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Anti-Topoisomerase I Antibody

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41. What is the effectiveness and safety of antiviral or antibody treatments for coronavirus?

What is the effectiveness and safety of antiviral or antibody treatments for coronavirus? What is the effectiveness and safety of antiviral or antibody treatments for coronavirus? - CEBM CEBM The Centre for Evidence-Based Medicine develops, promotes and disseminates better evidence for healthcare. Navigate this website What is the effectiveness and safety of antiviral or antibody treatments for coronavirus? March 26, 2020 Patricia Rios, Amruta Radhakrishnan, Jesmin Antony, Sonia M. Thomas (...) cause harmful adverse events so future investigations may consider focusing on other candidates for antiviral therapy. BACKGROUND The Infectious Disease Prevention and Control Branch of the Public Health Agency of Canada (PHAC) commissioned this rapid review on the effectiveness and safety of antiviral, antibody, or other medical countermeasures for the treatment of novel coronavirus (COVID-19). The overall objective of this rapid review was to identify safe and effective medical countermeasures

2020 Oxford COVID-19 Evidence Service

42. Covid-19: Effectiveness and safety of antiviral or antibody treatments for coronavirus

Covid-19: Effectiveness and safety of antiviral or antibody treatments for coronavirus Prepared By: Knowledge Translation Program Li Ka Shing Knowledge Institute St. Michael’s Hospital Contact: Dr. Andrea Tricco E: Andrea.Tricco@unityhealth.to T: 416-864-6060 ext.77521 Effectiveness and safety of antiviral or antibody treatments for coronavirus A rapid review Prepared for Public Health Agency of Canada Submitted 2/25/2020 . CC-BY-NC-ND 4.0 International license It is made available under (...) a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted March 23, 2020. . https://doi.org/10.1101/2020.03.19.20039008 doi: medRxiv preprint i Contributors: Patricia Rios, Amruta Radhakrishnan, Jesmin Antony, Sonia Thomas, Matthew Muller, Sharon E. Straus, Andrea C. Tricco. Acknowledgements: Jessie McGowan (literature search), Tamara Rader (literature search), Krystle

2020 Covid-19 Ad hoc papers

43. Effectiveness and safety of antiviral or antibody treatments for coronavirus: A rapid review

Effectiveness and safety of antiviral or antibody treatments for coronavirus: A rapid review Effectiveness and safety of antiviral or antibody treatments for coronavirus: A rapid review | medRxiv Search for this keyword Effectiveness and safety of antiviral or antibody treatments for coronavirus: A rapid review Patricia Rios , Amruta Radhakrishnan , Jesmin Antony , Sonia M. Thomas , Mathew Muller , Sharon E. Straus , Andrea C. Tricco doi: https://doi.org/10.1101/2020.03.19.20039008 Patricia (...) , St. Michael's Hospital, Unity Health Toronto and Dalla Lana School of Public Health & Institute of Health Policy, Management, and Evaluation, University of Toronto For correspondence: Abstract Background: To identify safe and effective medical countermeasures (e.g., antivirals/antibodies) to address the current outbreak of a novel coronavirus (COVID-19) Methods: Comprehensive literature searches were developed by an experienced librarian for MEDLINE, EMBASE, the Cochrane Library, and biorxiv.org

2020 Covid-19 Ad hoc papers

44. COVID-19: Roche Antibody Test

positive, out of the population who should have tested positive. In this case, a sensitivity of 100% tells us that everybody with a history of COVID-19 infection had a positive antibody test. (Tests with sensitivity or specificity that are truly 100% are very rare. I suspect that in this case, the sensitivity is very high, but maybe not actually 100%.) Specificity tells us the proportion of people who test negative, out of the population who should have tested negative. In this case, a specificity (...) COVID-19: Roche Antibody Test COVID-19: Roche Antibody Test - 14th May - CEBM CEBM The Centre for Evidence-Based Medicine develops, promotes and disseminates better evidence for healthcare. Navigate this website COVID-19: Roche Antibody Test – 14th May May 14, 2020 Susannah Fleming, Carl Heneghan , their new COVID-19 antibody test has “a specificity greater than 99.8% and a sensitivity of 100%.” What do sensitivity and specificity tell us? Sensitivity tells us the proportion of people who test

2020 Oxford COVID-19 Evidence Service

45. What is the seroprevalence of SARS-CoV-2 antibodies?

What is the seroprevalence of SARS-CoV-2 antibodies? Lessons from a rapid systematic review of early SARS-CoV-2 serosurveys Niklas Bobrovitz* ? 1,2 ? , DPhil, MSc, BHSc ? ? ; Rahul Krishan Arora* ? 1 ? , BHSc; Tingting Yan ? 2 ? , BHSc ?; Hannah Rahim ? 3 ? , BHSc; Nathan Duarte ? 4 ? ; Emily Boucher ? 3 ? , BHSc; Jordan Van Wyk ? 4 ? ; Timothy Grant Evans ? 5 ? , MD, DPhil 1 ? University of Oxford ? 2 ? University of Toronto ? 3 ? University of Calgary ? 4 ? University of Waterloo 5 ? McGill (...) are heterogeneous, suggesting that ?the urgency to examine seroprevalence may have compromised methodological rigour. Based on the limitations of included studies, ?future serosurvey investigators and stakeholders should ensure that: i) serological tests used undergo high-quality independent evaluations that include cross-reactivity; ii) all reports of serosurvey results, including media, describe the test used, sample size, and sampling method; and iii) initiatives are coordinated to prevent test fatigue

2020 Covid-19 Ad hoc papers

46. Randomized phase I clinical trial of anti-α-synuclein antibody BIIB054. Full Text available with Trip Pro

Randomized phase I clinical trial of anti-α-synuclein antibody BIIB054. Pathological and genetic evidence implicates toxic effects of aggregated α-synuclein in the pathophysiology of neuronal dysfunction and degeneration in Parkinson's disease. Immunotherapy targeting aggregated α-synuclein is a promising strategy for delaying disease progression.This study (NCT02459886) evaluated the safety, tolerability, and pharmacokinetics of BIIB054, a human-derived monoclonal antibody that preferentially

2019 Movement Disorders Controlled trial quality: uncertain

47. Circulating Plasmablasts Contribute to Antiphospholipid Antibody Production, Associated with Type I Interferon Upregulation. (Abstract)

Circulating Plasmablasts Contribute to Antiphospholipid Antibody Production, Associated with Type I Interferon Upregulation. Antiphospholipid antibodies (aPL) are pathogenic autoantibodies in antiphospholipid syndrome (APS). This study aimed to clarify the mechanism of aPL production.T cell and B cell subsets were evaluated in peripheral blood mononuclear cells (PBMCs) of 26 primary APS (PAPS), 19 systemic lupus erythematosus-associated APS (SLE/APS) patients and 10 healthy controls. SLE or APS (...) , the increase of plasmablasts was associated with TLR 7 and type I IFN, suggesting a common pathophysiology in SLE and APS. Targeting plasmablasts might be a novel, immunological therapeutic approach in the treatment of APS. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

2019 Journal of Thrombosis and Haemostasis

48. Assessing the safety and pharmacokinetics of the monoclonal antibodies, VRC07-523LS and PGT121 in HIV negative women in South Africa: study protocol for the CAPRISA 012A randomised controlled phase I trial. Full Text available with Trip Pro

Assessing the safety and pharmacokinetics of the monoclonal antibodies, VRC07-523LS and PGT121 in HIV negative women in South Africa: study protocol for the CAPRISA 012A randomised controlled phase I trial. Despite extensive prevention campaigns and scale-up of antiretroviral therapy, HIV incidence among young women in southern Africa remains high. While the development of an efficacious vaccine remains a challenge, the discovery of broadly neutralising monoclonal antibodies (mAbs) has created (...) the opportunity to explore passive immunisation as a long-acting injectable HIV prevention strategy. The purpose of this trial is to provide safety, pharmacokinetic (PK) and functional activity data of VRC07-523LS and PGT121 when administered subcutaneously (SC) to young South African women. Going forward, the aim is to select the ideal dose and/or monoclonal antibody for co-formulation and testing with CAP256-VRC26.25LS, a potent monoclonal antibody against subtype C virus, in an efficacy trial.CAPRISA 012A

2019 BMJ open Controlled trial quality: predicted high

49. The (non-)sense of detecting anti-cardiolipin and anti-β2glycoprotein I IgM antibodies in the antiphospholipid syndrome. Full Text available with Trip Pro

The (non-)sense of detecting anti-cardiolipin and anti-β2glycoprotein I IgM antibodies in the antiphospholipid syndrome. The antiphospholipid syndrome (APS) is characterized by thrombosis and/or pregnancy morbidity with the persistent presence of lupus anticoagulant (LAC), anti-cardiolipin (aCL) and/or anti-β2glycoprotein I (aβ2GPI) antibodies of the immunoglobulin G/immunoglobulin M (IgG/IgM) isotype. However, the role of aCL and aβ2GPI IgM as a serologic marker in APS is debated.We aimed (...) to assess the diagnostic and clinical value of IgM antiphospholipid antibodies (aPL) in APS within the classification criteria.Our multicenter study comprised 1008 patients, including APS patients and controls. Anti-CL and aβ2GPI IgG and IgM antibodies were detected with four commercially available solid phase assays.Positivity for aCL and/or aβ2GPI antibodies was significantly correlated with thrombosis and pregnancy morbidity, independent of the isotype and solid phase assay. Higher odds ratios were

2019 Journal of Thrombosis and Haemostasis

50. Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an i Full Text available with Trip Pro

Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an i Namilumab (AMG203), an immunoglobulin G1 monoclonal antibody that binds with high affinity to granulocyte-macrophage colony-stimulating factor (GM-CSF), was evaluated in a phase II randomized, double-blind, placebo-controlled study (...) comparing each of the three doses of namilumab to placebo. Safety and tolerability were assessed by adverse events (AEs) and pulmonary parameters. Results were analysed using the per-protocol population.One hundred eight patients from Europe and Japan (48.4 ± 12.02 years old; 77.8% female; mean DAS28-CRP 5.60-5.79; rheumatoid factor/anti-citrullinated protein antibodies + 75%) were randomized to placebo or namilumab 20, 80, or 150 mg (n = 27, 28, 25, and 28, respectively). Ninety-two were MTX-IR; 16

2019 Arthritis research & therapy Controlled trial quality: predicted high

51. DSA-FXM: Accelerated donor specific flow crossmatch discriminating class I and II antibody specifically and only to donor HLA for determining true incompatibility. (Abstract)

DSA-FXM: Accelerated donor specific flow crossmatch discriminating class I and II antibody specifically and only to donor HLA for determining true incompatibility. Worldwide, a final crossmatch is the gold standard for determining compatibility between patient and donor prior to solid organ transplantation and preventing hyperacute rejection. In the absence of autoantibodies, an incompatible crossmatch in a sensitized patient is attributed to mismatched donor human leukocyte antigens (HLA (...) ). However, current physical crossmatch methods cannot distinguish reactivity to HLA from other clinically irrelevant cell surface targets nor the class of HLA if it is the target. Result interpretation is difficult or impossible when autoantibodies, alloantibodies, and/or therapeutic antibodies coexist.Herein we describe a unique donor specific flow crossmatch (DSA-FXM) that distinguishes HLA class I and/or II DSA bound to HLA antigens on the donor cell surface in their native conformation

2019 Transplantation

52. Phase I Study of a CD45-Targeted Antibody-Radionuclide Conjugate for High-Risk Lymphoma. (Abstract)

Phase I Study of a CD45-Targeted Antibody-Radionuclide Conjugate for High-Risk Lymphoma. External-beam radiation is the single most effective therapy for localized lymphoma. However, toxicity limits its use for multifocal disease. We evaluated CD45 as a therapeutic target for an antibody-radionuclide conjugate (ARC) for the treatment of lymphoma based on its ubiquitous expression, infrequent antigen loss or blockade, and the ability to target minimal disease based on panhematopoietic (...) expression.We performed a phase I trial of escalating doses of single-agent CD45-targeted ARC based on per-patient dosimetry using the BC8 antibody labeled with iodine-131 (131I) followed by autologous stem cell support in adults with relapsed, refractory, or high-risk B-cell non-Hodgkin lymphoma (NHL), T-NHL, or Hodgkin lymphoma (HL). The primary objective was to estimate the maximum tolerated radiation absorbed dose.Sixteen patients were enrolled: 7 patients had B-NHL, 6 had HL, and 3 had T-NHL. Median

2019 Clinical Cancer Research

53. Retooling a Blood-based Biomarker: Phase I Assessment of the High-Affinity CA19-9 Antibody HuMab-5B1 for Immuno-PET Imaging of Pancreatic Cancer. (Abstract)

Retooling a Blood-based Biomarker: Phase I Assessment of the High-Affinity CA19-9 Antibody HuMab-5B1 for Immuno-PET Imaging of Pancreatic Cancer. In cancer patients with an abnormal biomarker finding, the source of the biomarker in the bloodstream must be located for confirmation of diagnosis, staging, and therapy planning. We evaluated if immuno-PET with the radiolabeled high-affinity antibody HuMab-5B1 (MVT-2163), binding to the cancer antigen CA19-9, can identify the source of elevated

2019 Clinical Cancer Research

54. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. (Abstract)

A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Regulatory T cells (Tregs) expressing CC chemokine receptor 4 (CCR4) can suppress antitumor immune responses and are associated with poor prognoses in several cancers. We assessed the safety and efficacy of combined mogamulizumab (anti-CCR4 antibody) and nivolumab [anti-programmed death-1 (PD-1) antibody] in immunotherapy-naïve patients (...) responses among 15 patients with hepatocellular carcinoma, and one confirmed and two unconfirmed responses among 15 patients with pancreatic adenocarcinoma. During treatment, populations of effector Tregs (CD4+CD45RA-FoxP3high) decreased and CD8+ T cells in tumor-infiltrating lymphocytes increased.Combining an anti-PD-1 antibody, nivolumab, with a Treg-depleting anti-CCR4 antibody, mogamulizumab, provides an acceptable safety profile, antitumor activity, and a potentially effective option in cancer

2019 Clinical Cancer Research

55. First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. (Abstract)

First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. To evaluate the safety, pharmacokinetics, and pharmacodynamics of Hu5F9-G4 (5F9), a humanized IgG4 antibody that targets CD47 to enable phagocytosis.Adult patients with solid tumors were treated in four cohorts: part A, to determine a priming dose; part B, to determine a weekly maintenance dose; part C, to study a loading dose in week 2; and a tumor biopsy cohort.Sixty-two patients (...) smear (36%), fatigue (64%), headaches (50%), fever (45%), chills (45%), hyperbilirubinemia (34%), lymphopenia (34%), infusion-related reactions (34%), and arthralgias (18%). No maximum tolerated dose was reached with maintenance doses up to 45 mg/kg. At doses of 10 mg/kg or more, the CD47 antigen sink was saturated by 5F9, and a 5F9 half-life of approximately 13 days was observed. Strong antibody staining of tumor tissue was observed in a patient at 30 mg/kg. Two patients with ovarian/fallopian tube

2019 Journal of Clinical Oncology

56. A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers. Full Text available with Trip Pro

A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers. Inhibition of interleukin (IL)-13, a Type 2 inflammatory mediator in asthma, improves lung function and reduces exacerbations; however, more effective therapies are needed. A subset of asthma patients also exhibits elevated IL-17, which is associated with greater (...) disease severity, neutrophilic inflammation, and steroid resistance. BITS7201A is a novel, humanized bispecific antibody that binds and neutralizes both IL-13 and IL-17.Safety, pharmacokinetics, and immunogenicity of BITS7201A were evaluated in a phase 1 study. Part A was a single ascending-dose design with 5 cohorts: 30-, 90-, and 300-mg subcutaneous (SC), and 300- and 750-mg intravenous (IV). Part B was a multiple ascending-dose design with 3 cohorts: 150-, 300-, and 600-mg SC every 4 weeks × 3

2019 BMC pulmonary medicine Controlled trial quality: uncertain

57. T cell Bispecific Antibodies in Node-Positive Breast Cancer: Novel Therapeutic Avenue for MHC class I Loss Variants. Full Text available with Trip Pro

T cell Bispecific Antibodies in Node-Positive Breast Cancer: Novel Therapeutic Avenue for MHC class I Loss Variants. Tumor-infiltrating lymphocytes (TILs) represent a prognostic factor for survival in primary breast cancers (BC). Nonetheless, neoepitope load and TILs cytolytic activity are modest in BC, compromising the efficacy of immune-activating antibodies, which do not yet compete against immunogenic chemotherapy.We analyzed by functional flow cytometry the immune dynamics of primary (...) and metastatic axillary nodes (mLN) in early breast cancers after exposure to T cell bispecific antibodies (TCB) bridging CD3ε and HER2 or CEACAM5, before and after chemotherapy. HLA class I loss was assessed by whole exome sequencing and immunohistochemistry. 100 primary BC, 64 surrounding "healthy tissue" (HT) and 24 mLN related-parameters were analyzed.HLA loss of heterozygosity was observed in early BC, at a clonal and subclonal level and was associated with regulatory T cells and Tim3 expression

2019 Annals of Oncology

58. Detection of Anti-Cardiolipin and Anti-β2glycoprotein I Antibodies Differs between Platforms without Influence on Association with Clinical Symptoms. (Abstract)

Detection of Anti-Cardiolipin and Anti-β2glycoprotein I Antibodies Differs between Platforms without Influence on Association with Clinical Symptoms.  The anti-phospholipid syndrome (APS) is characterized by thrombosis and/or pregnancy morbidity with persistent presence of anti-phospholipid antibodies (aPL). Laboratory criteria include aPL detection by coagulation tests for lupus anticoagulant (LAC) or solid phase assays measuring anti-β2 glycoprotein I (aβ2GPI) or anti-cardiolipin (aCL (...) ) immunoglobulin (Ig) G/IgM antibodies. External quality control programs illustrate that commercially available aPL assays produce variable results. We aimed to investigate the agreement and diagnostic accuracy of solid phase assays. In this multi-centre study, 1,168 patient samples were tested on one site for aCL and aβ2GPI IgG/IgM antibodies by four solid phase test systems. Samples included APS patients, controls and monoclonal antibodies (MoAB) against different epitopes of β2GPI. LAC was determined

2019 Thrombosis and haemostasis

59. Presence of Antitopoisomerase I Antibody Alone May Not Be Sufficient for the Diagnosis of Systemic Sclerosis. Full Text available with Trip Pro

Presence of Antitopoisomerase I Antibody Alone May Not Be Sufficient for the Diagnosis of Systemic Sclerosis. Systemic sclerosis (SSc) is characterized by altered immune function and vascular damage, which lead to extensive fibrosis. Experts underscore the importance of using SSc-specific autoantibodies to divide the disease into subsets for prognosis, management, and research1,2.

2019 Journal of Rheumatology

60. A Phase I Study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. (Abstract)

A Phase I Study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. ADCT-402 (loncastuximab tesirine) is an antibody-drug conjugate comprising a CD19-targeting antibody and pyrrolobenzodiazepine dimers. A first-in-human study evaluated the safety and preliminary clinical activity of loncastuximab tesirine in patients with B-cell non-Hodgkin lymphoma (NHL).A multicenter, phase I, dose-escalation

2019 Clinical Cancer Research

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