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Search Results Within Category "Infectious Diseases"

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16 Study Matches

The Lung Cell Study (TLC)

The purpose of our research study is to increase our understanding on the human lung immune response to infection. We aim to use this knowledge to develop novel approaches on the prevention and treatment of lung infections. To accomplish this, we plan to obtain cells from the airways and blood of healthy volunteers to perform immune experiments.

Monica Campo Patino
18 years and over
This study is also accepting healthy volunteers
STUDY00016947
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Inclusion Criteria:

Healthy volunteers
without systemic or respiratory disease.
• Former smokers (quit > 6 months ago) or never smoked, including marijuana
• Between the ages of 18-65 years
Exclusion Criteria:

• Current or recent illness within the preceding two weeks.
• Presence or prior history of cardiac, pulmonary, or systemic disease
• Bleeding disorder
• Current use of systemic anticoagulant or antiplatelet therapy
• Immunocompromised state (HIV infection, immunoglobulin deficiency, use of systemic immunosuppressant medications)
• Use of any inhaled substance, including tobacco, marijuana, e-cigarettes, cocaine, methamphetamines, or toxic vapors in the past six months or greater than ten pack-year smoking history
• Alcohol use disorder
• Allergy or prior adverse reaction to lidocaine, midazolam, or fentanyl Pregnancy
• Weight less than 110 lbs (for venipuncture)
• Older than 65 years of age
Immune Diseases, Infectious Diseases, Respiratory System
blood, blood donation, blood draw, bronchoscopy, health, Healthy, Healthy subject, Healthy Volunteer
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A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104

This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.

Mark Schleiss
Up to 18 years old
This study is also accepting healthy volunteers
SITE00001871
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Inclusion Criteria:

• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
Exclusion Criteria:

• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Children's Health, Infectious Diseases
CMV, cytomegalovirus, vaccine
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See this study on ClinicalTrials.gov

A Phase 1 Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants At Risk of Acquiring Neonatal Herpes Simplex Virus Disease

The purpose of this study is to determine the dose of medication (Valacyclovir) needed to prevent an infant from developing herpes simplex virus (HSV) if the infant was potentially exposed to HSV at the time of delivery as they passed through the birth canal.

Mark Schleiss
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001830
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Inclusion Criteria:

• Mother has a history of genital HSV infection
• Mother is receiving oral acyclovir, valacyclovir, or famciclovir suppressive therapy for 7 or more days before delivery
• Gestational age 38 or more weeks at birth
• Infant is no more than 2 days of age at study enrollment
• Weight at study enrollment at least 2,000 grams
Exclusion Criteria:

• Evidence of neonatal HSV infection
• Evidence of sepsis
• Kidney anomalies or dysfunction
• Maternal genital lesions suspicious for HSV at the time of delivery
• Infants known to be born to women who are HIV positive (HIV testing is not required )
• Infant currently receiving acyclovir, ganciclovir, famciclovir, or any investigational drugs
Infectious Diseases, Children's Health
herpes simplex virus, neonatal herpes, HSV
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Long COVID Ultrasound Trial

This research is being performed to study whether an investigational ultrasound treatment of the spleen can reduce the symptoms of Long COVID by reducing inflammation in the body. Ultrasound is widely used in human medicine because it is designed to be safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able to treat Long COVID.

Farha Ikramuddin
18 years and over
STUDY00020251
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of COVID-19 within one year of starting the study, documented by a positive test in which there is evidence in the medical records, physical or photographic evidence, or a note in the medical records from a medical professional documenting that they were positive for COVID-19
• symptoms present for 12 or more weeks including fatigue and one or more of: a. Myalgia b. General aches/pains c. Joint pain d. Cognitive dysfunction (brain fog)
Exclusion Criteria:

• history of intubation or admission to ICU to treat COVID-19
• pre-existing lung conditions such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or severe asthma
• women who are pregnant
• history of coronary artery disease (CAD) or stroke
• history of smoking
• any non-marijuana drug abuse history within 30 days
• history of alcohol abuse: greater than 2 drinks a day for men and 1 drink for females
• participant does not speak English
• additional medical and mental health diagnosis (study staff will review)
COVID-19
Covid, Long Covid
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Senolytics To slOw Progression of Sepsis

Researchers hope that using Fisetin, an antioxidant, will reduce inflammation in the body caused by sepsis, which could help your body and organs have more time to recover. Placebo in this study will be something that looks similar to the study treatment, but does not contain any active drug. Everyone will receive 4 pills, but your group will determine how many of the pills are Fisetin. Researchers will look at the potential effects Fisetin or placebo has on inflammation in the body and how sick participants are at 7 days and 28 days.

Michael Puskarich
18 years and over
This study is NOT accepting healthy volunteers
SITE00001869
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Inclusion Criteria:

• Age 65 or older
• Primary diagnosis of acute infection
• Expected length of hospital stay at least 48 hours
Exclusion Criteria:

• No acute infection
• Known hypersensitivity or allergy to Fisetin
• Not admitted to hospital
• Enrolled in another Sepsis clinical trial
Infectious Diseases
Fisetin, Sepsis
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00013494
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Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Cancer, Infectious Diseases
Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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See this study on ClinicalTrials.gov

A Retrospective Follow-Up Study of the Durability of Antiviral Therapy on Long-Term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

The purpose of this study is to find out if treatment of congenital cytomegalovirus (cCMV) with an antiviral medicine has any impact on hearing, development of cancers, overall development and sexual maturity development. No treatment for cCMV will be provided in this study.

Mark Schleiss
Not specified
This study is NOT accepting healthy volunteers
SITE00002065
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Inclusion Criteria:

• at least 2 years old
• received intravenous ganciclovir or oral valganciclovir to treat congenital cytomegalovirus (CMV) infection
• may have participated in the CASG study of the treatment of congenital CMV
Exclusion Criteria:

• unable to comply with study-related procedures
Children's Health, Infectious Diseases
CMV, Cytomegalovirus
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A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome? followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species (OASIS)

This study will look at an investigational study drug, called olorofim, to determine how safe the study drug is, how well it is tolerated and whether it is effective compared to AmBisome® (a standard of care treatment) to treat invasive fungal disease (IFD). We expect that you will be in this research study for up to 18 weeks or just over 4 months.

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019092
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Inclusion Criteria:

• over 18 years old
• weigh more than 40 kg (88 pounds)
• Invasive Aspergillosis (IA) at any site
• require therapy with an antifungal agent other than a mold-active azole
Exclusion Criteria:

• women who are pregnant or breastfeeding
• known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• people with chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis
• human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy
• certain heart and liver conditions (study staff will review)
Infectious Diseases, Respiratory System
Aspergillosis, IA, Invasive Aspergillosis (IA), Lung Infection
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See this study on ClinicalTrials.gov

CLINPRT-7: Intermediate Patient Population Expanded Access Protocol for MBP134 for Patients with Sudan Virus Disease (SVD)

The purpose of this open-label Expanded Access Protocol (EAP) is to provide access to MBP134, for treatment of Sudan Virus Disease (SVD). Patients will receive a single IV infusion of 50 mg/kg MBP134. Patients will be monitored and assessed daily through discharge for safety and the incidence of serious adverse events (SAEs), and of all adverse events (AEs) during infusions.

Susan Kline, MD
Not specified
This study is NOT accepting healthy volunteers
SITE00001888
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Inclusion Criteria:

• people of any age who have a documented positive RT-PCR for Sudan Virus Disease (SVD) in the last 10 days
• OR a documented positive RT-PCR test for SUDV more than 10 days ago but continue to have symptoms of SVD
• OR acute symptoms compatible with SVD and a close contact with some who has RT-PCR confirmed SVD
• OR Infants born to mothers who have a positive RT-PCR results for SUDV within 10 days of birth or with a documented positive RT-PCR test for SUDV in >10 days but with ongoing symptoms of SVD
• women of who are of child-bearing age must use highly effective contraception for 90 days after receiving the medication
Exclusion Criteria:

• any medical condition that, in the opinion of the physician, would unreasonably increase risk of side effects (study staff will assess)
Infectious Diseases, Rare Diseases
Sudan Virus Disease, SVD
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A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017568
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Inclusion Criteria:

• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
Exclusion Criteria:

• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Breathing, Lung & Sleep Health, Infectious Diseases
Clinics and Surgery Center (CSC), antifungal therapy, aspergillosis, fungal infection, lung infection, pulmonary aspergillosis
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See this study on ClinicalTrials.gov

Assess Pituitary Function in COVID-19 Patients and Correlate Results with Clinical Symptoms Fatigue

We are studying hormone levels and fatigue of people who have recently had COVID-19. Participants will complete questionnaires and have blood drawn to determine hormone levels. Participants who are experiencing high levels of fatigue or who have abnormal hormone levels will complete questionnaires and have blood drawn every three months for a year. We are hoping to determine how COVID-19 affects hormone levels and the pituitary gland, which is responsible for releasing hormones.

Takako Araki
18 years and over
This study is NOT accepting healthy volunteers
SITE00001460
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Inclusion Criteria:

• People who have COVID-19 documented with a positive SARS-CoV-2 test.
Exclusion Criteria:

• People with pituitary abnormalities diagnosed prior to the diagnosis of COVID-19.
• People receiving hormone replacement therapy, including thyroid hormone, estrogen replacement, (including oral contraceptives), testosterone, or growth hormone.
• People who are on active treatment with oral, topical, inhaled, or injectable corticosteroids (injection within 4 weeks of screening)
• People who have current and continuous (> 3 months) opioid use
• People who are not able to complete study procedures necessary for the study, such as an early morning blood draw.
COVID-19, Diabetes & Endocrine, Infectious Diseases
COVID, COVID-19, Fatigue
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Seasonal influenza vaccine high dose boosting in solid organ transplant recipients

This is a prospective, randomized control trial that will assess neutralizing antibody titers in solid organ transplant (SOT) recipients that receive 2 doses of the high-dose (HD) influenza vaccine during a influenza season. We will evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. The control group will receive 1 HD influenza vaccine and a placebo injection.

Lauren Fontana
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017687
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Inclusion Criteria:

• at least 18 years old
• history of a solid organ transplant (liver, lung, heart, kidney, pancreas) at least 1 year before starting the study
Exclusion Criteria:

• women who are pregnant
• received ATG or carfilzomib in the past 3 months
• received rituximab or basiliximab in the past 3 months
• prednisone dose is greater than 20mg/ day
• history of a severe allergy to influenza vaccine (e.g., Guillain-Barre syndrome, anaphylaxis, or angioedema)
• have received the influenza vaccine for the current season
Infectious Diseases
Clinics and Surgery Center (CSC), influenza, influenza vaccine, Solid organ transplant
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See this study on ClinicalTrials.gov

Antimicrobial Stewardship Community Awareness and Acceptance in Minnesota

This is a community-based study engaging diverse Minnesota adults aged >=18 years. The goal is to understand the public's acceptance and awareness of antimicrobial resistance and stewardship efforts and subsequently look at electronic educational methodology to increase antimicrobial stewardship public engagement.

Beth Thielen
18 years and over
This study is also accepting healthy volunteers
STUDY00019421
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Inclusion Criteria:
Adults >/= 18 years and able to understand written English
Exclusion Criteria:
None
Community Health, Infectious Diseases, Microbiota
Antibiotic resistance, public health
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Quantifying the Individual Heterogeneity of Presentation and Symptoms of Cognitive Impairment in Long COVID

This questionnaire and cognitive task study is being done to learn how different activities, like exercise, sleep, and stress, may affect symptoms of long COVID. We also want to know how symptoms may fluctuate over different times during the day and over several weeks. The study will take about 4 weeks to complete and will be done remotely.

Kelvin Lim
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017662
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Inclusion Criteria:

• able to speak English
• have access to a compute with internet access
• history of having COVID-19
• continue to experience symptoms of long COVID-19 such as fatigue, "brain fog", trouble sleeping, headaches, etc.
Exclusion Criteria:

• never tested positive for COVID-19
Brain & Nervous System, COVID-19
brain fog, COVID-19, fatigue, Long COVID-19
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Pediatric COVID-19: Does infection with the SARS-CoV-2 virus alter brain structure and function?

The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).

Igor Nestrasil
Not specified
This study is NOT accepting healthy volunteers
STUDY00010688
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Inclusion Criteria:

• diagnosis of COVID-19 in the past
• experiencing long covid symptoms for at least 2 months
• 3 to 25 years old at the time of entry into the study
Exclusion Criteria:

• active positive COVID-19 diagnosis (as confirmed by a medical provider &/or certified testing site) for at least 4 weeks prior to projected enrollment date
• surgically implanted pacemaker
• indwelling electronic device, including programmable shunts
• orthodontic braces, unless non-metallic
• implanted metal in the body other than titanium
• inability or unwillingness to complete an MRI
• pregnancy
• anyone not meeting standard MRI requirements according to CMMR protocol (ie presence of metal in body or implanted pacemaker) will be excluded from that portion of the study
COVID-19
long covid, COVID-19, Pediatric, MRI
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Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

We are continuing to study the SARS-CoV-2 coronavirus and the evolving new variants. We are looking at drugs that have Food and Drug Administration (FDA) approval for other uses. The goal is to determine if these drugs can make participants who get the coronavirus feel better faster and reduce death and hospitalizations.

Carolyn Bramante
18 years and over
This study is NOT accepting healthy volunteers
SITE00001271
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Inclusion Criteria:

• at least 30 years old
• confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days before starting study
• two or more current symptoms of acute infection for no more than 7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
Exclusion Criteria:

• current or recent (within 10 days of starting study) hospitalization for COVID-19 infection
• current or planned participation in another interventional trial to treat COVID-19 (study physician will review)
• current or recent use (within the last 14 days) of study drug or study drug/device combination
COVID-19, Infectious Diseases
Primary Care, COVID, COVID-19