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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.

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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001733
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
Exclusion Criteria:

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Conditions: Cancer, Women's Health
Keywords: endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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Renal Intervention for Chronic Hypertension Pilot Trial Using the Verve Medical RPDT System

The purpose of this study is to test a new treatment approach for adults with high blood pressure that has been difficult to control with medication. Researchers will study how well the treatment helps lower blood pressure and learn more about participants’ experiences with the treatment.

Principal Investigator: John Osborn Jr.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024597
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• currently taking 2 medications for high blood pressure and on a stable treatment plan for at least 30 days
• elevated blood pressure despite current treatment
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of certain heart, kidney, or urinary tract conditions
• pregnant, breastfeeding, or planning to become pregnant during the study
• currently receiving dialysis or prior kidney transplant
• currently enrolled in another hypertension study or previously received device-based treatment for high blood pressure
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Blood pressure, Hypertension, RICH
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HM2025-23: Phase 3 Randomized, Double-Blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 mutated or KMT2A Rearranged Acute Myeloid Leukemia

AML is a type of blood cancer where infection fighting cells called white blood cells (WBCs) don’t grow up or “mature” like they are supposed to. Instead, they stay stuck as infant or immature “blast” cells. This study will investigate the potential risks and benefits of adding a targeted therapy called ziftomenib to intensive therapy (7+3) OR non-intensive (Venetoclax + Azacitidine) for patients whose cancers are found to have KMT2A rearrangements or mutations in the NPM1 gene. We will also see if the use of ziftomenib as maintenance therapy following consolidation is beneficial.

Principal Investigator: Jeremy Allred
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026093
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Acute Myeloid Leukemia (AML)
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must agree to use a highly effective method of birth control
• see link to clincialtrials.gov for complete Inclusion criteria
Exclusion Criteria:

• received prior therapy for AML
• involvement of central nervous system
• history of another type of cancer
• women who are pregnant or breastfeeding
• other significant medical illness,
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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MT2024-13: First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma

The upfront treatment for astrocytoma is surgery, radiation therapy, and chemotherapy. There is currently no standard therapy for when the astrocytoma has returned (recurs) or re-grows (progresses). This study uses the investigational drug FT536, a cell therapy that stimulates the immune system into action to treat astrocytoma that has returned or regrown. FT536 is a type of cell therapy made up of “natural killer” or NK cells, a type of immune blood cell that are known to attack cancer cells. The primary purpose of this study is to identify a safe dose of FT536 cells when given as an intratumoral injection and to identify the side effects of treatment with FT536. Another purpose of this study is to understand how FT536 alters the immune system in the brain and body.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027280
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• confirmed Grade 4 astrocytoma that has reoccurred or progressed
• completed usual antitumor treatment including surgery, radiation therapy, and temozolomide with or without Optune/ Tumor Treatment Fields (TTF)
• able to have MRI scans with contrast agent
• completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function when starting the study
• must use a highly effective form of birth control from the first study visit until at least 3 months after the dose of FT536
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• prior treatment with bevacizumab or any other cellular therapy
• prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy
• women who are pregnant or breastfeeding
• history of another cancer in the past 5 years
• other significant medical or social conditions that would limit the ability to complete the study requirements
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Astrocytoma, Brain Cancer
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An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019579
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: c-diff, Clinics and Surgery Center (CSC), colon cancer, colon surgery, gut health, microbiota transplant
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A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants (AGLOW)

To evaluate the efficacy, safety, and pharmacokinetics of VX-407 in participants with Autosomal Dominant Polycystic Kidney Disease with PKD1 gene variants

Principal Investigator: Katti Woerner
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026103
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Participants between the ages of 18 and 65 years, inclusive.
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
• participants with a pre-existing diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD
• Solid organ or bone marrow transplantation, or nephrectomy
• Any condition possibly affecting drug absorption (e.g., gastrectomy, gastrointestinal tract surgery except appendectomy and cholecystectomy
• Clinically significant liver dysfunction
Conditions: Kidney, Prostate & Urinary, Rare Diseases
Keywords: autosomal dominant polycystic kidney disease (ADPKD), kidney disease, Clinics and Surgery Center (CSC)

MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie

The purpose of the study is to determine the safety and effectiveness of a new procedure to treat Mucopolysaccharidosis Type I Hurler-Scheie and Scheie (MPS I). This procedure involves collecting some white blood cells (termed “B cells”) and growing them outside of the body in a laboratory. While the cells are in the lab, the B cells will be changed to produce more of the IDUA that is missing. This process is called “genetic modification.” The newly modified B cells are then infused back into the participant.

Principal Investigator: Paul Orchard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016974
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome
• creatinine clearance, calculated or measured directly, that is greater than 60ml/min/1.73m2
• ejection fraction at least 40% by echocardiogram
• must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion
• must commit to traveling to the study site for the necessary follow-up evaluations
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• known family inherited cancer syndrome
• had a previous hematopoietic stem cell transplant (HSCT)
• any medical condition likely to interfere with assessment of safety or efficacy of the study treatment (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases
Keywords: Mucopolysaccharidosis IH/S, Mucopolysaccharidosis IS
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A Pilot Study of Treatment of Bone Metastases in Spine: Radio Frequency Ablation/ Bone Augmentation plus Radiotherapy Vs. Radiotherapy

This clinical study is for adults whose cancer has spread to the bones of the middle or lower back (spine). Doctors are comparing two common treatments: (1) a needle procedure to treat the tumor and strengthen the bone, followed by radiation, and (2) radiation therapy alone. The goal is to see which option better relieves pain, protects the spine, and improves quality of life. The treatment you receive will be chosen at random (by chance), meaning you will be placed into a study group by chance.

Principal Investigator: Reza Talaie
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020863
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed metastatic disease in the thoracic or lumbar region of the spine
• associated bone pain
• persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• prior radiation therapy to the same area of the spine
• spine stabilization surgery is being considered
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Bone pain, Spine Metastases
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HM2024-28: A Pilot Study to Investigate the Clinical Utility of Tremoflo Airway Oscillometry in the Pediatric and Adolescent Population with Pulmonary Pathology or at Risk of Lung Injury

The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.

Principal Investigator: Samuel Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023347
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
Exclusion Criteria:

• unlikely to complete required study components
Conditions: Cancer, Respiratory System
Keywords: child cancer, lungs, oxygen level, asthma, BPD, Cystic Fibrosis, interstitial lung disease
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CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)

The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014622
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• have a diagnosis of systemic sclerosis
• less than 5 years from onset of first symptom attributed to systemic sclerosis
Exclusion Criteria:

• cognitive impairment that interferes with ability to participate in the study
• unable to speak, read, and write English
Conditions: Arthritis & Rheumatic Diseases
Keywords: aging, Clinics and Surgery Center (CSC), Scleroderma
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AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025612
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
Exclusion Criteria:

• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: Acute Lymphoblastic Leukemia, ALL
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Perceptual consequences of low frequency hearing loss

The purpose of this study is to learn more about hearing and speech understanding in people with low-frequency hearing loss, with the goal of improving future diagnosis and treatment options.

Principal Investigator: Andrew Oxenham
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025257
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults between the ages of 18-85
• have hearing loss that mainly affects lower-pitched sounds and is not caused by problems in the outer or middle ear
Exclusion Criteria:

• mild cognitive impairment
Conditions: Ear, Nose & Throat
Keywords: ENT, hearing, hearing health, hearing loss, listening
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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654) (INAVO123)

The purpose of this research is to test safety, efficacy and compare the effects of a combination therapy involving inavolisib plus a CDK4/6i (palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole on patients with HR+, HER2- advanced breast cancer (ABC). In this study, you will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole. A placebo looks like a drug but has no active ingredient.

Principal Investigator: Douglas Yee, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025543
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women or men with confirmed metastatic breast cancer
• ER-positive and/or progesterone receptor-positive and HER2-negative tumor and mutation in PI3K Gene
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer
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CVD in Women with CF: Assessing Cardiovascular Risk in Menopausal Women with Cystic Fibrosis

Women with cystic fibrosis (CF) during peri- and postmenopausal stages may be at increased risk for cardiovascular disease, partly mediated by accelerated cardiometabolic risks. This cross-sectional study aims to address critical gaps in understanding cardiovascular disease (CVD) risk in women with CF and will inform early interventions tailored to this growing population.

Principal Investigator: Tasma Harindhanavudhi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027653
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women ages 45 years and older
• diagnosed with cystic fibrosis
Exclusion Criteria:

• pregnant or suspect you may be pregnant
• cognitive or memory difficulties
• unable to read or speak English
Conditions: Rare Diseases, Rare Diseases, Respiratory System, Heart & Vascular, Women's Health
Keywords: cf, cfrd, Clinics and Surgery Center (CSC), cvd, diabetes, menopause, cardiovascular disease, cystic fibrosis, aging
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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.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020724
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Radical Cystectomy, Urinary Diversion, UTI. bladder cancer
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A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer

The purpose of this study is to learn more about ocular (relating to the eye) side-effects of tisotumab vedotin (brand name: TIVDAK™). A side effect is anything the drug does to your body besides treating your disease. It is approved for women with cervical cancer that has spread through the body or come back during or after chemotherapy. We are doing a study to understand whether there are any ocular side-effects of TIVDAK.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025592
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• cervical cancer that has returned (recurrent) or spread to other parts of the body (metastasized) during or after chemotherapy
• doctor has decided that Tivdak® is an option for treatment
• agree to use effective contraception
Exclusion Criteria:

• active eye disease
• women who are breastfeeding, pregnant, or planning to become pregnant
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cervical cancer
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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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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
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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MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022432
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: LBLC, Mantle Cell Lymphoma (MCL), Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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Biorepository to Support ALS Research in Minnesota

The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022317
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• People living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders.
Exclusion Criteria:

• age less than 18 or greater than 90
Conditions: Brain & Nervous System, Rare Diseases, Rare Diseases
Keywords: ALS, amyotrophic lateral sclerosis, Clinics and Surgery Center (CSC)
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Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM sleep Behavior Disorder

This research is being completed to examine the cells, brain imaging, and speech in individuals with REM Sleep Behavior Disorder who are taking serotonergic medications such as Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine and Sertraline. The purpose of examining these is to try and see if we can predict signs of Dementia with Lewy bodies (a progressive form of dementia with an increase in decline of thinking, reasoning, and other functions). This may benefit others by enabling us to diagnose Dementia with Lewy Bodies sooner rather than later.

Principal Investigator: Michael Howell
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019626
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• diagnosis of polysomnogram-confirmed RBD (e.g. narcolepsy) with history of dream enactment or clear dream enactment visualized on video from polysomnogram
• dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication
• for Healthy Volunteers: on serotonergic medication for at least 6 months without history of dream enactment
• the following serotonergic medications are included for both groups: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Exclusion Criteria:

• Parkinsons disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimers disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
• untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
• unable to have a MRI scan
• women who are pregnant
• for Healthy Volunteers: same exclusion criteria as those with 5-HT RBD group, plus history of dream enactment, or increased REM motor tone
Conditions: Rare Diseases, Brain & Nervous System
Keywords: aging, dream enactment, Serotonergic REM sleep behavior
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Natural History Study for DNA Repair Disorders

This research is being done to help us better understand the different DNA repair disorders. We will collect data and samples that we will use to develop new therapies and medicine to help treat the disease. We expect that participants will be in this research study for 3 years. Visits will occur every six months and alternate between in-person and remote. Remote visits should be expected to last 1-2 hours, and in-person visits should be expected to last 3-4 hours.

Principal Investigator: Peter Kang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015911
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
Exclusion Criteria:

• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
Conditions: Rare Diseases
Keywords: Cockayne Syndrome, DNA Repair Disorder, Trichothiodystrophy, Xeroderma Pigmentosum, Clinics and Surgery Center (CSC)
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Minnesota Neurogenetics Repository

This research study is for participants who have an inherited neuromuscular disorder or neurogenetic disorder, or family members who are unaffected by such disorders

Principal Investigator: Peter Kang
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00011988
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:
-individuals with muscular dystrophy, particularly those without genetic diagnoses and those with indeterminate genetic test findings
• individuals with DNA repair disorders including Cockayne syndrome, trichothiodystrophy, and xeroderma pigmentosum
• family members with a genetic neurological or muscle disease
Exclusion Criteria:

• none
Conditions: Rare Diseases, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Muscular Dystrophy
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NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2 (NAPS2)

We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.

Principal Investigator: Michael Howell
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001442
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Sex: Male
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• male
• 54 to 75 years old
• Caucasian
Exclusion Criteria:

• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder
Conditions: Brain & Nervous System, Breathing, Lung & Sleep Health
Keywords: Clinics and Surgery Center (CSC), control, neurology, Parkinson's Disease, REM Sleep Behavior Disorder, sleep, RBD

A double-blind, randomized, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics and efficacy of BI 765423 administered intravenously on top of standard of care in patients with idiopathic pulmonary fibrosis

The purpose of this study is to find out if a study drug called BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis (IPF). This study compares BI 765423 with a placebo to see if there is a difference in lung function or blood test results related to lung health after 3 month. The placebo looks like BI 765423 but does not contain any active drug.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026265
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 40 years old
• diagnosis of idiopathic pulmonary fibrosis (IPF)
• women can only be included if they are unable to become pregnant i.e. post hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, or post menopausal
• men who have woman of childbearing potential (WOCBP) sexual partners must use contraception
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• acute exacerbation of IPF within at least 12 weeks prior
• significant cardiovascular disease such as severe hypertension, myocardial infarction, stroke, TIA
• significant pulmonary hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), IPF, Pulmonary Fibrosis
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HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.

Principal Investigator: Naveen Premnath
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023042
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of primary or secondary myelofibrosis
• may be 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 which are specified by diagnosis
Exclusion Criteria:

• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Myelofibrosis
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A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)

This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025544
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• locally advanced or metastatic solid tumor
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of tumor
Exclusion Criteria:

• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: cancer, metastatic cancer, Clinics and Surgery Center (CSC), solid tumor
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Cardiovascular health in adults conceived with assisted reproductive technology

The purpose of this study is to better understand heart and blood vessel health in adults conceived through assisted reproductive technology (such as IVF) compared to adults conceived naturally. Participants will complete one study visit lasting approximately 3–4 hours. During the visit, participants will complete questionnaires, have basic health measurements taken, and complete non-invasive tests that assess blood pressure, blood vessel function, and circulation. Researchers hope the findings will improve understanding of long-term cardiovascular health in adults conceived through assisted reproductive technology.

Principal Investigator: Daniel Craighead
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024302
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• self-identified as having been conceived through use of assisted reproductive technology (e.g., in vitro fertilization, cryopreservation)
• self-identified as having been conceived through natural conception
Exclusion Criteria:

• pregnant or suspect you may be pregnant
• current chronic cardiovascular or metabolic condition (such as heart disease or diabetes)
Conditions: Heart & Vascular
Keywords: Assisted reproductive technology, cardiovascular function, in vitro fertilization
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A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

This study tests whether the study drug, a T-cell engager therapy engineered to have fewer off-target effects by increasing its specificity to tumor cells, is safe and tolerable in subjects with metastatic castration-resistant prostate cancer (mCRPC) The study will also assess the potential Phase 2 dose regimens and determine a recommended Phase 2 dose.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024313
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years to 100 years old
• confirmed adenocarcinoma of the prostate
• Metastatic Castration-resistant Prostate Cancer (mCRPC) that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• prior solid organ transplant
• treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
• significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Prostatic Cancer, mCRPC, Metastatic Castration-resistant Prostate Cancer
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An Open-Label, Pilot Clinical Trial To Test The Efficacy Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023336
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• having surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) and don't expect to have chemotherapy or diverticulitis
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant
• history of celiac disease
• receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: bowel resection, bowel surgery, Clinics and Surgery Center (CSC), colon cancer
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Continuation of a Home/Community-Based Anal Cancer Screening Unit and Protocol at LGBTQ+ Focused Community Events

This study will help to identify challenges and barriers to self-performing anal cancer screening tests, and may identify unique ways to make this form of screening easier, more cost-effective, and more frequently performed. We believe that it has the potential to minimize the frequency of both disease and death from anal cancer among high-risk patient groups.

Principal Investigator: Elliot Arsoniadis
This study is also accepting healthy volunteers
IRB Number: STUDY00024573
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Sex: Male
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 35 years old
• assigned sex of “male” at birth
• engage in anoreceptive intercourse with male partners
• willing to provide reliable contact information
• in the case of a positive screen, willing to undergo a clinic visit and HRA
• fluent in English
Exclusion Criteria:

• previous diagnosis of high-grade anal dysplasia or anal cancer
Conditions: Cancer, Community Health, Prevention & Wellness
Keywords: Anal Cancer, Clinics and Surgery Center (CSC)
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