Approvable Letter Research Articles

Influencing Factors for Social Acceptance of Noma (Cancrum Oris) Patients in Niger: A Hospital Based Retrospective Study

Background: Noma causes severe orofacial disfigurement with significant mortality and morbidity, especially seen in malnourishment young children in the poor regions of the world. With majority of noma patient surviving with aesthetical effects, they were exposed to stigmatization and social rejection. Studies focusing on the socio-psychological impact of noma survivors have rarely been done. The aim of our study is to identify the differences in social acceptance/rejection and their influencing factors associated with social acceptance in noma patients. Methods: A cross-sectional study was conducted in the reception centre of NGO-Sentinelles (Niger), on patients with noma from Zinder, Maradi and Tahoua regions, between 9th May 2017 and 2nd June 2017. The survey was conducted on some patients admitted in the center and those discharged from the centre after treatment by a face-to-face interview. The questionnaire used for the interview comprised of 45 questions (Cronbach’s alpha coefficient =0.812) which contained pathological information, socio-demographic characteristics and socio-psychological information. Findings: We recorded 50 patients (43 from Zinder and 7 from Maradi and Tahoua). The younger patients (1-5years old), noma patients who stayed in school during follow-up treatment, patients who were referred by a health structure, patients enrolled into the centre in a short time (<30days), patients in acute phase of noma had a significantly high social acceptance rate with respectively 60.0, 82.9, 60.0, 57.1 and 94.3%; whereas single adults and cheek lesion site had the highest social rejection rate when compared to their corresponding factors with 60.0 and 86.7%. There were significant differences in victims’ perception of noma [χ2 =45.536, (P <0.001)] and acceptance of their new faces [P=0.023], between the social acceptance and social rejection rate, therefore all patients who accepted their new faces felt social acceptance. The social acceptance were significantly highly correlated with pathological history (admission method, phase of noma, care and treatment received at center) with rs raged from 0.609 to 0.810, moderately correlated with patient’s socio-demographic characteristics (age, marital status, and region) with rs raged from 0.381 to 0.474, and lowly correlated with clinical evolution after treatment (rs=0.293). Logistic regression results showed that the likelihood of social acceptance increased when the patients age was small (≤15 years), marital status was minor, and they were enrolled at the school before noma appearance, they were referred to the centre after diagnosis, the admission time to the centre was short (≤30 days), acute phase of noma, and care received at centre was non-surgery. The location of lesion on the cheek was a risk factor for social-acceptance, indicating cheek lesion from noma increased the likelihood of social rejection in our study. Conclusion: The sociodemographic characteristics, pathological history and psychological aspects of noma patients were correlated with each other, and they were important factors influencing their social acceptance/rejection rate. Funding: No funding received. Declaration of Interest: We declare that we have no conflicts of interest Ethical Approval: The ethics approval letter was provided by the NGO-Sentinelles. A collaboration agreement with the officials of NGO-Sentinelles to perform this study was made after a meeting with coordinators in both Switzerland and Niger.

Prevalence of overweight, obesity, and associated factors among adolescents in the occupied Palestinian territory: a cross-sectional study

BackgroundOverweight and obesity are multifactorial conditions that are spreading fast in both developing and developed countries. They are emerging as a major public health threat among children and adolescents, and present a serious morbidity and mortality burden. Adolescence is a critical period in which lifestyle and dietary behaviours are shaped that persist into adulthood. Therefore, adolescents are an ideal study target in terms of estimating the magnitude of the problem, understanding its risk factors and investigating potential effective intervention programmes. This study assesses the prevalence of overweight, obesity, and associated factors among adolescents in Palestinian schools. MethodsWeighted analysis was conducted on data from the Palestinian Micronutrient Survey, a national cross-sectional study carried out in 2013 by the Palestinian Ministry of Health in collaboration with UNICEF. For sample selection, stratified cluster random sampling was used. This school-based survey involved 2400 male and female adolescents aged 15–18 years in government schools in the West Bank and Gaza Strip. Data were analysed at univariate, bivariate, and multivariate levels, by the use of proportions, confidence intervals, and logistic regression. In the original survey, written informed consent was obtained from parents and guardians of the participants. A letter of approval to use the study data was obtained from the Ministry of Health (who own the data). The study was also approved by the Ethics Committee of the Institute of Community and Public Health. FindingsThe analysis indicates a prevalence of 23·6% (95% CI 20·6–26·5) for overweight and obesity, with a prevalence of 26·1% in the West Bank and 19·5% in the Gaza Strip. The multivariate analysis revealed that the likelihood of overweight and obesity was significantly higher for adolescents from the West Bank than from the Gaza Strip, for those eating two main meals or less than for those eating three meals, for those who reported a high frequency of vegetable intake, and those who observed a diet for weight loss. InterpretationThe data suggest that one in every four adolescents is overweight or obese, which is an alarming statistic and calls for attention. The high prevalence can be attributed to different lifestyles, eating behaviours, and dietary intake, which affect energy balance. These factors should be investigated within social, political, and economic contexts, and addressed comprehensively, first at the level of individuals and family, and then at the level of schools and the community. It should be noted that the original study included students in the 10th grade and 11th grade only, whereas adolescence covers a wider age group (10–19 years). FundingNone.

ANALISIS TINDAK PIDANA PELAYARAN TANPA DOKUMEN SURAT IZIN BERLAYAR (Studi Kasus Pada Putusan Pengadilan Negeri Maumere Register Nomor 48/PID.SUS/2014/ PN.MMR)

Criminal acts in the field of fisheries often occur in Indonesia. The problem that is often heard is of course the problem of illegal fishing carried out by foreign ships from neighboring countries. Weak supervision and coordination between agencies is one of the supporting factors for this to happen. In addition to illegal fishing crimes committed by foreign vessels, violations are also often committed by local fishermen or Indonesian-flagged vessels. The most common violations are licensing issues in the capture fisheries sector. One of them is the widespread operation of ships without a Sailing Approval Letter (port clearance). How is the legal regulation of fishing crime without having a sailing approval document. How is the responsibility of the perpetrators of fishing crimes without a sailing approval document. How is the legal analysis of shipping crimes based on the decision of the Maumere Register District Court Number 48/PID.SUS/2014/PN. MMR. The results of the study indicate that the legal regulation of fishing crime without having a sailing approval document is regulated in Article 98 of Law No. 45 of 2009 concerning amendments to Law No. 31 of 2004 concerning Fisheries. The accountability of the perpetrators of criminal acts of fishing without a letter of approval to sail in the decision of the criminal case Register Number 48/PID.SUS/2014/ PN.MMR, the panel of judges declared the defendant legally and convincingly proven guilty of committing a criminal act of operating a fishing vessel without a Letter of Approval Sailing and sentenced to imprisonment for 3 (months) months and a fine of Rp. 10,000,000,- (ten million rupiah), provided that if the fine is not paid, it will be replaced with imprisonment for 1 (one) month. Based on the decision of Maumere District Court Register Number 48/PID.SUS/2014/PN.MMR, it is stated that there is no reason that can be the basis for abolishing the crime against the defendant, both for reasons of forgiveness and justification so that the defendant is declared to be able to account for his actions. Keywords: Crime, Shipping, Sailing Approval Document

Postmarketing requirements for drugs approved by the Food and Drug Administration for the treatment of solid tumor cancers, 2010-2019.

e13597 Background: In recent years, efforts to improve the efficiency and speed of drug development and approval have driven a surge of Food and Drug Administration (FDA) approvals for cancer drugs. For many cancer therapies, the serious or life-threatening nature of the condition and unmet medical need confers eligibility for expedited programs. Many cancers are also rare diseases, and the increasing use of precision medicine principles to define cancer types further contributes to smaller trial sizes. With limited clinical evidence at the time of approval, cancer drugs may be subject to a greater burden of postmarketing requirements (PMRs). We analyzed PMRs for solid tumor therapies approved by the FDA over the past decade. Methods: The FDA’s novel drug approvals (2010-2019) were reviewed to identify drugs receiving primary approval for solid tumor indications. Approval letters were accessed via the Drugs@FDA database and analyzed for PMRs required under accelerated approval (AA), the Pediatric Research Equity Act (PREA) and the FDA Amendments Act of 2007 Section 505(o) (505(o)). Data are presented using descriptive statistics. Results: A total of 60 drugs received primary approval from the FDA for solid tumor indications between 2010 and 2019 (20 [33.3%] received AA, 33 [55.0%] received orphan designation, and 45 [75.0%] received Fast Track or Breakthrough Therapy designation). The proportion of drugs receiving AA doubled between the period 2010-2014 and 2015-2019 (Table). Of the 60 drugs approved, 52 (86.7%) received a total of 180 PMRs. All 20 drugs approved under AA received PMRs, with a total of 25 PMRs issued under AA. Data from new clinical trials were required for 22 (88.0%) of the 25 PMRs. No PMRs were issued under PREA. Additional safety data required under 505(o) comprised the largest proportion of PMRs; 155 total PMRs (86.1% of all PMRs) were issued for 45 (75.0%) of the drug approvals. Pharmacokinetic or other clinical safety data were required for 96 (61.9%) of the 155 PMRs. Conclusions: More than three-quarters of the cancer drugs approved for the treatment of solid tumors in the past 10 years were issued PMRs, with the majority requiring new safety data. The results of this study indicate that PMRs represent a critical mechanism by which FDA collects safety and efficacy for solid tumor therapies, and underscore the importance of PMR fulfillment. Post-marketing requirements (PMRs) for solid tumor drugs approved 2010-2019.[Table: see text]

Use of single-arm trials to support malignant hematology and oncology drug and biologic approvals: A 20-year FDA experience.

e13572 Background: Improved understanding of the underlying biology of cancer has led to a paradigm shift in cancer drug development and has paved the way for many products to receive accelerated or regular approval based on non-randomized/single arm trials (SATs). Given the high unmet medical need of cancer patients, challenges with lengthy and confounded survival endpoints, and difficulty enrolling rare biomarker-defined subsets of disease, SATs have been used to evaluate a variety of cancer therapies. Unlike time to event endpoints, the objective and clinically relevant endpoint of response rate (RR) and duration of response is interpretable in SATs, as spontaneous tumor shrinkage is not expected. Methods: A search of FDA databases identified all drugs and biologics approved for malignant hematology and oncology indications from January 1, 2001, to December 31, 2020 based on SATs. Data sources included approval letters, U.S. prescribing information, and clinical review documents. The definition of response varied by setting and time period (e.g. RECIST, WHO, IWG, etc.). Results: Between January 1, 2001 and December 31, 2020, FDA granted 153 new indications based on SATs, including 102 accelerated approvals (AAs) and 51 regular approvals (RAs). Overall, 69 approvals (45%) were for new molecular entities and 84 (55%) were expanded indications. Response rate was the most common endpoint used in the trial providing substantial evidence of efficacy to support approval [120/153, (78%)]. The durability of response was also considered to support evidence of clinical benefit. Of the 102 AAs, 38 (37%) have fulfilled their post-marketing requirement (PMR) to verify clinical benefit, 59 (58%) are pending verification of benefit, and 5 (5%) have been withdrawn from the market. Of note, 88% (52/59) of AAs pending verification of benefit occurred in the last 5 years alone (22 AAs in 2020, 8 in 2019, 8 in 2018, 12 in 2017, and 2 in 2016). Between 2001-2020, 58 (38%) new indications were granted for kinase inhibitors, 34 (22%) for immune checkpoint inhibitors (CPIs), and 61 (40%) for drugs with other mechanisms of action including but not limited to antibody-drug conjugates, cytotoxic drugs, and non-CPI monoclonal antibodies. Conclusions: In the last two decades, SATs have been effectively used to study anti-cancer therapies in well-defined patient populations using durable RR as an objective and interpretable clinical endpoint. Although randomized clinical trials remain the gold standard in clinical research, SATs have allowed for rapid advancements in oncology drug development and will continue to serve an important role in bringing new therapies to patients with unmet need.

Limitation of Harbormaster Responsibility in Ship Accidents

As the government in the port, the harbormaster has the responsibility to guarantee the safety and security of shipping. In shipping, the harbormaster, shipowner and captain are the trident of the security and safety of shipping. This research is a normative-legal research using a statute, comparative and conceptual approaches. The research results indicate that the concept of limiting the responsibility of a harbormaster in a ship accident is a ship accident not necessarily a criminal offense prior to the preliminary examination by the harbormaster and a further examination by the shipping court, if the results of the examination indicate a criminal act, the parties The police can conduct investigations into ship accident events based on the results of the examination by the harbormaster and the shipping court. In the event of a ship accident, the harbormaster has a relative or limited responsibility to the fulfillment and compliance of the implementation of maritime safety, security and safety of shipping in the form of the issuance of a sailing approval letter for ships leaving the port in accordance with applicable rules and procedures so that the harbormaster is not absolutely responsible for the circumstances that occur after the ship leaves port, but it has become the authority and responsibility of the ship commander.&#x0D; &#x0D; Received: 17 January 2021 / Accepted: 9 April 2021 / Published: 10 May 2021

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics ("therapeutics"). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for approved or other clinical indications. Therefore, we characterized US Food and Drug Administration postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018. We conducted a cross-sectional study of all novel therapeutics, including small-molecule drugs and biologics, receiving original US Food and Drug Administration approval from 2009 to 2018, using approval letters accessed through the Drug@FDA database. Outcomes included the number and characteristics of US Food and Drug Administration postmarketing requirements and commitments for new therapeutics at original approval, including the types of studies outlined, the indications to be investigated, and the clinical evidence to be generated. From 2009 to 2018, the US Food and Drug Administration approved 343 new therapeutics with 1978 postmarketing requirements and commitments. Overall, 750 (37.9%) postmarketing requirements and commitments outlined clinical studies. For 71 of 343 (20.7%) therapeutics, no postmarketing requirements or commitments for clinical studies were outlined, while at least 1 was outlined for 272 (79.3%; median 2 (interquartile range: 1-4)). Among these 272 therapeutics, the number of postmarketing requirements and commitments for clinical studies per therapeutic did not change from 2009 (median: 2 (interquartile range: 1-4)) to 2018 (median: 2 (interquartile range: 1-3)). Among the 750 postmarketing requirements and commitments for clinical studies, 448 (59.7%) outlined new prospective cohort studies, registries, or clinical trials, while the remainder outlined retrospective studies, secondary analyses, or completion of ongoing studies. Although 455 (60.7%) clinical studies investigated only original approved therapeutic indications, 123 (16.4%) enrolled from an expansion of the approved disease population and 61 (8.1%) investigated diseases unrelated to approved indications. The US Food and Drug Administration approves most new therapeutics with at least 1 postmarketing requirement or commitment for a clinical study, and outlines investigations of safety or efficacy for both approved and unapproved indications. The median number of 2 clinical studies outlined has remained relatively constant over the last decade. Given increasing emphasis by the US Food and Drug Administration on faster approval and lifecycle evaluation of therapeutics, these findings suggest that more postmarketing requirements and commitments may be necessary to address gaps in the clinical evidence available for therapeutics at approval.

Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore

An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors’ facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests. Copyright Ⓒ 2021 The Korean Society for Clinical Laboratory Science. All rights reserved.

ANALISIS YURIDIS TERHADAP KEBERANGKATAN KAPAL PENUMPANG TANPA ADANYA SURAT PERSETUJUAN BERLAYAR (STUDI PENELITIAN KANTOR KESYAHBANDARAN DAN OTORITAS PELABUHAN KHUSUS BATAM)

This journal is titled Juridical Analysis of Passenger ship departure without a sailing approval letter, research study in the Office of Kesyahbandaran and Special Port Authority of Batam, with construction Problem:-How is the legal arrangement of the passenger ship's departure without a sailing letter?; and implementation, constraints and regulatory solutions to passenger ship departures without a sailing letter? This qualification/journal writing type uses normative legal writing, which is supported by sociological/empirical legal research. To analyse some of the issues in this journal is used a major theory of Utilities/benefits theory, which is stated by Jeremy Betham, a legal theory aimed at realizing the sheer benefit of the people, as well as Accident theory by Heinrich (Domino theory) namely that an accident occurred from a series of events, there are 5 factors related in the series of accidents occur namely, the environment, human error, deed or unsafe conditions, accidents and injuries or losses, and Theory of Peace Theory (peace), according to this theory in a state of peace (peace) there is abundance, strong is not oppressed the weak, the right to actually get the right and there is protection for the people. The law must be able to create peace and prosperity not merely order. The legal arrangement of the ship's departure without the express approval letter is contained in the law No. 17 of 2008 on the Voyage and act No. 1 year 1946 on criminal law and law No. 8 year 1981 on law Criminal events.

АКАДЕМІЧНА ДОБРОЧЕСНІСТЬ, ЯКІСТЬ ОСВІТИ ТА ЯКІСТЬ ЖИТТЯ СТУДЕНТІВ В УМОВАХ ДИСТАНЦІЙНОГО НАВЧАННЯ ПІД ЧАС COVID-19

The study aims to examine quality of life aligned with functional difficulties among students under distant and blended learning during COVID-19 pandemic. The particular focus has been given to challenges related to academic integrity and quality of education at Higher Education Institutions (HEIs). The approval letter to recruit the participants through Students Union at Lesya Ukrainka Volyn National University (LUVNU) was obtained from Ethical Committee at LUVNU. 554 students, females 67,4%, average age 20,93 (SD = 3,29), 74,0 % undergraduate students, 88,4 % students from humanities and social sciences were recruited. Academic Integrity Questionnaire (Schwartz, Tatum, &amp; Hageman, 2013), and, COVID-related functional difficulties and stress associated with exposure to COVID-19 (Schiff, Zasiekina, Pat-Horenczyk, &amp; Benbenishty, 2020) have been used. The study applied the cross sectional, between subjects design utilizing the independent variables of health-related difficulties, learning-related difficulties and loneliness-related difficulties aligned with forced social isolation during pandemic, and fear to be infected for multiple regression analysis. The results in this study indicate that that the main students’ concern is associated with health-related difficulties. The only one independent significant predictor of students’ fear to be infected is health-related difficulties, although all dependent variables taken together (health-related difficulties, learning-related difficulties and loneliness-related difficulties) are robust predictors of students’ fear to be infected. The most acceptable situations for students in terms of dishonest behaviour are situations of collaborating on lab report when instructed not to; submitting same paper for two classes; purchasing and downloading a paper from online sources. The next study, therefore, moves on to discuss the main instruments for developing academic integrity and quality of education under distant and blended learning at HEis.

A Legal Review of Sailing Approval Letter: Systems and Procedures

Every ship that is going to sail is required to have a sailing approval letter issued by the harbormaster as an effort to control the security and safety of shipping. This research is a normative-legal research using a statute, comparative and conceptual approaches.The results show that the harbormaster as a government official at the port carries out and supervises efforts to fulfill shipping safety and security as a government administrative action by issuing a state document in the form of a sailing approval letter through a system of procedures for issuing a sailing approval letter. This letter is given to every ship that will sail or leave the port by ensuring that the ship, crew and cargo have technically-administratively fulfilled all sailworthiness requirements. The compliance of all parties in implementing the procedure for the issuance of the sailing approval will lead to the achievement of safety and security in shipping.

Comparative Evaluation of Mineral Trioxide Aggregate, Biodentine, and Calcium Phosphate Cement in Single Visit Apexification Procedure for Nonvital Immature Permanent Teeth: A Randomized Controlled Trial

Aim and objectiveThis study assesses the efficacy of mineral trioxide aggregate (MTA), biodentine, and calcium phosphate cement (CPC) as single visit apexification agents for nonvital immature permanent teeth, both clinically and radiographically.Materials and methodsThe study was conducted as a double-blinded randomized, controlled clinical trial after approval of the Institutional Ethical Committee of King George's Medical University, Lucknow, Uttar Pradesh, India, the approval letter (Ref. no. 81st ECM II B-Thesis/P24). A total of 60 patients in the age group of 6–15 years, fulfilling all the inclusion and exclusion criteria were enrolled for the study. Patients were randomly divided into three groups having 20 in each group.ResultsOn the basis of present study, it can hence, be inferred that clinical success for MTA, biodentine and calcium phosphate cement in apexification was 100%. The radiographic outcomes of calcium phosphate cement showed better results as compared to MTA and biodentine at 9 months of follow-up periods.ConclusionThese finding suggest that calcium phosphate cement can be used as a substitute for MTA and biodentine because of its comparable clinical and superior radiographic success.How to cite this articleYadav A, Chak RK, Khanna R. Comparative Evaluation of MTA, Biodentine and Calcium Phosphate Cement in Single Visit Apexification Procedure for Nonvital Immature Permanent Teeth: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2020;13(S-1):S1–S13.

Evaluation of gene Xpert in detecting suspected pulmonary tuberculosis from stool sample for children

Background: Case detection of pulmonary tuberculosis (PTB) is a challenge, even if different diagnostic methods used. Nowadays, it is improved, after the advancement of the detection method such as gene Xpert assay a prodigious change for adults. But in the pediatric PTB is still a challenge, due to the lack of well-developed physiological capacity. Young children are unable to produce enough amount of sputum to be detected by the gene Xpert. So, a substantial number of children are not diagnosed and fail to get treatment. Methods and materials: A cross-sectional study design was used, to evaluate 422 stool and sputum samples were collected from PTB suspected children (<15 years) by consecutive sampling technique. Both stool and sputum specimens were run in the gene Xpert at AHMC and sputum specimens were cultured using LJ culture medium at Oromia Regional Laboratory, Adama, Ethiopia. Specimen processing and testing were done in accordance with the standard mycobacterial safety precautions, procedures, and manufacturer's instruction. Descriptive statistical analysis was done by SPSS version 20, a chi-square test was used to show their association at 95% CI and P-value <0.05 was considered statistically significant, sensitivity, specificity, PPV and NPV of the tests were also calculated. The study was commenced after obtaining ethical approval and permission letter from respective bodies. All data obtained from the participants kept confidential. Results: A total of 422 children were enrolled. About, 70% were living in urban areas. Male to female proportion was 203/219. The mean age was 10.8 years, the majority (71.8%) of the participant age was less than 5years old. From 422 children investigated, 26 had been detected for PTB and 24 of them are confirmed by the sputum culture, with three invalid and four errors. Two of those PTB detected were rifampicin-resistant. Stool gene Xpert had a sensitivity, specificity, PPV and NPV (96%, 99.5%, 92.3%, 99.7%) respectively. Conclusion: The sensitivity of gene Xpert to detected MTB in the stool sample was higher as 96% (P = 0.000). Therefore, the stool can be used as an alternative sample for the diagnosis of PTB using gene Xpert assay for children unable to give respiratory samples.

Problems and development strategies for research ethics committees in China’s higher education institutions

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in...

Effectiveness of Convalescent Plasma Therapy in Indian Patients with COVID-19

Background: Convalescent plasma (CP) is being used as a treatment option in hospitalized patients with COVID-19. Till date, there is conflicting evidence on efficacy of CP in reducing COVID-19 related mortality.Objective: to evaluate the effect of CP on 28-day mortality reduction in patients with COVID-19.Methods: We did a multi-center, retrospective case control observational study from 1st May 2020 to 31st August 2020. A total of 1079 adult patients with moderate and severe COVID-19 requiring oxygen, were reviewed. Of these, 694 patients were admitted to ICU. Out of these, 333 were given CP along with best supportive care and remaining 361 received best supportive care only.Results: In the overall group of 1079 patients, mortality in plasma vs no plasma group was statistically not significant (22.4% vs 18.5%; p = 0.125). However, in patients with COVID-19 admitted to ICU, mortality was significantly lower in plasma group (25.5% vs 33.2%; p = 0.026). This benefit of reduced mortality was most seen in age group 60 to 74 years (26.7% vs 43.0%; p = 0.004), driven mostly by females of this age group (23.1% vs 53.5%; p = 0.013). Significant difference in mortality was observed in patients with one comorbidity (22.3% vs 36.5%; p = 0.004). Moreover, patients on ventilator had significantly lower mortality in the plasma arm (37.2% vs 49.3%; p = 0.009); particularly so for patients on invasive mechanical ventilation (63.9% vs 82.9%; p = 0.014).Conclusion: The use of CP reduced mortality in COVID-19 elderly patients admitted in ICU, above 60 years of age, particularly females, those with comorbidities and especially those who required some form of ventilation.Funding Statement: None to declare.Declaration of Interests: None to declare. Ethics Approval Statement: The manuscript has ethical clearance and approval from the ethics committee of the institute . A copy of the approval letter is attached. (Reference number isRS/MSSH/GMRCHS/IEC/IM/20-16).

The Decline of Tuberculosis Burden in Vietnam: A Comparison of Two Consecutive National Surveys

Background: Despite interventions, the global tuberculosis epidemic has shown only modest declines in recent years. However, estimates of burden for most high-burden countries are based on indirect methods. Vietnam, a tuberculosis high-burden country, conducted national tuberculosis prevalence surveys in 2007 and 2017 to directly estimate its tuberculosis burden and evaluate the impact of tuberculosis control interventions during the interval. In this study, we compared the prevalence of tuberculosis between the two surveys based on analogous methods. Method: Participants in both surveys were screened for TB by a questionnaire and chest X-ray. Individuals with a positive screening result were asked to provide sputum samples to test for Mycobacterium tuberculosis by light microscopy using direct Ziehl-Neelsen-stained smear and Lowenstein–Jensen solid culture. Culture-positive TB, smear-positive TB, and smear-negative TB cases were defined by microscopy and culture results. Findings: The prevalence of culture-positive TB decreased by 37% (11·5-55·4%), from 199 (160-248) per 100,000 adults in 2007 to 125 (98-159) per 100,000 adults in 2017. The prevalence of smear-positive TB dropped by 53% (27·0-69·7%), from 99 (78-125) per 100,000 adults to 46 (32-68) per 100,000 adults, while smear-negative TB showed no significant reduction. Interpretation: The burden of TB has reduced considerably in Vietnam in the last decade, with a shift from smear-positive to smear-negative disease. To further lower the TB burden, diagnosis should focus on identifying all pulmonary TB cases by replacing microscopy with molecular methods as the primary diagnostic method. Funding Statement: This study was funded by the Vietnam Ministry of Health, the The Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. Agency for International Development, the US Centers for Disease Control and Prevention - Vietnam Office (CDC), the KNCV Tuberculosis Foundation, and the World Health Organization (WHO). Declaration of Interests: We declare no competing interests. Ethics Approval Statement: This study has been given scientific and ethical approval by the Institutional Review Board of the Vietnam National Lung Hospital, under approval letter number 62/17/CTHĐKH-ĐĐ. All participants were explained about the risks and benefits of the study and signed an individual written informed consent. All of those with at least one positive test for TB were referred for TB treatment and followed up to verify that they received adequate healthcare and treatment.

CRIMINAL LIABILITY OF FISHERY PERPETRATOR ACCORDING TO FISHERY LAW NUMBER 45 OF 2009 CONCERNING AMENDMENT TO LAW NUMBER 31 OF 2004

Many occurrences of fisheries criminal offenses make the writer interested to learn about criminal provisions and the responsibility of the perpetrators according to Law No. 45 of 2009 concerning amendments to Law No. 31 of 2004 concerning Fishery. By studying, understanding, and analyzing these articles of law, the author significantly obtains the picture of whether this Fishery Law is appropriate and able to force the perpetrator of their responsibility for their actions. The purposes of this paper are 1) To analyze the patterns of fishery criminal so the perpetrators could be charged their responsibilities according to Law No. 45 of 2009, 2) To study and analyze how to determine the penalties according to the Law No. 45 of 2009. This paper is a qualitative descriptive. The method of this research is normative law with conceptual and institutional approaches. The result of the study showed that legislation in Indonesia relating to Fisheries, administratively, there are still several articles that are sticking out and controversy according to Law No. 45 of 2009 concerning amendments to Law No. 31 of 2004 concerning Fishery. For small fishermen who do not have a Yachting Approval Letter (SPB) in Indonesia should be subjected to administrative sanctions such as paying compensation. If administrative sanctions are not implemented, then the principle of ultimum remedium can be applied as a last choice in violations of fisheries and there are still several articles that are detrimental to the interests of the State as well as the interests of local fishermen which, if seen from criminal liability, may be imposed.

Sailing Approval Letter

The issuance of a Sailing Approval Letter is a process of supervision carried out by the Harbormaster of a ship leaving the port to ensure that the ship, ship crew and cargo have technically fulfilled the requirements of shipping safety and security as well as protection of the maritime environment. The approach method used in this research is juridical empirical and the research specification used is descriptive analytical. Data collection techniques used in this study are through interview and documentation guidelines. The result of this research is that the responsibility of the harbormaster is very heavy in ensuring the safety and security of shipping because the harbormaster is a government official at the port who has the highest authority to carry out and supervise the fulfillment of statutory provisions to ensure shipping safety and security. Understanding of the requirements for safety and security of shipping is a condition where safety and security requirements are met with regard to water transportation, ports, and the maritime environment.

PENERBITAN SURAT PERSETUJUAN BERLAYAR KAPAL PERIKANAN PADA KANTOR UNIT PENYELENGGARA PELABUHAN BANGGAI

In the context of shipping protection and safety, it is necessary to obtain approval of the Sailing Agreement by Syahbandar. This paper is to find out the procedures approved by the Fishing Boat Approval Letter at the Banggai Port Operator Unit Office, and to find out and analyze the factors that influence it. The research used is empirical juridical with primary, secondary and tertiary data collection. Procedures for approving Fishing Vessel Approval Letters at the Banggai Port Operational Unit Office, approving applications for approval of Sailing (SPB), checking the administration and physical condition of vessels, and issuing Sailing Approval Letters (SPB). As a factor influencing the Fishing Boat Sail Approval Letter in the Banggai Port Operator Unit Office, it consists of supporting factors, namely legal factors and supporting factors. While the inhibiting actors are the Number of Human Resources and the inaccuracy of applicants.

Prevalence of Postpartum Depression in A Tertiary Health Care

Postpartum Depression is an important public health problem in developing country like Nepal.Although prevalence of postpartum depression is high in our setting, it is most neglected area of mental health. These have negative consequences not only to mother but also to infant. Data related to postpartum depression in Nepal are limited, research in this particular field will contribute in knowing the gravity of the situation and helps to formulate the factor association to upcoming researchers. This research is done in order to find out the prevalence of postpartum depression. A descriptive cross-sectional study was carried out in Paropakar Maternity and Women's Hospital, among total 348 postnatal mothers who were selected through convenient sampling technique. Validated Nepalese version of Edinburg Postnatal Depression Scale was used to screen depressive symptoms. Data was collected after receiving ethical approval letter. Data entry was done using SPSS version 20. Out of total mothers, the prevalence of Postpartum Depression (PPD) was seen among 51 (14.7%) mothers. Postpartum Depression being a common yet neglected area of maternal health in Nepal, should be detected in early stage. As the study showed that about one sixth of mothers had postpartum depression, more focus should be given to maternal mental health.