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Perceptual consequences of low frequency hearing loss

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

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

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

• mild cognitive impairment
Conditions: Ear, Nose & Throat
Keywords: ENT, hearing, hearing health, hearing loss, listening
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A Phase 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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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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Assessment of Patients and Perspectives Regarding Primary Care Utilization within the Adult Cystic Fibrosis Population

The purpose of this project is to ask adults with cystic fibrosis (CF) about their opinions and experiences with working with a primary care provider (PCP). It is also to assess the utilization of primary care providers in a complex medical care patient population whose primary providers have historically had a medical home in the pulmonary subspecialty.

Principal Investigator: Sarah Kiel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00028181
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adults who have cystic fibrosis (CF) and receive care at the MN CF Center
Conditions: Breathing, Lung & Sleep Health, Rare Diseases
Keywords: CF, cystic fibrosis, lung, respiratory, 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
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A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

The purpose of this research study is to evaluate the safety and effectiveness of a new investigational drug called atumelnant for adults with classic Congenital Adrenal Hyperplasia (CAH) caused by 21-hydroxylase deficiency (21-OHD). Researchers want to learn how well atumelnant helps control CAH symptoms, how the body processes the drug (pharmacokinetics or PK), and whether it produces the expected effects in the body (pharmacodynamics or PD). The study will also evaluate whether participants may be able to reduce their steroid (glucocorticoid) dose while taking atumelnant.

Principal Investigator: Kyriakie Sarafoglou
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027082
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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 classical congenital adrenal hyperplasia (CAH)
• on a stable dose of your current steroid (glucocorticoid) treatment
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• diagnosis of any other form of CAH
• are pregnant, breastfeeding, or unable/unwilling to use effective birth control during the study
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Diabetes & Endocrine, Rare Diseases
Keywords: CAH, Classic Congenital Adrenal Hyperplasia
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MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis

The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025182
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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 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases, Immune Diseases
Keywords: Clinics and Surgery Center (CSC), Scleroderma
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Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial

This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020724
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
Exclusion Criteria:

• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Radical Cystectomy, Urinary Diversion, UTI. bladder cancer
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A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer

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

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

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

• active eye disease
• women who are breastfeeding, pregnant, or planning to become pregnant
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cervical cancer
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Influence of functional hypothalamic amenorrhea on autonomic blood pressure regulation in female endurance athletes

This study is being done to learn more about how hormone changes related to menstrual cycle disruption and underfueling in highly trained endurance athletes may affect blood pressure regulation, blood vessel function, and cardiovascular health. Researchers will measure heart rate, blood pressure, blood vessel function, and nervous system activity in endurance athletes to better understand how these factors differ between athletes.

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027777
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• females ages 18–35
• endurance athletes who regularly participate in sports such as running, cycling, swimming, skiing, rowing, or multisport activities
Exclusion Criteria:

• current injury limiting training participation
• pregnant or breastfeeding
• use of depo provera, nexplanon implants, or progestin-only oral contraceptives
• diabetes or significant heart, lung, neurologic, metabolic, or endocrine conditions
• nicotine/tobacco use in the last six months
• current use of heart or blood pressure medications
Conditions: Heart & Vascular, Prevention & Wellness, Women's Health
Keywords: Cardiovascular health, Clinics and Surgery Center (CSC), Endurance training, Women’s health
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DAS181-3-01: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

This research study is for participants who have a weakened immune system (are immunocompromised), have a lower lung infection and are currently using a machine or device to help them breathe. The study will look at whether the study drug, DAS181, works and how safe it is compared with a placebo in adults who have a weakened immune system (immunocompromised) and a parainfluenza virus (PIV) infection of the lower respiratory tract. A placebo looks the same as the study drug but does not contain any active ingredients.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00005735
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• needs supplemental oxygen ≥2 liters/minute due to low oxygen levels
• immunocompromised, as defined by one or more of the following: received a stem cell transplant, organ transplant, being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past, or has an immunodeficiency due to congenital abnormality
• men and women of childbearing potential must use effective birth control
• see link to clinical trials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• taking any other investigational drug used to treat pulmonary infection
• severe sepsis
• see link to clincialtrials.gov for complete exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Immune Compromised, Influenza, Lower Respiratory Tract Infection, Parainfluenza
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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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SENDCF-OB-25: Study to Enable New Diagnostics for Pulmonary Microbes in People with CF

The purpose of this study is to evaluate new ways to identify lung infections in people with cystic fibrosis (CF). Researchers will use the information to better understand lung health and help improve future testing methods for people with CF.

Principal Investigator: Sarah Kiel
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026614
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 16 and older
• diagnosis of Cystic Fibrosis (CF)
Conditions: Rare Diseases, Breathing, Lung & Sleep Health
Keywords: CF, Clinics and Surgery Center (CSC), cystic fibrosis, MNCF
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HEALEY ALS Platform Trial

The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000881
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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 or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
Exclusion Criteria:

• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
Conditions: Rare Diseases, Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), ALS, amyotrophic lateral sclerosis
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MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• acute exacerbation of IPF within at least 12 weeks prior
• significant cardiovascular disease such as severe hypertension, myocardial infarction, stroke, TIA
• significant pulmonary hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), IPF, Pulmonary Fibrosis
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An interventional efficacy and safety Phase 3 double-blind 2-arm study to investigate IV followed by oral fosmanogepix compared with IV caspofungin followed by oral fluconazole in adult participants with candidemia and/or invasive candidiasis.

The purpose of this study is to compare effects of the study drug fosmanogepix with already-approved drugs caspofungin and fluconazole to find out if fosmanogepix is safe and effective in treating patients with candidemia and/or invasive candidiasis.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023155
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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 candidemia and/or invasive candidiasis
• see link to cliinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• require hemodialysis, peritoneal dialysis, or hemofiltration
• received > 2 days (> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Infectious Diseases
Keywords: Candidemia, fungal infection, Clinics and Surgery Center (CSC)
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A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate how TAK-505 works in people with certain advanced solid tumors, including stomach, colorectal, lung, and head and neck cancers. The study will test TAK-505 at different dose levels to understand how it is tolerated, how it behaves in the body, and to help determine the dose that provides the best balance of effect and side effects for future studies.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027296
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed locally advanced or metastatic solid tumor (including stomach, colorectal, lung, and head and neck cancers) that has progressed after standard treatment or has no standard treatment options remaining
• adequate bone marrow, kidney, and liver function
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• significant uncontrolled medical conditions, including serious heart disease, lung disease, active infection, or recent major surgery active autoimmune disease requiring treatment or known HIV, hepatitis B, or hepatitis C infection
• active or unstable brain metastases or other untreated central nervous system disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Cancer, Cancer
Keywords: Clinics and Surgery Center (CSC)
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

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

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001932
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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MT2024-38: A Phase 1/2 Open-Label, Single-Ascending-Dose Study of EN-374, a Helper-Dependent Adenoviral-Based Gene Therapy, in Participants with X-Linked Chronic Granulomatous Disease

To evaluate the safety of the EN-374 treatment regimen (HSC mobilization, immune prophylaxis, EN-374 dose and administration, and enrichment of HSCs with O6BG/TMZ).

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025676
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Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old for initial phase of the study and then at least 3 months old for later phase
• diagnosis of X-CGD
• history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
• does not have a suitable, available and willing human related donor
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active infection
• history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• had investigational gene therapy
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Rare Diseases
Keywords: chronic granulomatous disease, recurrent bacterial or fungal infections, X-CGD
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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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Use of CA125 and Complementary biomarkers for the early detection of Ovarian Cancer in Low Risk Women (ID01-022)

This study aims to evaluate the ROCA2 algorithm, which calculates a woman's risk of having ovarian cancer based on age and biomarkers, for the early detection of ovarian cancer in a low risk cohort of women.

Principal Investigator: Samantha Hoffman
Age Group: 18 years and over
IRB Number: STUDY00027409
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Sex: Female
Age Group: 18 years and over
Inclusion Criteria:

• women age 50 to less than 75 years old
• postmenopausal, which means no period for one year or longer
• have at least one ovary
• cancer-free and have not received any chemotherapy or radiation therapy for at least 12 months, exceptions may be available
• have a health care provider who does yearly well-woman exam
• willing to have a biomarker blood test yearly
• willing to have a transvaginal ultrasound if indicated by screening test
Exclusion Criteria:

• prior removal of both ovaries
• have an active non-ovarian cancer
• high risk for ovarian cancer due to known familial predisposition (known mutation in BRCA1 or BRCA2, family history of ovarian or breast cancer). Study staff will review
Conditions: Cancer
Keywords: cancer screening, ovarian cancer
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A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)

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

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

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

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

This research is being done to collect blood and placenta samples to better understand how pregnancy impacts the health of mother and child. The goal of this research is to better understand what causes some pregnancy complications and how this impacts the longer term health of mothers and children.

Principal Investigator: Sarah Wernimont
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016978
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• pregnant women who are at least 18 years of age and their neonates/children
• seen in Obstetrics and Gynecology Clinics for pre-conception, prenatal or postpartum care
Conditions: Women's Health
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