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392 Study Matches

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

This study is designed to determine the recommended Phase II dose (RP2D), as well as evaluate the safety and efficacy for FT596 as monotherapy and in combination with rituximab or obinutuzumab in patients with relapsed/refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia.

Veronika Bachanova, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04245722
STUDY00008387
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Key
Inclusion Criteria:
Diagnosis of B-cell lymphoma or CLL as described below: B-Cell Lymphoma:
• Histologically documented lymphomas expected to express CD19 and CD20
• Relapsed/refractory disease following prior systemic immunochemotherapy regimen Chronic Lymphocytic Leukemia (CLL):
• Diagnosis of CLL per iwCLL guidelines
• Relapsed/refractory disease following at least two prior systemic treatment regimens ALL SUBJECTS:
• Capable of giving signed informed consent
• Age ≥ 18 years old
• Stated willingness to comply with study procedures and duration
• Contraceptive use for women and men as defined in the protocol Key
Exclusion Criteria:
ALL SUBJECTS:
• Females who are pregnant or breastfeeding
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
• Body weight <50 kg
• Evidence of insufficient organ function
• Receipt therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
• Currently receiving or likely to require systemic immunosuppressive therapy
• Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
• Receipt of an allograft organ transplant
• Known active central nervous system (CNS) involvement by malignancy
• Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• Clinically significant cardiovascular disease
• Known HIV infection
• Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
• Live vaccine <6 weeks prior to start of lympho-conditioning
• Known allergy to albumin (human) or DMSO
Drug: FT596, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Rituximab, Drug: Obinutuzumab
Lymphoma, B-Cell, Chronic Lymphocytic Leukemia
Lymphoma, Leukemia, Clinics and Surgery Center (CSC)
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will conduct a double-blind, placebo-controlled, randomized clinical trial at two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04783857
STUDY00010569
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Inclusion Criteria:

• stable physical and mental health with confirmed, uncomplicated pregnancy at gestational week 30-35
• established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider
• self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment
• history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
• self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• willingness to use non-hormonal contraceptives postpartum if sexually active until 12 weeks postpartum
Exclusion Criteria:

• current use of tobacco products (e.g., cigars, e-cigs), nicotine replacement therapy or smoking cessation medications
• current major depressive disorder based on the Structured Clinical Interview for DSM-5 (SCID)
• contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy)
• contraindications to DMPA treatment (e.g., current use of aminoglutethimide or planning to become pregnant in the next year)
• current use of illicit drugs or alcohol abuse
• treatment for illicit drug use or alcohol use disorder within the last 3 months
• any condition that, in the opinion of the clinical team, precludes participation in the trial.
Drug: Progesterone 200 MG Oral Capsule, Drug: Depot-Medroxyprogestereone Acetate, Other: Placebo Oral Tablet, Other: Placebo Injection
Smoking, Smoking Cessation, Smoking Reduction
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Clinical and Basic Investigations into Congenital Disorders of Glycosylation

Define natural history, validate patient reported outcome and share knowledge on congenital disorders of glycosylation. We will recruit and enroll patients with CDG in this study evaluating clinical variation and natural history when a patient is being seen as part of routine clinical care.

Kyriakie Sarafoglou
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04199000
STUDY00009013
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Inclusion Criteria:

• Patients diagnosed with congenital disorders of glycosylation based on genetic confirmatory testing
Exclusion Criteria:

• Patients without congenital disorders of glycosylation
Congenital Disorders of Glycosylation
CDG, CDDG, Congenital Disorders of Glycosylation, Congenital Disorders of Deglycosylation, ALG1, ALG3, ALG6, ALG12, ALG13, COG6, DPAGT1, DPM1, EDEM3, MAN1B1, MPDU1, MPI, NGLY1, PGAP3, PGM1, PIGA, PIGG, PIGN, PIGS, PIGT, PMM2, SLC35A2, SLC35C1, SLC39A8, SRD5A3, SSR4, FUT8, GALNT2, MAN2B2, VMA21
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Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

This is a prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness investigation. The primary objectives of this study are to evaluate the clinical safety and effectiveness of the Nanostim™ LP system in patients who are indicated for VVI(R) pacemaker.

Quan Pham, MD, FACC
NA
This study is NOT accepting healthy volunteers
NCT02030418
1404M50243
Bradycardia
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Poke and a placebo

Aaron Berg
Female
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04497220
STUDY00010360
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Inclusion Criteria:

• 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
Behavioral: Negative Connotation Langauge, Behavioral: Positive Connotation Language
Anesthesia
Epidural Anesthesia (labor)
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Preparing Heart and MindTM: A Patient Engagement Pathway for Women and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis

The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided technology-based intervention to lower distress and enhance caregiving among mothers and their caregiving partners after a major fetal anomaly diagnosis.

Anne McKechnie
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05282368
STUDY00005489
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Inclusion Criteria:

• A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
• Willing and able to comply with study procedures.
• Participants must be ≥ 18 years old.
• Participants must be able to read, write and speak English.
• Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
• The pregnant woman/person and her caregiving partner are planning for infant delivery and care.
• The fetal diagnosis of the major anomaly affects the heart (i.e., CCHD). See definition of CCHD included earlier in the protocol. Other anomalies could be present and potentially impair other organs.
• The infant's anomaly will likely require surgical and/or medical intervention within the first year of life.
• The fetus/infant is expected to live with surgical and/or medical intervention (this includes a vulnerable population).
• There may be genetic and/or chromosomal conditions in addition to the heart/structural anomalies
Exclusion Criteria:

• Pregnancy termination
• The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
• Adults lacking the capacity to consent
• Adults who do not have access to a smart phone, tablet, or device.
• Caregiving partner cannot enroll if mother is not enrolled
Behavioral: PHM™ Pathway
Parent Mental Health
parent, fetal anomaly, prenatal diagnosis, infant, heart disease, ehealth, intervention
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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

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
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04880473
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
Device: PrevisEA device
Gastrointestinal Complication
Postoperative ileus, Postoperative bowel obstruction, Emesis, Reversal of diet, Nasogastric tube, Abdominal sounds, Gastrointestinal impairment, Elective intestinal resection, Clinics and Surgery Center (CSC)
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Multi-arm Optimization of Stroke Thrombolysis (MOST)

This study is designed to find out whether adding one of two blood-thinning medications, argatroban or eptifibatide, to the standard treatment after a stroke helps to decrease the impact of strokes and is safe. Both are FDA-approved blood thinners, but are not approved for treating strokes.

Oladi Bentho
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03735979
STUDY00006255
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Inclusion Criteria:

• Acute ischemic stroke patients
• Treated with 0.9mg/kg IV rt-PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well
• Age ≥ 18
• NIHSS score ≥ 6 prior to IV thrombolysis
• Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis
Exclusion Criteria:

• Known allergy or hypersensitivity to argatroban or eptifibatide
• Previous stroke in the past 90 days
• Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
• Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
• Any surgery, or biopsy of parenchymal organ in the past 30 days
• Trauma with internal injuries or ulcerative wounds in the past 30 days
• Severe head trauma in the past 90 days
• Systolic blood pressure persistently >180mmHg post-IV thrombolysis despite antihypertensive intervention
• Diastolic blood pressure persistently >105mmHg post-IV thrombolysis despite antihypertensive intervention
• Serious systemic hemorrhage in the past 30 days
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >1.5
• Positive urine or serum pregnancy test for women of child bearing potential
• Glucose <50 or >400 mg/dl
• Platelets <100,000/mm3
• Hematocrit <25 %
• Elevated pre-thrombolysis PTT above laboratory upper limit of normal
• Creatinine > 4 mg/dl
• Ongoing renal dialysis, regardless of creatinine
• Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
• Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
• Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours
• Received glycoprotein IIb/IIIa inhibitors within the past 14 days
• Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score >3
• Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if rt-PA, TNK, eptifibatide or argatroban therapy was initiated a. Example: known cirrhosis or clinically significant hepatic disease
• Current participation in another research drug treatment or interventional device trial - Subjects could not start another experimental agent until after 90 days
• Informed consent from the patient or the legally authorized representative was not or could not be obtained
• High density lesion consistent with hemorrhage of any degree
• Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT Scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment
Drug: Argatroban, Drug: Eptifibatide, Drug: Placebo
Acute Ischemic Stroke
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Comparison of normothermia maintenance between resistive blanket and forced air warming systems in renal transplant surgery

The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in patients undergoing renal transplantation. Secondary outcome variables also include: • AUC of time versus temperature curves • temperatures at set points during operative period • Blood loss volumes

Cole Bennett
All
18 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04776954
STUDY00012072
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Inclusion Criteria:

• Undergoing elective renal transplantation
Exclusion Criteria:

• Previous surgery involving organ transplantation or nephrectomy. These patients are at higher risk of blood loss, making temperature regulation subject to more variables outside our control.
• End stage renal disease with decreased or no urine output from normal. Bladder temperature will not be valid in these patients.
• Previous upper extremity amputations
• Ongoing sepsis or other infection
• Thyroid dysfunction
• Emergency surgery
• Refusal of consent to participate in study
• Pregnancy
Device: Forced Air Warming System, Device: Resistive Blanket Warming System
Surgery, Temperature Change, Body
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Characterization of ultrasound reflection patterns caused by the ribs associated with ultrasound imaging of the spleen.

We are performing this study to determine how ultrasound echo patterns vary based on the location of an ultrasound transducer over the ribs when targeting the spleen. The information gathered will be used to improve portable, low cost splenic ultrasound stimulation devices currently under investigation as immunomodulatory therapies.

Morgan Newhoff
18 Years and over
NA
This study is also accepting healthy volunteers
ENT-2021-30182
STUDY00013747
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Inclusion Criteria:
Males and females aged 18 and older
Exclusion Criteria:
-Individuals who have undergone splenectomy -Individuals with breathing difficulties -Individuals unable to maintain these body positions: sitting, sitting with a 45? recline, lying on back (supine), lying on right side, and lying face down (prone) comfortably and independently -Individuals with breathing difficulties and/or individuals for whom modification of breathing patterns is difficult or uncomfortable. -Individuals who are unable to consent due to language barriers, illiteracy, or lacking the capacity to consent (see Vulnerable Populations section) -Pregnant women
Bone, Joint & Muscle
ultrasound
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Safety and efficacy of a self-administered treatment for MDD using an external combined occipital and trigeminal nerve stimulator (Relivion?DP). (MDD)

The MOOD Study will evaluate the safety and efficacy of a self-administered treatment for MDD using an external combined occipital and trigeminal nerve stimulator (Relivion®DP). This pivotal clinical investigation is intended to support future marketing applications (US FDA and CE) for Neurolief’s Relivion®DP device.

Ziad Nahas
All
18 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04279522
STUDY00014298
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Inclusion Criteria:

• Males and females 18-70 years of age:
• Up to 124 randomized subjects aged 22-70
• Up to 36 randomized subjects aged 18-21
• Primary diagnosis of unipolar major depressive disorder by DSM-V criteria.
• Current MDD episode lasts up to three years.
• Score on the Hamilton Depression Rating Scale (HDRS21) ≥ 20
• Symptoms of current major depressive episode that, as determined by the Investigator, for the current episode and according to the Antidepressant Treatment Resistance Form (ATRF) or Antidepressant Treatment Intolerance Form (ATIF):
• Did not respond or have insufficiently responded by less than 50% improvement; dose and duration defined & rated at minimum confidence level 3 on the ATRF;
• Did not respond or has insufficiently responded to at least one but no more than four adequate trials of antidepressant medications (4 ≥ ATRF ≥1) or
• Did not respond or has insufficiently responded due to poor tolerability to at least two inadequate antidepressant medication trials (ATIF ≥2).
• Subject must be on at least one (1) antidepressant medication (minimum therapeutic dose not required if tolerability precluded further dose titration) and is willing to remain on the same daily dose of antidepressant medication(s) for a minimum of 28 days prior to randomization and thereafter for the duration of the study.
• For subjects receiving current depression focused psychotherapy: psychotherapy initiated at least 1 month prior to baseline visit with a stable frequency of visits regimen, in the opinion of the Investigator.
• Subject is able to provide written Informed Consent and is capable of complying with the specified study requirements, as determined by the Investigator.
• Subject has cognitive and/or motor skills needed to operate a smartphone and can be contacted by phone, as determined by the Investigator.
Exclusion Criteria:

• History of intracranial surgery.
• Current denervation in one or more of the following: the supraorbital or supratrochlear branches of the trigeminal nerve, or the greater occipital branch of the occipital nerve.
• An implanted neurostimulators or any implanted metallic or electronic device in the head, a cardiac pacemaker or an implanted or wearable defibrillator, except for dental implants.
• Skin lesion, scars, or inflammation at the region of the stimulating electrodes.
• Subjects with a history of traumatic brain injury (TBI), defined as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury, within 3 months of study enrollment.
• Pregnancy or Lactation.
• Women of reproductive age not using a reliable contraceptive method as determined by the Investigator.
• In the opinion of the Investigator, subjects with a psychiatric history consistent with, suspicious for, or diagnostic of, bipolar depression or depression associated with psychosis.
• Borderline personality disorder, defined by DSM-V criteria, that in the judgement of the Investigator is likely to complicate the assessment of clinical response to study treatments or limits the patient's ability to comply with study procedures
• Subjects who, within one (1) year of study enrollment, have a history consistent with, suspicious for or diagnostic of, any of the following: psychosis, psychotic disorder, schizophrenia or schizoaffective disorder, in the opinion of the Investigator.
• Subjects who demonstrate or have a history of any cognitive disorder or impairment, memory loss, dementia, confusion or delirium that, in the opinion of the Investigator, may compromise the integrity of the study data or impact the ability of the subject to comply with the study requirements.
• Past 12 months active suicidal intent or plan as defined by a "yes" answer to Q4 or Q5 on the Columbia-Suicide Severity Rating Scale, (C-SSRS) or with a history of suicide attempt in the past twelve months.
• Subjects currently (past month) meeting diagnostic criteria for Obsessive-Compulsive Disorder or post-traumatic stress disorder and that is their primary diagnosis.
• Subjects meeting the DSM-V criteria for alcohol use disorder or other substance use disorder (not including tobacco/nicotine) within six (6) months prior to study enrollment.
• The subject has any past or present medical condition, disease, illness, disorder or injury that, in the opinion of the Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may confound the integrity of the study data.
• Participation in a previous study with the Relivion®DP or the Relivion® device.
• Treatment with Transcranial Magnetic Stimulation (TMS) in the past 6 months.
• Current treatment with any other approved or investigational brain stimulation therapies (i.e. Vagus or trigeminal nerve Stimulation, tDCS, TES).
• Failure to receive clinical benefit from an adequate trial of ECT in the current or a past depressive episode in the opinion of the Investigator.
• Subject having received Botox treatment in the head or neck region within 90 days prior to study enrollment.
• Subject having received supraorbital or occipital nerve blocks within 1 month prior to enrollment.
• Head circumference smaller than 51 centimeters or larger than 60 centimeters.
• Current neurological condition or disease which, in the opinion of the investigator, is likely to manifest a depressive syndrome or symptoms that would substantially confound the diagnosis or serial assessment of major depressive disorder.
• Subjects participating in other clinical trials evaluating experimental treatments or procedures.
Device: Relivion®DP- Active, Device: Relivion®DP- Sham
MDD
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The effect of inflammation and damage to lymph node structures on durable protective immunity following vaccination

Are you planning to receive the yellow fever vaccine for upcoming travel? This study may be for you! How well a vaccine works sometimes varies by geography, with good protection in one part of the world and poor protection in others. In this research study, the research team is investigating if this is due to different infections in communities, which could affect parts of the immune system that are needed for a good response to a vaccine. Healthy participants who receive the yellow fever vaccine in Uganda and Minnesota will have their levels of infections (from viruses, bacteria, fungi, parasites, and helminths [a type of parasitic worm]) compared. This will help us learn more about relationships between these infections, how they affect immune systems, and how that affects the body’s response to a vaccine.

Timothy Schacker
All
18 Years to 60 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04269265
STUDY00004946
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Inclusion Criteria:

• No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).
• If female of childbearing age must agree to contraception for one month following administration of the vaccination.
Exclusion Criteria:

• History of yellow fever or previous vaccination for yellow fever
• Known bleeding disorder
• Prior surgery complicated by clotting abnormality
• Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study
• History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein).
• Thymus disorder associated with abnormal immune function
• Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy.
• Pregnant or breastfeeding at the time of vaccination.
• Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.
Biological: Yellow Fever Vaccine
Yellow Fever
Clinics and Surgery Center (CSC)

Visual Surround Suppression and Perceptual Expectation Under Psilocybin

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
All
25 Years to 65 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04424225
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
• 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.
Drug: Psilocybin, Drug: Niacin
Perception Disturbance, Visual Suppression, Psychedelic Experiences
psilocybin, visual perception
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Investigation of Persistent HIV Immune Stimulation in Lymphoid Tissues During Therapy as a Cause of Sustained Immune Activation

Timothy Schacker
18 Years and over
NA
This study is NOT accepting healthy volunteers
IDIM-2020-28516
STUDY00009216
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Inclusion Criteria:

• Age >/= 18 years of age
• HIV infection
• Receiving an ART regimen
• Able to provide written voluntary consent before performance of any study related procedure.
Exclusion Criteria:

• BMI >/= 30
• Currently taking anticoagulant blood thinners such as warfarin, enoxaparin, heparin
• Pregnant or breastfeeding
• Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
• More than 3 pervious lymph node biopsies for the main study. No more than 2 lymph nodes for the sub-study.
Infectious Diseases
HIV, immune activation, immune response
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Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)

The Syner-G regimen research study seeks to evaluate the use of a combination of a medication called miglustat and a ketogenic diet for treatment of the gangliosidoses to learn if this combination will provide improved clinical outcomes compared to what we currently know about the natural course of the disease.

Jeanine Jarnes
All
up to 204 Months old
Phase 4
This study is NOT accepting healthy volunteers
NCT02030015
1311M46101
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Inclusion Criteria:

• Subjects must have a documented infantile or juvenile gangliosidosis disease.
• Age: 17 years or less at time of enrollment
• Subjects and their caregivers must be willing to work with a ketogenic diet team for management of the subject's ketogenic diet.
Exclusion Criteria:

• A desire to not participate
• Patients who are older than 17 years will not be enrolled in this study.
• Children with severe renal impairment will not be enrolled in this study.
• Post-pubertal females who are pregnant, or who are unwilling to use highly-effective methods to prevent pregnancy, will be excluded from this study.
• Breast-feeding females will be excluded from this study.
• Subjects who have an allergy to miglustat or any of the components within the drug product will be excluded from this study.
Drug: miglustat, Other: Ketogenic Diet
GM1 Gangliosidoses, GM2 Gangliosidoses, Tay-Sachs Disease, Sandhoff Disease
infantile Tay-Sachs disease, juvenile Tay-Sachs disease, infantile GM1 gangliosidosis, juvenile GM1 gangliosidosis, infantile GM2 gangliosidosis, juvenile GM2 gangliosidosis, Sandhoff disease, gangliosidoses, miglustat, ketogenic diet, SYNER-G regimen, Syner-G, Zavesca, Tay-Sachs disease, Tay Sachs disease
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Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA (GABA)

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

All
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT02829593
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Inclusion Criteria:

• well controlled type 1 diabetes (hemoglobin A1c <7.5%)
• age 18-65
• healthy controls
Exclusion Criteria:

• history of stroke, seizures, neurosurgical procedures, or arrhythmias
• use of drugs that can alter GABA metabolism (such as benzodiazepines).
• Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
Other: hypoglycemia (low blood sugar) and MRI
Type 1 Diabetes, Healthy
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Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia

This phase II trial studies how well trametinib works in treating patients (≥ 2 years and < 22 years of age) with juvenile myelomonocytic leukemia that has come back or does not respond to treatment. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Emily Greengard
All
1 Month to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03190915
STUDY00003883
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Inclusion Criteria:

• Patients must have had histologic verification of juvenile myelomonocytic leukemia (JMML) at original diagnosis and currently have relapsed or refractory disease; the diagnosis is made based on the following criteria
• JMML category 1 (all of the following): the diagnostic criteria must include all features in category 1 and EITHER (i) one of the features in category 2 OR (ii) two features from category 3 to make the diagnosis
• Splenomegaly
• > 1000 (1 x 10^9/uL) circulating monocytes
• < 20% blasts in the bone marrow or peripheral blood
• Absence of the t(9;22) or BCR/ABL fusion gene
• JMML category 2 (at least one of the following if at least two category 3 criteria are not present):
• Somatic mutation in RAS or PTPN11
• Clinical diagnosis of NF1 or NF1 gene mutation
• Homozygous mutation in CBL
• Monosomy 7
• JMML category 3 (at least two of the following if no category 2 criteria are met):
• Circulating myeloid precursors
• White blood cell count, > 10 000 (10 x 10^9/ uL)
• Increased hemoglobin F for age
• Clonal cytogenetic abnormality
• GM-CSF hypersensitivity
• Patients with refractory or relapsed JMML must have had at least one cycle of intensive frontline therapy or at least 2 cycles of a deoxyribonucleic acid (DNA) demethylating agent with persistence of disease, defined by clinical symptoms or the presence of a clonal abnormality; frontline therapy is defined as one cycle of intravenous chemotherapy that includes of any of the following agents: fludarabine, cytarabine, or any anthracycline but specifically excludes oral 6-mercaptopurine; frontline therapy will also include any conditioning regimen as part of a stem cell transplant; patients who transform to AML at any point with more than 20% blasts are not eligible for this trial
• Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
• Myelosuppressive chemotherapy: patients must have completely recovered from all acute toxic effects of chemotherapy, immunotherapy or radiotherapy prior to study enrollment; at least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of hydroxyurea
• Note: cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of protocol therapy
• Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur
• Monoclonal antibodies:
• At least 30 days after the completion of any type of immunotherapy, e.g. tumor vaccines
• At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
• Radiotherapy:
• >= 2 weeks must have elapsed since local palliative external radiation therapy (XRT) (small port)
• >= 6 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if traumatic brain injury (TBI) was received
• >= 4 weeks must have elapsed if other substantial bone marrow irradiation was given
• Stem cell transplant or rescue without TBI: no evidence of active graft versus (vs.) host disease and >= 3 months must have elapsed since transplant; >= 4 weeks must have elapsed since any donor lymphocyte infusion
• Patients must not be known to be refractory to red blood cell or platelet transfusions
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• Age: Maximum serum creatinine (mg/dL)
• 1 month to < 6 months: 0.4 (male) 0.4 (female)
• 6 months to < 1 year: 0.5 (male) 0.5 (female)
• 1 to < 2 years: 0.6 (male) 0.6 (female)
• 2 to < 6 years: 0.8 (male) 0.8 (female)
• 6 to < 10 years: 1 (male) 1 (female)
• 10 to < 13 years: 1.2 (male) 1.2 (female)
• 13 to < 16 years: 1.5 (male) 1.4 (female)
• >= 16 years: 1.7 (male) 1.4 (female)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN (=< 135 U/L) (for the purpose of this study, the ULN for SGPT is 45 U/L)
• Serum albumin >= 2 g/dL
• Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by multi-gated acquisition (MUGA)
• Corrected QT (by Bazett's formula [QTcB]) interval < 450 msecs
• Patients must be able to swallow tablets or liquid; use of a nasogastric or gastrostomy (G) tube is also allowed
Exclusion Criteria:

• Patients who are pregnant or breast-feeding are not eligible for this study as there is yet no available information regarding human fetal or teratogenic toxicities; negative pregnancy tests must be obtained in girls who are post-menarchal; patients of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy; women of childbearing potential should be advised to use effective contraception for 4 months after the last dose of trametinib; trametinib may also potentially be secreted in milk and therefore breastfeeding women are excluded; female patients should not breastfeed during treatment with trametinib, and for 4 months following the last dose; male patients must use a condom during intercourse and agree not to father a child during therapy and for 4 months following discontinuation of trametinib to avoid unnecessary exposure of trametinib to the fetus
• Concomitant Medications
• Corticosteroids: patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Note: hydrocortisone used as a pre-medication to prevent transfusion related reactions is not considered a concomitant corticosteroid
• Investigational drugs: patients who are currently receiving another investigational drug are not eligible
• Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible (except patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
• Anti-graft versus host disease (GVHD) or agents to prevent organ rejection post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
• Cardiac medications: any medications for treatment of left ventricular systolic dysfunction
• Patients who have an uncontrolled infection are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
• Patients with a history of hepatic sinusoid obstructive syndrome (veno-occlusive disease) within the prior 3 months are not eligible
• Patients with a history of or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible
• Patients with a history of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension
• Patients with uncontrolled systemic disease(s) such as hypertension or diabetes mellitus are not eligible; blood pressure must be =< the 95th percentile for age, height, and gender
• Patients with a history of allergic reaction attributed to compounds of similar chemical or biologic composition to the MEK inhibitor, trametinib are not eligible
• Patients with a clinical diagnosis of Noonan syndrome are not eligible; Note: patients with Casitas B-lineage lymphoma (CBL) syndrome, also known as Noonan-like syndrome, are eligible to enroll
Drug: Trametinib
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
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Algorithms for programming DBS systems for ET

This study seeks to leverage subject-specific computational models that can predict neural activation of axonal pathways adjacent to the active electrode(s) and implicated in the therapeutic mechanisms of Vim-DBS to in turn guide clinicians with which stimulation settings are likely to be the most therapeutic on tremorous activity.

Matthew Johnson
All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03984643
STUDY00005218
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Inclusion Criteria:

• diagnosis of ET
• medication-refractory tremor
• VIM-DBS implant (unilateral or bilateral)
• 7T MRI pre-operative scan under Dr. Harel's IRB (institutional review board) protocol (#1210M22183)
• Post-operative CT scan
Exclusion Criteria:

• history of musculoskeletal disorders that affect movement of the limbs
• other significant neurological disorder
• prior history of stereotactic neurosurgery (other than VIM-DBS surgery)
• pregnancy
Device: Vim-Deep Brain Stimulation
Essential Tremor
Clinics and Surgery Center (CSC)
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Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System

Michael Todd
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04406740
STUDY00002808
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Inclusion Criteria:

• patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
Exclusion Criteria:

• Emergent procedures will be excluded
• Procedures performed outside of regular Monday to Friday working hours will be excluded
• Inability to provide their own consent
Device: TwitchView EMG Unit, Device: Novel QTOF Device
Anesthesia
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A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury

Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.

Ann Van de Winckel
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05167032
STUDY00014710
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Inclusion Criteria:
18?75 years old, with an incomplete or complete SCI/D of ? 3months, medically stable.
Exclusion Criteria:
adults with MRI contra-indications (stabilizing hardware is typically MRI safe); uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain inju-ry) that prevent them from following directions or from learning; with ventilator dependency; or with other major medical complications. We will exclude pregnant women
Behavioral: Cognitive Multisensory Rehabilitation (CMR), Behavioral: Adaptive fitness
Spinal Cord Injuries, Brain & Nervous System
movement, sensation, spinal cord injury
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Psychological Factors Influencing Voice Outcomes: Impacts in Gender Diverse Adults

This study will measure the relationship between voice-related quality of life and psychosocial distress in transgender and gender diverse patients with a voice concern. Participants participate in an semi-structured interview to characterize their voice-related experiences and the role of voice-related perceived control related to their voice concerns.

Stephanie Misono
18 Years and over
NA
This study is NOT accepting healthy volunteers
ENT-2021-30266
STUDY00014077
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Inclusion Criteria:
? Adult aged 18-80 ? Identifies as transgender or gender diverse ? Has a voice concern ? Has access to email and a device (e.g., phone, tablet, or computer) with internet connection
Exclusion Criteria:
? Inability to read and speak English ? Inability to provide informed consent and independently complete questionnaires ? Pregnant
Community Health, Ear, Nose & Throat
Clinics and Surgery Center (CSC), gender, gender diverse, psychology, transgender, voice
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A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE)

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study including patients with IPF. The combination of PRM-151 with standard of care pirfenidone or nintedanib for 52 weeks will be evaluated, with primary objective as the absolute change from baseline to Week 52 in forced vital capacity (FVC).

Hyun Kim
All
40 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04552899
STUDY00011372
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Inclusion Criteria:

• Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
• High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
• Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening
• FVC >/= 45% predicted during screening as determined by the over-reader
• Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader
• Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to ( • If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
• If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening
• Anticipated life expectancy of at least 12 months at baseline
• Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
• For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
• Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
• For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Exclusion Criteria:

• Evidence of other known causes of Interstitial Lung Disease (ILD)
• FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
• Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
• Receiving nintedanib in combination with pirfenidone
• Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
• Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening
• Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
• Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
• Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening
• Class IV New York Heart Association chronic heart failure
• Historical evidence of left ventricular ejection fraction < 35%
• Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
• Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
• History of smoking, alcohol or substance abuse disorder, or a malignancy
• Previous treatment with PRM-151
• Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula
• Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
• Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
• Women of childbearing potential (Only for participants enrolling in Japan)
Drug: PRM-151 (Zinpentraxin Alfa), Drug: Placebo
Idiopathic Pulmonary Fibrosis
Clinics and Surgery Center (CSC)
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Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

The primary objectives of this study are: -To determine the impact of N-803 on the frequency and function of CD8+ T cells in B cell follicles. -To determine the safety of N-803 HIV+ ART suppressed individuals by assessment of adverse events experienced by participants during the conduct of the trial.

Timothy Schacker
All
18 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04808908
STUDY00007810
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Inclusion Criteria:

• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
• On continuous antiretroviral therapy for over 24 months without any interruptions of greater than 14 consecutive days, without plans to modify ARTduring the study period.
• Screening plasma HIV RNA levels < 20 copies/mL and on at least 1 determination in past 12 months (isolated single values greater than or equal to 20 but < 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
• Screening CD4+ T cell count greater than or equal to 350 cells/mm3 and nadir CD4+ T cell count of >200 per participant report.
• Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before screen. Inhaled, nasal spray, and topical steroids are acceptable.
• Acceptable blood pressure and heart rate parameters within normal limits (systolic = 88-140mmHg; diastolic = 50-<90mmHg; heart rate = 46-100 bpm). Treatment with antihypertensive medication is allowed. However, if someone is on a beta-blocker this must be switched to another class of medication as there is a theoretical risk for bradycardia if the participant were to experience cytokine release syndrome symptoms (which has not happened with this drug delivered SQ).
• Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during study participation and for 1 month following the final study visit (4 months after final dose of study drug). Acceptable birth control is defined as the following: (1) For female participants of childbearing potential, two of the following forms of contraception are required, one of which must be a barrier method:
• Condoms (male or female) with or without a spermicidal agent
• Diaphragm or cervical cap with spermicide
• Intrauterine device (IUD) with published data showing that expected failure rate is < 1% per year
• Tubal ligation
• Hormone-based contraceptive such as oral birth control pills
• Laboratory tests performed within 14 days of study enrollment must be a grade 0 or 1 as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, with the following exceptions:
• Platelet counts (≥ 150,000/mm3)
• Hemoglobin > 12.5 g/dL for men and > 11.5 g/dL for women. It is not acceptable for patients to be transfused to meet this requirement. The use of Epogen is permitted.
• Estimated Cr Cl (eGFR) > 50
Exclusion Criteria:

• Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
• Chronic liver disease defined as Class B and C on the Child-Pugh chronic liver disease scale.
• Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following:
• acute myocardial infarction
• acute coronary syndromes
• stable or unstable angina
• coronary or other arterial revascularization
• stroke
• transient ischemic attack (TIA)
• peripheral arterial disease presumed to be of atherosclerotic origin.
• History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 30 days prior to screen (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon, methotrexate, cancer chemotherapy). NOTE: use of inhaled, nasal steroid or topical steroid lotions and creams is not exclusionary. Prior exposure to N-803 is not exclusionary if prior exposure occurred at least 6 months before screen.
• Unable to undergo leukapheresis procedure
• Exposure to any experimental therapies within 90 days of study screen. Exposure to long acting injectable ART therapies is not exclusionary.
• Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy that is defined as meeting PPD criteria for TB exposure or a positive quantiferon gold test collected at screening.
• Active fungal infection requiring systemic antifungal therapy
• Active herpes outbreak or varicella-zoster virus infection requiring episodic treatment
• Chronic active hepatitis B or C. For Hepatitis B this will be defined as HBs antigen + and for Hepatitis C this will be defined as Hepatitis C antibody positive and Hepatitis C PCR+.
• History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the site Principle Investigator may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Any degree of baseline QT/QTc interval prolongation (QTc interval > 450 msec in males and > 470 msec in females.)
• Any ischemic changes seen in the stress treadmill test administered per the discretion of the PI in order to assess any other EKG abnormalities outlined in study protocol
• History or evidence of uncontrollable CNS disease such as dementia, demyelinating disease, Parkinson's, or a CNS degenerative disease that, in the opinion of the site Principle Investigator, may either put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
• Prior organ allograft or allogeneic transplantation
• Planning or current pregnancy or breastfeeding
• Any clinically indicated vaccination (other than influenza) administered within 14 days of screen
Biological: N-803
Hiv, HIV Infections, AIDS
Clinics and Surgery Center (CSC)
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Biomarkers of Exposure and Effect in SREC Users

The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.

Irina Stepanov
All
18 Years and over
Phase 1
This study is also accepting healthy volunteers
NCT04003805
STUDY00002033
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Inclusion Criteria:

• Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
• Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
• Biochemically confirmed regular smoking status by a NicAlert test level of 6;
• Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
• No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
• Subjects are in good physical health (no unstable medical condition);
• Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
• Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
• Women who are not pregnant or nursing or planning to become pregnant;
• Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:

• Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
• Currently using nicotine replacement or other tobacco cessation products;
• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
• Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
• Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
• Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
• Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
• Pregnant or breastfeeding;
• Failure to agree to take adequate protection to avoid becoming pregnant during the study;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic BP greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Expired air carbon monoxide (CO) level greater than 80 ppm;
• Self-reported allergies to propylene glycol or vegetable glycerin;
• Adverse reactions when previously using electronic cigarettes;
• Household member enrolled in the study concurrently;
• Unable to read for comprehension or completion of study documents;
• Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Drug: Standardized Research E-cigarette (SREC), Drug: Nicotine Mini-Lozenge
Smoking, Cigarette, Prevention & Wellness
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Participants patients meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if we can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate safety of VSG. We wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study a sample size of 19 in each group should offer significant information as to the difference in NAS score reduction between to two groups and to achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.

Sayeed Ikramuddin
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03587831
STUDY0002886
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Inclusion Criteria:

• Age 40 to 67 years at eligibility visit.
• At least one of the following: A) Liver biopsy within 6 months preceding enrollment consistent with non-alcoholic fatty liver disease with a NAFLD Activity Score ≥4 B) Diagnosed with type 2 diabetes mellitus or prediabetes for at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c< 9% and NOT requiring insulin
• Body Mass Index (BMI): 35.0-50.0 kg/m2 at eligibility visit
• Willingness to accept random assignment to either treatment group
• All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study
• Expect to live or work within approximately two-hours traveling time from the study clinic for the duration of the one-year trial
• Evidence of liver fat present in the baseline MR images
• Suitable for liver biopsy using the percutaneous approach
• Willingness to comply with the follow-up protocol and successful completion of the run-in (described below)
• Written informed consent
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.
• 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 twice 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, cirrhosis, or inflammatory bowel disease.
• 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.
• Brief psychological evaluation recommendation that individual not continue in the study.
• Current participation in a conflicting research protocol.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• 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 during initial eligibility review as well as on the day of scanning using the standard safety screening form.
• Individuals that require the trans-jugular approach for liver biopsy
• Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. Any history of dysphagia.
• More than 2 cups of coffee per day
• NAS fibrosis score > 3
Procedure: Vertical Sleeve Gastrectomy, Behavioral: Lifestyle Modification Counseling
Digestive & Liver Health, NASH - Nonalcoholic Steatohepatitis
Clinics and Surgery Center (CSC), Bariatric Surgery, NASH, VSG
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MT2017-28 The Head Start 4 Protocol - Newly Diagnosed Children (less than 10 years old) with Medulloblastoma and Other Central Nervous System Embryonal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Either Single Cycle (Low Risk Patients) or Randomization (High Risk Patients) to Either Single-Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue Added Title: Neuroanatomical, Cognitive and Family Aspects to Recovery from a Brain Tumor

This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population (children < 120 months) will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.

Christopher Moertel, MD
All
up to 10 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02875314
STUDY00000427
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Inclusion Criteria:

• Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)
• Patients may not have received irradiation or chemotherapy (except corticosteroids)
• Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
• Medulloblastoma
• Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
• Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
• Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection
• CNS Embryonal Tumors:
• Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.
• Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination
• Patients must have adequate organ functions at the time of registration:
• Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal.
• Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.
• Bone Marrow Function:
• Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count.
• Platelet Count > 100,000/µL (transfusion independent)
• Hemoglobin > 8 gm/dL (may have received RBC transfusions).
Exclusion Criteria:

• Patients older than 10 years of age at time of diagnosis
• Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas).
• Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.
Drug: Induction, Drug: Single Cycle Intensive Chemotherapy, Drug: Tandem 3 Cycle Intensive Chemotherapy
Medulloblastoma, Central Nervous System Embryonal Tumors
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Use of Entresto (sacubitril/valsartan) for the treatment of peripheral arterial disease

The primary objective of this study is to assess the effects of 12 weeks of Entresto on the functional clinical parameters maximal walking duration, pain free walking duration and 6 minute walk test of patients with PAD. In addition, to determine the effects of Entresto on peak VO2, cardiac output and systemic vascular resistance.

Otto Sanchez
All
18 Years to 80 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02636283
1702M08001
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Inclusion Criteria:

• Subject with symptoms of intermittent claudication, such as exercise-induced pain, cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the leg(s) (calf, thigh, buttocks), relieved by rest.
• Ankle-brachial index ≤ 0.90 acquired according to the American Heart Association guidelines.
• Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting pressure (or loss of previously present Doppler signal for both the posterior tibial and anterior tibial arteries immediately after exercise if arteries were incompressible).
• Patients on medical treatment for PAD without significant improvement in intermittent claudication within the last 6 months.
Exclusion Criteria:

• Age < 18 and > 80 years.
• Patients with physician diagnosed chronic kidney disease or heart failure stage II or IV or unstable angina.
• Echocardiographic evidence of cardiomyopathies and pulmonary hypertension.
• Patients that have received cancer treatment within the last year (except skin cancer).
• Severe limitations in mobility due to osteomuscular disorders present at time of interview.
• Dementia or other mental disorders that prevent patients from following a research protocol present at time of interview
• Patients engaged in an exercise rehabilitation program within the past 6 months.
• Patients schedule to undergo an arterial revascularization procedure during the study or have undergone one within the past 6 months.
• Inconsistent maximal walking distance on the treadmill test.
Drug: Entresto, Drug: Placebo group
Peripheral Arterial Disease
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A novel Peptamen-based enteral nutrition protocol for treatment of Crohn s disease A Pilot Trial

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
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
GI-2019-28202
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
Digestive & Liver Health, Microbiota
Crohn?s disease, IBD, dietary intervention, enteral nutrition, inflammatory bowel disease
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Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Lung Specimens

We propose to study explanted tissue of patients that are scheduled to undergo single or double lung transplant surgery as a late-stage disease therapeutic strategy. The primary endpoint will be to characterize the composition of the bacterial community in the lung. The secondary endpoint will be to describe bacterial gene expression in the lower airways.

Ryan Hunter
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02128711
1404M49426
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Inclusion Criteria:

• diagnosis of cystic fibrosis
• eligible for lung transplantation
• exhausted other available therapies without success
• informed consent
Exclusion Criteria:

• there are no exclusion criteria
Cystic Fibrosis
lung, cystic fibrosis, bacteria, positive diagnosis of CF,, Clinics and Surgery Center (CSC)
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Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysm

The primary objective of this research project is development and validation of a new, non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic aneurysm in the chest and abdomen in at risk patients. This study would initially be performed in patients with a known aneurysm and done in addition to their indicated surveillance CT scan.

Rumi Faizer
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT03479164
1510M79442
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Inclusion Criteria:

• Adult patients who carry the diagnosis of thoracic aortic aneurysm, aortic dissection, or abdominal aortic aneurysm and require CT imaging to evaluate the pathology
Exclusion Criteria:

• Current pregnancy
Other: Ultra Low-Dose CT
Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal
Clinics and Surgery Center (CSC)
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