scholarly journals Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries

2020 ◽  
Vol 37 (08) ◽  
pp. 792-799 ◽  
Author(s):  
Devin D. Smith ◽  
Jessica L. Pippen ◽  
Adebayo A. Adesomo ◽  
Kara M. Rood ◽  
Mark B. Landon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
World Health ◽  
Eligibility Criteria ◽  
Current State ◽  
Key Points ◽  
State Of Research ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Clinical Trials Registry

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Trialstreamer: A living, automatically updated database of clinical trial reports

2020 ◽  
Vol 27 (12) ◽  
pp. 1903-1912 ◽  
Author(s):  
Iain J Marshall ◽  
Benjamin Nye ◽  
Joël Kuiper ◽  
Anna Noel-Storr ◽  
Rachel Marshall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Automated System ◽  
World Health ◽  
Free Text ◽  
Medical Subject Headings ◽  
Gold Standard Method ◽  
Structured Information ◽  
Health Organization ◽  
Clinical Queries ◽  
Clinical Trials Registry

Abstract Objective Randomized controlled trials (RCTs) are the gold standard method for evaluating whether a treatment works in health care but can be difficult to find and make use of. We describe the development and evaluation of a system to automatically find and categorize all new RCT reports. Materials and Methods Trialstreamer continuously monitors PubMed and the World Health Organization International Clinical Trials Registry Platform, looking for new RCTs in humans using a validated classifier. We combine machine learning and rule-based methods to extract information from the RCT abstracts, including free-text descriptions of trial PICO (populations, interventions/comparators, and outcomes) elements and map these snippets to normalized MeSH (Medical Subject Headings) vocabulary terms. We additionally identify sample sizes, predict the risk of bias, and extract text conveying key findings. We store all extracted data in a database, which we make freely available for download, and via a search portal, which allows users to enter structured clinical queries. Results are ranked automatically to prioritize larger and higher-quality studies. Results As of early June 2020, we have indexed 673 191 publications of RCTs, of which 22 363 were published in the first 5 months of 2020 (142 per day). We additionally include 304 111 trial registrations from the International Clinical Trials Registry Platform. The median trial sample size was 66. Conclusions We present an automated system for finding and categorizing RCTs. This yields a novel resource: a database of structured information automatically extracted for all published RCTs in humans. We make daily updates of this database available on our website (https://trialstreamer.robotreviewer.net).

scholarly journals Analysis of the Registration Information on Interventions of Acupuncture and Moxibustion Trials in the International Clinical Trials Registry Platform

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Yali Liu ◽  
Wenjie Chen ◽  
Yingxin Tan ◽  
Xingyue Yang ◽  
Jia Liu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sham Acupuncture ◽  
World Health ◽  
Control Group ◽  
Duration Of Treatment ◽  
Acupuncture And Moxibustion ◽  
Health Organization ◽  
Number Of Treatment ◽  
Clinical Trials Registry

Purpose. To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention characteristics. Methods. Clinical trials from the International Clinical Trials Registry Platform of the World Health Organization in acupuncture and moxibustion were comprehensively collected from 2013 to 2015; data were independently screened and extracted by two retrievers, and relevant data involving either basic descriptions or intervention characteristics were analyzed. Results. 425 acupuncture and moxibustion registered clinical trials were included; 88.00% (374/425) were designed as controlled studies, among which 38.59% (164/425) had sham acupuncture as the control group. The most common diseases were pain-related at approximately 19.29% (82/425) of trials. Reports on the intervention information in these acupuncture and moxibustion clinical studies were not sufficiently presented; these reports included the reporting of names of points (39.8%), the method of needle stimulation (32.5%), needle type (29.6%), needle retention time (34.1%), the number of treatment sessions (22.4%), and the frequency and duration of treatment sessions (38.1%). Conclusion. The registration information for the clinical trials of acupuncture and moxibustion was quite low according to this investigational study. Steps should be taken to improve the quality of acupuncture and moxibustion registration information.

scholarly journals Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19

2020 ◽  
Author(s):  
Mahir Fidahic ◽  
Danijela Nujic ◽  
Renata Runjic ◽  
Marta Civljak ◽  
Filipa Markotic ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Reports ◽  
Original Data ◽  
World Health ◽  
Journal Articles ◽  
Scholarly Journals ◽  
Trial Protocols ◽  
Reported Study ◽  
Health Organization ◽  
Clinical Trials Registry

Abstract Background The research community reacted rapidly to the emergence of COVID-19. We aimed to assess characteristics of journal articles, preprint articles, and registered trial protocols about COVID-19 and its causal agent SARS-CoV-2.Methods We analyzed characteristics of journal articles with original data indexed by March 19, 2020, in World Health Organization (WHO) COVID-19 collection, articles published on preprint servers medRxiv and bioRxiv by April 3, 2010. Additionally, we assessed characteristics of clinical trials indexed in the WHO International Clinical Trials Registry Platform (WHO ICTRP) by April 7, 2020.Results Among the first 2118 articles on COVID-19 published in scholarly journals, 533 (25%) contained original data. The majority was published by authors from China (75%) and funded by Chinese sponsors (75%); a quarter was published in the Chinese language. Among 312 articles that self-reported study design, the most frequent were retrospective studies (N = 88; 28%) and case reports (N = 86; 28%), analyzing patients’ characteristics (38%). Median Journal Impact Factor of journals where articles were published was 5.099.

scholarly journals Clinical characteristics, management, maternal and neonatal outcome among seven severe and critically ill pregnant women with COVID-19 pneumonia

2020 ◽  
Vol 3 (2) ◽  
pp. 158-166
Author(s):  
Hazari Komal Sundeep ◽  
Paulose Litty ◽  
Kurien Nimmi ◽  
Mohammad Hozaifah ◽  
A Elgergawi Taghrid Faek ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Clinical Characteristics ◽  
Case Series ◽  
Fetal Outcome ◽  
World Health ◽  
Investigational Therapies ◽  
Serious Disease ◽  
Novel Coronavirus ◽  
Health Organization ◽  
In Pregnancy

Pneumonia caused by the Novel coronavirus disease 2019 (COVID-19) is a highly infectious disease and the ongoing outbreak has been declared as a Pandemic by the World health organization. Pneumonia is a serious disease in pregnancy and requires prompt attention. Viral pneumonia has higher morbidity and mortality compared to bacterial pneumonia in pregnancy. All efforts are well exerted to understand the newly emerged disease features but still some areas are gray. The treatment is primarily supportive with antivirals, steroids, anticoagulation and antibiotics for secondary bacterial infection. Severe cases require intensive care monitoring with oxygen support, mechanical ventilation. Investigational therapies include convalescent plasma, cytokine release inhibitors and other immunomodulatory agents like interferons. The mortality appears driven by the presence of severe Adult Respiratory Syndrome (ARDS) and organs failure. COVID pandemic is a challenging and stressful socio-economic situation with widespread fear of infection, disease and death. In the specialty of obstetrics and gynecology, studies are being conducted to ascertain the manifestation of disease in pregnant women and the fetal outcome. The aim of our case series is to describe the demographics, clinical characteristics, laboratory and radiological findings, feto- maternal outcome of severe and critical COVID pneumonia in pregnant women in Latifa Hospital.

scholarly journals Pregnancy and COVID-19, a brief review

2020 ◽  
Vol 5 ◽  
Author(s):  
Olga Vasylyeva
Keyword(s):  
Risk Factors ◽  
Pregnant Women ◽  
World Health ◽  
Virus Spread ◽  
Resource Center ◽  
The Us ◽  
The World ◽  
Total Death ◽  
Novel Coronavirus ◽  
Health Organization

COVID-19 is a novel coronavirus capable of causing a severe acute respiratory syndrome. First identified in December 2019 in Wuhan, China, the virus spread around the world and is characterized as a pandemic by the World Health Organization. According to Johns Hopkins Coronavirus Resource Center, presently total confirmed cases mounted 156,400 with total death of 5,833 around the world, among them 2,952 cases in the US and 57 deaths.  This article summarizes what is presently known about COVID-19 infection in pregnant women, and review unique risk factors for severity of viral illnesses among pregnant women.

Nowe surowce roślinne w Farmakopei Europejskiej. Część I. Gatunki rodzaju Bupleurum (przewiercień) – źródło nowego surowca saponinowego

2018 ◽  
Vol 19 (4) ◽  
Author(s):  
Halina Ekiert ◽  
Agnieszka Sondej ◽  
Marta Klimek-Szczykutowicz ◽  
Radosław J. Ekiert ◽  
Agnieszka Szopa
Keyword(s):  
Raw Materials ◽  
Raw Material ◽  
Basic Knowledge ◽  
World Health ◽  
Current State ◽  
Cosmetic Industry ◽  
Herbal Medicinal ◽  
State Of Research ◽  
Health Organization ◽  
Bupleuri Radix

One of the last supplements to the European Pharmacopoeia (Supl. 9.4) introduces several new herbal medicinal raw materials, so far unknown and not used in official Central European phytotherapy. The article describes plant species from Bupleurum genus providing new saponin raw material. The botanical and ecological characteristics as well as the current state of research on the chemistry of pharmacopoeial species from that genus were presented. The confirmed by scientific researches therapeutic applications of plant raw material – Bupleuri radix, were described particularly. Attention was paid to the position of that raw material in Traditional Chinese Medicine (TCM). It was emphasized that for about 20 years, it has had the World Health Organization (WHO) monograph. In addition, the importance of this plant in the food industry and its increasing status in the cosmetic industry were pointed. The aim of the article is the popularization of basic knowledge about pharmacopoeial species from Bupleurum genus in the Polish pharmaceutical, medical and phytotherapeutical environment.

scholarly journals A systemic review of clinical trials of COVID-19, registered in WHO-ICTRP

2020 ◽  
Vol 7 (3) ◽  
pp. 212
Author(s):  
Suyog Vyas ◽  
Kartiki S. Vyas
Keyword(s):  
Clinical Trials ◽  
Primary Outcome ◽  
World Health ◽  
Systemic Review ◽  
Plasma Therapy ◽  
Global Response ◽  
Treatment And Prevention ◽  
Health Organization ◽  
Study Type ◽  
Clinical Trials Registry

<p class="abstract">In September 2004, International Commission of Medical Journal Editors implemented a dramatic and important policy for the condition of publication of clinical trials. The condition was that clinical trials must be registered in a public trial registry. World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP) is the globally centralised network composed of primary registries and partner registries along with data providers. COVID-19 is a pandemic and a significant social and economical health burden. In this event numbers of trials have been undertaken by the medical professionals and research workers in every part of the world. Here we have analysed registered clinical trials for the detection, treatment and prevention of COVID-19 to provide a summary of global response w.s.r.to WHO-ITCRP. The objective of this study was to collect the data of registered clinical trials for the therapeutic and preventive measures for COVID-19 which are registered in WHO-ICTRP and analyse global response of COVID-19. WHO-ITCRP database has 20 fields of mapping. Out of these, we have analysed 6 fields of this registry, for this study purpose: public title, scientific title, study type, countries, intervention and primary outcome. Clinical trials are focused on chloroquine, hydroxychloroquine, lopinavir ritonavir combination, Remdesivir, Favipiravir, Tocilizumab and Interferon. Also, it is seen that convalescent plasma therapy is a promising intervention. Observational trials are directed mainly on the clinical features and distinguish COVID-19 from other influenza like illnesses.</p>

scholarly journals The Efficacy of Acupuncture in Chemotherapy-Induced Peripheral Neuropathy: Systematic Review and Meta-Analysis

2019 ◽  
Vol 18 ◽  
pp. 153473541988666 ◽  
Author(s):  
Tsai-Ju Chien ◽  
Chia-Yu Liu ◽  
Ching-Ju Fang ◽  
Chun-Yu Kuo
Keyword(s):  
Clinical Trials ◽  
Peripheral Neuropathy ◽  
Meta Analysis ◽  
Functional Limitation ◽  
World Health ◽  
China National Knowledge Infrastructure ◽  
Knowledge Infrastructure ◽  
Jadad Scale ◽  
Health Organization ◽  
Clinical Trials Registry

Background: Chemotherapy-induced peripheral neuropathy (CIPN) has no cure, but acupuncture may provide relief through its known neuromodulation or neuroendocrine adjustment. This review aimed to assess the efficacy of acupuncture in treating CIPN. Method: A literature review following the PRISMA Statement was performed, searching 7 databases from inception through August 2019. All studies were clinical trials of the effect of acupuncture on CIPN. The methodological quality of these trials was assessed using Cochrane criteria; meta-analysis software (RevMan 5.2) was used to analyze the data. Data Sources: The databases searched were the following: MEDLINE (Ovid), Embase, Cochrane CENTRAL, Scopus, World Health Organization International Clinical Trials Registry Platform, CNKI (China National Knowledge Infrastructure), and Wanfang Med Online. Results: We examined 386 cancer patients from 6 randomized control trials, which had high quality, based on the modified Jadad scale. Meta-analysis showed that acupuncture led to significant improvements in pain scores (−1.21, 95% confidence interval [CI] = −1.61 to −0.82, P < .00001) and nervous system symptoms based on Functional Assessment of Cancer Therapy/Neurotoxicity questionnaire scores (−2.02, 95% CI = −2.21 to −1.84, P < .00001). No significant change was noted in nerve conduction velocity (1.58, 95% CI = −2.67 to 5.83, P = .47). Conclusion: Acupuncture can effectively relieve CIPN pain and functional limitation. The limited number of subjects warrants a larger scale study.

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