treatment and for 30 days thereafter (90 days for serious AEs) and graded per NCI CTCAE v4.0. Pts are to be followed up for survival Q9W. Primary end point is PFS per RECIST v1.1 by central imaging vendor review. Secondary end points include ORR per RECIST v1.1 by central imaging vendor review, OS, and safety and tolerability. Other end points include DOR and HRQoL. Planned enrollment in KEYNOTE-177 is 270 pts across 23 countries. Clinical trial information: NCT02563002.
(Over)eating out at major UK restaurant chains: observational study of energy content of main meals
Authors: Eric Robinson, Andrew Jones, Victoria Whitelock, Bethan R Mead, Ashleigh Haynes
Journal: BMJ (2018)

To examine the energy content of main meals served in major UK restaurant chains and compare the energy content of meals in fast food and "full service" restaurant chains.Observational study.Menu and nutritional information provided by major UK restaurant chains.Mean energy content of meals, proportion of meals meeting public health recommendations for energy consumption (≤600 kcal), and proportion of meals with excessive energy content (≥1000 kcal).Main meals from 27 restaurant chains (21 full service; 6 fast food) were sampled. The mean energy content of all eligible restaurant meals (13 396 in total) was 977 (95% confidence interval 973 to 983) kcal. The percentage of all meals that met public health recommendations for energy content was low (9%; n=1226) and smaller than the percentage of meals with an excessive energy content (47%; 6251). Compared with fast food restaurants, full service restaurants offered significantly more excessively calorific main meals, fewer main meals meeting public health recommendations, and on average 268 (103 to 433) kcal more in main meals.The energy content of a large number of main meals in major UK restaurant chains is excessive, and only a minority meet public health recommendations. Although the poor nutritional quality of fast food meals has been well documented, the energy content of full service restaurant meals in the UK tends to be higher and is a cause for concern.Study protocol and analysis strategy pre-registered on Open Science Framework (https://osf.io/w5h8q/).
Analysis of immune checkpoint- and apoptosis-related lymphocyte markers expression and its association with the prevalence of regulatory lymphocyte populations in the establishment of microinvasive cervical carcinoma
Authors: O.V. Kurmyshkina, T.O. Volkova
Journal: Annals of Oncology (2018)

Background: Disbalance between the activities of different immunosuppressive and immunostimulating populations of regulatory lymphocytes of innate and adaptive immune compartments (such as CD4 Treg, CD8 Treg, NKreg, NK-like T, Tgammadelta) may occur as a result of chronic infection and be the cause of an altered expression of immune checkpoints which control the level of activation and apoptosis in effector lymphocytes. Immune checkpoints and apoptosis are being increasingly recognized as crucial mechanisms of tumor-immunity interaction during cervical cancer progression; however, their involvement in the induction of cervical neoplasia invasion is not well-characterized. Methods: Peripheral blood (PB) and fresh cervical tissue samples were obtained from women with high-grade cervical intraepithelial neoplasia (CIN) or cervical cancer stage IA; PB samples from healthy women were used as control. Subsets of PB lymphocytes were phenotyped using multicolor flow cytometry. Results: Coordinated changes of expression pattern of early apoptotic markers (CD95/CD95L, Annexin V, caspase-3) and immune checkpoint molecules (CD279, CD366, CD223) in PB populations of regulatory and conventional/effector CD4 and CD8 T lymphocytes distinguished by the level CD25 and CD127 expression were observed in patients microinvasive cancer and preinvasive CINs. Analysis of differentiation markers NK-like T, Tgammadelta and NK cells within CD3CD56 subsets indicated the involvement of the innate arm in growing immune disbalance during microcarcinoma development. Interestingly, analysis of transcriptomic data showed no significant increase in the expression of immune checkpoint-related and T/NK cell-activation pathways in samples of frankly invasive cancer compared to preinvasive neoplasia, while Treg differentiation pathway was upregulated. Conclusions: The data suggest that markers and PB lymphocytes analyzed may coordinately contribute to the formation of invasive capacity of cervical neoplastic lesions. Legal entity responsible for the study: Petrozavodsk State University. Funding: Russian Science Foundation (project no: 17-75-10027). Disclosure: All authors have declared no conflicts of interest.
OP0129 Greater trochanteric pain syndrome. ultrasound and clinical correlations
Authors: C Orellana, A Ponce, P Barceló
Journal: Annals of the Rheumatic Diseases (2001)

<h3>Background</h3> Greater trochanteric pain syndrome consists of a common clinical syndrome including ?classical? trochanteric bursitis but also gluteus medius pathology, with main clinical features being pain and tenderness over the lateral aspect of hip. <h3>Objectives</h3> To assess the prevalence of trochanteric bursitis and gluteus medius tendonitis by ultrasound examination, together or in isolation, in patients with greater trochanteric pain syndrome and to investigate whether different clinical features could be related to ultrasound findings. <h3>Methods</h3> 36 (34F/2M) patients with greater trochanteric pain syndrome were studied retrospectively. A coxofemoral or lumbar origin of pain was ruled out in all these patients. The following variables were used: age, disease duration, presence of obesity or leg length inequity, pain type (use-related/at rest) and location (trochanter, buttock or both), Trendelemburg sign and ressted hip abduction or internal rotation, and also the existence of calcifications or significant osteoarthritis changes on X-ray examination. <h3>Results</h3> Acute or chronic signs of gluteus medius tendinitis were found in 22 patients (61%), and inflammatory changes suggesting both trochanteric bursitis and gluteus medius pathology were detected in 12 (33%); isolated trochanteric bursitis was found in only 2 cases (6%). Disease duration was longer in patients with inflammatory changes at both locations (14 mo vs 6 mo, p = 0.018), but there were no differences relating age. No significant clinical features allowed differentiation of the ultrasound findings, although a tendency towards pain location defining the underlying pathology could be observed (p = 0.062 for trochanteric pain, p = 0.09 for buttock pain). Patients showing inflammatory changes in both gluteus and trochanteric bursa on ultrasound tended to be more obese than those without bursitis (p = 0.073) and calcications on X-ray tended to be found more frequently in those with only gluteus medius tendonitis (p = 0.082). <h3>Conclusion</h3> Isolated trochanteric bursitis was rarely found on ultrasound examination in patients with greater trochanteric pain syndrome, but gluteus medius tendon inflammatory changes could be found in the vast majority of cases, most of them without associated trochanteric bursitis. No reliable clinical features could be used to distinguish between ultrasound changes.
Abstract 15213: NAT2 Genotype and Outcomes in the Genetic Sub-Study of the African American Heart Failure Trial (AHeFT)
Authors: Barry E Bleske, Hao-Jie Zhu, Karen Hanley-Yanez, Indrani Halder, Dennis M McNamara
Journal: Circulation (2017)

Introduction: N-acetyl transferase 2 (NAT2) is a hepatic enzyme which plays a major role in the metabolism of hydralazine. A common functional polymorphism exists, T341C (rs1801280), which impacts ...
Snare resection after full-thickness resection device malfunction
Authors: Pardeep Maheshwari, Muhammad Farman, Senthil Palaniappan, Brendan Doyle, Stephen Patchett, Danny Cheriyan
Journal: Endoscopy (2018)

The full-thickness resection device (FTRD; Ovesco) is approved for the endoscopic resection of invasive lesions in the gastrointestinal tract. It has shown particular promise for incompletely resected colonic polyps and for early invasive lesions in frail elderly patients who are poor surgical candidates [1] [2]. The management of technical issues or malfunctions during use of the FTRD is poorly documented in the literature to date. We describe a rare incident of built-in snare breakage during the removal of a transverse colonic lesion in an elderly female patient.
Projecting ESRD Incidence and Prevalence in the United States through 2030
Authors: Keith P. McCullough, Hal Morgenstern, Rajiv Saran, William H. Herman, Bruce M. Robinson
Journal: Journal of the American Society of Nephrology (2018)

Background Population rates of obesity, hypertension, diabetes, age, and race can be used in simulation models to develop projections of ESRD incidence and prevalence. Such projections can inform long-range planning for ESRD resources needs. Methods We used an open compartmental simulation model to estimate the incidence and prevalence of ESRD in the United States through 2030 on the basis of wide-ranging projections of population obesity and ESRD death rates. Population trends in age, race, hypertension, and diabetes were on the basis of data from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey and the US Census. Results The increase in ESRD incidence rates within age and race groups has leveled off and/or declined in recent years, but our model indicates that population changes in age and race distribution, obesity and diabetes prevalence, and ESRD survival will result in a 11%–18% increase in the crude incidence rate from 2015 to 2030. This incidence trend along with reductions in ESRD mortality will increase the number of patients with ESRD by 29%–68% during the same period to between 971,000 and 1,259,000 in 2030. Conclusions The burden of ESRD will increase in the United States population through 2030 due to demographic, clinical, and lifestyle shifts in the population and improvements in RRT. Planning for ESRD resource allocation should allow for substantial continued growth in the population of patients with ESRD. Future interventions should be directed to preventing the progression of CKD to kidney failure.
Abstract 17660: Association Between Prehospital Oxygen Administration and Mortality in Severe Trauma Patients (PROMIS): Multicenter Propensity-Matched Cohort Study
Authors: Yutaka Kondo, Koichiro Gibo, Toshikazu Abe, Hiroshi Sekiguchi, Tatsuma Fukuda, Ichiro Kukita
Journal: Circulation (2017)

Introduction: We routinely give oxygen for trauma patients in prehospital settings although there are no obvious evidences of the efficacy. We want to clarify whether prehospital oxygen administrat...
Selinexor, a First-in-Class XPO1 Inhibitor, Is Efficacious and Tolerable in Patients with Myelodysplastic Syndromes Refractory to Hypomethylating Agents
Authors: Justin Taylor, Morgan Coleman, Kelsey Alvarez, Janine Pichardo, Filiz Sen, Stephen S. Chung, Raajit K. Rampal, Jae H. Park, Eytan M. Stein, Martin S. Tallman, Omar I Abdel-Wahab, Virginia M. Klimek
Journal: Blood (2018)
Physicians’ Voices on Gun Violence and Other Important Public Health Issues
Authors: Sandro Galea
Journal: JAMA (2018)

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Factors Associated With Outcomes of Patients With Primary Sclerosing Cholangitis and Development and Validation of a Risk Scoring System
Authors: Elizabeth C. Goode, Allan B. Clark, George F. Mells, Brijesh Srivastava, Kelly Spiess, William T.H. Gelson, Palak J. Trivedi, Kate D. Lynch, Edit Castren, Mette N. Vesterhus, Tom H. Karlsen, Sun‐Gou Ji, Carl A. Anderson, Douglas Thorburn, Mark Hudson, Michael A. Heneghan, Mark A. Aldersley, Andrew Bathgate, Richard N. Sandford, Graeme J. Alexander, Roger W. Chapman, Martine Walmsley, Gideon M. Hirschfield, Simon M. Rushbrook
Journal: Hepatology (2018)

We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real‐world clinical setting. Analyzing data from 1,001 patients recruited to the UK‐PSC research cohort, we evaluated clinical variables for their association with 2‐year and 10‐year outcome through Cox‐proportional hazards and C‐statistic analyses. We generated risk scores for short‐term and long‐term outcome prediction, validating their use in two independent cohorts totaling 451 patients. Thirty‐six percent of the derivation cohort were transplanted or died over a cumulative follow‐up of 7,904 years. Serum alkaline phosphatase of at least 2.4 × upper limit of normal at 1 year after diagnosis was predictive of 10‐year outcome (hazard ratio [HR] = 3.05; C = 0.63; median transplant‐free survival 63 versus 108 months; P < 0.0001), as was the presence of extrahepatic biliary disease (HR = 1.45; P = 0.01). We developed two risk scoring systems based on age, values of bilirubin, alkaline phosphatase, albumin, platelets, presence of extrahepatic biliary disease, and variceal hemorrhage, which predicted 2‐year and 10‐year outcomes with good discrimination (C statistic = 0.81 and 0.80, respectively). Both UK‐PSC risk scores were well‐validated in our external cohort and outperformed the Mayo Clinic and aspartate aminotransferase‐to‐platelet ratio index (APRI) scores (C statistic = 0.75 and 0.63, respectively). Although heterozygosity for the previously validated human leukocyte antigen (HLA)‐DR*03:01 risk allele predicted increased risk of adverse outcome (HR = 1.33; P = 0.001), its addition did not improve the predictive accuracy of the UK‐PSC risk scores. Conclusion: Our analyses, based on a detailed clinical evaluation of a large representative cohort of participants with PSC, furthers our understanding of clinical risk markers and reports the development and validation of a real‐world scoring system to identify those patients most likely to die or require liver transplantation.