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  • 1
    Language: English
    In: The lancet oncology, 2015, Vol.16 (1), p.98-107
    Description: Summary Background Results of previous study showed promising but short-lived activity of sorafenib in the treatment of patients with unresectable advanced and metastatic osteosarcoma. This treatment failure has been attributed to the mTOR pathway and might therefore be overcome with the addition of mTOR inhibitors. We aimed to investigate the activity of sorafenib in combination with everolimus in patients with inoperable high-grade osteosarcoma progressing after standard treatment. Methods We did this non-randomised phase 2 trial in three Italian Sarcoma Group centres. We enrolled adults (≥18 years) with relapsed or unresectable osteosarcoma progressing after standard treatment (methotrexate, cisplatin, and doxorubicin, with or without ifosfamide). Patients received 800 mg sorafenib plus 5 mg everolimus once a day until disease progression or unacceptable toxic effects. The primary endpoint was 6 month progression-free survival (PFS). All analyses were intention-to-treat. This trial is registered with ClinicalTrials.gov , number NCT01804374. Findings We enrolled 38 patients between June 16, 2011, and June 4, 2013. 17 (45%; 95% CI 28–61) of 38 patients were progression free at 6 months. Toxic effects led to dose reductions, or short interruptions, or both in 25 (66%) of 38 patients and permanent discontinuation for two (5%) patients. The most common grade 3–4 adverse events were lymphopenia and hypophosphataemia each in six (16%) patients, hand and foot syndrome in five (13%), thrombocytopenia in four (11%), and fatigue, oral mucositis, diarrhoea, and anaemia each in two (5%). One patient (3%) had a grade 3 pneumothorax that required trans-thoracic drainage, and that recurred at the time of disease progression. This was reported as a serious adverse event related to the study drugs in both instances. No other serious adverse events were reported during the trial. There were no treatment-related deaths. Interpretation Although the combination of sorafenib and everolimus showed activity as a further-line treatment for patients with advanced or unresectable osteosarcoma, it did not attain the prespecified target of 6 month PFS of 50% or greater. Funding Italian Sarcoma Group.
    Subject(s): Hematology, Oncology and Palliative Medicine ; Niacinamide - analogs & derivatives ; Osteosarcoma - drug therapy ; TOR Serine-Threonine Kinases - metabolism ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Male ; Bone Neoplasms - pathology ; TOR Serine-Threonine Kinases - antagonists & inhibitors ; Young Adult ; Neoplasm Grading ; Time Factors ; Adult ; Female ; Bone Neoplasms - drug therapy ; Everolimus ; Sirolimus - analogs & derivatives ; Bone Neoplasms - enzymology ; Osteosarcoma - enzymology ; Kaplan-Meier Estimate ; Treatment Outcome ; Disease Progression ; Niacinamide - administration & dosage ; Disease-Free Survival ; Sirolimus - administration & dosage ; Phenylurea Compounds - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Adolescent ; Intention to Treat Analysis ; Italy ; Osteosarcoma - secondary ; Antimitotic agents ; Chemotherapy ; Osteosarcoma ; Stem cells ; Clinical trials ; Product development ; Antineoplastic agents ; Standards ; Cancer ; Index Medicus
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 2
    Language: English
    In: Psycho-oncology (Chichester, England), 2020-09, Vol.29 (9), p.1384-1386
    Subject(s): Covid‐19 ; Childhood cancer survivors ; Pediatric Psycho‐oncology ; Caregiver ; Childhood cancer ; Pediatrics ; Index Medicus
    ISSN: 1057-9249
    E-ISSN: 1099-1611
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 3
    Language: English
    In: Journal of allergy and clinical immunology, 2015, Vol.137 (1), p.188-196.e4
    Description: Background Hemophagocytic lymphohistiocytosis (HLH) is a rare life-threatening disease affecting mostly children but also adults and characterized by hyperinflammatory features. A subset of patients, referred to as having familial hemophagocytic lymphohistiocytosis (FHL), have various underlying genetic abnormalities, the frequencies of which have not been systematically determined previously. Objective This work aims to further our understanding of the pathogenic bases of this rare condition based on an analysis of our 25 years of experience. Methods From our registry, we have analyzed a total of 500 unselected patients with HLH. Results Biallelic pathogenic mutations defining FHL were found in 171 (34%) patients; the proportion of FHL was much higher (64%) in patients given a diagnosis during the first year of life. Taken together, mutations of the genes PRF1 (FHL2) and UNC13D (FHL3) accounted for 70% of cases of FHL. Overall, a genetic diagnosis was possible in more than 90% of our patients with FHL. Perforin expression and the extent of degranulation have been more useful for diagnosing FHL than hemophagocytosis and the cytotoxicity assay. Of 281 (56%) patients classified as having “sporadic” HLH, 43 had monoallelic mutations in one of the FHL-defining genes. Given this gene dosage effect, FHL is not strictly recessive. Conclusion We suggest that the clinical syndrome HLH generally results from the combined effects of an exogenous trigger and genetic predisposition. Within this combination, different weights of exogenous and genetic factors account for the wide disease spectrum that ranges from HLH secondary to severe infection to FHL.
    Subject(s): Allergy and Immunology ; immunologic tests ; PRF1 ; Hemophagocytic lymphohistiocytosis ; UNC13D ; Genetic Predisposition to Disease ; Perforin - genetics ; Membrane Proteins - genetics ; Humans ; Middle Aged ; Child, Preschool ; Infant ; Male ; Young Adult ; Adolescent ; Adult ; Female ; Italy ; Registries ; Lymphohistiocytosis, Hemophagocytic - genetics ; Child ; Infant, Newborn ; Lymphohistiocytosis, Hemophagocytic - immunology ; Genetic research ; Transplantation ; Stem cells ; Medical genetics ; Analysis ; Index Medicus ; Abridged Index Medicus ; Immune Deficiencies, Infection, and Systemic Immune Disorders ; FHL, Familial hemophagocytic lymphohistiocytosis ; HSCT, Hematopoietic stem cell transplantation ; MAS, Macrophage activation syndrome ; XLP, X-linked lymphoproliferative syndrome ; HLH, Hemophagocytic lymphohistiocytosis ; NK, Natural killer
    ISSN: 0091-6749
    E-ISSN: 1097-6825
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 4
    Language: English
    In: Stem cells international, 2016-09-19, Vol.2016, p.4798639-22
    Description: Mesenchymal stem cells form a population of self-renewing, multipotent cells that can be isolated from several tissues. Multiple preclinical studies have demonstrated that the administration of exogenous MSC could prevent renal injury and could promote renal recovery through a series of complex mechanisms, in particular via immunomodulation of the immune system and release of paracrine factors and microvesicles. Due to their therapeutic potentials, MSC are being evaluated as a possible player in treatment of human kidney disease, and an increasing number of clinical trials to assess the safety, feasibility, and efficacy of MSC-based therapy in various kidney diseases have been proposed. In the present review, we will summarize the current knowledge on MSC infusion to treat acute kidney injury, chronic kidney disease, diabetic nephropathy, focal segmental glomerulosclerosis, systemic lupus erythematosus, and kidney transplantation. The data obtained from these clinical trials will provide further insight into safety, feasibility, and efficacy of MSC-based therapy in renal pathologies and allow the design of consensus protocol for clinical purpose.
    Subject(s): Prevention ; Type 2 diabetes ; Lupus ; Medical research ; Chronic kidney failure ; Stem cells ; Diabetic nephropathies ; Medicine, Experimental ; Transplantation ; Health aspects ; Review
    ISSN: 1687-966X
    ISSN: 1687-9678
    E-ISSN: 1687-9678
    Source: Academic Search Ultimate
    Source: PubMed Central
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 5
    Language: English
    In: The New England journal of medicine, 2020-05-07, Vol.382 (19), p.1811-1822
    Description: Primary hemophagocytic lymphohistiocytosis, a rare genetic immune disorder characterized by hyperinflammation, manifests in infancy and is associated with high mortality. In a study involving 34 children, an antibody to interferon-γ (emapalumab) produced responses in 65%; it served as a bridge to marrow transplantation in 70% of those who had received previous treatment.
    Subject(s): Antibodies, Neutralizing - administration & dosage ; Infections - etiology ; Humans ; Antibodies, Monoclonal - adverse effects ; Chemokine CXCL9 - blood ; Child, Preschool ; Infant ; Male ; Lymphohistiocytosis, Hemophagocytic - mortality ; Interferon-gamma - antagonists & inhibitors ; Anti-Inflammatory Agents - administration & dosage ; Antibodies, Neutralizing - adverse effects ; Female ; Drug Therapy, Combination ; Child ; Dexamethasone - administration & dosage ; Lymphohistiocytosis, Hemophagocytic - drug therapy ; Kaplan-Meier Estimate ; Hematopoietic Stem Cell Transplantation ; Treatment Outcome ; Lymphohistiocytosis, Hemophagocytic - therapy ; Lymphohistiocytosis, Hemophagocytic - complications ; Antibodies, Monoclonal - administration & dosage ; Adolescent ; Age of Onset ; Histoplasmosis ; Dexamethasone ; Statistical analysis ; Laboratories ; Toxicity ; Mortality ; Stem cell transplantation ; Histiocytosis ; Patients ; Hemopoiesis ; Confidence intervals ; Hypotheses ; γ-Interferon ; Lymphocytosis ; Chemokines ; Index Medicus ; Abridged Index Medicus
    ISSN: 0028-4793
    E-ISSN: 1533-4406
    Source: Single Journals
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 6
    Language: English
    In: Transfusion (Philadelphia, Pa.), 2015-04, Vol.55 (4), p.736-747
    Description: Background Extracorporeal photopheresis (ECP) has been shown as active therapy for graft‐versus‐host disease (GVHD). Study Design and Methods The aim was to ascertain the role of ECP in 71 patients with steroid‐refractory or ‐dependent acute and chronic GVHD (aGVHD and cGVHD) with special focus on hematologic variables and GVHD staging classification. A total of 34 patients were treated for aGVHD and 37 for cGVHD. Results The overall response rate (ORR) for aGVHD was 65% and the complete aGVHD‐free survival was 50% (95% confidence interval [CI], 36%‐70%). The ORR for cGVHD response was 81% while the complete cGVHD‐free survival was 50% (95% CI, 34%‐73%). The aGVHD‐free survival was associated with aGVHD grading (Grade II 81%, Grade III 33%, and Grade IV 0%, p ≤ 0.00) and the absence of visceral involvement (77% vs. 33%, p = 0.03). The cGVHD‐free survival was associated with the female sex (67% vs. 25%, p = 0.01) and with the limited form according to the Seattle classification (67% vs. 20%, p = 0.003). No role for hematologic values or apheresis cell count was found, except for the cGVHD ORR (p = 0.037). Transplant‐related mortality and overall survival were associated with ECP response 0% versus 54% (p = 0.0001) and 77% versus 45% (p = 0.03) for aGVHD patients and 7% versus 14% (p = 0.02) and 73% versus 20% (p = 0.0003) for cGVHD patients, respectively. Conclusions While confirming a higher probability of GVHD responses for early GVHD, our study shows no role of hematologic values or apheresis cell count on GVHD response.
    Subject(s): Graft vs Host Disease - therapy ; Hematologic Neoplasms - therapy ; Peripheral Blood Stem Cell Transplantation - adverse effects ; Prospective Studies ; Humans ; Immunosuppressive Agents - therapeutic use ; Middle Aged ; Child, Preschool ; Male ; Adrenal Cortex Hormones - therapeutic use ; Cord Blood Stem Cell Transplantation - adverse effects ; Adult ; Female ; Photopheresis ; Child ; Drug Resistance ; Treatment Outcome ; Combined Modality Therapy ; Graft vs Host Disease - blood ; Graft vs Host Disease - drug therapy ; Hematologic Neoplasms - blood ; Adolescent ; Survival Analysis ; Biomarkers ; Bone Marrow Transplantation - adverse effects ; Graft vs Host Disease - prevention & control ; Aged ; Transplantation Conditioning ; Blood Group Incompatibility - epidemiology ; Index Medicus ; Hemapheresis
    ISSN: 0041-1132
    E-ISSN: 1537-2995
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 7
    Language: English
    In: Journal of translational medicine, 2018-08-29, Vol.16 (1), p.237-237
    Description: Cytokine-induced killer (CIK) cells are a very promising cell population raising growing interest in the field of cellular antitumor therapy. The aim of our study was to validate the most advantageous expansion method for this advanced therapy medicinal product (ATMP) and to translate it from preclinical field to good manufacturing practices (GMP). GMP ensures that ATMP are consistently produced and controlled to the quality standards required to their intended use. For this reason, the use of the xenogenic sera tended to be minimized by GMP for their high variability and the associated risk of transmitting infectious agents. We decided to replace Fetal Bovine Serum (FBS), largely used as medium supplement for CIKs expansion, with other culture media. Firstly, Human Serum (HS) and Human Pool Plasma (HPP) were tested as medium supplements giving not compliant results to acceptance criteria, established for CIKs, probably for the great batch to batch variability. Consequently, we decided to test three different serum free expansion media: X-VIVO 15, (largely used by other groups) and Tex Macs and Cell Genix GMP SCGM: two GMP manufactured media. We performed a validation consisting in three run-sand even if the small number of experiments didn't permit us to obtained statistical results we demonstrated that both X-VIVO 15 and Tex Macs fulfilled the quality standards in terms of cellular growth, viability and identity while Cell Genix GMP SCGM resulted not compliant as it caused some technical problems such as high mortality. In conclusion, these preclinical validation data lay the bases for a GMP-compliant process to improve the CIKs expansion method.
    Subject(s): Cell Proliferation ; Cell Survival ; Humans ; Culture Media, Serum-Free ; Cell Culture Techniques - methods ; Cytokines - chemistry ; Killer Cells, Natural - cytology ; Animals ; Cell Culture Techniques - standards ; Cattle ; Culture Media ; Leukocytes, Mononuclear - cytology ; Cell Differentiation ; Serum - chemistry ; Validation ; Clinical translation ; GMP ; Cellular therapy
    ISSN: 1479-5876
    E-ISSN: 1479-5876
    Source: BioMedCentral Open Access
    Source: Academic Search Ultimate
    Source: PubMed Central
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 8
    Language: English
    In: Journal of clinical oncology, 2012-06-10, Vol.30 (17), p.2112-2118
    Description: We compared two chemotherapy regimens that included methotrexate (MTX), cisplatin (CDP), and doxorubicin (ADM) with or without ifosfamide (IFO) in patients with nonmetastatic osteosarcoma of the extremity. Patients age ≤ 40 years randomly received regimens with the same cumulative doses of drugs (ADM 420 mg/m(2), MTX 120 g/m(2), CDP 600 mg/m(2), and IFO 30 g/m(2)) but with different durations (arm A, 44 weeks; arm B, 34 weeks). IFO was given postoperatively when pathologic response to MTX-CDP-ADM was poor (arm A) or given in the primary phase of chemotherapy with MTX-CDP-ADM (arm B). End points of the study included pathologic response to preoperative chemotherapy, toxicity, and survival. Given the feasibility of accrual, the statistical plan only permitted detection of a 15% difference in 5-year overall survival (OS). From April 2001 to December 2006, 246 patients were enrolled. Two hundred thirty patients (94%) underwent limb salvage surgery (arm A, 92%; arm B, 96%; P = .5). Chemotherapy-induced necrosis was good in 45% of patients (48% in arm A, 42% in arm B; P = .3). Four patients died of treatment-related toxicity (arm A, n = 1; arm B, n = 3). A significantly higher incidence of hematologic toxicity was reported in arm B. With a median follow-up of 66 months (range, 1 to 104 months), 5-year OS and event-free survival (EFS) rates were not significantly different between arm A and arm B, with OS being 73% (95% CI, 65% to 81%) in arm A and 74% (95% CI, 66% to 82%) in arm B and EFS being 64% (95% CI, 56% to 73%) in arm A and 55% (95% CI, 46% to 64%) in arm B. IFO added to MTX, CDP, and ADM from the preoperative phase does not improve the good responder rate and increases hematologic toxicity. IFO should only be considered in patients who have a poor histologic response to MTX, CDP, and ADM.
    Subject(s): Biological and medical sciences ; Medical sciences ; Diseases of the osteoarticular system ; Tumors of striated muscle and skeleton ; Tumors ; Osteosarcoma - drug therapy ; Femur - pathology ; Humans ; Child, Preschool ; Male ; Tibia - pathology ; Cisplatin - administration & dosage ; Humerus - pathology ; Disease-Free Survival ; Ifosfamide - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Chemotherapy, Adjuvant - methods ; Adolescent ; Adult ; Female ; Methotrexate - administration & dosage ; Bone Neoplasms - drug therapy ; Child ; Doxorubicin - administration & dosage
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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  • 9
    Language: English
    In: Molecular cancer, 2009-12-10, Vol.8 (1), p.118-118
    Description: Osteosarcoma (OS) is the most common primary bone tumour in children and young adults. Despite improved prognosis, metastatic or relapsed OS remains largely incurable and no significant improvement has been observed in the last 20 years. Therefore, the search for alternative agents in OS is mandatory. We investigated phospho-ERK 1/2, MCL-1, and phospho-Ezrin/Radixin/Moesin (P-ERM) as potential therapeutic targets in OS. Activation of these pathways was shown by immunohistochemistry in about 70% of cases and in all OS cell lines analyzed. Mutational analysis revealed no activating mutations in KRAS whereas BRAF gene was found to be mutated in 4/30 OS samples from patients. Based on these results we tested the multi-kinase inhibitor sorafenib (BAY 43-9006) in preclinical models of OS. Sorafenib inhibited OS cell line proliferation, induced apoptosis and downregulated P-ERK1/2, MCL-1, and P-ERM in a dose-dependent manner. The dephosphorylation of ERM was not due to ERK inhibition. The downregulation of MCL-1 led to an increase in apoptosis in OS cell lines. In chick embryo chorioallantoic membranes, OS supernatants induced angiogenesis, which was blocked by sorafenib and it was also shown that sorafenib reduced VEGF and MMP2 production. In addition, sorafenib treatment dramatically reduced tumour volume of OS xenografts and lung metastasis in SCID mice. In conclusion, ERK1/2, MCL-1 and ERM pathways are shown to be active in OS. Sorafenib is able to inhibit their signal transduction, both in vitro and in vivo, displaying anti-tumoural activity, anti-angiogenic effects, and reducing metastatic colony formation in lungs. These data support the testing of sorafenib as a potential therapeutic option in metastatic or relapsed OS patients unresponsive to standard treatments.
    Subject(s): Niacinamide - analogs & derivatives ; Osteosarcoma - drug therapy ; Vascular Endothelial Growth Factor A - biosynthesis ; Cytoskeletal Proteins - antagonists & inhibitors ; Apoptosis - drug effects ; Humans ; Extracellular Signal-Regulated MAP Kinases - antagonists & inhibitors ; Male ; Antineoplastic Agents - therapeutic use ; Benzenesulfonates - therapeutic use ; Phenylurea Compounds ; Extracellular Signal-Regulated MAP Kinases - metabolism ; Vascular Endothelial Growth Factor A - antagonists & inhibitors ; Proto-Oncogene Proteins c-bcl-2 - metabolism ; Benzenesulfonates - pharmacology ; Neoplasm Metastasis - prevention & control ; Osteosarcoma - blood supply ; Cytoskeletal Proteins - metabolism ; Female ; Neovascularization, Pathologic - prevention & control ; Antineoplastic Agents - pharmacology ; Matrix Metalloproteinase 2 - biosynthesis ; Osteosarcoma - metabolism ; Pyridines - therapeutic use ; Down-Regulation - drug effects ; Cell Division - drug effects ; Animals ; Myeloid Cell Leukemia Sequence 1 Protein ; Cell Line, Tumor ; Matrix Metalloproteinase Inhibitors ; Proto-Oncogene Proteins c-bcl-2 - antagonists & inhibitors ; Mice ; Pyridines - pharmacology ; Osteosarcoma - pathology ; Development and progression ; Diagnosis ; Drug therapy ; Osteosarcoma ; Risk factors ; Index Medicus
    ISSN: 1476-4598
    E-ISSN: 1476-4598
    Source: BioMedCentral Open Access
    Source: Academic Search Ultimate
    Source: PubMed Central
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 10
    Language: English
    In: Pediatric transplantation, 2020-11, Vol.24 (7), p.e13806-n/a
    Description: aGvHD remains a major obstacle to successful HSCT. We report our experience on steroid‐refractory aGvHD III and IV from 1989 to 2017. Ninety patients with aGvHD III or IV were stratified according to the HSCT year: 1989‐1998, 1999‐2007, and 2008‐2017 and to aGvHD extension (GvHD III vs IV) and finally the probability of OS, RI, and TRM was calculated accordingly. aGvHD III patients had a substantial improvement over time: day 100 OS raised from 64% (95% CI 39‐89) in the first cohort to 100% in the latest (P = .022), and it was mainly due to a reduction of TRM (it was 28% [95% CI 12‐65] in the first cohort to 0% in the latest (P = .01). The aGvHD IV patients did not present a significant improvement. Day 100 OS was 42% (95% CI 16‐68) in the first group and 54% (95% CI 25‐83) in the year 2008‐2017 (P = NS), and the day‐100 TRM was very similar (it was 57% [95% CI 36‐90] in the first cohort and 45% [95% CI 23‐89] in the latest (P = NS). We report significant improvements in OS and TRM in patients diagnosed with grade III aGvHD. Patients with the most severe aGvHD appear to have no or fewer benefits on long‐term outcomes.
    Subject(s): severe acute graft‐versus‐host disease ; children ; survival ; Index Medicus
    ISSN: 1397-3142
    E-ISSN: 1399-3046
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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