An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial to Determine the Safety and Efficacy of New Natural Health Drink of Earth Tea in Human Adult, Patients with Mild Covid-19

Background/Objective: Coronavirus disease 2019 (COVID-19) is a viral respiratory illness that inflames the mucous membrane. Alveolar injury and eventually pneumonia result from this. It is brought on by the positive-sense single-stranded RNA virus SARS-CoV-2, also referred to as the novel coronavirus. The signs and symptoms of COVID-19 include fever, dry cough, exhaustion, sore throat, diarrhoea, headache, conjunctivitis, nasal congestion, body aches and pains, fatigue, loss of taste and smell, a skin rash, and discoloration of the fingers or toes. The main focus of research has been on current antiviral medications as prospective COVID-19 treatments. Hence, the present work was focused for clinical studies for the determinations of SARS-COV-2 (COVID-19) safety and efficacy of the new natural health drink of "Earth Tea". The product of "Earth Tea" Manufactured By Martin Sinclair B4B Corp,40, Remsen Ave, Brooklyn, NY 11212,United States. Method(s): An Open Label, Multicenter, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult Patients with Mild COVID-19 was the main goal of the study. To assess the safety and effectiveness of "Earth Tea" for COVID-19 as well as the safety and tolerability of a multi-dose given to human adult patients with COVID-19 infections. Result(s): In the analysis, patients showed a significant reduction in clinical cure and micro biologically cure analysis on Day 02 of evaluation visit. Moreover, significant reduction in the RT-PCR report noted on Day-02 and there were no adverse events reported during course of the study. Therefore, there were no Serious adverse events or deaths reported in this study. Conclusion(s): Based on these results obtained in the study, the product is an Earth Tea was found to have a significant efficacy and also a safe product. Copyright © 2022 Wolters Kluwer Medknow Publications. All rights reserved.

Single-arm diagnostic electrocardiography with printed graphene on wearable textiles.

Stimulated by the COVID-19 outbreak, the global healthcare industry better acknowledges the necessity of innovating novel methods for remote healthcare monitoring and treating patients outside clinics. Here we report the development of two different types of graphene textile electrodes differentiated by the employed fabrication techniques (i.e., dip-coating and spray printing) and successful demonstration of ergonomic and truly wearable, single-arm diagnostic electrocardiography (SADE) using only 3 electrodes positioned on only 1 arm. The performance of the printed graphene e-textile wearable systems were benchmarked against the "gold standard" silver/silver chloride (Ag/AgCl) "wet" electrodes; achieving excellent correlation up to ∼ 96% and ∼ 98% in ECG recordings (15 s duration) acquired with graphene textiles fabricated by dip-coating and spray printing techniques, respectively. In addition, we successfully implemented automatic detection of heartrate of 8 volunteers (mean value: 74.4 bpm) during 5 min of static and dynamic daily activities and benchmarked their recordings with a standard fingertip photoplethysmography (PPG) device. Heart rate variability (HRV) was calculated, and the root means successive square difference (rMMSD) metric was 30 ms during 5 min of recording. Other cardiac parameters such as R-R interval, QRS complex duration, S-T segment duration, and T-wave duration were also detected and compared to typical chest ECG values.

Adverse Events in Isotretinoin Therapy: A Single-Arm Meta-Analysis.

Isotretinoin (ISO) is an oral prescription-only retinoid, well known for its acne-treating effect. However, it affects a substantial number of human cell types, causing a broad spectrum of adverse effects. The purpose of this study is to establish the isotretinoin therapy adverse events among human clinical trials and their prevalence. Two authors (J.K., J.L.) systematically performed the literature review and assessment from December 2021-February 2022. Three databases (PubMed, ClinicalTrials, and Cochrane Library) were searched using the following terms: "isotretinoin acne vulgaris" for published studies in English from 1980-2021. Finally, 25 randomized controlled clinical trials (RCTs) and five open-label clinical trials provided 3274 acne vulgaris suffering patients. Isotretinoin therapy affects almost all of the systems in the human body, causing numerous adverse events. However, they mainly concern mild mucocutaneous conditions (severe cases are rare) and represent individual responses to a drug. In addition, all adverse events are reversible and can be avoided by specific preparations.

Real-world effectiveness of sofosbuvir/velpatasvir for the treatment of hepatitis C virus in prison settings

Plain language summary Achievement of elimination of HCV as a major public health threat requires focus on vulnerable populations such as people in prison. The prison population is at high risk of HCV infection but their treatment is complicated by social issues such as mental health disorders and drug use. Simple and effective treatment regimens are required to increase access to treatment and improve cure rates. This real-world analysis across Europe and Canada analyzed data from 20 prison populations. HCV-infected individuals were treated with sofosbuvir/velpatasvir, a once daily treatment which requires minimal monitoring. This regimen achieved high cure rates in the prison population despite the existence of complicating social issues. Background: People in prison are at high risk of hepatitis C virus (HCV) infection and often have a history of injection drug use and mental health disorders. Simple test-and-treat regimens which require minimal monitoring are critical. Methods: This integrated real-world analysis evaluated the effectiveness of once daily sofosbuvir/velpatasvir (SOF/VEL) in 20 prison cohorts across Europe and Canada. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with a valid SVR status. Secondary outcomes were reasons for not achieving SVR, adherence and time between HCV RNA diagnosis and SOF/VEL treatment. Results: Overall, 526 people in prison were included with 98.9% SVR achieved in the EP (n = 442). Cure rates were not compromised by drug use or existence of mental health disorders. Conclusion: SOF/VEL for 12 weeks is highly successful in prison settings and enables the implementation of a simple treatment algorithm in line with guideline recommendations and test-and-treat strategies.

Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design.

Coronavirus Disease 2019 (COVID-19) is a rapidly evolving global pandemic for which more than a thousand clinical trials have been registered to secure therapeutic effectiveness, expeditiously. Most of these are single-center non-randomized studies rather than multi-center, randomized controlled trials. Single-arm trials have several limitations and may be conducted when spontaneous improvement is not anticipated, small placebo effect exists, and randomization to a placebo is not ethical. In an emergency where saving lives takes precedence, it is ethical to conduct trials with any scientifically proven design, however, safety must not be compromised. A phase II or III trial can be conducted directly in a pandemic with appropriate checkpoints and stopping rules. COVID-19 has two management paradigms- antivirals, or treatment of its complications. Simultaneous assessment of two different treatments can be done using 2 × 2 factorial schema. World Health Organization's SOLIDARITY trial is a classic example of the global research protocol which can evaluate the preferred treatment to combat COVID-19 pandemic. Short of that, a trial design must incorporate the practicality of the intervention used, and an appropriate primary endpoint which should ideally be a clinical outcome. Collaboration between institutions is needed more than ever to successfully execute and accrue in randomized trials.