1,751 results on '"Stein, Mark A."'
Search Results
2. Sustainable food procurement in public catering : comparison of the UK with Denmark & Sweden
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Stein, Mark
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The research compares sustainable food procurement in public catering in three countries: Denmark, Sweden and the UK. The greatest difference between the UK and the other two countries was the very much higher percentage of organic food in Denmark and Sweden. Within Europe Denmark and Sweden are leaders in organic food consumption - both in the overall market and in public procurement. The rest of Europe - apart from the UK - appears to be going in the same direction. The PhD research examines Denmark and Sweden's achievements. It shows that Danish local authorities have often measured the percentage of organic food by weight rather than value. This means that the well-publicised achievements of the City of Copenhagen since 2001 in increasing organic food in its public kitchens to 88% are difficult to compare with that of local authorities in other countries which measure organic food by value. The achievements of Sweden in increasing organic food in its public kitchens from 2.5% in 2004 to 38% in 2020 are arguably more impressive but have had less academic recognition and international publicity. As regards procurement arrangements, Sweden is de-centralised with its 290 kommunes buying food singly or in small groupings and with a strong emphasis on local procurement. Denmark by contrast is highly centralised with a single national contract, although there are some local procurement initiatives. In the UK most food procurement is carried out through large city, sub-regional and regional contracts The move to increased cooking from fresh ingredients and seasonal menus has been a common feature of public kitchens in all three countries. Reducing meat has also been a common theme , although in rural parts of Denmark there has been controversy over the absence of vegetarian alternatives. Emphasis on reducing food waste has been very considerable in Sweden, significant in Denmark and rather limited in the UK. There has been much greater emphasis on measuring and reducing carbon footprint in Sweden than in Denmark or the UK. School food quality standards in Denmark and Sweden have improved. In England, by contrast, widespread outsourcing to private caterers has undercut local authority catering organisations and undermined school food quality. In the last two years school food in Scotland has diverged increasingly from England - with no outsourcing, improved quality standards and extra money for universal primary free meals. The research has thrown light on many issues not hitherto covered in academic literature. It proposes a framework for analysing public sector food procurement which could be used to analyse policies in any country.
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- 2022
3. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder
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Faraone, Stephen V, Banaschewski, Tobias, Coghill, David, Zheng, Yi, Biederman, Joseph, Bellgrove, Mark A, Newcorn, Jeffrey H, Gignac, Martin, Al Saud, Nouf M, Manor, Iris, Rohde, Luis Augusto, Yang, Li, Cortese, Samuele, Almagor, Doron, Stein, Mark A, Albatti, Turki H, Aljoudi, Haya F, Alqahtani, Mohammed MJ, Asherson, Philip, Atwoli, Lukoye, Bölte, Sven, Buitelaar, Jan K, Crunelle, Cleo L, Daley, David, Dalsgaard, Søren, Döpfner, Manfred, Espinet, Stacey, Fitzgerald, Michael, Franke, Barbara, Gerlach, Manfred, Haavik, Jan, Hartman, Catharina A, Hartung, Cynthia M, Hinshaw, Stephen P, Hoekstra, Pieter J, Hollis, Chris, Kollins, Scott H, Kooij, JJ Sandra, Kuntsi, Jonna, Larsson, Henrik, Li, Tingyu, Liu, Jing, Merzon, Eugene, Mattingly, Gregory, Mattos, Paulo, McCarthy, Suzanne, Mikami, Amori Yee, Molina, Brooke SG, Nigg, Joel T, Purper-Ouakil, Diane, Omigbodun, Olayinka O, Polanczyk, Guilherme V, Pollak, Yehuda, Poulton, Alison S, Rajkumar, Ravi Philip, Reding, Andrew, Reif, Andreas, Rubia, Katya, Rucklidge, Julia, Romanos, Marcel, Ramos-Quiroga, J Antoni, Schellekens, Arnt, Scheres, Anouk, Schoeman, Renata, Schweitzer, Julie B, Shah, Henal, Solanto, Mary V, Sonuga-Barke, Edmund, Soutullo, César, Steinhausen, Hans-Christoph, Swanson, James M, Thapar, Anita, Tripp, Gail, van de Glind, Geurt, van den Brink, Wim, Van der Oord, Saskia, Venter, Andre, Vitiello, Benedetto, Walitza, Susanne, and Wang, Yufeng
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Epidemiology ,Health Sciences ,Behavioral and Social Science ,Mental Illness ,Brain Disorders ,Clinical Research ,Attention Deficit Hyperactivity Disorder (ADHD) ,Mental Health ,Comparative Effectiveness Research ,Pediatric ,Mental health ,Attention Deficit Disorder with Hyperactivity ,Humans ,Network Meta-Analysis ,Publication Bias ,ADHD ,Diagnosis ,Treatment ,Course ,Outcome ,Genetics ,Brain ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Behavioral Science & Comparative Psychology ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundMisconceptions about ADHD stigmatize affected people, reduce credibility of providers, and prevent/delay treatment. To challenge misconceptions, we curated findings with strong evidence base.MethodsWe reviewed studies with more than 2000 participants or meta-analyses from five or more studies or 2000 or more participants. We excluded meta-analyses that did not assess publication bias, except for meta-analyses of prevalence. For network meta-analyses we required comparison adjusted funnel plots. We excluded treatment studies with waiting-list or treatment as usual controls. From this literature, we extracted evidence-based assertions about the disorder.ResultsWe generated 208 empirically supported statements about ADHD. The status of the included statements as empirically supported is approved by 80 authors from 27 countries and 6 continents. The contents of the manuscript are endorsed by 366 people who have read this document and agree with its contents.ConclusionsMany findings in ADHD are supported by meta-analysis. These allow for firm statements about the nature, course, outcome causes, and treatments for disorders that are useful for reducing misconceptions and stigma.
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- 2021
4. Restless sleep disorder in children with attention-deficit/hyperactivity disorder.
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Kapoor, Vidhi, Ferri, Raffaele, Stein, Mark, Ruth, Chris, Reed, Jennifer, and DelRosso, Lourdes
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attention-deficit/hyperactivity disorder ,children ,restless sleep disorder ,Attention Deficit Disorder with Hyperactivity ,Child ,Female ,Humans ,Male ,Polysomnography ,Restless Legs Syndrome ,Retrospective Studies ,Sleep Wake Disorders - Abstract
STUDY OBJECTIVES: Restless sleep is a very common parental complaint in children with attention-deficit/hyperactivity disorder (ADHD), but restless sleep has been seen in association with other comorbidities such as restless legs syndrome and obstructive sleep apnea. Restless sleep disorder (RSD) needs to be identified from other disorders when evaluating children with ADHD. In this study we aim to identify the prevalence of RSD in children with ADHD referred to our sleep center. METHODS: This is a retrospective study of children with ADHD who underwent polysomnography. The following diagnostic and descriptive data were obtained for each patient: age, sex, presence/absence of RSD, other sleep disorders, psychiatric comorbidities, and medications. RSD was diagnosed per diagnostic criteria. RESULTS: There were 66 children with ADHD. All of them underwent polysomnography, 17 were females, and 49 were males. Mean age was 11.6 years (± 3.6 standard deviation). The complaint of restless sleep was reported by the parents of 54 (81.1%) of the children; however, only 6 of them (9.1%) were diagnosed with RSD. Seventy-one percent had obstructive sleep apnea and 19.7% had restless legs syndrome. A significant number of patients had psychiatric comorbidities and were on various medications. CONCLUSIONS: Although restless sleep is a common complaint reported in 81.1% of children with ADHD, only 9.1% had RSD. Most causes of restless sleep are secondary and associated with other sleep disorders, psychiatric comorbidities, or medication use.
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- 2021
5. Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer.
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Yuh, Bertram E, Kwon, Young Suk, Shinder, Brian M, Singer, Eric A, Jang, Thomas L, Kim, Sinae, Stein, Mark N, Mayer, Tina, Ferrari, Anna, Lee, Nara, Parikh, Rahul R, Ruel, Nora, Kim, Wun-Jae, Horie, Shigeo, Byun, Seok-Soo, Ahlering, Thomas E, and Kim, Isaac Yi
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Clinical trial ,Cytoreduction ,Metastasis ,Prostate cancer ,Clinical Sciences ,Oncology and Carcinogenesis - Abstract
Background:Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. Methods:From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. Results:The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa . Yet, there may be a small subset of patients in whom surgery may cause a significant harm. Conclusion:Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.
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- 2019
6. Everolimus Exposure as a Predictor of Toxicity in Renal Cell Cancer Patients in the Adjuvant Setting: Results of a Pharmacokinetic Analysis for SWOG S0931 (EVEREST), a Phase III Study (NCT01120249).
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Synold, Timothy W, Plets, Melissa, Tangen, Catherine M, Heath, Elisabeth I, Palapattu, Ganesh S, Mack, Philip C, Stein, Mark N, Meng, Maxwell V, Lara, Primo, Vogelzang, Nicholas J, Thompson, Ian Murchie, and Ryan, Christopher W
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Renal cell carcinoma ,adjuvant chemotherapy ,everolimus ,pharmacokinetics ,therapeutic drug monitoring - Abstract
BackgroundS0931 is assessing recurrence-free survival in renal cell carcinoma (RCC) patients randomized to receive everolimus (EVE) versus placebo for one year following nephrectomy. Due to a higher than expected dropout rate, we assessed EVE trough levels in the adjuvant setting to evaluate the relationship between EVE exposure and probability of toxicity.MethodsPatients received 10 mg daily EVE for nine 6-week cycles. Pre-dose whole blood samples were collected pre-cycle 2 and pre-cycle 3 and analyzed for EVE. Patients with pre-cycle 2 and/or pre-cycle 3 EVE results were used in the analysis. Patients were segregated into quartiles (Q) based on EVE levels and logistic regression was used to model the most common adverse event outcomes using EVE trough as a predictor. Hazard and odds ratios were adjusted for age, BMI and performance status.ResultsA total of 467 patients were included in this analysis. Quartiles normalized to an EVE dose of 10 mg/day were 22.8 ng/mL, respectively. EVE trough levels increased with increasing age (p
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- 2019
7. Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012
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Hussain, Maha, Daignault-Newton, Stephanie, Twardowski, Przemyslaw W, Albany, Costantine, Stein, Mark N, Kunju, Lakshmi P, Siddiqui, Javed, Wu, Yi-Mi, Robinson, Dan, Lonigro, Robert J, Cao, Xuhong, Tomlins, Scott A, Mehra, Rohit, Cooney, Kathleen A, Montgomery, Bruce, Antonarakis, Emmanuel S, Shevrin, Daniel H, Corn, Paul G, Whang, Young E, Smith, David C, Caram, Megan V, Knudsen, Karen E, Stadler, Walter M, Feng, Felix Y, and Chinnaiyan, Arul M
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Genetics ,Prostate Cancer ,Cancer ,Urologic Diseases ,Aged ,Aged ,80 and over ,Androstenes ,Antineoplastic Combined Chemotherapy Protocols ,Benzimidazoles ,Biomarkers ,Tumor ,DNA Repair ,Humans ,Male ,Middle Aged ,Molecular Targeted Therapy ,Neoplasm Metastasis ,Poly(ADP-ribose) Polymerase Inhibitors ,Prednisone ,Prostatic Neoplasms ,Castration-Resistant ,Proto-Oncogene Proteins c-ets ,Receptors ,Androgen ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
Purpose To determine whether cotargeting poly (ADP-ribose) polymerase-1 plus androgen receptor is superior to androgen receptor inhibition in metastatic castration-resistant prostate cancer (mCRPC) and whether ETS fusions predict response. Patients and Methods Patients underwent metastatic site biopsy and were stratified by ETS status and randomly assigned to abiraterone plus prednisone without (arm A) or with veliparib (arm B). Primary objectives were: confirmed prostate-specific antigen (PSA) response rate (RR) and whether ETS fusions predicted response. Secondary objectives were: safety, measurable disease RR (mRR), progression-free survival (PFS), and molecular biomarker analysis. A total of 148 patients were randomly assigned to detect a 20% PSA RR improvement. Results A total of 148 patients with mCRPC were randomly assigned: arm A, n = 72; arm B, n = 76. There were no differences in PSA RR (63.9% v 72.4%; P = .27), mRR (45.0% v 52.2%; P = .51), or median PFS (10.1 v 11 months; P = .99). ETS fusions did not predict response. Exploratory analysis of tumor sequencing (80 patients) revealed: 41 patients (51%) were ETS positive, 20 (25%) had DNA-damage repair defect (DRD), 41 (51%) had AR amplification or copy gain, 34 (43%) had PTEN mutation, 33 (41%) had TP53 mutation, 39 (49%) had PIK3CA pathway activation, and 12 (15%) had WNT pathway alteration. Patients with DRD had significantly higher PSA RR (90% v 56.7%; P = .007) and mRR (87.5% v 38.6%; P = .001), PSA decline ≥ 90% (75% v 25%; P = .001), and longer median PFS (14.5 v 8.1 months; P = .025) versus those with wild-type tumors. Median PFS was longer in patients with normal PTEN (13.5 v 6.7 months; P = .02), TP53 (13.5 v 7.7 months; P = .01), and PIK3CA (13.8 v 8.3 months; P = .03) versus those with mutation or activation. In multivariable analysis adjusting for clinical covariates, DRD association with PFS remained significant. Conclusion Veliparib and ETS status did not affect response. Exploratory analysis identified a novel DRD association with mCRPC outcomes.
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- 2018
8. Response to the Letter to the Editor Regarding "Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials".
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Suez, Daniel, Stein, Mark, Gupta, Sudhir, Hussain, Iftikhar, Melamed, Isaac, Paris, Kenneth, Darter, Amy, Bourgeois, Christelle, Fritsch, Sandor, Leibl, Heinz, McCoy, Barbara, Gelmont, David, and Yel, Leman
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Humans ,Immunologic Deficiency Syndromes ,Immunoglobulin G ,Injections ,Subcutaneous ,Reference Standards ,Clinical Trials ,Phase III as Topic ,Drug-Related Side Effects and Adverse Reactions ,Data Analysis ,Good Health and Well Being ,Immunology - Published
- 2017
9. Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
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Autio, Karen A., Antonarakis, Emmanuel S., Mayer, Tina M., Shevrin, Daniel H., Stein, Mark N., Vaishampayan, Ulka N., Morris, Michael J., Slovin, Susan F., Heath, Elisabeth I., Tagawa, Scott T., Rathkopf, Dana E., Milowsky, Matthew I., Harrison, Michael R., Beer, Tomasz M., Balar, Arjun V., Armstrong, Andrew J., George, Daniel J., Paller, Channing J., Apollo, Arlyn, Danila, Daniel C., Graff, Julie N., Nordquist, Luke, Dayan Cohn, Erica S., Tse, Kin, Schreiber, Nicole A., Heller, Glenn, and Scher, Howard I.
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- 2021
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10. Treatment-free survival outcomes from the phase II study of nivolumab and salvage nivolumab/ipilimumab in advanced clear cell renal cell carcinoma (HCRN GU16-260-Cohort A)
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Atkins, Michael B, primary, Jegede, Opeyemi A, additional, Haas, Naomi B, additional, Mcdermott, David F, additional, Bilen, Mehmet A, additional, Stein, Mark, additional, Sosman, Jeffrey, additional, Alter, Robert, additional, Plimack, Elizabeth R, additional, Ornstein, Moshe C, additional, Hurwitz, Michael, additional, Peace, David J, additional, Einstein, David, additional, Catalano, Paul J, additional, Hammers, Hans, additional, and Regan, Meredith M, additional
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- 2024
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11. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma
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McNeel, Douglas G, Bander, Neil H, Beer, Tomasz M, Drake, Charles G, Fong, Lawrence, Harrelson, Stacey, Kantoff, Philip W, Madan, Ravi A, Oh, William K, Peace, David J, Petrylak, Daniel P, Porterfield, Hank, Sartor, Oliver, Shore, Neal D, Slovin, Susan F, Stein, Mark N, Vieweg, Johannes, and Gulley, James L
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Immunology ,Urologic Diseases ,Vaccine Related ,Aging ,Biotechnology ,Prostate Cancer ,Cancer ,Immunization ,5.1 Pharmaceuticals ,Development of treatments and therapeutic interventions ,Guidelines ,Immunotherapy ,Treatment ,Oncology and carcinogenesis - Abstract
Prostate cancer is the most commonly diagnosed malignancy and second leading cause of cancer death among men in the United States. In recent years, several new agents, including cancer immunotherapies, have been approved or are currently being investigated in late-stage clinical trials for the management of advanced prostate cancer. Therefore, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel, including physicians, nurses, and patient advocates, to develop consensus recommendations for the clinical application of immunotherapy for prostate cancer patients. To do so, a systematic literature search was performed to identify high-impact papers from 2006 until 2014 and was further supplemented with literature provided by the panel. Results from the consensus panel voting and discussion as well as the literature review were used to rate supporting evidence and generate recommendations for the use of immunotherapy in prostate cancer patients. Sipuleucel-T, an autologous dendritic cell vaccine, is the first and currently only immunotherapeutic agent approved for the clinical management of metastatic castrate resistant prostate cancer (mCRPC). The consensus panel utilized this model to discuss immunotherapy in the treatment of prostate cancer, issues related to patient selection, monitoring of patients during and post treatment, and sequence/combination with other anti-cancer treatments. Potential immunotherapies emerging from late-stage clinical trials are also discussed. As immunotherapy evolves as a therapeutic option for the treatment of prostate cancer, these recommendations will be updated accordingly.
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- 2016
12. Transforming food systems:The role of public procurement
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Stein, Mark, Mariana, Maurizio, Caranta, Roberto, Polychronakis, Yiannis, Andhov, Marta, Mikulic, Sven, Rise Nielsen, Line, Stein, Mark, Mariana, Maurizio, Caranta, Roberto, Polychronakis, Yiannis, Andhov, Marta, Mikulic, Sven, and Rise Nielsen, Line
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This chapter highlights the lack of sustainability in the industrialised food systems. It underscores the need for agroecological thinking to drive sustainable food system transitions. Certain interlocks, such as; ‘expectations of cheap food’, ‘measures of success’, ‘path dependency’ and ‘short-term thinking’, prevent the transition. Public procurement, as a potent demand-side mechanism, has the potential to tackle these interlocks. The analysis shows that the EU procurement regulatory framework allows public buyers to include sustainability considerations in technical specifications and thus leaves the option to alter what is needed to be considered a successful public food bidder. Similarly, the EU concept of “most economically advantageous tender” eclipses evaluation based on acquisition price only and emphasises holistic evaluation based on, for instance, quality, environmental and social characteristics. Furthermore, the EU institutions are challenging ‘path-dependency’ and ‘short-term thinking’ in public procurement of food via its multiple policies (for instance, the Farm to Fork strategy and EU GPP criteria). Still, utilising public procurement for transforming food systems depends on the discretionary decisions of individual contracting authorities, and long-sighted political leadership at a national level. The case of organic conversion in Danish public kitchens is described as an example of positive achievement.
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- 2024
13. Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America
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Suez, Daniel, Stein, Mark, Gupta, Sudhir, Hussain, Iftikhar, Melamed, Isaac, Paris, Kenneth, Darter, Amy, Bourgeois, Christelle, Fritsch, Sandor, Leibl, Heinz, McCoy, Barbara, Gelmont, David, and Yel, Leman
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Vaccine Related ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Adolescent ,Adult ,Aged ,Aged ,80 and over ,Bacterial Infections ,Child ,Child ,Preschool ,Female ,Humans ,Immunoglobulins ,Intravenous ,Immunologic Deficiency Syndromes ,Infusions ,Subcutaneous ,Male ,Middle Aged ,Quality of Life ,Treatment Outcome ,Young Adult ,Primary immunodeficiency diseases ,Immunoglobulin replacement therapy ,Subcutaneous administration ,20% immunoglobulin ,Pharmacokinetics ,20 % immunoglobulin ,Immunology - Abstract
Patients with primary immunodeficiency disease (PIDD) typically require life-long intravenous (IV) or subcutaneous (SC) immunoglobulin (Ig) replacement therapy to prevent recurrent infections. The efficacy, safety, and pharmacokinetics of a highly concentrated (20 %) Ig preparation for SC administration (IGSC 20 %) were evaluated in a prospective trial in patients with PIDD. A total of 74 patients (aged 3-83 years) received 4327 IGSC 20 % infusions over a median of 380.5 days. The rate of validated serious bacterial infections was 0.012 event/patient-year (p 14.5 g/l. The median maximum infusion rate was 60 ml/h/site (range 4.4-180), resulting in a median infusion duration of 0.95 h. A volume ≥30 ml was infused per site in 74.8 % of IGSC 20 % infusions. Most (84.9 %) infusions were administered using ≤2 infusion sites; for 99.8 % of infusions, there was no need to interrupt/stop administration or reduce the infusion rate. No related serious adverse event (AE) occurred during IGSC 20 % treatment; related non-serious AEs occurred at a rate of 0.036 event/infusion. The incidence of related local AEs was 0.015 event/infusion and of related systemic AEs was 0.021 event/infusion; most were mild in severity, none severe. Increased infusion rates or volumes were not associated with higher AE rates. The investigated IGSC 20 % treatment was shown to be effective and safe, enabling higher infusion rates and volumes per site compared to conventional SC treatments, resulting in fewer infusion sites and shorter infusion durations.
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- 2016
14. Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency.
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Wasserman, Richard L, Melamed, Isaac, Stein, Mark R, Engl, Werner, Sharkhawy, Marlies, Leibl, Heinz, Puck, Jennifer, Rubinstein, Arye, Kobrynski, Lisa, Gupta, Sudhir, Grant, Andrew J, Ratnayake, Anoshie, Richmond, Wendell G, Church, Joseph, Yel, Leman, and Gelmont, David
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Humans ,Bacterial Infections ,Immunologic Deficiency Syndromes ,Hyaluronoglucosaminidase ,Immunoglobulins ,Intravenous ,Recombinant Proteins ,Treatment Outcome ,Hospitalization ,Time Factors ,Adolescent ,Adult ,Aged ,Middle Aged ,Child ,Female ,Male ,Infusions ,Subcutaneous ,Young Adult ,Subcutaneous IgG replacement ,efficacy ,primary immunodeficiency ,recombinant human hyaluronidase ,tolerability ,Pediatric ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Immunology - Abstract
PurposeTreatment of primary immunodeficiency diseases (PIDD) with subcutaneous (SC) infusions of IgG preceded by injection of recombinant human hyaluronidase (rHuPH20) (IGHy) to increase SC tissue permeability was evaluated in two consecutive, prospective, non-controlled, multi-center studies.MethodsSubjects >4 years of age received SC IgG replacement at a weekly dose equivalent of 108 % of their previous intravenous (IV) dose, facilitated by prior injection of 75 U/g IgG of rHuPH20. Starting with weekly SC infusions, the interval was increased (ramped-up) to a 3- or 4-week schedule.ResultsEighty-three subjects (24
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- 2016
15. Evolving and Implanting Web-based E-Government Systems in Universities
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Reiß, Dirk, Rumpe, Bernhard, Schulze-Quester, Marvin, and Stein, Mark
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Computer Science - Computers and Society ,Computer Science - Software Engineering - Abstract
The Bologna Process has triggered a major restructuring of the current university diploma into a bachelor/master system. As one effect, the administration effort for the new system has increased dramatically. As a second effect, students need and demand a much better information policy, given the new possibilities of the internet. Both to increase efficiency of the university's administration and to provide students as well as lecturers with modern e government services, it is inevitable to evolve the current IT-infrastructure of a university into a modern web-based landscape of systems that support business processes on campus. In this paper, we describe the approach taken at the Braunschweig University of Technology to evolve the existing landscape of legacy systems by adding bridges between previously unrelated parts, adding and customizing unused modules of existing software to bring information and services online and to develop new software, where old modules could not serve the necessary purposes. Most of all, both implementation of the results in university's business processes and the resulting quick feedback and wishes for feature enhancement are seen as part of the software development processes and discussed in this paper., Comment: 14 pages, 3 figures
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- 2014
16. MontiWeb - Modular Development of Web Information Systems
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Dukaczewski, Michael, Reiss, Dirk, Stein, Mark, and Rumpe, Bernhard
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Computer Science - Software Engineering - Abstract
The development process of web information systems is often tedious, error prone and usually involves redundant steps of work. Therefore, it is rather e_x000E_fficient to employ a modeldriven approach for the systematic aspects that comprise such a system. This involves models for the data structure that shall be handled by the system (here: class diagrams), various editable and read-only presentations (views) on combinations and extractions of the underlying data (here: a special view language) and ways to connect these views and define data flow between them (here: activity diagrams). In this paper, we present the MontiWeb approach to model and generate these aspects in a modular manner by incorperating the MontiCore framework. Therefor we shortly introduce the infrastructure that helps to develop modular systems. This involves the whole development process from defining the modeling languages to final code generation as well as all steps in between. We present the text-based class and activity diagram languages as well as a view language that are used to model our system., Comment: 6 pages, 6 figures. Proceedings of the 9th OOPSLA Workshop on Domain-Specific Modeling (DSM' 09). Helsinki School of Economics. TR no B-108. Orlando, Florida, USA, October 2009
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- 2014
17. SNP genotyping using TaqMan technology: the CYP2D6*17 assay conundrum.
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Gaedigk, Andrea, Freeman, Natalie, Hartshorne, Toinette, Riffel, Amanda K, Irwin, David, Bishop, Jeffrey R, Stein, Mark A, Newcorn, Jeffrey H, Jaime, Lazara Karelia Montané, Cherner, Mariana, and Leeder, J Steven
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Humans ,Cytochrome P-450 CYP2D6 ,DNA Primers ,Polymerase Chain Reaction ,Sequence Alignment ,Sequence Analysis ,DNA ,Binding Sites ,Base Sequence ,Genotype ,Polymorphism ,Single Nucleotide ,Alleles ,Molecular Sequence Data ,Sequence Analysis ,DNA ,Polymorphism ,Single Nucleotide ,Genetics ,Biochemistry and Cell Biology ,Other Physical Sciences - Abstract
CYP2D6 contributes to the metabolism of many clinically used drugs and is increasingly tested to individualize drug therapy. The CYP2D6 gene is challenging to genotype due to the highly complex nature of its gene locus. TaqMan technology is widely used in the clinical and research settings for genotype analysis due to assay reliability, low cost, and the availability of commercially available assays. The assay identifying 1023C>T (rs28371706) defining a reduced function (CYP2D6*17) and several nonfunctional alleles, produced a small number of unexpected diplotype calls in three independent sets of samples, i.e. calls suggested the presence of a CYP2D6*4 subvariant containing 1023C>T. Gene resequencing did not reveal any unknown SNPs in the primer or probe binding sites in any of the samples, but all affected samples featured a trio of SNPs on their CYP2D6*4 allele between one of the PCR primer and probe binding sites. While the phenomenon was ultimately overcome by an alternate assay utilizing a PCR primer excluding the SNP trio, the mechanism causing this phenomenon remains elusive. This rare and unexpected event underscores the importance of assay validation in samples representing a variety of genotypes, but also vigilance of assay performance in highly polymorphic genes such as CYP2D6.
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- 2015
18. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency
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Wasserman, Richard L, Melamed, Isaac, Stein, Mark R, Gupta, Sudhir, Puck, Jennifer, Engl, Werner, Leibl, Heinz, McCoy, Barbara, Empson, Victoria G, Gelmont, David, Schiff, Richard I, and IGSC, 10 with rHuPH20 Study Group
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Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adolescent ,Adult ,Aged ,Child ,Child ,Preschool ,Humans ,Hyaluronoglucosaminidase ,Immunoglobulins ,Immunologic Deficiency Syndromes ,Infusions ,Subcutaneous ,Middle Aged ,Prospective Studies ,Recombinant Proteins ,Facilitated subcutaneous immunoglobulin ,intravenous immunoglobulin ,recombinant human hyaluronidase ,primary immunodeficiency ,efficacy ,tolerability ,bioavailability ,IGSC ,10% with rHuPH20 Study Group ,Immunology ,Allergy - Abstract
BackgroundSubcutaneous immunoglobulin (IGSC) replacement therapy for primary immunodeficiency (PI) is equally efficacious to intravenous immunoglobulin (IGIV), induces fewer systemic reactions, and may be self-infused. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. Recombinant human hyaluronidase (rHuPH20) increases SC tissue permeability and facilitates dispersion and absorption, enabling administration of monthly doses in one site.ObjectiveThis study investigated the efficacy and tolerability of rHuPH20-facilitated IGSC (IGHy) in patients with PI.MethodsIn this open-label, multicenter phase III study, 87 patients with PI aged ≥2 years received 10% IGIV for 3 months, then IGHy (n = 83) for approximately 14 to 18 months at 108% of the IGIV dose. IGHy infusions began weekly, increasing to 3- or 4-week intervals.ResultsThe majority (94.0%) of IGHy infusions were administered every 3 or 4 weeks, using one site (median, 1.09/month), with a mean volume of 292.2 mL. The bioavailability of IGHy measured by area under the concentration versus time curve was 93.3% of IGIV, which is pharmacokinetically equivalent. Systemic reactions were less frequent with IGHy than with IGIV (8.3% vs 25.0% of infusions). Local reactions to IGHy were generally mild to moderate, with a rate of 0.203 per infusion. The acute serious bacterial infection rate per subject-year for IGHy was low (0.025; upper 99% CI limit, 0.046). Overall infection rates per subject-year were 2.97 for IGHy and 4.51 for IGIV.ConclusionIGHy was effective, safe, and pharmacokinetically equivalent to IGIV at the same administration intervals, but it caused fewer systemic reactions. Tolerability was good despite high infusion volumes and rates.
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- 2012
19. Cognitive Adaptation to Severe Angina or Small Heart Attack
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Stein, Mark John
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155 - Published
- 2007
20. Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer
- Author
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Madan, Ravi A, primary, Bilusic, Marijo, additional, Stein, Mark N, additional, Donahue, Renee N, additional, Arlen, Philip M, additional, Karzai, Fatima, additional, Plimack, Elizabeth, additional, Wong, Yu-Ning, additional, Geynisman, Daniel M, additional, Zibelman, Matthew, additional, Mayer, Tina, additional, Strauss, Julius, additional, Chen, Gang, additional, Rauckhorst, Myrna, additional, McMahon, Sheri, additional, Couvillon, Anna, additional, Steinberg, Seth, additional, Figg, William D, additional, Dahut, William L, additional, Schlom, Jeffrey, additional, and Gulley, James L, additional
- Published
- 2023
- Full Text
- View/download PDF
21. Utilitarianism and Conflation
- Author
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Stein, Mark S.
- Published
- 2003
22. Cognitive aspects of childhood asthma
- Author
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Stein, Mark John
- Subjects
618.92238 ,RJ Pediatrics - Abstract
Research was undertaken to improve our knowledge about children’s awareness of respiratory sensations, beliefs about asthma of children with asthma and their parents, the nature and extent of childhood asthma sufferers’ psychological difficulties, and parents’ and children’s reasons for achieving good control of asthma. Recognition and accurate reporting of respiratory sensations have implications for asthma management. Illness beliefs explain differences in adaptation to chronic disease. Childhood asthma is situated within a family context. Asthma severity and the source of information may explain differences in reports of children’s psychological well-being. Low adherence with treatment recommendations has been reported, and chronic disease can influence quality of life. Participants were recruited from a hospital asthma database, primary care patient lists, and through state primary schools. The interviews involved physically healthy children, children with asthma, and the parents of children with asthma. Qualitative and quantitative methods involved the use of storyboards, semi- structured interviews, and questionnaires. The main arguments are that, (i) social interaction, in the context of childhood asthma, is a determinant of children’s sophisticated descriptions of respiratory sensations, (ii) children’s understanding of the different aspects of asthma is determined by their personal salience, and the necessity of acquiring strategies to resolve asthma-related difficulties, (iii) concordance in the beliefs of parents and their child about the child’s asthma is associated with less conflict about the child’s disease and disease-related situations, and the quality of family life mediates the relationship between belief concordance and the child’s psychological well-being, and (iv) participants’ reasons for achieving good control of asthma reflect the aspects of their lives that are most affected by asthma. It was concluded that the personal salience of different aspects of childhood asthma may encourage an awareness of symptoms, prompt discussion of internal states, foster concordance in beliefs, and motivate adherence with treatment recommendations.
- Published
- 2003
23. A closer look at common practice valuation approaches: Asset-based approach.
- Author
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Ruvins, Edward, Stein, Mark, and Kayserman, Susanna
- Subjects
DENTAL equipment ,STATISTICAL bias ,VALUATION ,ASSETS (Accounting) ,BUSINESS valuation ,COMPUTERS - Abstract
This article discusses the asset-based approach to valuing dental practices. The asset-based approach determines the value of a business by assessing its tangible assets and liabilities. This method is particularly useful for dental practices with significant tangible assets, such as equipment and real estate. The article explains different types of asset-based valuation methods, including the book value method, adjusted book value method, and liquidation value method. It also highlights the benefits and disadvantages of the asset-based approach, such as its simplicity and objectivity, but limited consideration of intangible assets and future cash flow. The article concludes by emphasizing the importance of understanding the market value of assets and the role of the asset-based approach in determining practice worth. [Extracted from the article]
- Published
- 2024
24. Dose intensification of TRAIL-inducing ONC201 inhibits metastasis and promotes intratumoral NK cell recruitment
- Author
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Wagner, Jessica, Kline, C. Leah, Zhou, Lanlan, Campbell, Kerry S., MacFarlane, Alexander W., Olszanski, Anthony J., Cai, Kathy Q., Hensley, Harvey H., Ross, Eric A., Ralff, Marie D., Zloza, Andrew, Chesson, Charles B., Newman, Jenna H., Kaufman, Howard, Bertino, Joseph, Stein, Mark, and El-Deiry, Wafik S.
- Subjects
Cancer treatment -- Methods ,Killer cells -- Health aspects -- Physiological aspects ,Ligands (Biochemistry) -- Health aspects -- Physiological aspects ,Antineoplastic agents -- Dosage and administration ,Cancer metastasis -- Drug therapy ,Health care industry - Abstract
ONC201 is a first-in-class, orally active antitumor agent that upregulates cytotoxic TRAIL pathway signaling in cancer cells. ONC201 has demonstrated safety and preliminary efficacy in a first-in-human trial in which patients were dosed every 3 weeks. We hypothesized that dose intensification of ONC201 may impact antitumor efficacy. We discovered that ONC201 exerts dose--and schedule-dependent effects on tumor progression and cell death signaling in vivo. With dose intensification, we note a potent anti-metastasis effect and inhibition of cancer cell migration and invasion. Our preclinical results prompted a change in ONC201 dosing in all open clinical trials. We observed accumulation of activated [NK.sup.+] and [CD3.sup.+] cells within ONC201-treated tumors and that NK cell depletion inhibits ONC201 efficacy in vivo, including against TRAIL/ONC201-resistant [Box.sup.-/-] tumors. Immunocompetent NCR1-GFP mice, in which NK cells express GFP, demonstrated [GFP.sup.+] NK cell infiltration of syngeneic MC38 colorectal tumors. Activation of primary human NK cells and increased degranulation occurred in response to ONC201. Coculture experiments identified a role for TRAIL in human NK-mediated antitumor cytotoxicity. Preclinical results indicate the potential utility for ONC201 plus anti-PD-1 therapy. We observed an increase in activated TRAIL-secreting NK cells in the peripheral blood of patients after ONC201 treatment. The results offer what we believe to be a unique pathway of immune stimulation for cancer therapy., Introduction We previously identified ONC201/TIC10 as a small molecule that upregulates endogenous TNF-related apoptosis-inducing ligand (TRAIL) in tumor and normal cells, and restores autocrine and paracrine antitumor activity within tumor [...]
- Published
- 2018
- Full Text
- View/download PDF
25. Apatorsen plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial carcinoma (Borealis-2)
- Author
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Rosenberg, Jonathan E., Hahn, Noah M., Regan, Meredith M., Werner, Lillian, Alva, Ajjai, George, Saby, Picus, Joel, Alter, Robert, Balar, Arjun, Hoffman-Censits, Jean, Grivas, Petros, Lauer, Richard, Guancial, Elizabeth A., Hoimes, Christopher, Sonpavde, Guru, Albany, Constantine, Stein, Mark N., Breen, Tim, Jacobs, Cindy, Anderson, Kirsten, Bellmunt, Joaquim, Lalani, Aly-Khan A., Pal, Sumanta, and Choueiri, Toni K.
- Published
- 2018
- Full Text
- View/download PDF
26. A phase I trial of riluzole and sorafenib in patients with advanced solid tumors: CTEP #8850
- Author
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Spencer, Kristen R., primary, Portal, Daniella E., additional, Aisner, Joseph, additional, Stein, Mark N., additional, Malhotra, Jyoti, additional, Shih, Weichung, additional, Chan, Nancy, additional, Silk, Ann W., additional, Ganesan, Shridar, additional, Goodin, Susan, additional, Gounder, Murugesan, additional, Lin, Hongxia, additional, Li, Jiadong, additional, Cerchio, Robert, additional, Marinaro, Christina, additional, Chen, Suzie, additional, and Mehnert, Janice M., additional
- Published
- 2023
- Full Text
- View/download PDF
27. Phase II study of nivolumab and salvage nivolumab/ipilimumab in treatment-naïve patients with advanced non-clear cell renal cell carcinoma (HCRN GU16-260-Cohort B)
- Author
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Atkins, Michael B, primary, Jegede, Opeyemi A, additional, Haas, Naomi B, additional, McDermott, David F, additional, Bilen, Mehmet A, additional, Stein, Mark, additional, Sosman, Jeffrey A, additional, Alter, Robert, additional, Plimack, Elizabeth R, additional, Ornstein, Moshe C, additional, Hurwitz, Michael, additional, Peace, David J, additional, Signoretti, Sabina, additional, Denize, Thomas, additional, Cimadamore, Alessia, additional, Wu, Catherine J, additional, Braun, David, additional, Einstein, David, additional, Catalano, Paul J, additional, and Hammers, Hans, additional
- Published
- 2023
- Full Text
- View/download PDF
28. Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder: results from phase II study, BTCRC-GU15-023
- Author
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Joshi, Monika, primary, Tuanquin, Leonard, additional, Zhu, Junjia, additional, Walter, Vonn, additional, Schell, Todd, additional, Kaag, Matthew, additional, Kilari, Deepak, additional, Liao, Jiangang, additional, Holder, Sheldon L, additional, Emamekhoo, Hamid, additional, Sankin, Alexander, additional, Merrill, Suzzane, additional, Zheng, Hong, additional, Warrick, Joshua, additional, Hauke, Ralph, additional, Gartrel, Benjamin, additional, Stein, Mark, additional, Drabick, Joseph, additional, Degraff, David J, additional, and Zakharia, Yousef, additional
- Published
- 2023
- Full Text
- View/download PDF
29. Congenital Toxoplasmosis Transmitted from an Immunologically Competent Mother Infected before Conception
- Author
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Hostetter, Margaret, Mack, Douglas, and Stein, Mark
- Published
- 1996
30. Society of Anesthesia and Sleep Medicine Guideline on Intraoperative Management of Adult Patients With Obstructive Sleep Apnea
- Author
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Memtsoudis, Stavros G., Cozowicz, Crispiana, Nagappa, Mahesh, Wong, Jean, Joshi, Girish P., Wong, David T., Doufas, Anthony G., Yilmaz, Meltem, Stein, Mark H., Krajewski, Megan L., Singh, Mandeep, Pichler, Lukas, Ramachandran, Satya Krishna, and Chung, Frances
- Published
- 2018
- Full Text
- View/download PDF
31. Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration
- Author
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Stein, Mark N., Malhotra, Jyoti, Tarapore, Rohinton S., Malhotra, Usha, Silk, Ann W., Chan, Nancy, Rodriguez, Lorna, Aisner, Joseph, Aiken, Robert D., Mayer, Tina, Haffty, Bruce G., Newman, Jenna H., Aspromonte, Salvatore M., Bommareddy, Praveen K., Estupinian, Ricardo, Chesson, Charles B., Sadimin, Evita T., Li, Shengguo, Medina, Daniel J., Saunders, Tracie, Frankel, Melissa, Kareddula, Aparna, Damare, Sherrie, Wesolowsky, Elayne, Gabel, Christian, El-Deiry, Wafik S., Prabhu, Varun V., Allen, Joshua E., Stogniew, Martin, Oster, Wolfgang, Bertino, Joseph R., Libutti, Steven K., Mehnert, Janice M., and Zloza, Andrew
- Published
- 2019
- Full Text
- View/download PDF
32. A Defiant Show by a Latin Artist
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Stein, Mark A.
- Subjects
Assemblage (Art) -- Exhibitions -- Criticism and interpretation ,General interest ,News, opinion and commentary - Abstract
El Museo del Barrio is presenting a retrospective of Raphael Montañez Ortiz's works to honor the 88-year-old artist and reinforce the institution's roots. This article is part of our latest [...]
- Published
- 2022
33. Dysequilibrium of the PTH-FGF23-vitamin D axis in relapsing remitting multiple sclerosis; a longitudinal study
- Author
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Stein, Mark Simon, Ward, Gregory John, Butzkueven, Helmut, Kilpatrick, Trevor John, and Harrison, Leonard Charles
- Published
- 2018
- Full Text
- View/download PDF
34. Immune activation and response to pembrolizumab in POLE-mutant endometrial cancer
- Author
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Mehnert, Janice M., Panda, Anshuman, Zhong, Hua, Hirshfield, Kim, Damare, Sherri, Lane, Katherine, Sokol, Levi, Stein, Mark N., Rodriguez-Rodriquez, Lorna, Kaufman, Howard L., Ali, Siraj, Ross, Jeffrey S., Pavlick, Dean C., Bhanot, Gyan, White, Eileen P., DiPaola, Robert S., Lovell, Ann, Cheng, Jonathan, and Ganesan, Shridar
- Subjects
Gene mutations -- Health aspects ,Endometrial cancer -- Genetic aspects -- Development and progression -- Care and treatment ,Molecular targeted therapy -- Innovations ,DNA polymerases -- Properties ,Health care industry - Abstract
Antibodies that target the immune checkpoint receptor programmed cell death protein 1 (PD-1) have resulted in prolonged and beneficial responses toward a variety of human cancers. However, anti-PD-1 therapy in some patients provides no benefit and/or results in adverse side effects. The factors that determine whether patients will be drug sensitive or resistant are not fully understood; therefore, genomic assessment of exceptional responders can provide important insight into patient response. Here, we identified a patient with endometrial cancer who had an exceptional response to the anti-PD-1 antibody pembrolizumab. Clinical grade targeted genomic profiling of a pretreatment tumor sample from this individual identified a mutation in DNA polymerase epsilon (POLE) that associated with an ultramutator phenotype. Analysis of The Cancer Genome Atlas (TCGA) revealed that the presence of POLE mutation associates with high mutational burden and elevated expression of several immune checkpoint genes. Together, these data suggest that cancers harboring POLE mutations are good candidates for immune checkpoint inhibitor therapy., Introduction Prolonged and deep responses to antibody therapy directed against the immune checkpoint programmed cell death protein 1 (PD-1) receptor have been demonstrated in multiple types of human cancer (1-7). [...]
- Published
- 2016
- Full Text
- View/download PDF
35. Toward Precision Medicine in ADHD
- Author
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Buitelaar, Jan, primary, Bölte, Sven, additional, Brandeis, Daniel, additional, Caye, Arthur, additional, Christmann, Nina, additional, Cortese, Samuele, additional, Coghill, David, additional, Faraone, Stephen V., additional, Franke, Barbara, additional, Gleitz, Markus, additional, Greven, Corina U., additional, Kooij, Sandra, additional, Leffa, Douglas Teixeira, additional, Rommelse, Nanda, additional, Newcorn, Jeffrey H., additional, Polanczyk, Guilherme V., additional, Rohde, Luis Augusto, additional, Simonoff, Emily, additional, Stein, Mark, additional, Vitiello, Benedetto, additional, Yazgan, Yanki, additional, Roesler, Michael, additional, Doepfner, Manfred, additional, and Banaschewski, Tobias, additional
- Published
- 2022
- Full Text
- View/download PDF
36. Abstract CT153: TiTAN: a phase 1 study of GEN-011, a neoantigen-targeted peripheral blood-derived T cell therapy with broad neoantigen targeting
- Author
-
Gillison, Maura, primary, Niu, Jiaxin, additional, Olson, Daniel, additional, Stein, Mark, additional, Aggen, David, additional, Acharya, Utkarsh, additional, Creelan, Benjamin, additional, Hernandez, Richard, additional, Price, Jessica, additional, Mancini, Kevin J., additional, Dowal, Louisa, additional, Foti, James, additional, Vemulapalli, Vijetha, additional, Shainheit, Mara, additional, Golshadi, Masoud, additional, Stapleton, Raymond D., additional, Flechtner, Jessica B., additional, and Davis, Thomas A., additional
- Published
- 2022
- Full Text
- View/download PDF
37. Public Food Procurement: A Transformative Instrument for Sustainable Food Systems
- Author
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Stein, Mark, primary, Hunter, Danny, additional, Swensson, Luana, additional, Schneider, Sergio, additional, and Tartanac, Florence, additional
- Published
- 2022
- Full Text
- View/download PDF
38. Neural Markers of Methylphenidate Response in Children With Attention Deficit Hyperactivity Disorder
- Author
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Arnett, Anne B., primary, Rutter, Tara M., additional, and Stein, Mark A., additional
- Published
- 2022
- Full Text
- View/download PDF
39. Gyms in Europe Aim To Lure Back People After Lockdowns
- Author
-
Stein, Mark A.
- Subjects
Europe -- Social aspects -- Health aspects ,Epidemics -- Economic aspects -- Social aspects -- Europe ,Quarantine -- Social aspects -- Economic aspects ,Personal care industry -- Social aspects -- Economic aspects ,Company distribution practices ,General interest ,News, opinion and commentary - Abstract
Workouts, like work itself, can be done at home, and clubs are learning how to lure customers back. This article is part of our Business Transformation special report, about how [...]
- Published
- 2021
40. Toward Precision Medicine in ADHD
- Author
-
Buitelaar, Jan, Bölte, Sven, Brandeis, Daniel, Caye, Arthur, Christmann, Nina, Cortese, Samuele, Coghill, David, Faraone, Stephen V, Franke, Barbara, Gleitz, Markus, Greven, Corina U, Kooij, Sandra, Leffa, Douglas Teixeira, Rommelse, Nanda, Newcorn, Jeffrey H, Polanczyk, Guilherme V, Rohde, Luis Augusto, Simonoff, Emily; https://orcid.org/0000-0002-5450-0823, Stein, Mark, Vitiello, Benedetto, Yazgan, Yanki, Roesler, Michael, Doepfner, Manfred, Banaschewski, Tobias; https://orcid.org/0000-0003-4595-1144, Buitelaar, Jan, Bölte, Sven, Brandeis, Daniel, Caye, Arthur, Christmann, Nina, Cortese, Samuele, Coghill, David, Faraone, Stephen V, Franke, Barbara, Gleitz, Markus, Greven, Corina U, Kooij, Sandra, Leffa, Douglas Teixeira, Rommelse, Nanda, Newcorn, Jeffrey H, Polanczyk, Guilherme V, Rohde, Luis Augusto, Simonoff, Emily; https://orcid.org/0000-0002-5450-0823, Stein, Mark, Vitiello, Benedetto, Yazgan, Yanki, Roesler, Michael, Doepfner, Manfred, and Banaschewski, Tobias; https://orcid.org/0000-0003-4595-1144
- Abstract
Attention-Deficit Hyperactivity Disorder (ADHD) is a complex and heterogeneous neurodevelopmental condition for which curative treatments are lacking. Whilst pharmacological treatments are generally effective and safe, there is considerable inter-individual variability among patients regarding treatment response, required dose, and tolerability. Many of the non-pharmacological treatments, which are preferred to drug-treatment by some patients, either lack efficacy for core symptoms or are associated with small effect sizes. No evidence-based decision tools are currently available to allocate pharmacological or psychosocial treatments based on the patient's clinical, environmental, cognitive, genetic, or biological characteristics. We systematically reviewed potential biomarkers that may help in diagnosing ADHD and/or stratifying ADHD into more homogeneous subgroups and/or predict clinical course, treatment response, and long-term outcome across the lifespan. Most work involved exploratory studies with cognitive, actigraphic and EEG diagnostic markers to predict ADHD, along with relatively few studies exploring markers to subtype ADHD and predict response to treatment. There is a critical need for multisite prospective carefully designed experimentally controlled or observational studies to identify biomarkers that index inter-individual variability and/or predict treatment response.
- Published
- 2022
41. Reduced Glx and GABA Inductions in the Anterior Cingulate Cortex and Caudate Nucleus Are Related to Impaired Control of Attention in Attention-Deficit/Hyperactivity Disorder
- Author
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Mamiya, Ping C., primary, Richards, Todd L., additional, Edden, Richard A. E., additional, Lee, Adrian K. C., additional, Stein, Mark A., additional, and Kuhl, Patricia K., additional
- Published
- 2022
- Full Text
- View/download PDF
42. ADXS31142 Immunotherapy ± Pembrolizumab Treatment for Metastatic Castration-Resistant Prostate Cancer: Open-Label Phase I/II KEYNOTE-046 Study
- Author
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Stein, Mark N, primary, Fong, Lawrence, additional, Tutrone, Ronald, additional, Mega, Anthony, additional, Lam, Elaine T, additional, Parsi, Megan, additional, Vangala, Surya, additional, Gutierrez, Andres A, additional, and Haas, Naomi B, additional
- Published
- 2022
- Full Text
- View/download PDF
43. Audience Analysis for 'The Making, Shaping and Treating of Steel': A Pilot Study. Final Report Presented to United States Steel and the Association of Iron and Steel Engineers. CDC Technical Report No. 10.
- Author
-
Stein, Mark J.
- Abstract
Prompted by the realization that a reference text presents special problems in audience address since there is typically a diverse set of users, a study was designed to provide preliminary data on the use of the reference text, "The Making, Shaping and Treating of Steel," a landmark book in the steel industry. Data on the use of the text were collected through interviews, requiring approximately one hour, with a sample of 19 users of the text from various segments of the industry. Questions were divided into four categories: (1) background questions involving relevant characteristics of the respondents, edition of the book used, and number of years used; (2) questions of last usage; (3) questions of general use; and (4) problems and suggestions for improvement. Results indicated that the text was considered by most users as the reference of first resort to which they turned for information, and its scope was viewed as comprehensive. However, respondents did complain that the book did not provide them with follow-up resources--more detailed or alternative presentations. On a scale of 1 to 5 (1=very good, very useful; 5=throw it out of the window), the readers rated the book at an average of 1.8, which indicates there are ways to improve the text. In fact, respondents offered 13 recommendations for improvement. (HOD)
- Published
- 1984
44. Borrowing Language.
- Author
-
Stein, Mark J.
- Abstract
A study analyzed how freshman composition students handled an assignment that forced them to perform an act of sophisticated literacy which was a variation between spontaneity (present) and repetition (past) with a focus on how novice writers borrow language, whether through quotation or misquotation. The assignment involved two masterpieces of American rhetoric; Nicholas Street's "The American States Acting Over the Part of the Children of Israel in the Wilderness and Thereby Impeding Their Entrance into Canaan's Rest," written in 1777, and Henry Ward Beecher's "The Battle Set in Array," written in 1861, just days after the bombing of Fort Sumter. Rhetorically these two examples of words that worked, are carried out by the preachers' use of the Exodus theme of the Old Testament. The preachers succeeded in their task through an artful mixing of Biblical language with the language of their times. Subjects, freshman composition students, were asked to do a number of writings based on these two sermons. Their main assignment was to write a paper detailing and evaluating how one of these two preachers drew analogies back to the Exodus theme and the likely success such an analogy would have in impelling congregants to political action. Results showed that students tended to use half-borrowings of words, overuse quotations and quotation marks, and waver in point of view. (RAE)
- Published
- 1987
45. Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases
- Author
-
Wasserman, Richard L, primary, Gupta, Sudhir, additional, Stein, Mark, additional, Rabbat, Christopher J, additional, Engl, Werner, additional, Leibl, Heinz, additional, and Yel, Leman, additional
- Published
- 2021
- Full Text
- View/download PDF
46. 485 Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
- Author
-
Gillison, Maura, primary, Awad, Mark, additional, Twardowski, Przemyslaw, additional, Sukari, Ammar, additional, Johnson, Melissa, additional, Lackner, Rudy, additional, Stein, Mark, additional, DeCillis, Arthur, additional, Hernandez, Richard, additional, Price, Jessica, additional, Mancini, Kevin, additional, Shainheit, Mara, additional, Santone, Gabriella, additional, Shukor, Syukri, additional, Bicak, Ece, additional, Vemulapalli, Vijetha, additional, Tjon, Emily, additional, Flechtner, Jessica, additional, Davis, Thomas, additional, and Cohen, Roger, additional
- Published
- 2021
- Full Text
- View/download PDF
47. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder
- Author
-
Faraone, Stephen V., Banaschewski, Tobias, Coghill, David, Zheng, Yi, Biederman, Joseph, Bellgrove, Mark A., Newcorn, Jeffrey H., Gignac, Martin, Al Saud, Nouf M., Manor, Iris, Rohde, Luis Augusto, Yang, Li, Cortese, Samuele, Almagor, Doron, Stein, Mark A., Albatti, Turki H., Aljoudi, Haya F., Alqahtani, Mohammed M.J., Asherson, Philip, Atwoli, Lukoye, Buitelaar, Jan K., Crunelle, Cleo L., Daley, David, Espinet, Stacey, Fitzgerald, Michael, Franke, Barbara, Haavik, Jan, Hartman, Catharina A., Hartung, Cynthia M., Hinshaw, Stephen P., Hoekstra, Pieter J., Hollis, Chris, Kollins, Scott H., Sandra Kooij, J.J., Kuntsi, Jonna, Larsson, Henrik, Li, Tingyu, Liu, Jing, Merzon, Eugene, Mattingly, Gregory, Mattos, Paulo, McCarthy, Suzanne, Mikami, Amori Yee, Molina, Brooke S.G., Nigg, Joel T., Purper-Ouakil, Diane, Omigbodun, Olayinka O., Polanczyk, Guilherme V., Pollak, Yehuda, Poulton, Alison S., Rajkumar, Ravi Philip, Reding, Andrew, Reif, Andreas, Rubia, Katya, Rucklidge, Julia, Romanos, Marcel, Ramos-Quiroga, J. Antoni, Schellekens, Arnt, Scheres, Anouk, Schoeman, Renata, Schweitzer, Julie B., Shah, Henal, Solanto, Mary V., Sonuga-Barke, Edmund, Steinhausen, Hans-Christoph, Swanson, James M., Thapar, Anita, Tripp, Gail, van de Glind, Geurt, Brink, Wim van den, Van der Oord, Saskia, Venter, Andre, Vitiello, Benedetto, Walitza, Susanne, and Wang, Yufeng
- Subjects
Behavioral Neuroscience ,Neuropsychology and Physiological Psychology ,Cognitive Neuroscience - Abstract
BackgroundMisconceptions about ADHD stigmatize affected people, reduce credibility of providers, and prevent/delay treatment. To challenge misconceptions, we curated findings with strong evidence base.MethodsWe reviewed studies with more than 2,000 participants or meta-analyses from five or more studies or 2,000 or more participants. We excluded meta-analyses that did not assess publication bias, except for meta-analyses of prevalence. For network meta-analyses we required comparison adjusted funnel plots. We excluded treatment studies with waiting-list or treatment as usual controls. From this literature, we extracted evidence-based assertions about the disorder.ResultsWe generated 208 empirically supported statements about ADHD. The status of the included statements as empirically supported is approved by 79 authors from 27 countries and 6 continents. The contents of the manuscript are endorsed by 362 people who have read this document and agree with its contents.ConclusionsMany findings in ADHD are supported by meta-analysis. These allow for firm statements about the nature, course, outcome causes, and treatments for disorders that are useful for reducing misconceptions and stigma.
- Published
- 2021
48. A closer look at common valuation approaches: Market-based approach.
- Author
-
Ruvins, Edward, Stein, Mark, and Kayserman, Susanna
- Subjects
DENTAL equipment ,DENTAL economics ,PRACTICE of dentistry ,MERGERS & acquisitions ,ASSETS (Accounting) - Abstract
This article from Dental Economics explores the market-based approach to valuing dental practices. The market-based approach involves using comparable sales data from similar dental practices to determine the value of a practice. This method is similar to valuing residential real estate based on recently sold houses in the same neighborhood. However, finding accurate and validated data can be challenging, especially in rural areas or new urban developments. The article also discusses two specific valuation methods under the market-based approach: public company comparables and precedent transactions. While the market-based approach has its advantages, such as simplicity and reliability, it also has limitations, such as the availability of data and the inability to capture unique features of a practice. Overall, the market-based approach is a statistically sound methodology for valuing dental practices. [Extracted from the article]
- Published
- 2024
49. “Winners” training and its troubles
- Author
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Stein, Mark
- Published
- 2000
- Full Text
- View/download PDF
50. Marginal improvement in survival among patients diagnosed with metastatic prostate cancer in the second‐line antiandrogen therapy era
- Author
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Kim, Isaac E., primary, Jang, Thomas L., additional, Kim, Sinae, additional, Lee, David Y., additional, Kim, Daniel D., additional, Singer, Eric A., additional, Ghodoussipour, Saum, additional, Stein, Mark N., additional, Aron, Monish, additional, Dall’Era, Marc A., additional, and Yi Kim, Isaac, additional
- Published
- 2021
- Full Text
- View/download PDF
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