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341 Study Matches

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

We are studying a new drug, INCB054707, used to treat people who have hidradenitis suppurativa which is a chronic skin condition characterized by lumps or boils in places such as the armpits or groin. The skin lesions develop because of inflammation of the follicle. We are studying two doses of the drug and we will compare the effectiveness and side effects that occur. We will also have a group that receives an inactive medication (placebo). After the first 12 weeks of taking the drug or placebo, all participants will receive the active drug. The study will last for about 62 weeks.

Noah Goldfarb
This study is NOT accepting healthy volunteers
STUDY00017728
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Inclusion Criteria:

• moderate to severe H.S. for at least 3 months
Exclusion Criteria:

• mild H.S.
• women who are pregnant (or who are considering pregnancy) or breastfeeding
Dermatology (Skin, Hair & Nails), Rare Diseases
Hidradenitis Suppurativa( HS)
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A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis (VOCAL)

The aim of this study is to investigate whether voclosporin, added to standard treatment, is able to reduce activity of lupus nephritis over a study treatment period of 24 weeks, and to determine its safety as well as the best dose for treatment of lupus nephritis in children or adolescents.

Michelle Rheault
This study is NOT accepting healthy volunteers
STUDY00018537
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Inclusion Criteria:

• 12 to 17 years old
• diagnosis of systemic lupus erythematosus (SLE)
• active lupus nephritis confirmed by a kidney biopsy
Exclusion Criteria:

• currently need dialysis
• clinically significant active medical or mental health conditions (study staff will review)
• certain medications, including: immunosuppression biologic agents, cyclophosphamide, calcineurin inhibitors (CNIs), start or change dose of ACE inhibitors/ARBs within 4 weeks prior to starting study, IV corticosteroids and IV immunoglobulin within 2 weeks of starting study
Immune Diseases, Kidney, Prostate & Urinary
Adolescent Lupus Nephritis, Lupus, Nephritis
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis (VALOR)

In this study, brepocitinib will be compared to a placebo. Brepocitinib is an investigational medicine because it has not yet been approved by any regulatory agency for use. Researchers will compare the results of taking the placebo to the results of taking the study medicine to see if there are any differences. This medicine may be helpful for your disease, but we do not have any information about this yet. 67% of participants will receive brepocitinib and 33% will receive the placebo which will be decided randomly by chance. Participation will last for up to 64 weeks (15 months). Visits will be scheduled about every 4 to 6 weeks.

David Pearson
This study is NOT accepting healthy volunteers
STUDY00016860
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Inclusion Criteria:

• diagnosis of dermatomyositis
• active muscle and skin disease or being treated with medications
• age 18-75
• weight at least 40 kg, less than 130 kg and a BMI less than 40 kg/m2
Exclusion Criteria:

• history of cancer in past 5 years
• dermatomyositis with irreversible muscle involvement
• active or recent infections
Arthritis & Rheumatic Diseases, Dermatology (Skin, Hair & Nails)
Clinics and Surgery Center (CSC), dermatomyositis
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A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

We are studying a new drug, called JNJ-80038114, to treat men who have advanced prostate cancer and are receiving anticancer therapy except for androgen deprivation. We are looking at the best dose, effectiveness of the drug and the side effects that occur.

Nicholas Zorko
This study is NOT accepting healthy volunteers
STUDY00017304
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Inclusion Criteria:

• metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate
• receiving anticancer therapy except for androgen deprivation
• able to care for self with some assistance
• adequate organ functions as defined by certain laboratory values (study staff will review)
Exclusion Criteria:

• receiving current anticancer therapy
• severe or long-lasting side effects related to prior anticancer therapy
• brain metastasis or history of seizures
• significant infections or lung, heart or other medical conditions (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Advanced Prostate Cancer, mCRPC, Metastatic castration-resistant prostate cancer, Prostate Cancer, Prostate Cancer
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PEPN22P1: Pharmacokinetic Study of VinCRIStine in Infants Dosed According to BSA-Banded Infant Dosing Tables and Older Children Dosed by Traditional BSA Methods

This early phase I trial compares a new method for dosing vincristine in infants and young children to the standard dosing method based on body size in older children. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The same dose of a drug cannot be given to all children because they vary a lot in size from infancy to adolescence. The dose of most anticancer drugs is based on a measure of body size called the body surface area (BSA). BSA is calculated from a patient's weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so adjustments have to be made to safely give anticancer drugs to the youngest patients. A new method for dosing anticancer drugs in infants and young children has been developed that uses body size to determine the dose. Collecting blood samples over time may help researchers understand how the new vincristine dosing method affects drug levels in the blood over time in infants and young children compared to older children.

Emily Greengard
STUDY00017658
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Inclusion Criteria:
Patients must be =< 12 years of age at the time of study enrollment. Patients will be stratified into 4 age groups: 0 to 6 months 6 months and 1 day to 12 months 12 months and 1 day to 36 months 36 months and 1 day to 12 years Newly diagnosed and relapsed cancer diagnosis that is being treated with vinCRIStine at the 1.5 mg/m^2 dose level Any disease status Patients must have a Lansky performance status of 50 or higher Patients must be receiving a treatment regimen that includes 1.5 mg/m^2 vinCRIStine (maximum dose 2 mg) Patients with a BSA < 0.6 m^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine Note: Patients can be studied after any dose of vinCRIStine Patients who are NOT enrolled on a COG clinical trial and who have a BSA < 0.6 m^2 and who are being dosed according to another infant dosing method (e.g., the 30-Rule) can receive a dose of vincristine from the infant dosing table for the pharmacokinetic study. These patients will NOT be part of the Dose Modification Assessment Patients with a seizure disorder may be enrolled if on allowable anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days Nervous system toxicities (Common Terminology Criteria for Adverse Events [CTCAE]) version (v)5 resulting from prior therapy must be grade =< 2 Central venous access device in place (e.g., percutaneous indwelling central catheter [PICC], port, Broviac) that can be used for pharmacokinetic (PK) sampling VinCRIStine may be given as an outpatient, as long as all sample time points can be collected, which will require return for hour 24 sampling
Exclusion Criteria:
Azoles antifungals and macrolide antibiotics: Patients who are currently receiving an azole or macrolide (e.g., fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, ketoconazole, eryromycin, clarithromycin, azithromycin, roxithromycin, or telithromycin) are not eligible CYP3A4/5 inducers/inhibitors: Patients receiving any medications or substances that are considered moderate or strong inhibitors or inducers of CYP3A4/5 are not eligible. Moderate or strong inducers or inhibitors of CYP3A4/5 should be avoided from 14 days prior to enrollment to the end of the study. Note: dexamethasone for central nervous system (CNS) tumors or metastases, on a stable dose, is allowed Anticonvulsants: Patients receiving moderate or strong CYP3A4/5 enzyme inducing anticonvulsants are not eligible. Patients with Charcot-Marie-Tooth disease A baseline neurological disorder with manifestations that overlap with vinCRIStine-associated neurotoxicities Patients receiving a modified dose (< 1.5 mg/m^2) of vinCRIStine due to prior toxicity Patients who in the opinion of the investigator may not be able to comply with the sampling requirements of the study
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients with Pulmonary Sarcoidosis

We are studying the use of Efzofitimod given IV at two different doses to treat people who have pulmonary sarcoidosis. Participants must be on stable treatment with an oral corticosteroid with or without immunosuppressant therapy. Some people will receive IV saline (placebo) and we will compare groups to see how well the drug works and what side effects occur. The trial will last for about one year.

Maneesh Bhargava
This study is NOT accepting healthy volunteers
STUDY00016463
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Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking stable dose of at least 7.5 mg of prednisone daily for 3 months and willing to taper dose down
• Body weight between 88-352 lbs
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Active heavy smoker (defined as > 20 cigarettes/day or e-cigarette equivalent)
• Active substance abuse (drugs, alcohol, or cannabis) or history of substance abuse within the last 12 months
• Pregnancy or breast-feeding
Rare Diseases, Breathing, Lung & Sleep Health, Respiratory System
Sarcoidosis, Clinics and Surgery Center (CSC)
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Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone metastases from Multiple Myeloma

This is a phase II prospective multi-institutional study. The main study objectives are: 1) To determine whether radiation treatment, with a total dose of 4 Gy, delivered over two days (2 fractions) to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to historical controls at 4 weeks. 2) To assess quality of life in patients treated with 4Gy to painful myeloma bone lesions. 3) To quantify analgesia use/reduction following 4Gy to a painful myeloma bone lesion. All opioid analgesia use will be converted into morphine equivalent in order to compare across the entire population. 4) To measure time to pain relief and duration of pain relief with 4Gy. 5) To assess pain relief in patients with more than 1 index lesion.

Stephanie Terezakis
STUDY00010991
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Inclusion Criteria:
Histologic diagnosis of multiple myeloma Painful bone metastasis (index lesion) that has a radiographic correlate Patient may have had any number of prior chemotherapy/immunotherapy regimens (changes to systemic therapy or use of bisphosphonates for 4 weeks before and after RT are allowed, but recording of these changes must be made so it can be accounted for) Eastern Cooperative Oncology Group (ECOG) 0-2 Brief Pain Inventory (BPI) score >= 2 Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Patients will be ineligible if the index lesion has received prior radiation therapy or prior palliative surgery. Patients may have received prior palliative or primary radiotherapy or surgery to other parts of the body, as long as the index lesion was not in the prior radiation fields and has not received prior palliative surgery Patients will also be ineligible if there is pathologic fracture or impending fracture at the site of the index lesion or planned surgical fixation of the bone at the index lesion Patients with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement from the index lesion, and/or with index lesions located at the skull base or orbital lesions Patients must not be pregnant
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A feasibility study of topical cannabinoids for treatment of aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) in women with hormone receptor-positive breast cancer (CanAroma)

Aromatase inhibitors (AIs) are commonly used in treating hormone-positive breast cancer. Unfortunately, many patients receiving this treatment experience Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS), with symptoms like joint and bone pain and joint stiffness. The current therapies used to improve AIMSS symptoms have limited effectiveness and can cause their own side effects. In this research study, we are examining the feasibility of topical medical cannabis cream as a treatment option for AIMSS.

Anne Blaes, MD
This study is NOT accepting healthy volunteers
STUDY00015727
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Inclusion Criteria:

• Stage I-III Breast Cancer.
• Currently taking Aromatase Inhibitor for at least 60 days.
• Aromatase Inhibitor use for no more than 48 months.
• Experiencing aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) symptoms.
• Minnesota resident
Exclusion Criteria:

• Currently using or has used cannabinoid products in the past 4 weeks.
• Active skin lesions on hands/wrists.
• Current or planned acupuncture treatments to hands and wrists.
• Plan to increase doses of other pain medications for improving AIMSS symptoms.
Cancer
aromatase inhibitors, Breast Cancer, hand, pain, stiffness, wrist, Cancer Survivors
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An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease

This is a study to assess the safety and efficacy of PR001A, an Aden-associated (AAV9) viral vector to treat neuronopathic Gaucher disease type 2 (GD2) in infants. PRA001A will be administered via suboccipital injection to the cisterna magna during a single neurosurgical session. GD2 is a fatal disease of early infancy that does not have any therapeutic options beyond palliative care. This study will enroll infants 0-24 months of age.

Chester Whitley, MD, PhD
This study is NOT accepting healthy volunteers
STUDY00008823
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Inclusion Criteria:

• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• 0 to 24 months of age
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
Exclusion Criteria:

• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
Rare Diseases
Gaucher disease, Type 2 (GD2)
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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON)

The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. The primary efficacy endpoint of the study is the change in absolute forced vital capacity (FVC) in subjects with IPF from baseline to Week 52.

Hyun Kim
This study is NOT accepting healthy volunteers
STUDY00018720
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Inclusion Criteria:

• at least 40 years old
• confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
• people taking pirfenidone or nintedanib must be on a stable and optimized dose for at least 30 days (may not take both of these drugs)
• women must agree to use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug
• men with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug
Exclusion Criteria:

• women who are pregnant or breast feeding
• receiving >10 L/min of oxygen supplementation by any mode of delivery at rest
• any other lung disease or significant cardiac disease (study staff will review)
Respiratory System
Idiopathic Pulmonary Fibrosis, IPF, Lung Disease
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A Phase 2, Randomized, Open-Label Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-Resistant Prostate Cancer (TAMARACK) (Tamarack)

To evaluate the efficacy of MGC018 versus control as measured by rPFS by BICR using PCWG3 criteria.

Emmanuel Antonarakis
This study is NOT accepting healthy volunteers
STUDY00017672
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Inclusion Criteria:

• adenocarcinoma of the prostate
• received abiraterone, enzalutamide, or apalutamide to treat mCRPC
• may have had one taxane regime
• disease progression by PSA or imaging
Exclusion Criteria:

• received more than 1 prior taxane-containing regimen
• received more than 3 total prior therapies for mCRPC
• study staff will review medical and mental health history and lab values
Cancer
Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer, Prostate Cancer
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

Emmanuel Antonarakis
This study is NOT accepting healthy volunteers
STUDY00017208
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• previous treatment required, study staff will review
• able to care for self with little help
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate Cancer, Prostate cancer
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CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)

We are enrolling people who have had complete surgical removal of a stage II or stage III colorectal cancer. We will draw blood samples for circulating tumor DNA (ctDNA) to find out if this blood test can be used to detect recurrence of the cancer. People will be followed for at least 3 years and up to 5 years.

Edward Greeno, M.D.
This study is NOT accepting healthy volunteers
MMCORC050
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Inclusion Criteria:

• diagnosis of carcinoma of the colon or rectum (CRC)
• complete surgical resection, with last surgery occurring within 180 days prior to enrollment
Exclusion Criteria:

• started adjuvant (after surgery) therapy for current CRC diagnosis
• women who are pregnant or breastfeeding
• history of any invasive cancer except non-melanoma skin cancer
Cancer
Colon Cancer, Colon Cancer, Colorectal Cancer
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Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients with EPI due to Chronic Pancreatitis (CP) (CisCP)

CP is a progressive fibro-inflammatory disease where EPI develops due to destruction of pancreatic parenchyma or pancreatic duct distortion. EPI results in maldigestion, leading to fat-soluble vitamin deficiencies, weight loss, malnutrition, and impaired quality of life (Qol). Signs and symptoms of EPI include abdominal bloating and cramping, diarrhea, foul-smelling, greasy stools (steatorrhea), and unintentional weight loss. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment of EPI. Treatment is aimed at reduction of maldigestion-related symptoms, and prevention of malnutrition and its related morbidity and mortality. CREON® is a PERT that has been FDA approved since 2009 for the treatment of EPI due to cystic fibrosis, CP, pancreatectomy, or other conditions

Guru Trikudanathan
This study is NOT accepting healthy volunteers
STUDY00012592
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Inclusion Criteria:

• at least 18 years old
• history of chronic pancreatitis (CP).
• diagnosis of Exocrine Pancreatic Insufficiency (EPI)
Exclusion Criteria:
-history of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Exocrine Pancreatic Insufficiency (EPI)
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BEGIN-OB-19: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN) (BEGIN)

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.

Elissa Downs
STUDY00010861
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Inclusion Criteria:
Part A: Less than 5 years of age at the first study visit. Documentation of a CF diagnosis. Part B: Participated in Part A OR less than 6 years of age at the first study visit. Documentation of a CF diagnosis. CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor). Physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor.
Exclusion Criteria:
Part A and Part B: Use of an investigational drug within 28 days prior to and including the first study visit. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit. Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
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STRIKE-PE: A Prospective, Multicenter Study of the IndigoTM Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally. Participants will be in this research study for about one year. Participants will be asked to complete a screening and baseline visit, device procedure in-patient visit as part of routine treatment for their PE, one post-procedure visit in the hospital and two follow-up visits. The study team will collect information on tests and procedures done during these visits from their medical records. They will also be asked to complete a quality of life questionnaire.

Christopher Jones
STUDY00013412
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Inclusion Criteria:
Clinical signs and symptoms consistent with acute PE with duration of 14 days or less RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram Frontline endovascular treatment with the Indigo Aspiration System per IFU Patient is ≥ 18 years of age Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin) Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study Known serious, uncontrolled sensitivity to radiographic agents Life expectancy < 180 days Patients on ECMO Pregnant patients Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
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MT2022-54 A MULTINATIONAL, MULTICENTER, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF FP-045 IN PATIENTS WITH FANCONI ANEMIA

This is a multinational, multi-center study to determine the Optimal Biologic Dose (OBD) and to evaluate the safety, tolerability, PK, and preliminary activity of FP-045 when administered orally in young adult/adolescent and pediatric patients with Fanconi anemia.

Meera Srikanthan
STUDY00018771
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Inclusion Criteria:
male or female aged 3-25 documented Fanconi anemia by chromosome breakage analysis females of child-bearing potential and males required to use highly effective birth control mild to moderate bone marrow failure with at least one cytopenia of > grade 1 severity
Exclusion Criteria:
history of any malignancy except focal squamous cell or basal cell carcinoma of the skin or carcinoma in situ of cervix has myelodysplastic syndrome or acute leukemia per world health organization (WHO) criteria has history of any significant medical conditions has aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5x upper limit of normal (ULN) or calculated creatinine clearance (Clcr) of < 50 mL/min has active Hepatitis B or C has an ongoing systemic infection requires a strong CYP3A4 inhibitor has had major surgery within 30 days Active graft versus host disease requiring systemic treatment Has a history of bone marrow or stem cell transplant
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A Phase 1b, Randomized, Vehicle-Controlled, Double-Blind, Pharmacokinetics, Pharmacodynamics, and Safety Study of ARQ-255 Topical Suspension in Healthy Volunteers and Subjects with Alopecia Areata

This is a phase 1b, vehicle-controlled, double-blind, multicenter study evaluating safety, tolerability, pharmacokinetic (PK), efficacy, and biomarker changes associated with treatment with ARQ-255 topical suspension 3% or vehicle in healthy volunteers and subjects with patchy AA affecting 40-75% of the total scalp.

Maria Hordinsky
This study is NOT accepting healthy volunteers
STUDY00017979
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Inclusion Criteria:

• 18 to 70 years of age
• have alopecia areata
• able to apply topical study medication
Exclusion Criteria:

• alopecia totalis
• alopecia universalis
Dermatology (Skin, Hair & Nails)
alopecia areata
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COG ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

The purpose of this prospective, randomized Phase 2 study is to find out if giving eflornithine (DFMO) along with dinutuximab, irinotecan, and temozolomide is tolerated in patients ≥ 1 year of age. It will also investigate how effective the drug combination is against relapsed or refractory neuroblastoma (NBL).

Emily Greengard
STUDY00006850
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Inclusion Criteria:
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. > 2 x upper limit of normal [ULN]), at the time of initial diagnosis. For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound as intended to treat high-risk disease. The doses of chemotherapy must be comparable to those used in frontline high-risk neuroblastoma therapies (examples include A3973, ANBL0532, ANBL09P1, ANBL12P1, and ANBL1531). Patients must have ONE of the following: First episode of recurrent high-risk disease following completion of aggressive multi-drug frontline high-risk therapy. First episode of progressive high-risk disease during aggressive multi-drug frontline therapy. Primary resistant/refractory disease (less than partial response by International Neuroblastoma Response Criteria [INRC]) detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, ANBL12P1, ANBL1531, etc.). Patients must have at least ONE of the following at the time of enrollment: Measurable tumor on magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable is defined as >= 10 mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose F-18 (FDG) uptake on positron emission tomography (PET) scan. MIBG-avid lesion detected on MIBG scan with positive uptake at a minimum of one site. This site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction. Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma. Biopsy is not required for patients who have a new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy. Patients with bone marrow disease only will be eligible if they have more than 5% disease involvement (documented neuroblastoma cells) in at least one sample from bilateral bone marrow biopsies. Note: Patients with elevated catecholamines (i.e. > 2 x ULN) only are NOT eligible for this study. Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. Primary refractory/resistant patients must have received at least 4 cycles of frontline high-risk chemotherapy. Frontline therapy may also have included surgery, chemotherapy, autologous stem cell transplantation (SCT) +/- MIBG, immunotherapy, radiotherapy, and retinoids but must NOT have received second line therapy for resistant/refractory, relapsed, or progressive disease. Patients who received intensified therapy for poor induction response or refractory disease (e.g. MIBG) will be considered to have received second line therapy and will not be eligible. At least 14 days must have elapsed since completion of myelosuppressive therapy. Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent. Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1. No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions. However, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response. Lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma. Palliative radiation while on study is not permitted. Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions (including stem cell infusions given as supportive care following 131 I-MIBG therapy) as long as hematologic and other eligibility criteria have been met. Patients are eligible >= 6 weeks after therapeutic 131 I-MIBG provided that all other eligibility criteria are met. Subjects who have previously received anti-GD2 monoclonal antibodies with or without retinoids for biologic therapy are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy or progressed/relapsed within 3 months of receiving anti-GD2 therapy. However, eligible patients may NOT have received anti-GD2 monoclonal antibodies in combination with chemotherapy. Subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads are eligible. Subjects who have previously received DFMO are eligible for this study provided they have not had progressive disease while receiving DFMO or progressed/relapsed within 3 months of completing DFMO. Patients must not have received long-acting myeloid growth factors (e.g. pegfilgrastim) within 14 days of entry on this study. Seven days must have elapsed since administration of a short-acting myeloid growth factor. For patients with solid tumors (without marrow involvement) including status post SCT: peripheral absolute neutrophil count (ANC) >= 750/uL (within 7 days prior to enrollment). For patients with solid tumors (without marrow involvement) including status post SCT: platelet count >= 75,000/uL (transfusion independent) (within 7 days prior to enrollment). Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and transfusion independent platelet count criteria are met (as above). However, these patients are not evaluable for hematological toxicity. Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: 1 to < 2 years (male 0.6 mg/dL, female 0.6 mg/dL) 2 to < 6 years (male 0.8 mg/dL, female 0.8 mg/dL) 6 to < 10 years (male 1 mg/dL, female 1 mg/dL) 10 to < 13 years (male 1.2 mg/dL, female 1.2 mg/dL) 13 to < 16 years (male 1.5 mg/dL, female 1.4 mg/dL) >= 16 years (male 1.7 mg/dL, female 1.4 mg/dL) (within 7 days prior to enrollment). Total bilirubin =< 1.5 x ULN for age (within 7 days prior to enrollment). Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L). For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment). Shortening fraction of >= 27% by echocardiography (ECHO) (within 7 days prior to enrollment). Ejection fraction of >= 50% by ECHO or gated radionuclide study (within 7 days prior to enrollment). No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry. Normal pulmonary function tests in patients who are capable of cooperating with testing (including diffusion capacity of the lung for carbon monoxide [DLCO)] are required if there is a clinical indication for determination. For patients who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT required. Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment. Patients with seizure disorders may be enrolled if seizures are well controlled on anti-convulsants. CNS toxicity =< grade 2.
Exclusion Criteria:
Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study. Based on the established teratogenic potential of alkylating agents, pregnant women will be excluded from this study. Because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study. Females of childbearing potential must have a negative pregnancy test to be eligible for this study. Patients with only elevated catecholamines (i.e. > 2 x ULN) are NOT eligible for this study. Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment. Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible. The only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions. The use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency. Patients on any other immunosuppressive medications (e.g. cyclosporine, tacrolimus) are not eligible. Patients must not have received prior treatment with irinotecan and temozolomide. Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to study enrollment. Patients receiving non-enzyme inducing anticonvulsants such as gabapentin, valproic acid, or levetiracetam will be eligible. Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible. Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma. Patients with symptoms of congestive heart failure are not eligible. Patients must not have >= grade 2 diarrhea. Patients who are unable to tolerate oral/nasogastric/gastrostomy medications will not be eligible for this trial. Additionally, patients with significant malabsorption will not be eligible for this trial. Patients must not have uncontrolled infection. Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy are not eligible. Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible.
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia

Kyriakie Sarafoglou
This study is NOT accepting healthy volunteers
STUDY00009488
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Inclusion Criteria:

• at least 18 years old
• childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based genetic mutation in CYP21A2 and/or documented elevated 17-OHP
• currently treated with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination)
• on a stable dose of GC replacement of at least 15 mg/day and less than 60 mg/day in HC equivalents
• people with the salt-wasting form of CAH, must be on a stable dose of mineralocorticoid replacement for at least 1 month
Exclusion Criteria:

• known or suspected diagnosis of any other known form of classic CAH (not due to 21 hydroxylase deficiency)
• history of bilateral adrenalectomy or hypopituitarism
• allergy or hypersensitivity to Tildacerfont, any of its forms, or any other CRF1 receptor antagonist
• current treatment with dexamethasone as GC therapy for CAH.
• clinical signs or symptoms of adrenal insufficiency
Diabetes & Endocrine, Rare Diseases
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Evaluate the perspectives of cancer survivor patients and caregivers on using an intrathecal drug delivery system as a continuum of pain management care using a qualitative study.

Targeted medication delivery near the spinal cord (intrathecal pump) may be offered for cancer pain treatment in carefully selected patients. Prior studies showed an improved functional status reduction in oral medications and their side effects. Cancer survivors receiving intrathecal pump treatment for pain are eligible to participate in the research and share their stories. After consenting zoom interview (45 minutes) will be conducted before and after the treatment to improve our understanding of patient perceptions of pain treatment with an intrathecal pump.

Vasudha Goel
This study is NOT accepting healthy volunteers
STUDY00016356
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Inclusion Criteria:

• cancer survivors with pain for more than 3 months duration who may benefit from intrathecal pump treatment for pain
Exclusion Criteria:

• people who are not eligible for treatment with an intrathecal pump
Cancer
Cancer Pain, Cancer Survivor, Cancer Survivors, Intrathecal drug delivery systems (IDDS), Palliative Care, Chronic Pai
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This study is intended to determine the clinical benefit of tabelecleucel (EBV-specific cytotoxic T-lymphocytes) in subjects with EBV-associated diseases.

Joseph Maakaron
STUDY00013494
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Inclusion Criteria:
Diagnosis of EBV+ disorder Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16 years; Lansky score >= 20 for participants from >=1 year to < 16 years Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator Cohort-specific
Inclusion Criteria:
For participants with PID LPD: R/R or newly diagnosed PID LPD for whom the standard first-line therapy is inappropriate, as determined by investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification (Cheson BD, et al. J Clin Oncol. 2014;27:3059) during or after treatment or failure to achieve a CR or partial response (PR) (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic disease only, systemic and CNS disease, or CNS disease only For participants with AID LPD: R/R or newly diagnosed AID LPD for whom the standard first line therapy is inappropriate, as determined by the investigator. The LPD is confirmed by at least biopsy-proven EBV+ LPD or positive CSF cytology, with or without radiographically measurable intracranial disease, with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic disease only, systemic and CNS disease, or CNS disease only For participants with AID etiology or AID attributable to immunosenescence, objective laboratory evidence of immunodeficiency For participants with CNS PTLD: R/R or newly diagnosed EBV+ CNS PTLD for whom the standard first-line therapy is inappropriate, as determined by the investigator. The CNS PTLD is histologically confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF. Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy Participant may have systemic and CNS disease or CNS disease only For participants with EBV+ PTLD, including CD20-negative disease: Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or chemotherapy) is inappropriate, as determined by the investigator Participants must have systemic disease measurable per Lugano Classification criteria, except when contraindicated or mandated by local practice, then MRI may be used For participants with sarcoma, including LMS, or smooth muscle tumors: EBV+ sarcoma or smooth muscle tumor with rapidly progressive disease defined as progressive disease per RECIST 1.1 criteria as documented radiographically within a 6-month interval prior to enrollment Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, as determined by the investigator Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor Measurable disease using diagnostic CT and/or MRI following RECIST 1.1 criteria (Eisenhauer et al. 2009. Eur J Cancer 45[2]:228-247)
Exclusion Criteria:
Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment Need for vasopressor or ventilatory support at the time of enrollment Prior therapy (in order of increasing washout period) prior to enrollment as follows: Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression Within 8 weeks: prior tabelecleucel (>8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab) Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above Women who are breastfeeding or pregnant Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment) Any conditions that may put the study outcomes at undue risk (life expectancy < 60 days or any life-threatening illness, medical condition, or organ system dysfunction) For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant For participants with EBV+ PTLD: prior systemic therapy for PTLD
Clinics and Surgery Center (CSC)
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A Phase I Study of HCW9218, a Bifunctional TGF-B; Antagonist/IL-15 Protein Complex, in Select Advanced Solid Tumors After Failing at Least Two Prior Therapies

This is an early study of a new drug, HCW9218, to treat certain solid tumors (except pancreatic cancer and brain tumors) that have not responded to usual treatment. People must have received at least two other types of treatment for the cancer. We are testing different doses of the drug to find the maximum dose that is tolerated.

Melissa Geller, MD
This study is NOT accepting healthy volunteers
STUDY00015102
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Inclusion Criteria:

• advanced/metastatic solid tumor cancer (except pancreatic and primary brain cancers)
• failed at least 2 prior lines of therapy given either in the recurrent or metastatic setting - refractory to or intolerant of existing therapy(ies)
• 18 years or older
• able to care for self and do light work
Exclusion Criteria:

• women who are pregnant or breast feeding
• tumor has spread to the brain
• history of medical or mental health issues (study staff will review)
Cancer
Phase I Clinic, Clinics and Surgery Center (CSC)
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MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study

The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).

Shernan Holtan
STUDY00014365
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Inclusion Criteria:
HCT recipients over 12 years of age within the first 7 days of initial treatment of high-risk aGVHD, defined as: Newly diagnosed Minnesota high-risk aGVHD -OR- Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/ml tested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information, see Fairview Lab Guide: http://labguide.fairview.org/showtest.asp?testid=6766&format=long -OR- Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested by Viracor. For ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/ Renal: Serum creatinine ≤2.5x upper limit of normal (ULN) Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35% Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds).
Exclusion Criteria:
Progressive malignancy Uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations) Unwilling or unable to stop GnRH antagonists, aromatase inhibitors, or anti-androgens History of a hormone responsive malignancy Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status Pregnancy Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Clinics and Surgery Center (CSC)
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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

David Potter
This study is NOT accepting healthy volunteers
STUDY00018283
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Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Cancer, Women's Health
Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (PACIFIC)

The purpose of this study is to find out the safety and tolerability (the degree to which side effects affect a participant’s willingness to continue taking study drug) of the study drug EP547 in patients with itch associated with cholestatic liver disease and to determine the amount of EP547 in the blood after dosing. EP547 is an experimental drug that is not approved by the Food and Drug Administration (FDA) for the treatment of itch associated with liver disease or of any other conditions. This study will have 9 study visits which includes a screening period of up to 4 weeks long, a 12-week treatment period, and a follow-up visit 2 weeks after stopping study treatment.

John Lake
This study is NOT accepting healthy volunteers
STUDY00016629
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Inclusion Criteria:

• diagnosed with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC
• consistent moderate to severe pruritus (itching)
Exclusion Criteria:

• prior or planned liver transplantation
• liver cirrhosis
• significant small bowel resection or short bowel syndrome
Dermatology (Skin, Hair & Nails), Digestive & Liver Health
Clinics and Surgery Center (CSC), Itching, Pruritus
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A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer

This study uses different drug combinations to treat women who have endometrial cancer that has come back or has not responded to treatment. The drugs have different ways of stopping the growth of tumor cells and we are looking to see if different combinations are more effective.

Edward Greeno, M.D.
This study is NOT accepting healthy volunteers
MMCORC011
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments
• following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell histology is excluded
• must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
• Body weight > 30 kg
• able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption
Exclusion Criteria:

• Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion
• Pregnant women are excluded
Cancer
Endometrial Cancer
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OMS721-IGA-001: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day at baseline. During the study, all patients will continue optimized renin-angiotensin system (RAS) blockade. The study consists of five periods: Screening, Run-In, Initial Treatment (Weeks 1-12), Response Evaluation (Weeks 13-24), and Follow-Up (Weeks 25 to end-of-study). The study duration for each patient is expected to last up to 160 weeks.

Patrick Nachman
This study is NOT accepting healthy volunteers
STUDY00002971
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Inclusion Criteria:

• age 18 years or older
• diagnosis of IgAN confirmed with biopsy no more than 8 years prior
• specific lab indicators of kidney function (study staff will review)
Exclusion Criteria:

• IgAN is being treated with immunosuppressants, cytotoxic drugs, eculizumab
• high blood pressure
• women who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug
• Type 1 diabetes mellitus
• history to kidney transplant
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), IgAN, Immunoglobulin A (IgA) Nephropathy, Kidney Disease, Renal Disease
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MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie

To evaluate the safety and tolerability of ISP-001 in patients with MPS I. To evaluate the long-term safety and tolerability of ISP-001. Determine the pharmacodynamic effect of ISP-001 on biomarkers in plasma, urine, and bone marrow. To explore the effect of ISP-001 on systemic manifestations of disease. Determine overall activity levels and sleep related issues.

Paul Orchard
STUDY00016974
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Inclusion Criteria:
Diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome. Age ≥ 18 years at time of study registration. Creatinine clearance, calculated or measured directly, that is >60ml/min/1.73m2. Ejection fraction ≥ 40% by echocardiogram. Must commit to traveling to the study site for the necessary follow-up evaluations. Must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion.
Exclusion Criteria:
Known familial inherited cancer syndrome. Suspected cases will be investigated, per the physicians discretion, using relevant genetic tests to determine presence of germline mutations. History of B cell related cancer, EBV lymphoproliferative disease or autoimmune disorders. Evidence of active graft-vs-host disease. Underwent a previous hematopoietic stem cell transplant (HSCT). Requirement for systemic immune suppression. Requirement for continuous supplemental oxygen. Any medical condition likely to interfere with assessment of safety or efficacy of the study treatment. In the investigator's judgement, the subject is unlikely to complete all protocol-required study visits or procedures, including follow up visits, or comply with the study requirements for participation. Other protocol defined inclusion/exclusion criteria may apply.
Rare Diseases
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SPR001-205 A Phase 2 Study to Evaluate the Safety, Pharmacokinetics,;and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children: Aged 6 to 17 Years with Congenital Adrenal Hyperplasia

Kyriakie Sarafoglou
This study is NOT accepting healthy volunteers
STUDY00014680
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Inclusion Criteria:

• childhood diagnosis of classic congenital adrenal hyperplasia (CAH) a genetic mutation in CYP21A2
• currently taking steroids to treat CAH and on a stable dose for 1 month or more
Exclusion Criteria:

• clinically significant unstable medical or mental health condition (study staff will review)
• females who are pregnant or nursing
• unable to swallow medications
Rare Diseases, Children's Health
CAH, Congenital Adrenal Hyperplasia
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