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Electrophysiology of Fetal Arrhythmia (fMCG)
Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Ronald Wakai, PhD
18 Years and over
• uncomplicated pregnancy at gestational age >12 weeks
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age >15 weeks
• uncomplicated pregnancy <12 weeks gestation
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age <15 weeks
Fetal Arrhythmia, Supervision of high risk pregnancy, Healthy Volunteers
Mechanisms of Cerebrovascular Control
The objective of this study is to identify insulin-specific cerebral blood flow (CBF) control mechanisms, and establish cerebrovascular responsive baseline in younger (18-45 yrs) metabolic syndrome adults (MetSyn) who are at substantial risk of stroke and other types of cardiovascular mortality even if they never develop diabetes. The central hypothesis is that vasodilator actions of insulin are impaired in MetSyn due to loss of dilator and gain of constrictor signals. This study will focus on 2 mechanisms that likely limit CBF in MetSyn: 1) Disruption of nitric oxide (NO) vasodilation, and 2) Exaggerated endothelin (ET-1) constriction. Three specific aims will be addressed: Aim 1: To test the hypothesis that physiologic surges of insulin acutely increase CBF in young adults, but adults with MetSyn exhibit paradoxical insulin-mediated vasoconstriction. Aim 2: To test the hypotheses that key mechanisms responsible for poor CBF in MetSyn are shifts in NO and ET-1 signaling. Specifically, in healthy controls, NO mediates robust dilation, with little to no ET-1 constriction. In contrast, adults with MetSyn exhibit uncoupled NO synthase (NOS) and exaggerated ET-1 constriction. Aim 3: To test the hypothesis that insulin regulation of CBF is regionally distinct (e.g. Middle Cerebral Artery (MCA) reactive than Anterior Cerebral Artery (ACA) or basilar), and the negative effects of insulin resistance (IR) are similarly regionally specific.
William Schrage, PhD
18 Years to 45 Years old
• Inclusion Criteria (all):
• Sedentary (≤ 90 minutes of vigorous physical activity per week)
• Women must be premenopausal with a regular menstrual cycle
• For the Ambrisentan trial, participants must be male, due to potential harmful effects of drug on fetus
• Inclusion Criteria (Controls):
• Participants will be lean (BMI ≥19
• Sedentary (≤ 90 minutes of vigorous physical activity per week)
• Without any cardiovascular co-morbidities
Inclusion Criteria:(Metabolic Syndrome):
• Participants must qualify under the National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) definition of metabolic syndrome as modified by the American Heart Association and International Diabetes Federation. Participants must meet 3 or more of the following 5 criteria:
• fasting glucose ≥ 100 mg/dL,
• fasting triglycerides ≥ 150 mg/dL,
• elevated blood pressure (≥ 130 systolic and/or ≥ 85 diastolic mmHg),
• waist circumference at the iliac crest > 102 cm (men) or ≥ 88 cm (women).
• Fasting glucose ≥ 126 mg/dL
• Having ≥1- ≤ 2 of the above criteria for MetSyn.
• Personal medical history of coronary artery disease, stroke, heart attack, heart valve disease, congestive heart failure, previous heart surgery, history of lung disease (Note: asthma that is not currently active and being treated is NOT considered an exclusion criteria) or peripheral artery disease, or history of renal/kidney and liver/hepatic disease.
• Taking metabolic medications (insulin-sensitizing, lipid-lowering medications, etc.) or any medications for cardiovascular-related issues will be excluded.
• Current use of tobacco (i.e. smoke, smokeless, and vapor). If participant has used tobacco products ≤10 in the last year and ≤1 time in the last month, he or she will still be considered eligible.
• Females will be excluded if pregnant, lactating, or postmenopausal.
• Participants having any contraindications of having an MRI (such as claustrophobia, metallic implant, etc.).
• Participant has an abnormality or contraindication to study participation, which is not covered in the eligibility criteria.
Metabolic syndrome, Healthy Volunteers, Diabetes, Metabolism & Hormones, Metabolic Syndrome X
Peripheral Vasodilation in Obese Humans (ObeseDilate)
The growing population of obese adults is predicted to create a large public health burden in the next few decades. This study examines function of small blood vessels providing blood flow to skeletal muscles, to test if younger obese individuals (≤40 years old, BMI >30) are already displaying reductions in blood vessel function. This study will test if the signals blood vessels use to increase blood flow are changing in these same subjects. Findings from this study may help create treatments to delay or prevent some of the negative effects of obesity on vascular health.
William Schrage, PhD
18 Years to 40 Years old
• Age: ≥18
•≤ 40 years of age
• Blood pressure systolic ≤125 and diastolic ≤85 mmHg (Lean control) and <140 and diastolic <90 mmHg (Obese subjects)
• BMI <25 kg/m2 (Lean control) and ≥30 kg/m2 (Obese subjects)
• Fasting blood glucose <100 mg/dL
• Fasting LDL <130 mg/dL
• Fasting blood triglycerides <150 mg/dL
• Females: Premenopausal with a regular menstrual cycle. Negative pregnancy test. Note: Must be studied in the early follicular phase (day 1-5) of their menstrual cycle or the low hormone phase of oral contraceptive use.
• Specific to obese subjects only (to exclude obese subjects with metabolic syndrome): a. If Systolic BP 130 ≤ BP < 140 mmHg or Diastolic BP 85 ≤ BP < 90 mmHg i. HDL < 40 mg/dL for men ii. HDL < 50 mg/dL for women
• Increased risk of bleeding
• Sensitivity to lidocaine
• Procoagulant or other clotting disorders
• Taking cardiovascular medications (anti-hypertensives, statins, platelet inhibitors, etc.) or metabolic medications (insulin-sensitizing)
• Regularly (≥5 days/week) take acetylsalicylic acid and/or non-steroidal anti-inflammatory drugs (NSAIDs)
• Self-reported current diagnosis of exhibiting obstructive sleep apnea
• Self-reported current or past diagnosis of diabetes
• Self-reported history of peripheral vascular disease
• Self-reported history of hepatic disease
• Self-reported history of renal disease
• Self-reported history of hematologic disease
• Self-reported history of stroke
• Current use of tobacco (i.e. smoke, smokeless, and vapor). Prior tobacco use with >1 year abstaining is allowed.
• Participation in vigorous aerobic exercise >90 minutes per week
• Arterial structures in the arm that are not conducive to study in the laboratory setting
• Females: Self-reported pregnancy and/or breastfeeding, diagnosed with polycystic ovarian syndrome, or without regular menses. Urine pregnancy test will be performed on study day to ensure subject is not pregnant on study day.
• An abnormality or contraindication to study participation which is not covered in the eligibility criteria.
Obesity, Obesity, unspecified, Healthy Volunteers
Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)
The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a three year observation period off therapy.
6 Months to 18 Months old
• Adequate completion of informed consent process with written documentation. The participant's legally acceptable representative must have provided the appropriate written informed consent. Assent forms will not be used due to the age of the participant population; however, for procedures later in the study when participants are older, age appropriate assent will be obtained, if required by local Institutional Review Board (IRB).
• Age: 6-18 months of age inclusive at randomization which means 5 to 17 months of age inclusive on entry into the one month run-in period. At least half of all enrolled children will be between 6 and 12 months of age at randomization.
• Participants will meet at least one of the following criteria, which have been associated with an increased risk of wheezing respiratory illnesses and asthma: a) Parental history of asthma -or- b) Physician-diagnosed atopic dermatitis in the participant
•or- c) Physician-diagnosed asthma in a blood sibling aged 4 years or more.
• Participants may be either male or female.
• Participants will have at least one parent/guardian who can communicate with the study staff to allow assessment of study outcomes. All study materials used by parent/guardian will be made available in English and in Spanish. The child's parent/guardian must have a working direct contact telephone.
• Participants may not have had more than two prior WLRI episodes.
• Participants may not have had any SWLRI episodes.
• Participants may not have a physician's diagnosis of asthma.
• Participants may not have a systemic illness (other than allergy) including (but not limited to) recurrent seizures, chronic gastroesophageal reflux (GER) requiring medical treatment, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis or other chronic infections, primary or secondary immunodeficiency, gastrointestinal malformation or disease or cardiac disorder (except a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur).
• Participants may not have been born earlier than 36 weeks of gestation.
• Participants may not have received oxygen for more than 5 days in the neonatal period, or received mechanical ventilation with the exclusion of ventilation during anesthesia for a minor surgical procedure.
• Participants may not have significant neurodevelopmental delay.
• Participants may not be below the 3rd percentile for weight.
• Participants may not have any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis.
• Participants may not have a history of any life-threatening respiratory illness that required intubation and mechanical ventilation.
• The participant's family may not be expected to relocate out of study area within 3 years of the initiation of the study.
• Participants may not have received inhaled or systemic corticosteroids for respiratory related illness ever, or for other conditions in the month prior to randomization.
• Participants may not have ever received immunotherapy.
• Participants may not have ever received i.v. gammaglobulins or systemic immunosuppressants.
• Participants may not have received probiotics (Lactobacilli and Bifidobacteria) in medicinal form; (i.e. not including food), regularly for more than 4 months in the 6 to <12 mo age group or 6 months in the 12 to 18 month group prior to enrollment.
• Participant has known sensitivity to any of the study products and any of the ingredients to be administered.
• Participant has previously been randomized in this study. Participants who failed run-in and were not randomized may have study participation terminated and then be re-enrolled for a second run-in period.
• Participant is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s).
• Participant has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the participant, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator's opinion.
• The one month run-in period will be used to evaluate adherence to study drug administration and electronic communication. At randomization the participant must continue to meet enrolment criteria and also have demonstrated 80% adherence to the placebo during treatment period; i.e. 8 out of 10 days and a75% response rate to weekly mobile phone text queries; i.e. 3 out of 4 weekly text queries.
• Ongoing infection (of any organ system) at the time of randomization. This includes infections that are being adequately treated.
• Unable or unlikely to complete study assessments or the study intervention poses undue risk to patient in the opinion of the Investigator.
• Families will speak English and/or Spanish.
Asthma, Wheezing, Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics of MK-1654 in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.
Ellen Wald, MD
up to 8 Months old
Phase 1/Phase 2
• is healthy, based on screening safety laboratory, medical history, and physical examination results
• is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records
• weighs ≥2 kg at screening
• has been recommended to receive palivizumab per local standard of care
• has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening
• has a known hypersensitivity to any component of the respiratory syncytial virus (RSV) monoclonal antibody
• has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)
• has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive), or hepatitis C (HCV ribonucleic acid [RNA] positive)
• has known history of functional or anatomic asplenia
• has a diagnosis of failure to thrive within 14 days of screening
• has known or history of a coagulation disorder contraindicating intramuscular injection
• has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment
• has prior known documented RSV infection
• has hemodynamically significant congenital heart disease
• has chronic lung disease of prematurity requiring ongoing medical therapy
• has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study
• has any history of malignancy prior to randomization
• if any of the following apply, the Day 1 visit may be rescheduled for a time when these criteria are not met:
• has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
• is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
• has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose
• has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus Calmette-Guerin vaccine) less than 30 days pre-dose
• has received any prior vaccine or monoclonal antibody (mAb) for the prevention of RSV
• is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study (participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor)
• has enrolled previously in this study and been discontinued
• participant's mother participated in a RSV vaccine clinical study while pregnant and participant is ≤3 months of chronological age
• is unable to provide blood sample at screening
• cannot be adequately followed for safety according to the protocol plan
• has a parent/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study
• is, or has, an immediate family member (eg, spouse, parent/guardian, sibling, or child) who is directly involved with the study at the site or with the Sponsor
Respiratory Tract Infection, Respiratory Syncytial Virus, Healthy Volunteers, Lung & Respiratory, Children's & Adolescent Health, Prevention & Screening
SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding (SHIELD)
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.
Nasia Safdar, MD
18 Years and over
Early Phase 1
• Participant is a essential worker performing at least some in-person job duties (not 100% remote)
• Participant is willing and able to perform intervention and data collection procedures.
• Participant is able to provide informed consent in English language.
• Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment
• Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy)
• Participant has a known medical and/or surgical reason prohibiting nasal swab sampling.
• Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment.
• Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
COVID-19, SARS-CoV 2, Healthy Volunteers, Infections, Immune System & Allergies
Does Insulin Sensitivity Impact the Potential of Metformin to Slow Aging
Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the investigators hypothesize that metformin treatment in subjects free of type 2 diabetes will improve insulin sensitivity and glucoregulation in insulin resistant individuals, but will decrease insulin sensitivity and glucoregulation in insulin sensitive subjects. Further, the investigators hypothesize that long-term metformin treatment will remodel mitochondria in a way that decreases mitochondrial function in subjects that are insulin sensitive, but improves mitochondrial function in subjects that are insulin resistant. The investigators will use a dual-site, 12- week drug intervention trial performed in a double-blind, placebo-controlled manner on 148 subjects recruited from two separate sites (Oklahoma Medical Research Foundation (OMRF) and University of Wisconsin-Madison (UWM)). After consent and initial subject screening for chronic disease, subjects will be stratified to insulin sensitive (IS) or insulin resistant (IR) groups. Over a 12- week intervention, half of each group will take metformin and half will take a placebo. Pre- and post--intervention, subjects will complete a series of procedures to assess insulin sensitivity, glucose regulation, and biomarkers of aging. The same subjects will provide a skeletal muscle biopsy pre-- and post-intervention to assess the change in mitochondrial function and mitochondrial remodeling with and without metformin treatment. By completion of this project, the investigators expect to provide evidence that helps further delineate who may benefit from metformin treatment to slow aging.
Adam Konopka, PhD
40 Years to 75 Years old
• 40-75 years of age (inclusive)
• Free of chronic disease
• Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
• Able to use and be contacted by telephone.
• Able to speak, read, and understand English, and complete a questionnaire in English
• Independently mobile
• Heart disease (history, abnormal ECG, abnormal stress ECG)
• Cerebrovascular disease (history)
• Cancer (history)
• Chronic respiratory disease (history, forced expiratory volume at one second/forced vital capacity [FEV1/FVC] < 70, FEV1 < 80% predicted)
• Chronic liver disease (history, alanine transaminase [ALT] > 52 IU/L)
• Diabetes (history, HbA1C ≥ 6.5, fasting blood glucose≥126 mg/dl, oral glucose tolerance test [OGTT] ≥ 200 mg/dl at 2 hrs)
• Impaired kidney function (eGFR ,45 mL/min)
• B12 lab values outside of normal range (<193 or >982 pg/mL)
• Alzheimer's (history)
• Chronic kidney disease (history, abnormal blood kidney panel including serum creatinine > 1.4)
• Problems with bleeding, on medication that prolongs bleeding time (if subject cannot safely stop prior to biopsy)
• Those on glucose lowering drugs
• Those planning to have imaging that requires intravenous contrast dye (within 6 weeks) or are on any of the following medications since they are contraindicated with the use of metformin: Dofetilide, Lamotrigine, Pegvisomant, Somatropin, Trimethoprim, Trospium, Gatifloxacin, Cephalexin, Cimetidine, Dalfampridine
• Tobacco use
• Allergies to lidocaine or metformin
Healthy Volunteers, Aging & Geriatrics, Aging, Insulin Sensitivity, Chronic Disease, Mitochondria, Insulin Resistance
COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations (SARS)
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: - To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and - If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders
12 Years to 69 Years old
Inclusion Criteria:Individuals who meet all of the following criteria are eligible for enrollment as study participants: Both groups (e.g., High-Allergy and Mast Cell Disorder (HA/MCD) Group and Comparison Group): 1. Able to understand and provide informed consent 2. Male or non-pregnant female 12 to 69 years of age, inclusive, on the date of first study vaccination/placebo administration 3. Females of childbearing potential must have a negative pregnancy test prior to the first vaccination and placebo administration, if applicable. --If a participant becomes pregnant after receiving a placebo dose but prior to receiving study vaccination, she will be discontinued from the study 4. Females of reproductive potential° and sexually active must agree to use FDA approved methods of birth control for the duration of the study. These include hormonal contraceptives, intrauterine device, double barrier contraception (i.e., condom plus diaphragm), or male partner with documented vasectomy.
• Menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone of ≥25 U/mL must be documented.
• Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception. High-Allergy and Mast Cell Disorder (HA/MCD) Group: Individuals who meet at least one of the following criteria are eligible for enrollment in the HA/MCD group: 1. History of a severe allergic reaction to food(s), allergen immunotherapy, or insect venom(s) with use of epinephrine within the last 15 years 2. History of an Emergency Department visit with convincing evidence of a systemic allergic reaction (consistent with CoFAR Grade 3 or higher) to food(s), allergen immunotherapy, or insect venom(s) within the last 15 years 3. History of documented, immediate allergic reactions to 2 or more unrelated drugs within the last 15 years 4. A convincing clinical history, or a history that is accompanied by a positive skin test, of an immediate reaction to a drug or vaccine within the last 15 years 5. History of physician-diagnosed idiopathic anaphylaxis requiring epinephrine or an Emergency Department visit in the last 15 years 6. History of a physician-diagnosed mast cell disorder (e.g., mastocytosis, mast cell activation syndrome [MCAS], or hereditary alpha-tryptasemia). MCAS must meet consensus criteria as defined below:
• Criterion A: Typical clinical signs of severe, recurrent (episodic) systemic Mast Cell Activation are present (often in form of anaphylaxis) ---Definition of systemic: involving at least 2 organ systems
• Criterion B: Involvement of Mast Cell (MC) is documented by biochemical studies --- Preferred marker: increase in serum tryptase level from the individual's baseline to plus 20% + 2 ng/ml
• Criterion C: Response of symptoms to therapy with MC-stabilizing agents, drugs directed against MC mediator production or drugs blocking mediator release or effects of MC-derived mediators
• NOTE: All 3 Mast Cell Activation Syndrome (MCAS) criteria (A + B + C) must be fulfilled to call a condition MCAS. Comparison Group: Individuals who meet all of the following criteria are eligible for enrollment in the comparison group: 1. No history of allergic asthma or atopic dermatitis within the last 10 years 2. No history of chronic spontaneous urticaria, or angioedema 3. No history of allergic reactions to foods or insect venoms 4. No history of allergic reactions to drugs or vaccines 5. No history of anaphylaxis 6. No history of a mast cell disorder (e.g., mastocytosis, mast cell activation syndrome [MCAS], or hereditary alpha- tryptasemia)
Exclusion Criteria:Individuals who meet any of these criteria are not eligible for enrollment as study participants: 1. Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent, as applicable, or to comply with study protocol 2. Weight less than 36 kg (79 lbs) 3. Prior receipt of any doses of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) Vaccine, Moderna COVID-19 Vaccine, or any other COVID-19 vaccine 4. History of a severe reaction to any component of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine 5. History of contact dermatitis with confirmed patch test reaction to Prevalence of polyethylene glycol (PEG) 6. History of reaction to Doxil® 7. Known exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and still within the quarantine window 8. Symptoms consistent with acute COVID-19 infection or known COVID-19 infection (positive Polymerase chain reaction [PCR] or antigen test) and still within the quarantine window 9. Have an acute illness, including body temperature greater than 100.4 degrees Fahrenheit, within 14 days of the first study vaccination/placebo administration or 3 days prior to each subsequent vaccination 10. History of autoimmune or other disorders requiring systemic immune modulators 11. History of acute urticaria within 28 days of randomization 12. Pregnant 13. Have received any vaccines within 14 days of the first study vaccination/placebo administration or plan to receive other vaccines during the study period 14. Had any allergen immunotherapy administration within 24 hours prior to vaccination/placebo administration or plan to receive within 24 hours after vaccination/placebo administration 15. Have received a biologic therapy within 6 months of randomization 16. Use of systemic steroids for any reason within 28 days of randomization 17. Use of Zileuton® within 14 days of randomization 18. Use of Emergency Use Authorization (EUA) monoclonal antibodies casirivimab and imdevimab, or bamlanivimab, or any other antibody agent for treatment or prevention of COVID-19 within 3 months of randomization 19. Have past or current medical problems or findings from physical exam or laboratory testing not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study or which may interfere with the ability to comply with study requirements
Infections, Immune System & Allergies, Healthy Volunteers, SARS-CoV Infection, COVID-19, Allergic Reaction, Mast Cell Disorder
Systems Biology of Early Atopy (SUNBEAM)
The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: - To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years, with an emphasis on atopic dermatitis and food allergy - To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes - To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development
Inclusion Criteria:Pregnant Women- Pregnant women who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent 3. Pregnant at any stage 4. Planning to give birth at a study-site designated center 5. Agrees to enroll offspring into the study at birth 6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order Biological Fathers- Biological fathers who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
Exclusion Criteria:Pregnant Women- Pregnant women who meet any of these criteria are not eligible for enrollment: 1. Inability or unwillingness to comply with study protocol 2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment 3. Fetus has a major chromosomal anomaly 4. Plans to move and would not be available for in-person visits at a study site 5. Plans to give up her child for adoption at birth 6. Pregnancy is the result of an egg donation Infants- Infants who meet any of these criteria are not eligible for enrollment: 1. Delivered earlier than 34 weeks of gestation 2. Sibling already enrolled 3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest Biological Father- 1. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment ----Note Regarding Legal Guardians who are not the Biological Parents: 1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment 2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:
• Agrees to meet the child's study requirements, and
• Provides written informed consent for the child's continued participation. 3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures
Allergic Diseases, Food Allergy, Atopic Dermatitis, Healthy Volunteers, Food & Nutrition, Infections, Immune System & Allergies
Pilot RECAP Study in Healthy Normal Volunteers (RECAP)
The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.
Christopher Nicholas, PhD
21 Years to 60 Years old
• Age 21 to 60 years at screening
• Medically healthy (does not meet criteria for an exclusionary medical condition)
• No current DSM-5 psychiatric diagnosis
• No current use of psychotropic medications
• Ability/willingness to complete all study activities
• Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)
• Speaks and reads English
• No use of psychedelic drugs within prior 3 months
• Able to swallow oral medications
• Current exclusionary medical illness
• Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behavior within prior 12 months
• Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
• Clinically significant electrocardiogram (ECG)
• Hypertension or tachycardia
• First degree relative(s) with a history of schizophrenia, schizophreniform disorder, bipolar I disorder, bipolar II disorder, major depressive disorder with psychotic features
Psychedelic Experiences, Amnesia, Major depressive disorder, recurrent, Persistent mood [affective] disorders, Healthy Volunteers, Mental & Behavioral Health