Hospital disaster preparedness in Iranian province: A cross-sectional study using a standard tool

Objective: Hospitals are the first place to refer the victims of emergencies and disasters. Hamadan province, as one of the provinces in western Iran, like other parts of this country is exposed to various emergencies and disasters. This study was conducted to evaluate the level of hospital disaster preparedness in the Hamadan province of Iran using a standard tool.Methods: This study was conducted in Hamadan province’s hospitals in Iran. The Persian version of the World Health Organization Hospital Emergency Response Checklist was used as an evaluation tool. It consists of nine key components: command and control, triage, human resources, communications, surge capacity, logistics/supply management, safety and security, continuity of essential services, and post-disaster recovery. Data entry and analysis were performed using IBM® SPSS® software (version 18).Results: Fifteen hospitals participated in this study (response rate 83 percent). Most hospitals (53.33 percent) were in moderate preparedness level, 26.66 percent are in good, and 13.33 percent are at a poor level. There was no significant relationship between “the hospital type” and “the hospital size” (number of beds) and preparedness score (p 0.05).Conclusions: This study showed that most of the hospitals in the Hamadan province regarding the components of “logistics” and “essential services” are at a poor disaster preparedness level. Accordingly, the hospital authorities and managers must adopt a comprehensive strategy for strengthening the hospital disaster preparedness measures, especially in these components.

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A Study of Hospital Disaster Preparedness in South Yemen

Prehospital and Disaster Medicine ◽

10.1017/s1049023x18000158 ◽

2018 ◽

Vol 33 (2) ◽

pp. 133-138 ◽

Cited By ~ 3

Author(s):

Waheeb Nasr Naser ◽

Pier Luigi Ingrassia ◽

Salem Aladhrae ◽

Wegdan Ali Abdulraheem

Keyword(s):

Disaster Preparedness ◽

Cross Sectional Study ◽

World Health ◽

Publication Type ◽

Cross Sectional ◽

Private Hospitals ◽

Comprehensive Strategy ◽

Hospital Preparedness ◽

Health Organization ◽

Hospital Disaster Preparedness

AbstractIntroductionDespite emphasis by disaster experts on the importance of disaster preparedness, disaster management in Yemen has attracted only a little attention. Most of the efforts have focused on post-disaster relief activities rather than the pre-disaster preparedness and risk reduction. Hospitals have a crucial role in emergency response and should be prepared. Thus, the aim of this study was intended to assess the hospital preparedness of Aden Capital, South Yemen against disasters.MethodA cross-sectional study was conducted in June 2016. The sample was all Aden City facilities with a total number of 10 hospitals: five public and five private hospitals. A survey was done by using the World Health Organization (WHO; Geneva, Switzerland) standards checklist 2011.ResultsThe overall preparedness of Aden City hospitals to disasters fell at the unacceptable level of readiness, with an average mean of 46.6 (SD = 38.31; range 24-82). Of 10 hospitals, two ranked insufficient while eight hospitals were at unacceptable levels of preparedness.ConclusionAll hospitals were noted grossly unprepared for potential disasters. Therefore, it is recommended that greater efforts be invested in creating a comprehensive strategy and national or local guidelines to establish an emergency management system based on the anticipated hazard and the needed resources.NaserWN, IngrassiaPL, AladhraeS, AbdulraheemWA. A study of hospital disaster preparedness in South Yemen. Prehosp Disaster Med. 2018;33(2):133–138.

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Adequacy of alcohol-based handrub solution production practice in response to COVID-19 in public hospitals found in Addis Ababa, Ethiopia: a multicentered cross-sectional study

Journal of Pharmaceutical Policy and Practice ◽

10.1186/s40545-021-00321-y ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Muluken Nigatu Selam ◽

Regasa Bayisa ◽

Andualem Ababu ◽

Mahdi Abdella ◽

Edessa Diriba ◽

...

Keyword(s):

Addis Ababa ◽

Data Entry ◽

Cross Sectional Study ◽

Public Hospitals ◽

Raw Material ◽

World Health ◽

Categorical Variables ◽

Cross Sectional ◽

Production Practice ◽

Health Organization

Abstract Background Proper hand hygiene using alcohol-based handrub (ABHR) is an effective preventive approach for the current Coronavirus Disease 2019 (COVID-19) pandemic and other infections. World Health Organization recommends local production of ABHR solution in healthcare settings which provides a feasible alternative to the use of relatively expensive commercially produced hand sanitizers. The aim of this study was to explore the adequacy of ABHR solution production practice in response to COVID-19 in public hospitals of Addis Ababa, Ethiopia. Methods A cross-sectional observational study was applied using assessment checklist for evaluation of the adequacy of ABHR production practice in compounding units of public hospitals. The evaluation was done with regard to the standard requirements as per the checklist. Statistical Package for Social Sciences (SPSS) version 23 was used for data entry and analysis. Descriptive statistics was employed for analyses of data and categorical variables were described by frequencies and percentages. Results Out of the 13 public hospitals observed in the study, 11 facilities had dedicated premises for compounding of ABHR solution. Seven facilities determined the concentration of ethanol in ABHR solution using alcoholmeters. Only one health facility had a titration kit and performed a strength test for the hydrogen peroxide raw material. Thermal and chemical disinfection processes were practiced for cleaning of recycled dispensing bottles only in 3 and 2 hospitals, respectively. Most of the hospitals (11 facilities) had standard operating procedures (SOPs) for production, but the majority lack SOPs for beyond-use-date assignment (11 facilities), premise and equipment cleaning (12 facilities), and disinfection of recycled bottles (12 facilities). Conclusion Most hospitals have fulfilled the majority requirements of premises required for compounding of ABHR solution in their facilities. Five hospitals did not verify the concentration of ethanol in the ABHR solution which might affect the effectiveness of the product. Generally, lower compliance of the majority studied hospitals to good compounding practice was observed during ABHR solution production especially for product preparation, quality control, and documentation.

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Evaluation of Drug Use Based on WHO Prescribing Indicator in Mizan- Tepi University Teaching Hospital, south Western Ethiopia: A Cross Sectional Study

Current Drug Therapy ◽

10.2174/1574885515999200819092717 ◽

2020 ◽

Vol 15 ◽

Author(s):

Solomon Hambisa ◽

Rediet Feleke ◽

Ameha Zewudie ◽

Mohammed Yimam

Keyword(s):

Drug Use ◽

World Health Organization ◽

Teaching Hospital ◽

Cross Sectional Study ◽

University Teaching ◽

World Health ◽

Sectional Study ◽

Hospital Data ◽

Cross Sectional ◽

Health Organization

Background:: Rational drug use comprises aspects of prescribing, dispensing and patient use of medicines for different health problems. This study is aimed to assess drug prescribing practice based on the world health organization prescribing indicators in Mizan-Tepi University teaching hospital. Methods:: An institutional based retrospective cross sectional study was conducted to evaluate prescribing practices in Mizan-Tepi University teaching hospital. Data were collected based on World health organization drug use indicators using prescription papers. 600 prescriptions dispensed through the general outpatient pharmacy of the hospital were collected by systematic random sampling method from prescriptions written for a 1-year time in Mizan-Tepi University teaching hospital. Results:: The present study found that the average number of drugs per prescription was 2.04 ± 0.87 in Mizan-Tepi University teaching hospital with a range between 1 and 5. Prescribing by generic name was 97.6 % and 47.8% of prescriptions contained antibiotics in the hospital. 27.7% of prescriptions contained at least one injectable medication in Mizan-Tepi University teaching hospital. From prescribed drugs, 96.7% of them were prescribed from Ethiopian essential drug list. Conclusion:: Present study indicated that the average number of drugs prescribed per encounter, the percentage of generic prescribing and prescribing from the EDL were close to optimal value. However, the percentage of encounters with antibiotics and injections prescribed were found be very high. Thus, the study highlights some improvements in prescribing habits, particularly by focusing on the inappropriate consumption of antibiotics and injections.

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The impact of coronavirus outbreak on breastfeeding guidelines among Brazilian hospitals and maternity services: a cross-sectional study

International Breastfeeding Journal ◽

10.1186/s13006-021-00377-1 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Walusa Assad Gonçalves-Ferri ◽

◽

Fábia Martins Pereira-Cellini ◽

Kelly Coca ◽

Davi Casale Aragon ◽

...

Keyword(s):

Cross Sectional Study ◽

World Health ◽

Breastfeeding Support ◽

Cross Sectional ◽

Maternity Services ◽

Community Needs ◽

Care Services ◽

Skin Contact ◽

Health Organization ◽

The Impact

Abstract Background The World Health Organization recognizes exclusive breastfeeding a safe source of nutrition available for children in most humanitarian emergencies, as in the current pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Despite the Brazilian national guideline protecting breastfeeding practices, there are many concerns about protecting infants from their infected mothers. This study aimed to analyze how the Brazilian hospitals and maternity services promote and support mothers suspected or diagnosed with coronavirus disease (COVID-19). Methods This is a descriptive cross-sectional and multicenter study which collected data from 24 Brazilian hospitals and maternity services between March and July 2020. Representatives of the institutions completed a questionnaire based on acts to promote and support breastfeeding, the Baby-Friendly Hospital Initiative, and Brazil’s federal law recommendations. Results The results showed that in delivery rooms, 98.5% of the services prohibited immediate and uninterrupted skin-to-skin contact between mothers and their infants and did not support mothers to initiate breastfeeding in the first hour. On the postnatal ward, 98.5% of the services allowed breastfeeding while implementing respiratory hygiene practices to prevent transmission of COVID-19. Companions for mothers were forbidden in 83.3% of the hospitals. Hospital discharge was mostly between 24 and 28 h (79.1%); discharge guidelines were not individualized. Additionally, a lack of support was noticed from the home environment’s health community network (83.3%). Hospital and home breast pumping were allowed (87.5%), but breast milk donation was not accepted (95.8%). There was a lack of guidance regarding the use of infant comforting strategies. Guidelines specific for vulnerable populations were not covered in the material evaluated. Conclusions In Brazil, hospitals have not followed recommendations to protect, promote, and support breastfeeding during the COVID-19 outbreak. The disagreement between international guidelines has been a major issue. The absence of recommendations on breastfeeding support during the pandemic led to difficulties in developing standards among hospitals in different regions of Brazil and other countries worldwide. The scientific community needs to discuss how to improve maternal and infant care services to protect breastfeeding in the current pandemic.

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The Utilization of Protective Face Masks among Polish Healthcare Workers during COVID-19 Pandemic: Do We Pass the Exam?

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18020841 ◽

2021 ◽

Vol 18 (2) ◽

pp. 841

Author(s):

Radomir Reszke ◽

Łukasz Matusiak ◽

Piotr K. Krajewski ◽

Marta Szepietowska ◽

Rafał Białynicki-Birula ◽

...

Keyword(s):

Healthcare Workers ◽

Medical Profession ◽

Cross Sectional Study ◽

Internet Survey ◽

World Health ◽

Cross Sectional ◽

Protective Measures ◽

Who Criteria ◽

The Face ◽

Health Organization

Relevant personal protective measures during the COVID-19 pandemic include face masks, possibly decreasing the risk of infection among the general population and healthcare workers (HCW) if utilized properly. The aim of the study was to assess whether different Polish HCW utilize face masks according to the 2020 World Health Organization guidance (WHO) criteria. This cross-sectional study included 1156 respondents who participated in an internet survey evaluating mask-related behaviors. All the WHO criteria were complied with by 1.4% of participants, regardless of medical profession, specialty or place of employment. HCW mostly adhered to criterion 1 (C1; strict covering of the face and mouth with the mask; 90.8%), C4 (washing/disinfecting the hands after touching/taking off the mask; 49%) and C3 (taking off the mask properly without touching the anterior surface; 43.4%), whereas C2 (avoidance of touching the mask with hands) was complied with least commonly (6.8%). HCW with mask-induced itch (31.6%) complied to C2 less often (odds ratio 0.53; p = 0.01). The study reveals that Polish HCW rarely adhere to all the 2020 WHO guidance criteria on the use of masks, whereas the adherence to particular criteria is variable and may be associated with the presence of skin-related conditions and other factors. Better compliance with the recommendations in the future is necessary to increase personal safety of HCW and prevent the transmission of SARS-CoV-2.

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Managing the Return to Football During the COVID-19 Pandemic: A Survey of the Head Team Physicians of the Football Bowl Subdivision Programs

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121992045 ◽

2021 ◽

Vol 9 (1) ◽

pp. 232596712199204

Author(s):

Alexander D. Slabaugh ◽

John W. Belk ◽

Jonathan C. Jackson ◽

Richard J. Robins ◽

Eric C. McCarty ◽

...

Keyword(s):

Primary Care ◽

Primary Care Physicians ◽

National Collegiate Athletic Association ◽

College Football ◽

Cross Sectional Study ◽

Return To Play ◽

World Health ◽

Cross Sectional ◽

Football Bowl Subdivision ◽

Health Organization

Background: COVID-19 is a severe respiratory virus that spreads via person-to-person contact through respiratory droplets. Since being declared a pandemic in early March 2020, the World Health Organization had yet to release guidelines regarding the return of college or professional sports for the 2020-2021 season. Purpose: To survey the head orthopedic surgeons and primary care team physicians for the National Collegiate Athletic Association (NCAA) Football Bowl Subdivision (FBS) football teams so as to gauge the management of common COVID-19 issues for the fall 2020 college football season. Study Design: Cross-sectional study. Methods: The head team orthopaedic surgeons and primary care physicians for all 130 FBS football teams were surveyed regarding their opinions on the management of college football during the COVID-19 pandemic. A total of 30 questions regarding testing, return-to-play protocol, isolating athletes, and other management issues were posed via email survey sent on June 5, 2020. Results: Of the 210 team physicians surveyed, 103 (49%) completed the questionnaire. Overall, 36.9% of respondents felt that it was unsafe for college athletes to return to playing football during fall 2020. While the majority of football programs (96.1%) were testing athletes for COVID-19 as they returned to campus, only 78.6% of programs required athletes to undergo a mandatory quarantine period before resuming involvement in athletic department activities. Of the programs that were quarantining their players upon return to campus, 20% did so for 1 week, 20% for 2 weeks, and 32.9% quarantined their athletes until they had a negative COVID-19 test. Conclusion: While US Centers for Disease Control and Prevention guidelines evolve and geographic regions experience a range of COVID-19 infections, determining a universal strategy for return to socialization and participation in sports remains a challenge. The current study highlighted areas of consensus and strong agreement, but the results also demonstrated a need for clarity and consistency in operations, leadership, and guidance for medical professionals in multiple areas as they attempt to safely mitigate risk for college football players amid the COVID-19 pandemic.

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An analysis of heavy metals contamination and estimating the daily intakes of vegetables from Uganda

Toxicology Research and Application ◽

10.1177/2397847320985255 ◽

2021 ◽

Vol 5 ◽

pp. 239784732098525

Author(s):

Keneth Iceland Kasozi ◽

Eric Oloya Otim ◽

Herbert Izo Ninsiima ◽

Gerald Zirintunda ◽

Andrew Tamale ◽

...

Keyword(s):

Heavy Metals ◽

Daily Intake ◽

Principal Component ◽

Absorption Spectrometry ◽

Cross Sectional Study ◽

Essential Elements ◽

World Health ◽

Cross Sectional ◽

Health Organization ◽

Daily Intakes

Background: Environmental contamination with elevated levels of copper (Cu), cobalt (Co), iron (Fe), zinc (Zn), lead (Pb), chromium (Cr6+), cadmium (Cd), and nickel (Ni)—all states of which are found in Uganda—raises health risk to the public. Pb, Cr6+, Cd, and Ni for instance are generally considered nonessential to cellular functions, notwithstanding the importance of the oxidative state of the metals in bioavailability. As such, we aimed in this study (i) to evaluate heavy metal concentrations in four vegetables from a typical open-air market in Uganda, (ii) to assess the safety of consuming these vegetables against the World Health Organization (WHO) recommended limits of heavy metals consumption, and (iii) to formulate a model of estimated daily intake (EDI) among consumers in the country. Methods: This was a cross-sectional study conducted in five georeferenced markets of Bushenyi district in January 2020. Amaranthus, cabbages, scarlet eggplants, and tomatoes were collected from open markets, processed, and analyzed by atomic absorption spectrometry. Modeled EDI, principal component (PCA) and cluster analysis (CA) were conducted to identify relationships in the samples. Results: The levels of essential elements in the four vegetables were found to fall from Co > Cu > Fe > Zn. Those of non-essential metals were significantly higher and followed the pattern Cd > Cr > Pb > Ni. The highest EDI values were those of Cu in scarlet eggplants, Zn in amaranthus, Fe in amaranthus, Co in amaranthus, Pb in cabbages, total Cr in scarlet eggplant, Cd in cabbages and tomatoes, and Ni in cabbages. In comparison to international limits, EDIs for Zn, Cu, Co and Fe were low while Ni in cabbages were high. PCA showed high variations in scarlet eggplant and amaranthus. The study vegetables were found to be related with each other, not according to the location of the markets from where they were obtained, but according to their species by CA. Conclusion: The presence of non-essential elements above WHO limits raises policy challenges for the consumption and marketing of vegetables in the study area. Furthermore, low EDIs of essential elements in the vegetables create demand for nutritious foods to promote healthy communities.

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Regional differences in general practitioners’ behaviours regarding influenza vaccination: a cross-sectional study

BMC Health Services Research ◽

10.1186/s12913-021-06177-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jonathan Arlt ◽

Kristina Flaegel ◽

Katja Goetz ◽

Jost Steinhaeuser

Keyword(s):

Influenza Vaccination ◽

General Practitioners ◽

Personal Characteristics ◽

Cross Sectional Study ◽

Central Research Institute ◽

World Health ◽

Central Research ◽

Cross Sectional ◽

Vaccination Rates ◽

Health Organization

Abstract Background The World Health Organization recommends vaccination rates of 75% against seasonal influenza for patients over 65 years old. In the 2013/2014 season, the German vaccination rates ranged between 14 and 65%. This study aimed to compare the attitudes, personal characteristics and vaccination behaviours of general practitioners (GPs) in regions with high and low vaccination rates in Germany. Methods In May 2016, a questionnaire was sent to 1594 GPs practising in 16 districts with the highest and the lowest vaccination rates in Western and Eastern Germany as described by the Central Research Institute of Ambulatory Health Care in Germany for the 2013/2014 season. Descriptive statistics and multiple regression analyses were computed to identify potential factors associated with high vaccination rates. Results A total response rate of 32% (515/1594 participants) was observed in the study. GPs reported their attitudes towards vaccination in general and vaccination against influenza as mostly ‘very positive’ (80%, n = 352 and 65%, n = 288, respectively). GPs practising in regions with low vaccination rates reported their attitudes towards vaccinations in general (p = 0.004) and towards influenza vaccination (p = 0.001) more negatively than their colleagues from regions with high vaccination rates. Multiple logistic regression identified an increasing influence of year-dependent changing efficiency on GPs’ influenza rates as the strongest factor for predicting GPs from highly vaccinating regions (OR = 4.31 [1.12–16.60]), followed by the patient’s vaccination refusal despite GP advice due to already receiving a vaccination from another physician (OR = 3.20 [1.89–5.43]) and vaccination information gathering through medical colleagues (OR = 2.26 [1.19–4.29]). Conclusions The results of this study suggest a correlation between GPs’ attitudes and regional vaccination rates. Beneath GPs’ individual attitudes, the regional attitude patterns of patients, colleagues and medical assistants surrounding those GPs seem decisive and should be integrated into future campaigns to increase vaccination rates at a regional level.

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Compliance with the 24-Hour Movement Behavior Guidelines and Associations with Adiposity in European Preschoolers: Results from the ToyBox-Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147499 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7499

Author(s):

Marga Decraene ◽

Vera Verbestel ◽

Greet Cardon ◽

Violeta Iotova ◽

Berthold Koletzko ◽

...

Keyword(s):

Sleep Duration ◽

Screen Time ◽

Total Sample ◽

Cross Sectional Study ◽

World Health ◽

Movement Behavior ◽

Cross Sectional ◽

Guideline Compliance ◽

Z Scores ◽

Health Organization

In 2019, the World Health Organization (WHO) published 24 h movement behavior guidelines for preschoolers with recommendations for physical activity (PA), screen time (ST), and sleep. The present study investigated the proportion of preschoolers complying with these guidelines (on a total week, weekdays and weekend days), and the associations with adiposity. This cross-sectional study included 2468 preschoolers (mean age: 4.75 years; 41.9% boys) from six European countries. The associations were investigated in the total sample and in girls and boys separately. PA was objectively assessed by step counts/day. Parent-reported questionnaires provided ST and sleep duration data. Generalized estimating equations were used to analyze the association between guideline compliance and adiposity indicators, i.e., body mass index (BMI) z-score and waist to height ratio (WHR). Only 10.1% of the preschoolers complied with the 24 h movement behavior guidelines, 69.2% with the sleep duration guideline, 39.8% with the ST guideline and 32.7% with the PA guideline. No association was found between guideline compliance with all three movement behaviors and adiposity. However, associations were found for isolated weekday screen time (BMI z-scores and WHR: p = 0.04) and weekend day sleep duration (BMI z-scores and WHR: p = 0.03) guideline compliance with both lower adiposity indicators. The latter association for sleep duration was also found in girls separately (BMI z-scores: p = 0.02; WHR: p = 0.03), but not in boys. Longitudinal studies, including intervention studies, are needed to increase preschoolers’ guideline compliance and to gain more insight into the manifestation of adiposity in children and its association with 24 h movement behaviors from a young age onwards.

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Diagnostic accuracy of symptoms as a diagnostic tool for SARS-CoV 2 infection: a cross-sectional study in a cohort of 2,173 patients

BMC Infectious Diseases ◽

10.1186/s12879-021-05930-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Carlos Alfonso Romero-Gameros ◽

Tania Colin-Martínez ◽

Salomón Waizel-Haiat ◽

Guadalupe Vargas-Ortega ◽

Eduardo Ferat-Osorio ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Diagnostic Tool ◽

Clinical Decision Making ◽

Multivariate Logistic Regression Analysis ◽

Clinical Decision ◽

Cross Sectional Study ◽

World Health ◽

Likelihood Ratios ◽

Cross Sectional ◽

Health Organization

Abstract Background The SARS-CoV-2 pandemic continues to be a priority health problem; According to the World Health Organization data from October 13, 2020, 37,704,153 confirmed COVID-19 cases have been reported, including 1,079,029 deaths, since the outbreak. The identification of potential symptoms has been reported to be a useful tool for clinical decision-making in emergency departments to avoid overload and improve the quality of care. The aim of this study was to evaluate the performances of symptoms as a diagnostic tool for SARS -CoV-2 infection. Methods An observational, cross-sectional, prospective and analytical study was carried out, during the period of time from April 14 to July 21, 2020. Data (demographic variables, medical history, respiratory and non-respiratory symptoms) were collected by emergency physicians. The diagnosis of COVID-19 was made using SARS-CoV-2 RT-PCR. The diagnostic accuracy of these characteristics for COVID-19 was evaluated by calculating the positive and negative likelihood ratios. A Mantel-Haenszel and multivariate logistic regression analysis was performed to assess the association of symptoms with COVID-19. Results A prevalence of 53.72% of SARS-CoV-2 infection was observed. The symptom with the highest sensitivity was cough 71%, and a specificity of 52.68%. The symptomatological scale, constructed from 6 symptoms, obtained a sensitivity of 83.45% and a specificity of 32.86%, taking ≥2 symptoms as a cut-off point. The symptoms with the greatest association with SARS-CoV-2 were: anosmia odds ratio (OR) 3.2 (95% CI; 2.52–4.17), fever OR 2.98 (95% CI; 2.47–3.58), dyspnea OR 2.9 (95% CI; 2.39–3.51]) and cough OR 2.73 (95% CI: 2.27–3.28). Conclusion The combination of ≥2 symptoms / signs (fever, cough, anosmia, dyspnea and oxygen saturation < 93%, and headache) results in a highly sensitivity model for a quick and accurate diagnosis of COVID-19, and should be used in the absence of ancillary diagnostic studies. Symptomatology, alone and in combination, may be an appropriate strategy to use in the emergency department to guide the behaviors to respond to the disease. Trial registration Institutional registration R-2020-3601-145, Federal Commission for the Protection against Sanitary Risks 17 CI-09-015-034, National Bioethics Commission: 09 CEI-023-2017082.

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