scholarly journals Critical appraisal of fundamental items in approved clinical trial research proposals in Mashhad University of Medical Sciences

2017 ◽  
Vol 31 (1) ◽  
pp. 424-427
Author(s):  
Mohammad-Taghi Shakeri ◽  
Ali Taghipour ◽  
Masoumeh Sadeghi ◽  
Hossein Nezami ◽  
Ali-Reza Amirabadizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Critical Appraisal ◽  
Medical Sciences ◽  
Clinical Trial Research

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

A Critical Appraisal of Assessment and Evaluation Reforms At Datta Meghe Institute of Medical Sciences (Deemed to be University) From 2006 Till 2017: A Study Protocol (Preprint)

2020 ◽  
Author(s):  
Dr. Priyanka Jaiswal ◽  
Dr. Ved Prakash Mishra ◽  
Dr. Minal Chaudhary ◽  
Dr. Sunita Vagha ◽  
Dr. Sachin Damke ◽  
...  
Keyword(s):  
Study Protocol ◽  
Critical Appraisal ◽  
Evaluation Process ◽  
Outcome Analysis ◽  
Medical Sciences ◽  
User Friendliness ◽  
Assessment And Evaluation ◽  
Need Analysis ◽  
The University ◽  
Regulations And Guidelines

UNSTRUCTURED DattaMeghe Institute of Medical Sciences has been declared as Deemed to be University [DMIMS (DU)] under section 3 of UGC Act, 1996 in the year 2005. The University examinations are conducted as per the rules, regulations and guidelines issued by the various Apical councils of India from time to time. The first University exam was conducted in the year 2006. DMIMS (DU) has initiated various reforms by its own in assessment and evaluation process based on needs. For any system to thrive, it needs to be constantly upgraded and critically evaluated. Therefore, a study is undertaken with this in mind and thereby aimed at evaluation and validation of the assessment and evaluation reforms formulated and implemented at DMIMS (DU) since its inception (year 2006).Need analysis for the assessment and evaluation reforms will be carried out on the basis of feedbacks and reports received from respective stakeholders (Students, Faculty and External examiners) from time to time. Outcome analysis of the Feedbacks and reports will be done subsequently after the implementation of the assessment and evaluation reforms. Further based on the outcome analysis, reforms will be validated into following parameters: Objectivity, Responsiveness, User friendliness, Residual component (not covered in above 3 parameters)and a satisfactory index will be derived. If satisfactory index for reform is 100%, it will be concluded that reforms are well received and good to excellent in nature. Total 33 assessment and evaluation reforms have beenimplemented since year 2006. These reforms will be categorised into Pre-Examination (n=18), On Site Examination (n=05) and Post Examination (n=10), and in each category, they will befurther classified into academic (Total =15) and administrative (Total = 18) on the basis of their domain for the ease of structuring and implementation.All the 33 reforms will be validated on the basis of defined parameters. They will be found satisfactory.

scholarly journals Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Helda Tutunchi ◽  
Majid Mobasseri ◽  
Samira Pourmoradian ◽  
Hamid Soleimanzadeh ◽  
Behnam Kafil ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Complete Blood Count ◽  
Controlled Clinical Trial ◽  
Medical Sciences ◽  
Boron Compounds ◽  
Double Blind ◽  
Link Type ◽  
Nutrition Research ◽  
Full Protocol

Abstract Objectives In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19. Trial design The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups. Participants The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran. Intervention and comparator Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences. Main outcomes The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization. Randomisation Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule. Blinding (masking) The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis. Numbers to be randomised (sample size) The calculated total sample size is 40 patients, with 10 patients in each group. Trial Status The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020. Trial registration This clinical trial has been registered by the title of “Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial” in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20090609002017N35”, https://www.irct.ir/trial/48058. The registration date is 17 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Inference of Crosstalk Effects between DNA Methylation and lncRNA Regulation in NSCLC

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Binhua Tang
Keyword(s):  
Clinical Trial ◽  
Dna Methylation ◽  
Lung Carcinoma ◽  
Analytic Functions ◽  
Nsclc Tissue ◽  
Genome Wide Analysis ◽  
Clinical Trial Research ◽  
Omics Integration ◽  
Genome Wide ◽  
Tissue Profiling

Intercellular crosstalk effects between DNA methylation and lncRNA regulation remain elusive in lung carcinoma epigenetics. We present an application toolkit MetLnc in integration and annotation for group-wise NSCLC tissue-based DNA methylation and lncRNA profiling resources, to comprehensively analyze differentially methylated loci and lncRNAs through genome-wide analysis. Together with multiple analytic functions, MetLnc acts as an efficient approach on epigenetic omics integration and interrogation. Via the benchmark with group-wise NSCLC tissue profiling and TCGA cohort resources, we study differentially methylated CpG loci and lncRNAs as meaningful clues for inferring crosstalk effects between DNA methylation and lncRNA regulation; together we conclude with investigated biomarkers for further epigenetics and clinical trial research.

scholarly journals Clinical trial research on COVID-19 in Germany – a systematic analysis

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 913
Author(s):  
Julian Hirt ◽  
Abeelan Rasadurai ◽  
Matthias Briel ◽  
Pascal Düblin ◽  
Perrine Janiaud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Agenda ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
First Year ◽  
Industry Funding ◽  
Systematic Analysis ◽  
Clinical Trial Research ◽  
German Contribution

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345).  From the planned German participants, 13.4%  were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

Sign in / Sign up

Export Citation Format

Share Document