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Article ; Online: Anti-IgE Significantly Changes Circulating Interleukin-25, Vitamin-D and Interleukin-33 Levels in Patients with Allergic Asthma.

Yalcin, Arzu D / Uzun, Rusen

2019 Volume 25, Issue 35, Page(s) 3784–3795

Abstract: Background: Multi-center, randomized-controlled trials and observational studies have demonstrated that, in severe asthmatic patients receiving omalizumab treatment, the frequency of exacerbations, the number of urgent adverse events, and the need for ... ...

Abstract	Background: Multi-center, randomized-controlled trials and observational studies have demonstrated that, in severe asthmatic patients receiving omalizumab treatment, the frequency of exacerbations, the number of urgent adverse events, and the need for oral steroids tend to decrease. Materials and methods: This study included a total of 32 patients. The patients were divided into two groups as Group IA (pre-omalizumab) and Group IB (post-omalizumab). Serum IL-25 and IL-33 levels were measured and the number of emergency admissions, length of hospitalization (day), Asthma Control Test (ACT) scores, eosinophil cationic protein (ECP), and fractional exhaled nitric oxide (FeNO) value were analyzed. Results: ACT and FeNO values increased after omalizumab treatment, while IL-33, IL-25 levels decreased after the completion of omalizumab treatment. Furthermore, there was a weak, positive, and significant relationship between the changes in the ECP levels and IL-33 levels (r=0.38, p=0.03). Conclusion: To the best of our knowledge, this is the first study to compare circulating IL-25 and IL-33 levels with specific IgE synthesis in the literature. Multivariate correlation analysis showed that the changes in serum IL-33 levels were significantly correlated with the changes in the mite sIgE levels and length of hospital stay (Fmodel=11.2, p=0.01, r2=0.45). On the other hand, there was no significant relationship between the other variables and changes in the IL-25 levels.
MeSH term(s)	Adult ; Aged ; Anti-Asthmatic Agents/therapeutic use ; Antibodies, Anti-Idiotypic/therapeutic use ; Asthma/blood ; Female ; Humans ; Interleukin-17/blood ; Interleukin-33/blood ; Male ; Middle Aged ; Omalizumab/therapeutic use ; Treatment Outcome ; Vitamin D/blood
Chemical Substances	Anti-Asthmatic Agents ; Antibodies, Anti-Idiotypic ; Interleukin-17 ; Interleukin-33 ; anti-IgE antibodies ; Vitamin D (1406-16-2) ; Omalizumab (2P471X1Z11)
Language	English
Publishing date	2019-09-30
Publishing country	United Arab Emirates
Document type	Journal Article
ZDB-ID	1304236-1
ISSN	1873-4286 ; 1381-6128
ISSN (online)	1873-4286
ISSN	1381-6128
DOI	10.2174/1381612825666190930095725
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Challenges in Tuberculosis Clinical Trials in the Face of the COVID-19 Pandemic: A Sponsor's Perspective.

Rusen, I D

Tropical medicine and infectious disease

2020 Volume 5, Issue 2

Abstract: The COVID-19 pandemic has caused unforeseen and extreme changes in societal and health system functioning not previously experienced in most countries in a lifetime. The impact of the pandemic on clinical trials can be especially profound given their ... ...

Abstract	The COVID-19 pandemic has caused unforeseen and extreme changes in societal and health system functioning not previously experienced in most countries in a lifetime. The impact of the pandemic on clinical trials can be especially profound given their complexities and operational requirements. The STREAM Clinical Trial is the largest trial for MDR-TB ever conducted. Currently operating in seven countries, the trial had 126 participants on treatment and 312 additional participants in active follow up as of March 31, 2020. Areas of particular concern during this global emergency include treatment continuity, supply chain management and participant safety monitoring. This commentary highlights some of the challenges faced due to the pandemic and the steps taken to protect the safety of trial participants and the integrity of the trial.
Keywords	covid19
Language	English
Publishing date	2020-05-27
Publishing country	Switzerland
Document type	Journal Article
ISSN	2414-6366
ISSN (online)	2414-6366
DOI	10.3390/tropicalmed5020086
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Article: Protecting those who care for others.

Rusen, I D

Public health action

2018 Volume 7, Issue 4, Page(s) 244

Language	English
Publishing date	2018-01-12
Publishing country	France
Document type	Editorial
ISSN	2220-8372
ISSN	2220-8372
DOI	10.5588/pha.17.0110
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Challenges in Tuberculosis Clinical Trials in the Face of the COVID-19 Pandemic: A Sponsor's Perspective

Rusen, I D

Abstract	The COVID-19 pandemic has caused unforeseen and extreme changes in societal and health system functioning not previously experienced in most countries in a lifetime. The impact of the pandemic on clinical trials can be especially profound given their complexities and operational requirements. The STREAM Clinical Trial is the largest trial for MDR-TB ever conducted. Currently operating in seven countries, the trial had 126 participants on treatment and 312 additional participants in active follow up as of March 31, 2020. Areas of particular concern during this global emergency include treatment continuity, supply chain management and participant safety monitoring. This commentary highlights some of the challenges faced due to the pandemic and the steps taken to protect the safety of trial participants and the integrity of the trial.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #381912
Database	COVID19

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Article ; Online: Radiographic characteristics of rifampicin-resistant tuberculosis in the STREAM stage 1 trial and their influence on time to culture conversion in the short regimen.

Chiang, Chen-Yuan / Bern, Henry / Goodall, Ruth / Chien, Shun-Tien / Rusen, I D / Nunn, Andrew

BMC infectious diseases

2024 Volume 24, Issue 1, Page(s) 144

Abstract: Background: Stage 1 of the STREAM trial demonstrated that the 9 month (Short) regimen developed in Bangladesh was non-inferior to the 20 month (Long) 2011 World Health Organization recommended regimen. We assess the association between HIV infection and ...

Abstract	Background: Stage 1 of the STREAM trial demonstrated that the 9 month (Short) regimen developed in Bangladesh was non-inferior to the 20 month (Long) 2011 World Health Organization recommended regimen. We assess the association between HIV infection and radiographic manifestations of tuberculosis and factors associated with time to culture conversion in Stage 1 of the STREAM trial. Methods: Reading of chest radiographs was undertaken independently by two clinicians, and films with discordant reading were read by a third reader. Recording of abnormal opacity of the lung parenchyma included location (right upper, right lower, left upper, and left lower) and extent of disease (minimal, moderately-advanced, and far advanced). Time to culture conversion was defined as the number of days from initiation of treatment to the first of two consecutive negative culture results, and compared using the log-rank test, stratified by country. Cox proportional hazards models, stratified by country and adjusted for HIV status, were used to identify factors associated with culture conversion. Results: Of the 364 participants, all but one had an abnormal chest X-ray: 347 (95%) had opacities over upper lung fields, 318 (87%) had opacities over lower lung fields, 124 (34%) had far advanced pulmonary involvement, and 281 (77%) had cavitation. There was no significant association between HIV and locations of lung parenchymal opacities, extent of opacities, the presence of cavitation, and location of cavitation. Participants infected with HIV were significantly less likely to have the highest positivity grade (3+) of sputum culture (p = 0.035) as compared to participants not infected with HIV. Cavitation was significantly associated with high smear positivity grades (p < 0.001) and high culture positivity grades (p = 0.004) among all participants. Co-infection with HIV was associated with a shorter time to culture conversion (hazard ratio 1.59, 95% CI 1.05-2.40). Conclusions: Radiographic manifestations of tuberculosis among the HIV-infected in the era of anti-retroviral therapy may not differ from that among those who were not infected with HIV. Radiographic manifestations were not consistently associated with time to culture conversion, perhaps indicating that the Short regimen is sufficiently powerful in achieving sputum conversion across the spectrum of radiographic pulmonary involvements. Trial registration: ISRCTN ISRCTN78372190. Registered 14/10/2010. The date of first registration 10/02/2016.
MeSH term(s)	Humans ; Antitubercular Agents/therapeutic use ; HIV Infections/complications ; HIV Infections/drug therapy ; Myocardial Infarction ; Rifampin/therapeutic use ; Sputum ; Tuberculosis, Multidrug-Resistant/drug therapy ; Tuberculosis, Pulmonary/diagnostic imaging ; Tuberculosis, Pulmonary/drug therapy
Chemical Substances	Antitubercular Agents ; Rifampin (VJT6J7R4TR)
Language	English
Publishing date	2024-01-30
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	2041550-3
ISSN	1471-2334 ; 1471-2334
ISSN (online)	1471-2334
ISSN	1471-2334
DOI	10.1186/s12879-024-09039-z
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Article ; Online: Challenges in Tuberculosis Clinical Trials in the Face of the COVID-19 Pandemic

I.D. Rusen

Tropical Medicine and Infectious Disease, Vol 5, Iss 86, p

A Sponsor’s Perspective

2020 Volume 86

Abstract	The COVID-19 pandemic has caused unforeseen and extreme changes in societal and health system functioning not previously experienced in most countries in a lifetime. The impact of the pandemic on clinical trials can be especially profound given their complexities and operational requirements. The STREAM Clinical Trial is the largest trial for MDR-TB ever conducted. Currently operating in seven countries, the trial had 126 participants on treatment and 312 additional participants in active follow up as of March 31, 2020. Areas of particular concern during this global emergency include treatment continuity, supply chain management and participant safety monitoring. This commentary highlights some of the challenges faced due to the pandemic and the steps taken to protect the safety of trial participants and the integrity of the trial.
Keywords	MDR-TB ; clinical trials ; COVID-19 ; Medicine ; R
Language	English
Publishing date	2020-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Implementation challenges and lessons learned from the STREAM clinical trial-a survey of trial sites.

Patel, Leena N / Gurumurthy, Meera / Bronson, Gay / Sanders, Karen / Rusen, I D

Trials

2023 Volume 24, Issue 1, Page(s) 51

Abstract: Background: Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and ... ...

Abstract	Background: Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and different regulatory requirements. STREAM was an MDR-TB clinical trial that recruited over 1000 participants. We documented challenges and best practices/lessons learned from the site perspective to improve implementation of future trials. Methods: We conducted a voluntary survey of trial staff at all sites to obtain information on challenges encountered and best practices/lessons learned from implementation of the STREAM trial. Respondents were asked to identify substantive aspects of trial implementation from a list that included: trial administration, laboratory strengthening/infrastructure, pharmacy and supply chain management, community engagement, regulatory and ethics requirements, health economics, and other (respondent designated) about which a practical guide would be useful to improve future trial implementation. For each aspect of trial implementation selected, respondents were asked to report challenges and best practices/lessons learned during STREAM. Lastly, respondents were asked to list up to three things they would do differently when implementing future trials. Summary statistics were generated for quantitative data and thematic analysis was undertaken for qualitative data. Results: Of 67 responses received from 13 of 15 sites, 47 (70%) were included in the analyses, after excluding duplicate or incomplete responses. Approximately half the respondents were investigators or trial coordinators. The top three aspects of trial implementation identified for a best practices/lessons learned practical guide to improve future trial implementation were: trial administration, community engagement, and laboratory strengthening/infrastructure. For both challenges and best practices/lessons learned, three common themes were identified across different aspects of trial implementation. Investment in capacity building and ongoing monitoring; investment in infrastructure and well-designed trial processes; and communication and coordination between staff and meaningful engagement of stakeholders were all thought to be critical to successful trial implementation. Conclusions: Existing practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation.
MeSH term(s)	Humans ; Surveys and Questionnaires ; Tuberculosis, Multidrug-Resistant
Language	English
Publishing date	2023-01-23
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07068-8
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Psychological and social impact and lifestyle changes among pregnant women of COVID-19 pandemic: A qualitative study.

Güner, Özlem / Öztürk, Ruşen

Archives of psychiatric nursing

2021 Volume 36, Page(s) 70–77

Abstract: ... change in social life, (d) psychological effects of the pandemic and methods for coping with them. Also, 14 sub ...

Abstract	Purpose: This study aimed to examine the challenges faced by pregnant women and their daily life activities during the COVID-19 pandemic, to assess the psychological impacts of the pandemic and their expectations to improve women's mental health, thereby increasing the awareness of healthcare professionals of the subject. Methods: The research was conducted with the participation of 30 pregnant women, who were selected by purposive sampling using the phenomenological approach, between 15 June 2020 and 15 August 2020. Telephone interviews were conducted with pregnant women due to social isolation measures during the Coronavirus pandemic. Results: In the study, the following four themes were determined: (a) measures taken against the pandemic, (b) problems regarding the antenatal period during the pandemic, (c) gestation period and change in social life, (d) psychological effects of the pandemic and methods for coping with them. Also, 14 sub-themes were determined regarding these themes. Conclusion: The results of the study revealed that the pandemic had multidimensional impacts on pregnant women, including their social life and physical health. Psychologically, it caused many negative emotional states, particularly concerns and fears. During the pandemic, healthcare professionals should be aware of the needs of pregnant women and plan protective and informative interventions for both their physiological and psychological health.
MeSH term(s)	COVID-19 ; Female ; Humans ; Life Style ; Pandemics ; Pregnancy ; Pregnant Women ; SARS-CoV-2 ; Social Change
Language	English
Publishing date	2021-12-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639197-7
ISSN	1532-8228 ; 0883-9417
ISSN (online)	1532-8228
ISSN	0883-9417
DOI	10.1016/j.apnu.2021.12.005
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Article ; Online: Building the evidence base for shortened MDR-TB treatment regimens.

Rusen, I D / Chiang, Chen-Yuan

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

2018 Volume 22, Issue 1, Page(s) 1–2

MeSH term(s)	Africa ; Antitubercular Agents ; Clinical Protocols ; Humans ; Treatment Outcome ; Tuberculosis, Multidrug-Resistant
Chemical Substances	Antitubercular Agents
Language	English
Publishing date	2018-01-02
Publishing country	France
Document type	Editorial ; Comment
ZDB-ID	1385624-8
ISSN	1815-7920 ; 1027-3719
ISSN (online)	1815-7920
ISSN	1027-3719
DOI	10.5588/ijtld.17.0776
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Article ; Online: Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

Leena N. Patel / Meera Gurumurthy / Gay Bronson / Karen Sanders / I. D. Rusen

Trials, Vol 24, Iss 1, Pp 1-

2023 Volume 10

Abstract: Abstract Background Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and ... ...

Abstract	Abstract Background Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and different regulatory requirements. STREAM was an MDR-TB clinical trial that recruited over 1000 participants. We documented challenges and best practices/lessons learned from the site perspective to improve implementation of future trials. Methods We conducted a voluntary survey of trial staff at all sites to obtain information on challenges encountered and best practices/lessons learned from implementation of the STREAM trial. Respondents were asked to identify substantive aspects of trial implementation from a list that included: trial administration, laboratory strengthening/infrastructure, pharmacy and supply chain management, community engagement, regulatory and ethics requirements, health economics, and other (respondent designated) about which a practical guide would be useful to improve future trial implementation. For each aspect of trial implementation selected, respondents were asked to report challenges and best practices/lessons learned during STREAM. Lastly, respondents were asked to list up to three things they would do differently when implementing future trials. Summary statistics were generated for quantitative data and thematic analysis was undertaken for qualitative data. Results Of 67 responses received from 13 of 15 sites, 47 (70%) were included in the analyses, after excluding duplicate or incomplete responses. Approximately half the respondents were investigators or trial coordinators. The top three aspects of trial implementation identified for a best practices/lessons learned practical guide to improve future trial implementation were: trial administration, community engagement, and laboratory strengthening/infrastructure. For both challenges and best practices/lessons learned, three common themes were identified across different aspects ...
Keywords	MDR-TB ; Trial implementation ; Challenges ; Lessons learned ; Best practices ; Site perspective ; Medicine (General) ; R5-920
Subject code	380
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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