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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.

412 Study Matches

MT2022-30: A double-blind, randomized, placebo-controlled, interventional, multicenter, phase llI clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB)", allo-APZ2-EB-III

This is a study of an investigational drug (also known as the “study drug”) called allo-APZ2-OTS as a possible treatment for RDEB. The study drug contains allogeneic dermal ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs). These cells suppress inflammation and produce proteins that are important for wound healing. The study drug is expected to counteract local inflammation, improve wound healing and skin strength, and speed up wound closure.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
SITE00001758
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Inclusion Criteria:

• confirmed diagnosis of RDEB or JEB
• wound meeting the following criteria: 5-50 cm, present for at least 21 days and less than 9 months without signs of acute infection
• women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial
Exclusion Criteria:

• current cancer diagnosis including squamous cell carcinoma and basal cell carcinoma
• women who are pregnant or breast feeding
• clinically significant or unstable medical or mental health diagnosis (study staff will review)
Rare Diseases
EB, Epidermolysis Bullosa, RDEB
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Phase 1, Multi-Center, Open-Label Study of VT3989 in Patients with Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the Neurofibromatosis Type 2 Gene (mutant NF2 or mNF2)

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Robert Kratzke
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019430
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Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• 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
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019273
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Inclusion Criteria:

• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• 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
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
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REST-PSLL: Re-engineering Surgical Recovery and Transitions Using Technology Patient Safety Learning Laboratory

We are conducting this research to: better understand barriers and facilitators of successful at-home care after an emergency laparotomy (EL) surgical procedure, create technology solutions for EL patient recovery tools to support at-home care and evaluate the success of the new at-home care tools. Participation includes a video-recorded or audio-recorded interview, either in person or virtual, with a study team member. The interview questions will ask about various topics related to the post-surgical experience. Prior to the interview, participants will also be asked to complete a 30-minute survey to help the study team prepare for the interview. Additionally, if a participant is having ongoing post surgery complications, they may be invited to opt-in to a second 60-minute interview.

Genevieve Melton-Meaux
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020064
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Inclusion Criteria:

• Emergency abdominal (laparotomy) surgery within the past 6 months
Exclusion Criteria:

• Emergency laparotomy surgery for only gallbladder or appendix removal.
Digestive & Liver Health
Emergency abdominal surgery, abdominal injury, emergency, stomach, small intestine, colon
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MT2023-05: GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)

The primary purpose of this study is to identify a safe dose of GTB-3650. The study also provides preliminary disease response information for larger future studies. GTB-3650 is designed to target CD33 on leukemia/MDS cells. Cancer cells must overexpress CD33 (also referred to as CD33+), a marker found in some blood/bone marrow cancers. Based on similar studies and lab studies, it is felt there is a chance of benefit from the study treatment but the duration of benefit is unknown.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00022729
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Inclusion Criteria:

• at least 18 years old
• diagnosis of refractory or relapsed myeloid cancer
• not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are usually given for treatment
• sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the last dose of study drug
• for the Dose Finding Component Only: must agree to stay within a 60 minute drive of the Study Center through the last study visit after the first dose (29 days)
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• candidate for hematopoietic stem cell transplant (HSCT)
• known history of HIV
• active Hepatitis B or Hepatitis C
• known autoimmune disease requiring active treatment
Cancer
Acute Myeloid Leukemia, AML, Myelodysplastic Syndromes, Myeloid Malignancy
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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
18 years and over
This study is NOT accepting healthy volunteers
SITE00001846
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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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018 / ACTIV: A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

We are studying an investigational medicine for treatment of people in the hospital with COVID-19. This medicine is investigational because it can only be used in research. We are trying to find out if this investigational medicine is effective when given in addition to the current standard treatment for COVID-19. We are also trying to make sure it is safe for people who are sick in the hospital to take. The treatment being tested in this study is not yet approved by the U.S. Food and Drug Administration (FDA) or any other national government agency.

Mahsa Abassi
18 years and over
This study is NOT accepting healthy volunteers
SITE00001781
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Inclusion Criteria:

• admitted to the hospital with symptoms of respiratory infection
• positive test for SARS-CoV2 infection (COVID) within the prior 14 days
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• expect to be discharged in the next 24 hours
• unable to swallow tablets
• women who are pregnant or breast feeding
• liver or kidney failure
• men and women who are unwilling to use contraception to prevent pregnancy
Infectious Diseases, Respiratory System
Clinics and Surgery Center (CSC), COVID, hospitalized, inpatient, pneumonia, respiratory infection

MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019229
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Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
Cancer
Solid Tumors, Clinics and Surgery Center (CSC)
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MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
SITE00002088
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Inclusion Criteria:

• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from 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 criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.

David Potter
18 years and over
This study is NOT accepting healthy volunteers
SITE00001932
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Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Cancer
Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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COLLABS: Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial

The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services that people will receive as part of this research.

Arjun Gupta
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021793
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Inclusion Criteria:

• diagnosis of advanced stage colorectal cancer
• receiving care at the Masonic Cancer Center
• able to understand, speak, read, and write in English
Exclusion Criteria:

• lack capacity to consent
Cancer
Colon cancer, legal care
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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.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
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
Cancer
blood cancer, hematopoietic stem cell transplantation (HSCT)
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MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T(TM)

This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.

Benjamin Manning
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019932
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Inclusion Criteria:

• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• 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
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
Cancer
Clinics and Surgery Center (CSC), advanced cancer, cancer, metastatic cancer, solid tumors
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MT2024-06: Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation

To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) after allogeneic hematopoietic cell transplantation (alloHCT)

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00021822
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Inclusion Criteria:

• at least 18 years old
• relapsed following hematopoietic cell transplant (HCT)
• unable to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, such as light house work, office work
• Original alloHCT donor is available and willing to undergo apheresis
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• patients who have undergone more than one alloHCT
• ongoing active acute or chronic Graft vs Host Disease (GVHD) and are taking systemic immunosuppressive agents
• active CNS disease
• active or uncontrolled viral, bacterial, or fungal infection
• history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, AML, Leukemia, Myeloid
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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.

Anne Blaes, MD
18 years and over
This study is NOT accepting healthy volunteers
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
Cancer
Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial

This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020724
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Inclusion Criteria:

• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
Exclusion Criteria:

• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Radical Cystectomy, Urinary Diversion, UTI. bladder cancer
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A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis

The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).

Jo-Anne Young, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017568
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Inclusion Criteria:

• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
Exclusion Criteria:

• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
Breathing, Lung & Sleep Health, Infectious Diseases
Clinics and Surgery Center (CSC), antifungal therapy, aspergillosis, fungal infection, lung infection, pulmonary aspergillosis
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.

Keith Skubitz, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001953
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Inclusion Criteria:

• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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HM2023-07: Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy (MonumenTAL-3)

Talquetamab is an experimental medication being studied to see if it may be beneficial in the treatment of multiple myeloma.

Daniel O'Leary
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018679
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Inclusion Criteria:

• diagnosed with multiple myeloma that has not responded to treatment or has reoccurred after at least one treatment
• able to care for self with some assistance
Exclusion Criteria:

• active cancer in central nervous system or clinical symptoms
• maximum amount of steriods taken in the past two weeks (study staff will review)
• disease hasn't responded to this type of drug (anti-CD38 monoclonal antibody)
Cancer
Multiple Myeloma
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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

There is no consensus on the radiation dose required to relieve the pain from bone lesions from multiple myeloma. Usually, patients receive between 10 and 12 radiation treatments to achieve pain relief. But a shorter course of radiotherapy may be more effective. This study will evaluate whether pain relief can be achieved using only 1 or 2 radiation treatments, which will be delivered to a painful bone lesion. Your study doctor will decide whether you receive 1 or 2 treatments. The total amount of radiation you will receive will be the same whether it is done in one or two treatment sessions.

Stephanie Terezakis
18 years and over
This study is NOT accepting healthy volunteers
STUDY00010991
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Inclusion Criteria:

• diagnosis of multiple myeloma
• painful bone metastasis that has been confirmed by a xray
• may have had any number of prior chemotherapy/immunotherapy regimens
• at least able to walk and do all selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for additional requirements
Exclusion Criteria:

• received prior radiation therapy or prior palliative surgery to the bone lesion that is causing pain
• pathologic fracture or impending fracture at the area of the bone lesion causing pain
• women who are pregnant
• additional criteria apply (study staff will review)
Cancer
Bone Pain, Metastatic Malignant Neoplasm in the Bone, Multiple Myeloma, Plasma Cell Myeloma
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The women with inflammatory Bowel Disease and Motherhood: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Eugenia Shmidt
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003958
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Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Digestive & Liver Health, Women's Health
Fertility, IBD, Inflammatory Bowel Disease
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Addition of a pectoserratus block to interscalene block in patients undergoing total shoulder replacement.

This research is being done to determine if pectoserratus block with bupivacaine will provide improvement in pain control and decrease opioid use, relative to pectoserratus block with a saline solution, among patients undergoing total shoulder arthroplasty.

Jacob Hutchins
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019840
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Inclusion Criteria:

• 18 years to 85 years old
• having a total shoulder arthroplasty or reverse total shoulder arthroplasty
Exclusion Criteria:

• unable to receive regional anesthesia or nerve block
• Non-English speakers
• women who are pregnant
• currently using opioids and people who have chronic pain
Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Shoulder Replacement, Total Shoulder Arthroplasty
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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).

Sanjal Desai
18 years and over
This study is NOT accepting healthy volunteers
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
Cancer
Clinics and Surgery Center (CSC), Large B-Cell Lymphoma, LBCL, lymphoma
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017906
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Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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MT2023-35: A Pilot Study to Identify Risk Factors for Long-Term Functional and Pulmonary Outcomes Following Allogeneic Hematopoietic Cell Transplantation for Oncologic Diagnoses.

The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what are the best methods for diagnosing lung problems and follow-up care. The lung problems that may develop after transplant varies from patient to patient, and we don’t exactly know what risk factors influence who develops them or how patients respond to pulmonary (breathing system) therapies. Also, we wish to improve how we monitor lung function and quality of life after transplant, especially in children and young adults.

Alex Hoover
This study is NOT accepting healthy volunteers
STUDY00021591
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Inclusion Criteria:

• age 0 to 25 years at the time of Hematopoietic Cell Transplantation (HCT)
• received stem cell transplant for cancer
• receive ongoing care at the University of Minnesota Childhood Cancer/BMT Survivor Program
Exclusion Criteria:

• people who don't speak or read English
Cancer
Clinics and Surgery Center (CSC), HCT, Hematopoietic Cell Transplantation
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MT2023-22: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers

There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, either daratumumab in subjects with relapsed/refractory MM or rituximab in subjects with relapsed/refractory NHL. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM or NHL when given in combination with daratumumab or rituximab, respectively.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019972
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Inclusion Criteria:

• diagnosis of Multiple Myeloma (MM) that has relapsed or is refractory disease after 3 or more prior lines of therapy
• OR Non-Hodgkin Lymphoma (NHL) that has relapsed or is refractory after 2 or more lines of chemotherapy
• restricted in physically 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:

• significant cardiac disease
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
• untreated central nervous system, epidural tumor metastasis, or brain metastasis
Cancer
Clinics and Surgery Center (CSC), MM, Multiple Myeloma, NHL, Refractory Multiple Myeloma, Refractory Non-Hodgkin Lymphoma
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A Multicenter Observational Study to Characterize Growth in Children with Idiopathic Short Stature

This research is being done to learn more about how children with idiopathic short stature grow. About 600 children with idiopathic short stature will be in this study across the world. The study will last a minimum of 6 months (i.e., three study visits). After a child has been in this study for at least 6 months, participants may be offered the option to exit this study and enroll in a different study with growth promoting agents.

Nishitha Pillai
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021903
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Inclusion Criteria:

• participants must be at least 2 years old
• no more than 14 years old if female, or less than16 years old if male
• height Z-score is at least -2.5 SDs compared to age and sex matched norms
• able to walk ambulatory stand without assistance (not applicable for children who are less than 5 years of age and less than 104 cm i.e. 41 inches in length)
Exclusion Criteria:

• systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic or metabolic disease
• presence of one or more pituitary hormone deficiencies (ACTH [adrenocorticotropic hormone], ADH [antidiuretic hormone], FSH [follicle-stimulating hormone], GH [growth hormone], LH [luteinising hormone], TSH [thyroid-stimulating hormone]).
• diagnosis of hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated).
• Growth Hormone (GH) level below 10 ng/mL following a stimulation test. This does not apply to potential participants who are currently being treated with hGH for ISS
• known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turners syndrome, disproportionate skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis, Rasopathy (including Noonan’s Syndrome), or absence of GH receptors
• bone age advanced over chronological age by more than 3 years
• active cancer, chemotherapy or radiation therapy
Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Growth, Growth Hormone, Idiopathic Short Stature, ISS
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ADVL2322; A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 years of age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML); REFRaME-P1

This study is testing a new treatment, luveltamab tazevibulin, for infants and children under 12 with relapsed/refractory CBFA2T3::GLIS2 AML with ≥ 5% bone marrow involvement with leukemic blasts. The treatment will be given at two dose levels (3.5 or 4.3 mg/kg every 2 weeks), and participants will be randomly assigned to one dose level.

Robin Williams
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00022403
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Inclusion Criteria:

• Age: < 12 years.
• Diagnosis: relapsed or refractory Acute Myeloid Leukemia (AML) with CBFA2T3::GLIS2 fusion
• Required documentation of the CBFA2T3::GLIS2 translocation by Next Generation Sequencing FoundationOne® Heme assay.
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• Active CNS disease at the time of enrollment
• Subjects with the following constitutional conditions are not eligible: Fanconi anemia, Shwachman Diamond syndrome, subjects with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21, telomere disorders, germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy.
Blood Disorders, Cancer
Acute Myeloid Leukemia (AML), refractory, relapsed
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Tissue Collection and Characterization: Longitudinal Senescence Analysis

The purpose of this study is to better understand the makeup and composition of blood and fat tissue in people with a variety of health conditions. We are specifically interested in identifying and characterizing a specialized state of cells called senescence. This is when cells in our body stop dividing, but still produce inflammatory signals in the body. Senescent cells have been linked to a variety of metabolic diseases related to inflammation. We are collecting fat tissue and blood samples to look for genes that are associated with inflammation and senescence. These samples will be collected from healthy people as well as people with different metabolic diseases, who are already undergoing ENT surgery as part of their care at the University of Minnesota, to find meaningful patterns that can help lead to better treatments.

Sayeed Ikramuddin
18 years and over
This study is also accepting healthy volunteers
STUDY00021497
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Inclusion Criteria:

• undergoing abdominal or ENT surgical procedure with general anesthesia
• laparoscopic procedures including cholecystectomy, bariatric surgery, hernia repair (incisional or hiatal) in which the liver is accessible, esophageal surgery, or GI reconstruction
Exclusion Criteria:

• women who are pregnant or breast feeding
Digestive & Liver Health
Clinics and Surgery Center (CSC), abdomen, anesthesia, ENT surgery, surgery
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007800
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Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Cancer, Respiratory System
Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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