scholarly journals Use of iris scanning as a method of biometric recognition of healthy adults participating in an Ebola vaccine trial in the Democratic Republic of the Congo. (Preprint)

2021 ◽  
Author(s):  
Trésor Zola Matuvanga ◽  
Ginger Johnson ◽  
Ynke Larivière ◽  
Emmanuel Esanga ◽  
Junior Matangila-Rika ◽  
...  

BACKGROUND As part of an Ebola outbreak preparedness initiative, a partnership between the University of Antwerp and the University of Kinshasa, through an Innovative Medicines Initiative-European Union (project ‘EBOVAC 3’), implemented a clinical trial on an Ebola vaccine regimen to be administered to health care provider participants (HCP-P) in Tshuapa Province (Democratic Republic of the Congo). The EBOVAC3 clinical trial used iris scan technology to identify all HCP-P participating in the vaccine trial so the right participant received the right vaccine at the right visit. OBJECTIVE To assess the acceptability, accuracy and feasibility of iris scan technology as an identification method within a population of HCP-P in a vaccine trial in a remote setting. METHODS A mixed-method study was utilized. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and assessed at enrolment. Feasibility and accuracy research was conducted using a longitudinal trial study design where iris scanning was compared to the unique study ID card to identify HCP-P at enrolment, and at their follow-up visits. RESULTS During the FGDs, main concerns raised by HCP-P about the iris scan technology were that it may cause physical problems to their eyes or expose them to spiritual problems through sorcery. Though, 99.1% (95%CI: 97.1;100.0) of HCP-P in the FGDs agreed to be identified by the iris scan. Also, at enrolment 99.0% (95%CI:98.3; 99.7) HCP-P accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (95%CI:91.2; 95.0) of the participants returning for scheduled follow-up visits. Iris scanning operation lasted no more than 2 minutes 30 seconds for 96.0% (95%CI: 99.0;100.0) and one attempt was enough to identify the majority of study volunteers [69.5% (95% CI:66.1;73.0)]. CONCLUSIONS Iris scan is highly acceptable as an identification tool in a clinical trial in HCP-Ps. Its operationalization during the trial demonstrated a high-level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but it requires a trained operator in order to reduce the duration and the number of attempts to identify a participant.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046835
Author(s):  
Ynke Larivière ◽  
Trésor Zola ◽  
Elke Stoppie ◽  
Vivi Maketa ◽  
Junior Matangila ◽  
...  

IntroductionThis article describes the protocol of an Ebola vaccine clinical trial which investigates the safety and immunogenicity of a two-dose prophylactic Ebola vaccine regimen comprised of two Ebola vaccines (Ad26.ZEBOV and MVA-BN-Filo) administered 56 days apart, followed by a booster vaccination with Ad26.ZEBOV offered at either 1 year or 2 years (randomisation 1:1) after the first dose. This clinical trial is part of the EBOVAC3 project (an Innovative Medicines Initiative 2 Joint Undertaking), and is the first to evaluate the safety and immunogenicity of two different booster vaccination arms in a large cohort of adults.Methods and analysisThis study is an open-label, monocentric, phase 2, randomised vaccine trial. A total of 700 healthcare providers and frontliners are planned to be recruited from the Tshuapa province in the Democratic Republic of the Congo (DRC). The primary and secondary objectives of the study assess the immunogenicity of the first (Ad26.ZEBOV), second (MVA-BN-Filo) and booster (Ad26.ZEBOV) dose. Immunogenicity is assessed through the evaluation of EBOV glycoprotein binding antibody responses after vaccination. Safety is assessed through the collection of serious adverse events from the first dose until 6 months post booster vaccination and the collection of solicited and unsolicited adverse events for 1 week after the booster dose.Ethics and disseminationThe protocol was approved by the National Ethics Committee of the Ministry of Health of the DRC (n°121/CNES/BN/PMMF/2019). The clinical trial was registered on 4 December 2019 on ClinicalTrials.gov. Trial activities are planned to finish in October 2022. All participants are required to provide written informed consent and no study-related procedures will be performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.Trial registration numberNCT04186000; Pre-results.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Célestin Kaputu-Kalala-Malu ◽  
Eric Mafuta Musalu ◽  
Tim Walker ◽  
Olga Ntumba-Tshitenge ◽  
Steve Ahuka-Mundeke

Abstract Background Ebola Virus Disease (EVD) is a deadly and feared infectious disease, which can be responsible of debilitating physical and psychological sequelae in survivors including depression and anxiety disorders. Unfortunately, there are scarce data on survivor sequelae in Democratic Republic of the Congo. So this study assessed PTSD, depression and anxiety symptoms among EVD survivors enrolled in the follow-up program of the psychosocial care team of Beni town’s general hospital. Methods A cross-sectional study used consecutive sampling to recruit 144 Ebola virus disease survivors who came for follow up from October 23 to November 13; 2019. Basic socio-demographic data, presence of headache and short-term memory function were assessed. The Post-traumatic Checklist Scale and Hospital Anxiety and Depression Scale were used to assess psychological burden among participants. Descriptive statistics were used to summarized data and Pearson’s or likelihood chi-square were used to test association between psychiatric disorders and associated factors. Results The prevalence of PTSD, depression and anxiety was 24.3, 24.3 and 33.3% respectively. Being male (OR = 0.42, 95% CI: 0.16, 0.95, p = 0.049), suffering from persistent headache (OR = 2.62, 95% CI: 1.12, 6.14, p = 0.014), losing a loved one because of EVD (OR: 2.60, 95% CI: 1.11, 6.15, p = 0. 015) and being young − 18-24 years - (OR: 0. 261, 95% CI: 0. 08, 0.82, p = 0,026) were statistically associated with PTSD diagnosis. Having short-term memory impairment and suffering from persistent headache were statistically associated with depression and anxiety diagnoses (OR = 2.44, 95% CI: 1.03, 5.82, p = 0.026); (OR = 2.24, 95% CI: 1.04, 4.85, p = 0.025); (OR = 2.62, 95% CI: 1.12, 6.14, p = 0.014); (OR = 2.31, 95% CI: 1.06, 5.01, p = 0.020). Conclusion The prevalence of PTSD, depression and anxiety is high among EVD survivors. Development of specialized psychiatric services to sustain psychiatric and psychological health amongst survivors in the cultural context of the Eastern part of the DRC should be considered by the teams fighting against EVD in the DRC.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S609-S609
Author(s):  
Qaasim Mian ◽  
Kasereka Masumbuko Claude ◽  
Michael Hawkes

Abstract Background The current Ebola epidemic in Eastern Democratic Republic of the Congo (DRC) has surpassed 1,300 cases and 800 deaths. Social resistance is a major barrier to control efforts, and invites an exploration of community beliefs around Ebola and its origins. Methods Mixed-methods study, using focus group discussions (FGDs) with key community informants and a 19-item survey questionnaire broadly sampling the outbreak zone. Results Between 4 to 17 August, 2018, we conducted 4 FGDs (20 participants) and surveyed 286 community members across Eastern DRC. FGDs revealed a widespread rumor in Mangina early in the epidemic of two twins bewitched by their aunt after eating her cat, who developed bleeding symptoms and triggered the epidemic. However, this myth appeared to dissipate as the epidemic progressed and biomedical transmission became generally accepted (medical syncretism). In our survey, 6% of respondents endorsed supernatural origins of Ebola. This subgroup did not differ from other respondents in terms of knowledge of biomedical modes of transmission or resistant attitudes toward infection control measures, but was more likely to believe that traditional healers could cure Ebola. Wild animals of the forest were recognized as sources of the Ebola virus by 53% of survey respondents. Our findings suggest that skepticism and/or denial of the biomedical discourse, coupled with and mistrust and fear of ETUs may fuel “underground” transmission of Ebola outside western-style medical facilities, as patients seek care from traditional healers, who are ill-equipped to deal with a highly contagious biohazard. Conclusion A deeper understanding of beliefs around Ebola origins may illuminate strategies to engage communities in control efforts. Disclosures All authors: No reported disclosures.


1987 ◽  
Author(s):  
J Zahavi ◽  
S Zaltzman ◽  
E Firsteter ◽  
E Avrahami

A semi-quantitative RNP using 99Technetium macroaggregated albumin for the evaluation and follow-up of DVT and CVI has been developed. Values were assigned to the deep veins of the calf, knee, tigh and pelvis based upon the localization and the characteristics of the images obtained: stasis, hot spots and collateral circulation. A maximum score of 18 reflected complete thrombosis of all 4 segments. 208 patients (mean age 53.7 years, range 18-92), 161 of whom had a proven risk factor for DVT were studied. 99Technetium was injected into the dorsal foot vein of 407 limbs with appropriate tourniquets and early and late imaging of the limbs, pelvis and lungs was performed. In 48 patients, 83 limbs, X-ray contrast phlebography (CP) was also done. The mean RNP score was 4.1 units (range 0.4-18) and higher in the left than the right lower limb. It was mostly high in patients with proximal recurrent DVT or in DVT superimposed on CVI. The score was easy to follow and helpful in the assessment of the extent of DVT. It was particularly helpful in 3 instances. 1) Assessment of venous patency following anticoagulant therapy. 2) Estimation of recurrent DVT. 3) Differentiation of recent DVT from venous insufficiency. Overall RNP method had a sensitivity of 87.6%, a specificity of 54% and an accuracy of 64.8%. The sensitivity was similar in above & below-knee thrombi. Yet the specificity was higher in above-knee thrombi. The highest accuracy (87.3%) was observed in pelvic and groin thrombi. The distribution of thrombi on CP was 19% below the knee, 31% above it and 50% both above and below the knee. Pulmonary embolism (PE) was initially observed in 54 patients (26%) with no clinical evidence of DVT and therefore untreated. This high level is most probably related to the high incidence of proximal DVT in the patients. 181 patients were treated with heparin & coumadin and the RNP score was decreased to 3.6 units (range 0.4-8.8). PE occurred during treatment in 11 (6.1%) and recurrent DVT in 16 (8.8%) patients. CVI was observed in 23 patients before treatment and in another 24 patients (13.2%) after treatment. These results indicate that the RNP method is a simple, semi-quantitative and useful technique for the evaluation and follow-up of DVT and CVI. It is most helpful in the assessment of the extent of DVT. It is also a rapid, noninvasive and cost effective techniaue.


1996 ◽  
Vol 85 (01) ◽  
pp. 4-14
Author(s):  
J. Blommers ◽  
D.J. Kuik ◽  
L. Feenstra ◽  
P.D. Bezemer ◽  
E.S.M. De Lange-De Klerk

AbstractThe effects of homoeopathic medicines on children suffering from recurrent upper respiratory tract infection (URTI) were studied in a randomized double-blind placebo-controlled clinical trial conducted at the paediatric outpatients department of the university hospital of the Vrije Universiteit in Amsterdam from 1987 to 1992.The study was designed to meet both the requirements of proper homoeopathic practice and the current standards of a clinical trial. The purpose of a randomized placebo-controlled double-blind trial is to identify the effects of the agents under investigation by equalizing the effects of other factors that may influence outcome.The object of the trial, eligibility criteria, follow-up period, treatments and concurrent interventions, data collection and effect measures are discussed in the light of homoeopathic thinking.


Policy Papers ◽  
2008 ◽  
Vol 2008 (50) ◽  
Author(s):  

This paper raises and discusses issues related to how the Fund provides financial assistance to its members. It is part of the strategic review to ensure the Fund remains relevant and effective. The objective is not to increase Fund lending, but to make sure the Fund has the right instruments and policies to help all of its members—with appropriate protection of Fund resources—as they integrate into a world of growing and increasingly complex cross-border flows. Other institutions (including major central banks and the World Bank) also are retooling their lending instruments and in the process grappling with similar issues. The paper offers a high-level view of the issues and does not make specific policy proposals. Policy proposals will be presented in follow-up papers, some of which are planned for Board discussion later in 2008.


Author(s):  
Balingene KAHOMBO

This paper examines, from a legal and socio-economic perspective, how the right to development materializes its promises and realization in the Democratic Republic of the Congo (DRC). In this regards, it analyzes its incorporation in the Congolese legal order, defines its constituent elements, and the measures which have been adopted to implement the constitutional framework. It also identifies challenges to the right to development in the DRC and permissive conditions for its effective enjoyment. The main conclusion is that the right to development enshrined in the Congolese law remains more a matter of claims and aspirations than a tangible reality reflecting an increase in the quality of life of the Congolese people. Obstacles to the realization and enjoyment of the right to development include the adverse effects of capitalist liberalism, the extraversion of Congolese development policies, and the culture of predation which dates back to the colonial period. The Congolese leadership has a historic responsibility to trigger or impose the much needed change. This will require not only the integration of the DRC’s international commitments in its domestic development policies based on an internal dynamic putting Congolese at the center of every socio-economic initiative, but also a state which has effective authority over its territory to defend the rule of law, is more interventionist so as to stop the current intentional destruction of the country, and promotes ethical behaviours in public services.


2018 ◽  
Vol 17 (4) ◽  
pp. 472 ◽  
Author(s):  
Massimo Viviano ◽  
Clelia Miracco ◽  
Guido Lorenzini ◽  
Gennaro Baldino ◽  
Serena Cocca

Leiomyosarcoma (LMS) is a rare mesenchymal malignancy, of which 3–10% of cases occur in the head and neck region. We report a 22-year-old woman who was referred to the University Hospital of Siena, Italy, in 2016 with an ostensibly benign asymptomatic lump on the mandibular gingiva. The lesion grew rapidly, causing otalgia in the right ear. An excisional biopsy was performed and primary LMS was diagnosed histologically. Subsequently, the patient underwent radical re-excision of the perilesional mucosa, a partial bone resection and the extraction of four teeth. No recurrences or metastases were detectable at a 20-month follow-up. This report discusses the differential diagnosis of LMS with regards to other benign and malignant lesions and reviews the recent literature on primary and secondary oral LMS. Due to its innocuous clinical features—including its asymptomatic nature and presentation at a young age—this aggressive malignancy can go undetected; therefore, an early histopathological diagnosis is crucial.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Pitchou Mukaz Mbey ◽  
Olivier Mukuku ◽  
Willy Kalau Arung ◽  
Guylain Kitoko Tengu ◽  
Nasser Lubosha Amisi ◽  
...  

Introduction. Prostate cancer is currently a public health problem with a frequency that varies from country to country. This study aims to describe the epidemiological, clinical, and histopathological and outcome features of prostate cancer in Lubumbashi in the Democratic Republic of Congo. Materials and Methods. This was a descriptive longitudinal study of patients diagnosed with prostate cancer at the University Clinics of Lubumbashi. The study period was 3 years (2017 to 2019). Parameters studied were age and clinical, biological (PSA level, prostatic specific antigen), histopathological, and outcome features. Results. The mean age of patients was 68.7 years (range: 47 and 90 years). The 60 to 69 age group was the most affected (43.18%). Elderly subjects (≥60 years old) represented 89.77% of the cases (n = 79). Voiding disorders were the main reason for consultation in 55.68% of the cases. The mean PSA level was 133.7 ng/ml (range: 4 and 1564.5 ng/ml) at diagnosis and 125.4 ng/ml after 3 months of follow-up (range: 0.16 and 1782.1 ng/ml). Adenocarcinoma was the predominant histological type (100%). In prognosis, 31.82% of patients had a Gleason score greater than 7 and 59.10% had a high risk at the D’Amico risk classification for Prostate Cancer. Hormone therapy was administered alone in 75% of the cases and in combination with pulpectomy in 13.64% of the cases. The 3-year overall survival was 56.82%. Conclusion. Prostate cancer is frequent and has a poor outcome in our country. The establishment of an individual screening policy would be an undeniable advantage in improving the prognosis.


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