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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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A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous or Oral Lichen Planus or Lichen Planopilaris (ALPINE)

The purpose of this study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of lichen planopilaris (LPP). Brepocitinib (the “study drug”) is designed to decrease inflammation. The study will look at how safe and effective brepocitinib is and will monitor long-term safety when it is taken for up to 52 weeks. The study drug will be compared to a placebo which is a tablet that looks exactly like the study drug but does not contain any active ingredient.

Principal Investigator: Maria Hordinsky
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027335
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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 lichen planopilaris (LPP)
Exclusion Criteria:

• have a history of certain blood or lymphatic system cancers, currently have cancer, or have been treated for most cancers within the past 5 years
• have a high risk of blood clots, heart disease, stroke, or shingles
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Clinics and Surgery Center (CSC), lichen planopilaris, LPP
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A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer

The main goal of this study is to see if it's safe for people to take xaluritamig together with either darolutamide or abiraterone.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025859
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of metastatic adenocarcinoma of the prostate
• started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (pre-enrollment treatment with enzalutamide, abiraterone, apalutamide, or darolutamide are allowed).
• first treatment with ADT should be no longer than 12 weeks before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of central nervous system (CNS) metastases
• autoimmune disease requiring systemic treatment in the past 2 years
• prior radiotherapy (to the prostate and/or to all visible metastatic lesions; palliative radiation within 2 weeks prior to first dose of study treatment is allowed
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Hormone-sensitive Prostate Cancer, mHSPC, prostate cancer
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Assessing Changes in Knowledge and Attitudes Toward Transcranial Magnetic Stimulation (TMS) After a Demonstration-Based Intervention

The purpose of this study is to learn whether watching a short educational video changes what people know and think about transcranial magnetic stimulation (TMS), a non-medication treatment for depression that uses magnetic pulses. Researchers will also compare different video styles to determine which is most effective at increasing knowledge and improving attitudes about TMS.

Principal Investigator: Jeremy Chaikind
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00028471
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 18+
Conditions: Mental Health & Addiction
Keywords: Survey, MNFair
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALTO-300 WITH AN OPEN-LABEL EXTENSION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER

The purpose of this study is to evaluate the safety and effectiveness of ALTO-300, an investigational medication being studied for adults with Major Depressive Disorder (MDD). This study will compare ALTO-300 to a placebo to learn more about how the medication may improve symptoms of depression and to identify factors that may help predict who is most likely to benefit from treatment.

Principal Investigator: Cristina Albott
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027511
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18-70 years old
• diagnosed with moderate to severe major depressive disorder (MDD)
• currently taking one approved antidepressant medication (SSRI, SNRI, or bupropion) for at least 6 weeks with no recent dose changes
Exclusion Criteria:

• diagnosed with fibromyalgia
• pregnant or breastfeeding
Conditions: Mental Health & Addiction
Keywords: agomelatine, ALTO-300, depression, Major Depressive Disorder, MDD
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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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Efficacy, safety, and pharmacokinetics of cargrilinitide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

This study will evaluate the efficacy, safety and pharmacokinetics of a combination drug called CagriSema, which is a combination of cagrilintide s.c. 2.4 mg and semaglutide s.c. 2.4 mg for the management of weight in children and adolescents with overweight or obesity. Participants in the study may receive study medication for up to 250 weeks.

Principal Investigator: Eric Bomberg
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026377
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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 who are 8 to <18 years old
• history of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counselling) for at least 3 months
• BMI requirements vary by age
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• treatment with any medication prescribed for obesity or weight management within 90 days before starting this study -Type 1 diabetes or monogenic diabetes
• HbA1c greater than or equal to 6.5% if diagnosis of Type 2 diabetes has not been made
• recurrent severe hypoglycaemic episodes within 1 year before starting the study
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Children's Health
Keywords: Clinics and Surgery Center (CSC), obesity, overweight
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HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

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

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

• diagnosis of primary or secondary myelofibrosis
• may be restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria which are specified by diagnosis
Exclusion Criteria:

• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Myelofibrosis
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A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Letermovir (MK-8228) is a medication that is used to prevent cytomegalovirus (CMV) infection and disease. This trial is testing letermovir in children and adolescents who weigh less than 40 kilograms and have had a kidney transplant. Letermovir is experimental in this trial. Everyone in this trial will get letermovir. The dose a child gets will depend on their weight at the start of the trial. The child, the trial doctor and the trial staff will know your child is getting letermovir and what dose they are getting.

Principal Investigator: Shannon Andrews
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026525
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Sex: Male or Female
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 17 years old
• recipient of a primary or secondary allograft kidney
• at least 4 weeks posttransplant and not more than 52 weeks posttransplant
• has stable kidney function since the transplant
• able to take letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube
• weighs ≥2.5 and <40 kg at enrollment (5.5 to 88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• has CMV disease
• on dialysis or plasmapheresis
• multi-organ transplant recipient (e.g., kidney-pancreas)
• any uncontrolled infection
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Children's Health, Infectious Diseases, Kidney, Prostate & Urinary
Keywords: CMV, cytomegalovirus, kidney transplant
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A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY

The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024824
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Fallopian Tube Cancer, Ovarian Cancer, Clinics and Surgery Center (CSC)
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CVD in Women with CF: Assessing Cardiovascular Risk in Menopausal Women with Cystic Fibrosis

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

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

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

• pregnant or suspect you may be pregnant
• cognitive or memory difficulties
• unable to read or speak English
Conditions: Rare Diseases, Rare Diseases, Respiratory System, Heart & Vascular, Women's Health
Keywords: cf, cfrd, Clinics and Surgery Center (CSC), cvd, diabetes, menopause, cardiovascular disease, cystic fibrosis, aging
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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

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

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

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

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Conditions: Cancer, Women's Health
Keywords: endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants with Fragile X Syndrome

Researchers are studying an investigational medication called MRM-3379 for males with Fragile X syndrome (FXS), a genetic condition that can affect learning, memory, communication, and behavior. The goal of this study is to evaluate the safety and tolerability of MRM-3379 and explore whether it may help improve cognitive function by supporting brain cell communication. The study will also examine how the body processes the medication.

Principal Investigator: Amy Esler
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027846
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Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• male, ages 13-45
• diagnosed with Fragile X syndrome (FXS) confirmed through genetic testing
• able to complete study activities that assess language and thinking abilities
• have a consistent caregiver who is willing and able to provide regular support during the study
• able to swallow tablets or capsules
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Rare Diseases, Brain & Nervous System
Keywords: Fragile X Syndrome, FXS
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Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies

This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015219
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastasis, solid tumor
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Project GRaNoLA (Gender Role and Norm: Learning and Accepting)

This study is exploring how children understand and form opinions about differences in how adults express their gender through appearance, speech, and behavior. Researchers are interested in learning how children think about gender expression and whether their perceptions vary based on different aspects of how gender is represented.

Principal Investigator: Melissa Koenig
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00024846
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• children between 5 and 10 years old
• able to understand and speak English
Exclusion Criteria:

• history of developmental disorders, language delays/disorders, or vision or hearing impairments
Conditions: Children's Health
Keywords: Children, Cognitive Development, Learning, MNFair
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MT2022-49: Early identification of cognitive side-effects of immunotherapy

This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019811
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
Exclusion Criteria:

• presence of speech or hearing problem
• diagnosis of cognitive impairment
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), CAR-T, Chimeric Antigen Receptor T-Cell Therapy
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Tic Impacts Survey

This study is about learning how tics affect daily life and everyday activities. If you participate, you'll complete online surveys about how tics impact your daily routines, work or school, hobbies, and other activities. Researchers also want to learn how other health conditions may affect daily functioning and what strategies or accommodations people use to manage the impact of tics.

Principal Investigator: Christine Conelea
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026795
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• aged 18 years or older
• self-report having tics
• access to an internet-connected device
Conditions: Brain & Nervous System
Keywords: chronic tic disorders (CTD), Tourette syndrome (TS), vocal tics
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Kinematic signatures of postural instability and gait in Parkinson Disease

The purpose of this research is to better understand balance and walking in patients with Parkinson’s Disease. This research study uses small wearable devices that attach to clothing and can measure the body’s location while performing walking and balance tests.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00005877
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make health-care decisions for themselvess
Conditions: Brain & Nervous System
Keywords: Parkinson's, Parkinson's Disease, Deep Brain Stimulator, DBS, aging
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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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Influence of menopause and sex hormone deficiency on autonomic and vascular determinants of blood pressure

This study is being done to learn more about how menopause influences the autonomic (fight or flight) and vascular (blood vessels) function in midlife females. To understand how blood pressure is regulated, we will make several measurements, including heart rate, blood pressure, sympathetic function (also known as the fight or flight system), and how blood vessels regulate blood flow.

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022683
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• women who are 45-55 years old
• premenopausal
• currently have a normal menstrual cycle
• not planning to become pregnant for the duration of participation in the study
• able to read, write & speak English
Exclusion Criteria:

• diabetes
• pregnant or breastfeeding
• cardiac or lung disorders
• severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
• hypertension
• obstructive sleep apnea
• current use of heart or blood pressure medications or antidepressants
• history of treatment with chemotherapy/radiation
• coagulopathy disorders and/or use of anticoagulant medications
• current use of hormonal contraceptives
• nicotine/tobacco use in the last six months
• current alcohol abuse
Conditions: Women's Health
Keywords: midlife, aging, Menopause, Pre menopause, Clinics and Surgery Center (CSC)

Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients with Soft Tissue and Bone Sarcoma (TARGET-RT) (TARGET-RT)

This study aims to improve treatment and outcomes for children, adolescents, and young adults with metastatic sarcoma and help guide future care for this disease.

Principal Investigator: Leslie Chang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026346
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• younger than 39 years old or were first diagnosed with a soft tissue or bone sarcoma before age 39
• have a newly diagnosed, recurrent, or progressive (continued to grow) soft tissue or bone sarcoma
• have sarcoma that has spread (metastasized) to another part of the body and can be measured on imaging scans
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have cancer that has spread to the brain or spinal fluid
• have metastatic disease that cannot be measured on imaging scans
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Rare Diseases
Keywords: Oligometastatic, radiotherapy
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HM2026-09: Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma who Have Received 1-3 Prior Lines of Therapy (Trilogy5) (TRIlogy-4)

The purpose of this study is to evaluate a new study drug, JNJ-79635322, in adults with multiple myeloma that has returned after treatment or has not responded to previous treatment. Participants must have received 1 to 3 prior lines of therapy, including lenalidomide and an anti-CD38 antibody. Researchers want to learn how safe the study drug is and how well it works compared with the current standard treatment for multiple myeloma.

Principal Investigator: Daniel O'Leary
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00028442
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody
• see the ClinicalTrials.gov listing for complete inclusion criteria
Exclusion Criteria:

• have an active hepatitis infection
• have multiple myeloma that has spread to the brain or central nervous system
• have certain allergies to the study medications or their ingredients
• have had major surgery within the past 2 weeks, are still recovering from surgery, or have surgery planned during the study
• have received or plan to receive a live vaccine within 4 weeks before starting the study or during study treatment
• see the ClinicalTrials.gov listing for complete exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), blood cancer, blood disorders, MM, Multiple Myeloma
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MT2025-51: A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FOR LARGE B-CELL LYMPHOMA (ALPHA3) (ALPHA3)

This study is for adults with large B-cell lymphoma whose cancer responded to standard treatment but still shows small amounts of disease on a specialized blood test. Participants will be randomly assigned to receive either an investigational CAR T-cell therapy or standard follow-up observation to compare safety and how well each approach helps prevent the lymphoma from returning.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027450
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• diagnosed with certain types of large B-cell lymphoma (LBCL)
• completed standard first-line treatment without needing additional therapy
• cancer is in complete remission or partial remission suitable for observation after first-line treatment
Exclusion Criteria:

• lymphoma has spread to the brain or spinal cord, or developed from another type of cancer
• previously treated with anti-CD19 therapy
• active autoimmune disease or a serious infection requiring treatment
• another cancer or bone marrow disorder diagnosed within the past 3 years
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer, large B-cell lymphoma, LBCL
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Acoustic analysis of voice, speech, and breath sounds in subglottic stenosis

This study is about understanding how subglottic stenosis (narrowing within the airway) affects voice, speech, and breathing sounds. Changes in airflow from airway narrowing can alter how the voice sounds, how speech is timed, and how breaths are taken during speaking. By using advanced, noninvasive sound analysis, we hope to identify patterns that may help detect airway narrowing earlier and track improvement after treatment.

Principal Investigator: Stephanie Misono
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027491
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 18 years of age
• diagnosis of subglottic stenosis by otolaryngologist and/or pulmonologist
• no known laryngeal or pulmonary comorbidities potentially contributing to voice or breathing problems (except asthma)
• able to read, write, and communicate in English
• Healthy Volunteers who will be matched by age & sex to study participants: at least 18 years of age, no known primary laryngeal or pulmonary comorbidities, no symptoms of shortness of breath and able to read, write, and communicate in English
Exclusion Criteria:

• current voice/resonance, breathing, or swallowing disorder
• women who are pregnant
• current upper respiratory infection
• Healthy Volunteers: women who are pregnant or upper respiratory infection or obstruction
Conditions: Breathing, Lung & Sleep Health, Ear, Nose & Throat, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), subglottic stenosis, SGS, airway narrowing
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ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001628
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
Conditions: Cancer, Cancer
Keywords: Acute Myeloid Leukemia, AML
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Emotion Regulation Knowledge Study

The purpose of this study is to develop and evaluate a storybook-based tool that measures how children ages 4 and older understand and manage their emotions. Researchers will examine how children choose different emotion regulation strategies in a variety of situations, such as interactions with family, friends, or when alone, and how these skills relate to children's social and emotional development.

Principal Investigator: Ka Ip
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00026826
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• children ages 4–12 years
• parent or legal guardian able to provide informed consent
• child and parent willing to participate in a single research visit involving an iPad-based storybook activity and a brief parent survey
Conditions: Children's Health, Mental Health & Addiction
Keywords: Child development, Emotion regulation, Social-emotional development, Families, iPad-based activities
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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001846
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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An Open-Label Study Of The Safety, Pharmacokinetics, Pharmacodynamics, And Efficacy Of 12-Month Treatment With Migalastat In Pediatric Subjects (Aged 2 To < 12 Years) With Fabry Disease And Amenable GLA Variants

The purpose of this study is to evaluate the safety and effectiveness of migalastat, an investigational treatment for children with Fabry disease. Researchers will also study how the medication is processed by the body and how it affects the disease. Participants will receive migalastat for up to 12 months and complete regular study visits and health assessments throughout the study.

Principal Investigator: Chester Whitley, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025577
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to under 12 years of age
• diagnosis of Fabry disease
• see the ClinicalTrials.gov listing for complete inclusion criteria
Exclusion Criteria:

• moderate to severe kidney disease or requiring dialysis or a kidney transplant
• previous gene therapy or certain medications that may interfere with the study
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
Conditions: Children's Health, Rare Diseases, Rare Diseases
Keywords: Fabry disease
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Pediatric 3D Scanned Images Database

The purpose of this study is to collect 3D measurements of children's faces, heads, hands, and feet using a safe, non-invasive 3D scanner. These measurements will help researchers design and improve medical devices that better fit children's unique needs.

Principal Investigator: Gwenyth Fischer
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00027644
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• infants, children, and adolescents from 35 weeks gestational age to under 18 years old who are receiving care in the hospital or participating at the State Fair Research Building at the Minnesota State Fair
Exclusion Criteria:

• individuals who are too medically unstable to participate or require a breathing tube through the mouth
Conditions: Breathing, Lung & Sleep Health, Children's Health, Ear, Nose & Throat
Keywords: 3D Scan, BiPAP, CPAP, Database, Medical Device, MNFair
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A Randomized Phase III Trial Evaluating the Safety and Efficacy of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant and Adjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OVATION-3)

The purpose of this research is to learn more about whether IMNN-001 combined with standard chemotherapy is safe and effective for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer, compared to standard chemotherapy alone.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027578
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 18 years of age or older
• diagnosed with advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (Stage IIIB/C or IV)
• eligible to receive chemotherapy before surgery
• willing and able to provide a tumor tissue sample for biomarker testing
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• prior treatment for high-grade ovarian, fallopian tube, or primary peritoneal cancer
• pregnant, breastfeeding, or inability to use required contraception
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), fallopian tube cancer, Ovarian cancer, Primary Peritoneal cancer
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Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020255
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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
• having bowel diversion urologic surgery
Exclusion Criteria:

• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Conditions: Kidney, Prostate & Urinary
Keywords: bowel diversion urologic surgery, ileostomy, stoma
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