Methodology of Clinical Trials Aimed at Assessing Interventions for Cutaneous Leishmaniasis
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{"title"=>"Methodology of Clinical Trials Aimed at Assessing Interventions for Cutaneous Leishmaniasis", "type"=>"journal", "authors"=>[{"first_name"=>"Piero", "last_name"=>"Olliaro", "scopus_author_id"=>"7005144054"}, {"first_name"=>"Michel", "last_name"=>"Vaillant", "scopus_author_id"=>"23475593900"}, {"first_name"=>"Byron", "last_name"=>"Arana", "scopus_author_id"=>"6701523727"}, {"first_name"=>"Max", "last_name"=>"Grogl", "scopus_author_id"=>"7003504428"}, {"first_name"=>"Farrokh", "last_name"=>"Modabber", "scopus_author_id"=>"7003515434"}, {"first_name"=>"Alan", "last_name"=>"Magill", "scopus_author_id"=>"7006717053"}, {"first_name"=>"Olivier", "last_name"=>"Lapujade", "scopus_author_id"=>"42061889300"}, {"first_name"=>"Pierre", "last_name"=>"Buffet", "scopus_author_id"=>"7003492908"}, {"first_name"=>"Jorge", "last_name"=>"Alvar", "scopus_author_id"=>"7006875837"}], "year"=>2013, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"pui"=>"368694455", "issn"=>"19352735", "isbn"=>"1935-2735 (Electronic)\\r1935-2727 (Linking)", "doi"=>"10.1371/journal.pntd.0002130", "scopus"=>"2-s2.0-84875984416", "pmid"=>"23556016", "sgr"=>"84875984416"}, "id"=>"1c4e2ec2-4a1c-39dd-9ea7-4ffe5703a6ef", "abstract"=>"Author SummarySolid evidence is needed to decide how to treat conditions. In the case of cutaneous leishmaniasis, the diversity of clinical conditions, combined with the heterogeneity and weaknesses of the methodologies used in clinical trials, make it difficult to derive robust conclusions as to which treatments should be used. There also other imperatives - ethical (not exposing patients to treatments that cannot be assessed adequately) and financial (optimize use of limited resources for a neglected condition). This paper is meant to provide clinical investigators with guidance for the design, conduct, analysis and report of clinical trials to assess the efficacy and safety of treatments of this condition.", "link"=>"http://www.mendeley.com/research/methodology-clinical-trials-aimed-assessing-interventions-cutaneous-leishmaniasis-1", "reader_count"=>36, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>1, "Researcher"=>12, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>2, "Other"=>3, "Student > Master"=>3, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Professor > Associate Professor"=>1, "Researcher"=>12, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>5, "Student > Postgraduate"=>2, "Other"=>3, "Student > Master"=>3, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Engineering"=>1, "Unspecified"=>4, "Nursing and Health Professions"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Agricultural and Biological Sciences"=>7, "Medicine and Dentistry"=>16, "Business, Management and Accounting"=>1, "Veterinary Science and Veterinary Medicine"=>2, "Immunology and Microbiology"=>2, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>16}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>7}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>4}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>2}}, "reader_count_by_country"=>{"Brazil"=>1}, "group_count"=>5}

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/1013104"], "description"=>"<p>Success rate ranging 60–90%; exclusions ranging 0–25%; non-inferiority margin (delta) 6%, 8% and 10%.</p>", "links"=>[], "tags"=>["non-inferiority"], "article_id"=>673513, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.t004", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Samples_size_calculation_N_per_group_for_non_inferiority_trials_/673513", "title"=>"Samples size calculation (N per group) for non-inferiority trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-03-21 00:58:33"}
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  • {"files"=>["https://ndownloader.figshare.com/files/1013147"], "description"=>"<p>the log-rank test in a non-inferiority design.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>673557, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.t006", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_size_calculation_for_the_comparison_of_two_survival_curves_/673557", "title"=>"Sample size calculation for the comparison of two survival curves.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-03-21 00:59:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/1013213"], "description"=>"<p>Efficacy in the reference arm from 80%–95%, delta 5–10%, alpha error 0.01, power 90%.</p><p>The Non-inferiority margin represents the smallest acceptable difference with respect to the success rate with the reference treatment.</p>", "links"=>[], "tags"=>["calculations", "non-inferiority"], "article_id"=>673623, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.t003", "stats"=>{"downloads"=>3, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_size_calculations_for_non_inferiority_trials_/673623", "title"=>"Sample size calculations for non-inferiority trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-03-21 01:00:23"}
  • {"files"=>["https://ndownloader.figshare.com/files/994154"], "description"=>"<p>Ø = complete re-epithelialisation; <50% = less than 50% of the initial size; >50% = greater than 50% of the initial size.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>657364, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.g003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Decision_tree_for_the_assessment_of_treatment_outcome_/657364", "title"=>"Decision tree for the assessment of treatment outcome.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-03-22 06:15:24"}
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  • {"files"=>["https://ndownloader.figshare.com/files/1013127"], "description"=>"<p>pa = 0.18, 0.20 and 0.25; and two-sided test, pa = 0.20.</p>", "links"=>[], "tags"=>["one-sided", "triangular"], "article_id"=>673532, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.t005", "stats"=>{"downloads"=>0, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_size_calculation_for_the_one_sided_triangular_test_/673532", "title"=>"Sample size calculation for the one-sided triangular test.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-03-21 00:58:52"}
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  • {"files"=>["https://ndownloader.figshare.com/files/994162"], "description"=>"<p>Kaplan-Meier analysis (product-limit estimate of time to event).</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>657372, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.g007", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_analysis_product_limit_estimate_of_time_to_event_/657372", "title"=>"Kaplan-Meier analysis (product-limit estimate of time to event).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-03-22 06:17:43"}
  • {"files"=>["https://ndownloader.figshare.com/files/1013195"], "description"=>"<p>Efficacy in the reference arm from 60–80%, delta 10–30%, alpha error 0.05, power 80–95%.</p>", "links"=>[], "tags"=>["calculations", "superiority"], "article_id"=>673601, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.t002", "stats"=>{"downloads"=>4, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_size_calculations_for_superiority_trials_/673601", "title"=>"Sample size calculations for superiority trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-03-21 01:00:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/994152"], "description"=>"<p>Measuring lesions.</p>", "links"=>[], "tags"=>["Infectious diseases"], "article_id"=>657362, "categories"=>["Infectious Diseases"], "users"=>["Piero Olliaro", "Michel Vaillant", "Byron Arana", "Max Grögl", "Farrokh Modabber", "Alan Magill", "Olivier Lapujade", "Pierre Buffet", "Jorge Alvar"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0002130.g002", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Measuring_lesions_/657362", "title"=>"Measuring lesions.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-03-22 06:15:02"}

PMC Usage Stats | Further Information

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Relative Metric

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