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within category "Healthy Volunteers"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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
Female
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03047161
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Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
HealthyVolunteers, Supervision of high risk pregnancy, Other, Fetal Arrhythmia
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
The purpose of this research is assess imaging and identification of soft plaque that
undergoes large deformations or strain will identify plaque vulnerable to rupture which could
lead to 'silent strokes'. Validation of current study results with MRI will foster use of
real-time ultrasound (US) strain imaging and strain indices as a screening tool for
identifying normal human participants susceptible to increased vascular aging and developing
plaque prone to rupture or micro-embolization.
Current research will evaluate Lagrangian carotid strain imaging (LCSI) for prediction of
vascular health on volunteers. In this study, investigators will evaluate age-related strain
variations (due to plaque deposition) in the carotid artery, establishing groundwork that
will help identify typical and atypical values for these indices. Investigator's hypothesis
is that plaques with higher strain indices (softer plaques) are more prone to rupture than
plaques with lower strain indices (stiffer) plaques, thus requiring intervention. Clinical
criteria for treatment has focused primarily on the degree of stenosis. Long-term objectives
are to provide non-invasive methods for screening participants at risk for vascular aging or
plaque rupture in asymptomatic participants, expanding upon current criteria for risk
assessments based on focal transient ischemic attack (TIA) or strokes. Variations in vessel
strain have been associated with, or are precursors to, plaque deposition, vascular aging, or
cerebrovascular diseases. Increased arterial strain and pressure changes have been linked to
brain aging using magnetic resonance imaging (MRI) based vascular indices, and memory
deficits commonly linked to Alzheimer dementia. Stiffening and thickening of the arterial
walls have also been associated with cerebrovascular disease. Investigators hypothesize that
strain indices as vascular biomarkers can be utilized for screening possible 'vulnerable
participants' validated with MRI, with the potential ability to improve endothelial function
and reverse vascular aging. Strain indices may enable differentiating study participants with
vascular cognitive impairment (VCI) from other dementias. Cognitive testing is unable to make
this differentiation.
Tomy Varghese, Ph.D.
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04632485
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Inclusion Criteria:
Aim 1 (Ultrasound (US) only):
• Adults at least 18 years
• Are able to provide written informed consent on their own behalf
Aim 2 (US and MRI):
• Participation in the US study (Aim 1)
• Determined by presence of hypoechogenic or echolucent lipid-rich soft plaque during
initial ultrasound imaging session
• Adults willing to participate over 5 years
Exclusion Criteria:
Aim 1 (US only)
• Women that are currently pregnant
• Inability to cooperate with the ultrasound study, in particular those unable to sit
without gross movement for the duration the ultrasound study (estimated at 60-90
minutes)
• Open wounds or sores in the anterior neck
• History of cardiac disease, stroke or TIA
• History of statin medication
• History of hypertension medications
Aim 2 (US and MRI):
• Women that are currently pregnant
• Inability to cooperate with the ultrasound study, in particular those unable to sit
without gross movement for the duration the ultrasound study (estimated at 60-90
minutes)
• Patients that require intravenous (IV) conscious sedation for imaging are not
eligible; patients requiring mild, oral anxiolytics for research imaging will be
allowed to participate as long as:
• The participants has their own prescription for the medication;
• The informed consent process is conducted prior to the self-administration of this
medication; and,
• The participant comes to the research visit with a driver
• Contraindications to MR
• Unable to lie in the MRI scanner for 45-60 minutes
• Patients with a contraindication to gadolinium based contrast agents, including
allergy or impaired renal function (per University of Wisconsin Health Guidelines)
Healthy, Carotid Artery Diseases, HealthyVolunteers, Other
Antecedent Metabolic Health and Metformin Aging Study (ANTHEM)
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
All
40 Years to 75 Years old
Phase 3
This study is also accepting healthy volunteers
NCT04264897
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Inclusion Criteria:
• 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
Exclusion Criteria:
• Pregnancy
• 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
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by
amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study
will also evaluate the long-term safety and tolerability of lecanemab in participants
enrolled in the Extension Phase.
Cynthia Carlsson, MD
All
55 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04468659
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Inclusion criteria:
Participants must meet all of the following criteria to be included in this study:
1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a
plasma biomarker result that is predictive of intermediate or elevated brain amyloid
at Screening or known before Screening to have elevated or intermediate amyloid
according to previous PET, cerebrospinal fluid (CSF), or plasma testing
• Those 55 to 64 must have 1 of the following additional risk factors, given the
relatively low rates of amyloid positivity less than (<) 65 years, before screening:
• First degree relative diagnosed with dementia onset before age 75, or
• Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or
• Known before screening to have elevated brain amyloid according to previous
plasma biomarker results, PET imaging, or CSF testing
2. Global Clinical Dementia Rating (CDR) score of 0 at screening
3. Mini Mental State Examination score greater than or equal to (>=) 27 (with educational
adjustments) at screening.
4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at
screening of >=6
5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately
greater than (>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of
brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids
on screening scan
6. Has a study partner that is willing to participate as a source of information and has
approximately weekly contact with the participant (contact can be in-person, via
telephone or electronic communication). The study partner must have sufficient contact
such that the investigator feels the study partner can provide meaningful information
about the participant's daily function
7. Provide written (or electronic, if allowed per country-specific regulations) informed
consent
8. Willing and able to comply with all aspects of the protocol
For extension phase :
1. Completed the Core Study, or meet the following progression criteria during the Core
Study:
• Two consecutive CDR visits with Global Scores > zero when measured at least 6
months apart within the Core Study
• The principal investigator's confirmation that the participant has clinically
declined consistent progression to EAD
2. Must continue to have a study partner who is willing and able to provide follow-up
information on the participant throughout the course of the Extension Phase. The study
partner must provide separate written informed consent for the Extension Phase. Study
partners must continue to have sufficient contact such that the investigator feels the
study partner can provide meaningful information about the participant's daily
functions
3. Provide written informed consent for the Extension Phase. If a participant lacks
capacity to consent in the investigator's opinion, the participant's assent should be
obtained, if required and in accordance with local laws, regulations, and customs,
plus the written informed consent of a legal representative (capacity to consent and
the definition of a legal representative should be determined in accordance with
applicable local laws and regulations). In countries where local laws, regulations,
and customs do not permit participants who lack capacity to consent to participate in
this study (example, Spain), they will not be enrolled
4. Willing and able to comply with all aspects of the protocol
Exclusion criteria:
Participants who meet any of the following criteria will be excluded from this study:
1. Females who are breastfeeding or pregnant at screening or baseline
2. Females of childbearing potential who:
• Within 28 days before study entry, did not use a highly effective method of
contraception For sites outside of Europe, it is permissible that if a highly
effective method of contraception is not appropriate or acceptable to the participant,
then the participant must agree to use a medically acceptable method of contraception
3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of
screening
4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that,
in the opinion of the investigator, could interfere with study procedures
5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including
cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and
cardiac devices other than those approved as safe for use in MRI scanners), or exhibit
other significant pathological findings on brain MRI at Screening
6. Hypersensitivity to any monoclonal antibody treatment
7. Any immunological disease which is not adequately controlled, or which requires
treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of
monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the
study
8. Bleeding disorder that is not under adequate control (including a platelet count
<50,000 or international normalized ratio [INR] >1.5) at screening
9. Results of laboratory tests conducted during screening that are outside the following
limits:
• Thyroid stimulating hormone (TSH) above normal range
• Abnormally low (below lower limit of normal [LLN]) serum vitamin B12 levels for
the testing laboratory (if participant is taking vitamin B12 injections, level
should be at or above the LLN for the testing laboratory). A low vitamin B12 is
exclusionary, unless the required follow-up labs (homocysteine and methylmalonic
acid [MMA]) indicate that it is not physiologically significant
10. Known to be human immunodeficiency virus (HIV) positive
11. Any other clinically significant abnormalities that in the opinion of the investigator
require further investigation or treatment or may interfere with study procedures or
safety
12. Malignant neoplasms within 3 years of screening (except for basal or squamous cell
carcinoma in situ of the skin, or localized prostate cancer in male participants with
treatment cycles completed at least 6 months before screening). Participants who had
malignant neoplasms but who have had at least 3 years of documented uninterrupted
remission before screening need not be excluded
13. Answer "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type
4 or 5, or any suicidal behavior assessment within 6 months before screening, at
screening, or at baseline, or has been hospitalized or treated for suicidal behavior
in the past 5 years before screening
14. Known or suspected history of drug or alcohol abuse or dependence within 2 years
before screening or a positive urine drug test at screening. Participants who test
positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug
testing need not be excluded unless in the clinical opinion of the investigator this
is due to potential drug abuse
15. Taking prohibited medications
16. Participation in a clinical study involving:
• Any anti-amyloid plaque lowering immunotherapy (example, therapeutic monoclonal
antibody or active anti-amyloid vaccine) at any time, unless it can be documented
that the participant was randomized to placebo or never received study drug
• Any immunoglobulin therapy, or vaccine within 6 months before Screening, unless
it can be documented that the participant was randomized to placebo or never
received study drug
• Lecanemab
• Any new chemical entities or investigational drug for AD within 6 months before
randomization unless it can be documented that the participant received only
placebo
• Any other investigational medication or device study in the 8 weeks or 5
half-lives (whichever is longer) of the medication before randomization unless it
can be documented that the participant was in a placebo treatment arm
17. Planned surgery during the pre-randomization phase or within 3 months of
randomization, which requires general anesthesia
For extension phase:
1. Discontinued from the Core Study or from study treatment
2. Under study drug interruption due to ARIA or other AE at the time of transition to the
extension phase
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
James Gern
All
0 Years and over
NA
This study is also accepting healthy volunteers
NCT04798079
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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
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI)
biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including
fractional flow change in the portal vein and elevated azygos flow.
End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and
portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol
abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its
aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage
liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic
collaterals that shunt blood away from the liver develop due to increased portal pressure.
Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal
internal bleeding. GEV bleeding carries ~20% mortality at 6 weeks, and ~34% overall
mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance
to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines
recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of
high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%.
However, endoscopy is invasive and often unnecessary when no treatment is required.
Therefore, the American Association for the Study of Liver Diseases has identified the
development of "non-invasive markers that predict the presence of high-risk varices" as a
major unmet need.
Scott Reeder, MD, PhD
All
18 Years and over
Pilot
This study is also accepting healthy volunteers
NCT04867954
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Inclusion Criteria for Aim 1:
•
Healthy volunteers
: Adults (>18 years) with no known liver pathology
• Obese volunteers: Adults (>18 years), no known liver pathology, body mass index (BMI)
≥ 35
• Patients: Adults (>18 years) with known cirrhosis and known Gastroesophageal varices
Exclusion Criteria for Aim 1:
• contraindications to MRI
• hypersensitivity reactions to both contrast agents
• patients with recent treatment for varices with embolization, TIPS, or other
endovascular treatment
• patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic
vein, or superior mesenteric vein.
• patients with large HCC with known PC involvement.
Inclusion criteria for Aim 2-4:
• Adults (>18 years) with known cirrhosis scheduled for EGD to assess for GEV.
Exclusion Criteria for Aim 2-4:
• Contraindications to MRI
• Recent treatment (< 1 year) for varices
• recent (< 1 year) GEV bleeding
• Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein
• Large hepatocellular carcinoma (HCC) with known PV involvement
• hypersensitivity reactions to both contrast agents
Vitamin A Status in Patients With Vocal Fold Leukoplakia
This study will determine systemic vitamin A status and lesion histopathology of participants
with vocal fold hyperkeratosis resulting in clinical leukoplakia.
Nathan Welham
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05323292
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Inclusion Criteria:
1. Willing to provide informed consent.
2. Willing to comply with all study procedures and be available for the duration of the
study.
3. Ability to take oral medication.
4. At least 18 years of age.
5. Leukoplakia study groups:
1. Leukoplakia due to hyperkeratosis with dysplasia: biopsy-confirmed diagnosis of
hyperkeratosis with dysplasia.
2. Leukoplakia due to hyperkeratosis with no dysplasia: biopsy-confirmed diagnosis
of hyperkeratosis with no dysplasia.
6. Control group: Laryngoscopy showing no evidence of vocal fold mucosal disease.
Exclusion Criteria:
1. History of malignant vocal fold mucosal pathology.
2. History of metabolic or liver disorder.
3. History of anorexia or bulimia.
4. Pregnant, lactating, or planning on becoming pregnant during the study period.
5. History of >4.5 kg weight loss in the past 90 days.
6. Medical or other inability to complete an 8 hour fast.
7. Acute respiratory or gastrointestinal illness.
8. Currently incarcerated.
9. Impaired decision-making capacity.
10. No or limited English speaking ability; illiterate or low-literacy ability.
11. Profound visual or hearing impairment that limits written or verbal communication.
12. Status relationship with a member of the study team.
13. Not suitable for study participation due to other reasons at the discretion of the
investigators.
Diseases of vocal cords and larynx, Other, Vitamin A, Vitamin A Deficiency, Leukoplakia, Vocal Cord Neoplasm, HealthyVolunteers, Food & Nutrition
The objective of RAP PAC is to identify safe and effective weekly dose(s) for the mTOR
inhibitors sirolimus and everolimus that intervene on the underlying fundamental biology of
aging. Participants who are 55-89 years old that are free of overt chronic diseases will be
assigned to either 6 weeks of sirolimus or everolimus (5 mg, 10 mg, or 15 mg once per week).
The investigators will complete the everolimus arm first and then subsequently complete the
sirolimus arm of the study. Total time on study would be up to 17 weeks to complete baseline
and follow up visits.
Adam Konopka
All
55 Years to 89 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05949658
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Inclusion Criteria:
• Middle-age adults free of overt chronic disease
• Willing to provide informed consent
• Willing to comply with all study procedures and be available for the duration of the
study
• Able to use and be contacted by telephone
• Ability to take oral medication
• Not planning to change diet or physical activity status
• Adequate organ function as indicated by standard laboratory tests: hematology
(complete blood count), and clinical chemistry
• Males must agree to avoid impregnation of women during and for four weeks after
completing study visits through use of an acceptable method of contraception
Exclusion Criteria:
• Heart disease (history, abnormal ECG)
• Cerebrovascular disease (history)
• Cancer or less than 5 years in remission (history)
• Chronic respiratory disease (history, FEV1/FVC < 70, FEV1 < 80% predicted)
• Chronic liver disease (history, abnormal blood liver panel, ALT >104 IU/L, AST >80
IU/L)
• Diabetes (history, HbA1C ≥ 6.5, fasting blood glucose≥126 mg/dl, OGTT ≥ 200 mg/dl at 2
hrs.)
• Alzheimer's (history)
• Chronic kidney disease (history, abnormal blood kidney panel including serum
creatinine>1.4, eGFR≤60 ml/min/1.73m2)
• Problems with bleeding, on medication that prolongs bleeding time (if subject cannot
safely stop prior to biopsy)
• Taking azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune),
dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone
(Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and
tacrolimus (Prograf) or other medications proposed to lower the immune system
• Taking strong or moderate CYP3A4 and/or P-glycoprotein (PgP) inhibitors such as
ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,
telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, amprenavir,
fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem
• Taking strong CYP3A4 activators such as phenytoin, carbamazepine, rifampin, rifabutin,
rifapentine, phenobarbital
• Subjects who are not willing to restrict the use of grapefruit, grapefruit juice,
cannabidiol (CBD) and other foods/substances that are known to inhibit cytochrome P450
and PgP activity and may increase everolimus exposures and should be avoided during
treatment
• Subjects who are not willing to restrict the use of St. John's Wort (Hypericum
perforatum) because it may decrease everolimus exposure unpredictably.
• Subjects who are not willing to avoid blood donations 8 weeks prior to the first visit
and 8 weeks after the last visit
• Low white-blood cell count (<4,000 cell/µL)
• History of stomatitis or ulcers in the mouth
• Those on glucose lowering drugs
• Participating in intensive exercise training program (high to moderate intensity
exercise greater than 150 minutes per week) or planning to start new exercise program
during study period
• Tobacco use
• Allergies to lidocaine, sirolimus, or everolimus
• Subjects currently enrolled in other clinical trials. Subjects may be eligible after a
washout period that will be reviewed on a case-by-case basis.
• Individuals with limited English proficiency
• Subjects who are planning to have elective surgery 12 weeks prior to or during the
intervention
The goal of this observational study is to determine the feasibility of renal Near Infrared
Spectroscopy (NIRS) monitoring in the newborn nursery for newborns at low risk of coarctation
of the aorta (CoA). The main questions it aims to answer are:
- whether continuous renal NIRS monitoring is feasible;
- whether NIRS monitoring results in higher nursing and parent/caregiver satisfaction than
current standard monitoring; and,
- whether participants who develop CoA will spend a smaller proportion of time within the
normal range than patients who do not have CoA.
Participants will be observed through continuous renal oxygenation monitoring with NIRS.
Matthew Harer, MD
All
15 Years and over
Pilot/Feasibility
This study is NOT accepting healthy volunteers
NCT05842876
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Neonate
Inclusion Criteria:
• Delivered at ≥ 35 weeks of gestation
• <12 hours of age
• Inpatient at Meriter Hospital, Inc. NICU or Newborn Nursery or AFCH PICU or NICU
• Diagnosed as at risk for CoA
Neonate
Exclusion Criteria:
• Major congenital anomalies of the kidney
• Attending physician's discretion to not place sensors due to clinical concerns
• In the researcher's medical opinion, there is a significant likelihood that the
neonate would not survive the first 3 days of life
Primary Caregiver
Inclusion Criteria:
• Able to understand and the willing to sign a written informed consent document
• Willing to comply with all study procedures and be available for the duration of the
study
• Birth parent (i.e., the parent who gave birth to the baby) who is the primary
caregiver of a neonate who is eligible to participate in study
• Agrees to enroll neonate into study
• Aged 15 years or older
• Pregnant mother with a baby diagnosed prenatally as at risk for CoA will be eligible
for the study. They must also meet the following criteria:
• Require an "arch watch care plan" as a results of prenatal ultrasonography findings
• Agree to enroll offspring into the study at birth
Primary Caregiver
Exclusion Criteria:
• Subject is unable to provide informed consent, including subjects who are in foster
care and subjects within state custody
• Pregnant woman who does not plan to maintain custody of the child after birth, such as
instances of adoption or surrogacy
Newborn Nursery Nursing Staff:
• All Newborn Nursery nursing staff at Meriter Hospital, Inc.'s Newborn Nursery are
eligible to participate
This study is called the Microbes and Respiratory Illnesses (MARI) Study. Children growing up
on farms are exposed to many types of microbes that could be beneficial. It is thought that
increased exposure to certain types of microbes early in life helps to develop a healthy
immune system and reduce the risk for severe common cold illnesses, breathing problems, and
allergies.
James Gern
All
4 Years to 12 Years old
N/A
This study is also accepting healthy volunteers
NCT06059027
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Inclusion Criteria:
1. Participant and/or parent guardian must be able to understand and provide informed
consent
2. Children ages 4-12 years of age
3. Cohort 1: Family is self-identified as Plain community member
4. Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
5. Cohort 3: Madison-area children with no history of asthma by parental report
6. Cohort 4: Madison-area children who have an active respiratory illness
Exclusion Criteria:
1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol
2. Chronic sinusitis (frequent sinus infections)
3. Plans to move out of the area before completing the study
4. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study
5. Enrolled family member
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease
vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately
9,000 healthy participants 5 years and older will be recruited from areas with high levels of
endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of
saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50%
chance of receiving placebo. A subset of participants will receive VLA15 from 3 different
lots or placebo (1:1:1:3 ratio) to assess lot equivalence.
Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9
months and then receive a booster dose about 12 months later. Vaccination of participants
will occur at a time of year such that the primary series is completed before the peak Lyme
disease season followed by a booster dose just prior to the beginning of the second Lyme
disease season.
Comparison will be made between the Lyme disease cases of people receiving the study vaccine
to those of the people who are not. This will help us determine if the study vaccine is safe
and effective.
If enrolled, participants will need to visit the research site at least 7 times during the
study. There will also be at least 5 telephone contacts. It is expected that each participant
will take part in this study for up to about 2 and a half years.
Robert Striker
All
5 Years and over
Phase 3
This study is also accepting healthy volunteers
NCT05477524
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Key
Inclusion Criteria:
• Participants who reside in areas with endemic Lyme disease and who lead lifestyles
that put them at increased risk for Lyme disease. For example, this could include, but
not be limited to:
• Individuals who work in B burgdorferi-infected/tick-infested areas, especially those
with occupations that may be associated with higher risk of exposure, such as
landscaping, forestry, and wildlife and parks management.
• Individuals who pursue recreational activities such as hiking, camping, fishing,
hunting, jogging, or gardening in such areas.
• Individuals who live on land plots with tree lines and come into contact with these
trees regularly.
• Individuals who have dogs that regularly are outdoors and frequently return with
attached ticks.
• Individuals who participate in activities in areas with tall grass, smaller wooded
areas beside forests, open fields, lakesides, and riversides.
Key
Exclusion Criteria:
• Any female participants that are pregnant (or have a positive urine pregnancy test) or
are breastfeeding.
• Any diagnosis of Lyme disease within the past 3 months.
• Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated
Lyme disease regardless of when diagnosed.
• Known tick bite within the past 4 weeks.
• Newly developed or unstable underlying conditions that may interfere with the
assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis,
second/third-degree AV heart block, chronic pain syndromes, and chronic skin
conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
• Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic)
that may interfere with the assessment of Lyme disease.
• Chronic systemic doxycycline or minocycline or other tetracycline class drug use for
acne or any other chronic suppressive antibiotics used to treat other conditions.
Comparison of Microglial Activation in Severe Asthma and Healthy Controls (MAIA-SC)
The goal of this clinical trial is to learn about how asthma influences brain function. The
main questions it aims to answer are:
- How airway inflammation in asthma affects the brain; and,
- Whether airway inflammation in asthma is related to symptoms of depression and anxiety
Over the course of 3 visits, participants will:
- Complete questionnaires
- Complete computer tasks
- Undergo allergy skin test and breathing tests
- Give two blood samples
- Give a sputum sample
- Complete brain imaging scans
Researchers will compare results between participants with asthma, and participants who do
not have asthma.
Melissa Rosenkranz, PhD
All
18 Years to 75 Years old
N/A
This study is also accepting healthy volunteers
NCT06299592
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Inclusion Criteria:
• Ability to understand and the willingness to sign a written informed consent document
• Individuals with no health concerns that might affect the outcome of the study
• Age 18-75 years of age
• Ability to tolerate a simulated MRI brain scanning session
• In the opinion of the investigator, capable and willing to grant written informed
consent and cooperate with study procedures and requirements
• High-affinity TSPO-binding genotype. Mixed (high/low) binding-affinity genotype may be
included at PIs discretion
• For participants with severe asthma:
• Physician diagnosis of asthma for at least six months prior to screening (can be
determined at the discretion of an asthma/allergy physician member of the study team)
• Severe asthmatics must meet the ATS definition of severe asthma and/or be currently
receiving a GINA 5 therapy (or greater), which may include ongoing use of currently
approved biologic immunomodulators
Exclusion Criteria:
• Current smoker (defined as more than 0.5 pack per week for the past 6 months and any
smoking within two weeks of study procedures) or has a smoking history exceeding 5
pack years within the last 10 years
• Currently receiving immunotherapy
• Use of psychotropic medication that might affect function of neurocircuitry implicated
in our hypotheses (at the discretion of the PI/Co-I)
• Inability to hold medications detailed in the medication hold schedule
• Needle phobia or claustrophobia
• Major health problems such as autoimmune disease, history of carotid stenosis, heart
disease, uncontrolled hypertension, or lung diseases other than asthma, history of
significant arrhythmias, and any of the following in the last 6 months: stroke/TIA,
myocardial infarction, stent placement, or acute coronary syndrome. The listed health
problems are definitively exclusionary, but decisions regarding major health problems
not listed will be based upon the judgment of the investigator
• Use of biologic medication that might affect signaling pathways under investigation
(at the discretion of the PI/Co-I)
• Pre-existing chronic infectious disease
• Scheduled use of non-selective beta-blockers prior to each study visit.
• Use of an investigational drug within 30 days of entering the study. This criterion
will be reviewed on a case by case basis by the PI/Co-I to determine appropriate
washout period. Appropriate wash out period may be greater than 30 days depending on
the half-life of the investigational drug. Participants may be eligible for study
participation after completing the washout period designated by the PI or Co-I
(physician only).
• Any MRI incompatibility as determined by most current MRI screening form
• History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder
• History of serious head trauma or seizure disorder (can be included at the discretion
of the PI or Co-I)
• Unable, in the judgement of the investigator, to comply with directions and/or
tolerate the procedures required for participation in this study
• Pregnant or breast-feeding or has a planned pregnancy during the course of the study
• Any other medical condition or disease that would impact participant safety or data
integrity in the opinion of the PI/CO-I
Asthma, Other, Infections, Immune System & Allergies, HealthyVolunteers
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