World Journal of Current Medical and Pharmaceutical Research https://wjcmpr.com/index.php/journal <p><strong>World Journal of Current Medical and Pharmaceutical Research </strong>(WJCMPR) is a double-blind peer-reviewed bimonthly open access international journal dedicated to the promotion of research in health and Pharmaceutical sciences. We define Open Access-journals as journals that use a funding model that does not charge readers. The journal publishes Research articles, Review article, Case studies and Short communication from broad areas like Medicine, Dentistry, Pharmacy, Anatomy, Physiology, Biochemistry, Neurology, Surgery, Orthopedics, Ophthalmol</p> World Journal of Current Medical and Pharmaceutical Research en-US World Journal of Current Medical and Pharmaceutical Research 2582-0222 <h2><span style="font-size: 14px;">Copyright © Author(s) retain the copyright of this article.</span></h2> Clinical trials tranformation intiative-decentralized clinical trials: a review article https://wjcmpr.com/index.php/journal/article/view/190 <p>In clinical research, Decentralized clinical trials (DCTs) can provide opportunities to maximize efficiencies. Unlike the traditional clinical trial model, Decentralized Clinical Trials (DCTs) promote telemedicine, mobile/local healthcare providers (HCPs), mobile/web-based technology, and direct distribution of Investigational Medicinal Products (IMP) to patients, among other things.&nbsp; Hence, DCTs are in the spotlight as technology, infrastructure, and knowledge providing a backbone in clinical research.</p> <p>Background: Advances in electronic communication, data storage, emerging technologies, and biosensor development provides new opportunities to exchange information, such as the patient is tested from their home locations and are with locations distant from the investigator. Trials that take place at locations distant from the investigator (i.e., spectrum: CCTs → Hybrid Models → DCTs) in any or all study-related procedures and data is collected electronically fall in the category of the decentralized clinical trial. Trials should be designed to integrate the current healthcare system of the study subject, optimize convenience for study subjects and take advantage of existing programs and data sources including The study subjects themselves through the utilization of telecommunication, videoconferences, mobile or internet-based tools for patient reporting, mobile technology tools and biosensors. Local healthcare providers, home-based healthcare services, pharmacies, clinics, regional hospitals, their perceived obstacles have impeded the widespread use of mobile devices in clinical trials. To encourage solutions to these challenges, The Clinical Trial Transformation Initiative (CTTI) has released best practices and practical methods to advance solutions to these issues that clinical trial sponsors can now use.</p> <p>Conclusion: Decentralized clinical trials are not only operationally feasible and show high recruitment rates, have better compliance, lower dropout rates, and are conducted faster. DCT meets the goal of the industry in being low-risk, high returns trials and can offer a reliable, time-based, and cost-effective approach.</p> Shirisha Jakkula Pravalika Pasupuleti Mujeebuddin C.S Ravindra Pratap Gaur Sujay S Patil Copyright (c) 2021 Dr Ranadeep Raj https://creativecommons.org/licenses/by-nc/4.0 2021-10-04 2021-10-04 107 115 10.37022/wjcmpr.v3i5.190 Regulatory considerations for emergency use authorizations of medical products U/s 564 of the federal food drug and cosmetic act, usa https://wjcmpr.com/index.php/journal/article/view/192 <p>The United States (US) remains the greatest medical device (MD) market on earth $156 billion (40 percent of the overall MD market in 2017). By 2023, it is depended upon to create to $208 billion. As per USFDA, the MD are orchestrated into three classifications. The U.S. Food and Drug Administration's and Center for Devices and Radiological Health (CDRH) supervises MD advertised in the United States. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&amp;C) is a group of laws passed by Congress in 1938 offering power to the U.S. Food and Drug organization (FDA) to administer the safety of food, drugs, cosmetic products and MD’s. An Emergency Use Authorization (EUA) under Section 564 of the FD&amp;C Act considers the unique utilization of medications and other clinical products during particular kinds of crises. This review articles focused the process of EUA of medical products u/s 564 of the Federal Food Drug and Cosmetic Act, USA.</p> Chudamani Sunandini Katikala Ramaiah Maddi Copyright (c) 2021 Chudamani Sunandini Katikala, Ramaiah Maddi https://creativecommons.org/licenses/by-nc/4.0 2021-10-08 2021-10-08 116 119 10.37022/wjcmpr.v3i5.192 Jatamansi (nardostachys jatamansi): insight of its morphological, Ethno-pharmacological and therapeutical aspect https://wjcmpr.com/index.php/journal/article/view/194 <p class="Default" style="text-align: justify; line-height: 150%;">Plants have been use for the treatment, mitigation and cure of the disease since time immemorial. The natural recourses are considered as safe for human use. Ayurveda advocates the <em>Jatamansi </em>in various human ailments. In the present review article we tried to establish the morphological, ehno-pharmacological and therapeutic aspect of the <em>Jatamansi</em>. The various search engines like, Google scholar, EMBASE, pub med, pub med central are used to search the literary information and published article. We tried to put the facts that are demand of this article and explore the proficiency of the <em>Jatamansi </em>as panacea for various ailments.</p> Ehsan Mohammad Ashwini Kumar Kushwaha Copyright (c) 2021 Ehsan Mohammad, Ashwini Kumar Kushwaha https://creativecommons.org/licenses/by-nc/4.0 2021-10-16 2021-10-16 127 130 10.37022/wjcmpr.v3i5.194 Coronavirus Disease 19 (COVID-19) Affects the Occurrence of Acute Heart Attacks: Case Report https://wjcmpr.com/index.php/journal/article/view/191 <p><strong>Background.</strong> Global Pandemic of COVID-19 is a viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) that primary target in respiratory system and spread rapidly around the world through droplets and direct contact. On the other side, COVID-19 affects to damage the myocardial causing acute heart attacks including Unstable Angina (UAP), Non-ST Elevation Myocardial Infraction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI) and still represents a major cause of morbidity and mortality worldwide that affects about 15.5 million in the United States. The common risk factors of ACS are male sex, family history of early myocardial infarction (55 years old), hypertension, diabetes, hyperlipidemia, smoking, sedentary lifestyle, and obesity. However, in this case report the viral infection is the only main cause of ACS</p> <p><strong>Case Description.</strong> A male 65 years old came to ER complained shortness of breath with no comobid. The ECG showed sinus rhythm, right bundle branch block, lateral ischemia. The COVID-19 RT-PCR resulted was positive with elevation of cardiac enzymes.</p> <p><strong>Discussion.</strong> ACE2 mediated SARS-CoV-2 enters into the lung alveolar epithelial cell and host cell. ACE2 is also spread widely in human heart, and vessels. Infection of endothelial and pericytes could lead to microvascular and microvascular dysfunction. Cytokine storm, increasing interleukin (IL)-6, IL-7, IL-22, and CXCL10 may leading to atherosclerosis plaque instability or rupture and contributing to development of acute coronary events.</p> <p><strong>Conclusion.</strong> COVID-19 can lead to NSTEMI. Although cardiac biomarker was high, NSTEMI need further examination including coronary angiography.</p> I Made Bayu Puradipa Cyndiana Widia Dewi Sinardja Copyright (c) 2021 I Made Bayu Puradipa https://creativecommons.org/licenses/by-nc/4.0 2021-10-08 2021-10-08 120 122 10.37022/wjcmpr.v3i5.191 Tolvaptan to Achieving High Urine Output and Avoiding Hyponatremia in COVID-19 with ADHF Patient: Case Report https://wjcmpr.com/index.php/journal/article/view/195 <p style="margin: 0cm; margin-bottom: .0001pt; text-align: justify;"><strong>Background</strong>: Pandemic of Coronavirus Disease 2019 (COVID-19) is a world health problem, with rapidly growing infected subjects. Recently, hyponatremia has been found to be associated with increased morbidity and mortality in hospitalized patients with severe acute respiratory syndrome-Coronavirus 2 (SARS-COV2) pneumonia. On the other hand, Acute heart failure (AHF) is a leading cause of hospitalization and readmission in the US. The standard management of AHF is removing the fluid primarily with loop diuretics or ultrafiltration. Unfortunately, the loop diuretics could lead to electrolyte imbalance.</p> <p style="margin: 0cm; margin-bottom: .0001pt; text-align: justify;"><strong>Case Description:</strong> A Male 71 years old with confirmed COVID-19 came to emergency room with shortness of breath and history of coronary artery disease (CAD). Unfortunately, the infection leads patient to non-ST Elevation Myocardial Infarction (NSTEMI). During the treatment, patient down to acute decompensated heart failure (ADHF). The congestion did not respond to Furosemide 40mg intravenously and Spironolactone 25mg orally.</p> <p style="margin: 0cm; margin-bottom: .0001pt; text-align: justify;"><strong>Discussion:</strong> Arginine‑vasopressin (AVP) levels are elevated in heart failure. AVP acts via V2 cause fluid retention and hyponatremia. Aquaretic (i.e., Tolvaptan) are antagonists of AVP-2 receptors in the renal tubules to promote solute-free water clearance and correct hyponatremia.</p> <p style="margin: 0cm; margin-bottom: .0001pt; text-align: justify;"><strong>Conclusion:</strong> Important to avoid hyponatremia to prevent mortality and sepsis in patient COVID-19.</p> I Made Bayu Puradipa Cyndiana Widia Dewi Sinardja Copyright (c) 2021 I Made Bayu Puradipa https://creativecommons.org/licenses/by-nc/4.0 2021-10-08 2021-10-08 123 126 10.37022/wjcmpr.v3i5.195