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.
Age 18 to 67 years at eligible visit
Diagnosed with NASH with a total NAS ≥ 3 including a ballooning score of at least 1, or non-NASH/NAFLD with a total NAS ≤3, or Diagnosed with T2DM or prediabetes, HbA1c< 8% , or CAP score greater than or equal to 248 on Fibroscan
Body Mass Index (BMI) 30.0-55.0 kg/m2 at eligibility visit
Willingness to accept surgical intervention after an individual seminar session
All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all patients enrolled in the study
Expect to live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Willingness to comply with the follow-up protocol and successful completion of the run-in
Written informed consent
Suitable for liver biopsy using the percutaneous approach
Vulnerable populations will not be targeted for inclusion, but those noted in section 9.1 may be allowed to participate provided they met all of the inclusion and none of the exclusion criteria.
Exclusion Criteria:
Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
Cardiac stress test indicating that surgery or IMM would not be safe.
Pulmonary embolus or thrombophlebitis in the past six months
Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
Serum creatinine >1.5 mg/dL.
Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than 2.5 the upper limit of normal. Elevated INR.
Alcohol intake more than one drink or >20 grams per day
History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
Gastric or duodenal ulcer in the past six months.
History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
Previous organ transplantation.
Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, or cirrhosis
Currently pregnant or nursing, or planning to become pregnant in the next two years.
History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
Depression A CESD score more than 17 and a psychologist determination that the patient is not a good fit for surgery.
Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
12-lead EKG indicating that surgery would not be safe.
Serum c-peptide <1.0 ng/ml post prandial.
Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
Contraindication to MRI scanning. MRI contraindications are assessed by MR technologists on the day of scanning using a standard safety screening form.
History of endoscopy demonstrating esophagitis or Barretts changes in the esophagus. Any history of dysphagia.
Treatment with drugs associated with nonalcoholic fatty liver disease (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening.
Treatment with pioglitazone or high-dose vitamin E (>400 IU/day) within the last 2 months prior to the initial screening.
We are studying a new phone app, UrApp, for parents (or caregivers) to use when managing the care of children who have been diagnosed with nephrotic syndrome in the last six weeks. We will look at medication and urine monitoring with two groups; one will use the app, the other will have usual care. Study participation will last for one year.
Michelle Rheault
All
18 Years to old
N/A
This study is NOT accepting healthy volunteers
STUDY00006828
STUDY00006828
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Inclusion Criteria:
Caregivers of patients ages 1-17 with steroid sensitive nephrotic syndrome (clinical diagnosis with edema, nephrotic range proteinuria [urine protein to creatinine ratio >2 mg/mg, or ≥ 300 mg/dL or ≥ 3+ protein on urine dipstick], and hypoalbuminemia ≤ 2.5 g/dL; resolution of proteinuria [negative/trace protein on urine dipstick] within 4 weeks of corticosteroid treatment)
Caregivers of pediatric patients with steroid sensitive nephrotic syndrome diagnosed within 42 days at the time of enrollment
Access to internet/wireless fidelity (Wi-Fi) in the home
Caregiver proficiency with the English language
Exclusion Criteria:
Caregivers of pediatric patients with end-stage kidney disease
Caregivers of pediatric patients with renal transplantation
Caregivers of pediatric patients with clinical or histologic evidence of secondary nephrotic syndrome (e.g., systemic lupus erythematosus)
The purpose of this study is to evaluate the therapeutic feasibility of a Peptamen-based, oral nutrition dietary regimen for treatment of adult Crohn’s disease. Specifically we are evaluating if consuming 80-100% of caloric needs from Peptamen 1.5 for 4 weeks is feasible for the potential future use therapeutically in adult Crohn’s disease.
Byron Vaughn
Male or Female
18 Years and over
This study is NOT accepting healthy volunteers
STUDY00008169
STUDY00008169
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Inclusion Criteria:
? 18-89 years of age
? Diagnosis of Crohn's disease
? Moderate to severe Crohn's disease on current therapy
Exclusion Criteria:
? Diagnosis of short bowel syndrome
? Presence of ileostomy or colostomy
? Chronic Kidney Disease Stage III-V
To prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate a participant’s pain and/or improve their quality of life. We hypothesize that the removal of non-obstructing renal calculi will decrease or eliminate the participant’s pain and will improve their quality of life.
Michael Borofsky
All
18 Years to old
N/A
This study is NOT accepting healthy volunteers
STUDY00004167
STUDY00004167
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Inclusion Criteria:
Patients with renal colic and non-obstructing renal calculi. No stone greater than 10 mm in longest diameter
All other causes of pain have been eliminated (by clinical judgment; if the cause of pain is in doubt: assessment by a family doctor or medical specialist will be obtained)
Patients older than 18 years old
Moderate to severe pain (> or = 5 on BPI pain scale: pain at its worst in the last 24hrs)
Exclusion Criteria:
Patient's with anatomic abnormalities (calyceal diverticulum)
Ureteral calculi
Nephrocalcinosis
RTA, medullary sponge kidney, sarcoidosis
Hydronephrosis or hydrocalycosis
Minimal pain (<5 on BPI pain scale: pain at its worst in the last 24 hrs)
This study proposes a cross-sectional case-control pilot study. Spinal Cord Injury (SCI) is associated with altered bone metabolism, male infertility, and increased rates of insulin resistance. The researchers will perform testing for 30 men with SCI and 10 without SCI. Data will be used to power subsequent clinical trials.
A Fairview letter of support has also been uploaded.
Leslie Morse
Male
18 Years and over
This study is also accepting healthy volunteers
STUDY00011054
STUDY00011054
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Inclusion Criteria:
SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study
-Male age 18-50
-Have completed inpatient rehabilitation and are living in the community
-Have motor complete SCI
Use a wheelchair as primary mobility mode
-English and non-English speakers
No SCI
Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study
-Male age 18-50
-Able to ambulate independently
-English and non-English speakers
Exclusion Criteria:
SCI
Exclusion Criteria:
-presence of other neurological condition
-use of chronic ventilator support
-metabolic bone disease
-thyroid disorder
-current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year).
-Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
No SCI
Exclusion Criteria:
-presence of neurological condition
-metabolic bone disease
-thyroid disorder
-current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year).
-known history of or found on baseline testing to have osteoporosis.
-known history of or found on baseline testing to have diabetes.
-known history of or found on baseline testing to have infertility.
-Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.
Stephanie Misono
Male or Female
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
STUDY00012174
STUDY00012174
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Inclusion Criteria:
- Adults aged 18-80
- >8 weeks of non-productive cough
- Cough visual analogue scale (VAS): Rating of 40 or greater on a 0-100 cough severity scale
- CXR or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available)
- Clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinonasal source is not primary cough etiology
- Ability to provide informed consent and independently complete questionnaires
- Ability to read and speak English
Exclusion Criteria:
- Current or recent (quit < 3 months ago) smoking
- Known currently infectious cause for cough (e.g., TB, pertussis, COVID)
- History of known or suspected aspiration pneumonia
- Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
- Untreated carotid disease
- Electronic implants (e.g., pacemaker)
- Specific medication use conditions, including:
- Taking ACE-inhibitors
- Around the clock use of benzodiazepines
- Anticipate new medications targeting cough during the period of the study
- If on neuromodulators and/or opioids, anticipate change in dose during the period of the study
- Currently doing speech therapy for cough
- BMI > 30 (for transmission of VTS through soft tissue)
- Contraindications to safe VTS device use, including:
- Allergy to adhesives
- Unable to manipulate device
- Recent intubation/neck surgery (within 8 weeks)
- Drug/alcohol dependency or abuse
- Pregnant
- No regular access to wifi internet
pregnancy
requesting an epidural for the first time
Exclusion Criteria:
previous epidural (either for labor or for surgery)
BMI greater than 40 kg/m^2
previous lumbar spine surgery
inability to speak English
a history of chronic pain or are on chronic opioids
a history of opioid drug abuse
This pilot clinical trial will evaluate the initial safety and
feasibility of intestinal microbiota transplantation (IMT) in
patients with pulmonary arterial hypertension (PAH). This trial
will inform development of future trials in treatment of PAH.
Active drug in capsule form composed of freeze-dried,
encapsulated intestinal microbiota from healthy donors will be
administered to patients with PAH. This study will also allow for
limited evaluation of pharmacokinetics in terms of donor
microbiota engraftment and pharmacodynamics in terms of
potential mechanisms. It will also allow for limited evaluation of
cardiac endurance and function prior to and after IMT.
Thenappan Thenappan
All
18 Years to 75 Years old
Phase 1
This study is NOT accepting healthy volunteers
STUDY00012951
STUDY00012951
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Inclusion Criteria:
Diagnosis of pulmonary arterial hypertension (PAH)
On stable treatment for PAH for one month prior to enrollment
Able to swallow capsultes
Able to provide blood sample and fecal sample
Exclusion Criteria:
Dysphagia to pills
Clinically active inflammatory bowel disease
Pregnancy or breastfeeding
Life expectancy of <6 months
Presence of ileostomy or colostomy
Taking immunosuppressants (calcineurin inhibitors, prednisone greater than or equal to 20mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
Neurotropenia (an absolute neurotrophil count < 0.5 x 10^9 cells/L)
History of solid organ or bone marrow transplant
Anticipated recurrent antibiotic use (participants with frequent urinary tract infections or sinusitis)
History of severe anaphylactic food allergy
History of celiac disease
History of receiving cancer chemotherapy, immunotherapy, or radiation
The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.
Raluca Gray
Male or Female
18 Years and over
This study is NOT accepting healthy volunteers
STUDY00015986
STUDY00015986
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Inclusion Criteria:
Diagnosis: upper airway stenosis
with tracheotomy or t-tube.
Seen at the Lions Voice Clinic.
Ability to provide informed
consent.
Ability to complete questionnaires in English by
themselves.
Exclusion Criteria:
<18 years old.
Mechanical
ventilation.
Neurological
co-morbidity such as stroke, cerebral palsy, neurodegenerative disease.
New diagnosis (<1
year) of head and neck cancer as the indication for tracheotomy.
Breathing, Lung & Sleep Health, Ear, Nose & Throat
Clinics and Surgery Center (CSC), Montgomery t-tube, airway stenosis, stenosis, t-tube, trach, tracheotomy
A general objective of this research is to improve our understanding of the effect of sensory feedback on movement, and to determine how cortical lateralization affects motor behavior in neurologically intact individuals. We will determine differences in motor control in the left and right hands under visual perturbations, in terms of muscle activity and several kinematic measures. “Visual perturbations”, in the context of this study, refer to an unexpected change in the visual field.
Shanie Jayasinghe
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00016778
STUDY00016778
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Inclusion Criteria:
? Adults 18 years of age or older
? Right hand dominant
Exclusion Criteria:
? Pregnant women
? Use of pacemaker or similar device that can be affected by electromagnetic interference
? A history of:
? neurological disease
? major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
? hospital admission for substance abuse
? Currently:
? experiencing peripheral disorders affecting sensation or movement of the arms, including pain or arthritis
? taking drugs or medication with known sedative properties that might interfere with sensory-motor function
? experiencing significant joint pain that is activity limiting
movement, neuroscience, healthy volunteers, controls, motor learning, motor control
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
Emily Nagel
All
28 Weeks to 32 Weeks old
This study is NOT accepting healthy volunteers
STUDY00016926
STUDY00016926
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Inclusion Criteria:
preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery and b) pre-gravid or first trimester BMI between 18.5 to 40 kg/m^2
Exclusion Criteria:
infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
mothers: a) alcohol consumption >1 drink per week or any tobacco consumption during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).
Igor Nestrasil
Male or Female
Not specified
This study is NOT accepting healthy volunteers
STUDY00010688
STUDY00010688
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Inclusion Criteria:
• Diagnosis of COVID-19 in the past
• Experiencing long covid symptoms for at least 2 months
• 3 - 25 years old at the time of screening
Exclusion Criteria:
• Active positive COVID-19 diagnosis (as confirmed by a medical provider &/or certified testing site) for at least 4 weeks prior to projected enrollment date
• Any surgically implanted pacemaker
• Any indwelling electronic device, including programmable shunts
• Orthodontic braces, unless non-metallic
• Other implanted metal in the body other than titanium
• An inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Pregnancy
• Any subject not meeting standard MRI requirements according to CMMR protocol (ie presence of metal in body or implanted pacemaker) will be excluded from that portion of the study.
The objective of this research is to improve our understanding of asymmetries in the neural control of movement, and to determine how these asymmetries affect overall functional independence in stroke survivors. We will determine whether the left and right cerebral hemispheres exhibit differences in motor execution and cognitive aspects of movement in terms of reaction time, movement accuracy, working memory capacity, and action selection. We expect any differences in these processes to reflect in distinct motor behaviors of each arm. Our aims are: 1) to determine how motor performance asymmetries between hands are affected by increased cognitive load, 2) to determine the relationship between lateralized motor control processes and functional independence in left and right brain damaged stroke survivors. These questions will be examined using standard clinical exams and recordings of arm movements during tasks completed on the Kinereach virtual reality motion capture system. I have previous experience with examining lateralization of motor control mechanisms in both neurologically intact individuals and stroke survivors. The proposed research will allow us to build on this work to also examine the lateralization of cognitive aspects of motor control, which will be important in designing more personalized motor rehabilitation strategies in the future.
Shanie Jayasinghe
Male or Female
18 Years and over
This study is NOT accepting healthy volunteers
STUDY00015809
STUDY00015809
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Inclusion Criteria:
Right-handed; chronic stage of stroke; Weakness on one side; able to understand instructions; stroke on only one side of brain
Exclusion Criteria:
More than 1 stroke; pacemaker; pregnant; substance abuse; major psychiatric diagnosis; significant joint pain; arthritis; neurological disease other than stroke; prescription drugs with sedative properties.
Brain & Nervous System, Community Health, Heart & Vascular
Prospective study to compare safety of upper versus lower extremity injection agitated saline (bubble study) using echocardiography of the heart.
Carmelo Panetta
Male or Female
18 Years and over
This study is NOT accepting healthy volunteers
STUDY00016117
STUDY00016117
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Inclusion Criteria:
• Age ?18 at the time of informed consent signature.
• Capable of complying with protocol requirements, including follow-up.
• A Consent Form signed by Subject or legal representative.
• Subjects have a history of concern for right to left shunt, such as a paradoxical embolus as source of a cryptogenic CVA requiring transthoracic echocardiography with agitated saline injection (bubble study)
• No evidence of right to left shunt on injection of upper extremity using transthoracic echocardiography within the previous 6 months
• If taking warfarin, patient is eligible if clinically able to hold warfarin for 3 days prior to procedure.
Exclusion Criteria:
• Enrolled in another drug or medical device study within 30 days of study enrollment.
• Absence or size < 2mm diameter of both greater saphenous veins
• Depth of the greater saphenous vein is > 3cm from the skin surface
• Presence of deep vein thrombosis in either greater saphenous veins
• Platelet count less than 50,000
• International Normalized Ratio (INR) > 3 or liver failure within the last 6 months,
• Taking oral anticoagulant (DOAC) within 24 hours
The purpose of this pilot research study is to test whether a tool called “High-Resolution Manometry” can diagnose laryngeal dystonia (also known as spasmodic dysphonia) and measure how well treatment works.
High-Resolution Manometry measures pressures from a small catheter that is passed from your nose into your throat. We believe that pressures in the throat might be different for people with laryngeal dystonia than for people without laryngeal dystonia, or with other types of voice disorders.
If we can diagnose laryngeal dystonia shortly after symptoms start, we can get patients the treatment they need sooner.
Jesse Hoffmeister
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00015206
STUDY00015206
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Inclusion Criteria:
Patients with adductor laryngeal dystonia:
• Have experienced improvement in voice quality
following injection of botulinum toxin into the thyroarytenoid complex
• Have received their most-recent injection within
6 months
• Age 18-80 years old
• Able to participate in informed consent
• Able to read and write in English
Healthy Controls
• Age 18-80
• Have no known voice problem
• Have a VHI-10 score of 10 or below
• Able to participate in the informed consent
process
• Able to read and write in English
Exclusion Criteria:
Patients with adductor laryngeal dystonia:
• Diagnosis of vocal tremor, abductor laryngeal
dystonia, any type of vocal fold lesion, or vocal fold paralysis
• Known swallowing disorder (oropharyngeal or esophageal), with the exception of transient post-botulinum toxin injection-induced dysphagia
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to
study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or
esophageal surgery
• Known nasal, pharyngeal, or esophageal
obstruction
Healthy Controls
• VHI-10 Score of 11 or above
• Report having a current voice or swallowing
disorder
• Pregnant
• Prisoner
• Allergy to topical anesthetic
• Cannot fast for 6 hours (4 hour fast prior to
study, up to 2 hours to complete the study)
• Recent facial trauma
• Recent nasal, pharyngeal, laryngeal, or
esophageal surgery
• Known nasal, pharyngeal, or esophageal
obstruction
The research objective is to demonstrate efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a pilot study. In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics during and after an 8-week course of spleen-directed daily ultrasound treatments.
Erik Peterson
Male or Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
STUDY00016143
STUDY00016143
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Inclusion Criteria:
• Males and females ages 18 and above
• Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010_revised_criteria_classification_ra.pdf)
• Classification as ?definite RA? is based on the confirmed presence of synovial thickening in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0?5), serologic abnormality (score range 0?3), elevated acute-phase response (score range 0?1), and symptom duration (2 levels; range 0?1)
• Exhibiting symptoms or signs of inadequate inflammatory disease control according to one of two measures:
a. Multidimensional HAQ score of greater than 0.3
b. DAS-28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP)
• Candidate participant?s rheumatoid arthritis medical therapy should be stable for two weeks leading up to the study. Moreover, participants must be willing to maintain their current medication regimen throughout the study enrollment period (in adjunct to the additional investigational ultrasound treatment)
Exclusion Criteria:
• Active bacterial or viral infection
• Pregnant women or those trying to become pregnant
• Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
• Having received Rituximab monoclonal antibody medication within 30 days prior to enrollment
• Presence of an implanted device
• Asplenia
• Splenomegaly
• Ascites
• Recent abdominal surgery
• Currently participating in an investigational drug or device study
• Open wound/sores near stimulation sites
• Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ
• Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.
Marie Hickey
Female
18 Years and over
Pilot
This study is also accepting healthy volunteers
STUDY00016313
STUDY00016313
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Inclusion Criteria:
? Pregnant women (please see description of safeguards in Section: Vulnerable populations) in their second or third trimester with a diagnosis of gestational diabetes. Gestation is determined by either self-report of estimated delivery date, or from medical records information (last menstrual period, ultrasound dating or other sources of information on date of conception), depending on which method of recruitment is used.
Screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) approach is commonly used. A 50-g oral glucose challenge test (OGCT) is performed between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive the oral glucose tolerance test (OGTT). During the OGTT, a fasting glucose level is obtained, followed by administration of a 75-g or 100-g glucose load, then evaluation of glucose levels after 1, 2, and often 3 hours. A diagnosis of gestational diabetes is made when 2 or more glucose values fall at or above the specified glucose thresholds (ACOG 2017).
? BMI 18.5-45 kg/m2 at first prenatal visit
? Age 21-45 at time of delivery
? Pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
? Singleton pregnancy
Exclusion Criteria:
? Alcohol consumption >1 drink per week during pregnancy/lactation
? Tobacco consumption during pregnancy/lactation
? Inability to speak/understand English
? Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
? History of type I Diabetes
? Mothers currently taking over the counter probiotic preparation
This keystone study will invite adolescents into a 2-semester creative arts / science program, with arts activities taking place at WAM and at the Masonic Institute of the Developing Brain (MIDB).
Kathryn Cullen
Male or Female
up to 18 Years old
This study is also accepting healthy volunteers
STUDY00015930
STUDY00015930
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Inclusion Criteria:
age 14-17
Exclusion Criteria:
MRI contraindications (e.g.
claustrophobia, braces); neurodevelopmental disorder (e.g. intellectual
disability, severe autism); major medical and/or neurological illness
Background: Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults, and women experience them 5x as often as men. Most DRF occur with low impact injuries to the wrist with an outstretched hand, and are often managed via closed treatment and cast immobilization. Women sustaining a DRF are at risk for upper limb immobility, sensorimotor changes, edema and type I complex regional pain syndrome (CRPS). Since CRPS onset is likely influenced by alterations in the brain’s somatosensory region, a rehabilitation intervention, Graded Motor Imagery (GMI), aims to restore cortical representation, including sensory and motor function, of the affected limb. To date, there are no studies on the use of GMI in reducing risk of or preventing the onset of type I CRPS in women with DRF treated with cast immobilization. Due to a higher likelihood of women with this injury developing type I CRPS, it is important to early intervention is needed.
Methods/Design: This article describes a six-week randomized comparative effectiveness trial, where the outcomes of a modified GMI program (mGMI) + standard of care (SOC) group (n=33) are compared to a SOC only control group (n=33). Immediately following cast immobilization, both groups participate in four 1-hour clinic-based sessions, and a home program for 10 minutes three times daily until cast removal. Blinded assessments occur within 1 week of cast immobilization (baseline), at three weeks post cast immbolization, cast removal, and at three months post cast removal. The primary outcomes are patient reported wrist/hand function and symptomology on the Patient Rated Wristand Hand Evaluation, McGill Pain Questionnaire, and Budapest CRPS Criteria. The secondary outcomes are grip strength, active range of motion as per goniometry, circumferential edema measurements, and joint position sense.
Discussion: This study will investigate the early effects of mGMI + SOC hand therapy compared to SOC alone. We intend to investigate whether an intervention, specifically mGMI, used to treat preexisiting pain and motor dysfunction might also be used to mitigate these problems prior to their onset. If positive effects are observed, mGMI + SOC may be considered for incorporation into early rehabilitation program.
Corey McGee, PhD, MS, OTR/L, CHT
Female
55 Years to old
N/A
This study is NOT accepting healthy volunteers
1701M03721
1701M03721
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Inclusion Criteria:
Women 55 years or older who have received closed treatment of distal radius fractures
Exclusion Criteria:
Central nervous system disorders (e.g., Brain injury, Spinal Cord Injury, Parkinson's, Multiple Sclerosis)
Surgical fixation of fracture
Non english speaking
Concomitant ipsilateral injuries (i..e., BBFF)
Other injuries to the affected limb interfering with baseline affected limb function
Cognitive disorders which would preclude from following the testing commands and home program participation
Conditions of the contralateral upper limb which would result in painful and markedly limited active hand, wrist and forearm motion as this may impact the brain's ability to perceive safe and proficient movement during mirror therapy.
Visual impairments resulting in the inability to participate in GMI components
Standard Care, Motor Representation Techniques, Standard Care, Motor Representation Techniques
The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
Christine Conelea
Male or Female
Not specified
N/A
This study is NOT accepting healthy volunteers
STUDY00010519
STUDY00010519
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Inclusion Criteria:
-- 12-21 years old
-- right-handed
-- able to undergo MRI
-- currently experiencing chronic motor and/or vocal tics
Exclusion Criteria:
-- currently receiving therapy focused on tics
-- currently taking neuroleptic/antipsychotic medications
Comprehensive Behavioral Intervention for Tics (CBIT), Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta Burst Stimulation (cTBS), Comprehensive Behavioral Intervention for Tics (CBIT), Repetitive Transcranial Magnetic Stimulation (rTMS), Continuous Theta Burst Stimulation (cTBS)
Brain & Nervous System, Children's Health, Mental Health & Addiction
CBIT, TMS, Tourette's, neurodevelopmental disorders, tics, transcranial magnetic stimulation
This is a minimal risk, prospective, non-randomized, open label, multi-center study designed to assess the performance of the PrevisEA device in the prediction of GII. MH4 levels recorded by the device at 12 hours after placement of the device will provide a prediction of no GII development or GII development within 10 days after the procedure and is based on a previously optimized and validated MH4 cutoff level.
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later.
The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
Wolfgang Gaertner, MD
Male or Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
STUDY00012967
STUDY00012967
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Inclusion Criteria:
Age ≥ 18 and ≤ 90 years
Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
Segmental ileocolic resection with or without diversion
Segmental colon resection with or without diversion
Segmental coloproctectomy with or without diversion
Low anterior resection with or without diversion
Abdominoperineal resection
Total abdominal colectomy with or without diversion
Proctocolectomy with or without end ileostomy or diversion
Closure of end colostomy (Hartmann's reversal)
Exclusion Criteria:
Allergies to any of the device components (i.e., adhesive)
Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
Patients undergoing:
Small bowel resection without colonic resection
Transanal proctectomy without transabdominal approach
Perineal proctosigmoidectomy
Closure of loop colostomy or ileostomy
Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
The study involves a randomized, double blind, placebo controlled, crossover design with two different groups pairing the psychoactive drug psilocybin, or the active placebo Niacin, with a combination of perceptual tasks.
The proposed study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control.
We will obtain a psychophysical (behavioral) measurement of the impact of acute psilocybin intoxication on visual surround suppression in healthy human volunteers. Baseline data will be collected as participants complete the perceptual tasks pre-drug administration. Participants will repeat the tasks again three hours and five hours after an oral dose of psilocybin.
Jessica Nielson
Male or Female
25 Years to 65 Years old
Phase 1
This study is also accepting healthy volunteers
STUDY00009765
STUDY00009765
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Inclusion Criteria:
Have given written informed consent
Have at least a high-school level of education or equivalent (e.g. GED), and be able to read and write in English
General health status: Participants should be in good physical (BMI between 20.0 and 28.0 kg/m2) and psychiatric health.
Experience taking psilocybin (at the PI's discretion).
Participants must also have a person that can reliably transport them to and from the CRU for dosing session days.
Geographic location: Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including not limited to Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn
Participants must be willing to wear a face mask at all times during in-person study visits, except for dosing sessions, to ensure COVID-19 protection.
Participants must be willing to get a COVID-19 test and share results with the study team prior to all in-person visits.
Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.
Agrees to refrain from using recreational drugs while enrolled in the study, including, but not limited to, hallucinogens, ketamine, and marijuana.
Exclusion Criteria:
Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except due to another medical condition), or Bipolar I or II Disorder, personality disorder, major depressive disorder, posttraumatic stress disorder, panic disorder, obsessive compulsive disorder, dysthymic disorder.
Current or past history within the last 5 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine, nicotine, and hallucinogens)
Those with a first or second-degree relative with a current or past history of meeting DSM-5 criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder, because they might have an underlying genetic susceptibility for psychosis.
Presence of symptoms of the following DSM-5 disorders within the past 6 months (as assessed by the MINI-7):
Major depressive Episode
Suicidality
Manic and Hypomanic Episodes
Panic disorder
Agoraphobia
Social Anxiety Disorder
Obsessive-Compulsive Disorder
Posttraumatic Stress Disorder
Alcohol Use Disorder
Substance Use Disorder (Non-Alcoholic)
Psychotic Disorders and Mood Disorders with Psychotic Features
Anorexia Nervosa
Bulimia Nervosa
Binge Eating Disorder
Generalized Anxiety Disorder
Antisocial Personality Disorder
Mood Disorders:
Major Depressive Disorder (MDD)
MDD with Psychotic Features
Bipolar I
Bipolar II
Other Specified Bipolar and Related Disorder
Presence of abuse or dependence of drugs measured by the MINI-7 in the past 12 months:
Lithium, Sodium Valproate (Depakote), Lamotrigine (Lamictal) - Manic/Bipolar disorders
Stimulants: amphetamines, "speed", crystal meth, "crank", Dexedrine, Ritalin, diet pills.
Cocaine: snorting, IV, freebase, crack, "speedball".
Opiates: heroin, morphine, Dilaudid, opium, Demerol, methadone, Darvon, codeine, Percodan, Vicodin, OxyContin.
Dissociative Drugs: PCP (Phencyclidine ,"Angel Dust", "Peace Pill", "Hog"), or ketamine ("Special K").
Inhalants: "glue", ethyl chloride, "rush", nitrous oxide ("laughing gas"), amyl or butyl nitrate ("poppers").
Cannabis: marijuana, hashish ("hash"), THC, "pot", "grass", "weed", "reefer".
Sedatives, Hypnotics or Anxiolytics: Quaalude, Seconal ("reds"), Valium, Xanax, Librium, Ativan, Dalmane, Halcion, barbiturates, Miltown, GHB, Roofinol, "Roofies".
Miscellaneous: steroids, nonprescription sleep or diet pills. Cough Medicine?
History of medication or substance induced psychosis.
Medically significant condition considered unsuitable for the current study (e.g. diabetes, epilepsy, severe cardiovascular disease, etc)
History of suicide attempts or mania
Positive pregnancy test or currently breast-feeding
Currently taking on a regular (e.g., daily) basis any prescription medications, with the exception of birth control or other hormone therapy
A strong bias either for or against psychedelic substances, or if their responses about psychedelic use indicate that they abuse them from frequent use (more than once per month, with the exception of microdosing).
MRI EXCLUSION: we will also exclude anyone with head trauma, claustrophobia incompatible with scanning, cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant, prior history as a metal worker and/or certain metallic objects in the body that cannot be approved for MR scanning by the CMRR safety committee, history of clinically significant vertigo, seizure disorder, middle ear disorder, or double vision, or tattoos that were done less than 4 weeks from the first scheduled MRI.
Significant movement disorders including tardive dyskinesia that could disrupt EEG recordings will also be excluded.
Uncontrolled hypertension, with an average blood pressure reading across 4 measurements over 2 separate days greater than 140/90mmHg.
Unwilling to wear a face mask during in-person study visits that require them.
Unwilling to get tested for COVID-19 and share results with study personnel prior to all in-person visits.
Are unvaccinated against COVID-19, are not current with their COVID-19 vaccine booster, or are unwilling to share their proof of COVID-19 vaccination with the study team.
The researchers aim to prove that Qigong practice can result in reduced or relieved neuropathic pain, improved mood, life satisfaction, self-efficacy, enjoyment to move, and community integration; and decreased fear of movement, use of medication or health care services for adults with spinal cord injury.
Ann Van de Winckel
All
18 Years to 75 Years old
N/A
This study is NOT accepting healthy volunteers
STUDY00011997
STUDY00011997
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Inclusion Criteria:
Spinal cord injury of greater than or equal to 3 months
Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
Highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Exclusion Criteria:
MRI contra-indications (stabilizing hardware is typically MRI safe)
Uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
Ventilator dependency
Pregnancy to plans to become pregnant during study
Inability to perform kinesthetic imagery.
Participants who cannot feel index finger movements will not perform the robot task but will perform all other resting-state and tasks in the MRI scanner.
The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.
Emily Greengard
All
to 21 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
STUDY00013998
STUDY00013998
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Inclusion Criteria:
Parts A and B only:
Participants must be less than or equal to (≤)18 years of age.
Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5 -- Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies.
For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
Part C only:
Participants must be less than (<) 21 years of age.
Participants have a BSA ≥0.3 m².
Participants with first relapse/refractory neuroblastoma.
All Parts
Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.
A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age.
Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
Able to swallow.
Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment).
Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label.
Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment.
Caregivers and participants willing to make themselves available for the duration of the trial.
Exclusion Criteria:
Received allogenic bone marrow or solid organ transplant.
Received live vaccination.
Intolerability or hypersensitivity to any of the study treatments or its components.
Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
Pregnant or breastfeeding.
Active systemic infections or viral load.
Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.
Parts A and C only: Have a bowel obstruction.
Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.
Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).
Christopher Moertel, MD
All
18 Years to old
Phase 1
This study is NOT accepting healthy volunteers
STUDY00014832
STUDY00014832
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Inclusion Criteria:
NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
Aged 18 years or older at the time of written consent
Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care
Exclusion Criteria:
Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
Conditions requiring systemic immunosuppression
Swallowing difficulties or strong gag reflex which may interfere with study compliance
Any comorbidities that may affect study participation in the judgement of enrolling investigator
Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
Treatment with high phenolic olive oil or curcumin within six months of study entry
Known pregnancy or anticipated conception during the 1 year study period
curcumin, high phenolic extra virgin olive oil (HP-EVOO), curcumin, high phenolic extra virgin olive oil (HP-EVOO)
This study is designed to find the maximum tolerated dose (MTD) of FT538 when given in combination with daratumumab for the treatment of acute myeloid leukemia (AML).
Joseph Maakaron
All
12 Years to old
Phase 1
This study is NOT accepting healthy volunteers
STUDY00012524
STUDY00012524
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Disease specific
Inclusion Criteria:
Acute myeloid leukemia relapsed/refractory after 2 lines of therapy; with CD38 expression
CD38 expression is defined by ≥20% of malignant cells with CD38 expression by flow cytometry on the most recent marrow biopsy (within 30 days of enrollment - archived or fresh).
Relapsed/refractory is defined as failure to achieve at least a Morphological Leukemia Free State (MLFS) or reverting from MLFS.
Lines of therapy are defined as (must have had 2 prior therapies):
One cycle of Intensive induction chemotherapy such as 7+3, 5+2, MEC, FLAG, FLAG-Ida, CLAG ± small molecule inhibitor
Four weeks of HMA-based induction ± small molecule inhibitor
Hematopoietic stem cell transplantation (HSCT) if relapse that occurs > 90 days after HSCT
Gemtuzumab Ozogamicin
LDAC + glasdegib
Biomarker-specific targeted agents (FLT3 inhibitors, IDH1/2 inhibitors, others if available)
Other treatments could be considered after discussion with the PI
Inclusion Criteria:
Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and < 16 years of age
Evidence of adequate organ function within 14 days of starting study treatment defined as:
Estimated Glomerular Filtration Rate (estimated creatinine clearance) ≥50 mL/min/1.73m^2
Total bilirubin ≤ 5 × upper limit normal (ULN), not applicable for patients with Gilbert's syndrome
AST ≤3 × ULN and ALT ≤ 3 × ULN, not applicable if determined to be directly due to underlying malignancy
LVEF ≥ 40% by echocardiogram or MUGA
Contraceptive use by men or women
Female subjects: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of cyclophosphamide (CY), at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
Male subjects: Males with a female partner of childbearing potential or a pregnant female partner must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 4 months after the final dose of CY and at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia (APL)
Pregnant or breastfeeding, Menstruating females of child-bearing potential must have a negative pregnancy test within 14 days of study treatment start
Known allergy to any of study drugs or their components
Clinically significant cardiovascular disease including any of the following: myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher or cardiac ejection fraction <40%
Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) during the FT538 dosing period (3 days before the 1st dose through 14 days after the last dose) excluding pre-medications - inhaled and topical steroids are permitted
Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the to the first dose of daratumumab. Maintenance hydroxyurea for blast control up to the initiation of lympho-conditioning is permitted
Known active central nervous system (CNS) involvement or treated CNS disease that has not cleared. If prior disease related CNS involvement must have completed effective treatment of their CNS disease at least 2 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging
Non-malignant CNS disease such as epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
Clinically significant untreated/uncontrolled infection
Live vaccine <6 weeks prior to start of lympho-conditioning
Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR
Prior solid organ transplant
Allogeneic HSCT relapse occurring <90 days after HSCT
Active graft-versus-host-disease (GvHD) requiring systemic immunosuppression within 14 days prior to enrollment
Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to the participant.
This protocol aims to characterize the safety and tolerability of loncastuximab tesirine in combination with gemcitabine, lenalidomide, polatuzumab vedotin, or umbralisib, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for any of the combinations in subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This project aims to address the resistance mechanisms to single agent therapies and enhance efficacy by engaging different targets, in synergistic or additive manner.
Marie Hu
All
18 Years to old
Phase I
This study is NOT accepting healthy volunteers
STUDY00015805
STUDY00015805
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Inclusion Criteria:
Male or female participant aged 18 years or older
Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-cell non-Hodgkin Lymphoma (B-NHL) (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens
Participants who have received previous cluster of differentiation 19 (CD19)-directed therapy must have a biopsy that shows CD19 expression after completion of the CD19-directed therapy
Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. follicular lymphoma [FL] and marginal zone lymphoma [MZL])
Measurable disease as defined by the 2014 Lugano Classification
Availability of formalin-fixed paraffin-embedded tumor tissue block
Eastern Cooperative Oncology Group performance status 0 to 2
Adequate organ function
Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent (for the arm that includes lenalidomide, from at least 4 weeks before starting lenalidomide) until at least 9 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose of study drug
Exclusion Criteria:
Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human anti-drug antibody (ADA) to a CD19 antibody
Known history of hypersensitivity to gemcitabine, lenalidomide, polatuzumab vedotin, or umbralisib leading to treatment discontinuation (applied to relevant arm and/or cohort of the specific drug administered)
Previous therapy with loncastuximab tesirine
Previous treatment of gemcitabine, lenalidomide, polatuzumab vedotin or umbralisib (applied to relevant arm and/or cohort of the specific drug administered)
Allogenic or autologous stem cell transplant within 60 days prior to start of study drug Cycle 1, Day 1 (C1D1) (cycle is 21 days)
Human immunodeficiency virus (HIV) seropositive
Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
For the arm that includes umbralisib, confirmed cytomegalovirus (CMV) infection (participants who are CMV immunoglobulin G [IgG] or immunoglobulin M [IgM] positive but CMV deoxyribonucleic acid [DNA] negative by polymerase chain reaction [PCR] are eligible)
For the arm that includes umbralisib, history of or ongoing inflammatory bowel disease
History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Lymphoma with active central nervous system (CNS) involvement at the time of screening, including leptomeningeal disease
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
Breastfeeding or pregnant
Significant medical comorbidities
Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drugs (C1D1; cycle is 21 days), except shorter if approved by the Sponsor
This study is looking at 48 adult patients that have been diagnosed with type 1 diabetes within the past 4 years and giving them subcutaneous injections weekly of NNC0361-0041 plasmid to assess the safety and tolerability. This is a phase1 study that will enrolled over a 28 week period.
Antoinette Moran
All
18 Years to 45 Years old
Phase 1
This study is NOT accepting healthy volunteers
STUDY00011044
STUDY00011044
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Inclusion Criteria:
Willing to provide Informed Consent
Participants must live in a location with rapid access to emergency medical services
Age 18-45 years (both inclusive) at the time of signing informed consent
Must have a diagnosis of T1D for less than 48 months at randomization
Must have at least one diabetes-related autoantibody present (GAD65A; mIAA, if obtained within 10 days of the onset of insulin therapy; IA-2A; ICA; or ZnT8A)
Must have stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during an MMTT conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
Be willing to comply with intensive diabetes management
HbA1c ≤8.5% at screening
Subjects who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative within 37 days of randomization and may not have had signs or symptoms of a CMV and/or EBV compatible illness lasting longer than 7 days within 37 days of randomization
Be up to date on recommended immunizations
Be at least 6 weeks from last live immunization
Be at least 4 weeks from killed vaccine other than flu vaccine
Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
Be willing and medically acceptable to postpone live vaccines during the treatment period and for 3 months following last dose of study drug
If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly effective contraceptive method for the 12 months of the study
Males of reproductive age must use adequate contraceptive method during the treatment phase and for 3 months following last dose of study drug
Participants are required to receive an authorized non-live COVID-19 vaccination and be fully vaccinated, including eligible boosters as indicated, at least two weeks prior to randomization.
Exclusion Criteria:
Potential participants must not meet any of the following exclusion criteria:
One or more screening laboratory values as stated
Leukocytes < 3,000/μL
Neutrophils <1,500 /μL
Lymphocytes <800 /μL
Platelets <100,000 /μL
Haemoglobin <6.2 mmol/L (10.0 g/dL)
Potassium >5.5 mmol/L or <3.0 mmol/L
Sodium >150mmol/L or < 130mmol/L
AST or ALT ≥2.5 times the upper limits of normal
Bilirubin ≥ 1.5 times upper limit of normal
Glomerular Filtration Rate (eGFR) value of eGFR < 60 ml/min/1.73 m2 as defined by KDIGO 2012 (43)
Any other laboratory abnormality that might, in the judgment of the investigator, place the subject at unacceptable risk for participation in this trial
Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
Use of other immunosuppressive agents including chronic use of systemic steroids. Topical products are acceptable (nasal, conjunctival, skin)
Have active signs or symptoms of acute infection at the time of randomization
Have current, confirmed COVID-19 infection
Chronic active infection other than localized skin infections
Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
Have evidence of current or past HIV, Hepatitis B infection
Have evidence of active Hepatitis C infection
Vaccination with a live virus within the last 6 weeks and killed vaccine within 4 weeks (except 2 weeks for flu vaccine)
Be currently pregnant or lactating, or anticipate getting pregnant within the one-year study period.
Have severe obesity: adults BMI ≥ 40
Have a history of malignancies
Untreated hypothyroidism or active Graves' disease
History of severe reaction to prior vaccination
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days after last blood draw (or 5 half-lives of investigational drug, whichever is greater) before screening, or currently enrolled in any other clinical trial
Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
Supine blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. To exclude white-coat nervousness a single repeat measurement is allowed
Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk
Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
This study is designed to assess the safety and tolerability of the
combination of CLBR001 and SWI019 in patients with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation.
Joseph Maakaron
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
STUDY00011917
STUDY00011917
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Inclusion Criteria:
Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
Patients must be ineligible for allogeneic stem cell transplant (SCT)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
Willing to undergo pre- and post-treatment core needle biopsy
Adequate hematological, renal, pulmonary, cardiac, and liver function
Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
Men sexually active with female partners of child bearing potential must agree to practice effective contraception
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
Exclusion Criteria:
Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
Pregnant or lactating women
Active bacterial, viral, and fungal infections
History of allogeneic stem cell transplantation
Treatment with any prior lentiviral or retroviral based CAR-T
Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
Involvement of cardiac tissue by lymphoma
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
HIV-1 and HIV-2 antibody positive patients
Primary objective, Part A (dose escalation): To assess the safety of escalating doses of CTX110 in subjects with relapsed or refractory B cell malignancies to determine the recommended Part B dose
Primary objective, Part B (cohort expansion): To assess the efficacy of CTX110 in subjects with relapsed or refractory B cell malignancies, as measured by objective response rate (ORR)
Joseph Maakaron
All
18 Years to old
Phase 1
This study is NOT accepting healthy volunteers
STUDY00010648
STUDY00010648
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Key
Inclusion Criteria:
For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX110 infusion.
Agree to participate in an additional long-term follow-up study after completion of this study.
Key
Exclusion Criteria:
Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
History of central nervous system (CNS) involvement by malignancy
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of enrollment.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.
CTX110, CTX110
B-cell Malignancy, Non-Hodgkin Lymphoma, B-cell Lymphoma, Adult B Cell ALL