{"id":"https://openalex.org/W2142297682","doi":"https://doi.org/10.1186/1745-6215-12-166","title":"Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial","display_name":"Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial","publication_year":2011,"publication_date":"2011-06-30","ids":{"openalex":"https://openalex.org/W2142297682","doi":"https://doi.org/10.1186/1745-6215-12-166","mag":"2142297682","pmid":"https://pubmed.ncbi.nlm.nih.gov/21718522","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/3155829"},"language":"en","primary_location":{"id":"doi:10.1186/1745-6215-12-166","doi":"https://doi.org/10.1186/1745-6215-12-166","is_oa":true,"landing_page_url":"https://doi.org/10.1186/1745-6215-12-166","pdf_url":"https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/1745-6215-12-166","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","datacite","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/1745-6215-12-166","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5031353369","display_name":"Raymond Omollo","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1298973761","display_name":"Drugs for Neglected Diseases Initiative","ror":"https://ror.org/022mz6y25","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I1298973761"]},{"id":"https://openalex.org/I2841861","display_name":"Kenya Medical Research Institute","ror":"https://ror.org/04r1cxt79","country_code":"KE","type":"facility","lineage":["https://openalex.org/I2841861"]}],"countries":["CH","KE"],"is_corresponding":false,"raw_author_name":"Raymond Omollo","raw_affiliation_strings":["Drugs for Neglected Diseases initiative (DNDi) Africa, Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drugs for Neglected Diseases initiative (DNDi) Africa, Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I1298973761","https://openalex.org/I2841861"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036676892","display_name":"Neal D. E. Alexander","orcid":"https://orcid.org/0000-0002-6707-7876","observed_orcids":["https://orcid.org/0000-0002-6707-7876"]},"institutions":[{"id":"https://openalex.org/I4210089966","display_name":"London School of Hygiene & Tropical Medicine","ror":"https://ror.org/00a0jsq62","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I4210089966"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Neal Alexander","raw_affiliation_strings":["MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK","institution_ids":["https://openalex.org/I4210089966"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5052826230","display_name":"Tansy Edwards","orcid":"https://orcid.org/0000-0002-6110-014X","observed_orcids":["https://orcid.org/0000-0002-6110-014X"]},"institutions":[{"id":"https://openalex.org/I4210089966","display_name":"London School of Hygiene & Tropical Medicine","ror":"https://ror.org/00a0jsq62","country_code":"GB","type":"education","lineage":["https://openalex.org/I124357947","https://openalex.org/I4210089966"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Tansy Edwards","raw_affiliation_strings":["MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK","institution_ids":["https://openalex.org/I4210089966"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005073543","display_name":"Eltahir Awad Gasim Khalil","orcid":"https://orcid.org/0000-0002-5165-6902","observed_orcids":["https://orcid.org/0000-0002-5165-6902"]},"institutions":[{"id":"https://openalex.org/I150406212","display_name":"University of Khartoum","ror":"https://ror.org/02jbayz55","country_code":"SD","type":"education","lineage":["https://openalex.org/I150406212"]}],"countries":["SD"],"is_corresponding":false,"raw_author_name":"Eltahir AG Khalil","raw_affiliation_strings":["Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan","institution_ids":["https://openalex.org/I150406212"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109176266","display_name":"Brima Musa Younis","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I150406212","display_name":"University of Khartoum","ror":"https://ror.org/02jbayz55","country_code":"SD","type":"education","lineage":["https://openalex.org/I150406212"]}],"countries":["SD"],"is_corresponding":false,"raw_author_name":"Brima M Younis","raw_affiliation_strings":["Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan","institution_ids":["https://openalex.org/I150406212"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076024645","display_name":"Abuzaid A. Abuzaid","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I150406212","display_name":"University of Khartoum","ror":"https://ror.org/02jbayz55","country_code":"SD","type":"education","lineage":["https://openalex.org/I150406212"]}],"countries":["SD"],"is_corresponding":false,"raw_author_name":"Abuzaid A Abuzaid","raw_affiliation_strings":["Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan","institution_ids":["https://openalex.org/I150406212"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063364805","display_name":"Monique K. Wasunna","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1298973761","display_name":"Drugs for Neglected Diseases Initiative","ror":"https://ror.org/022mz6y25","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I1298973761"]},{"id":"https://openalex.org/I2841861","display_name":"Kenya Medical Research Institute","ror":"https://ror.org/04r1cxt79","country_code":"KE","type":"facility","lineage":["https://openalex.org/I2841861"]}],"countries":["CH","KE"],"is_corresponding":false,"raw_author_name":"Monique Wasunna","raw_affiliation_strings":["Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","Drugs for Neglected Diseases initiative (DNDi) Africa, Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I2841861"]},{"raw_affiliation_string":"Drugs for Neglected Diseases initiative (DNDi) Africa, Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I1298973761","https://openalex.org/I2841861"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5020493768","display_name":"Njenga Njoroge","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2841861","display_name":"Kenya Medical Research Institute","ror":"https://ror.org/04r1cxt79","country_code":"KE","type":"facility","lineage":["https://openalex.org/I2841861"]}],"countries":["KE"],"is_corresponding":false,"raw_author_name":"Njenga Njoroge","raw_affiliation_strings":["Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I2841861"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5081075011","display_name":"Dedan Kinoti","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2841861","display_name":"Kenya Medical Research Institute","ror":"https://ror.org/04r1cxt79","country_code":"KE","type":"facility","lineage":["https://openalex.org/I2841861"]}],"countries":["KE"],"is_corresponding":false,"raw_author_name":"Dedan Kinoti","raw_affiliation_strings":["Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I2841861"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076831851","display_name":"George Kirigi","orcid":"https://orcid.org/0000-0002-4324-6137","observed_orcids":["https://orcid.org/0000-0002-4324-6137"]},"institutions":[{"id":"https://openalex.org/I2841861","display_name":"Kenya Medical Research Institute","ror":"https://ror.org/04r1cxt79","country_code":"KE","type":"facility","lineage":["https://openalex.org/I2841861"]}],"countries":["KE"],"is_corresponding":false,"raw_author_name":"George Kirigi","raw_affiliation_strings":["Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya","institution_ids":["https://openalex.org/I2841861"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5054194543","display_name":"Thomas P. C. Dorlo","orcid":"https://orcid.org/0000-0003-3076-8435","observed_orcids":["https://orcid.org/0000-0003-3076-8435"]},"institutions":[{"id":"https://openalex.org/I2802065108","display_name":"Slotervaartziekenhuis","ror":"https://ror.org/01w502745","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I2802065108"]},{"id":"https://openalex.org/I2802928900","display_name":"Amsterdam UMC Location University of Amsterdam","ror":"https://ror.org/03t4gr691","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I2802928900","https://openalex.org/I4210151833"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Thomas PC Dorlo","raw_affiliation_strings":["Department of Pharmacy & Pharmacology, Slotervaart Hospital, Amsterdam, The Netherlands","Division of Infectious Diseases, Tropical Medicine & AIDS, Academic Medical Center, Amsterdam, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy & Pharmacology, Slotervaart Hospital, Amsterdam, The Netherlands","institution_ids":["https://openalex.org/I2802065108"]},{"raw_affiliation_string":"Division of Infectious Diseases, Tropical Medicine & AIDS, Academic Medical Center, Amsterdam, The Netherlands","institution_ids":["https://openalex.org/I2802928900"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083165391","display_name":"Sally Ellis","orcid":"https://orcid.org/0000-0002-7172-647X","observed_orcids":["https://orcid.org/0000-0002-7172-647X"]},"institutions":[{"id":"https://openalex.org/I1298973761","display_name":"Drugs for Neglected Diseases Initiative","ror":"https://ror.org/022mz6y25","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I1298973761"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Sally Ellis","raw_affiliation_strings":["DNDi, Geneva, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DNDi, Geneva, Switzerland","institution_ids":["https://openalex.org/I1298973761"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056783375","display_name":"Manica Balasegaram","orcid":"https://orcid.org/0000-0002-2091-6660","observed_orcids":["https://orcid.org/0000-0002-2091-6660"]},"institutions":[{"id":"https://openalex.org/I1298973761","display_name":"Drugs for Neglected Diseases Initiative","ror":"https://ror.org/022mz6y25","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I1298973761"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Manica Balasegaram","raw_affiliation_strings":["DNDi, Geneva, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DNDi, Geneva, Switzerland","institution_ids":["https://openalex.org/I1298973761"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5101538594","display_name":"Ahmed Mudawi Musa","orcid":"https://orcid.org/0000-0003-0590-6170","observed_orcids":["https://orcid.org/0000-0003-0590-6170"]},"institutions":[{"id":"https://openalex.org/I150406212","display_name":"University of Khartoum","ror":"https://ror.org/02jbayz55","country_code":"SD","type":"education","lineage":["https://openalex.org/I150406212"]}],"countries":["SD"],"is_corresponding":true,"raw_author_name":"Ahmed M Musa","raw_affiliation_strings":["Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan","institution_ids":["https://openalex.org/I150406212"]}]}],"institutions":[],"countries_distinct_count":5,"institutions_distinct_count":6,"corresponding_author_ids":["https://openalex.org/A5101538594"],"corresponding_institution_ids":["https://openalex.org/I150406212"],"apc_list":{"value":2790,"currency":"USD","value_usd":2790},"apc_paid":{"value":2790,"currency":"USD","value_usd":2790},"fwci":5.6404,"has_fulltext":true,"cited_by_count":73,"citation_normalized_percentile":{"value":0.95936509,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"12","issue":"1","first_page":"166","last_page":"166"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10823","display_name":"Research on Leishmaniasis Studies","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10823","display_name":"Research on Leishmaniasis Studies","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12107","display_name":"Leprosy Research and Treatment","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10890","display_name":"Trypanosoma species research and implications","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/visceral-leishmaniasis","display_name":"visceral leishmaniasis","score":0.9459999799728394},{"id":"https://openalex.org/keywords/miltefosine","display_name":"miltefosine","score":0.9710000157356262},{"id":"https://openalex.org/keywords/sodium-stibogluconate","display_name":"sodium stibogluconate","score":0.9959999918937683},{"id":"https://openalex.org/keywords/liposomal-amphotericin-b","display_name":"liposomal amphotericin B","score":1.0},{"id":"https://openalex.org/keywords/treatment-efficacy","display_name":"treatment efficacy","score":0.628000020980835},{"id":"https://openalex.org/keywords/cure-rate","display_name":"cure rate","score":0.7179999947547913},{"id":"https://openalex.org/keywords/east-africa","display_name":"East Africa","score":0.6000000238418579},{"id":"https://openalex.org/keywords/group-sequential-analysis","display_name":"group sequential analysis","score":0.7649999856948853},{"id":"https://openalex.org/keywords/triangular-test","display_name":"triangular test","score":0.5450000166893005}],"concepts":[{"id":"https://openalex.org/C2781417161","wikidata":"https://www.wikidata.org/wiki/Q411787","display_name":"Miltefosine","level":4,"score":0.9250550270080566},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.859683632850647},{"id":"https://openalex.org/C2780122544","wikidata":"https://www.wikidata.org/wiki/Q2757844","display_name":"Sodium stibogluconate","level":4,"score":0.8485788702964783},{"id":"https://openalex.org/C2781413609","wikidata":"https://www.wikidata.org/wiki/Q7308373","display_name":"Regimen","level":2,"score":0.7150291204452515},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.5585482716560364},{"id":"https://openalex.org/C2778689377","wikidata":"https://www.wikidata.org/wiki/Q2046113","display_name":"Visceral leishmaniasis","level":3,"score":0.5431702136993408},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.4990394115447998},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.491102933883667},{"id":"https://openalex.org/C2776555147","wikidata":"https://www.wikidata.org/wiki/Q331283","display_name":"Leishmaniasis","level":2,"score":0.4602038562297821},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4451344907283783},{"id":"https://openalex.org/C2779629538","wikidata":"https://www.wikidata.org/wiki/Q412223","display_name":"Amphotericin B","level":3,"score":0.4333111345767975},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.3643620014190674},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.1977262794971466},{"id":"https://openalex.org/C16005928","wikidata":"https://www.wikidata.org/wiki/Q171171","display_name":"Dermatology","level":1,"score":0.07310765981674194},{"id":"https://openalex.org/C2779548794","wikidata":"https://www.wikidata.org/wiki/Q578726","display_name":"Antifungal","level":2,"score":0.061719805002212524}],"mesh":[{"descriptor_ui":"D000293","descriptor_name":"Adolescent","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000666","descriptor_name":"Amphotericin B","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000666","descriptor_name":"Amphotericin B","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D000967","descriptor_name":"Antimony Sodium Gluconate","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000967","descriptor_name":"Antimony Sodium Gluconate","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004359","descriptor_name":"Drug Therapy, Combination","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007630","descriptor_name":"Kenya","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007898","descriptor_name":"Leishmaniasis, Visceral","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":false},{"descriptor_ui":"D007898","descriptor_name":"Leishmaniasis, Visceral","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010767","descriptor_name":"Phosphorylcholine","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D010767","descriptor_name":"Phosphorylcholine","qualifier_ui":"Q000031","qualifier_name":"analogs & derivatives","is_major_topic":true},{"descriptor_ui":"D010767","descriptor_name":"Phosphorylcholine","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D010767","descriptor_name":"Phosphorylcholine","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D013397","descriptor_name":"Sudan","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013997","descriptor_name":"Time Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014344","descriptor_name":"Trypanocidal Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D014344","descriptor_name":"Trypanocidal Agents","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D014344","descriptor_name":"Trypanocidal Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":14,"locations":[{"id":"doi:10.1186/1745-6215-12-166","doi":"https://doi.org/10.1186/1745-6215-12-166","is_oa":true,"landing_page_url":"https://doi.org/10.1186/1745-6215-12-166","pdf_url":"https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/1745-6215-12-166","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:2161725","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3155829","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:3155829","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3155829","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"Text"},{"id":"pmid:21718522","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/21718522","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"Clinical Trial, Phase II"},{"id":"pmh:oai:dare.uva.nl:openaire_cris_publications/da1e762c-8015-41a8-b46d-08c07224ab57","doi":null,"is_oa":true,"landing_page_url":"https://dare.uva.nl/personal/pure/en/publications/safety-and-efficacy-of-miltefosine-alone-and-in-combination-with-sodium-stibogluconate-and-liposomal-amphotericin-b-for-the-treatment-of-primary-visceral-leishmaniasis-in-east-africa-study-protocol-for-a-randomized-controlled-trial(da1e762c-8015-41a8-b46d-08c07224ab57).html","pdf_url":null,"source":{"id":"https://openalex.org/S4306400088","display_name":"UvA-DARE (University of Amsterdam)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I887064364","host_organization_name":"University of Amsterdam","host_organization_lineage":["https://openalex.org/I887064364"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Omollo, R, Alexander, N, Edwards, T, Khalil, E A G, Younis, B M, Abuzaid, A A, Wasunna, M, Njoroge, N, Kinoti, D, Kirigi, G, Dorlo, T P C, Ellis, S, Balasegaram, M & Musa, A M 2011, 'Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial', Trials, vol. 12, no. 1, pp. 166. https://doi.org/10.1186/1745-6215-12-166","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:pure.amsterdamumc.nl:openaire_cris_publications/c4e1a6c6-472a-4c91-8f66-fbcf2fdbe6e0","doi":null,"is_oa":false,"landing_page_url":"https://pure.amsterdamumc.nl/en/publications/c4e1a6c6-472a-4c91-8f66-fbcf2fdbe6e0","pdf_url":null,"source":{"id":"https://openalex.org/S7407055222","display_name":"Pure Amsterdam UMC","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Omollo, R, Alexander, N, Edwards, T, Khalil, E A G, Younis, B M, Abuzaid, A A, Wasunna, M, Njoroge, N, Kinoti, D, Kirigi, G, Dorlo, T P C, Ellis, S, Balasegaram, M & Musa, A M 2011, 'Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial', Trials, vol. 12, no. 1, pp. 166. https://doi.org/10.1186/1745-6215-12-166","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:dare.uva.nl:openaire/da1e762c-8015-41a8-b46d-08c07224ab57","doi":null,"is_oa":true,"landing_page_url":"https://handle.uba.uva.nl/personal/pure/en/publications/safety-and-efficacy-of-miltefosine-alone-and-in-combination-with-sodium-stibogluconate-and-liposomal-amphotericin-b-for-the-treatment-of-primary-visceral-leishmaniasis-in-east-africa-study-protocol-for-a-randomized-controlled-trial(da1e762c-8015-41a8-b46d-08c07224ab57).html","pdf_url":"https://pure.uva.nl/ws/files/1707360/119610_364727.pdf","source":{"id":"https://openalex.org/S4306400088","display_name":"UvA-DARE (University of Amsterdam)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I887064364","host_organization_name":"University of Amsterdam","host_organization_lineage":["https://openalex.org/I887064364"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"Omollo, R, Alexander, N, Edwards, T, Khalil, E A G, Younis, B M, Abuzaid, A A, Wasunna, M, Njoroge, N, Kinoti, D, Kirigi, G, Dorlo, T P C, Ellis, S, Balasegaram, M & Musa, A M 2011, 'Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial', Trials, vol. 12, no. 1, pp. 166. https://doi.org/10.1186/1745-6215-12-166","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:researchonline.lshtm.ac.uk:2697218","doi":null,"is_oa":false,"landing_page_url":"https://researchonline.lshtm.ac.uk/view/creators/eidenale.html>;","pdf_url":null,"source":{"id":"https://openalex.org/S4306402527","display_name":"LSHTM Research Online (London School of Hygiene and Tropical Medicine)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210089966","host_organization_name":"London School of Hygiene & Tropical Medicine","host_organization_lineage":["https://openalex.org/I4210089966"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":null,"raw_type":"Article"},{"id":"pmh:oai:CiteSeerX.psu:10.1.1.289.7304","doi":null,"is_oa":false,"landing_page_url":"http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.289.7304","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"ftp://ftp.ncbi.nlm.nih.gov/pub/pmc/23/c8/Trials_2011_Jun_30_12_166.tar.gz","raw_type":"text"},{"id":"pmh:amcpub:oai:pure.amc.nl:publications/70548dfc-ffd9-4820-8711-d6957618e196","doi":null,"is_oa":false,"landing_page_url":"https://pure.amc.nl/en/publications/safety-and-efficacy-of-miltefosine-alone-and-in-combination-with-sodium-stibogluconate-and-liposomal-amphotericin-b-for-the-treatment-of-primary-visceral-leishmaniasis-in-east-africa-study-protocol-for-a-randomized-controlled-trial(70548dfc-ffd9-4820-8711-d6957618e196).html","pdf_url":null,"source":{"id":"https://openalex.org/S4306401843","display_name":"Data Archiving and Networked Services (DANS)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1322597698","host_organization_name":"Royal Netherlands Academy of Arts and Sciences","host_organization_lineage":["https://openalex.org/I1322597698"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Trials, 12(1). BioMed Central","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:doaj.org/article:78f7db7fae0b4e7da274ff6e64c88081","doi":null,"is_oa":false,"landing_page_url":"https://doaj.org/article/78f7db7fae0b4e7da274ff6e64c88081","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Trials, Vol 12, Iss 1, p 166 (2011)","raw_type":"article"},{"id":"pmh:uvapub:oai:dare.uva.nl:publications/da1e762c-8015-41a8-b46d-08c07224ab57","doi":null,"is_oa":true,"landing_page_url":"https://dare.uva.nl/personal/pure/en/publications/safety-and-efficacy-of-miltefosine-alone-and-in-combination-with-sodium-stibogluconate-and-liposomal-amphotericin-b-for-the-treatment-of-primary-visceral-leishmaniasis-in-east-africa-study-protocol-for-a-randomized-controlled-trial(da1e762c-8015-41a8-b46d-08c07224ab57).html","pdf_url":null,"source":{"id":"https://openalex.org/S4306401843","display_name":"Data Archiving and Networked Services (DANS)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1322597698","host_organization_name":"Royal Netherlands Academy of Arts and Sciences","host_organization_lineage":["https://openalex.org/I1322597698"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Trials, 12(1). BioMed Central","raw_type":"info:eu-repo/semantics/article"},{"id":"doi:10.60692/6eh54-2e962","doi":"https://doi.org/10.60692/6eh54-2e962","is_oa":true,"landing_page_url":"https://doi.org/10.60692/6eh54-2e962","pdf_url":null,"source":{"id":"https://openalex.org/S7407051682","display_name":"Greater South Information System","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},{"id":"doi:10.60692/dcp0g-kg571","doi":"https://doi.org/10.60692/dcp0g-kg571","is_oa":true,"landing_page_url":"https://doi.org/10.60692/dcp0g-kg571","pdf_url":null,"source":{"id":"https://openalex.org/S7407051682","display_name":"Greater South Information System","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"}],"best_oa_location":{"id":"doi:10.1186/1745-6215-12-166","doi":"https://doi.org/10.1186/1745-6215-12-166","is_oa":true,"landing_page_url":"https://doi.org/10.1186/1745-6215-12-166","pdf_url":"https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/1745-6215-12-166","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":1.0,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Study Protocol","id":"https://openalex.org/study-designs/study-protocol"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320306115","display_name":"United States Agency for International Development","ror":"https://ror.org/01n6e6j62"},{"id":"https://openalex.org/F4320321637","display_name":"Department for International Development","ror":"https://ror.org/05rf29967"},{"id":"https://openalex.org/F4320328261","display_name":"Drugs for Neglected Diseases initiative","ror":"https://ror.org/022mz6y25"},{"id":"https://openalex.org/F4320334954","display_name":"Agencia Espa\u00f1ola de Cooperaci\u00f3n Internacional para el Desarrollo","ror":"https://ror.org/00r6akf90"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2142297682.pdf","grobid_xml":"https://content.openalex.org/works/W2142297682.grobid-xml"},"referenced_works_count":28,"referenced_works":["https://openalex.org/W67744072","https://openalex.org/W1996094668","https://openalex.org/W2016587111","https://openalex.org/W2021443540","https://openalex.org/W2027728949","https://openalex.org/W2038565126","https://openalex.org/W2044554457","https://openalex.org/W2064185909","https://openalex.org/W2067291412","https://openalex.org/W2084752824","https://openalex.org/W2096439392","https://openalex.org/W2099090406","https://openalex.org/W2101502132","https://openalex.org/W2115969254","https://openalex.org/W2116331138","https://openalex.org/W2136086972","https://openalex.org/W2144756920","https://openalex.org/W2152820036","https://openalex.org/W2497721881","https://openalex.org/W2564042923","https://openalex.org/W2582743722","https://openalex.org/W2760351771","https://openalex.org/W2798011490","https://openalex.org/W3016408864","https://openalex.org/W4210365244","https://openalex.org/W4245580890","https://openalex.org/W4285719527","https://openalex.org/W4302341942"],"related_works":["https://openalex.org/W7099841392","https://openalex.org/W4297252423","https://openalex.org/W2519666645","https://openalex.org/W4400875717","https://openalex.org/W7099054410","https://openalex.org/W1996094668","https://openalex.org/W2132358686","https://openalex.org/W2732308772","https://openalex.org/W7096979255","https://openalex.org/W2109788582"],"abstract_inverted_index":{"BACKGROUND:":[0],"Treatment":[1],"options":[2],"for":[3,65,164,220],"visceral":[4],"leishmaniasis":[5],"(VL)":[6],"in":[7,41,68,154],"East":[8,69],"Africa":[9],"are":[10,62],"far":[11],"from":[12],"satisfactory":[13],"due":[14],"to":[15,31,58,83,174,191],"cost,":[16],"toxicity,":[17],"prolonged":[18],"treatment":[19,34,221],"duration":[20],"or":[21,40,48,136,183],"emergence":[22],"of":[23,54,87,89,151,162,194,198,206,222],"parasite":[24],"resistance.":[25],"Hence":[26],"there":[27],"is":[28,57,80,109,124,179],"a":[29,125,158,177,189,218],"need":[30],"explore":[32],"alternative":[33],"protocols":[35],"such":[36],"as":[37],"miltefosine":[38,102,104],"alone":[39],"combinations":[42],"including":[43],"miltefosine,":[44],"sodium":[45],"stibogluconate":[46],"(SSG)":[47],"liposomal":[49,93],"amphotericin":[50,94,99],"B.":[51],"The":[52,106,227],"aim":[53],"this":[55],"trial":[56,79,234],"identify":[59,175],"regimen(s)":[60],"which":[61],"sufficiently":[63],"promising":[64],"future":[66],"trials":[67],"Africa.":[70],"METHODS/DESIGN:":[71],"A":[72,211],"phase":[73],"II":[74,245],"randomized,":[75],"parallel":[76],"arm,":[77],"open-labelled":[78],"being":[81],"conducted":[82],"assess":[84],"the":[85,90,195,203,233,250],"efficacy":[86,215],"each":[88,155],"three":[91],"regimens:":[92],"B":[95,100],"with":[96,101,114,157,202,213,224],"SSG,":[97],"Liposomal":[98],"and":[103,140,248],"alone.":[105],"primary":[107],"endpoint":[108,116],"cure":[110,123,201],"at":[111,117],"day":[112,118,199,207],"28":[113,200],"secondary":[115],"210":[119,208],"(6":[120],"months).":[121],"Initial":[122],"single":[126],"composite":[127],"measure":[128],"based":[129],"on":[130],"parasitologic":[131],"evaluation":[132],"(bone":[133],"marrow,":[134],"spleen":[135],"lymph":[137],"node":[138],"aspirate)":[139],"clinical":[141],"assessment.":[142],"Repeated":[143],"interim":[144],"analyses":[145],"have":[146],"been":[147],"planned":[148],"after":[149],"recruitment":[150,235],"15":[152],"patients":[153],"arm":[156],"maximum":[159],"sample":[160,252],"size":[161],"63":[163],"each.":[165],"These":[166],"will":[167],"follow":[168],"group-sequential":[169],"methods":[170],"(the":[171],"triangular":[172],"test)":[173],"when":[176],"regimen":[178,212],"inadequate":[180],"(<75%":[181],"efficacy)":[182],"adequate":[184,214],"(>90%":[185],"efficacy).":[186],"We":[187],"describe":[188],"method":[190],"ensure":[192],"consistency":[193],"sequential":[196],"analysis":[197,205],"non-sequential":[204],"cure.":[209],"DISCUSSION:":[210],"would":[216],"be":[217],"candidate":[219],"VL":[223],"reasonable":[225],"costs.":[226],"design":[228],"allows":[229],"repeated":[230],"testing":[231],"throughout":[232],"period":[236],"while":[237],"maintaining":[238],"good":[239],"statistical":[240],"properties":[241],"(Type":[242],"I":[243],"&":[244],"error":[246],"rates)":[247],"reducing":[249],"expected":[251],"sizes.":[253],"TRIAL":[254],"REGISTRATION:":[255],"ClinicalTrials.gov:":[256],"NCT01067443.":[257]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":13},{"year":2024,"cited_by_count":4},{"year":2023,"cited_by_count":5},{"year":2022,"cited_by_count":4},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":4},{"year":2016,"cited_by_count":9},{"year":2015,"cited_by_count":7},{"year":2014,"cited_by_count":6},{"year":2013,"cited_by_count":6},{"year":2012,"cited_by_count":5}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2016-06-24T00:00:00"}
