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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.

416 Study Matches

Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease

The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.

Principal Investigator: Takako Araki
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022764
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Inclusion Criteria:

• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
Exclusion Criteria:

• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
Conditions: Breathing, Lung & Sleep Health, Diabetes & Endocrine, Rare Diseases
Keywords: CD, Cushing Disease
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Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents

The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.

Principal Investigator: Karina Quevedo
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001202
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Inclusion Criteria:

• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
Exclusion Criteria:

• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: adolescents, mental health, self-harm, suicidal, suicide attempt, suicide ideation, teen brain train
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A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine in platinum-resistant ovarian cancer

This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025091
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Inclusion Criteria:

• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC)
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ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)

This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.

Principal Investigator: Gregory Vercellotti
Age Group: 12 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001194
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Inclusion Criteria:
* Documented diagnosis of AHP, per physician's determination
Exclusion Criteria:
* Currently enrolled in a clinical trial for any investigational agent
Conditions: Digestive & Liver Health, Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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Bladder Management Patient Reported Outcomes for Young Adults with Spina Bifida

The purpose of this study is to determine how different bladder management methods affect the quality of life for young people with spina bifida. We hope to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with spina bifida.

Principal Investigator: Sean Elliott
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024162
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Inclusion Criteria:

• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
Exclusion Criteria:

• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC)
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MT2022-45 Primary Immune Regulatory Disorders (PIRD): Longitudinal Study of Clinical Presentation, Treatment and Outcomes

Primary Immune Regulatory Disorders (PIRD disorders) are a group of diseases that cause the immune system to function abnormally and cause infections, autoimmunity or inflammation that can begin early in life. PIRD is usually caused by changes in genes in DNA. Researchers are trying to learn what types of medical problems patients with PIRD have and how these respond to treatment. Researchers also want to learn which genes cause PIRD and how it can cause the medical problems of PIRD.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001766
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Inclusion Criteria:

• age 0 to 99 years
• diagnosis of immune-mediated bowel disease affecting at least one segment of the bowel
• evidence of interstitial lung disease (ground-glass opacities) or pulmonary nodules/cysts
• decreased lung function
• additional inclusion and exclusion criteria apply (study staff will review)
• also enrolling parent, sibling, or child of eligible participants
Exclusion Criteria:

• documented HIV infection
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult atypical hemolytic uremic syndrome (aHUS) patients who are naive to complement inhibitor therapy (APPELHUS)

To evaluate the efficacy and safety of iptacopan at a dose of 200 mg twice a day for 52 weeks in patients with atypical hemolytic uremic syndrome (aHUS).

Principal Investigator: Nattawat Klomjit
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020503
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Inclusion Criteria:

• at least 18 years old
• evidence of active Thrombotic Microangiopathy (TMA)
Exclusion Criteria:

• previous or ongoing treatment with complement inhibitors, including anti-C5 antibody
• ADAMTS13 deficiency
• positive test for Shiga toxin * direct Coombs test
• had a bone marrow transplant or hematopoietic stem cell transplant, or a heart, lung, small bowel, pancreas or live transplant
Conditions: Blood Disorders, Kidney, Prostate & Urinary, Rare Diseases
Keywords: Clinics and Surgery Center (CSC)
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D2D - What's Bugging You? Assessing the public's knowledge, attitudes, and perceptions of tick and mosquito borne diseases.

You are invited to take part in a survey to help us learn more about what people know and think about diseases that are spread by ticks and mosquitoes. This study is being conducted by the researchers at the University of Minnesota Medical School on the Duluth Campus. The goal is to understand how people feel about these diseases and how much they know about how to protect themselves.

Principal Investigator: Clara Smoniewski
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00025228
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Inclusion Criteria:

• MN and WI residents
• age 16 and up
• English speaking
Conditions: Infectious Diseases, Prevention & Wellness, Community Health
Keywords: climate change, Lyme disease, vector-borne disease
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Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain

The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021883
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Inclusion Criteria:

• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
Exclusion Criteria:

• cannot have any implanted stimulation devices
Conditions: Bone, Joint & Muscle
Keywords: Back Pain
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HEALthy Brain and Child Development Study

We are doing a study to learn how children develop early in life. There will be about 300 parent-child pairs in this study in Minnesota and about 7,500 pairs total across the country. There will be study visits from pregnancy through the first 10 years of your child’s life.

Principal Investigator: Sylia Wilson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001502
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Inclusion Criteria:

• at least 18 years old
• currently pregnant
• speak English
Conditions: Children's Health, Community Health, Women's Health
Keywords: D2D
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Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma

This study examines the impact of social and genetic factors on outcomes in adolescent and young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma.

Principal Investigator: Chaithanya Bhaskar
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC089
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Inclusion Criteria:

• between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
• completed therapy and had with a complete response
• last date of prior systemic therapy was no more than one year ago
• must be English speaking
• have internet access through computer, tablet, or smartphone and an email address
• at least able to do limited selfcare, may be confined to bed or chair more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions

We are investigating how paired non-invasive electrical stimulation of surface body regions and sound changes sound perception and tinnitus. Body stimulation regions include: external ear/behind the ear, shoulder, neck, forearm, hand, and upper arm. We aim to better understand the optimal conditions of this paired stimulation, which opens opportunities for applying this method to improving hearing loss or tinnitus. We are studying three groups of people: those with normal hearing, those with mild to moderate hearing loss, and those with tinnitus.

Principal Investigator: Hubert Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016992
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Inclusion Criteria:

• normal hearing or hearing loss with or without tinnitus
• not users of Cochlear Implant or hearing aids
Conditions: Ear, Nose & Throat
Keywords: hearing loss, tinnitus, auditory plasticity, neuromodulation, transcutaneous electrical stimulation
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HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

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

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

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

• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Myelofibrosis
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A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)

The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021600
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Inclusion Criteria:

• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
Conditions: Cancer
Keywords: Cholangiocarcinoma, Clinics and Surgery Center (CSC)
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A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024172
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Inclusion Criteria:

• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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Geniculate Artery Embolization

Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.

Principal Investigator: Reza Talaie
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006202
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Inclusion Criteria:

• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
Exclusion Criteria:

• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
Conditions: Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), Osteoarthritis
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CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)

The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014622
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Inclusion Criteria:

• at least 18 years old
• have a diagnosis of systemic sclerosis
• less than 5 years from onset of first symptom attributed to systemic sclerosis
Exclusion Criteria:

• cognitive impairment that interferes with ability to participate in the study
• unable to speak, read, and write English
Conditions: Arthritis & Rheumatic Diseases
Keywords: Clinics and Surgery Center (CSC), Scleroderma
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A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.

Principal Investigator: David Perlman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020802
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Inclusion Criteria:

• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
Exclusion Criteria:

• Pregnancy or breast-feeding
Conditions: Breathing, Lung & Sleep Health, Rare Diseases, Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Sarcoidosis
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A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)

The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002030
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study for short stature
Conditions: Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
Keywords: growth hormone and growth hormone deficiency

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 4 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.

Principal Investigator: Jayanthi Sasisekaran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00013042
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Inclusion Criteria:

• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Conditions: Children's Health, Community Health
Keywords: adults, attention, fluency, language, memory, speech production, Stuttering, children
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Cannabidiol (CBD) and Stress Response: Psychobiological Mechanisms

This study includes healthy adults between the ages of 21-70 who either use or do not cannabidiol (CBD) regularly. The purpose of this study is to learn about how CBD users and nonusers respond to stress. Participants must be willing to attend one in-person visit at the University of Minnesota Duluth campus

Principal Investigator: Mustafa al'Absi
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024552
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Inclusion Criteria:

• 21 to 70 years old
• generally healthy
• use CBD regularly or do not use CBD
• willing to attend one in-person visit at the University of Minnesota Duluth campus
Exclusion Criteria:

• current, unstable physical or mental health condition
• women who are currently pregnant
• current use of illicit substances (other than cannabis)
Conditions: Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
Keywords: Cannabidiol, CBD, stress
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Neural Correlates of Goal Prioritization and Conscientiousness

This research will use neuroimaging to study the brain systems involved in prioritizing goals effectively, as well as testing whether variation in those systems is associated with the personality trait conscientiousness, which reflects organization, self-discipline, and industriousness and predicts important health and other life outcomes.

Principal Investigator: Colin DeYoung
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019311
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Inclusion Criteria:

• age 20 - 50
• right handed
• no major psychiatric illness
Exclusion Criteria:

• claustrophobia
• any metal or devices in the body (e.g., pace makers, aneurysm clips etc.)
Conditions: Brain & Nervous System
Keywords: Brain imaging, Personality
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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.

Principal Investigator: Mark Schleiss
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: 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
Conditions: Children's Health, Infectious Diseases
Keywords: CMV, cytomegalovirus, vaccine
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Effects of tobacco and nicotine cessation on biomarkers

This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.

Principal Investigator: Stephen Hecht, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020438
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Inclusion Criteria:

• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
Exclusion Criteria:

• marijuana use
Conditions: Prevention & Wellness
Keywords: cigarettes, lozenges, nicotine, patches, smoking, smoking cessation, tobacco
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MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019229
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Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for additional Inclusion criteria
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Solid Tumors, Clinics and Surgery Center (CSC)
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A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)

The purpose of the study is to evaluate the safety and effectiveness of dostarlimab as compared with standard treatment with surgery in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021453
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Inclusion Criteria:

• has adenocarcinoma of the colon that has not been treated
• plan is to do surgery for the cancer that is T4N0 or Stage III
• tumor shows presence of either dMMR status or MSI-H
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
• history of interstitial lung disease or pneumonitis
• cirrhosis or current unstable liver or biliary disease
• history of allogenic stem cell transplantation or organ transplantation
• women who are pregnant, breastfeeding, or expecting to conceive children during the study
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), colon cancer
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A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial) (ROCC)

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.

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001439
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Inclusion Criteria:

• 18 years or older
• confirmed cervical cancer with the histological type of adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma (Including glassy cell)
• Stage IA2, IBI, IB2 cancer
• able to care for self and do light work
Exclusion Criteria:

• unable to have a MRI
• history of prior pelvic or abdominal radiotherapy
• history of cancer less than 5 years ago with the exception of non-melanoma skin cancer.
Conditions: Cancer, Women's Health
Keywords: Cervical Cancer, Clinics and Surgery Center (CSC)
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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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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 Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

The purpose of this study is to find out if the drug letrozole is better or worse than not receiving treatment (called observation) following surgery for your type of cancer. Letrozole could prevent your cancer from returning but the cancer could grow while on treatment. There is currently no definitive data to support the use of Letrozole treatment for early stage Leiomyosarcoma. Letrozole has already been FDA-approved to treat other cancers, but it is investigational in this research.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023351
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Inclusion Criteria:

• confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus
• tumor expresses ER positivity by immunohistochemistry
• completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks prior
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• able to swallow oral medication
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• any other severe disease
• also has another cancer or has been treated for cancer in the past three years
• women who are pregnant or breastfeeding
• currently receiving chemotherapy or radiation therapy
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Women's Health
Keywords: Uterine Leiomyosarcoma, Clinics and Surgery Center (CSC)
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A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (ASCENT-GYN-01)

The purpose of this research study is to learn if sacituzumab govitecan (also called SG or Trodelvy®) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel).

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022912
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Inclusion Criteria:

• diagnosis of endometrial cancer that has not responded to treatment or has recurred
• up to 3 prior lines of systemic therapy including platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately
• assigned female at birth
• if of child bearing age, must use birth control as specified by the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• eligible for rechallenge with platinum-based chemotherapy
• continue to have significant side effects from treatment
• active second cancer or a history of another active cancer in the past 3 years
• a history of significant cardiovascular disease including myocardial infarction, significant arrhythmia, congestive heart failure
• history of HIV-1 or 2
• active hepatitis B virus (HBV) or hepatitis C virus (HCV)
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Endometrial Cancer, Clinics and Surgery Center (CSC)
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