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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.

538 Study Matches

RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn s 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.

Byron Vaughn
18 Years and over
Phase IV
This study is NOT accepting healthy volunteers
NCT04835506
STUDY00013632
Crohn Disease, Digestive & Liver Health
Clinics and Surgery Center (CSC)
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A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

This is a Phase 3, randomized, observer-blinded, placebo-controlled study in healthy participants 16 to 40 years of age. The primary efficacy objective is to demonstrate vaccine effect of mRNA-1647 against primary cytomegalovirus (CMV) infection in female participants who are CMV-seronegative at enrollment.

Mark Schleiss
Female
16 Years to 40 Years old
Phase 3
This study is also accepting healthy volunteers
NCT05085366
STUDY00013943
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Key
Inclusion Criteria:

• Participants aged ≥20 years, has or anticipates having direct exposure (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
• CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
• CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
• Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
• Has a body mass index of 15-35 kilograms (kg)/square meter (m^2), inclusive.
• Female participants: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active, has practiced adequate contraception for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257). Key
Exclusion Criteria:

• Female participant is of non-childbearing potential.
• History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
• Received or plans to receive any nonstudy vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
• Any Coronavirus disease 2019 (COVID-19) vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
• COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
• Influenza vaccines may be administered > 14 days prior to or after any study injection.
• Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
• Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of first injection or plans to do so during the course of the study.
• Previous receipt of an investigational CMV vaccine.
• Receipt of systemic immunoglobulins or blood products <3 months prior to the day of first injection.
• Participated in an interventional clinical study <28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
• Participant has donated ≥450 milliliters (mL) of blood products <28 days prior to Screening.
• Participant is a member of study team or is an immediate family member or household member of study personnel.
Biological: mRNA-1647, Biological: Placebo
Cytomegalovirus Infection
mRNA-1647, Moderna, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA
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Biomarkers of Exposure and Effect in SREC Users

The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.

Irina Stepanov
All
18 Years and over
Phase 1
This study is also accepting healthy volunteers
NCT04003805
STUDY00002033
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Inclusion Criteria:

• Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
• Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
• Biochemically confirmed regular smoking status by a NicAlert test level of 6;
• Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
• No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
• Subjects are in good physical health (no unstable medical condition);
• Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
• Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
• Women who are not pregnant or nursing or planning to become pregnant;
• Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:

• Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
• Currently using nicotine replacement or other tobacco cessation products;
• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
• Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
• Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
• Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
• Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
• Pregnant or breastfeeding;
• Failure to agree to take adequate protection to avoid becoming pregnant during the study;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic BP greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Expired air carbon monoxide (CO) level greater than 80 ppm;
• Self-reported allergies to propylene glycol or vegetable glycerin;
• Adverse reactions when previously using electronic cigarettes;
• Household member enrolled in the study concurrently;
• Unable to read for comprehension or completion of study documents;
• Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Drug: Standardized Research E-cigarette (SREC), Drug: Nicotine Mini-Lozenge
Smoking, Cigarette, Prevention & Wellness
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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT

This is a randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of CBD administered as ZYN002, a transdermal gel, for the treatment of children and adolescent patients with FXS. Qualified male and female patients with FXS will enter a two-week single-blind placebo lead-in period. Following the placebo lead-in, patients meeting randomization criteria will receive double-blind treatment for 16 weeks. The study will be comprised of a Screening visit and a combination of seven onsite (face-to-face) and virtual study visits. Approximately 204 male and female patients, ages 3 to < 18 years, will be randomized 1:1 to either trial drug or placebo. Randomization will be stratified by gender (male, female), methylation status (complete, partial), and by weight (≤50 kg, >50 kg).

Amy Esler
Phase III
This study is NOT accepting healthy volunteers
NCT03802799
STUDY00014264
Fragile X Syndrome
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MT2021-25: Phase I/II Multicenter study evaluating the Safety and Efficacy of Alllogeneic GDA-201 Natural Killer cells in patients with relapsed/refractory B-Cell Non-Hodgkin Lymphoma

This study is designed to assess the safety of GDA-201 + rituximab, as well as the maximum tolerated dose in patients with B cell lymphomas in phase I; in phase II, it will assess safety and efficacy of GDA-201 in cohorts of patients with follicular lymphoma, high grade B cell lymphoma (including diffuse large B-cell), high grade B cell lymphoma not otherwise specified, and primary mediastinal B cell lymphoma.

Veronika Bachanova, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05296525
STUDY00015044
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Inclusion Criteria:

• Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:
• Received at least 2 prior lines of therapy
• Transplant ineligible patients allowed assuming they meet criterion a.
• Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion
• FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL
• Patients must be at least 18 years of age
• Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion Criteria:

• CNS lymphoma
• Time between previous treatment and first dose of study treatment (rituximab):
• Allogeneic HSCT < 6 months prior to study treatment
• Autologous HSCT < 3 months prior to study treatment
• CAR-T < 2 months prior to study treatment
Drug: GDA-201
Non-Hodgkin Lymphoma
lymphoma, GDA-201, NK cells, rituximab, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Clinics and Surgery Center (CSC)
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Traveling-wave Transcranial Electric Stimulation (TravelingTES)

This is a non-invasive brain stimulation study in healthy, adult volunteers that will examine the electrophysiological and behavioral effects of dual-site transcranial alternating current stimulation (TACS).

All
18 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT05399381
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Inclusion Criteria:

• Age between 18 and 45 years old.
• Confident level of English language.
Exclusion Criteria:

• History or evidence of chronic neurological or mental disorder.
• Metal or electric implant in the head, neck, or chest area.
• History of head injuries with loss of consciousness.
• Any acute or chronic medical condition that requires ongoing pharmacological treatment.
• Pregnancy or breast-feeding.
• Alcohol or drug addiction.
Device: Transcranial alternating current stimulation (tACS)
Working Memory
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A Study to EXhibit Percutaneous coronary Artery dilatation with Non-Slip Element balloon

Prospective, multi-center, single arm clinical study to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during percutaneous coronary intervention in subjects with stenotic coronary arteries. Subjects will be followed through hospital discharge.

Carmelo Panetta
Pivotal
This study is NOT accepting healthy volunteers
NCT04985773
STUDY00014775
Coronary Artery Stenosis, Coronary Stenosis, In-stent Restenosis
Coronary dilation catheter, Non-slip Element balloon, Percutaneous coronary artery dilatation, Restenosis
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A randomized, participant and investigator blinded, sponsor open-label, placebo-controlled, single dose study to investigate the safety and tolerability of XXB750 in heart failure participants with reduced ejection fraction (HFrEF)

This is a multi-center, randomized, sponsor open-label, participant and investigator blinded, placebo-controlled, single dose study to investigate the safety and tolerability of a single subcutaneous dose of XXB750 in HFrEF.

Les Forgosh
18 Years and over
Phase I
This study is NOT accepting healthy volunteers
NCT05328752
STUDY00015604
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Inclusion Criteria:
-Men or women age 18 to 75 years -NYHA functional class II-III -LVEF greater than or equal to 45% documented at screening -Systolic blood pressure 110-180 mmHg and heart rate less than or equal to 90 beats per minute -On stable therapies of ACE inhibitor/ARB and beta-blocker for 4 weeks prior to screening
Exclusion Criteria:
-Acute heart failure, acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening -Hemodynamically significant mitral and/or aortic calve disease, except mitral regurgitation secondary to LV dilatation at screening -Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period -History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening -eGFR less than 45 mL/min/1.73m^2 at screening -Treatment with Sacubitril/Valsartan currently or within 2 weeks from screening -BMI greater than 35 kg/m^2
Heart & Vascular, Heart Failure With Reduced Ejection Fraction (HFrEF)
HFrEF, Heart Failure, heart failure, reduced ejection fraction
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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
Female
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04486352
STUDY00013241
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Key
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. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be counted as a systemic therapeutic regimen.
• Measurable disease per RECIST 1.1
• Formalin-fixed, paraffin-embedded tumor tissue, a specimen as proximal to the current recurrence as possible, must be submitted to the Central Lab for molecular testing (FoundationOne CDxTM)
• Life expectancy > 12 weeks
• Recovery from effects of recent radiotherapy, surgery, or chemotherapy Key
Exclusion Criteria:

• Endometrial tumors with the following histologies: squamous carcinomas, sarcomas
• Other invasive malignancies within the last 5 years, except for non-melanoma skin cancer with no evidence of disease within the past 5 years AND localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago
• Synchronous primary invasive ovarian or cervical cancer
• Have an active or history of autoimmune disease or immune deficiency
• Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan
• Active tuberculosis
• Severe infections within 4 weeks
• Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication
• Have significant cardiovascular disease
• Are administered treatment with a live attenuated vaccine within 4 weeks, or anticipation of need for such a vaccine during the course of the study
• Have prior allogeneic bone marrow transplantation or solid organ transplant
• Prior treatment with T-cell costimulating or immune checkpoint blockade therapies including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapeutic antibodies
• History of treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
• History of treatment with systemic immunosuppressive medications within 2 weeks except acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency
• Have a history or clinical evidence of any untreated CNS disease, seizures not controlled with standard medical therapy, or history of cerebrovascular accident (stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months
Drug: Atezolizumab - 28 Day Cycle, Drug: Bevacizumab, Drug: Ipatasertib, Drug: Talazoparib, Drug: Trastuzumab emtansine, Drug: Tiragolumab, Drug: Atezolizumab - 21 Day Cycle
Endometrial Cancer
Clinics and Surgery Center (CSC)
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Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program

The Disease Monitoring Program (DMP) will collect information for up to 10 years from adult and pediatric participants with a confirmed diagnosis of Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) on any treatment. The main purpose of the DMP is to assess the long-term safety and effectiveness of Dojolvi® (triheptanoin) in participants with LC-FAOD, and to establish the natural history, progression, and burden of LC-FAOD to patients and caregivers. Participants will be able to be part of this study for up to 10 years.

All
Not specified
This study is NOT accepting healthy volunteers
NCT04632953
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Inclusion Criteria:

• Confirmed diagnosis of any LC-FAOD sub-type. Diagnosis must be confirmed by results of acylcarnitine profiles, and/or mutation analysis obtained from medical records or equivalent documentation.
• Willing and able to comply with all study procedures.
• Willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures. For minors (<16 or<18 years of age, as defined by region) willing and able (if possible) to provide written assent and have a legally authorized representative willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures.
• Female of child-bearing potential who become pregnant during the study will be invited to remain in the study. Pregnant females with LC-FAOD will be informed of the study and invited to enroll.
• Pregnant females carrying affected fetus(es) with confirmed pre-natal diagnosis of LC-FAOD, will also be informed of the study and invited to enroll.
Exclusion Criteria:

• Presence of a concurrent disease or condition that would interfere with study participation or affect patient's safety in the opinion of the Investigator.
• Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of not completing the study or would affect the interpretation of study results.
Other: No Intervention
Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)
CACT Deficiency, Carnitine Acylcarnitine Translocase Deficiency, CPT1, CPT2, Carnitine Palmitoyltransferase Deficiencies, VLCAD, Very Long Chain Acyl Coa Dehydrogenase Deficiency, LCHAD Deficiency, Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency, TFP Deficiency, Trifunctional Protein Deficiency
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Prospective Study to Evaluate the Beneficial use of CellularMatrix BCT-HA in Aesthetic Medicine: A Clinical and Histological Evaluation.

Feasibility Study to Evaluate the Safety and Efficacy of Cellular Matrix BCT-HA Kit as a New Treatment Option for Dehydrated and Wrinkled Skin

Maria Hordinsky
18 Years and over
Phase IV
This study is also accepting healthy volunteers
DERM-2021-30292
STUDY00014930
Dermatology (Skin, Hair & Nails)
Clinics and Surgery Center (CSC), Hair loss, PRP
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Study of Nutraceutical Intervention with High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, type 1 (NF1)

This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).

Christopher Moertel, MD
Phase I
This study is NOT accepting healthy volunteers
NCT05363267
STUDY00014832
Neurofibromatosis 1, Rare Diseases
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Neural mechanisms of early visual dysfunction in psychosis

Michael-Paul Schallmo
18 Years and over
NA
This study is also accepting healthy volunteers
PSYCH-2019-28336
STUDY00007958
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Inclusion Criteria:
18-60 years old; Normal or corrected-to-normal vision; Current diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
Claustrophobia; Current substance dependence (besides nicotine); Any vision anomaly (e.g. strabismus/crossed eyes, lazy eye, color blindness); Current or past diagnosis of bipolar I disorder
Brain & Nervous System, Vision & Eyes
EEG, MRI, neuroscience, psychosis, vision
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Observational study to compare Non-Invasive Venous waveform Analysis (NIVA) with Pulmonary Capillary Wedge Pressure (PCWP) during right heart catheterization

NIVA measurements will be obtained concurrently with pulmonary catheter wedge pressures during right heart catheterization.

Eric Wise
18 Years and over
NA
This study is NOT accepting healthy volunteers
SURG-2021-30253
STUDY000014969
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, greater than or equal to 18 years of age
Exclusion Criteria:
Right Heart Catheterization Study Arm & Summative Arm: An individual who meets any of the following criteria will be excluded from participation or data analysis (if found post-hoc around time of RHC) in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Carries the diagnosis of superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Pregnant or lactating
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating. SARS-CoV2 Study Arm: An individual who meets any of the following criteria will be excluded from participation in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating.
Diabetes & Endocrine
Clinics and Surgery Center (CSC), NIVA Right Heart Catheterization Study
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Neighborhood Park Youth Sports Program Fee Waiver and Intensive Family Outreach (PARKS)

All
6 Years to 12 Years old
Phase 3
This study is also accepting healthy volunteers
NCT05231837
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Inclusion Criteria:

• age 6-12 years
• do not meet guidelines for recommended level of physical activity
• live in neighborhood served by one of 24 study parks
• able to be physically active
• do not plan to move in the next two years
Exclusion Criteria:

• younger than 6 or older than 12 years of age
• do not live within 2 miles of study park
• already meet physical activity guidelines
• not able to be physically active plan to move within two years
Behavioral: Experimental: Fee Waiver, Behavioral: Fee Waiver Plus Intensive Outreach
Physical Activity
Physical Activity Low Income Youth Parks
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Composur: Study to Understand the Performance of Vibegron in Participants With Overactive Bladder (OAB)

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT05067478
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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 prior to the Baseline Visit
• Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
• Previous exposure to mirabegron monotherapy and/or mirabegron plus solifenacin and/or previous exposure to anticholinergics prior to initiation of vibegron
Exclusion Criteria:

• Any contraindication to the use of vibegron per the United States label
• History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
• History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
• Participants at risk of urinary retention (as determined by the investigator)
• Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• Pregnant or breastfeeding or plans to do so during the study
• Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
• Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason
Drug: Vibegron
Overactive Bladder
Vibegron, Urinary bladder, overactive, Beta-3 adrenergic receptor (β3-AR) agonists, Urge urinary incontinence, OAB
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Ten Thousand Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Logan Spector
Not specified
NA
This study is also accepting healthy volunteers
PEDS-2017-25905
STUDY00000877
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Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Cancer, Microbiota, Prevention & Wellness
Colon Cancer, Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
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Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study] (ULTRA)

The research objective is to demonstrate efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a pilot study. In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics during and after an 8-week course of spleen-directed daily ultrasound treatments.

Erik Peterson
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05417854
STUDY00016143
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Inclusion Criteria:

• Males and females ages 18 and above
• Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010_revised_criteria_classification_ra.pdf)
• Classification as ?definite RA? is based on the confirmed presence of synovial thickening in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0?5), serologic abnormality (score range 0?3), elevated acute-phase response (score range 0?1), and symptom duration (2 levels; range 0?1)
• Exhibiting symptoms or signs of inadequate inflammatory disease control according to one of two measures: a. Multidimensional HAQ score of greater than 0.3 b. DAS-28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP)
• Candidate participant?s rheumatoid arthritis medical therapy should be stable for two weeks leading up to the study. Moreover, participants must be willing to maintain their current medication regimen throughout the study enrollment period (in adjunct to the additional investigational ultrasound treatment)
Exclusion Criteria:

• Active bacterial or viral infection
• Pregnant women or those trying to become pregnant
• Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
• Having received Rituximab monoclonal antibody medication within 30 days prior to enrollment
• Presence of an implanted device
• Asplenia
• Splenomegaly
• Ascites
• Recent abdominal surgery
• Currently participating in an investigational drug or device study
• Open wound/sores near stimulation sites
• Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ
• Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Device: Splenic Ultrasound
Rheumatoid Arthritis, Arthritis & Rheumatic Diseases, Immune Diseases
Rheumatoid Arthritis
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Biomechanical Mechanisms of Soft Tissue Deformation during the Volleyball Spike

No current studies have examined in vivo glenohumeral kinematics during the overhead volleyball spike despite the high prevalence of spike-related shoulder pain. The extreme shoulder positions achieved by volleyball players during the spike motion may contribute to unique deformations that could result in structural change or pathology of the rotator cuff and long head biceps tendons. The purpose of this study is to determine the extent to which GH kinematics differ between SAB and a simulated volleyball spike at a self-selected position of ball contact.

Paula Ludewig
18 Years and over
NA
This study is also accepting healthy volunteers
PMR-2022-30925
STUDY00015763
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Inclusion Criteria:
between 18-35 years of age; play competitive volleyball at the club level (committed to collegiate participation) or NCAA D3 level or above; fluent in English; have no shoulder pain that limits volleyball participation; have a negative clinical screening exam; able to provide informed consent
Exclusion Criteria:
any injuries, impairments, or pain of the dominant (hitting) upper extremity that limit participation in volleyball; shoulder pain found to be related to the cervical spine; have a history of trauma and/or surgery of the hitting shoulder; or are currently pregnant.
Bone, Joint & Muscle
Volleyball, athlete, shoulder, spike mechanics
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Thoracentesis QI Study

All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05424120
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Inclusion Criteria:

• Age >18
• Evidence of pleural effusion on imaging
• Clinical indication for thoracentesis
Exclusion Criteria:

• Age <18
• Standard contraindication for thoracentesis procedure
• Patients on positive pressure ventilation
• Patients who have opted out of research in EPIC
Procedure: Manual aspiration, Procedure: Wall suction, Procedure: Vacuum bottle drainage
Pleural Effusion
pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage
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A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension

Primary Objective (Randomized Controlled Trial [RCT] Cohort) To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications. Primary Efficacy Endpoint Change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline to 3 months post-procedure. • To evaluate the acute and chronic safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications. • To evaluate the sustained efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications. • To evaluate the performance of the Peregrine Kit (co-packaged combination of the alcohol and the Peregrine Catheter) for its intended use.

John Osborn Jr.
Phase III
This study is NOT accepting healthy volunteers
NCT02910414
STUDY00014168
Hypertension
Alcohol, Renal Denervation
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Hydraderm for Androgenic Alopecia

All
18 Years to 65 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT05426629
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Inclusion Criteria:

• Participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA Authorization
• Participants who have androgenetic alopecia
• Healthy men and women, ages 18 - 65 years of age
• Participants who understand the study and can follow study instructions and are willing to attend the required study visits
• Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.
• Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
• Participants who agree to use the same shampoo for the duration of the study
Exclusion Criteria:

• Participants who have not had a change to hair loss treatment for 4 months prior to study enrollment
• Participants who have an active or known skin inflammation or infection within the treatment area.
• Participants who have an active or known acute skin allergies
• Participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area
• Participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy.
• Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy.
• Immunosuppression
• Participants who are HIV+ / Hepatitis B + / Hepatitis C+
• Participants who have been diagnosed or have a known history of any hematopathology disorders
• Participants who have been diagnosed or have a known history of haemostasis disorders
• Participants who have been diagnosed or have a known history of an autoimmune diseases
• Participants who are undergoing chemotherapy
• Participants with a history of any skin cancer on the scalp
• Participants who have had skin biopsy or procedure on scalp in last month
• Participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area
• Non-English speakers
Device: Venus Glow
Androgenic Alopecia
alopecia, hair loss, pattern hair loss, hydradermabrasion, female pattern hair loss, male pattern hair loss, dermatology
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Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback

The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.

Jerica Berge
NA
This study is also accepting healthy volunteers
NCT02669797
STUDY00000706
Childhood Obesity
Childhood Obesity, Ecological Momentary Intervention, Video Feedback
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A Phase 1/2 non-randomized, open-label, multi-cohort,multi-center study assessing the clinical benefit of SAR444245 (THOR- 707) combined with cemiplimab for the treatment of participants with advanced unresectable or metastatic skin cancers

SAR444245, with its site-specific pegylation, was designed to substantially reduce association with the interleukin (IL)-2 α receptor, while retaining stimulatory activity for cells expressing the moderate affinity IL-2 βγ receptor. Preclinical studies demonstrated that treatment with SAR444245 leads to polyclonal expansion of CD8+ T cells in murine and non-human primate (NHP) models while anti-PD1 antibody prevents T cell suppression through the programmed cell death-1/programmed cell death-ligand 1 (PD1/PD-L1) pathway. The combination of anti-PD1 treatment with SAR444245 was tested in the syngeneic murine colon cancer Ct-26 model and induced enhanced anti-tumor activity demonstrated as an increased number of complete responses (CR) and tumor-free surviving animals compared to each agent given in monotherapy. These data support evaluation of SAR444245 in combination with an anti-PD1 antibody. The proposed study aims to establish proof-of-concept that combining the anti-PD1 monoclonal antibody cemiplimab with the not-alpha IL-2 SAR444245 will result in a significant increase in the percentage of immune checkpoint inhibitors (ICI)-naïve patients with melanoma and cutaneous squamous cell carcinoma (CSCC) experiencing an objective response rate (ORR)

Evidio Domingo Musibay
Phase I/II
This study is NOT accepting healthy volunteers
NCT04913220
STUDY00014167
Malignant Melanoma, Squamous Cell Carcinoma of Skin
Clinics and Surgery Center (CSC)
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KIN-1902-2001: A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

Primary Objective: The primary objective of this study is: • To evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS). Key Secondary Objective: • To evaluate the effect of namilumab on proportion of subjects on OCS taper without rescue. Other Secondary Objectives: The other secondary objectives of this study are: • To assess the safety and tolerability of namilumab; • To assess the effect of namilumab on measures of pulmonary function; • To assess the effect of namilumab on Patient Reported Outcomes (PROs): o St. George’s Respiratory Questionnaire (SGRQ); o Modified King’s Sarcoidosis Questionnaire (mKSQ); o Fatigue Assessment Scale (FAS); o Subject Global Assessment (SGA); o Leicester Cough Questionnaire (LCQ); o Pain Visual Analog Scale (VAS); o General Sleep Disturbance Scale (GSDS); o Bothersomeness and Subject Global Impression of Change (BSGIC). • To assess the effect of namilumab on dyspnea; • To assess the effect of namilumab on cumulative OCS use and toxicity; • To assess the effect of namilumab on the rate of clinical benefit; • To evaluate the effect of namilumab on clinical worsening. • To assess the effect of namilumab on sarcoid associated skin lesions (when present); • To assess the effect of namilumab on the severity of extrapulmonary organ involvement; • To assess the effect of namilumab on use of rescue therapy; • To assess the population pharmacokinetics (PPK) and exposure-response (E-R) relationships for efficacy and safety of namilumab; • To assess the effect of namilumab on laboratory parameters; • To assess the efficacy of namilumab on the radiologic features of CPS; • To assess the effect of namilumab on 6-Minute Walking Distance (6MWD).

Maneesh Bhargava
Phase II
This study is NOT accepting healthy volunteers
NCT05314517
STUDY00014721
Sarcoidosis, Pulmonary
Clinics and Surgery Center (CSC)
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EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

Nicole Hartung
Phase III
This study is NOT accepting healthy volunteers
NCT04266249
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Invasive Breast Carcinoma, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8
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A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)

This study is to investigate if robotic assisted laparoscopy (small incision surgery), is worse than open surgery (otherwise known as a laparotomy) when performing a radical hysterectomy for cervical cancer. Previous research has been done and shown that patients receiving laparoscopy had an increased risk of recurrence of their cervical cancer. But since that time a lot has been learned and improvements have been made, hence why we are relooking at the differences between the two surgical approaches.

Colleen Rivard
Phase III
This study is NOT accepting healthy volunteers
NCT04831580
STUDY00014918
Cervical Cancer
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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer

Jocelin Huang
Phase III
This study is NOT accepting healthy volunteers
NCT04852887
Stage I Breast Cancer
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