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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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MT2017-17:T Cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in patients with Inherited Bone Marrow Failure (BMF) Disorders

The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003182
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 65 years of age
• have a diagnosis of Fanconi anemia
• have a suitable donor for peripheral blood cells
• women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• see link to clinicaltrials.gov for additional criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• cancer within previous 2 years
Conditions: Blood Disorders, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
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MT2023-01:Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to evaluate the safety of a new NK cell therapy for people with relapsed or treatment-resistant acute myeloid leukemia (AML). Participants will receive chemotherapy followed by an infusion of specially selected donor immune cells designed to help the body recognize and fight leukemia cells. Researchers will study the safety of this treatment, determine the most appropriate dose, and learn more about how the therapy works in the body.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027586
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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)
• adequate heart, lung, liver, and kidney function
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• diagnosed with leukemia involving the brain or spinal fluid
• active HIV, Hepatitis B, Hepatitis C, other serious infection, recent heart attack, or another active cancer requiring recent chemotherapy
• 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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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US). Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. Participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

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

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

• current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• major depressive disorder
• current or within the past 3 months treatment for drug or alcohol use
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: post partum, smoking
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MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1601M82901
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Conditions: Cancer
Keywords: Neuroblastoma
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A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects with Advanced Solid Tumors (BEHOLD-1)

This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025827
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube or endometrial cancer that is metastatic or not able to have surgical treatment
• received or are intolerant to 1 but no more than 3 lines of prior systemic therapy
• 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 criteria
Exclusion Criteria:

• pleural/abdominal effusion/ascites requiring clinical intervention or presence of pericardial effusion
• brain metastasis unless asymptomatic
• heart arrhythmias or ECG abnormalities
• Left ventricular ejection fraction (LVEF) < 50%
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cancer, neoplasm, solid tumors
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015805
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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 relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• 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:

• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-Cell Non-Hodgkin Lymphoma, B-NHL
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DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)

The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026413
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do 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 complete Inclusion criteria
Exclusion Criteria:

• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Cancer
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

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

Principal Investigator: Meera Srikanthan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

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

• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), Acquired Amegakaryocytic Thrombocytopenia, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, SA
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)

The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026133
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer
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COgnitive STrategies in Early Psychosis 1

This study is about decision making in psychosis spectrum disorders, like schizophrenia. We will study how a single dose of a study agent called modafinil changes how people complete computer tasks and changes how the brain functions. We hope to improve our understanding of psychosis to help people in the future.

Principal Investigator: Sophia Vinogradov
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00025500
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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 35 years old
• speak English as primary language
Exclusion Criteria:

• major medical diagnosis such as neurological disorder, kidney, heart, liver disease
• people who are pregnant, breastfeeding, or planning to become pregnant
• have a diagnosis or immediate family history of a psychotic, bipolar, or autism spectrum disorder
• study staff will review additional criteria
Conditions: Mental Health & Addiction
Keywords: mental health
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MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)

The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
IRB Number: STUDY00027246
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Sex: Male
Age Group: 18 years and over
Inclusion Criteria:

• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
Keywords: Clinics and Surgery Center (CSC)
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A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors with Azirkitug as a Single Agent and in Combination(s) with Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

This trial will evaluate whether azirkitug (ABBV-514) as monotherapy and in combination with budigalimab (ABBV-181) or bevacizumab is safe and tolerable for people with locally advanced or metastatic solid tumors.

Principal Investigator: Naomi Fujioka
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026235
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• advanced or metastatic cancer who have previously been treated
• see link to clinicaltrials.gov for complete Inclusion Criteria
Exclusion Criteria:

• active autoimmune or immunodeficiency disease
• women who are pregnant
• significant heart disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Colorectal Cancer, Gastric/Esophageal Cancer, Head and Neck Carcinoma, Serous Ovarian Cancer
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HM2025-16: Phase Ib/II Trial of Epcoritamab plus Ibrutinib in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma.

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026284
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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 B-cell non-Hodgkin lymphoma
• have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody
• treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days
• capable of all selfcare and able to walk but unable to carry out any work activities; up and about more than 50% of waking hours
• women of child-bearing potential and men must agree to use adequate contraception 2 weeks before starting treatment, for the duration of study participation and for 12 months after completing treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active central nervous system (CNS) involvement
• active uncontrolled infection
• current uncontrolled or symptomatic cardiovascular conditions
• liver cirrhosis with moderate to severe liver impairment
• significant lung disease
• treatment with coumadin/warfarin
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-cell non-Hodgkin lymphoma, Lymphoma
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Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)

Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.

Principal Investigator: Beth Thielen
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019522
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
Exclusion Criteria:

• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Conditions: Community Health, Infectious Diseases, Respiratory System
Keywords: germs, infection, respiratory illness, RSV, virus, cough
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MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.

Principal Investigator: Christopher Graham
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027522
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Hematological Diseases, Stem Cell Transplant
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MT2025-31: A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

The purpose of this study is to test a new CAR T-cell therapy called AZD0120 in adults with multiple myeloma that has returned or has not responded to previous treatments. Researchers want to learn whether this therapy is safe, determine the best dose to use, and see how well it works against the cancer. The study will also look at how the treatment affects the immune system and participants’ quality of life.

Principal Investigator: Daniel O'Leary
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026811
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including commonly used multiple myeloma therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• had serious side effects from prior CAR T-cell or similar immune-based therapies
• have another active cancer, significant medical condition (such as heart, neurological, mental health, autoimmune, or serious infection-related conditions), or plasma cell leukemia (some exceptions may apply)
• have had a recent stroke, seizure, bleeding in the brain, dementia, or major changes in mental status
• have multiple myeloma affecting the brain or central nervous system
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), blood cancer, blood disorders, MM, Multiple Myeloma
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MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis (Regulate-RA)

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Principal Investigator: Daniel Mueller
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023753
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Arthritis & Rheumatic Diseases, Immune Diseases
Keywords: Autoimmune, Clinics and Surgery Center (CSC), RA, Rheumatoid Arthritis
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An open-label study to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice (NefXtend)

This study is about finding out if the study drug, TARPEYO®, can be taken for a longer time (2 years) than the current recommended 9 months, to better help people with primary IgA nephropathy (IgAN).

Principal Investigator: Nattawat Klomjit
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024442
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed with biopsy-proven IgA nephropathy (IgAN)
• completed of 9 months of treatment of Tarpeyo 16mg twice a day (we start screening participants after 7 1/2 months of Tarpeyo treatment so we have enough time to complete all requirements before entering the study). Please contact the study team as early as possible.
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• treated with systemic immunosuppressants including glucocorticosteroids other than Tarpeyo during treatment of Tarpeyo
• current or planned dialysis
• undergone kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Kidney, Prostate & Urinary
Keywords: Berger's Disease, Clinics and Surgery Center (CSC), IgA Nephropathy, IgAN
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MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Principal Investigator: Supriya Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009953
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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 Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Non-Hodgkin Lymphoma, Clinics and Surgery Center (CSC)
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MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)

The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.

Principal Investigator: Binoy Yohannan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027728
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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 systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), amyloid light chain (AL) amyloidosis
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PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA

The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.

Principal Investigator: Frank Ondrey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001771
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: Clinics and Surgery Center (CSC), Oral Leukoplakia
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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.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022729
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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
• 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
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML, Myelodysplastic Syndromes, Myeloid Malignancy
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A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)

This study is looking at if we give ATG followed by either adalimumab or verapamil if those combinations will help in preserving insulin secretion 2 years after newly diagnosed type 1 diabetes.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025666
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 9 to <21 years
• recently diagnosed with T1D and can start the treatment phase within 6 months of diagnosis
• body weight more than 66 pounds
• fully vaccinated for age and willing to avoid certain live vaccines during the study
• able to read and understand English or Spanish
• use only insulin to control blood sugar (no other glucose-lowering medicines)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of serious bacterial, viral, fungal, or other infections or current active infection
• history of underlying heart disease
• history of cancer other than of skin
• severe allergy to milk or adhesives
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
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A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)

The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.

Principal Investigator: Heather Beckwith
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023538
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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 adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

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

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

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

• stage IV (metastatic) breast cancer
• known active liver disease -medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)

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

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

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

• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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NRG-GU012: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (SAMURAI)

The primary purpose of this study is to find out if adding a highly focused form of radiation therapy (called SABR) to the main kidney tumor, along with immunotherapy, helps people with advanced kidney cancer live longer or do better than using immunotherapy by itself.

Principal Investigator: Ian Okazaki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025313
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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 renal cell cancer with positive lymph nodes that can't be removed or metastasis to another area
• not recommended for or refused immediate nephrectomy
• must agree to use a highly effective contraception while on study drug and for 6 months following the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• untreated or unstable brain metastases
• prior radiotherapy to the kidney
• systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before starting the study
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Kidney Cancer, Metastatic Renal Cell Carcinoma
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Multimodality Therapy with Immunotherapy in Stage I-IIIA Pleural Mesothelioma

The purpose of this study is to learn the effects, good or bad, of the study drug, vosoritide, for treating children who have hypochondroplasia. This condition affects the growth of bone and cartilage and in which kids who have it are shorter than other kids of the same age. In this study, your child will get either the study drug or placebo, which is an inactive medicine.

Principal Investigator: Robert Kratzke
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026290
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• daignosis of Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma
• have not received treatment
• not pregnant or breastfeeding
• able to 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 complete inclusion criteria
Exclusion Criteria:

• people who are not able to have surgical treatment
• history of symptomatic interstitial lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), lung cancer, Mesothelioma
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TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes (TADPOL)

This study is looking at the safety and effects of Difluoromethylornithine (DFMO) and its effect on insulin production in people who have been newly diagnosed with type 1 diabetes. DFMO is a drug that is FDA-approved for other uses, but is being looked at in this study for preserving beta cell function. Participants will be randomized (like flipping a coin) to take either the placebo medicine or Difluoromethylornithine (DFMO) for 6 months followed by 6 months of no medication. Of all people participating in the study, 2 out of 3 people will receive DFMO and 1 out of 3 people will receive placebo treatment. Participation in this study will be approximately 12 months.

Principal Investigator: Brandon Nathan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024995
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 4 to 40 years old
• diagnosis of Type 1 Diabetes (T1D) and started insulin no more than 100 days before starting this clinical trial
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• any severe, active disease that interferes with food intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids
• unable to swallow pills
• current use of anti-psychotic medication
• allergy to milk or soy
• women & men of child bearing age must agree to use approved birth control
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months

Principal Investigator: Thenappan Thenappan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025446
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 Years to 83 years old
• male or female of non-childbearing potential
• diagnosis of Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
• Chronic medication for heart failure or cardiovascular disease is at a stable dose
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• started a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study
• history or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular disease liver disease, infectious disease, or malignancy
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), diagnosis of PH-HFpEF, Heart Failure, Pulmonary Hypertension
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