COVID-19 Clinical Trials and Expanded Access

This study, which has a randomized controlled experimental design, was planned todetermine the effect of music therapy on the anxiety level of family health personnelworking in primary health care centers during the COVID-19 pandemic. The study will becarried out between 4 August and 31 December with nurses, midwives and other familyhealth personnel working in family health centers. Participants will be randomized intotwo groups, a control and an intervention group. Individuals in the intervention groupwill receive 15 minutes of music therapy once a day for 5 days. No intervention will bemade in the control group. Data Descriptive Question and State-Trait Anxiety Inventoryonline design; It will be collected on the Google Forms platform.. Data analysis will bedone using SPSS 20 program.

This is a prospective study in which a process of identifying and improving a reductionof functional capacity in COVID-19 survivors >50 years old.The overall goal of this study to identify the feasibility and value of risk-guidedmedical therapy and exercise intervention in COVID-19 survivors.

This phase 2 trial studies the immune response to GEO-CM04S1 (previously designated asCOH04S1) compared to standard of care (SOC) mRNA SARS-COV-2 vaccine in patients withblood cancer who have received stem cell transplant or cellular therapy.GEO-CM04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, createdfrom a new version of MVA, called synthetic MVA. GEO-CM04S1 works by inducing immunity(the ability to recognize and fight against an infection) to SARS-CoV-2. The immunesystem is stimulated to produce antibodies against SARS-CoV-2 that would block the virusfrom entering healthy cells. The immune system also grows new disease fighting T cellsthat can recognize and destroy infected cells. Giving GEO-CM04S1 after cellular therapymay work better in reducing the chances of contracting coronavirus disease 2019(COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancercompared to SOC mRNA SARS-CoV-2 vaccine.

Novel coronavirus 2019 (COVID-19) has emerged as a major international public healthconcern. While much of the morbidity and mortality associated with COVID-19 has beenattributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emergingdata suggest that disorders of coagulation, in particular hypercoagulability and venousthromboembolism (VTE), may represent an additional major, and possibly preventable,complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and TangN, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulationtesting results, especially markedly elevated D-dimer and FDP, have been associated witha poor prognosis in COVID-19 infection. We propose the following Electronic Health Record(EHR)-guided 10000-patient, retrospective observational cohort study to assess VTEincidence, risk factors, prevention and management patterns, and thrombotic outcomes inpatients with COVID-19 infection. In order to gain the valuable perspective of otherregional and national centers providing care for large populations of COVID-19, we havestarted a collaborative network with 5 additional sites which will provide us withde-identified data from 1000 patients each. These 5000 patients in addition to the5000-patient cohort we are enrolling within the Mass General Brigham Network willcomprise this study population.

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

This project covers several research aims. In a cohort study, the investigators aim tocompare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgicaltreatment and study factors associated with good or bad outcomes.

This is study is comprised of three approaches. First, the investigators will conduct aretrospective cohort study to determine factors associated with COVID-19 severity andcomplications and understand COVID-19 outcomes, including all-cause mortality,post-discharge events, and impacts of rehabilitation services (third aim). The second aimis a mixed-method study and follows COVID-19 patients with repeated surveys to determinepatient-reported functional outcomes, health recovery, and rehabilitation needs afterCOVID-19. The investigators will recruit patients and their informal caregivers forinterviews to assess their function and rehabilitation needs.

Initially, it was suspected that Covid-19 would primarily affect the airways, but severalstudies have now shown that it is a disease with multisystem manifestations. Covid-19 hasthe potential to affect physical, cognitive, and psychological functions in multipleways. It has been clear that a significant proportion of patients with Covid-19 developlong-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describethe wide range of prolonged symptoms following the infection. Patients who have been inhospital for Covid-19 for a long time may need specialized rehabilitation, however, alsonon-hospitalized patients with mild symptoms may need specific rehabilitation to be ableto meet the complex symptoms and problems that may arise. Previous studies on therecovery and rehabilitation after other coronavirus shows the importance to developtailored interventions so that these patients receive appropriate rehabilitationThe aim of this study is to evaluate the effects of inspiratory muscle training on adultpatients with PACS and decreased respiratory muscle strength.A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80% or less of predicted value in inspiratory muscle strength (maximal inspiratorypressure) will be eligible for enrollment. Patients will be randomized either to anintervention group or a control group. The intervention will consist of inspiratorymuscle training performed twice daily for 8 weeks. This will be combined with an 8-weekphysical exercise training program. The control group will perform the same physicalexercise training according to standard care. All measurements will be performed atbaseline and after 8 weeks.Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximalexpiratory pressure, pulmonary function, physical capacity, physical activity,respiratory status and symptoms, health-related quality of life, work ability, fatigue,self-reported outcome measure of physical function and voice function.Covid-19 has the potential to affect physical, cognitive, and psychological functions inmultiple ways and lead to a negative impact on quality of life in the long-termperspective. Therefore, development of a rehabilitation program with specific tailoredinterventions will be necessary to improve physical and psychological function, as wellas health-related quality of life and work ability.

This study investigates the changes in practice by pulmonary procedural programs acrossthe United States as they faced the coronavirus pandemic. Information gathered from thisstudy may help guide pulmonary programs on a wider scale and improve their practice. Thestudy may also help researchers understand where they should focus research efforts tobetter respond to a pandemic in the future.

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are aheterogeneous group of tumors arising in connective tissues embryologically derived fromthe mesenchyme. For some of these tumors relapse and mortality rates are stillsignificantly high. Therefore, further studies are needed to better understandpathogenetic processes underlying sarcomas to offer new and more effective treatments.Next generation sequencing (NGS) has opened new frontiers for cancer research allowing toidentify somatic or constitutional mutations known or yet unknown with the aim to betterunderstand carcinogenesis. The establishment of the genomic profile of the tumor couldalso help clinicians to personalize patients treatment based on their genetic andmolecular alterations.