COVID-19 Clinical Trials and Expanded Access

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment fordepression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn howto optimize the treatment to improve symptoms of depression and OCD. This researchproject will test a new accelerated 5-day accelerated rTMS protocol for treating symptomsof depression and OCD.A second goal of this study is to identify biomarkers of depression and OCD in the brainusing functional magnetic resonance imaging (fMRI). This approach will predict who willbenefit from TMS, determine the optimal treatment target, and improve treatment outcomes.Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before andafter each treatment course to measure the effect of treatment on symptom severity and onfMRI measures of functional connectivity.Participants will be randomized to receive rTMS targeting either the lateral prefrontalcortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a5-day course of rTMS delivered hourly for 10 hours per day. Participants who show apartial response to treatment but not a full response will then receive a second 5-daycourse. Treatment non-responders will be crossed over to receive rTMS targeting theopposite brain area.The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement insymptoms for patients with depression and OCD in just 5 days, and that response rates canbe further improved by adding a second 5-day treatment course.

Stress is underpinned by a biological reaction of the organism allowing the production ofenergy to respond to a change in the environment (or stressor). Stress reaction isexpressed in behavioural, cognitive, emotional and physiological terms. This biologicalresponse is non-specific because it is the same regardless of the stressor. Its evolutionover time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome(GAS) which comprises three successive phases. (i) The first phase, known as the alarmphase, corresponds to the activation of all biological mechanisms according to a trendregulation, allowing a rapid response to the stressor. (ii) The second phase ofresistance which adjusts the stress response to the intensity of the perceived aggressionaccording to a constant regulation. (iii) When the aggression disappears, a recoveryphase dominated by the return of the parasympathetic brake allows a return to homeostasis(eustress).The "primum movens" of all pathologies is therefore the inability of the individual toadapt his stress response in duration and/or intensity to the course of the phases of theGAS (distress). The perception of not being in control of the situation contributes tothe perceived stress and constitutes a well-established risk of distress. It is a riskfactor for the emergence of burnout. It induces a biological cost called allostatic cost.Allostasis is a concept that characterizes the process of restoring homeostasis in thepresence of a physiological challenge. The term "allostasis" means "achieving stabilitythrough change", and refers in part to the process of increasing sympathetic activity andcorticotropic axis to promote adaptation and restore homeostasis. Allostasis works wellwhen allostasis systems are initiated when needed and turned off when they are no longerrequired. Restoring homeostasis involves effective functioning of the parasympatheticsystem. However, when the allostasis systems remain active, such as during chronicstress, they can cause tissue burnout and accelerate pathophysiological processes.The perception of uncontrollability depends on the stress situation, the psychologicaland physiological characteristics of the subject and his or her technical skills inresponding to the stressors of the situation. In particular, subjects with a high levelof mindfulness are more accepting of uncontrollability and less likely to activate thestress response.The COVID-19 pandemic situation is a situation characterized by many uncertainties aboutthe individual, family and work environment and the risk of COVID infection. Healthcareworkers, like the military, are high-risk occupations that are particularly exposed tothese uncertainties in the course of their work and continue to work in an uncertainsituation. These professionals are described as a population at risk ofoccupational/operational burnout that the level of burnout operationalises. Thisancillary study in a population of civilian and military non-healthcare workers willcomplement the study conducted among military health care workers. It will make itpossible to isolate the specificity of each profession (civilian or military, healthcarepersonnel or not) with regard to the risk of burnout in the COVID context.The objective of this project is to evaluate the impact of the perception of non-controlin the operational burnout of experts in their field of practice and to study thepsychological and physiological mechanisms mediating the relationship between thesubject's characteristics, perceived non-control and burnout.

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complicationthat lead to in intensive care hospitalization.This complication determines a variable mortality from 25 to 30%. To correct hypoxemia(often severe) is often needed non-invasive or invasive mechanical ventilation.Mechanical ventilation is not a therapeutic strategy, but it allows to extend thetime-to-recovery necessary to solve COVID-19 respiratory failure cause.Calibration of ventilatory support is essential to ensure adequate time-to-recoverywithout contributing to onset lung and / or diaphragmatic damage.Basal diaphragmatic activity assessment, device for administering the oxygenation supportchoice and setting ventilatory support parameters are decisive.Ultrasound is the best method for measuring diaphragmatic work. The aim of this study isto evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted toIntensive Care Unit (ICU) for acute respiratory failure and to record its function onweaning.

With the aging of today's population, stroke is the top three causes of disability anddeath among people over the age of 60 in the world. About 5.5 million people die eachyear from strokes in Taiwan, and Taiwan's top ten causes of death in cerebrovasculardisease rank fourth in the world. Constipation is the most common complication of strokepatients and increases the risk of brain damage and re-stroke. Although the clinical useof drugs can relieve intestinal symptoms, there is also a risk of potential side effects.The systematic literature points out that the use of acupoint stimulation can improvespontaneous bowel movements and promote bowel motility, but there is no conclusion oneffective acupuncture points. Therefore, the purpose of this study is to improve theconstipation of patients with stroke by non-invasive and precise acupoint care.This study used a single-blind randomized control trial. The neurosurgery ward of amedical center in the north was used as the research site, and patients with ischemicstroke were used as the research objects. The experimental group received precisionacupoint care, and the control group received routine care. The questionnaire was used tocollect basic patient information (basic attributes, disease care and TCM constitution),and gut-related assessments. Data analysis was performed using IBM SPSS 22.0 software fordescriptive statistical analysis and inferential statistical analysis, and p

A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in PatientsHospitalized with COVID-19

Myocardial infarction (MI), as one of the many complications of COVID-19, is one of thecontributing patients of patients' death. This study attempts on developing anintervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygenin cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patchdeveloped from amnion bilayer seeded with amnion epithelial stem cells and patient'sautologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG)surgery are given heart patch, and then patients condition are observed by ECG, Echo,blood test, and radiology (technetium-99m)

Preliminary reports have been received from several sources that the periodic inhaling ofthe nebulized mist from water that has a heightened level of kinetic activity has quickly(less than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On atleast several occasions, a repeat PCR test performed several after inhaling a particularwater-based product was negative. There are no perceived adverse effects from inhalingthe water mist by using a nebulizer or humidifier. It is important, however, to validatethese preliminary findings and to include the inhaling of the mist from water, which doesnot have an elevated level of kinetic activity. This will be by performed in apatient-blinded manner by sequentially inhaling the two types of water over consecutive2-day periods with Covid-19 testing at the end of each of the two day periods.Participants will be randomized as to whether they are to inhale the mist from the testor the control water.

The investigators aim to deliver a tele-wellness supported app to Baltimore City's FamilyChild Care Home (FCCH) providers who are caring for children of Essential Personnel. Oncea pre-survey is conducted, login information will be assigned to 30 Family Child CareHome providers and parents the FCCH serve. Providers and Parents will receive self-careand parenting/parent engagement support through the app and through a tele-wellnessservice, Ask a Nurse, provided by community health nurses at the Johns Hopkins School ofNursing. Children will have access to gamified learning materials in early literacy,math, social-emotional learning, and nutrition.

Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2Coronavirus, poses an increasing threat to individual health and health care systems. Theindividual disease course ranges from mild to life threatening, the pandemic spread leadsto a shortage of health care resources including intensive care availability. It shouldbe the overarching goal to allocate sparse health care resources to those most at needand to simultaneously avoid unnecessary blocking of resources by clinically unjustifiedhospitalizations.Individuals with preexisting cardiovascular conditions are at the highest risk of healthdeterioration, even at younger age. Objective criteria for hospitalization are notimmediately available in a outpatient settings. Hence, hospitalization and emergencymedical contact is often triggered by subjectively interpreted symptoms. The goal of thisproject is thus to improve the availability of objective measurements in the outpatientsetting by means of an innovative, smartwatch mediated telemedicine approach.To achieve this goal, the investigators will conduct a randomized clinical trialcomparing a smartwatch based telemedicine intervention with standard of care. Theintervention group will receive regular objective measurements of heart rate, ECG, andSpO2 and will get access to a 24/7 medical care hotline for consultation. Theinvestigators hypothesize that the intervention group will benefit by a significantreduction in unnecessary hospitalizations and unplanned emergency medicine contacts.

The purpose of this study is to characterize microvascular reactivity on the forearmmuscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients,and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.