369 Clinical Trials for Various Conditions
The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics.
The purpose of the study is to describe the rate of occurrence of clinical diagnosis of acute respiratory infection (an infection that affects normal breathing) and different types of respiratory pathogens (harmful organisms) of new respiratory infections in a population at high risk for severe illness.
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: * To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. * To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
Zinc and green tea supplementation have both been independently studied for supporting immune health during cold and flu-like illness in non-hospitalized patients with clinical trials demonstrating promising but inconsistent results. Combination therapy may offer an improved effect as the antioxidant compounds found in green tea have been shown to increase cellular zinc concentrations thereby inhibiting viral replication. This study seeks to evaluate the effect of combination supplementation using established doses of zinc and green tea extract on symptom duration and severity from cold and flu-like illness, including COVID-19, in adult community patients enrolled in a randomized placebo-controlled trial.
This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.
The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.
A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients will be assembled to determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the three months after respiratory viral infection.
This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures: Part I * Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. * Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects are given a placebo (a solution with no active ingredient.) Subjects are observed in the clinic for 30 minutes after treatment. * Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. * Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. * Day 12: Subjects are contacted by phone to review their diary card. * Day 28: Subjects are contacted by phone to review their diary card. Part II * Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. * Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants. * Day 3: Subjects receive a second dose of medication and are observed again for 30 minutes. * Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. * Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. * Day 14: Subjects are contacted by phone to review their diary card. * Day 28: Subjects are contacted by phone to review their diary card.
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers.
Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract. The central hypothesis of this protocol is that vitamin supplements will enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza virus vaccine with placebo. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced immune response. PRIMARY OBJECTIVE: * To assess the vaccine-induced and total antibody (including IgG and IgA) response after influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days in sera SECONDARY OBJECTIVE: * To assess the neutralizing response toward influenza virus vaccine in the sera.
This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using the FilmArrayTM System, a novel highly sensitive and rapid assay for RV detection. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis. Patients will be accrued on the study over a one year period.
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded
The Study aims to prospectively survey the incidence of respiratory virus infections using molecular methodologies, in children undergoing hematopoietic stem cell transplantation
Background: Respiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus infections. The samples in this natural history study will be used in future research. Objective: To obtain samples from people with respiratory viruses to learn more about respiratory virus infections and the immune responses against them. Eligibility: People aged 3 and older who have or are suspected to have a respiratory virus infection. Design: Participants will be screened with a medical record review. Participants will give blood samples. Data from their medical records will be collected. Participants will give nose samples. A soft plastic strip will be put into each nostril for a minute. They may also give nose, mouth (back of the throat), or saliva samples using swabs. Participants may receive kits by mail to collect nose and blood samples at home. They will use soft plastic strips to collect nose samples. To collect blood, they will prick their finger and dab a few drops of blood on four plastic tips. If a participant is in the hospital, air samples may be collected in their room. Participation will last for up to 2 years. After 2 years, participants may be asked for their consent again to give new samples and new medical data.
Background: Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways. Objective: To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed. Eligibility: Healthy adults who have enrolled, were recently enrolled, or are scheduled to enroll in a challenge study. Design: Participants will stay at NIH for the duration of the challenge study (at least 9 days) and then will have outpatient follow-up visits (2-4). While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements. Participants will have a smartphone that records at all times to listen for coughing and changes in voice. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take videos of their face. They will play a game to test their reflexes and focus. They will measure their head temperature with their smartwatch. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participants will be sent a smartwatch to wear at home at night to collect additional healthy data. Participation will last the duration of each challenge study, and may range from 10 weeks to 2 years.
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.
Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone. Some of the subjects will have participated in previous studies for these 2 vaccines. The study will last 4 months with subject participation being 28 days. The purpose of this study is to measure immune response to the vaccinations.
The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.
Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progression of severe viral infections like COVID-19 after high-risk exposure to a person with possible respiratory viral infection such as SARS-CoV-2 infection in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls).
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propose the first randomized controlled trial (RCT) to estimate the burden of GI associated with private well water. We will test if household treatment of private well water by ultraviolet light (UV) vs. sham (inactive UV device) decreases the incidence of GI in children under 5. We will also examine the presence of viral, bacterial, and protozoan pathogens in stool and well water from participants. These data will fill a knowledge gap on sporadic GI associated with federally-unregulated private water supplies in the US.
This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.
This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.
The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.
Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory illness (e.g., flu) and when they are feeling healthy. The research will also study an investigational flu@home test and app. If successful, results from the study could be used in the future to better identify people with respiratory illness. In addition, this study will test the accuracy of an at-home flu test kit compared to laboratory test results.
This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.
Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred. This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.