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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.

440 Study Matches

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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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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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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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: aging, 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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Cardiovascular health in adults conceived with assisted reproductive technology

The purpose of this study is to better understand heart and blood vessel health in adults conceived through assisted reproductive technology (such as IVF) compared to adults conceived naturally. Participants will complete one study visit lasting approximately 3–4 hours. During the visit, participants will complete questionnaires, have basic health measurements taken, and complete non-invasive tests that assess blood pressure, blood vessel function, and circulation. Researchers hope the findings will improve understanding of long-term cardiovascular health in adults conceived through assisted reproductive technology.

Principal Investigator: Daniel Craighead
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024302
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• self-identified as having been conceived through use of assisted reproductive technology (e.g., in vitro fertilization, cryopreservation)
• self-identified as having been conceived through natural conception
Exclusion Criteria:

• pregnant or suspect you may be pregnant
• current chronic cardiovascular or metabolic condition (such as heart disease or diabetes)
Conditions: Heart & Vascular
Keywords: Assisted reproductive technology, cardiovascular function, in vitro fertilization
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A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

This study tests whether the study drug, a T-cell engager therapy engineered to have fewer off-target effects by increasing its specificity to tumor cells, is safe and tolerable in subjects with metastatic castration-resistant prostate cancer (mCRPC) The study will also assess the potential Phase 2 dose regimens and determine a recommended Phase 2 dose.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024313
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 years to 100 years old
• confirmed adenocarcinoma of the prostate
• Metastatic Castration-resistant Prostate Cancer (mCRPC) that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• prior solid organ transplant
• treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
• significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Castration Resistant Prostatic Cancer, mCRPC, Metastatic Castration-resistant Prostate 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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Continuation of a Home/Community-Based Anal Cancer Screening Unit and Protocol at LGBTQ+ Focused Community Events

This study will help to identify challenges and barriers to self-performing anal cancer screening tests, and may identify unique ways to make this form of screening easier, more cost-effective, and more frequently performed. We believe that it has the potential to minimize the frequency of both disease and death from anal cancer among high-risk patient groups.

Principal Investigator: Elliot Arsoniadis
This study is also accepting healthy volunteers
IRB Number: STUDY00024573
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Sex: Male
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 35 years old
• assigned sex of “male” at birth
• engage in anoreceptive intercourse with male partners
• willing to provide reliable contact information
• in the case of a positive screen, willing to undergo a clinic visit and HRA
• fluent in English
Exclusion Criteria:

• previous diagnosis of high-grade anal dysplasia or anal cancer
Conditions: Cancer, Community Health, Prevention & Wellness
Keywords: Anal Cancer, Clinics and Surgery Center (CSC)
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A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants with Congenital Adrenal Hyperplasia Including a Long-Term Extension

The purpose of this research is to evaluate the safety, efficacy, and pharmacokinetics of a new investigational drug called CRN04894, also called atumelnant for treating pediatric participants with Congenital Adrenal Hyperplasia (CAH). We want to see how safe atumelnant is at different doses and how well the body accepts (tolerates) it and how it moves through the body (how it gets in, spreads around, gets used, and then leaves), also known as pharmacokinetics (PK). We also want to see if if atumelnant produces the expected effect in the body, if it helps control the CAH, and if we can reduce the steroid (GC) dose.

Principal Investigator: Kyriakie Sarafoglou
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026063
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Male or female at birth,
• less than 18 years old
• diagnosis of classical congenital adrenal hyperplasia (CAH)
Exclusion Criteria:

• diagnosis of any other form of CAH
Conditions: Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Keywords: Classical CAH, classical congenital adrenal hyperplasia
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Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

The goal of this study is to evaluate the combination of cabozantinib and nivolumab in people with advanced melanoma or squamous cell head and neck cancer. Researchers want to learn whether these drugs can help shrink or stabilize cancer and whether certain tumor biomarkers may help predict how well patients respond to treatment.

Principal Investigator: Puneet Cheema
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCROC100
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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 advanced melanoma or squamous cell head and neck cancer
• cancer has worsened during or shortly after prior PD-1 immunotherapy treatment
• able to care for yourself and perform most daily activities
• must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Head and Neck Squamous Cell Carcinoma, HNSCC, Melanoma
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Neural Bases of Disgust Conditioning in Anorexia Nervosa

We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.

Principal Investigator: Lisa M Anderson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00009646
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
Exclusion Criteria:

• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
Conditions: Mental Health & Addiction
Keywords: Anorexia, Eating Disorder, Mental Health
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A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets administered once daily in pediatric subjects aged 5 to 17 years with active, mild to moderate ulcerative colitis

The purpose of this research study is to test the safety and effectiveness of Budesonide in low and high dose extended- release tablets in pediatric participants with active, mild to moderate Ulcerative Colitis and to evaluate the level of budesonide that remains in the blood after taking it. Participants will be asked to take an oral (by mouth) form of Budesonide or a placebo once daily for 8 weeks. A placebo is a tablet that does not contain any active study drug (Budesonide).

Principal Investigator: Vikram Christian
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022572
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 5 to 17 years old
• diagnosis of Ulcerative Colitis (UC)
• weight is greater than 13.6 kg (30 pounds)
• active UC of mild or moderate severity
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• current or prior diagnosis of Crohn's disease or indeterminate colitis
• prior gastrointestinal surgery, except appendectomy or hernia
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Digestive & Liver Health
Keywords: UC, Ulcerative Colitis
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MT2025-06: Postmarketing, Prospective, Observational, Study to Assess and Characterize the Risk of Secondary Malignancies, and Long-term Safety Following Treatment with atidarsagene autotemcel (Lenmeldy )

To assess and characterize the risk of malignancies, and long-term safety following treatment with atidarsagene autotemcel (Lenmeldy).

Principal Investigator: Paul Orchard
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025694
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• live in the United States
• has been or will be treated for MLD with Lenmeldy
Conditions: Rare Diseases
Keywords: Metachromatic Leukodystrophy, MLD
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Technology Assisted Treatment for Binge Eating Disorder

This research is being done to study binge eating and potential treatment strategies. An app on a sensor logging device will log eating behavior data. The device will incorporate data and refine the performance of the HabitAware sensor logging model to recognize binge eating episodes. We hope this research will help inform novel treatments for targeting binge eating behavior.

Principal Investigator: Carol Peterson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018933
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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 and 65 years
• diagnosis of bulimia nervosa, binge eating disorder, or other eating disorder
Exclusion Criteria:

• women who are pregnant or breast feeding
• history of psychosis or bipolar disorder
• substance use disorder within the past six months
• BMI less than 18.5 kg/m2
• history of acute suicidality requiring hospitalization
• food allergies
Conditions: Mental Health & Addiction
Keywords: Binge Eating Disorder
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) (I CAN)

To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN

Principal Investigator: Sahar Koubar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021814
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Immunoglobulin A Nephropathy (IgAN) diagnosis established on kidney biopsy
• stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to starting the study
• if receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diagnosis of rapid progressive glomerulonephritis
• clinically significant renal disease other than IgAN
• uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
• history of kidney transplant or planned kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), iga Nephropathy, igan, Immunoglobulin A Nephropathy

A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]

The purpose of this research is to compare the effects of nivolumab with vusolimogene oderparepvec (VO) against standard of care treatment drug(s) currently available for patients with advanced melanoma. We expect that taking part in this research will last up to 60 months.

Principal Investigator: Benjamin Manning
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023233
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 12 years old
• confirmed metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma that cannot be surgically removed
• disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence for at least 8 weeks
• documented BRAF V600 mutation status
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• more than 2 lines of systemic therapy for advanced melanoma
• known acute or chronic hepatitis
• known human immunodeficiency virus (HIV) infection
• prior cancer in the previous 3 years, except for locally curable cancers that have apparently been cured
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Melanoma, Melanoma
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Tic Clips

This study is about learning more about the full range of what tics can look like. Participating includes filling out surveys and submitting two brief videos of yourself. We know tics can be really different across people. By getting a lot of videos of people doing tics, we hope to better understand the variety of tics that exist.

Principal Investigator: Christine Conelea
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022426
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Aged 4 years or older
• Self-report having tics
• Adult participant or parent is able to read in English
• Access to an internet connected device with video recording capability
Conditions: Brain & Nervous System, Children's Health
Keywords: CBIT, Motor tics, Tic Disorder, Tourette's syndrome, Vocal tics
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Standardized Microbiota Transplant Therapy in Crohn's Disease

The goal of this study is to determine if healthy donor microbes released in the small intestine act the same way as healthy donor microbes released in the large intestine for people with Crohn's Disease. We will see what good bacteria are present in intestinal biopsies at 8 weeks and look for improvement in inflammation with colonoscopy.

Principal Investigator: Byron Vaughn
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023114
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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 89 years old
• English speaking
• Diagnosis of Crohn's Disease (CD)
• currently experiencing a flare (Study will enroll people through 2027)
• Current CD therapies are in the maintenance phase of dosing
• Women who could become pregnant must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device)
• See link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Extensive bowel resection or ileostomy or colostomy
• Diagnosis of ulcerative colitis
• Women who are pregnant or breastfeeding
• History of anaphylactic food allergies
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Crohn's Disease, Fecal Microbiota, Gut bacteria, CD
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Neuroplasticity in REM Sleep Behavior Disorder

REM sleep behavior disorder (RBD) is a condition in which people physically act out their dreams while sleeping. Some people with RBD may later develop neurological conditions such as Parkinson's disease or related disorders. This study will examine changes in the brain over a two-year period using advanced brain imaging (7T MRI) and other neurological tests. Researchers will compare people with RBD to people without the disorder to better understand how the brain changes over time and identify potential early signs of neurological disease.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016232
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• aged 21-75
• diagnosed with REM Sleep Behavior Disorder (RBD)
Conditions: Brain & Nervous System
Keywords: aging, RBD, REM Sleep Behavior Disorder
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Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals with Peripheral Neuropathy and Balance Problems - A Randomized Control Trial

The main purpose of this study is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. Walkasins have been developed to improve balance and walking by enhancing a person’s ability to feel the pressure beneath his/her feet as he/she walks.

Principal Investigator: Islam Zineldin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025212
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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 55 years old
• able to complete all activities without the use of an assistive device
• diagnosis of peripheral neuropathy (if due to chemotherapy, must be 1 year after completion)
• experiencing problems with gait or balance
Exclusion Criteria:

• able to stand on one leg for at least 30 seconds
• acute thrombophlebitis, including deep vein thrombosis, or severe peripheral vascular disease
• lymphedema
• swelling, infection, inflamed area of skin or eruptions on the lower leg
• weigh more than 300 pounds
Conditions: Bone, Joint & Muscle, Brain & Nervous System
Keywords: Peripheral Neuropathies, Balance, Gait Disorders
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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 also accepting healthy volunteers
IRB Number: STUDY00021394
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:
This study is currently recruiting healthy people who fit the following:
• formerly smoked cigarettes daily
• quit smoking in the last 2-10 years OR
• never used any tobacco products
Exclusion Criteria:

• younger than 21 years old
• unstable health condition
• use other tobacco products
Conditions: Community Health, Prevention & Wellness
Keywords: biomarkers, cigarettes, nicotine, smokeless tobacco, tobacco, former smoker, previous smoker, quit smoking
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Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression

This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006945
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
Exclusion Criteria:

• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Conditions: Mental Health & Addiction
Keywords: Clinics and Surgery Center (CSC), Chronic Depression, Depression
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A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)

This study is for children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a study drug called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.

Principal Investigator: Michelle Rheault
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027290
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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 17 years old
• Chronic kidney disease (CKD) of any type
• on a stable dose of maximally tolerated standard therapy for at least 30 days
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Type 1 or Type 2 diabetes mellitus
• chronic dialysis or functioning kidney transplant or scheduled for transplantation
• Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age
• gastrointestinal disorders that might interfere withdrug absorption
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Kidney, Prostate & Urinary
Keywords: Chronic kidney disease, CKD
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Characterizing Neuropathic Pain in Individuals Receiving Inpatient Treatment for an Alcohol Use Disorder

This study aims to learn more about neurological symptoms associated with alcohol use. The study team plans to characterize neuropathic pain in individuals receiving in-patient treatment for alcohol use compared with moderate drinkers of the same age.

Principal Investigator: Jeff Boissoneault
Age Group: 18 years and over
IRB Number: STUDY00025425
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Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:

• between 21 and 65 years of age
• must speak English
• Moderate drinkers group: Use alcohol at least 2-4 times per month
• Treatment group: patients in the Fairview Lodging Program primarily seeking treatment for alcohol - use of nicotine, cannabis, cocaine, and hallucinogens are permissible
Conditions: Brain & Nervous System, Mental Health & Addiction
Keywords: alcohol use, Pain, sensation
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