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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.

394 Study Matches

HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00001341
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Inclusion Criteria:

• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
Exclusion Criteria:

• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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Efficacy and safety of GLP-1 agonist therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study

In this study we will be looking at the safety and effectiveness of the medication GLP-1 (Semaglutide) in patients who are overweight and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).

Amir Moheet
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018575
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Inclusion Criteria:

• diagnosis of cystic fibrosis
• diabetic using insulin
• BMI 26 kg/m2 or greater
• able to read & speak English
Exclusion Criteria:

• personal or family history of medullary thyroid cancer
• chronic GI problems requiring hospitalization in the past year
• history of suicide attempts or active ideas of suicide
Rare Diseases, Breathing, Lung & Sleep Health
Cystic Fibrosis, Clinics and Surgery Center (CSC)
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Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (PACIFIC)

The purpose of this study is to find out the safety and tolerability (the degree to which side effects affect a participant’s willingness to continue taking study drug) of the study drug EP547 in patients with itch associated with cholestatic liver disease and to determine the amount of EP547 in the blood after dosing. EP547 is an experimental drug that is not approved by the Food and Drug Administration (FDA) for the treatment of itch associated with liver disease or of any other conditions. This study will have 9 study visits which includes a screening period of up to 4 weeks long, a 12-week treatment period, and a follow-up visit 2 weeks after stopping study treatment.

Mary Thomson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00016629
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Inclusion Criteria:

• diagnosed with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC
• consistent moderate to severe pruritus (itching)
Exclusion Criteria:

• prior or planned liver transplantation
• liver cirrhosis
• significant small bowel resection or short bowel syndrome
Dermatology (Skin, Hair & Nails), Digestive & Liver Health
Clinics and Surgery Center (CSC), Itching, Pruritus
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Eugenia Shmidt
Not specified
This study is NOT accepting healthy volunteers
STUDY00013632
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease
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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

This device listens to and records abdominal sounds, which provides data that can help predict gastrointestinal impairment (GII). GII is a condition that is defined as the failure of oral re-feeding after abdominal surgery. This happens when any of the following events happen beyond 24-hours after abdominal surgery; vomiting, need to reverse the diet, or need to place a nasogastric (NG) tube.

Wolfgang Gaertner, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012967
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Inclusion Criteria:

• 18 to 90 years of age
• having an elective intestinal resection surgery (specific types, study staff will review)
Exclusion Criteria:

• allergy to skin adhesive
• unable to have device applied to the skin on the abdomen
• evidence of infection before surgery, including a deep wound infection or urinary tract infection
• specific types of surgery (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bowel surgery
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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) Trial (SHARP)

We are studying the effectiveness of a new procedure to treat people who have episodes of acute pancreatitis with pancreas divisum. Of the participants, half will receive the new procedure called endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic spincterotomy (miES) the other half with receive only ERCP. We will monitor outcomes for at least eighteen months.

Martin Freeman
18 years and over
This study is NOT accepting healthy volunteers
SITE00000387
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Inclusion Criteria:

• at least 18 years old
• two or more episodes of acute pancreatitis, with one occurring in the last 24 months
• there is no certain explanation for recurrent acute pancreatitis
Exclusion Criteria:

• prior minor papilla therapy (endoscopic or surgical)
• other causes of pancreatitis (study staff will review)
• regular use of opioid medication for abdominal pain for the past three months
Digestive & Liver Health
Clinics and Surgery Center (CSC), ERCP, Pancreatitis
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003837
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Inclusion Criteria:

• people who received OCS preserved double lung transplants
• OR people who receive a single lung transplant from OCS preserved lung pairs from either standard criteria donors
• AND all donor lungs that were perfused on OCS Lung System
Brain & Nervous System
Clinics and Surgery Center (CSC), Lung Transplant
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Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use

The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA placed for procedures with duration greater than 1 hour.

Jacob Hutchins
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012614
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Inclusion Criteria:

• having outpatient ambulatory surgery
• receiving general anesthesia utilizing a laryngeal mask airway
• surgery expected to last longer than 1 hour
Exclusion Criteria:

• chronic laryngitis
• chronic bronchitis
• asthma
• gastroesophageal reflux disease
• smoked within the last week
• non-English speaking
Breathing, Lung & Sleep Health
Clinics and Surgery Center (CSC), Anesthesia, Surgery
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The MyGender Dolls: Development of a Therapeutic Intervention for Transgender and Gender Diverse Children and their Caregivers

The goals of the current proposal are to systematically approach the development and iterative testing of a novel, culturally-responsive, evidence-informed psychotherapeutic activities (MyGender Dolls) for transgender and gender diverse (TGD) children (ages 5-10) and their caregivers. There are two primary objectives: 1) to develop and refine the MyGender Dolls psychotherapeutic activities based on feedback from community stakeholders, and 2) to assess the initial feasibility, acceptability, and usability of the MyGender Dolls with TGD children and their caregivers.

G. Nic Rider
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00019477
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Inclusion Criteria:

• child aged 5 to 10 years old who identifies as transgender or gender diverse
• parent of a child aged 5 to 10 years old who identifies as transgender or gender diverse
Exclusion Criteria:

• child younger than 5 years old and older than 10 years old
• child who does not identify as transgender or gender diverse
Children's Health, Mental Health & Addiction, Prevention & Wellness
Transgender, Non-Binary, Gender Diverse, Children
Visit study website
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Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK OFF JSpA) (BACK-OFF JSpA)

This study is enrolling participants who have been diagnosed with juvenile spondyloarthritis, are taking a tumor necrosis factor inhibitor (TNFi) and have reached a clinically inactive disease state for a minimum of six months. Researchers want to know if children who have maintained inactive disease for at least 6 months can maintain quiet disease without taking their medication as frequently or stop the TNFi therapy. Quiet disease means that disease related symptoms are not active or being experienced in the patient. Researchers also want to know the safest method to bring patients off medication. If a flare does occur during therapy reduction, researchers want to find out whether they can predict when a flare is most likely to happen, and how quickly an inactive disease state can be recaptured.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
SITE00001260
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Inclusion Criteria:

• age 8 to 21 years
• juvenile SpA diagnosis symptom with symptoms starting before their 16th birthday
• currently taking one of the following therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab) at standard doses
• have reached a clinically inactive state for at least 6 months
• English speaking or Spanish speaking
• willing to taper off medications
Exclusion Criteria:

• History of inflammatory bowel disease or history of uveitis
• psoriasis that started before TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Arthritis & Rheumatic Diseases, Children's Health, Rare Diseases
arthritis, Juvenile Spondyloarthritis
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A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families

This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.

Rebekah Hudock
Not specified
This study is NOT accepting healthy volunteers
STUDY00013507
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Inclusion Criteria:

• between the ages of 15-25
• have a medical diagnosis of Autism Spectrum Disorder (ASD) or educational eligibility for special education services under the category of autism
• verbally fluent (can speak in complete sentences and have basic conversation) and speak and understand English
• have access to WiFi and two devices with webcams
• at least one caregiver are able to commit to attending 8 90-minute virtual intervention sessions
Exclusion Criteria:

• do not live in MN
• medical, behavioral, or mental health concerns that make it too difficult to participate in the study or that necessitates a higher level of care
Children's Health, Mental Health & Addiction
ASD, Autism, Autism Spectrum Disorder
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A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and;Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute&Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care

The main purpose of this research study is to see whether enpatoran works for people with SLE or CLE, and to find out more about how safe and well tolerated it is. Participation in this research study will last for approximately 33 weeks (this includes a 24-week study drug period).

David Pearson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001757
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Inclusion Criteria:

• adults 18-75 years of age
• disease duration at least 6 months of either active discoid or subacute cutaneous lupus OR active systemic lupus
• on stable dose(s) of standard-of-care therapies for lupus
• willing to use contraception for the study period
Exclusion Criteria:

• Drug-induced lupus, within 3 months of induction therapy for lupus nephritis, or active CNS lupus
• history of epilepsy, significant cardiovascular events including arrhythmia, solid organ transplantation, or malignancy
• active infection including HIV, HBV, HCV, or tuberculosis
• there are specified wait times for people taking certain prior drugs (study staff will review)
Arthritis & Rheumatic Diseases, Dermatology (Skin, Hair & Nails), Rare Diseases
lupus, discoid, SLE, CLE, DLE, SCLE, WILLOW, enpatoran, M5049, Merck, EMD Serono, Pearson
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A Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)

The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001240
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
Exclusion Criteria:

• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), EndoCA, Endometrial Cancer
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Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111

We are looking at the effectiveness of adding an immunotherapy drug, pembrolizumab, to usual treatment for people who have salivary gland cancer that can’t be treated with surgery or radiation. The cancer must be androgen receptor positive.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00004710
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Inclusion Criteria:

• at least 18 years old
• locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
• tumor is androgen receptor-positive
• unable to do physically strenuous activity but can walk and is able to do work of a light nature, such as house work or office work
• prior chemotherapy, radiation, or surgery as part of curative intent therapy are allowed
• any number of prior lines of systemic therapy are permitted as long as it did not include anti-androgen therapy or immune checkpoint blockade
• men and women of child bearing age must agree to use contraception during the treatment period and for at least 8 months after the last dose of study treatment
• contact study staff for additional requirements
Exclusion Criteria:

• received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
• received prior androgen deprivation therapy
• pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the first visit through 120 days after the last dose of trial treatment.
• additional cancer that is progressing or has required active treatment within the past 2 years
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Salivary Gland Carcinoma
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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 22-55 years old with Medicare or Medicare Advantage insurance.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006945
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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
Mental Health & Addiction
Clinics and Surgery Center (CSC), Chronic Depression, Depression
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Britt Erickson
35 years to 50 years old
This study is NOT accepting healthy volunteers
SITE00001183
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Inclusion Criteria:

• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
Exclusion Criteria:

• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)

To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)

Nattawat Klomjit
Not specified
This study is NOT accepting healthy volunteers
STUDY00020504
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Inclusion Criteria:

• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
Clinics and Surgery Center (CSC), Glomerulonephritis, IC-MPGN
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MT2023-06: A CLINICAL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LERIGLITAZONE IN ADULT MALE SUBJECTS WITH CEREBRAL ADRENOLEUKODYSTROPHY (CALYX)

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

Troy Lund
18 years and over
This study is NOT accepting healthy volunteers
SITE00001908
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Inclusion Criteria:

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

• or treatment with ex-vivo gene therapy (eli-Cel).
• known type 1 or type 2 diabetes
• see link to clinicaltrials.gov for additional exclusion criteria
Rare Diseases
Clinics and Surgery Center (CSC), CEREBRAL ADRENOLEUKODYSTROPHY, cALD
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MT2022-56: A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma

The purpose of this study is to test the safety of FT576 at different doses and schedules and to understand the way the body processes and responds to FT576. The study will also find out what effects FT576, when given alone (also called monotherapy) or in combination with an anti-cancer drug (called a monoclonal antibody), may have on you and your cancer. FT576 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
SITE00001809
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Inclusion Criteria:

• diagnosis of multiple myeloma after 3 or more previous treatments
• able to complete activities of daily living with minimal help
Exclusion Criteria:

• history of significant heart disease
• low red or white blood counts
• abnormal liver function tests
Cancer
Multiple Myeloma, Myeloma, Clinics and Surgery Center (CSC)
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MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) (MAYFLOWERS)

This study is being done to look at how pregnancy affects the health of women with cystic fibrosis (CF) and to look at the health of babies born to women with CF. It is expected that most but not all women will be taking the newest CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator medication called TRIKAFTA®. It is not known how this medication will affect the health of mother and infant.

Joanne Billings
16 years and over
This study is NOT accepting healthy volunteers
SITE00001209
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Inclusion Criteria:

• at least 16 years old
• pregnant, intending to continue pregnancy
• enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Exclusion Criteria:

• none
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), Cystic Fibrosis, Pregnancy
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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours

This is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.

Douglas Yee, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013618
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Inclusion Criteria:

• advanced solid tumor that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy
• restricted in strenuous activity but can walk and is able to do light work e.g., light house work, office work
• contact study staff for additional requirements
Exclusion Criteria:

• inability to perform the required imaging procedures (e.g., inability to lay flat during scan time)
• uncontrolled brain metastasis
• history of organ transplantation, including stem cell transplantation
• other significant medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Advanced Solid Tumors
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Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.

The main purpose of the study is to collect blood samples and medical information to help Nucleix in the development of an investigational test that aims to differentiate between individuals at high risk with and without lung cancer.

Abbie Begnaud
18 years and over
This study is NOT accepting healthy volunteers
SITE00001631
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Inclusion Criteria:

• Current or past smokers, with at least 20 pack-years
• People who have with either a high suspicion for lung cancer, with surgery planned for biopsy or removal
• People who have lung cancer that hasn't been treated yet
Exclusion Criteria:

• People who have diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
• Current lung cancer is known to be stage III or IV by pathology.
• People having regular screening to monitor a lung nodule
Cancer, Respiratory System
Lung Cancer Screening, Clinics and Surgery Center (CSC)
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Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder

This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.

Nissrine Nakib
18 years and over
This study is NOT accepting healthy volunteers
SITE00001699
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Inclusion Criteria:

• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
Exclusion Criteria:

• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
Kidney, Prostate & Urinary, Women's Health
Clinics and Surgery Center (CSC), OAB, Overactive Bladder
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RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)

We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.

Joanne Billings
Not specified
This study is NOT accepting healthy volunteers
1702M07621
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Inclusion Criteria:

• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
Exclusion Criteria:

• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), CF, Cystic Fibrosis
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Efficacy and safety of SGLT2 inhibitor therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study

In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) (generic name: empagliflozin) for patients who are overweight/obese and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).

Amir Moheet
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019241
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Inclusion Criteria:

• 18 years or older
• diagnosis of cystic fibrosis related diabetes (CFRD)
• BMI >25 kg/m2
• woman who could become pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study
Exclusion Criteria:

• acute respiratory exacerbation requiring IV antibiotics or systemic glucocorticoids within prior 4 weeks
• less than 12 weeks since start of a new CFTR corrector/modulator therapy
• type 1 diabetes
• history of diabetic ketoacidosis
• history of recurrent genital or urinary tract infections
• women who are pregnant or breastfeeding
• history of eating disorder
• there are additional exclusion criteria (study staff will review)
Rare Diseases, Diabetes & Endocrine
CF, CFRD, Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Diabetes
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Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter

This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.

Jayanthi Sasisekaran
Not specified
This study is also accepting healthy volunteers
STUDY00013042
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Inclusion Criteria:

• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Children's Health, Community Health
adults, attention, fluency, language, memory, speech production, Stuttering, children
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Research Evaluating Vagal Excitation and Anatomical Links

We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
SITE00002000
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Inclusion Criteria:

• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
Exclusion Criteria:

• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
Brain & Nervous System, Mental Health & Addiction
Clinics and Surgery Center (CSC), Depression, Epilepsy, Vagal Nerve Stimulator, VNS
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A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104

This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.

Mark Schleiss
Up to 18 years old
This study is also accepting healthy volunteers
SITE00001871
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Inclusion Criteria:

• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
Exclusion Criteria:

• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Children's Health, Infectious Diseases
CMV, cytomegalovirus, vaccine
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Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'

The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.

Stephen Hecht, PhD
18 years and over
This study is also accepting healthy volunteers
0908M70881
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Inclusion Criteria:

• 21 years or older
• Daily user of tobacco or nicotine products
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Cancer, Community Health, Prevention & Wellness
nicotine, nicotine replacement, smokeless tobacco, smoker, smoking, tobacco, vaper, vaping
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MT2023-16: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer

This study will test TAK-186, an antibody that selectively targets EGRF-expressing tumor cells, to see if TAK-186 is safe in patients with unresectable, locally advanced or metastatic cancer.

Heather Beckwith
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019459
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Inclusion Criteria:

• unresectable, locally advanced or metastatic solid tumors are considered to express epidermal growth factor receptor (EGFR)
• willing to have new biopsy(s) for the study if it is possible
• able to care for self and do light work
• women of childbearing potential must be willing to use 2 forms of contraception throughout the study, starting at screening through 90 days after the last dose of TAK-186
• Males with partners of childbearing potential must use barrier contraception during the entire study treatment period through 120 days after the last dose of study drug and must not donate sperm during this period. Must also have partner use 2 forms of contraception (see above requirement)
• contact study staff for additional study requirements
Exclusion Criteria:

• history of known autoimmune disease with some exceptions
• major surgery or traumatic injury within 8 weeks before first dose of study drug
• unhealed wounds from surgery or injury
• serious underlying medical or psychiatric condition that would impair the ability of the participant to consent, receive or tolerate the planned treatment (study staff will review)
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Cancer of Head and Neck (SCCHN)
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