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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

432 Study Matches

DAS181-3-01: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

This research study is for participants who have a weakened immune system (are immunocompromised), have a lower lung infection and are currently using a machine or device to help them breathe. The study will look at whether the study drug, DAS181, works and how safe it is compared with a placebo in adults who have a weakened immune system (immunocompromised) and a parainfluenza virus (PIV) infection of the lower respiratory tract. A placebo looks the same as the study drug but does not contain any active ingredients.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00005735
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Inclusion Criteria:

• needs supplemental oxygen ≥2 liters/minute due to low oxygen levels
• immunocompromised, as defined by one or more of the following: received a stem cell transplant, organ transplant, being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past, or has an immunodeficiency due to congenital abnormality
• men and women of childbearing potential must use effective birth control
• see link to clinical trials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• taking any other investigational drug used to treat pulmonary infection
• severe sepsis
• see link to clincialtrials.gov for complete exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Immune Compromised, Influenza, Lower Respiratory Tract Infection, Parainfluenza
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A Phase 1B/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7- H3 Antibody-Drug Conjugate (ADC), In combination with Atezolizumab with or Without Carboplatin as First Line Induction or Maintenance, In Subjects with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)

This study is being done to learn more about the safety and effectiveness of ifinatamab deruxtecan (I-DXd) against extensive stage small cell lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022784
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Inclusion Criteria:

• diagnosis of extensive small cell lung cancer
• have not received any prior treatment (first line therapy)
• may be unable to do physically strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• agree to use a contraceptive method that is highly effective
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:

• any of the following within the past 6 months: cerebrovascular accident, (CVA) transient ischemic attack, (TIA) or another arterial thromboembolic event
• uncontrolled or significant cardiovascular disease
• history of another cancer in the past 5 years
• history of bone marrow, stem cell, or solid organ transplant
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), small cell lung cancer
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PEPN2312; A Phase 1 study of GRN163L (Imetelstat, IND# 170891, NSC# 754228) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia that is in second or greater relapse or that is refractory to relapse therapy; myelodysplastic syndrome or juvenile myelomonocytic leukemia in first or greater relapse or is refractory to relapse therapy

This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, 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. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.

Principal Investigator: Robin Williams
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022789
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Inclusion Criteria:

• Between 1 year and less than or equal to 18 years of age at enrollment
• Patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related AML, MDS or JMML.
• In second or greater relapse or refractory AML or First or greater relapse of MDS, or First or greater relapse of JMML
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Pregnant or breast-feeding
• Currently receiving investigational drugs or other anti-cancer agents
Conditions: Cancer
Keywords: acute myeloid leukemia, AML, JMML, juvenile myelomonocytic leukemia, MDS, myelodysplastic syndrome
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ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly.

Principal Investigator: Robert Galvin
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY0016411
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Inclusion Criteria:

• patients must be >= 12 months and =< 21 years of age at the time of enrollment on Step 0
• patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities
• lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk
Conditions: Cancer
Keywords: Anaplastic Astrocytoma, Diffuse Intrinsic Pontine Glioma, Glioblastoma, Malignant Glioma
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HM2024-11: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLATUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA

The purpose of this study is to compare the efficacy and safety of glofitamab, a novel cluster of differentiation (CD) 20/CD3 bispecific antibody, in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola‑R‑CHP) versus Pola‑R‑CHP in patients with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022042
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Inclusion Criteria:

• 18 to 80 years old
• have not received any treatment for Large B-Cell Lymphoma
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior solid organ transplantation
• history of significant cardiovascular disease
• current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• clinically significant liver disease
• chronic hepatitis B infection, hepatitis C, or HIV
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Large B-Cell Lymphoma, LBCL, lymphoma
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HM2023-21: A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)

The purpose of this study is to compare the effects of talquetamab in combination with teclistamab (Tal-Tec), the effects of talquetamab in combination with pomalidomide (Tal-P), and the effects of either the combination of elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in treating patients with multiple myeloma, who have not responded to previous treatment.

Principal Investigator: Daniel O'Leary
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022479
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Inclusion Criteria:

• diagnosis of multiple myeloma
• cancer that has recurred or has not improved with treatment
• previously treated 1 to 4 times (lines of therapy)
• able to walk and complete all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stroke, transient ischemic attack, or seizure in the past 6 months
• active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Conditions: Cancer
Keywords: Relapsed or Refractory Multiple Myeloma
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A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023107
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Inclusion Criteria:

• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
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HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination with CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML).

This study is meant for participants who have been diagnosed with acute myeloid leukemia (AML) and have a specific mutation in a gene called TP53. The study will give these participants an investigational drug called bortezomib in combination with an approved drug for AML, CPX-351 (brand name: Vyxeos). The researchers are studying this combination to find out if it is safe to give to people, as well as to find out how well it works for people who have AML with the TP53 mutation.

Principal Investigator: Joseph Norton
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024980
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Inclusion Criteria:

• have not received any systemic chemotherapy for the treatment of AML
• able to care for self but may be unable to carry on normal activity or to do active work
• sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active central nervous system malignancy or symptoms of CNS involvement
• cardiac disease including congestive heart failure with symptoms, heart attack (myocardial infarction) in the past 6 months, serious arrhythmia, unstable angina
• women who are pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)

Disruption of estrogen signaling by drugs called selective estrogen receptor degraders (SERDs) is one of the treatment options for patients with estrogen receptor positive (ER+) cancers. Imlunestrant is a SERD that disrupts estrogen signaling, and therefore should stop or slow down tumor growth in ER+ cancers. This study will help answer research questions about the safety of imlunestrant and any side effects, and how imlunestrant compares to standard-of-care endocrine therapy.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018436
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Inclusion Criteria:

• diagnosis of ER+, HER2- early-stage invasive breast cancer without evidence of distant metastasis
• completed surgery
• received at least 24 months but not more than 60 months of any endocrine therapy after treatment
• may be limited with strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
Exclusion Criteria:

• any evidence of metastatic disease
• more than a 6 month consecutive gap in therapy during the course of prior adjuvant endocrine therapy
• history of any other cancer
• women who are pregnant, breastfeeding, or expecting to conceive or men expecting to father children
Conditions: Cancer
Keywords: Breast cancer, ER+, Hormone positive, hormone therapy
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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 enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US). Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. Participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020047
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Inclusion Criteria:

• 18 to 45 years old
• uncomplicated pregnancy at gestational week 30 or beyond, or birth of a child within the past 6 months
• history of ≥ 4 cigarettes per month during the six months prior to pregnancy
• motivation to become and/or stop smoking after delivery
• willing to use birth control for the 12 weeks of the study
• live in the continental US and have a device to connect to the internet for participation
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• major depressive disorder
• current or within the past 3 months treatment for drug or alcohol use
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: post partum, smoking
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A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

The purpose of this study is to find out if the drug letrozole is better or worse than not receiving treatment (called observation) following surgery for your type of cancer. Letrozole could prevent your cancer from returning but the cancer could grow while on treatment. There is currently no definitive data to support the use of Letrozole treatment for early stage Leiomyosarcoma. Letrozole has already been FDA-approved to treat other cancers, but it is investigational in this research.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023351
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Inclusion Criteria:

• confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus
• tumor expresses ER positivity by immunohistochemistry
• completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks prior
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• able to swallow oral medication
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• any other severe disease
• also has another cancer or has been treated for cancer in the past three years
• women who are pregnant or breastfeeding
• currently receiving chemotherapy or radiation therapy
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Women's Health
Keywords: Uterine Leiomyosarcoma, Clinics and Surgery Center (CSC)
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ACNS2321; A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas

This study aims to reduce the radiotherapy (RT) dose necessary to successfully treat patients with intracranial germ cell tumors who are in a state of complete response (CR) following chemotherapy. In this study, a further reduction in whole ventricular irradiation (WVI) will be tested. The primary aim of the study is to determine whether 12 Gy of WVI, and 12 Gy tumor boost, would be successful. Event-free survival (EFS) in patients with central nervous system germinoma, who meet criteria for CR or continued complete response (CCR) following chemotherapy/second-look surgery, would be the primary measurement of success.

Principal Investigator: Clay Hoerig
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024783
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Inclusion Criteria:

• Age: Patients must be ≥ 3 years and < 30 years at the time of study enrollment. Diagnosis:
• Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGβ 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required.
• Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (DI) AND hCGβ ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required.
• Patients with hCGβ 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required.
• Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible.
• Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible.
• Patients with germinoma admixed with mature teratoma are eligible.
Exclusion Criteria:

• Patients with any of the following malignant pathological elements are not eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed GCT (i.e., may include some germinoma).
• Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible.
• Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible.
Conditions: Brain & Nervous System, Cancer, Children's Health
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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)

The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early Triple Negative Breast Cancer (TNBC) when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants with low tumor expression of the estrogen and/or progesterone receptors (1 to 10%) will also be included in this study. The study treatment will be chosen by chance—like flipping a coin. There is a 1 out of 2 chances to receive Sacituzumab govitecan in combination with Pembrolizumab and 1 out of 2 chances to receive a study treatment of study doctor’s choice of either pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants and their study doctor will know what study drug is being taken.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021239
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Inclusion Criteria:

• invasive triple negative breast cancer (TNBC) still remains in the breast or lymph nodes after therapy and surgery
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

We are doing this study because we want to find out if observation is as good as the usual care for breast cancer. The usual approach for patients with early-stage triple-negative breast cancer (TNBC) who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery. Participants will either get pembrolizumab for up to 27 weeks, or will not receive any treatment and will be observed for up to 27 weeks. We will continue to follow participants every 6 months for 5 years and watch for side effects or cancer coming back. After that, participants will be checked every year for a total of 10 years after the study.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021547
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Inclusion Criteria:

• at least 18 years old
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• no cancer remaining in the breast or lymph nodes after the completion of neoadjuvant therapy (complete response)
• Estrogen (ER) and progesterone (PR) no more than 10% and HER2-negative
• if cancer was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
• must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles
• not pregnant and not nursing
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• known active liver disease -medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Principal Investigator: Douglas Yee, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011111
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Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Conditions: Cancer
Keywords: Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2, Clinics and Surgery Center (CSC)

An Expanded Access Program for the non-invasive detection of clear cell renal cell carcinoma (ccRCC) in patients with renal masses utilizing 89Zirconium-labelled girentuximab (89Zr-DFO-girentuximab)

This Expanded Access Program (EAP) will enable the use of 89Zr-DFO-girentuximab with PET/CT scans to detect clear cell renal cell carcinoma in patients with kidney masses. It aims to gather real-world safety and effectiveness data and understand how PET imaging affects patient management.

Principal Investigator: Ian Okazaki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024231
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Inclusion Criteria:

• 18 to 99 years old
• evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI
• agree to practice highly effective contraception until a minimum of 42 days after receiving study drug
Exclusion Criteria:

• mass known to be a metastasis of another primary tumor
• active non-renal cancer requiring therapy
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clear Cell Renal Cell Carcinoma, Kidney Cancer, Clinics and Surgery Center (CSC)
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: R33 Phase

This study will look at the effects of treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and Transcranial Magnetic Stimulation (TMS) for young people who have tic disorder. Participants must be 12- 21 years old and able to have an MRI. All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered to be the first treatment for tics. Participants will also be assigned randomly (by chance) to receive TMS or a sham (treatment not delivered) just before each CBIT session. The device for TMS delivers electromagnetic stimulation to a specific area of the brain with a small coil on the scalp. The effectiveness of the CBIT for the two groups, with and without the TMS, will be compared.

Principal Investigator: Christine Conelea
Age Group: 12 years to 21 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023755
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Inclusion Criteria:

• between the ages of 12 – 21
• currently experiencing chronic motor and/or vocal tics
• right-handed
• able to undergo MRI
• study staff will review additional exclusion criteria
Exclusion Criteria:

• left-handed
• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: TMS, Tourette's syndrome, Vocal tics, CBIT, Motor tics, Tic Disorder
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Magnetic Resonance Imaging of Osteonecrosis of the Femoral Head

The purpose of this research study is to investigate new magnetic resonance imaging (MRI) methods to better detect and monitor osteonecrosis of the femoral head (ONFH) before and after treatment. ONFH causes injury to the hip joint that can lead to osteoarthritis (the breaking/wearing down of cartilage & tissues within the joint) and the eventual need for a hip replacement. It can be difficult to detect ONFH early on using current medical imaging techniques, which is when treatments may be the most effective. Furthermore, available treatments are not always effective at preventing the progression (spread or growth) of ONFH. This research may benefit others with ONFH by providing more effective medical imaging tools to detect ONFH earlier and inform treatment decisions to increase the chance of stopping or delaying the progression of ONFH and preventing hip osteoarthritis.

Principal Investigator: Casey Johnson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016964
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Inclusion Criteria:

• diagnosed with Stage 1 or Stage 2 osteonecrosis of the femoral head (ONFH)
• intend to have core decompression surgery to treat the ONFH
Exclusion Criteria:

• excluded from having an MRI based on Center for Magnetic Resonance Research (CMRR) safety criteria
• existing implantation of metal device in affected hip
• any health conditions that would pose a challenge for you to participate
• unavailable to undergo follow up MRI 6 months after core decompression treatment
Conditions: Bone, Joint & Muscle
Keywords: core decompression treatment, MRI, Osteonecrosis, early diagnosis, hip
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MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021552
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Inclusion Criteria:

• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Conditions: Cancer
Keywords: blood cancer, hematopoietic stem cell transplantation (HSCT)
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006945
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Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Chronic Depression, Depression
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A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC

This study will evaluate the safety and tolerability of EG 70, a gene therapy, which is given inside the bladder. This study will measure its effectiveness on eliminating bladder tumors in participants with NMIBC who have failed or did not receive adequate Bacillus Calmette- Guérin (BCG) therapy. The study drug will be given into the lining of the bladder. This may cause an immune response inside the bladder and kill the cancer cells.

Principal Investigator: Joseph Zabell
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001148
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Inclusion Criteria:

• BCG-unresponsive NMIBC with carcinoma in situ (CIS
• ineligible for or have elected not to undergo cystectomy
• women of childbearing potential must be willing to use highly effective birth control methods; Males are required to use a condom for the duration of the study treatment through 3 months post-dose
• at least walking and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• other active cancer that required treatment in the past two years
• history of partial cystectomy
• history of severe asthma or other respiratory diseases
• human immunodeficiency virus, Hepatitis B, or Hepatitis C infection
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Bladder Cancer With Carcinoma in Situ, CIS, Clinics and Surgery Center (CSC), NMIBC
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Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

This study is being done to learn more about the influence of the menopausal transition on autonomic and vascular function in midlife females. Participants will have their vitals taken and height, weight and waist-to-hip ratio measurements done, complete questionnaires, have blood draws, have electrical activity of a nerve in the leg measured (optional), have blood vessel function measured in the arm, perform breathing exercises, and complete a cold pressor test (putting a hand in ice-cold water). Participants will also have a scan to measure body composition and bone density.

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022683
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Inclusion Criteria:

• women who are 45-55 years old
• premenopausal
• currently have a normal menstrual cycle
• not planning to become pregnant for the duration of participation in the study
• able to read, write & speak English
Exclusion Criteria:

• diabetes
• pregnant or breastfeeding
• cardiac or lung disorders
• severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
• hypertension
• obstructive sleep apnea
• current use of heart or blood pressure medications or antidepressants
• history of treatment with chemotherapy/radiation
• coagulopathy disorders and/or use of anticoagulant medications
• current use of hormonal contraceptives
• nicotine/tobacco use in the last six months
• current alcohol abuse
Conditions: Women's Health
Keywords: Menopause, Pre menopause, Clinics and Surgery Center (CSC)

A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) (ACTION3)

A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024254
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Inclusion Criteria:

• 12-80 years old;
• Primary FSGS, genetic FSGS or FSGS of undetermined cause
• Receiving an ARB, or willing to take one for the study
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• Secondary FSGS
• Not previously treated with standard of care therapies (including steroids)
• Unable to swallow oral medication
• see clinical to clinicaltrials.gov for complete exclusion criteria
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: Focal Segmental Glomerular Sclerosis, FSGS

Effect of Kava on Anxiety and Stress in Cancer Survivors

Anxiety and stress are significant problems for cancer survivors. The purpose of this study is to learn what effect a 14-day course of kava can have on anxiety and stress in cancer survivors, and about the side effects of kava for cancer survivors.

Principal Investigator: Naomi Fujioka
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015828
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Inclusion Criteria:

• Adult ≥ 18 years old
• Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
• Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
Exclusion Criteria:

• Known allergy to kava
• Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
• Use of herbal supplements within 14 days of study registration,
• Anti-cancer therapy within 28 days prior to registration and/or during study participation, except for aromatase inhibitors
• Known liver disease such as cirrhosis
• Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
• Chronic use of high-intensity statin therapy
• Women who are pregnant, intend to become pregnant, or are nursing
Conditions: Cancer
Keywords: anxiety, cancer survivor, Clinics and Surgery Center (CSC), kava
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Principal Investigator: Colleen Correll
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Conditions: Arthritis & Rheumatic Diseases, Cancer
Keywords: juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00008043
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Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Conditions: Brain & Nervous System
Keywords: Parkinson
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Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma

To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.

Principal Investigator: Clay Hoerig
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1606M89501
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Inclusion Criteria:

• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
Exclusion Criteria:

• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
Conditions: Cancer, Cancer
Keywords: OPG, Optic Pathway Glioma
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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).

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014365
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Inclusion Criteria:

• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• 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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute-graft-versus-host Disease, aGVHD, HCT, Hematopoietic Cell Transplant
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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Inclusion Criteria:

• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), Acquired Amegakaryocytic Thrombocytopenia, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, SA
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An interventional efficacy and safety Phase 3 double-blind 2-arm study to investigate IV followed by oral fosmanogepix compared with IV caspofungin followed by oral fluconazole in adult participants with candidemia and/or invasive candidiasis.

The purpose of this study is to compare effects of the study drug fosmanogepix with already-approved drugs caspofungin and fluconazole to find out if fosmanogepix is safe and effective in treating patients with candidemia and/or invasive candidiasis.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023155
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Inclusion Criteria:

• diagnosis of candidemia and/or invasive candidiasis
• see link to cliinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• require hemodialysis, peritoneal dialysis, or hemofiltration
• received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Infectious Diseases
Keywords: Candidemia, fungal infection, Clinics and Surgery Center (CSC)
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