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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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LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons with Colorectal Cancer

The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer and their caregiver. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services as part of this research. Participation in this study lasts for up to 3 months.

Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025970
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Participant has a diagnosis advanced stage (Stage III or Stage IV) colorectal cancer in the past 3 months, starting or planning to start systemic cancer therapy, able to identify a caregiver for study participation, and able to understand, speak, read, and write in English
• Caregiver: identified as a caregiver by a person who has colorectal cancer and able to understand, speak, read, and write in English
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• does not have the ability to provide informed consent
Conditions: Cancer
Keywords: Caregiver Burden, Colorectal Cancer, Legal Intervention, Clinics and Surgery Center (CSC)
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MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie

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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AALL2321; A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.

Principal Investigator: Peter Gordon
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025534
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Eligibility Screening: All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age: Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis: Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 WHO classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage.
Exclusion Criteria:

• Patients with Down Syndrome.
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
• Prior therapy: Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy.
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: ALL, KMT2A-G, KMT2A-R, KMT2A-Rearranged, Newly Diagnosed Acute Lymphoblastic Leukemia
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Individualized Diabetes Education Assisted by CGM (IDEA-CGM)

This study aims to learn more about how continuous glucose monitor (CGM) data can be used to personalize lifestyle interventions for type 2 diabetes. Participation in the study would require 4-5 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with study staff every 2 weeks (virtually), keep food logs, periodically wear an activity monitor and/or a CGM, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).

Principal Investigator: Anne Bantle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022947
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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 of age
• Diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 6.8 – 8.5 %
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with insulin, sulfonylurea, or meglitinide
• Use of a non-diabetes medication affecting blood glucose (e.g. corticosteroid)
• BMI < 25 kg/m2, or <23 kg/m2 for participants who self-identify as Asian
• Weight change > 5 pounds in the 3 months prior to study enrollment
• Estimated glomerular filtration rate <60 ml/minute/1.73 m2
• Pregnant or breastfeeding
• Anemia
• Changes to diabetes medications, including change in dose, in the 3 months prior to enrollment
• Presence of any disease that would make adherence to the protocol difficult
Conditions: Diabetes & Endocrine
Keywords: blood glucose, blood sugar, continuous glucose monitor (CGM), Diet, nutrition
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A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy (BLOSSOM)

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the one’s own tissues. We are doing this study to see if the investigational medication called anifrolumab may have an effect in treating pediatric SLE, to see how well it is tolerated or how safe it is, to measure levels of anifrolumab in the blood and learn more about the disease and associated health problems.

Principal Investigator: Bryce Binstadt
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020549
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 5 years to less than 18 years old
• weight at lest 15 kg (33 pounds)
• diagnosis of Systemic Lupus Erythematosus (SLE)
• being treated with prednisone, or antimalarial drugs
• no active or chronic TB or contact with someone who has TB
• females and males must be willing to use birth control during the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• history of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months
• history of multiple infections requiring hospitalization and IV antibiotics over the past year
• history of cancer
• history of severe COVID-19 infection
• prior treatment with anifrolumab
Conditions: Arthritis & Rheumatic Diseases, Immune Diseases, Rare Diseases
Keywords: Diagnosis of SLE, Lupus, Systemic Lupus Erythematosus
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A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled bySecond Generation H1-Antihistamines (RECLAIM)

The purpose of this study is to evaluate the efficacy of remibrutinib in comparison to dupilumab. We want to see which one works better for helping adults who have chronic spontaneous urticaria (CSU) and haven't had relief with use of second-generation antihistamines in treating adult participants who have CSU.

Principal Investigator: Paul Bigliardi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025930
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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 Urticaria
Exclusion Criteria:

• prior use of remibrutinib, dupilumab or other BTK inhibitors
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Chronic Spontaneous Urticaria
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

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

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001932
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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 advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial) (INNOVATE)

The study is to evaluate the safety and effectiveness of the investigational BrioVAD® System compared to the commercially available HeartMate 3™ LVAS. Both the BrioVAD System and the HeartMate 3 LVAS are left ventricular assist devices (LVAD) that help pump blood from the lower left chamber of the heart to the rest of the body. An LVAD is used to treat weakened hearts or heart failure and may be a temporary measure while waiting for a heart transplant or a permanent solution.

Principal Investigator: Andrew Shaffer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025330
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• has received institutional approval for Left Ventricular Assist Device (LVAD) implantation
• advanced heart failure refractory to advanced heart failure management or NYHA Class III with experience shortness of breath with mild physical activity
• left ventricular ejection fraction (LVEF) ≤ 25%
• women of childbearing age agree to use adequate contraception and have a negative pregnancy test
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• had cardiothoracic surgery within 30 days of implant
• unable to have warfarin anticoagulation
• history of organ transplantation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Cardiovascular Diseases, CHF, Congestive Heart Failure, Heart Disease, LVAD
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A Phase Ib open label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

The goal of this study is to find out whether combining different study drugs makes tumors shrink in people with advanced head and neck cancer. This type of cancer is in the mouth, nose, throat, and sinuses. The study drugs are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 1 out of 3 groups, by chance (like drawing names from a hat), and which of the study treatments participants will receive.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024665
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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 or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) of the primary tumor location of oral cavity, oropharynx, hypopharynx, and larynx
• have not received prior systemic treatment for metastatic or recurrent HNSCC
• do not have contraindications to pembrolizumab
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Nasopharyngeal cancer (NPC)
• progressive HNSCC within 6 months of completion of systemic therapy
• prior allogeneic stem cell or solid organ transplantation
• see link to clinicaltrials.gov for complete Exclusion critieria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Head and Neck Squamous Cell Carcinoma, HNSCC
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PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001347
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
Conditions: Cancer
Keywords: recurrent cancer, refractory cancer, solid tumors
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001730
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

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

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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Protocol M23-716: A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

This study will assess how effective and safe the use of the medication named Upadacitinib is for the treatment of signs and symptoms of severe hair loss in adults.

Principal Investigator: Maria Hordinsky
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021415
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Sex: Male or Female
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12-63 years of age
• have more than 50% hair loss
Exclusion Criteria:

• pregnancy
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Alopecia Areata
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NRG-BN013: Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) versus Fractionated SRS (FSRS) for Intact Brain Metastases

We are doing this study to compare the effectiveness of Single Fraction Stereotactic Radiosurgery (SRS) to radiation treatment called fractionated SRS (or FSRS). SRS delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. FSRS that delivers a high dose of radiation given over 3 treatments. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue.

Principal Investigator: Lindsey Sloan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026403
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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 one of the following solid tumor malignancies within 5 years prior to registration: non-small cell lung cancer (NSLS), melanoma, breast cancer, renal cell cancer, gastrointestinal cancer
• no prior radiotherapy to the brain
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Brain Metastases
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A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA (ALLEGRO-100)

Ritlecitinib (LITFULO™, PF-06651600) 50 mg daily is currently approved for people 12 years of age and older to treat severe alopecia areata (hair loss). Ritlecitinib 100 mg will be compared to Ritlecitinib 50 mg to find out if a larger daily dose is safe and can improve regrowth of hair. The study will last about 57 weeks and will have up to 9 visits. Everyone will get one of the two doses of the study drug.

Principal Investigator: Maria Hordinsky
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025039
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Alopecia Areata
• 12 years of age and older
Exclusion Criteria:

• JAK Inhibitor use
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Alopecia Areata
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Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. (HERMES)

We are looking at a new drug called 'ziltivekimab' to see if it can be used to treat people living with heart failure and inflammation. People will get either ziltivekimab or a placebo (inactive dummy drug). The study drug is an injection given into the fold of the skin on the stomach, thigh or upper arm once every month. People will take the study drug for up to 4 years.

Principal Investigator: Les Forgosh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001919
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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 heart failure
• hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous diuretic treatment, within the last 9 months prior to starting the study
• left ventricular ejection fraction (LVEF) greater than 40% documented by echocardiogram in the past year
• contact study staff for additional requirements
Exclusion Criteria:

• myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days
• planned cardiac procedures (ablation, revascularization
• primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD etc.)
• women who are pregnant, breast-feeding or planning to get pregnant during the study period.
• contact study staff for additional exclusion criteria
Conditions: Heart & Vascular
Keywords: Heart Failure
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A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)

This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023797
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), non-small cell lung cancer, NSCLC
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MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.

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

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021781
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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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Satisfaction and usability assessment of a take-home device for tinnitus

This study is about assessing compliance, satisfaction, and usability of a take-home device for tinnitus management, specifically a bimodal neuromodulation device using customized acoustic stimulation paired with electrical ear stimulation. This study also examines whether integrative health (IH) practices – such as deep breathing – paired with bimodal neuromodulation can enhance long-term plasticity of the brain and reduce stress.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00025024
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Subjective tinnitus (only you can hear your tinnitus)
• tinnitus has a dominant pitch
• willing to commit to a 18-week study
Exclusion Criteria:

• Objective tinnitus (other people can hear your tinnitus too)
• users of hearing aids or cochlear implants, or an electro-active implanted device
Conditions: Ear, Nose & Throat
Keywords: bimodal stimulation, hearing, neuromodulation, Tinnitus, ringing
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MT2023-35: A Pilot Study to Identify Risk Factors for Long-Term Functional and Pulmonary Outcomes Following Allogeneic Hematopoietic Cell Transplantation for Oncologic Diagnoses.

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

Principal Investigator: Alex Hoover
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021591
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Sex: Male or Female
This study is NOT accepting healthy volunteers
Inclusion Criteria:

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

• people who don't speak or read English
Conditions: Cancer
Keywords: HCT, Hematopoietic Cell Transplantation
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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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A Pivotal Study Evaluating Safety and Efficacy of the ShiraTronics Migraine Therapy System in RELIEVing, Interrupting, and Preventing Chronic Migraine (RELIEV-CM2)

This research study is testing a potential new treatment for refractory chronic migraine (RCM). The potential new treatment is called ShiraTronics Migraine Therapy. The purpose of this study is to demonstrate the safety and effectiveness of the ShiraTronics Migraine Therapy System. The ShiraTronics System delivers mild electrical pulses to nerves associated with migraine pain around the back and front of your head. These electrical pulses interrupt or change the transmission of pain signals to the brain, which can potentially relieve your chronic migraine pain and symptoms. The ShiraTronics System is approved by the United States Food and Drug Administration for investigational (under research) use, and not approved for sale.

Principal Investigator: Abby Metzler
Age Group: 18 years and over
IRB Number: STUDY00022988
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• at least 22 years old
• migraines started before 50 years old
• migraines occurring for at least 12 months before starting the study
• 15 - 26 headache days/month, among which ≥ 8 days has the features of probable migraine, and minimum of 2 headache-free days/month
• use of preventive(s) migraine medication for at least 3 months before starting the study
Exclusion Criteria:

• headache or migraine other than refractory chronic migraine (RCM)
• previously implanted neurostimulator
• received botulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within the past 3 months
• cervical radiofrequency ablation within 12 months
• other implanted electrical stimulation device or any metallic implant located in the head including CSF shunt and surgical clip above the shoulder line (excluding dental implants)
• women who are pregnant or breastfeeding or planning a pregnancy during participation in the study
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), chronic headache, Migraine Headache, Neurostimulator
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A Phase 3, Open label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen in Children from 6 Years to less than 18 Years of Age with Active ANCA-associated Vasculitis (AAV)

Blood vessel inflammation can damage parts of the body. The medicines we use to treat AAV try to turn off the blood vessel inflammation to prevent damage to the body. The purpose of this study is to see how safe and how well a medicine called avacopan works when combined with a child’s regular medicine used to treat their AAV. This medicine is not approved in children, so will be called a “study drug.”

Principal Investigator: Bryce Binstadt
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023481
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 6 to 17 years old
• diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
• weigh at least 15 kg (33 lbs)
Exclusion Criteria:

• any other known multisystem autoimmune disease
• any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids
Conditions: Rare Diseases
Keywords: AAV, Active ANCA-associated Vasculitis, Vasculitis
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MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

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

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00002088
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
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PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001450
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
Conditions: Cancer, Cancer
Keywords: Brain Cancer, Glioma, Recurrent Lymphoma
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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot study

The trial offers women with ductal cell carcinoma in situ (DCIS) 6 months of neoadjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

Principal Investigator: Jane Hui
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022523
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of HR+ DCIS (at least 50% ER or PR (from biopsy at diagnosis) with or without microinvasion
• may have received endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• breast cancer is invasive
• unable to swallow tablets or capsules
• gastrointestinal conditions that would interfere with absorption of medication -- see link to clinical trials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer, DCIS
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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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At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study (At-home ULTRA)

The research objective is to evaluate performance of ultrasound stimulation of the spleen for the treatment of rheumatoid arthritis (RA). In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics for up to 24 weeks of investigational ultrasound treatment.

Principal Investigator: Erik Peterson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025536
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• active moderate to severe seropositive rheumatoid arthritis (RA)
• have at least 6 total tender and/or swollen joints
• receiving stable background treatment with a csDMARD (e.g. methotrexate) for at least 8 weeks prior to start of the study. Participants must be willing to maintain their background medication regimen throughout the 28-week study period
• may receive up to 10 mg of daily prednisone as part of treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the study and be willing to maintain the stable dose until after the Week 24 of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or trying to get pregnant
• active bacterial or viral infection
• implanted device or other solid object on the spleen side of the torso
• recent abdominal surgery
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Arthritis & Rheumatic Diseases
Keywords: RA, rheumatoid arthritis, spleen, stimulation, treatment, Ultrasound
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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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MT2025-13 Long-term Follow-up of Subjects Who Received TRX103 in a Clinical Study Sponsored by Tr1X, Inc

This study will enroll people who receive TRX103 as part of a separate research study, in order to monitor these patients for long-term safety, and discover more about the long-term effects of TRX103.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025462
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have received TRX103 in a clinical study and have either completed the study or have discontinued early from the study
Exclusion Criteria:

• withdrawal from a clinical study before infusion of TRX103
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC)
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State Representation in Early Psychosis 2

In this study, participants will complete two to three appointments within two weeks. During these appointments, they will complete interviews and questionnaires about their life experiences and mental health. An EEG test will also be conducted while they complete computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis spectrum disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

Principal Investigator: Scott Sponheim
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00024589
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 15 to 45 years old
• able to speak and write English
• no hospitalizations and on stable doses of medications for the past one month or more
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis
• matched healthy volunteers
Exclusion Criteria:

• previous clinically significant head injury
• severe substance or alcohol use within past 3 months - major neurological disorder - medical condition that would interfere with participation
• currently at risk for suicidal behavior
Conditions: Mental Health & Addiction
Keywords: Psychosis, Schizoaffective Disorder, Schizophrenia
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