Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.398
S. Susmallian, O. Ponomarenko, R. Barnea
{"title":"Laparoscopic Totally Extraperitoneal Repair Versus Open Prolene Hernia System For Inguinal Hernia Repair: a Clinical Trial","authors":"S. Susmallian, O. Ponomarenko, R. Barnea","doi":"10.35248/2167-0870.20.10.398","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.398","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"23 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91539877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.399
D. Robinson, F. Pitkin, R. Whitely
Skin and soft tissue infections (SSTIs) are common clinical conditions ranging from mild superficial/cutaneous legions to life-threatening disseminated infections. Roughly 15% of the patients that seek medical intervention have a skin lesion or disease which is infectious. The emergence and rapid spread of antimicrobial resistance has complicated the therapy and negatively impacted patient outcomes in cases of SSTIs. This study serves to highlight the most common causative agents of SSTIs in Jamaica based on frequency of isolation, their drug resistance, and also their frequency associated with the different demographic groups during the time period covered. Data pertaining to culture and sensitivity of SSTIs done between 2012 and 2015 was collated from the main reference lab in Jamaica, with permission from Ministry of Health (MOH), and analyzed with the IBM SPSS 25 system. The patients included 139 females, 163 males and 75 of unknown gender. The order etiological agents causing skin and soft tissue infections in Jamaica closely mirrors the order reported in North America, Latin America and Europe with S. aureus being the most prevalent followed by various Enterobacteriaceae, P. aeruginosa and β-hemolytic Streptococci. This study showed that 77.1% of the SSTI isolates were resistant to at least one drug while 18.8% were deemed to be multidrug-resistant (MDR) and one case of extensive drug-resistance (XDR) was noted in 2012. The frequency of overall drug resistance and MDR isolates increased from 2013 to 2015. With the etiology of SSTIs in Jamaica mirroring global trends, it critical that we pay close attention to current global trends and recommendations concerning the management of SSTIs in order to improve patient outcomes.
{"title":"Contemporary Causes of Skin and Soft Tissue Infections in Jamaica","authors":"D. Robinson, F. Pitkin, R. Whitely","doi":"10.35248/2167-0870.20.10.399","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.399","url":null,"abstract":"Skin and soft tissue infections (SSTIs) are common clinical conditions ranging from mild superficial/cutaneous legions to life-threatening disseminated infections. Roughly 15% of the patients that seek medical intervention have a skin lesion or disease which is infectious. The emergence and rapid spread of antimicrobial resistance has complicated the therapy and negatively impacted patient outcomes in cases of SSTIs. This study serves to highlight the most common causative agents of SSTIs in Jamaica based on frequency of isolation, their drug resistance, and also their frequency associated with the different demographic groups during the time period covered. Data pertaining to culture and sensitivity of SSTIs done between 2012 and 2015 was collated from the main reference lab in Jamaica, with permission from Ministry of Health (MOH), and analyzed with the IBM SPSS 25 system. The patients included 139 females, 163 males and 75 of unknown gender. The order etiological agents causing skin and soft tissue infections in Jamaica closely mirrors the order reported in North America, Latin America and Europe with S. aureus being the most prevalent followed by various Enterobacteriaceae, P. aeruginosa and β-hemolytic Streptococci. This study showed that 77.1% of the SSTI isolates were resistant to at least one drug while 18.8% were deemed to be multidrug-resistant (MDR) and one case of extensive drug-resistance (XDR) was noted in 2012. The frequency of overall drug resistance and MDR isolates increased from 2013 to 2015. With the etiology of SSTIs in Jamaica mirroring global trends, it critical that we pay close attention to current global trends and recommendations concerning the management of SSTIs in order to improve patient outcomes.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"61 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91024897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.S4.E001
M. Christian
{"title":"Ethical Issues for Pregnant Women with Influenza Randomized Clinical Trials","authors":"M. Christian","doi":"10.35248/2167-0870.20.S4.E001","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S4.E001","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"42 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77254221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.S3.003
G. Isaia, R. Marinello, V. Tibaldi, C. Tamone, M. Bo
This paper reports the case of a patient with a long-standing history of Alzheimer's Disease with dysphagia and total functional dependence, and a left-arm fracture one month before hospitalization with consequently bedrest.
{"title":"Does this Patient Really Die for Covid-19?","authors":"G. Isaia, R. Marinello, V. Tibaldi, C. Tamone, M. Bo","doi":"10.35248/2167-0870.20.S3.003","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S3.003","url":null,"abstract":"This paper reports the case of a patient with a long-standing history of Alzheimer's Disease with dysphagia and total functional dependence, and a left-arm fracture one month before hospitalization with consequently bedrest.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"62 1","pages":"4-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72702369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.409
T. Anudeep, Madhan Jeyaraman, Dharma U. Shetty, M. Hemmanthraj, Ajay Ss, Rajeswari Somasundaram, Vinodh Kumar, R. Jain, Shirodkar Jasw, I. Dilip
The world is battling a pandemic caused by the newly emerged strain of coronavirus; upon identification SARSCoV-2 and in interim named nCOVID-19 by the World Health Organization (WHO). The contagion has sparked a war against humanity with the current global toll of 1,12,241 human lives. Till date no definitive treatment against SARS-CoV-2 has been established. Similar picture of lack of licensed definitive therapy can be traced back to Ebola outbreak and the WHO directed for considering convalescent plasma (CP) therapy for its control. The history of CP as therapeutics dates back to 20th century which renders a scope for consideration in the management of nCOVID-19. Experience from prior outbreak of SARS-CoV-1 has shown that convalescent sera contain neutralizing antibodies to the relevant virus. The core principle of this passive antibody therapy is based on retrieving virus neutralizing antibodies from recovered patients with all ethical considerations and using it as prophylaxis in exposed cases or as therapy in infected patients. It is more effective as prophylaxis than as a treatment modality for the disease. However, when used in early phase of disease, the evidences have reported a decrease in mortality. Cocktails with monoclonal antibodies have also been reported beneficial, but calls for establishing pros and cons in further detail. The sole objective of this review article is to explain how and why the convalescent plasma can serve as a plausible therapeutic modality. In addition, it renders a bird’s eye view on current clinical trials for the same.
{"title":"Convalescent Plasma as a Plausible Therapeutic Option for nCOVID-19: A Review","authors":"T. Anudeep, Madhan Jeyaraman, Dharma U. Shetty, M. Hemmanthraj, Ajay Ss, Rajeswari Somasundaram, Vinodh Kumar, R. Jain, Shirodkar Jasw, I. Dilip","doi":"10.35248/2167-0870.20.10.409","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.409","url":null,"abstract":"The world is battling a pandemic caused by the newly emerged strain of coronavirus; upon identification SARSCoV-2 and in interim named nCOVID-19 by the World Health Organization (WHO). The contagion has sparked a war against humanity with the current global toll of 1,12,241 human lives. Till date no definitive treatment against SARS-CoV-2 has been established. Similar picture of lack of licensed definitive therapy can be traced back to Ebola outbreak and the WHO directed for considering convalescent plasma (CP) therapy for its control. The history of CP as therapeutics dates back to 20th century which renders a scope for consideration in the management of nCOVID-19. Experience from prior outbreak of SARS-CoV-1 has shown that convalescent sera contain neutralizing antibodies to the relevant virus. The core principle of this passive antibody therapy is based on retrieving virus neutralizing antibodies from recovered patients with all ethical considerations and using it as prophylaxis in exposed cases or as therapy in infected patients. It is more effective as prophylaxis than as a treatment modality for the disease. However, when used in early phase of disease, the evidences have reported a decrease in mortality. Cocktails with monoclonal antibodies have also been reported beneficial, but calls for establishing pros and cons in further detail. The sole objective of this review article is to explain how and why the convalescent plasma can serve as a plausible therapeutic modality. In addition, it renders a bird’s eye view on current clinical trials for the same.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"40 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86214187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.S7.E001
D. Prie
{"title":"Clinical Trails and Challenges","authors":"D. Prie","doi":"10.35248/2167-0870.20.S7.E001","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S7.E001","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"5 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91091345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.400
S. Alsuwaidan
The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.
{"title":"Research Project Management on Clinical Trials-1","authors":"S. Alsuwaidan","doi":"10.35248/2167-0870.20.10.400","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.400","url":null,"abstract":"The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"321 1","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80238295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.422
Sayaka Ito, Haruka Miyata, Tomoaki Fujita, Y. Nonoyama, T. Nakazawa, ShigeharuFukao
Chronic subdural hematoma (CSDH) is one of the most common clinical entities in neurosurgical practice. Although the therapeutic management is well established with burr-hole craniostomy and drainage, patients with CSDH still suffer from recurrence up to 33% [1-3]. Recently reported randomized controlled studies revealed that drainage is the most effective treatment in controlling recurrence [4,5]. As far as we know, there is no reported trials revealing whether simple drainage without irrigation (simple drainage) or with irrigation (irrigation drainage) could treat CSDH with less recurrence rate compared to the other. The purpose of this study is toanalyze thepostoperative recurrence rate and complications between drainage with and without irrigation. The present trial is permitted by Institutional Review Board of Kyoto Okamoto Memorial Hospital (No. 2020-18).
{"title":"Commentary on Assessment of Burr-Hole Craniostomy for Chronic Subdural Hematoma: A Randomized Unblinded Comparative Trial of Burr-HoleCraniostomies and Drainage with or without Irrigation for Newly Progressed Chronic Subdural Hematoma","authors":"Sayaka Ito, Haruka Miyata, Tomoaki Fujita, Y. Nonoyama, T. Nakazawa, ShigeharuFukao","doi":"10.35248/2167-0870.20.10.422","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.422","url":null,"abstract":"Chronic subdural hematoma (CSDH) is one of the most common clinical entities in neurosurgical practice. Although the therapeutic management is well established with burr-hole craniostomy and drainage, patients with CSDH still suffer from recurrence up to 33% [1-3]. Recently reported randomized controlled studies revealed that drainage is the most effective treatment in controlling recurrence [4,5]. As far as we know, there is no reported trials revealing whether simple drainage without irrigation (simple drainage) or with irrigation (irrigation drainage) could treat CSDH with less recurrence rate compared to the other. The purpose of this study is toanalyze thepostoperative recurrence rate and complications between drainage with and without irrigation. The present trial is permitted by Institutional Review Board of Kyoto Okamoto Memorial Hospital (No. 2020-18).","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"28 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88701861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.396
A. Noubadoum, Diouf Jb, Sougou Nm, P. Adomson
Introduction: Malaria is one of the leading causes of infant and child mortality, despite the efforts made in Senegal. The objective of this study is to describe the epidemiological, clinical, Para clinical, therapeutic and evolutionary aspects of malaria in children in a pediatric ward of a Dakar hospital. Patients and methods: This is a retrospective descriptive study, with an analytical focus over a 5-year period from January 1st, 2013 to December 31st, 2017, in the pediatrics department of Roi Baudouin Hospital Center, involving 259 children hospitalized for malaria. Results: The frequency of hospitalization during the period was estimated at 7.7%.The mean age was 82.9 months, with a median of 84 months, and the age range from 1 month to 5 years was the most representative (35.9%) with extremes from 1 to 180 months. The majority of cases occurred in the last quarter of the year, with a peak in October (19.7%). Clinical manifestations on admission were dominated by fever, which was found in 93.1% of cases. More than 30.9% of the children showed clinical signs of severity on entry, with jaundice (37.5%) in the foreground, followed respectively by disturbances of consciousness (29.0%) and respiratory distress (19.0%). The majority of patients were treated with quinine (80.3%) and overall progress was satisfactory with a cure rate of 97.7%. Factors associated with death were represented by a time to management more than 7 days and the presence of co-infections, with a P. value equal to 0.002 and 0.04 respectively.
{"title":"Malaria in Children in Guediawaye, Senegal","authors":"A. Noubadoum, Diouf Jb, Sougou Nm, P. Adomson","doi":"10.35248/2167-0870.20.10.396","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.396","url":null,"abstract":"Introduction: Malaria is one of the leading causes of infant and child mortality, despite the efforts made in Senegal. The objective of this study is to describe the epidemiological, clinical, Para clinical, therapeutic and evolutionary aspects of malaria in children in a pediatric ward of a Dakar hospital. Patients and methods: This is a retrospective descriptive study, with an analytical focus over a 5-year period from January 1st, 2013 to December 31st, 2017, in the pediatrics department of Roi Baudouin Hospital Center, involving 259 children hospitalized for malaria. Results: The frequency of hospitalization during the period was estimated at 7.7%.The mean age was 82.9 months, with a median of 84 months, and the age range from 1 month to 5 years was the most representative (35.9%) with extremes from 1 to 180 months. The majority of cases occurred in the last quarter of the year, with a peak in October (19.7%). Clinical manifestations on admission were dominated by fever, which was found in 93.1% of cases. More than 30.9% of the children showed clinical signs of severity on entry, with jaundice (37.5%) in the foreground, followed respectively by disturbances of consciousness (29.0%) and respiratory distress (19.0%). The majority of patients were treated with quinine (80.3%) and overall progress was satisfactory with a cure rate of 97.7%. Factors associated with death were represented by a time to management more than 7 days and the presence of co-infections, with a P. value equal to 0.002 and 0.04 respectively.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"48 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86737124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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