This study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (PPE) compared to during a video interaction with the doctor or nurse without PPE. The goal of this research study is to learn whether patients who visit the Acute Cancer Care Center at MD Anderson believe they get better (more empathetic) care from doctors who visit them in person wearing PPE or from doctors who visit them by video call and do not wear PPE.

Type: Interventional

Start Date: Jun 2021

open study

The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.

Type: Interventional

Start Date: Dec 2021

open study

This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

Type: Observational

Start Date: Nov 2020

open study

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.

Type: Observational

Start Date: Jun 2020

open study

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

Type: Observational

Start Date: Apr 2020

open study

Background: Loss of the sense of smell can seriously affect a person s quality of life. The ability to smell can be damaged by many factors, including illnesses, injuries, and exposure to toxic chemicals. The effects can vary, including complete loss of smell, partial loss, and parosomia, which is when things smell differently than they should. Objective: To study how brain function changes in people with different types of smell disorders. Also, to look at how smell loss affects quality of life over time. Eligibility: People aged 18 years or older with a disorder that affects their sense of smell. Healthy volunteers are also needed. Design: Participants will have 5 study visits over 1 year. They will have various tests and procedures: Smell tests. They will have several tests that involve smelling different items and answering questions. Questionnaires. They will answer questions about their health, mood, sense of smell, and daily habits. Magnetic resonance imaging (MRI) scans. They will lie on a bed that slides into a tube. Padding will hold their head still. They will smell different odors while in the scanner. Electrobulbogram (EBG). They will wear a soft cap with sensors that measure brain activity. They will smell different odors while wearing the cap. Nasal endoscopy. A flexible tube will be inserted into a nostril to view the inside of the nose. Biopsy. A numbing substance will be sprayed into the nose. Then a scissor-like tool will be used to collect a sample of tissue from one or both nasal passages. Samples of blood, urine, and nasal fluid will be taken.

Type: Observational

Start Date: Jan 2026

open study

The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours. Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours. Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness. Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.

Type: Observational

Start Date: Aug 2025

open study

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age.

Type: Interventional

Start Date: Jul 2024

open study

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine. The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

Type: Interventional

Start Date: Aug 2023

open study

The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.

Type: Interventional

Start Date: Jan 2023

open study

This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.

Type: Interventional

Start Date: Jan 2023

open study

The primary objectives of the study are: - To characterize the concentrations of casirivimab+imdevimab in serum over time - To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: • To assess the immunogenicity of casirivimab+imdevimab

Type: Interventional

Start Date: Dec 2021

open study

Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization. The study is designed to describe vaccine efficacy of a booster dose of BNT162b2 over time against COVID-19 - At a dose of 30µg (as studied in the Phase 2/3 study C4591001) - In healthy adults 16 years of age and older - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States, Brazil and South Africa Substudy B: The study will assess the safety and tolerability of a single dose of BNT162b2 as compared to placebo control, through the potential analysis of serum troponin levels, in participants ≥12 and ≤30 years of age who have received 2 or 3 prior doses of BNT162b2 (30-µg doses) with their last dose at least 4 months (120 days) prior to randomization. - Blood samples will be collected for troponin testing - The duration of the study for each participant will be up to approximately 2 months. - The study will be conducted in the United States, Germany, Poland and South Africa Substudy C: The study will assess the safety, tolerability, and immunogenicity of a booster (third) dose of BNT162b2 at doses of 10 µg or 30 µg in participants who have completed a 2-dose primary series of BNT162b2 (30 µg doses) at least 5 months (150 days) prior to randomization. - In healthy adults 12 years of age and older - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States, Germany and South Africa Substudy D: The study will assess the safety, tolerability, and immunogenicity of a 2-dose primary series of BNT162b2 OMI, and as a booster (third, fourth or fifth) dose - Participants in Cohort 1 will have completed a 2-dose primary series of BNT162b2 (30-µg doses), with their last dose 90 to 240 days prior to enrolment - Participants in Cohort 2 will be enrolled from Study C4591001 and C4591031 Substudy A and will have completed a 2-dose primary series and received a single booster (third) dose of BNT162b2, with their last dose 90 to 180 days prior to randomization - Participants in Cohort 3 who are COVID-19 vaccine-naïve and have not experienced COVID-19 will be enrolled to receive 2 doses (primary series) of BNT162b2 OMI, 3 weeks apart, with a dose of BNT162b2 approximately 5 months (150 days) later. If participants do not consent to receive BNT162b2 as a third dose, they will not receive a third dose. No participants should receive BNT162b2 OMI as a third dose. - In healthy adults 18 to 55 years of age - The duration of the study for each participant will be up to approximately 12 months. - The study will be conducted in the United States and South Africa Substudy E: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose - In healthy adults 18 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being 5 to 12 months (150 to 360 days) prior to randomization - The duration of the study for each participant will be approximately 6 months. - The study will be conducted in the United States Substudy F: This study will assess the safety, tolerability, and immunogenicity of high-dose BNT162b2 (60 µg), high-dose BNT162b2 OMI (60 µg), and a high-dose combination of BNT162b2 and BNT162b2 OMI at 60 µg (30 µg each), given as a single dose. - In healthy adults 60 years of age and older who have received 3 prior doses of BNT162b2 (30 µg) with the most recent dose being ≥4 months prior to randomization - The duration of the study for each participant will be approximately 6 months. - The study will be conducted in Israel

Type: Interventional

Start Date: Jul 2021

open study

Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.

Type: Interventional

Start Date: Oct 2023

open study

This study investigates the experiences of cancer patients with neuropathy during the COVID-19 pandemic to learn how the COVID-19 pandemic affects their quality of life and clinical outcomes. This study will also explore whether there are differences between patients who received neurofeedback (NFB, a type of therapy that is thought to help normalize brain activity) and those who did not. Learning about quality of life in cancer patients with neuropathy during the COVID-19 pandemic may help guide development of programs and policies to improve chronic pain patient care and outcomes during a major global healthcare crisis.

Type: Observational

Start Date: May 2020

open study

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

Type: Observational

Start Date: May 2021

open study

COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.

Type: Observational [Patient Registry]

Start Date: Jul 2020

open study

The purpose of this study is to test whether Fisetin, a senolytic drug, can assist in preventing an increase in the disease's progression and alleviate complications of coronavirus due to an excessive inflammatory reaction.

Type: Interventional

Start Date: Aug 2020

open study

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

Type: Observational

Start Date: Apr 2020

open study

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

Type: Observational

Start Date: May 2019

open study

Background: Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and/or COVID-19 vaccine. Objective: To understand what happens to the body s immune system throughout the year after getting the flu and/or COVID-19 vaccine. Eligibility: Adults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and/or COVID-19 vaccine. Design: Participants will not get any vaccines as part of this study. Participants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations. Participants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended. Once a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history. Once a month, participants will have blood drawn. Once a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute. Participants may be able to collect samples at home and mail them to NIH if they are not able to visit in person. Participation will last for about 12 13 months.

Type: Observational

Start Date: Aug 2021

open study

Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes.

Type: Interventional

Start Date: May 2020

open study

This trial is designed to assess immunological biomarkers measured from blood samples that can be used to reliably predict how well vaccines work against symptomatic COVID-19 as well as to evaluate the feasibility of remote, self-collected specimens when conducting a correlates analysis. For a lot of research studies, people need to go to the study doctor's office regularly. For this study, we want to see if it is okay that people do the study doctor visits virtually, fill out questionnaires electronically, and collect their own samples remotely. Participants will enroll in the study after receiving a COVID-19 vaccine in their community, and saliva and blood specimens will be collected at pre-defined time-points over a 12-month period. Additionally, participants will report weekly whether they experience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab for testing. Most participants will complete all activities remotely and via electronic communications, but a small number will complete activities in person at the doctor's office to provide a comparison group. Samples from the study will be analyzed to determine whether the biomarkers can be measured, and data from the study will be used to evaluate the feasibility of doing the specimen and data collection without the participant going to the doctor's office in person.

Type: Observational

Start Date: Dec 2024

open study