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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.

413 Study Matches

Visual Perception in Visual Snow Syndrome

This study seeks to understand visual perception in people with Visual Snow Syndrome and how this relates to brain function.

Principal Investigator: Michael-Paul Schallmo
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014113
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Inclusion Criteria:

• Between 18 - 60 years old
• Good general physical health
• No history of other neurological disorders or problems
• Fluent in English
Conditions: Vision & Eyes
Keywords: Visual snow, visual snow syndrome
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Sex differences in the effecTs of brEaking uP sedentary behavior on vascUlar function in Type 2 Diabetes (STEP UP T2D)

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Most studies that have examined the effects of changing sedentary behavior (SB) have focused on young healthy males and prioritized glycemic outcomes. We will look at the effect of 3 different ways of breaking up sitting: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, differences between men and women will be evaluated.

Principal Investigator: Mary Whipple
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018030
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Inclusion Criteria:

• men who are 60 years or older
• Type 2 diabetes (hemoglobin A1c 6.5% or more and/or previous diagnosis of type 2 diabetes)
• sedentary for at least 6 hours/day
• willing to abstain from food, caffeine, alcohol and exercise for at least 24 hours, and tobacco/smoking for at least 12 hours prior to each study visit
• able to speak and read English
Exclusion Criteria:

• Type 1 diabetes
• uncontrolled hypertension (resting systolic greater than 160 or diastolic greater than 110 mmHg)
• starting hormone therapy or changing in hormone therapy (dose/frequency/route of administration) in the previous 3 months
• on renal dialysis
• history of deep vein thrombosis (DVT)
• evidence of cognitive impairment
• physical impairment or disability that interferes with ability to engage in exercise (severe osteoarthritis, lower extremity amputation [other than toe(s)/partial foot], use of a walker or wheelchair, etc.)
• unstable medical/psychiatric condition that could impact study participation
Conditions: Diabetes & Endocrine, Prevention & Wellness, Women's Health
Keywords: physical activity, sedentary behavior, sitting
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.

Principal Investigator: Rahel Ghebre, Dr
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC048
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Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
Exclusion Criteria:

• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Conditions: Cancer
Keywords: Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
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Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.

Principal Investigator: Nicole Hartung
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC068
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Inclusion Criteria:

• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
Exclusion Criteria:

• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Conditions: Cancer
Keywords: Immunotherapy, Lung Cancer, Lung Cancer, Non Small cell lung cancer, NSCLC, Stage IV lung cancer
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A Phase 2, Open-Label, Basket Study of Atrasentan in
Patients with Proteinuric Glomerular Diseases (AFFINITY)

The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012146
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Inclusion Criteria:

• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
Exclusion Criteria:

• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: Glomerular Disease, Alport Syndrome, IgAN, FSGS, Proteinuric Glomerular Diseases
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Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

We are studying brain mechanisms related to chronic temporomandibular disorder (TMD) pain. We are looking at brain structural and functional characteristics that can potentially explain why some people experience persistent pain in their jaws for months or years. We will compare this to information we get from people who do not experience TMD pain. We expect that this new knowledge will improve our understanding of this chronic pain condition and help us develop better treatments.

Principal Investigator: Estephan Moana-Filho
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013924
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Inclusion Criteria:

• Female participants only (biological sex)
• Age between 18-65 years
• Pain-free participants OR
• Chronic jaw pain ( > 3 months)
Exclusion Criteria:

• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Conditions: Bone, Joint & Muscle, Brain & Nervous System, Dentistry
Keywords: Functional Brain Imaging, Sensory Testing, Temporomandibular Disorders, Jaw Pain, TMJ
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Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Principal Investigator: Sonya Wang
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020174
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Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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Treatment of Refractory Nausea

We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC057
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Inclusion Criteria:

• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
Exclusion Criteria:

• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Chemotherapy, Nausea
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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
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Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)

The purpose of this research is to learn more about the immune function of patients who are critically ill and may or may not have sepsis through assessment of blood samples at the time of their illness. We will use the blood to determine whether the immune system is suppressed (slowed or stunted) and measure the amount of suppression. Our research team will compare blood from healthy participants to people who are critically ill to better understand immune system suppression.

Principal Investigator: Thomas Griffith
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001746
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Inclusion Criteria:

• Adults age 45 and older
• Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria:

• Current, chronic steroid use
• Pregnancy
• Current or recent (within 7 days) use of antibiotics.
Conditions: Immune Diseases
Keywords: Sepsis
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Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)

The purpose of the study is to see how restricting the eating window (called time-restricted eating) might affect eating habits, weight, and blood measures compared to reducing food intake. Time-restricted eating means that people would have a daily 8 hour eating window during which time they can eat whatever they want. Outside of the eating window, people would only take water and your medications. We expect that participants will be in this research study for about 7 months.

Principal Investigator: Lisa Chow
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014853
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Inclusion Criteria:

• 18 to 65 years old
• overweight/obese and have type 2 diabetes treated with diet or metformin
• BMI between 25-45 kg/m2
• HbA1c between 6.5-8.5%
• self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• own a smartphone
Exclusion Criteria:

• women who are pregnant or are planning to become pregnant
• eating disorders
Conditions: Diabetes & Endocrine
Keywords: Type 2 diabetes, intermittent fasting, caloric restriction, time restricted eating
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Computational Modeling of Tic Change Trajectories in Tourette Syndrome

We are looking for participants who have tics. We would like to measure your tics before, during and after a course of Comprehensive Behavioral Intervention for Tics (CBIT) .

Principal Investigator: Brianna Wellen
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021987
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Inclusion Criteria:

• age 12-17
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months
• at least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only)
• full scale IQ greater than 80
Exclusion Criteria:

• previous diagnosis of psychosis or cognitive disability
• substance abuse or dependence within the past year
• neuroleptic/antipsychotic medications
Conditions: Brain & Nervous System
Keywords: Tics, Tourette Syndrome

Optimizing transcranial magnetic stimulation for stimulant use disorder

We want to learn more about your brain processes, and how a type of brain stimulation device called TMS can be used to enhance treatment for stimulant use disorder.

Principal Investigator: Kelvin Lim
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00021548
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Inclusion Criteria:

• age 18 or older
• able to abstain from drug and alcohol use for at least 2 weeks
• confident level of English language proficiency
Exclusion Criteria:

• any organic brain disorder (such as traumatic brain injury, stroke)
• head injury resulting in skull fracture or loss of consciousness for 30 minutes or more
• unable to have TMS (history of seizures, metallic cranial plates/screws or implanted device)
• unable to have a MRI (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia)
• any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included)
• pregnancy or breastfeeding
Conditions: Mental Health & Addiction
Keywords: brain imaging, EEG, MRI, neuromodulation, TMS
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MT2024-06D: Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation

To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) after allogeneic hematopoietic cell transplantation (alloHCT)

Principal Investigator: Joseph Maakaron
IRB Number: STUDY00021822
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy

This trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who had a complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC077
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Inclusion Criteria:

• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Triple Negative Breast Cancer (TNBC) without any remaining disease after neoadjuvant chemotherapy with pembrolizumab for at least 6 cycles
• no more than 12 weeks between surgery and starting the trial
• see link to clinicaltrails.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• women who are pregnant or breast feeding
• history of any prior invasive breast cancer in either breast
• active liver disease
• medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer
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Collaborative Solutions for Breaking Up Sedentary Time in Black Older Adults with Type 2 Diabetes: The Interrupt T2D Study

Black Americans are 60% more likely to be diagnosed with Type 2 Diabetes (T2D) and 2 times more likely to die from T2D than non-Hispanic White Americans. Recent research has shown that sedentary behavior (such as sitting or lying down) have a significant negative impact on health. We are doing a small study with older people who identify as Black or African American and have T2D to look at ways to reduce sedentary behavior. The study will last about 1-2 months for each participant.

Principal Investigator: Mary Whipple
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021174
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Inclusion Criteria:

• self-identify as Black or African American.
• 55 years and older
• speak and read English.
• self-reported diagnosis of type 2 diabetes (T2D)
Exclusion Criteria:

• evidence of cognitive impairment that could impact ability to consent and/or participation
• physical impairment or disability that interferes with ability to engage in physical activity such as severe osteoarthritis, lower extremity amputation (other than toe(s) or partial foot), regular use of a walker or wheelchair, etc.
• unstable medical or mental health condition (study staff will review)
Conditions: Diabetes & Endocrine, Heart & Vascular, Prevention & Wellness
Keywords: behavior change, community engaged research, diabetes, physical activity, sedentary behavior, T2D
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE)

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000513
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Inclusion Criteria:

• at least 18 years old
• diagnosis of Peripheral Artery Disease (PAD) with leg symptoms
• BMI 25kg/m2 or more
Exclusion Criteria:

• above or below knee amputation, critical limb ischemia, or wheelchair confinement
• walking is limited by a condition other than PAD
• heart attack or stroke in the past 3 months
• medical or mental health disease that will interfere with study participations (study staff will review)
• currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• unwilling/unable to use a smart phone and unwilling to attend weekly study sessions
• unable to speak English
Conditions: Heart & Vascular
Keywords: cocoa, intercede, pad, peripheral arterial disease, peripheral artery disease, prove
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Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

This study will enroll children aged 6 to 12 years who have difficulty in maintaining a healthy weight and see if the medication Vyvanse may help them to reduce their weight.

Principal Investigator: Claudia Fox
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019097
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Inclusion Criteria:

• children 6 to 12 years old
• severe obesity defined as BMI greater than or equal to 1.2 times the 95th percentile
• failed attempt of lifestyle therapy
Exclusion Criteria:

• significant congenital or structural heart disease or arrhythmia
• hypertension
• history of chemical dependency
• Diabetes mellitus (type 1 or 2)
• current or recent ( less than 3 months ago) use of anti-obesity medication(s)
• additional medical or mental health conditions (study staff will review)
Conditions: Children's Health, Diabetes & Endocrine
Keywords: healthy weight, Obesity
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Post-contracture release radiation for Dupuytren's disease

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Principal Investigator: Kathryn Dusenbery
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00002191
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Inclusion Criteria:

• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

• people who have Dupuytren's disease and are not currently seeking treatment
Keywords: Dupuytren Contracture, Dupuytren's Disease
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Proteomics of Post-Operative Complications in Patients undergoing CABG

This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.

Principal Investigator: Brian Steffen
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018957
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Inclusion Criteria:

• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
Exclusion Criteria:

• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
Conditions: Heart & Vascular
Keywords: Coronary Artery Bypass Graft (CABG), Heart Surgery
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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.

Principal Investigator: Jen Poynter
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: 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
Conditions: Cancer, Microbiota, Prevention & Wellness
Keywords: Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS, D2D
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A randomized, double-blind, placebo- controlled study of LMN-201 for prevention of C. difficile infection recurrence (RePreve)

This study is recruiting people who have developed an infection of the lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff). The standard treatment for this infection is with antibiotics, but in some people, the infection keeps coming back. The purpose of this research is to test whether an investigational drug can prevent a return of the infection. We want to make sure LMN-201 is safe when used as part of standard of care for C. diff, and we want to see if we can improve treatment and reduce re-infection.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022202
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Inclusion Criteria:

• diagnosis of Clostridioides Difficile Infection (CDI) defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency and a positive stool C. difficile toxin B immunoassay and no other likely explanation for diarrhea
• able to take oral medication and willing to adhere to the study medication
• have access to a mobile smartphone
• women and men of reproductive potential must use of highly effective contraception during study participation and for an additional 4 weeks after the end of study drug administration
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• violent diarrhea from C. difficile colitis
• Underlying gastrointestinal disorder characterized by diarrhea such as chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, etc.
• women who are pregnant, trying to get pregnant or breast feeding
Conditions: Infectious Diseases
Keywords: C-Diff, CDI, Clostridioides Difficile Infection
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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.

Principal Investigator: Nathaniel Gaeckle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001599
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Inclusion Criteria:

• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
Exclusion Criteria:

• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs
Conditions: Respiratory System
Keywords: COPD
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The TrialNet Natural History Study of the Development of Type 1 Diabetes

TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: SITE00000016
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Inclusion Criteria:

• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:

• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Conditions: Diabetes & Endocrine
Keywords: T1DM, Type 1 Diabetes

Understanding modifiable barriers to treatment adherence in youth with type 2 diabetes to inform intervention development

This study will seek to learn about barriers to management of Type 2 diabetes for children ages 10-17. This study is recruiting children, and their parent/guardian, who are managing with oral medication or insulin.

Principal Investigator: Amy Noser
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019484
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Inclusion Criteria:

• 10 to 17 years old
• confirmed diagnosis of type 2 diabetes
• prescribed pharmacologic therapy for treatment of type 2 diabetes (oral medication or insulin)
• live with a parent/caregiver at least 50% of the time who is willing to participate in the study
• able to read and speak English
• the parent/caregiver must be the adult who spends the largest proportion of time caring for the child (or at least 50%) & able to speak and read English
Exclusion Criteria:

• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
Conditions: Children's Health, Diabetes & Endocrine
Keywords: Type 2 Diabetes
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Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents

Risk for suicidal behavior in young people may include particular types of brain functions. The goal of this research is to learn more about the biology of the brain as it relates to suicidal thoughts and behaviors.

Principal Investigator: Charles Lewis
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00011433
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Inclusion Criteria:

• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
Healthy volunteers
also needed
Exclusion Criteria:

• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Conditions: Children's Health, Mental Health & Addiction
Keywords: Depression, Suicide, Adolescent
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CMRR Healthy Participant Registry

The purpose of this Health Participant Registry is to collect the names, contact information and answers to safety screening questions that assist in the determination of magnetic resonance (MR) compatibility of individuals who have expressed interest in MR research.

Principal Investigator: Jeramy Kulesa
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: 00015977
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Inclusion Criteria:

• at least 18 years old
• English speaking
• able to have a MRI scan, must complete assessment
Exclusion Criteria:

• women who are pregnant
Keywords: Imaging, MRI
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MT2021-26: Ruxolitinib for Early Lung Dysfunction after HSCT: a Phase II Study (HSCT)

While hematopoietic stem cell transplant (HSCT) is an effective therapy, as many as 25% of patients develop problems with their lungs as a result of this treatment. Bronchiolitis obliterans (BO) is a type of lung injury after HSCT due to graft versus host disease. BO is commonly diagnosed late in patients, when lung injury is hard to treat and can be irreversible, leading to long-term lung disease or even death. The purpose of this research is to learn more about ruxolitinib as an early treatment for lung injury and BO after HSCT. Patients who are diagnosed with early lung dysfunction will be eligible for this research study.

Principal Investigator: Samuel Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014986
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Inclusion Criteria:

• 5 to 60 years old
• undergone allogeneic HCT and experiencing respiratory difficulty
• if able to become pregnant or father a child, must use two highly effective methods of birth control for 90 days after the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active uncontrolled pulmonary infection
• women who are pregnant or breast feeding
• treated with investigational agent for GVHD within the 30 days prior to first dose of study treatment
Conditions: Cancer
Keywords: GVHD, Hematopoietic Stem Cell Transplant, HSCT, Lung, Respiratory
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See this study on ClinicalTrials.gov

Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma

To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.

Principal Investigator: Christopher Moertel, MD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1606M89501
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Inclusion Criteria:

• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
Exclusion Criteria:

• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
Conditions: Cancer, Cancer
Keywords: OPG, Optic Pathway Glioma
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)

The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022419
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Inclusion Criteria:

• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Exclusion Criteria:

• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
Conditions: Rare Diseases, Infectious Diseases
Keywords: C. Diff Infection, CDI, Clostridium Difficile, Clostridium Difficile Infections, Diarrhea
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See this study on ClinicalTrials.gov