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

2019 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Cross Sectional ◽  
Data Set ◽  
Study Type ◽  
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, countries, retrospective 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. We will separately report the results from interventional and other studies. Inclusion criteria for interventional studies will be studies that include the word “intervention” or “interventional” in “study type” of the data set. Other studies will refer to studies other than interventional studies such as cohort, case-control, and cross-sectional studies. 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 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

2019 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Cross Sectional ◽  
Data Set ◽  
Study Type ◽  
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, countries, retrospective 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. We will separately report the results from interventional and other studies. Inclusion criteria for interventional studies will be studies that include the word “intervention” or “interventional” in “study type” of the data set. Other studies will refer to studies other than interventional studies such as cohort, case-control, and cross-sectional studies. 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 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 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 Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

scholarly journals A novel telerehabilitation with educational program for caregivers using telelecture is a feasible procedure for fall prevention in elderly people – A pilot study

2020 ◽  
Author(s):  
Kentaro Moriichi ◽  
Mikihiro Fujiya ◽  
Takanori Ro ◽  
Tetsuo Ota ◽  
Hitomi Nishimiya ◽  
...  
Keyword(s):  
Elderly People ◽  
Fall Prevention ◽  
Educational Program ◽  
Medical Information ◽  
The Elderly ◽  
Berg Balance Scale ◽  
University Hospital ◽  
Telemedicine System ◽  
Before And After ◽  
Clinical Trials Registry

Abstract Background: The importance of fall prevention rehabilitations has been well recognized. Recently, telerehabilitation was developed, however, there have been no reports on the use of telerehabilitation with direct support from specialists for fall prevention among the elderly. We herein reported telerehabilitation by carers educated by our novel educational program.Methods: Nine elderly people in two nursing homes were enrolled using our original criteria. Carers are educated with our educational program using telelecture system. Telerehabilitation was performed by carers following the instruction from rehabilitation specialists in Asahikawa Medical University using the telemedicine system every 2-4 weeks for three months. Carers were assessed with our original questionnaire before and after the telelecture. Berg Balance Scale (BBS), Timed Up & Go test (TUG test), Hand-held dynamometer (HHD) and Mini-Mental State Examination (MMSE) were assessed before and after telerehabilitation.Results: The average number of times to perform telerehabilitation in all institutes was 4.7. Levels of understanding of carers were significantly increased after the telelecture. No adverse event occurred during the study period. Median BBSs before and three months after telerehabilitation were 43 and 49, respectively. Those of TUG test, right and left HHD and MMSE were 17.89 and 18.53, 7.95 and 11.55, 9.85 and 13.20, and 16 and 19, respectively. All results were improved after telerehabilitation.Conclusions: Our telerehabilitation program exhibited significant effects in elderly people as well as levels of understanding rehabilitation of caregivers in the facilities for the elderly people safely.Trial registration: University Hospital Medical Information Network Clinical Trials Registry（UMIN-CTR）UMIN000041439, August 17th, 2020

scholarly journals The role of body temperature on respiratory rate in children with acute respiratory infections

2021 ◽  
Vol 21 (2) ◽  
pp. 640-646
Author(s):  
Beril Ozdemır ◽  
Sıddıka Songül Yalçın
Keyword(s):  
Body Temperature ◽  
Respiratory Rate ◽  
Respiratory Infections ◽  
Severe Pneumonia ◽  
University Hospital ◽  
World Health ◽  
Acute Respiratory Infections ◽  
Low Oxygen ◽  
Cross Sectional ◽  
The Relationship

Background: The World Health Organization (WHO) recommends the use of tachypnea as a proxy to the diagnosis of pneumonia. Objective: The purpose of this study was to examine the relationship between body temperature alterations and respiratory rate (RR) difference (RRD) in children with acute respiratory infections(ARI). Methods:This cross-sectional study included 297 children with age 2-60 months who presented with cough and fever at the pediatric emergency and outpatient clinics in the Department of Pediatrics, Baskent University Hospital, from January 2016 through June 2018. Each parent completed a structured questionnaire to collect background data. Weight and height were taken. Body temperature, respiratory rate, presence of the chest indrawing, rales, wheezing and laryngeal stridor were also recorded. RRD was defined as the differences in RR at admission and after 3 days of treatment. Results: Both respiratory rate and RRD were moderately correlated with body temperature (r=0.71, p<0.001 and r=0.65, p<0.001; respectively). For every 1°C increase in temperature, RRD increased by 5.7/minutes in overall, 7.2/minute in the patients under 12 months of age, 6.4/minute in the female. The relationship between body temperature and RRD wasn’t statistically significant in patients with rhonchi, chest indrawing, and low oxygen saturation. Conclusion: Respiratory rate should be evaluated according to the degree of body temperature in children with ARI. How- ever, the interaction between body temperature and respiratory rate could not be observed in cases with rhonchi and severe pneumonia. Keywords: Fever; tachypnea; pneumonia; respiratory rate difference; children.

Comparison of two fluoroscopic images to ensure efficient scope insertion for biliary intervention in patients with Roux-en-Y hepaticojejunostomy

Endoscopy ◽  
2017 ◽  
Vol 49 (12) ◽  
pp. 1256-1261 ◽  
Author(s):  
Koichiro Tsutsumi ◽  
Hironari Kato ◽  
Ken Hirao ◽  
Sho Mizukawa ◽  
Shinichiro Muro ◽  
...  
Keyword(s):  
Medical Information ◽  
Standard Procedure ◽  
University Hospital ◽  
Information Network ◽  
Imaging Method ◽  
Anastomotic Site ◽  
Biliary Disease ◽  
Endoscopic Retrograde ◽  
Time Required ◽  
Clinical Trials Registry

Abstract Background and study aims No standard procedure for endoscopic retrograde cholangiopancreatography is available for patients with Roux-en-Y hepaticojejunostomy (RYHJ) with side-to-end hepaticojejunostomy. We therefore explored methods of efficient scope insertion at a hepaticojejunostomy site. Patients and methods Patients with suspected biliary disease were prospectively enrolled. Based on two fluoroscopic images obtained on scope insertion into each lumen of a two-pronged Roux-en-Y anastomosis, we selected the lumen in which the distal end of the scope progressed toward the patient’s liver or head. The accuracy of this method for selecting the correct lumen leading to the hepaticojejunostomy site was investigated. Results Of the 33 included patients, successful insertion to the hepaticojejunostomy site was achieved in 32 (97 %), 26 (81 %) of whom had undergone the imaging method. The accuracy of the method was 88 % (23/26). The time required for insertion between the anastomotic site and the hepaticojejunostomy site was shorter when the lumen selection had been correct (13 minutes [7 – 30] (n = 23) vs. 18 minutes [8 – 28] (n = 9); P = 0.95). Conclusion This method based on two fluoroscopic images was useful for achieving efficient scope insertion in patients with RYHJ.Trial registered at University Hospital Medical Information Network Clinical Trials Registry (UMIN000014183).

scholarly journals Preparedness Assessment of Physicians during Coronavirus Disease-19 Pandemic: A Cross-sectional Study

2021 ◽  
Vol 9 (E) ◽  
pp. 179-186
Author(s):  
Eman Moawad Elhabashi ◽  
Reham Farouk Tawfik ◽  
Fatma Maamoun Abou-Hashima ◽  
Arwa Mohamed El Shafei ◽  
Fayrouz El-Aguizy
Keyword(s):  
Health Care ◽  
Knowledge Score ◽  
University Hospital ◽  
World Health ◽  
Infection Prevention And Control ◽  
Attitude Score ◽  
Global Public Health ◽  
Cross Sectional ◽  
Health Crisis ◽  
Attitudes And Practices

BACKGROUND: Since first confirmed case of coronavirus disease (COVID)-19 in December 2019 by Chinese health authorities and subsequent World Health Organization (WHO) declaration that COVID-19 is a global public health crisis, radical changes have occurred all over the world associating massive lockdown with increased numbers of infected cases and related mortalities. As health care workers (HCWs) are at a great risk to get COVID-19 infection and hence can be a dangerous source of spreading it to the community, it was important to assess HCWs knowledge, attitude, and practice toward COVID-19 infection prevention and control (IPC) to help limit the outcomes of COVID-19. AIM: The objectives of the study were to assess the knowledge, attitudes, and practices of physicians regarding COVID-19 IPC. METHODS: Research setting is “Kasr Al-Ainy” Faculty of Medicine, Cairo University Hospital. Design: A cross-sectional analytical observational hospital-based research in June 2020. Population: A convenient sample of 50 physicians working at Cairo University Hospital was included. Data collection: Self-administered questionnaires derived from the WHO IPC guide during health care when COVID-19 is suspected were used. RESULTS: Mean age of studied group was 30.5 ± 3.97, while their mean years of practice were 4.7 ± 3.55. Mean knowledge score among physicians was 5.6 (± 0.56), two-thirds of them had sufficient knowledge regarding COVID-19 IPC as their mean attitude score among 24.9 (± 2.8). While mean practice scores 5.6 (± 1.05), yet only 68% of the participating physicians use a new set of personal protective equipment when care is given to a different patient. CONCLUSION: Physician’s moderate knowledge, poor attitude, and modest practice toward COVID-19 IPC were found to be not sufficient, not favorable nor safe enough to expected standards.

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