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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.

438 Study Matches

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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MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

Principal Investigator: Parastoo Fazeli
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020865
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
Exclusion Criteria:

• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
Conditions: Immune Diseases
Keywords: Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
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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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Bupropion for the Prevention of Postpartum Smoking Relapse

Currently, more than half of all women who are able to quit smoking cigarettes during pregnancy start smoking again within six months after they give birth. We want to find out if the drug bupropion (a commercially-available medicine) can help women who quit smoking during pregnancy to continue not smoking after they give birth. All study visits can be completed either in-person or virtually.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007684
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 to 40
• lifetime history of smoking at least 100 cigarettes, quit smoking during current pregnancy
• uncomplicated delivery, at least 37 weeks gestation
• home within 10 days of delivery
• don't want to start smoking again
Exclusion Criteria:

• currently use other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• currently use cessation aids
• currently use illicit drugs or alcohol dependence
• taking an antidepressant
• family history of seizures or seizure disorder
Conditions: Mental Health & Addiction, Women's Health
Keywords: postpartum, smoking, smoking cessation
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MT2023-06: A CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LERIGLITAZONE IN ADULT MALE SUBJECTS WITH CEREBRAL ADRENOLEUKODYSTROPHY (CALYX)

This study has 2 parts: a double-blind period and an open-label extension. In the double-blind period of this study, the study medicine will be compared to a placebo. A placebo is a treatment that looks and tastes exactly like the study medicine but does not contain any active ingredient. In this study, you will receive leriglitazone or placebo. Whether you receive leriglitazone or placebo will be decided randomly (by chance, like flipping a coin). In this study, 1 out of every 2 subjects (50%) will receive leriglitazone and 1 out of every 2 subjects (50%) will receive placebo. To make this study fair, you and the study doctor will not be told which treatment you will receive, this is called “blinding”. In the open-label extension, all subjects will receive leriglitazone.

Principal Investigator: Troy Lund
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001908
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of progressive cerebral adrenoleukodystrophy (cALD), defined as GdE with brain lesions
• bone marrow transplantation (HSCT) is not recommended patient is not willing to undergo HSCT
• no major cognitive impairment
• see link to clinicaltrials.gov for additional inclusion criteria
Exclusion Criteria:

• or treatment with ex-vivo gene therapy (eli-Cel).
• known type 1 or type 2 diabetes
• see link to clinicaltrials.gov for additional exclusion criteria
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CEREBRAL ADRENOLEUKODYSTROPHY, cALD
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HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination with CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML).

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

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

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

• active central nervous system malignancy or symptoms of CNS involvement
• cardiac disease including congestive heart failure with symptoms, heart attack (myocardial infarction) in the past 6 months, serious arrhythmia, unstable angina
• women who are pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

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

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

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

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), blood cancer, hematopoietic stem cell transplantation (HSCT)
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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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Development of Tobacco Related Biomarkers

To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.

Principal Investigator: Stephen Hecht, PhD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021394
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:
This study is recruiting healthy people who fit one of the following:
• formerly smoked cigarettes daily
• uses smokeless tobacco
• smokes cigars
• uses nicotine gum, lozenges, patches, nasal spray, pouches, or inhaler
Exclusion Criteria:

• younger than 21 years old
• unstable health condition
Conditions: Community Health, Prevention & Wellness
Keywords: cigarettes, nicotine, smokeless tobacco, tobacco, former smoker, previous smoker, quit smoking, smoker
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Detecting Ovarian Cancer by Analyzing Volatile Organic Compounds (VOCs) in Human Breath

The purpose of this study is to evaluate the ability of a device (Vocxi Health’s MyBreath Print®) to capture and measure volatile organic compounds (VOCs) in breath samples from women who have a pelvic mass and will be having surgery. The ultimate goal is to develop a screening test for ovarian cancer. We expect that study will take approximately 45 minutes and breath samples will be obtained before and after surgery.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022603
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women who have a pelvic mass and will have surgery
• diagnosis of ovarian, fallopian tube or primary peritoneal cancers or women with a non-malignant ovarian mass (excluding low malignant potential tumors)
• no prior history of cancer
Exclusion Criteria:

• unable to tolerate normal breathing while wearing device mask
Conditions: Cancer
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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654) (INAVO123)

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

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

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

• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer
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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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A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes

The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.

Principal Investigator: Antoinette Moran
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024994
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
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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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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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MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.

Principal Investigator: Ashish Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023330
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people 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 transplant
• study staff will review additional requirements
Exclusion Criteria:

• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
Conditions: Blood Disorders
Keywords: Clinics and Surgery Center (CSC), SCD, Sickle cell disease
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MN CF Center Consent (PortCF) Cystic Fibrosis (CF) Center Program Accreditation and Funding

This retrospective, longitudinal project is to collect certain demographic and clinical health status information for entry into the CF Foundation Patient Registry (also known as PortCF). The registry has played an important role in CF research and will continue to do so. In addition, much of the same information is entered into the University of Minnesota Cystic Fibrosis Center Research Database. This patient database has been maintained since 1975.

Principal Investigator: Sarah Kiel
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 7405M00054
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• possible diagnosis of Cystic Fibrosis (CF) or CF-related complications
• receive care at the MN CF Center
Keywords: Clinics and Surgery Center (CSC), cystic fibrosis, CF, MNCF
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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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A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator s Choice in Participants with Chemotherapy-naïve Metastatic Castration resistant Prostate Cancer

This research study is being done to learn more about how safe and effective the investigational drug xaluritamig is when given in combination with abiraterone acetate compared to standard care (study doctor’s choice of abiraterone acetate, docetaxel, or cabazitaxel) in people with prostate cancer that has spread to other parts of the body but has not yet been treated with chemotherapy in the metastatic castration-resistant prostate cancer (mCRPC) setting.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026650
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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) treated with enzalutamide, darolutamide or apalutamide oral medications
• cancer is adenocarcinoma type
• prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT)
• no prior chemotherapy in the mCRPC setting (up to 6 cycles of docetaxel in the castration sensitive setting is allowed)
• unable 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 complete Inclusion criteria
Exclusion Criteria:

• history of central nervous system (CNS) metastases
• disease progression on or intolerance to abiraterone
• 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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RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA

We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.

Principal Investigator: Curtis Hanba
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025188
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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 invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Eyelid Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma, 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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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Principal Investigator: Elliot Arsoniadis
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017257
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Sex: Male
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Conditions: Cancer, Prevention & Wellness
Keywords: Anal Cancer
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An Open-Label, Pilot Clinical Trial To Test The Efficacy Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

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

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

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

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant
• history of celiac disease
• receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: bowel resection, bowel surgery, Clinics and Surgery Center (CSC), colon cancer
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EX-VIVO TARGETED TREATMENT OF CANCEROUS EXTIRPATED PROSTATE TISSUE

This study focuses on testing new treatments on prostate tissue that has been removed during surgery. All testing is done in a lab setting to help develop and improve potential treatment options.

Principal Investigator: Christopher Warlick, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00010808
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• scheduled to undergo a radical prostatectomy
• able to understand and provide informed consent
Conditions: Cancer, Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

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

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019273
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
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A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Solar-Stage)

The purpose of this study is to test the safety and effectiveness of Copper Cu 64 PSMA I&T in detecting lesions during a PET scan. This study is open to men with newly diagnosed prostate cancer who plan to have a prostatectomy and lymph node removal. Copper Cu 64 PSMA I&T is an investigational PET imaging agent, given to you via IV injection, similar to the way other imaging agents are used in many other types of scans. Cu 64 specifically targets the prostate specific membrane antigen (PSMA) that is found on the surface of metastatic prostate cancer cells. Increased image contrast may make it easier for the doctor to see smaller lesions compared to other imaging agents.

Principal Investigator: Subodh Regmi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022112
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed with prostate adenocarcinoma with intermediate / high risk features
• planned prostatectomy with pelvic lymph node dissection
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received any therapy for prostate cancer before surgery
• not able to have a PET scan
• had a prostate-specific membrane antigen (PSMA) PET scan in the past 90 days
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000965
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
Exclusion Criteria:

• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML
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Evaluation of Microbiota Transplant Therapy in Patients with Alopecia Areata

The purpose of this study is to determine if microbiota transplant therapy (MTT) is an effective treatment for patients with alopecia areata, alopecia totalis, and alopecia universalis. We will be testing two different ways of doing the Microbiota transplant therapy (MTT): half the people who choose to be part of this study will take antibiotics before the transplant and half will take placebo antibiotics. We will collect 5 types of samples (2 or more times during the study): blood samples, skin samples, skin swabs, hair, and fecal samples.

Principal Investigator: Maria Hordinsky
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023721
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years of age
• moderate to severe alopecia areata with at least 30% scalp hair loss
• hair loss lasting for at least 3 months
• must be willing to stop using other types of medications to treat Alopecia Areata throughout the study
• evidence of active, ongoing regrowth of hair
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active medical conditions or cancer
• current gastrointestinal infection or use of antibiotics
• current treatment for gastrointestinal diagnosis or previous GI surgery (past 3 months)
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: alopecia, Hair loss
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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 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years& Less than 18 Years of Age with Alopecia Areata

We are conducting a research study for children ages 6-17 with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Principal Investigator: Maria Hordinsky
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001967
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• children 6 to 18 years old
• at or above the 5th percentile of weight for age
• diagnosis of Alopecia Areata (AA) for at least 1 year
• current AA episode of at least 6 months duration with hair loss encompassing 50% or more of the scalp
• history of trial and failure with at least 1 available treatment
• history of psychological counseling related to AA
Exclusion Criteria:

• primarily diffuse type of AA (characterized by diffuse hair shedding)
• currently experiencing other forms of alopecia including, but not limited to: trichotillomania, TE, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis)
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: AA, Alopecia Areata, hair loss
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