81 Clinical Trials for Various Conditions
The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care.
This study is designed to assess the causes and impact of acute respiratory illness (common colds, flu, bronchitis, pneumonia) in adults age 65 and older. One of the ways to determine the virus causing a particular illness is to get a blood specimen when a person is sick and again later and look for the body's specific responses that identify the virus. Approximately 3000 subjects will be evaluated and their medical records assessed for details of recent illness and general health to help in understanding the subjects' current illness.
The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests.
This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.
This is a longitudinal, prospective observational study focusing on health-related outcomes relative to potential changes in the respiratory microbiome seen with weekly SARS-CoV-2 testing in nursing home residents.
OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.
This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a repeat pharmacokinetic study during the final oral dose administered as the first dose on day 7 to ascertain CPC accumulation.
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (LRTD), viral lower respiratory tract infection (vLRTI), and upper respiratory tract disease (URTD).
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).
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.
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
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 .
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 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.
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.
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.
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 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.
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.
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.