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  1. AU="Yoon, Sangwook"
  2. AU="Sedor, John R."
  3. AU="Legrand, Julien"
  4. AU="Mintz, Kevin Todd"
  5. AU="Kösters, Markus"
  6. AU="Castano-Duque, Lina"
  7. AU="Lowry, Gregory V"
  8. AU="Gao, Xiaojuan"
  9. AU="Daniłowicz-Szymanowicz, Ludmiła"
  10. AU="Weber, Jesse N"
  11. AU="Fages-Masmiquel, Ester"
  12. AU="Macias Gil, Raul"
  13. AU="Planchat, Arnaud"
  14. AU="McElrath, Erin E"
  15. AU="Koji Ueda"
  16. AU="Pillas, Diana J"
  17. AU="Thomson, Jason J"
  18. AU="Mitra, Kalyan"
  19. AU="Sanjay Desai"
  20. AU=Cox David J AU=Cox David J
  21. AU="Grebenok, Robert J."
  22. AU="Blackburne, Brittney"
  23. AU="Bortoleti, Bruna Taciane da Silva"
  24. AU="Ehrbar, Martin"
  25. AU="Lepre, Davide"
  26. AU="Olszewska, Zuzanna"
  27. AU="Vojta, Leslie"
  28. AU=Wickstrom Eric AU=Wickstrom Eric
  29. AU="Gangavarapu, Sridevi"
  30. AU="Hussein, Hazem Abdelwaheb"
  31. AU=Cai Yixin AU=Cai Yixin
  32. AU="Hüls, Anke"
  33. AU="Poondru, Srinivasu"
  34. AU="Coca, Daniel"
  35. AU="Lebeau, Paul"
  36. AU="Dehghani, Sedigheh"
  37. AU="Ishibashi, Kenji"
  38. AU="Xu, Yanhua"
  39. AU="Matera, Katarzyna"
  40. AU="Ait-Ouarab, Slimane"
  41. AU="Nicola, Coppede"
  42. AU="Dewitt, John M"
  43. AU="Sorin M. Dudea"
  44. AU="Tanusha D. Ramdin"
  45. AU="Hao, Zehui"
  46. AU="Chauhan, Aman"

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  1. Artikel ; Online: A Developer's Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10.

    Choi, Dasom / Lee, Soohyun / Kim, Seungmin / Yoon, Sangwook

    Clinical drug investigation

    2022  Band 42, Heft 4, Seite(n) 285–300

    Abstract: To date, four rituximab biosimilars have received regulatory approval from the European Medicines Agency and/or US Food and Drug Administration. CT-P10 was the first rituximab biosimilar to be approved by each agency, in 2017 and 2018, respectively. ... ...

    Abstract To date, four rituximab biosimilars have received regulatory approval from the European Medicines Agency and/or US Food and Drug Administration. CT-P10 was the first rituximab biosimilar to be approved by each agency, in 2017 and 2018, respectively. Regulatory approval of CT-P10 followed demonstration of pharmacokinetic equivalence to the reference product in a phase I study in patients with rheumatoid arthritis. Phase III pivotal studies of CT-P10 subsequently demonstrated equivalence or non-inferiority of pharmacokinetics and efficacy between CT-P10 and reference rituximab in patients with rheumatoid arthritis, advanced-stage follicular lymphoma, and low-tumour-burden follicular lymphoma. Almost 5 years after its initial regulatory approval, significant real-world experience has accumulated with CT-P10 use, particularly in diffuse large B-cell lymphoma, one of the indications approved by extrapolation. This article summarises the pivotal data underlying regulatory approval for the four licensed rituximab biosimilars, before focusing on real-world data gathered with CT-P10. These data provide further support for the safety and effectiveness of CT-P10 and should boost healthcare professional and patient confidence in its use. Pharmacoeconomic analyses support the potential healthcare system cost savings offered by rituximab biosimilar uptake, which could lead to improved patient access to biologic treatments. Opportunities arising from biosimilar uptake extend further, potentially enabling innovative investigator-led research and therapeutic advances.
    Mesh-Begriff(e) Antibodies, Monoclonal, Murine-Derived ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/pharmacokinetics ; Clinical Trials, Phase I as Topic ; Humans ; Lymphoma, Follicular/drug therapy ; Lymphoma, Follicular/pathology ; Rituximab/pharmacokinetics ; Rituximab/therapeutic use
    Chemische Substanzen Antibodies, Monoclonal, Murine-Derived ; Biosimilar Pharmaceuticals ; CT-P10 ; Rituximab (4F4X42SYQ6)
    Sprache Englisch
    Erscheinungsdatum 2022-03-24
    Erscheinungsland New Zealand
    Dokumenttyp Journal Article ; Review
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-022-01133-x
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  2. Artikel ; Online: Stepping Forward to the Next Level: Totality of Evidence for the First High-Concentration Adalimumab Biosimilar, CT-P17.

    Viapiana, Ombretta / Lee, Soohyun / Yoon, SangWook / Fautrel, Bruno

    Clinical drug investigation

    2022  Band 42, Heft 2, Seite(n) 103–112

    Abstract: Biosimilar regulatory evaluation considers the totality of evidence gathered through analytical, non-clinical and clinical studies. CT-P17 is the first high-concentration (100 mg/mL), citrate-free adalimumab biosimilar to receive regulatory approval in ... ...

    Abstract Biosimilar regulatory evaluation considers the totality of evidence gathered through analytical, non-clinical and clinical studies. CT-P17 is the first high-concentration (100 mg/mL), citrate-free adalimumab biosimilar to receive regulatory approval in Europe for all indications held by reference adalimumab, following comprehensive non-clinical and clinical development programmes. State-of-the art physicochemical and biological methods demonstrated quality, analytical and functional comparability between CT-P17 and reference adalimumab; non-clinical in vivo studies supported biosimilarity. Three phase I and two phase III studies were conducted, with pharmacokinetic equivalence of CT-P17 and reference adalimumab shown in healthy volunteers, and equivalent efficacy demonstrated in patients with rheumatoid arthritis. Safety and immunogenicity profiles were comparable between CT-P17 and reference adalimumab across studies. CT-P17 is available for administration by autoinjector/prefilled pen (AI/PFP), prefilled syringe (PFS) and PFS with needle guard, providing diverse self-injection options for patients. Equivalent pharmacokinetics and comparable overall safety and usability were demonstrated between AI/PFP and PFS devices during the clinical development programme. All CT-P17 devices include fine, 29-gauge needles; combined with the citrate-free, high-concentration formulation, these characteristics reflect the newer reference adalimumab formulation (100 mg/mL) and are associated with reduced injection-site pain. The high-concentration formulation also facilitates treatment delivery via fewer injections. Compared with reference adalimumab, CT-P17 remains stable for longer at room temperature, enhancing ease of storage for patients and healthcare providers. In summary, the totality of evidence supports the biosimilarity of CT-P17 to high-concentration reference adalimumab, and several distinctive features differentiate it from existing adalimumab biosimilars.
    Mesh-Begriff(e) Adalimumab ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals ; Humans ; Therapeutic Equivalency ; Tomography, X-Ray Computed
    Chemische Substanzen Biosimilar Pharmaceuticals ; Adalimumab (FYS6T7F842)
    Sprache Englisch
    Erscheinungsdatum 2022-01-13
    Erscheinungsland New Zealand
    Dokumenttyp Journal Article ; Review
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-021-01107-5
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  3. Artikel ; Online: Monoclonal antibody therapies in the management of SARS-CoV-2 infection.

    Miguez-Rey, Enrique / Choi, Dasom / Kim, Seungmin / Yoon, Sangwook / Săndulescu, Oana

    Expert opinion on investigational drugs

    2022  Band 31, Heft 1, Seite(n) 41–58

    Abstract: Introduction: Neutralizing antibodies (NAbs) that target key domains of the spike protein in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may have therapeutic value because of their specificity. Depending on the targeted epitope, single ... ...

    Abstract Introduction: Neutralizing antibodies (NAbs) that target key domains of the spike protein in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may have therapeutic value because of their specificity. Depending on the targeted epitope, single agents may be effective, but combined treatment involving multiple NAbs may be necessary to prevent the emergence of resistant variants.
    Areas covered: This article highlights the accelerated regulatory processes established to facilitate the review and approval of potential therapies. An overview of treatment approaches for SARS-CoV-2 infection, with detailed examination of the preclinical and clinical evidence supporting the use of NAbs, is provided. Finally, insights are offered into the potential benefits and challenges associated with the use of these agents.
    Expert opinion: NAbs offer an effective, evidence-based therapeutic intervention during the early stages of SARS-CoV-2 infection when viral replication is the primary factor driving disease progression. As the pandemic progresses, appropriate use of NAbs will be important to minimize the risk of escape variants. Ultimately, the availability of effective treatments for COVID-19 will allow the establishment of treatment algorithms for minimizing the substantial rates of hospitalization, morbidity (including long COVID) and mortality currently associated with the disease.
    Mesh-Begriff(e) Antibodies, Monoclonal/therapeutic use ; Antibodies, Neutralizing/therapeutic use ; COVID-19/complications ; Humans ; SARS-CoV-2
    Chemische Substanzen Antibodies, Monoclonal ; Antibodies, Neutralizing
    Sprache Englisch
    Erscheinungsdatum 2022-02-14
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 1182884-5
    ISSN 1744-7658 ; 0967-8298 ; 1354-3784
    ISSN (online) 1744-7658
    ISSN 0967-8298 ; 1354-3784
    DOI 10.1080/13543784.2022.2030310
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    Zs.A 3739: Hefte anzeigen Standort:
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  4. Artikel ; Online: Re-Routing Infliximab Therapy: Subcutaneous Infliximab Opens a Path Towards Greater Convenience and Clinical Benefit.

    Alten, Rieke / An, Yoorim / Kim, Dong-Hyeon / Yoon, SangWook / Peyrin-Biroulet, Laurent

    Clinical drug investigation

    2022  Band 42, Heft 6, Seite(n) 477–489

    Abstract: Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous ... ...

    Abstract Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab demonstrated an improved pharmacokinetic profile compared with intravenous infliximab: the more stable exposure and increased systemic drug concentrations mean it has been cited as a biobetter. Alongside the pharmacokinetic advantages, potential benefits for efficacy, immunogenicity, and health-related quality-of-life outcomes have been suggested with subcutaneous infliximab. During the coronavirus disease 2019 pandemic, the benefits of subcutaneous over intravenous therapies became apparent: switching from intravenous to subcutaneous infliximab reduced the hospital visit-related healthcare resource burden and potential viral transmission. Clinical advantages observed in pivotal trials are also being seen in the real world. Accumulating experience from four European countries (the UK, Spain, France, and Germany) in patients with rheumatic diseases and inflammatory bowel disease supports clinical trial findings that subcutaneous infliximab is well tolerated, increases serum drug concentrations, and offers maintained or improved efficacy outcomes for patients switching from intravenous infliximab. Initial evidence is emerging with subcutaneous infliximab treatment after intravenous infliximab failure. High patient satisfaction and pharmacoeconomic benefits have also been reported with subcutaneous infliximab. Treatments aligned with patient preferences for the flexibility and convenience of at-home subcutaneous administration could boost adherence and treatment outcomes. Altogether, findings suggest that switching from intravenous to subcutaneous infliximab could be advantageous, and healthcare professionals should be prepared to discuss supporting data as part of shared decision making during patient consultations.
    Mesh-Begriff(e) Antibodies, Monoclonal/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals/therapeutic use ; COVID-19/drug therapy ; Humans ; Inflammatory Bowel Diseases/chemically induced ; Inflammatory Bowel Diseases/drug therapy ; Infliximab/therapeutic use ; Treatment Outcome
    Chemische Substanzen Antibodies, Monoclonal ; Biosimilar Pharmaceuticals ; Infliximab (B72HH48FLU)
    Sprache Englisch
    Erscheinungsdatum 2022-06-03
    Erscheinungsland New Zealand
    Dokumenttyp Journal Article ; Review
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-022-01162-6
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  5. Artikel: Comparative Complications Associated With BMP Use In Patients Undergoing ACDF for Degenerative Spinal Conditions: Systematic Review and Meta-Analysis.

    Martin, Christopher T / Holton, Kenneth / Broida, Samuel E / Hickmann, Anne-Katrin / Bakker, Caitlin / Lender, Paul A / Watanabe, Kota / Meisel, Hans Jörg / Buser, Zorica / Presciutti, Steven M / Yoon, Sangwook Tim

    Global spine journal

    2024  Band 14, Heft 2_suppl, Seite(n) 94S–109S

    Abstract: Study design: Systematic Review and Meta-Analysis.: Objectives: To compare complication incidence in patients with or without the use of recombinant human Bone Morphogenic Protein-2 (BMP2) undergoing anterior cervical discectomy and fusion (ACDF) for ...

    Abstract Study design: Systematic Review and Meta-Analysis.
    Objectives: To compare complication incidence in patients with or without the use of recombinant human Bone Morphogenic Protein-2 (BMP2) undergoing anterior cervical discectomy and fusion (ACDF) for degenerative conditions.
    Methods: A systematic search of eight online databases was conducted using PRISMA guidelines. Inclusion criteria included English language studies with a minimum of 10 adult patients undergoing instrumented ACDF surgery for a degenerative spinal condition in which BMP2 was used in all patients or one of the treatment arms. Studies with patients undergoing circumferential fusions, with non-degenerative indications, or which did not report post-operative complication data were excluded. Patients with and without BMP2 were compared in terms of the incidence of dysphagia/dysphonia, anterior soft tissue complications (hematoma, seroma, infection, dysphagia/dysphonia), nonunion, medical complications, and new neurologic deficits.
    Results: Of 1832 preliminary search results, 27 manuscripts were included. Meta-analysis revealed the relative risk of dysphagia or dysphonia (RR = 1.39, CI 95% 1.18 - 1.64,
    Conclusions: This meta-analysis identified a high rate of arthrodesis when BMP2 was used in ACDF, but confirmed increased rates of dysphagia and anterior soft tissue complications. Surgeons may consider reserving BMP2 implementation for cases with a high risk of non-union, and should be aware of the risk of airway compromise.
    Sprache Englisch
    Erscheinungsdatum 2024-02-29
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2648287-3
    ISSN 2192-5690 ; 2192-5682
    ISSN (online) 2192-5690
    ISSN 2192-5682
    DOI 10.1177/21925682231166325
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  6. Artikel: Development of an International AO Spine Guideline for the Use of Osteobiologics in Anterior Cervical Fusion and Decompression (AO-GO).

    Buser, Zorica / Meisel, Hans Jörg / Agarwal, Neha / Wu, Yabin / Jain, Amit / van Hooff, Miranda / Alini, Mauro / Yoon, Sangwook Tim / Wang, Jeffrey C / Santesso, Nancy

    Global spine journal

    2024  Band 14, Heft 2_suppl, Seite(n) 14S–23S

    Abstract: Study design: Methodological study for guideline development.: Objective: AO Spine Guideline for Using Osteobiologics (AO-GO) project for spine degenerative pathologies was an international, multidisciplinary collaborative initiative to identify and ... ...

    Abstract Study design: Methodological study for guideline development.
    Objective: AO Spine Guideline for Using Osteobiologics (AO-GO) project for spine degenerative pathologies was an international, multidisciplinary collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in Anterior Cervical Fusion and Decompression (ACDF). The aim was to formulate precisely defined, clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics, considering regional preferences and cost-effectiveness.
    Methods: Guideline was completed in two phases: Phase 1- evidence synthesis; Phase 2- recommendation development based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. In Phase 1, key questions identified by a panel of experts were addressed in a series of systematic reviews of randomized and non-randomized studies. In Phase 2, the GRADE approach was used to formulate a series of recommendations, including expert panel discussions via web calls and face-to-face meetings.
    Discussion: AO-GO aims to bridge an important gap between evidence and use of osteobiologics in spine fusion surgeries. Owing to differences in osteobiologics preparation and functional characteristics, regulatory requirements for approval may vary, therefore it is highly likely that these products enter market without quality clinical trials. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making processes in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries. In Phase 3, the guideline will be disseminated and validated using prospectively collected clinical data in a separate effort of the AO Spine Knowledge Forum Degenerative in a global multicenter clinical study.
    Sprache Englisch
    Erscheinungsdatum 2024-02-29
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2648287-3
    ISSN 2192-5690 ; 2192-5682
    ISSN (online) 2192-5690
    ISSN 2192-5682
    DOI 10.1177/21925682231201601
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  7. Artikel: Development of CT Effective Dose Conversion Factors from Clinical CT Examinations in the Republic of Korea.

    Lee, Sang-Kyung / Kim, Jung Su / Yoon, Sang-Wook / Kim, Jung Min

    Diagnostics (Basel, Switzerland)

    2020  Band 10, Heft 9

    Abstract: The aim of this study was to determine the conversion factors for the effective dose (ED) per dose length product (DLP) for various computed tomography (CT) protocols based on the 2007 recommendations of the International Commission on Radiological ... ...

    Abstract The aim of this study was to determine the conversion factors for the effective dose (ED) per dose length product (DLP) for various computed tomography (CT) protocols based on the 2007 recommendations of the International Commission on Radiological Protection (ICRP). CT dose data from 369 CT scanners and 13,625 patients were collected through a nationwide survey. Data from 3793 patients with a difference in height within 5% of computational human phantoms were selected to calculate ED and DLP. The anatomical CT scan ranges for 11 scan protocols (adult-10, pediatric-1) were determined by experts, and scan lengths were obtained by matching scan ranges to computational phantoms. ED and DLP were calculated using the NCICT program. For each CT protocol, ED/DLP conversion factors were calculated from ED and DLP. Estimated ED conversion factors were 0.00172, 0.00751, 0.00858, 0.01843, 0.01103, 0.02532, 0.01794, 0.02811, 0.02815, 0.02175, 0.00626, 0.00458, 0.00308, and 0.00233 mSv∙mGy
    Sprache Englisch
    Erscheinungsdatum 2020-09-21
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article
    ZDB-ID 2662336-5
    ISSN 2075-4418
    ISSN 2075-4418
    DOI 10.3390/diagnostics10090727
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  8. Artikel ; Online: Updated National Diagnostic Reference Levels and Achievable Doses for CT Protocols: A National Survey of Korean Hospitals.

    Nam, Sora / Park, Hyemin / Kwon, Soonmu / Cho, Pyong-Kon / Yoon, Yongsu / Yoon, Sang-Wook / Kim, Jungsu

    Tomography (Ann Arbor, Mich.)

    2022  Band 8, Heft 5, Seite(n) 2450–2459

    Abstract: ... Background: ... In 2021, the Korean government proposed a new CT diagnostic reference level. This study performed a nationwide survey and developed new DRLs and AD for 13 common CT examinations. We compared other countries' DRLs for CT examinations. < ... ...

    Abstract Background: In 2021, the Korean government proposed a new CT diagnostic reference level. This study performed a nationwide survey and developed new DRLs and AD for 13 common CT examinations. We compared other countries' DRLs for CT examinations. Methods: This study investigated the CTDI<sub>vol</sub> and DLP of the 12 types of CT protocols for adults and brain CT protocol for pediatrics. A total of 7829 CT examinations were performed using 225 scanners. We defined the DRLs values in the distribution of radiation exposure levels to determine the nationwide patient dose and distribution status of the dose. Results: This study showed that the new Korean national CT DRLs are slightly higher or similar to those of previous surveys and are similar or lower than those of other countries. In some protocols, although the DLP value increased, the CTDI<sub>vol</sub> decreased; therefore, it can be concluded that the patient's dose in CT examinations was well managed. Conclusions: The new CT DRLs were slightly higher than or similar to that of the previous survey and were evaluated to be similar or lower than CT DRLs of other countries. These DRLs will be used for radiation optimization and effective dose calculation for an individual.
    Mesh-Begriff(e) Adult ; Child ; Humans ; Radiation Dosage ; Diagnostic Reference Levels ; Tomography, X-Ray Computed/methods ; Reference Values ; Hospitals ; Republic of Korea
    Sprache Englisch
    Erscheinungsdatum 2022-09-29
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2379-139X
    ISSN (online) 2379-139X
    DOI 10.3390/tomography8050203
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: Improving Surgical Triage in Spine Clinic: Predicting Likelihood of Surgery Using Machine Learning.

    Broida, Samuel E / Schrum, Mariah L / Yoon, Eric / Sweeney, Aidan P / Dhruv, Neil N / Gombolay, Matthew C / Yoon, Sangwook T

    World neurosurgery

    2022  Band 163, Seite(n) e192–e198

    Abstract: Background: Correctly triaging patients to a surgeon or a nonoperative provider is an important part of the referral process. Clinics typically triage new patients based on simple intake questions. This is time-consuming and does not incorporate ... ...

    Abstract Background: Correctly triaging patients to a surgeon or a nonoperative provider is an important part of the referral process. Clinics typically triage new patients based on simple intake questions. This is time-consuming and does not incorporate objective data. Our goal was to use machine learning to more accurately screen surgical candidates seen in a spine clinic.
    Methods: Using questionnaire data and magnetic resonance imaging reports, a set of artificial neural networks was trained to predict whether a patient would be recommended for spine surgery. Questionnaire responses included demographics, chief complaint, and pain characteristics. The primary end point was the surgeon's determination of whether a patient was an operative candidate. Model accuracy in predicting this end point was assessed using a separate subset of patients.
    Results: The retrospective dataset included 1663 patients in cervical and lumbar cohorts. Questionnaire data were available for all participants, and magnetic resonance imaging reports were available for 242 patients. Within 6 months of initial evaluation, 717 (43.1%) patients were deemed surgical candidates by the surgeon. Our models predicted surgeons' recommendations with area under the curve scores of 0.686 for lumbar (positive predictive value 66%, negative predictive value 80%) and 0.821 for cervical (positive predictive value 83%, negative predictive value 85%) patients.
    Conclusions: Our models used patient data to accurately predict whether patients will receive a surgical recommendation. The high negative predictive value demonstrates that this approach can reduce the burden of nonsurgical patients in surgery clinic without losing many surgical candidates. This could reduce unnecessary visits for patients, increase the proportion of operative candidates seen by surgeons, and improve quality of patient care.
    Mesh-Begriff(e) Humans ; Machine Learning ; Referral and Consultation ; Retrospective Studies ; Spine ; Triage/methods
    Sprache Englisch
    Erscheinungsdatum 2022-03-26
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2534351-8
    ISSN 1878-8769 ; 1878-8750
    ISSN (online) 1878-8769
    ISSN 1878-8750
    DOI 10.1016/j.wneu.2022.03.096
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  10. Artikel ; Online: Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials.

    Peyrin-Biroulet, Laurent / Arkkila, Perttu / Armuzzi, Alessandro / Danese, Silvio / Ferrante, Marc / Jordi Guardiola / Jahnsen, Jørgen / Louis, Edouard / Lukáš, Milan / Reinisch, Walter / Roblin, Xavier / Smith, Philip J / Kwon, Taek / Kim, Jeeyoung / Yoon, Sangwook / Kim, Dong-Hyeon / Atreya, Raja

    BMC gastroenterology

    2024  Band 24, Heft 1, Seite(n) 121

    Abstract: Background: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, ...

    Abstract Background: While indirect comparison of infliximab (IFX) and vedolizumab (VDZ) in adults with Crohn's disease (CD) or ulcerative colitis (UC) shows that IFX has better effectiveness during induction, and comparable efficacy during maintenance treatment, comparative data specific to subcutaneous (SC) IFX (i.e., CT-P13 SC) versus VDZ are limited.
    Aim: Pooled analysis of randomised studies to compare efficacy and safety with IFX SC and VDZ in moderate-to-severe inflammatory bowel disease.
    Methods: Parallel-group, randomised studies evaluating IFX SC and VDZ in patients with moderate-to-severe CD or UC were identified. Eligible studies reported ≥ 1 prespecified outcome of interest at Week 6 (reflecting treatment during the induction phase) and/or at 1 year (Weeks 50-54; reflecting treatment during the maintenance phase). Prespecified efficacy and safety outcomes considered in this pooled analysis included the proportions of patients achieving disease-specific clinical responses, clinical remission, or discontinuing due to lack of efficacy, and the proportions of patients experiencing adverse events (AEs), serious AEs, infections, serious infections, or discontinuing due to AEs. Data from multiple studies or study arms were extracted and pooled using a random-effect model; comparative analyses were performed separately for patients with CD and UC.
    Results: We identified three eligible CD trials and four eligible UC trials that assigned over 1200 participants per disease cohort to either IFX SC or VDZ. In patients with CD, intravenous induction therapy with IFX demonstrated better efficacy (non-overlapping 95% confidence intervals [CIs]) compared with VDZ; during the maintenance phase, IFX SC showed numerically better efficacy (overlapping 95% CIs) than VDZ. A lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In patients with UC, efficacy profiles were similar with IFX SC and VDZ during the induction and maintenance phases, and a lower proportion of IFX SC-treated patients discontinued therapy due to lack of efficacy over 1 year. In both cohorts, safety profiles for IFX SC and VDZ were generally comparable during 1 year.
    Conclusion: IFX SC demonstrated better efficacy than VDZ in patients with CD, and similar efficacy to VDZ in patients with UC; 1-year safety was comparable with IFX SC and VDZ.
    Mesh-Begriff(e) Adult ; Humans ; Colitis, Ulcerative/drug therapy ; Infliximab/adverse effects ; Crohn Disease/drug therapy ; Gastrointestinal Agents/adverse effects ; Remission Induction ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Antibodies, Monoclonal, Humanized
    Chemische Substanzen Infliximab (B72HH48FLU) ; vedolizumab (9RV78Q2002) ; Gastrointestinal Agents ; Antibodies, Monoclonal, Humanized
    Sprache Englisch
    Erscheinungsdatum 2024-03-27
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2041351-8
    ISSN 1471-230X ; 1471-230X
    ISSN (online) 1471-230X
    ISSN 1471-230X
    DOI 10.1186/s12876-024-03163-5
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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