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Tytuł :
Whole-genome sequencing of Schistosoma mansoni reveals extensive diversity with limited selection despite mass drug administration.
Autorzy :
Berger DJ; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK. .; Department of Pathology and Pathogen Biology, Centre for Emerging, Endemic and Exotic Diseases, Royal Veterinary College, University of London, Herts, UK. .
Crellen T; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.; Imperial College London, Department of Infectious Disease Epidemiology, London, UK.; Big Data Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Lamberton PHL; Imperial College London, Department of Infectious Disease Epidemiology, London, UK.; Institute for Biodiversity, Animal Health, and Comparative Medicine, and Wellcome Centre for Integrative Parasitology, University of Glasgow, Glasgow, UK.
Allan F; The Natural History Museum, Department of Life Sciences, London, UK.
Tracey A; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
Noonan JD; Institute of Parasitology, Faculty of Agricultural and Environmental Sciences, McGill University, Montreal, Quebec, Canada.
Kabatereine NB; Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Kampala, Uganda.
Tukahebwa EM; Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Kampala, Uganda.
Adriko M; Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Kampala, Uganda.
Holroyd N; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK.
Webster JP; Department of Pathology and Pathogen Biology, Centre for Emerging, Endemic and Exotic Diseases, Royal Veterinary College, University of London, Herts, UK. .; Imperial College London, Department of Infectious Disease Epidemiology, London, UK. .
Berriman M; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK. .
Cotton JA; Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, Cambridgeshire, UK. .
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Źródło :
Nature communications [Nat Commun] 2021 Aug 06; Vol. 12 (1), pp. 4776. Date of Electronic Publication: 2021 Aug 06.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Mass Drug Administration*
Whole Genome Sequencing*
Praziquantel/*pharmacology
Schistosoma mansoni/*genetics
Animals ; Child ; Female ; Humans ; Male ; Schistosoma mansoni/drug effects ; Schistosomiasis mansoni/drug therapy ; Uganda
Czasopismo naukowe
Tytuł :
A contentious FDA ruling for Alzheimer's disease.
Autorzy :
The Lancet Neurology
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Źródło :
The Lancet. Neurology [Lancet Neurol] 2021 Aug; Vol. 20 (8), pp. 585. Date of Electronic Publication: 2021 Jul 05.
Typ publikacji :
Editorial
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Alzheimer Disease/*drug therapy
Antibodies, Monoclonal/*therapeutic use
Antibodies, Monoclonal, Humanized/*therapeutic use
Amyloid/drug effects ; Humans ; United States
Opinia redakcyjna
Tytuł :
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
Autorzy :
Sahre MD; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Milligan L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Graham RA; Theravance Biopharma US, Inc., South San Francisco, California, USA.
Reynolds KS; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Terzic A; Center for Regenerative Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Benjamin J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Schuck R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Thompson AM; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Aug; Vol. 110 (2), pp. 285-288. Date of Electronic Publication: 2021 Feb 16.
Typ publikacji :
Journal Article
MeSH Terms :
Advisory Committees/*organization & administration
Clinical Trials as Topic/*organization & administration
Kidney Diseases/*metabolism
Pharmacology, Clinical/*organization & administration
United States Food and Drug Administration/*organization & administration
Advisory Committees/standards ; Area Under Curve ; Clinical Trials as Topic/standards ; Drug Dosage Calculations ; Half-Life ; Kidney Diseases/epidemiology ; Multiple Chronic Conditions/epidemiology ; Pharmacology, Clinical/standards ; United States ; United States Food and Drug Administration/standards
Czasopismo naukowe
Tytuł :
A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.
Autorzy :
Cocoros NM; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Fuller CC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Adimadhyam S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Ball R; US Food and Drug Administration, Silver Spring, Maryland, USA.
Brown JS; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Dal Pan GJ; US Food and Drug Administration, Silver Spring, Maryland, USA.
Kluberg SA; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Lo Re V 3rd; Division of Infectious Diseases, Department of Medicine, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Maro JC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Nguyen M; US Food and Drug Administration, Silver Spring, Maryland, USA.
Orr R; US Food and Drug Administration, Silver Spring, Maryland, USA.
Paraoan D; US Food and Drug Administration, Silver Spring, Maryland, USA.
Perlin J; HCA Healthcare, Nashville, Tennessee, USA.
Poland RE; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.; HCA Healthcare, Nashville, Tennessee, USA.
Driscoll MR; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Sands K; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.; HCA Healthcare, Nashville, Tennessee, USA.
Toh S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Yih WK; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Platt R; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
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Corporate Authors :
And the FDA-Sentinel COVID-19 Working Group
Źródło :
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2021 Jul; Vol. 30 (7), pp. 827-837. Date of Electronic Publication: 2021 Apr 18.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Review
MeSH Terms :
COVID-19/*therapy
Health Information Management/*organization & administration
Product Surveillance, Postmarketing/*methods
Public Health Surveillance/*methods
United States Food and Drug Administration/*organization & administration
Antiviral Agents/therapeutic use ; COVID-19/epidemiology ; COVID-19/virology ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; Communicable Disease Control/legislation & jurisprudence ; Databases, Factual/statistics & numerical data ; Electronic Health Records/statistics & numerical data ; Health Policy ; Humans ; Pandemics/prevention & control ; Pandemics/statistics & numerical data ; United States/epidemiology ; United States Food and Drug Administration/legislation & jurisprudence
Czasopismo naukowe
Tytuł :
Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.
Autorzy :
Maxwell K
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Źródło :
American journal of law & medicine [Am J Law Med] 2021 Jul; Vol. 47 (2-3), pp. 291-326.
Typ publikacji :
Journal Article
MeSH Terms :
Government Regulation*
United States Food and Drug Administration*
Device Approval/*legislation & jurisprudence
Medical Device Legislation/*standards
COVID-19/prevention & control ; Humans ; United States
Czasopismo naukowe
Tytuł :
Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.
Autorzy :
Wesley BD; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD. Electronic address: .
Sewell CA; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Chang CY; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Hatfield KP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Nguyen CP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
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Źródło :
American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2021 Jul; Vol. 225 (1), pp. 21-32.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*/legislation & jurisprudence
Drug Approval*/statistics & numerical data
Pregnancy*
Prescription Drugs*
United States Food and Drug Administration*
Animals ; Clinical Trials as Topic ; Female ; Fetus/drug effects ; Humans ; Lactation ; Pregnancy Complications/drug therapy ; Risk Assessment ; Teratogens ; United States
Czasopismo naukowe
Tytuł :
An introduction to risk evaluation and mitigation strategies.
Autorzy :
Dohm J; Covington & Burling LLP, DC, United States.
Ji M; Covington & Burling LLP, DC, United States. Electronic address: .
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Źródło :
Contraception [Contraception] 2021 Jul; Vol. 104 (1), pp. 4-7. Date of Electronic Publication: 2021 Apr 24.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Risk Evaluation and Mitigation*
United States Food and Drug Administration*
Abortifacient Agents, Steroidal ; Drug and Narcotic Control ; Humans ; Mifepristone ; United States
Czasopismo naukowe
Tytuł :
Mass drug administration with azithromycin for trachoma elimination and the population structure of Streptococcus pneumoniae in the nasopharynx.
Autorzy :
Gladstone RA; Parasites and Microbes, Wellcome Sanger Institute, Hinxton, UK. Electronic address: .
Bojang E; Medical Research Council Unit The Gambia at LSHTM, Fajara, Banjul, Gambia.
Hart J; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Harding-Esch EM; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Mabey D; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Sillah A; National Eye Health Programme, Ministry of Health and Social Welfare, Kanifing, Gambia.
Bailey RL; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Burr SE; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Roca A; Medical Research Council Unit The Gambia at LSHTM, Fajara, Banjul, Gambia; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK.
Bentley SD; Parasites and Microbes, Wellcome Sanger Institute, Hinxton, UK.
Holland MJ; London School of Hygiene & Tropical Medicine, Keppel Street, London, UK. Electronic address: .
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Źródło :
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2021 Jun; Vol. 27 (6), pp. 864-870. Date of Electronic Publication: 2020 Aug 01.
Typ publikacji :
Journal Article
MeSH Terms :
Mass Drug Administration*
Azithromycin/*therapeutic use
Nasopharynx/*microbiology
Streptococcus pneumoniae/*drug effects
Trachoma/*prevention & control
Gambia/epidemiology ; Humans ; Trachoma/epidemiology ; Trachoma/microbiology
Czasopismo naukowe
Tytuł :
[Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States].
Autorzy :
Zhang C; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Zhou L; Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
Wang Y; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Tian L; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Yu X; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Ji X; National Center of Standards Evaluation, SAMR, Beijing, 100088. E-mail:.
Zhang H; NationalInstitutes for Food and Drug Control, Beijing, 100050.
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Źródło :
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2021 Jun 08; Vol. 45 (3), pp. 315-320.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
China ; United States
Czasopismo naukowe
Tytuł :
A randomized clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy.
Autorzy :
Hsu T; Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.; Department of Medicine, The University of Ottawa, Ottawa, Canada.
Fergusson D; Department of Medicine, The University of Ottawa, Ottawa, Canada.; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Stober C; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Daigle K; Department of Nursing, The Ottawa Hospital and the Ottawa Hospital Cancer Centre, Ottawa, Canada.
Moledina N; Department of Nursing, The Ottawa Hospital and the Ottawa Hospital Cancer Centre, Ottawa, Canada.
Vandermeer L; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Pond G; Department of Oncology, McMaster University, Hamilton, Canada.
Hilton J; Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada.; Department of Medicine, The University of Ottawa, Ottawa, Canada.
Hutton B; Department of Medicine, The University of Ottawa, Ottawa, Canada.; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Clemons M; Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Canada. .; Department of Medicine, The University of Ottawa, Ottawa, Canada. .; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. .; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Canada. .
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Corporate Authors :
REaCT investigators
Źródło :
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [Support Care Cancer] 2021 Jun; Vol. 29 (6), pp. 3113-3120. Date of Electronic Publication: 2020 Oct 15.
Typ publikacji :
Journal Article; Randomized Controlled Trial
MeSH Terms :
Drug Administration Schedule*
Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
Dexamethasone/*therapeutic use
Docetaxel/*therapeutic use
Glucocorticoids/*therapeutic use
Premedication/*methods
Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Dexamethasone/pharmacology ; Docetaxel/pharmacology ; Female ; Glucocorticoids/pharmacology ; Humans ; Male ; Middle Aged
Czasopismo naukowe
Tytuł :
Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.
Autorzy :
Akoh CC; Duke University Medical Center, Box 2887, Durham, NC 27710, United States. Electronic address: .
Chen J; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
Kadakia R; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
Park YU; Department of Orthopedic Surgery, Ajou University Hospital, Ajou University School of Medicine, Suwon, Gyeonggido, Republic of Korea.
Kim H; Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
Adams SB; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
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Źródło :
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons [Foot Ankle Surg] 2021 Jun; Vol. 27 (4), pp. 381-388. Date of Electronic Publication: 2020 May 18.
Typ publikacji :
Journal Article
MeSH Terms :
Databases, Factual*
United States Food and Drug Administration*
Arthrodesis/*instrumentation
Arthroplasty, Replacement/*instrumentation
Hallux/*surgery
Hallux Rigidus/*surgery
Joint Prosthesis/*adverse effects
Metatarsophalangeal Joint/*surgery
Osteoarthritis/*surgery
Adult ; Aged ; Female ; Follow-Up Studies ; Humans ; Incidence ; Male ; Middle Aged ; Osteoarthritis/epidemiology ; Prosthesis Failure/etiology ; Prosthesis-Related Infections/etiology ; Treatment Outcome ; United States/epidemiology
Czasopismo naukowe
Tytuł :
"Dangling" Accelerated Approvals in Oncology.
Autorzy :
Beaver JA; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
Pazdur R; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
Pokaż więcej
Źródło :
The New England journal of medicine [N Engl J Med] 2021 May 06; Vol. 384 (18), pp. e68. Date of Electronic Publication: 2021 Apr 21.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Antibodies, Monoclonal/*therapeutic use
Antineoplastic Agents/*therapeutic use
B7-H1 Antigen/*antagonists & inhibitors
Programmed Cell Death 1 Receptor/*antagonists & inhibitors
Clinical Trials as Topic ; Humans ; Medical Oncology ; United States
Czasopismo naukowe
Tytuł :
A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020.
Autorzy :
Kayki-Mutlu G; Department of Pharmacology, Faculty of Pharmacy, Ankara University, Ankara, Turkey.
Michel MC; Department of Pharmacology, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany. .
Pokaż więcej
Źródło :
Naunyn-Schmiedeberg's archives of pharmacology [Naunyn Schmiedebergs Arch Pharmacol] 2021 May; Vol. 394 (5), pp. 839-852. Date of Electronic Publication: 2021 Apr 16.
Typ publikacji :
Journal Article; Review
MeSH Terms :
COVID-19*
Drug Approval*
Pandemics*
United States Food and Drug Administration*
Pharmacology, Clinical/*trends
Animals ; Drug Discovery ; Humans ; United States
Czasopismo naukowe
Tytuł :
Control of scabies in a tribal community using mass screening and treatment with oral ivermectin -A cluster randomized controlled trial in Gadchiroli, India.
Autorzy :
Behera P; Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.
Munshi H; Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.
Kalkonde Y; Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.
Deshmukh M; Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.
Bang A; Society for Education Action and Research in Community Health (SEARCH), Gadchiroli, Maharashtra, India.
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Źródło :
PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2021 Apr 16; Vol. 15 (4), pp. e0009330. Date of Electronic Publication: 2021 Apr 16 (Print Publication: 2021).
Typ publikacji :
Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms :
Mass Drug Administration*
Anti-Infective Agents/*administration & dosage
Impetigo/*drug therapy
Ivermectin/*administration & dosage
Scabies/*drug therapy
Administration, Oral ; Adolescent ; Adult ; Anti-Infective Agents/adverse effects ; Child ; Child, Preschool ; Community Health Services ; Female ; Humans ; Impetigo/epidemiology ; India/epidemiology ; Ivermectin/adverse effects ; Logistic Models ; Male ; Mass Screening ; Middle Aged ; Scabies/epidemiology ; Treatment Outcome ; Young Adult
Czasopismo naukowe

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