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Study Matches
Childhood Allergy and the Neonatal Environment (CANOE)
The purpose of this research study is to study the relationship between childhood asthma,
allergies, and early-life environmental factors that may cause childhood asthma and
allergies. Previous birth cohort studies have found early-life environmental factors such as
allergies, pollutants, viruses and bacteria have all contributed to the development of asthma
and allergies. Investigators are doing this research because there continues to be a strong
need to understand the root causes of asthma and allergies. The CANOE study is an
observational cohort study, which means investigators are not asking participants or
participant's child to change their medications and investigators will not be giving
participants or participant's child a study drug.
Anne Singh
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04215783
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Inclusion Criteria:
1. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic
parent or sibling (at least one shared biological parent) by parental report. The
presence of paternal or sibling allergy or asthma will be ascertained by maternal
report.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.
Exclusion Criteria:
1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the
study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.
• Progesterone use is only an exclusion if currently being taken at time of
enrollment for preterm birth. Previous use to prevent preterm birth or use at any
time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are
permitted).
6. Past or current medical problems or findings from physical examination or laboratory
testing which, in the opinion of the investigator or designee, 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.
Asthma in Children, Allergy, Allergic rhinitis due to animal (cat) (dog) hair and dander, Allergic rhinitis due to food, Allergic rhinitis due to pollen, Asthma, Other, Infections, Immune System & Allergies
The mission of the SARP is to improve the understanding of severe asthma through integrated
study of its clinical and biological features and to evaluate their changes over time. The
ultimate goal of these efforts is to promote better treatments for severe asthma.
Loren Denlinger, MD, PhD
All
6 Years and over
N/A
This study is also accepting healthy volunteers
NCT01606826
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Asthmatic Patients:
Inclusion Criteria:
1. Physician diagnosis of asthma,
2. Age 6 years and older
3. Evidence of historical reversibility, including either:
• FEV1 bronchodilator reversibility ≥ 12%, or
• Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.
Exclusion Criteria:
1. Pregnancy during the characterization phase,
2. Current smoking,
3. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years
if <30 years of age (Note: if a subject has a smoking history, no smoking within the
past year),
4. Other chronic pulmonary disorders associated with asthma-like symptoms, including (but
not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic
bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and
at the PI's discretion), severe scoliosis or chest wall deformities that affect lung
function, or congenital disorders of the lungs or airways,
5. History of premature birth before 35 weeks gestation,
6. Unwillingness to receive an intramuscular triamcinolone acetonide injection,
7. Evidence that the participant or family may be unreliable or poorly adherent to their
asthma treatment or study procedures,
8. Planning to relocate from the clinical center area before study completion,
9. Any other criteria that place the subject at unnecessary risk according to the
judgment of the Principal Investigator and/or attending physician(s) of record, or
10. Currently participating in an investigational drug trial for asthma therapies.
Healthy Controls:
Inclusion criteria: Healthy subjects between the age of 18 and 65 years. Exclusion criteria
1. History of chronic diseases that affect the lungs,
2. A history suggestive of allergic rhinitis, eczema or chronic sinusitis,
3. An improvement in FEV1 of more than 12% following 4 puffs of albuterol,
4. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years
if <30 years of age, or any smoking within the past year,
5. Respiratory tract infection within the past 4 weeks,
6. Pregnancy,
7. History of premature birth (<35 weeks).
This trial is a randomized, double-blind, placebo controlled trial designed to test whether
two years treatment of preschool children aged 2-3 years of age at high risk for asthma with
omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as
reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2
year observation period off study drug.
Daniel Jackson
All
24 Months to 47 Months old
Phase 2
This study is NOT accepting healthy volunteers
NCT02570984
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Inclusion Criteria:
1. Parent/guardian must be able to understand and provide signed and dated written
informed consent; he/she must also be able to communicate with study staff.
2. 24-47 months of age at randomization
3. 2-4 wheezing episodes in the past year
4. positive allergy to aeroallergen
5. first degree relative with history or current diagnosis of asthma or allergy
6. If is participating in a food immunotherapy treatment that is not part of a clinical
trial, has been on an established maintenance regimen implemented continuously for a
minimum of 2 months.
Exclusion Criteria:
1. >4 episodes of wheezing in the past year
2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
3. Need for systemic corticosteroids or a hospitalization for respiratory symptoms within
four weeks prior to screening.
4. Three or more courses of systemic corticosteroids for wheezing illnesses in the last
year
5. More than four days of symptoms of wheezing, or tightness in the chest or cough in the
past two weeks causing at least minimal limitation of activity
6. More than four days of albuterol treatment (for symptoms) in the past two weeks
7. More than one night of symptoms of wheezing, or tightness in the chest or cough
causing sleep disruption in the past two weeks
8. More than one night of albuterol treatment (for symptoms) in the past two weeks
9. Prematurity (<34 weeks gestation)
10. Need for oxygen for more than 5 days in the neonatal period
11. History of intubation or mechanical ventilation for respiratory illness
12. Other significant medical conditions, including: major congenital anomalies, cystic
fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery,
history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders
13. Expecting to relocate within 4 years of study initiation to a place which would make
in-person clinical visits impossible
14. Deemed unable to adhere to study activities
15. Prior aeroallergen immunotherapy or use of biologics including anti-IgE
16. Prior IVIG or systemic immunosuppressant other than corticosteroids
17. History of hypoxic seizures during a wheezing episode
18. Total IgE outside of the omalizumab dosing range.
19. Enrolled in any clinical medication trial within the past 30 days.
20. With platelet counts < 150 x 109/L at the Screening Visit (V0)
21. 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 may impact the quality or interpretation
of the data obtained from the study.
22. History of severe anaphylactic/anaphylactoid reactions from any cause
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS)
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in
prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or
mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH)
compared to macitentan 10 mg.
James Runo, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04273945
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Inclusion Criteria:
• Target population: greater than or equal to (>=) 18 (or the legal age of consent in
the jurisdiction in which the study is taking place) years of age
• Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health
Organization Functional Class (WHO FC) II, III, or IV
• Target population: PAH subtype falling in one of the below classifications:
Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease,
HIV infection, Portal hypertension, and Congenital heart disease with
small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial
septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular
septal defect) which does not account for the elevated pulmonary vascular resistance
(PVR) or persistent PAH documented by an Right heart catheterization (RHC) >= 1 year
after simple systemic-to pulmonary shunt repair
• PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to
screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20 millimeters of
mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end
diastolic pressure (LVEDP) less than or equal to (<=) 15 mm Hg, and PVR >= 3 Wood
Units (that is, >= 240 dyn*sec/cm^5)
• Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters
(m) and maximum distance of 440m at screening. Participants able to walk more than
440m at screening are eligible if they are in WHO FC III or IV and n-terminal
prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide
(NT-proBNP) level is >=300 nanograms per liter (ng/L) at screening, based on central
laboratory results
Exclusion Criteria:
• Known presence of three or more of the following risk factors for heart failure with
preserved ejection fraction at screening, based on records that confirm documented
medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2),
Diabetes mellitus of any type, Essential hypertension (even if well controlled);
Coronary artery disease, that is, any of the following: history of stable angina, or
known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial
infarction, or history of or planned coronary artery bypass grafting and/or coronary
artery stenting
• Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after
bronchodilator administration) ) in participants with a known or suspected history of
significant lung disease as documented by a spirometry test performed within 1 year
prior to screening
• Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based
on records that confirm documented medical history
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >
1.5*upper limit of normal (ULN) at screening
• Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
Pulmonary Arterial Hypertension, Other pulmonary heart diseases, Other
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3)
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated
patients frequently experience debilitating side effects, and many patients delay the start
of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and
fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and
hematologic toxicity. To date, most of the evidence underlying the current treatment
recommendations has come from observational studies in which either a macrolide has been
combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The
proposed study will answer whether a third drug is necessary or whether taking two drugs can
increase tolerability without a substantial loss of efficacy.
Christopher Saddler
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03672630
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Inclusion Criteria:
• Culture positive pulmonary MAC meeting ATS/IDSA disease criteria
• Age over 18 years
• Ability to provide informed consent
Exclusion Criteria:
• Fibrocavitary disease
• Planned surgery for MAC disease
• Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial
treatment for MAC
• Patients who are currently taking or have taken multi-drug antimicrobial treatment for
NTM within the prior 30 days
• Diagnosis of Cystic fibrosis
• Diagnosis of HIV
• History of solid organ or hematologic transplant
• Significant drug-drug interaction not clinically manageable in the opinion of the
investigator
• Contraindication to any component of the study treatment regimen
Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection, Infection due to other mycobacteria, Other, Infections, Immune System & Allergies
RejuvenAir® System Trial for COPD With Chronic Bronchitis (SPRAY-CB)
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air
within the lungs and is a major public health problem that is projected to rank fifth
worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB)
is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically
defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2,
but many studies have used different definitions to define it- chronic cough and sputum
production for one year or cough and sputum production on most days of the week. CB is
associated with multiple clinical consequences, including; the worsening of lung function
decline, increasing risk of acute exacerbations of COPD, increased risk of developing
pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
J Ferguson, MD
All
40 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03893370
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Inclusion Criteria
• Males and females ≥40 to ≤80 years of age
• Subject is able to read, understand, and sign a written Informed Consent in order to
participate in the Study
• Subject has a diagnosis of chronic bronchitis (CB) and/or chronic obstructive
pulmonary disease (COPD) for a minimum of two years. (Chronic Bronchitis is defined
clinically as chronic productive cough for 3 months in each of 2 successive years in a
patient in whom other causes of productive cough have been excluded)
• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction
defined by a post-bronchodilator of ≥30% FEV1 to <80% predicted with a baseline
FEV1/FVC of <0.70
• Subject has a Baseline SGRQ of ≥50
• Subject demonstrates daily cough and significant mucus.
• Subject is being treated according to current medically accepted treatment guidelines
for chronic bronchitis for minimum of 3 months prior to enrollment into the study.
Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard
medications recommended) for the duration of the study
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not
smoking for the duration of the study
• Subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over
subjects may undergo two additional bronchoscopic procedures, if they agree to
treatment), per hospital guidelines
• Subject demonstrates ability and willingness to use a daily eDiary
Exclusion Criteria
• Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring
medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially
planned study bronchoscopy
• Current diagnosis of Asthma
• Subject has Alpha-1 antitrypsin deficiency as defined by blood level <59 mg/dL
• Subject has other origins of respiratory disease aside from chronic bronchitis and
COPD
• Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed
by a physician
• Subject has untreatable or life threatening arrhythmias, inability to adequately
oxygenate during the bronchoscopy, or has acute respiratory failure
• Subject has bullous emphysema characterized as large bullae >30 millimeters on HRCT;
or subject has stenosis in the tracheobronchial system, tracheobronchomegaly,
trachea-bronchomalacia, amyloidosis or cystic fibrosis
• Subject has clinically significant bronchiectasis
• Subject has had a solid transplant procedure
• Subject has a known mucosal tear, has undergone prior lung surgery such as
pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted,
lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other
therapies
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin,
Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject has a serious medical condition, such as: uncontrolled coagulopathy or
bleeding disorder, congestive heart failure, uncontrolled angina, myocardial
infarction in the past year, renal failure, liver disease, cerebrovascular accident
within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or
uncontrolled gastric reflux
• Subject is pregnant, nursing, or planning to get pregnant during study duration
• Subject has or is receiving chemotherapy or active radiation therapy within the past 6
months or is expected to receive chemotherapy during participation in this study
• Subject is or has been in another treatment study within 6 weeks of enrollment and
agrees to not participate in any other treatment studies for the duration of study
participation
• Subject has known sensitivity to medication required to perform bronchoscopy (such as
lidocaine, atropine, and benzodiazepines)
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
Prospective Study of Pregnancy in Women With Cystic Fibrosis (MAYFLOWERS)
In this study, the investigators aim to evaluate changes in lung function in women with
cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to
highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.
Erin Lowery
Female
16 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04828382
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Inclusion Criteria:
• Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation
Patient Registry (CFFPR)
Exclusion Criteria:
• None
Pregnancy Related, Cystic Fibrosis, Cystic fibrosis, Other
This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST)
against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be
on study for 52 weeks.
Sandesh Parajuli
All
18 Years to 75 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05042076
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Inclusion Criteria:
• Age18 ≤ 75 years
• Have BKV infection/viremia following kidney transplantation, where BKV viremia is
defined as positive BKV qPCR (≥ 250 copies)
• Have evidence of invasive BKV infection (BK Nephropathy)
• Experience one of the following:
• New, persistent and/or worsening BKV-related symptoms, signs and/or markers of
end organ compromise despite being on lower immunosuppressive medication
• Adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy
proven rejection)
• Eligible Donor
• Provide Written informed consent
Exclusion Criteria:
• Non-kidney organ transplant recipient
• Patient with acute rejection of the kidney allograft at time of T-cell transfer
• Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
• Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days prior to T-cell transfer
• Extra renal tissue invasive BK infection
• Concomitant enrollment in another clinical trial interfering with endpoints of this
study
• Any medical condition which could compromise participation in the study according to
the investigator's assessment
• Known HIV infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment Note:
Women of childbearing potential must have a negative urine pregnancy test at study
entry.
• Patients unwilling or unable to comply with the protocol or unable to give informed
consent
Donor Eligibility
• ≥ 18 years old
• Available and capable of undergoing a single standard 2 blood volume leukapheresis
• HLA Compatible (see Donor selection priority below):
• Original kidney transplant donor
• Fully HLA matched family member (6/6 HLA match considering HLA-A, HLA-B and
HLA-DRB1 genes)
• Partially matched family member (≥ 2/6 HLA match, considering HLA-A, HLA-B and
HLA-DRB1 genes)
• BK IgG seropositive
• Meets the criteria for donor eligibility defined in the UW Program for Advanced Cell
Therapy Standard Operating Policies and Procedures for Donor Evaluation and
Eligibility Determination for the Donation of Viral Specific T Cells, which is in
compliance with FACT standards for Immune Effector Cells, and 21 CFR 1271, subpart C.
• Provide written informed consent
Donor selection priority: The original kidney donor will be the first choice of donor
peripheral mononuclear cells. If the original donor is not available or does not meet all
donor eligibility criteria, alternative related donors will be selected, with preference
for fully matched related donors (6/6 HLA match, considering HLA-A, -B, and -DRB1 genes)
over related donors with partial HLA match (≥ 2/6 HLA match, considering HLA-A, -B, and
-DRB1 genes).
Note that if the selected donor is related, but not a biological parent or child of the
recipient (i.e., at least haploidentical), then high resolution testing of HLA-A and HLA-B
will be performed on donor and recipient (if high resolution HLA genotyping not already
available in the medical record). If the degree of matching at high resolution reveals a
less favorable match than an alternative donor, then prioritization of the alternative
donor will occur.
Kidney replaced by transplant, Other, Kidney Transplant Infection, BK Virus Infection, Infections, Immune System & Allergies, Kidney Disease & Urinary
Trial of Therapeutic Hypothermia in Patients With ARDS (CHILL)
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a
complication of medical and surgical diseases, has a mortality of ~40%, and has no known
treatment other than optimization of support. Data from basic research, animal models, and
retrospective studies, case series, and small prospective studies suggest that therapeutic
hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients
with ARDS; however, shivering is a major complication of TH, often requiring paralysis with
neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL
ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe
ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in
patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of
Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature
management in patients in 14 clinical centers with the Clinical Coordination Center and Data
Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over ~3.5
years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with
ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is
28-day ventilator-free days. Secondary outcomes include safety, physiologic measures,
mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on
days 1, 2, 3, 4, and 7.
Majid Afshar
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04545424
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Inclusion Criteria:
1. endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;
2. admitted to a participating ICU
3. radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural
effusions, atelectasis, or hydrostatic pulmonary edema
4. P/F ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P/F ratio may
be inferred from SpO2 values based on Table 3 from Brown et al as long as following
conditions are met:
1. SpO2 values are 80-96%
2. SpO2 is measured ≥10 min after any change in FIO2
3. PEEP is ≥ 8 cm H2O
4. the pulse oximeter waveform tracing is adequate
5. the qualifying inferred P/F ratio is confirmed 1-6h after initial determination.
5. access to an LAR to provide consent.
6. Criteria 3 AND 4 must be met within 72h of enrollment and randomization, not be fully
explained by hydrostatic pulmonary edema, and must have occurred within 7 days of
exposure to an ARDS-risk factor (including continuous exposure to persistent processes
(e.g. sepsis, pneumonia, COVID-19).
• Patients may be enrolled and decision about randomization delayed if all criteria
other than P/F ratio ≤ 200 are met and then randomized if and when the P/F ratio
≤200 (as long as this occurs within 72h of randomization). Patients on high flow
nasal oxygen or non-invasive pressure ventilation may be consented if they meet
criteria for starting the 72h ARDS window but may not be enrolled and randomized
until they are intubated.
Exclusion Criteria:
1. Missed moderate-severe ARDS window (>72hrs) •Window starts when patient is intubated
with a qualifying P/F ratio of ≤ 200 with PEEP ≥ 8 cm H2O or on high flow nasal oxygen
with well-fitting nasal cannula with flow ≥ 40 LPM and FiO2 ≥ 0.65 or on non-invasive
pressure ventilation with PEEP ≥ 8 cm H2O and FiO2 ≥ 0.6.
2. Missed NMB window: (>48 hrs)
3. Missed mechanical ventilation window (>7 days)
4. Refractory hypotension (continuous infusion of >0.3 mcg/kg/min of norepinephrine or
equivalent dose of other vasopressors within 2 hours prior to randomization)
5. Core temperature <35.5°C for ≥6 hours while not receiving CRRT on day of randomization
6. Significant, active bleeding (>3u blood products and/or surgical/IR intervention) on
day of randomization
7. Platelets <10K/mm3 (uncorrected) on day of randomization
8. Active hematologic malignancy
9. Skin process that precludes cooling device
10. Moribund, not likely to survive 72h
11. Pre-morbid condition makes it unlikely that patient will survive 28 days
12. Do Not Resuscitate status at time of randomization (excluding patients receiving full
support EXCEPT CPR for cardiac arrest)
13. Not likely to remain intubated for ≥48h
14. Physician of record unwilling to participate
15. Severe underlying lung disease
1. Needs > 2 LPM or >28% continuous home O2 (adjusted for altitude
2. On BIPAP (except for OSA)
3. Prior lung transplantation
16. Pregnant at time of randomization
17. BMI consistently >50 kg/m2
18. Known NYHA class IV heart disease
19. Acute Coronary Syndrome (MI, unstable angina) within 30 days of randomization
20. Cardiac arrest within 30 days of randomization
21. Burns over >20% of the body surface
22. Severe chronic liver disease (Child-Pugh score 12-15)
23. Previously randomized in CHILL study
24. Simultaneous enrollment in another inpatient interventional trial started during the
current hospitalization.
25. On ECMO during the current hospitalization.
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects (PROTECT)
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut
in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will
evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the
immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA.
This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects
with PA.
Mark Moss
All
18 Years to 50 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05476497
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Part A Main
Inclusion Criteria:
1. Capable of giving signed informed consent.
2. Subject who has a signed and dated Informed Consent Form (ICF).
3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).
6. Good general health, as determined by the Investigator.
7. A positive SPT to histamine.
The following additional inclusion criteria are only applicable to the healthy
subjects in Group A1:
8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including
broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
9. Subjects with no history of allergy or intolerance to peanut or any other food and who
consume peanuts with no effect.
10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole
peanut extract.
11. Peanut specific immunoglobulin E (IgE) <0.1 kU/L.
12. Ara h 2 specific IgE <0.1 kU/L.
13. Subjects with negative basophil activation test (BAT).
The following additional inclusion criteria are only applicable to the subjects with
PA in Group A2:
14. Clinical history of physician diagnosed PA.
15. Peanut allergen sensitivity confirmed by SPT and IgE.
16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.
17. Subjects who are able to handle and correctly use an adrenaline auto-injector.
Part B Main
Inclusion Criteria:
1. Capable of giving signed informed consent.
2. Subject who has a signed and dated ICF.
3. Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).
6. Clinical history of physician diagnosed PA.
7. Peanut allergen sensitivity confirmed by SPT and IgE (Peanut specific IgE ≥5.0 kU/L
and Ara h 2 specific IgE ≥2.0 kU/L)
8. Subjects with positive BAT.
9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.
10. Good general health, as determined by the Investigator.
11. Subjects who are able to handle and correctly use an adrenaline auto-injector.
Main Exclusion Criteria Part A and B:
1. Pregnant or lactating subject.
2. Presence of any medical condition that may reduce the ability to survive a serious
allergic reaction.
3. Subjects with atopic dermatitis with >25% skin surface involvement.
4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
5. History of severe or life-threatening anaphylactic reactions to peanut resulting in
neurological compromise or requiring mechanical ventilation.
6. Clinical history of severe systemic or life-threatening anaphylactic reactions to
other foods (apart from peanut), insect venom, exercise, drugs, etc. or idiopathic
anaphylaxis.
7. Unable to receive epinephrine therapy or at greater risk of developing adverse
reactions after epinephrine administration as assessed by the site Investigator.
8. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could
interfere with the subject's ability to participate in the clinical trial.
9. Participation in a clinical research trial with any investigational drug/placebo
within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
10. Personal, financial or other dependent relationship (e.g., employee or immediate
relative) with the clinical trial site, Sponsor, Sponsor's representative, or another
individual who has access to the clinical trial protocol.
11. Vulnerable subjects or those in judicial or governmental detention, detainment or
imprisonment in a public institution.
Peanut Allergy, Allergic rhinitis due to food, Other, Infections, Immune System & Allergies
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON)
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Stephen Halliday
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04708782
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Inclusion Criteria:
1. Subject gives voluntary informed consent to participate in the study.
2. Subject is ≥40 years of age, inclusive, at the time of signing informed consent.
3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical
Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution
computed tomography (HRCT) (performed within the previous 12 months), and if
available, surgical lung biopsy.
4. FVC ≥45% predicted at Screening.
5. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30
days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not
permitted.
6. Women of childbearing potential must be non-pregnant (as confirmed by a urine
pregnancy test at Screening and Baseline) and non-lactating, and will abstain from
intercourse (when it is in line with their preferred and usual lifestyle) or use 2
medically acceptable, highly effective forms of contraception for the duration of the
study, and at least 30 days after discontinuing study drug.
7. Males with a partner of childbearing potential must use a condom for the duration of
treatment and for at least 48 hours after discontinuing study drug.
8. In the opinion of the Investigator, the subject is able to communicate effectively
with study personnel, and is considered reliable, willing, and likely to be
cooperative with protocol requirements, including attending all study visits.
Exclusion Criteria:
1. Subject is pregnant or lactating.
2. Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.
3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or
prostacyclin analogue that resulted in discontinuation or inability to effectively
titrate that therapy.
4. The subject has received any PAH-approved therapy, including prostacyclin therapy
(epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity
testing), IP receptor agonists (selexipag), endothelin receptor antagonists,
phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase
stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile
dysfunction is permitted, provided no doses are taken within 48 hours of any
study-related efficacy assessments.
5. Use of any of the following medications: azathioprine (AZA), cyclosporine,
mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the
combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline;
cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior
to Baseline.
6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery
at rest at Baseline.
7. Exacerbation of IPF or active pulmonary or upper respiratory infection within 30 days
prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for
treatment of the infection or acute exacerbation more than 30 days prior to Baseline
to be eligible. If hospitalized for an acute exacerbation of IPF or a pulmonary or
upper respiratory infection, subjects must have been discharged more than 90 days
prior to Baseline to be eligible.
8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior
to Baseline or unstable angina within 30 days prior to Baseline.
9. In the opinion of the Investigator, the subject has any condition that would interfere
with the interpretation of study assessments or would impair study participation or
cooperation.
10. Use of any other investigational drug/device or participation in any investigational
study in which the subject received a medical intervention (ie, procedure, device,
medication/supplement) within 30 days prior to Screening. Subjects participating in
non-interventional, observational, or registry studies are eligible.
11. Life expectancy <6 months due to IPF or a concomitant illness.
12. Acute pulmonary embolism within 90 days prior to Baseline.
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Andrew Braun
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05444257
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Key
Inclusion Criteria:
• Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and
VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but
did not permanently discontinue study drug, and completed study visits up to the last
scheduled visit of the Treatment Period in the parent study
Key
Exclusion Criteria:
• History of drug intolerance in a parent study
• Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply.
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559
in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of
America.
Evan Warner
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04276558
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Inclusion Criteria:
1. Have read, understood, and signed the informed consent form (ICF).
2. Be a male or female aged ≥18 years at the time of ICF signature.
3. Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye
(study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow
eye can be enrolled.
for the study eye
4. Have no objective clinical evidence of improvement in the PED or corneal ulceration
within the 2 weeks before the screening visit despite use of conventional non-surgical
treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral
doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined
by the investigator's or referring physician's medical record.
5. Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
within the area of the PED or corneal ulcer and outside of the area of the defect in
at least one corneal quadrant.
6. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
1. Have participated in any clinical trial with an investigational drug/device within 2
months before the Screening Visit and throughout the study duration.
2. Have a known hypersensitivity to one of the components of the study drug or procedural
medications (eg, fluorescein), including to a compound chemically related to MT8
3. Have a presence or history of any ocular or systemic disorder or condition that might
hinder the efficacy of the study treatment or its evaluation, could possibly interfere
with the interpretation of study results, or could be judged by the investigator to be
incompatible with the study visit schedule or conduct (eg, progressive or degenerative
corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly
controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or
that may compromise the safety of the patient.
4. Have a significant history of alcohol abuse or drug/solvent abuse
5. Be unwilling to comply with any study assessments or procedures.
6. Be a woman who is pregnant, nursing or planning a pregnancy.
7. Be a woman of childbearing potential not using a highly effective method of birth
control.
8. Be a male patient who is not permanently sterile and who is not willing to use condoms
during the study and for 4 weeks after the end of study treatment.
For the study eye:
9. Have any active ocular infection (bacterial, viral, fungal or protozoal) or active
inflammation not related to NK in the study eye.
10. Have any other ocular disease requiring topical ocular treatment in the study eye
during the course of the study treatment period, except for glaucoma if treated by
preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks
before screening and during the study),
11. Receive topical ophthalmological treatments other than the study drug provided by the
study Sponsor and the treatments allowed by the study protocol (eg, preservative-free
artificial tears; preservative-free eye drop (single-agent treatment, once daily,
stable regimen 4 weeks before screening and during the study) for glaucoma; topical
antibiotics; other than tetracycline).
12. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
13. Have severe vision loss in the study eye with no potential for visual improvement in
the opinion of the investigator as a result of the study treatment.
14. Have evidence of corneal ulceration/melting involving the posterior third of the
corneal stroma, or perforation in the study eye.
15. Have a history of any ocular surgery (including laser or refractive surgical
procedures) within 3 months before the Screening Visit in the study eye. An exception
to the preceding statement will be allowed if the ocular surgery is considered to be
the cause of the Stage 2 or 3 NK.
16. Have a history of corneal transplantation in the study eye, except if performed to
treat NK and at least 6 months prior screening.
17. Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy,
conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has
disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after
the procedure) in the study eye.
18. Use therapeutic contact lenses or wear contact lenses for refractive correction during
the study treatment periods in the eye(s) with NK.
19. Have an anticipated need for punctal occlusion during the study treatment period.
Patients with punctal occlusion or punctal plugs inserted before the study are
eligible for enrolment provided that the punctal occlusion is maintained during the
study.
20. Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering from
glaucoma requiring ophthalmic drops for topical treatment at the Screening Visit or
during the study are not eligible, except if the ophthalmic drops is a
preservative-free treatment administered maximum once daily as a single-agent
treatment and at a stable regimen 4 weeks before screening and at the same dose during
the study. Patients treated with oral intraocular pressure-lowering drugs at the
Screening Visit and during the study may be enrolled if their glaucoma status is
assessed as stable and controlled.
For the fellow eye
21. Have Stage 2 or 3 NK or perforation.
For any eye:
22. Have a history of ocular cancer.
23. Have had prior treatment with Oxervate™
Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study (STOP360AG)
The purpose of this study is to look at pulmonary exacerbations in people with cystic
fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a
vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in
people with CF that needs medical intervention. Both doctors and CF patients are trying to
understand the best way to treat pulmonary exacerbations. This study is trying to answer the
following questions about treating a pulmonary exacerbation:
- Do participants have the same improvement in lung function and symptoms if they are
treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two
different types of antibiotics (tobramycin and β-lactams)?
- Is taking one type of antibiotic just as good as taking two types?
Andrew Braun
All
6 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05548283
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Inclusion Criteria:
• All genders ≥ 6 years of age at Visit 1
• Documentation of a CF diagnosis
• Clinician intent to treat index CF PEx with a planned 14-day course of IV
antimicrobials
• At least one documented Pa positive culture within two years prior to Visit 1
Exclusion Criteria:
• Participant is not pregnant
• No known renal impairment or history of solid organ transplantation
• No IV antimicrobial treatment, ICU admission, pneumothorax, or hemoptysis within 6
weeks prior to Visit 1
• No use of investigational therapies, new CF transmembrane conductance regulator (CFTR)
modulators, or treatment for Nontuberculous mycobacteria (NTM) within 4 weeks prior to
Visit 1
• No history of hypersensitivity, vestibular, or auditory toxicity with aminoglycosides
• No more than one day of IV aminoglycosides administered for the current PEx treatment
prior to Visit 1
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Other
Vamikibart in Participants With Uveitic Macular Edema (Sandcat)
This study will assess the efficacy and safety of vamikibart in participants with uveitic
macular edema.
Laura Kopplin
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05642325
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Inclusion Criteria:
• Female participants: Agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraception as defined by the protocol
• Diagnosis of macular edema associated with non-infectious uveitis (NIU)
• Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any
anatomical type (anterior, intermediate, posterior, panuveitis)
• BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic
Retinopathy Study (EDTRS)-like charts
Exclusion Criteria:
• Evidence of active or latent syphilis infection
• Evidence of active or latent tuberculosis infection and/or positive tuberculosis
assay, or previous or current HIV diagnosis
• Serious acute or chronic medical or psychiatric illness
• History of major ocular and non-ocular surgical procedures
• Uncontrolled IOP or glaucoma or chronic hypotony
• Any anatomical changes or media opacity in the study eye preventing evaluation of
retina, vitreous, and capture of study images
• Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1;
received IVT Methotrexate within 4 months prior to Day 1
• Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy
within 3 months of Day 1
• Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to
Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior
to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an
OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the
3 years prior to D1
• Diagnosis of macular edema due to any cause other than NIU
• Any major ocular conditions that may require medical or surgical intervention during
the study period to prevent vision loss
Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
The study's objective is to evaluate the additive value of renal biomarkers (from blood and
urine) for identifying individuals at high risk for severe acute kidney injury (AKI) above
that of a novel natural language processing (NLP)-based AKI risk algorithm. The risk
algorithm is based on electronic health records (EHR) data (labs, vitals, clinical notes, and
test reports). Patients will enroll at the University of Chicago Medical Center and the
University of Wisconsin Hospital, where the risk score will run in real time. The risk score
will identify those patients with the highest risk for the future development of Stage 2 AKI
and collect blood and urine for biomarker measurement over the subsequent 3 days.
Matthew Churpek
All
18 Years and over
IV
This study is NOT accepting healthy volunteers
NCT05988658
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Inclusion Criteria:
1. Age ≥ 18 years
2. E-STOP AKI 2.0 score in the top 10% of risk (historically from all hospitalized
patients) within the last 12 hours. (First time across this 10% risk threshold during
this hospital stay).
3. Admitted to an inpatient ward, intermediate, or ICU care at the University of Chicago
Medical Center (UCMC) or University of Wisconsin Health (UWHealth). (No Emergency
Department patients)
4. Patient or their legally authorized representative must be able to read, speak, and
understand English, for the purposes of consenting. Otherwise, inclusion in this
protocol will be done without regard to race, ethnic origin or gender
Exclusion Criteria:
1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal
transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine >4.0 mg/dl at the time of admission or available in the EHR
from the last 6 months
5. Patients with prior episode of KDIGO defined AKI during this same hospitalization-
regardless of E-STOP AKI 2.0 score
6. Patients with prior renal consultation during their admission.
7. Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago
during this same hospital stay.
8. Incarcerated patients
9. Pregnant patients
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (CDI-SCOPE)
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for
administration by the practice of colonoscopy. More specifically, the purpose of this trial
is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy
to adults with rCDI. The experience of physicians will be documented through a
physician-experience questionnaire to explore the usability of RBX2660 in clinical practice
for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660
treatment, each trial participant will be offered to undergo a structured interview.
Nasia Safdar, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05831189
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Inclusion Criteria:
• have documented evidence of rCDI (≥1 recurrence after a primary CDI episode)
• be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed
by a stool test for the presence of toxigenic C. difficile or C. difficile toxin
• be eligible for FMT as judged by the investigator or current treatment guidelines for
rCDI in the US
• be a candidate for colonoscopy as judged by the investigator
Exclusion Criteria:
• Use or planned use of systemic antibiotics for an indication other than the qualifying
rCDI episode.
• Current uncontrolled chronic diarrhea not related to CDI.
• Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12
months before screening.
• Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have
a current colostomy or ileostomy
Clostridium Difficile Infection Recurrence, Enterocolitis due to Clostridium difficile, Other, Infections, Immune System & Allergies, Digestive Health & Liver Disease
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522
in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis
transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Andrew Braun
All
18 Years to 65 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05668741
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Key
Inclusion Criteria:
• Body mass index is less than (<) 30.0 kilograms per meter square (kg/m^2)
• A total body weight greater than (>) 50 kg
• Stable CF disease
• CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy
o Example mutations include but are not limited to, mutations that do not produce CFTR
protein (i.e., Class I): nonsense mutations (e.g., G542X, W1282X) and canonical splice
mutations (e.g., 621+1G->T)
• Forced expiratory volume in 1 second (FEV1) value for SAD: greater than or equal to
(≥)40 percent (%), MAD: ≥ 40% to less than or equal to (≤) 90%
Key
Exclusion Criteria:
• History of uncontrolled asthma within a year prior to screening
• History of solid organ or hematological transplantation
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh
Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
• Arterial oxygen saturation on room air less than (<) 94% at screening
Other protocol defined Inclusion/Exclusion criteria may apply.
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
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis
(CF).
Hara Levy, MD
All
1 Year and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05844449
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Key
Inclusion Criteria:
• Participants who have completed study drug treatment in the parent study
(VX21-121-105; NCT Number: NCT05422222)
Key
Exclusion Criteria:
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe
hepatic impairment that might pose an additional risk in administering study drug
• History of solid organ, hematological transplantation, or cancer
• History of drug intolerance in the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.
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, Healthy Volunteers
*Note: Email is generally not a secure way to communicate sensitive or health-related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email.