
A Randomized Trial of Vitamin D to Reduce Respiratory Infection
Respiratory InfectionThe goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

Children Immune Functions(2)
DiarrheaUpper Respiratory InfectionsTo investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Pharmacological Study of High Doses of Ceftriaxone in Meningitidis
MeningitisNeurological InfectionsThe aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.

Protecting Pregnant Women From Infectious Diseases
InfluenzaPertussisThe primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.

Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed...
Systemic InfectionsTo assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.

Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol...
Upper Respiratory InfectionsThis is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population. The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor. The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category: mild to moderate body pain, headache, fever or sore throat nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population

Challenge Infection of Healthy Adult Volunteers With RSV A2
Upper Respiratory Tract InfectionsBackground: One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Researchers want to study RSV infection in a safe, controlled setting in healthy adults to help develop new treatments. Objective: To test the safety of a high dose of RSV A2 by spraying the virus into the nose, and studying how the body responds. Eligibility: Healthy adults ages 18-50 Design: Participants will be screened during 2 screening visits with: Medical interview Physical exam Blood and nasal samples Chest X-ray (chest radiograph) Participants will have a heart test. Sticky patches on the body will detect heart electrical activity. Pulmonary function test (PFT). They will blow into a machine to measure airflow. Urine tests for pregnancy or drug use. Participants will be admitted to the hospital before they get RSV A2. Participants will get a single dose of RSV A2 as two sprays, one into each nostril. Participants will stay in the hospital under isolation for as long as it takes the body to clear RSV A2 from nasal fluids. This can take as long as 14 days or more. Participants cannot take any cold medicine to try to feel better. Every day, participants will: Answer questions about their symptoms Have nasal washes and/or nasal swabs collected Have a physical exam Participants will have blood drawn most days. After discharge, participants will keep a health diary. Participants will have 2 follow-up visits at 1 month and 2 months after receiving the RSV A2 dose. A history and physical examination, a blood draw, and nasal wash and swab will be performed.

The Effect of the Fermented Tea Beverage Kombucha on the Oral and Gut Microflora
Microbial ColonizationThe purpose of the project is to investigate if consumption of the fermented tea beverage kombucha has an effect on the gut and/or oral microbiota, and further if it depends on the content of living bacteria or is inherent even to sterilized kombucha. This will be studied by a clinical trial in which healthy individuals will be given living kombucha, sterilized kombucha or water. The participants will consume one bottle (33 cl) of their designated drink per day for 21 days. Fecal and saliva samples will be collected before, directly and ten days after the intervention. These will then be examined to see if there is a change in the micro flora due to the kombucha.

Metformin Therapy in HCV Infection
Chronic Hepatitis C InfectionHepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection. A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

Centralized Reminder Recall - Flu RCT2
InfluenzaHuman7 moreThis study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted. Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).