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A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023107
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
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An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.

Principal Investigator: Gautam Jha
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018433
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
Conditions: Cancer
Keywords: Urothelial Carcinoma
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SUSTAINED RELEASE ORAL FORMULATION FOR TREATMENT OF PARKINSON'S DISEASE

Medications used to treat Parkinson's disease will be delivered using a sachet ; placed in the oral/buccal cavity (between cheek and gum of lower jaw). This study may be a good fit for you if you are healthy, between the ages of 18 and 65, and aren’t currently taking regular medications. We expect that you will be in this research study for one visit, approximately 7 hours total. Compensation and transportation expenses will be provided.

Principal Investigator: Khalaf Bushara
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00024501
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Normal healthy
• 18-65 years of age
• Not currently taking medications regularly
• Able to fast 6 hours, only water allowed
Conditions: Brain & Nervous System
Keywords: Healthy adults
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Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Locally Advanced or Metastatic Solid Tumors

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Principal Investigator: Robert Kratzke
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019430
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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Acoustic analysis of voice, speech, and breath sounds in subglottic stenosis

This study is about understanding how subglottic stenosis (narrowing within the airway) affects voice, speech, and breathing sounds. Changes in airflow from airway narrowing can alter how the voice sounds, how speech is timed, and how breaths are taken during speaking. By using advanced, noninvasive sound analysis, we hope to identify patterns that may help detect airway narrowing earlier and track improvement after treatment.

Principal Investigator: Stephanie Misono
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027491
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 18 years of age
• diagnosis of subglottic stenosis by otolaryngologist and/or pulmonologist
• no known laryngeal or pulmonary comorbidities potentially contributing to voice or breathing problems (except asthma)
• able to read, write, and communicate in English
• Healthy Volunteers who will be matched by age & sex to study participants: at least 18 years of age, no known primary laryngeal or pulmonary comorbidities, no symptoms of shortness of breath and able to read, write, and communicate in English
Exclusion Criteria:

• current voice/resonance, breathing, or swallowing disorder
• women who are pregnant
• current upper respiratory infection
• Healthy Volunteers: women who are pregnant or upper respiratory infection or obstruction
Conditions: Breathing, Lung & Sleep Health, Ear, Nose & Throat, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), subglottic stenosis, SGS, airway narrowing
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The Parallel Auditory Brainstem Response

This study aims to test the accuracy and speed of the pABR for future clinical use by recruiting infants and adults with a range of hearing loss profiles from normal hearing to severe loss.

Principal Investigator: Melissa Polonenko
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: SITE00001873
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• 0-5 months of age
Conditions: Ear, Nose & Throat
Keywords: electrophysiology, Hearing, Hearing loss, Listening, audible
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RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

This study compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC061
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• HER2 negative unresectable or metastatic adenocarcinoma of esophagus, gastroesophageal junction, or stomach
• have not received any prior treatment for this occurrence
• prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year ago
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• untreated, symptomatic brain metastasis
• allogeneic tissue/organ transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Esophageal cancer, Gastric cancer
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MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma

This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020893
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma
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A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Letermovir (MK-8228) is a medication that is used to prevent cytomegalovirus (CMV) infection and disease. This trial is testing letermovir in children and adolescents who weigh less than 40 kilograms and have had a kidney transplant. Letermovir is experimental in this trial. Everyone in this trial will get letermovir. The dose a child gets will depend on their weight at the start of the trial. The child, the trial doctor and the trial staff will know your child is getting letermovir and what dose they are getting.

Principal Investigator: Shannon Andrews
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026525
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Sex: Male or Female
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 17 years old
• recipient of a primary or secondary allograft kidney
• at least 4 weeks posttransplant and not more than 52 weeks posttransplant
• has stable kidney function since the transplant
• able to take letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube
• weighs ≥2.5 and <40 kg at enrollment (5.5 to 88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• has CMV disease
• on dialysis or plasmapheresis
• multi-organ transplant recipient (e.g., kidney-pancreas)
• any uncontrolled infection
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Children's Health, Infectious Diseases, Kidney, Prostate & Urinary
Keywords: CMV, cytomegalovirus, kidney transplant
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Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women with Posttraumatic Stress Disorder (PTSD)

This research study is being done so that we can better understand why women with post-traumatic stress disorder (PTSD) may have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women. The study is also testing whether a dietary supplement called beetroot juice might help improve the function of blood vessels in women suffering from PTSD. Study participation involves coming to the University of Minnesota campus in Minneapolis for two visits. Each of the visits with take about 3 and a half hours.

Principal Investigator: Ida-Arlaine Fonkoue
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00027129
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• Adults >18 years old and <40 years
• Women
• Premenopausal
• Trauma-exposed
• PTSD
Exclusion Criteria:

• Hypertension
• Any cardiovascular disease
• Medications for cardiovascular diseases
• Any gastrointestinal diseases
Conditions: Women's Health
Keywords: Posttraumatic stress disorder (PTSD), Premenopausal women, Trauma: Mental Health, Heart Health

Neural Mechanisms of Closed-loop Phase-locked Transcranial Magnetic Stimulation

We are investigating ways to improve methods of brain stimulation. The purpose of this study is to try a new way to deliver transcranial magnetic stimulation (TMS) to the brain. Participants will be asked to come in for three separate 4-hour research visits. Each research visit will take place approximately seven days after the previous one. During the research visits, we will put a mesh cap on the head to measure electrical activity in the brain (also known as an EEG). Once the cap is on, we will use a transcranial magnetic stimulation (TMS) device to deliver small pulses of electricity to the brain to see how it reacts to the stimulation.

Principal Investigator: Alik Widge
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020385
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Sex: Male or Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• adults (Age 18 to 65) without any psychiatric diagnoses
• adults (Age 18 to 65) with depression diagnosis
Exclusion Criteria:

• diagnosed with a psychiatric disorder other than depression
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of or recent withdrawal from medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or an implanted medical device
Conditions: Mental Health & Addiction
Keywords: brain stimulation, EEG, healthy control, TMS, transcranial magnetic stimulation, depression
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Obesity and Heart Failure (MARITIME-HF)

This study is being done to learn more about maridebart cafraglutide (MariTide [formerly AMG 133]) for people with heart failure (HF) and obesity in addition to their routine medical care. Participants will receive treatment with either MariTide or a placebo, which will be called a study drug. A placebo looks the same as the investigational medicine but contains no actual medicine.

Principal Investigator: Tamas Alexy
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026740
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age ≥ 18 years
• BMI ≥ 30 kg/m2 at screening
• diagnosis of heart failure
• NYHA Class II-IV
• left ventricular ejection fraction of of at least 40%
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Type 1 diabetes
• acute or chronic hepatitis
• history of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior, any prior suicide attempt, or history of self injury in past 5 years
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Heart & Vascular
Keywords: body mass index (BMI) 30 kg/m2, Clinics and Surgery Center (CSC), heart failure (HF) with preserved or mildly reduced EF, obesity
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MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

Principal Investigator: Mark Juckett
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021552
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), blood cancer, hematopoietic stem cell transplantation (HSCT)
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Detecting Ovarian Cancer by Analyzing Volatile Organic Compounds (VOCs) in Human Breath

The purpose of this study is to evaluate the ability of a device (Vocxi Health’s MyBreath Print®) to capture and measure volatile organic compounds (VOCs) in breath samples from women who have a pelvic mass and will be having surgery. The ultimate goal is to develop a screening test for ovarian cancer. We expect that study will take approximately 45 minutes and breath samples will be obtained before and after surgery.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022603
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women who have a pelvic mass and will have surgery
• diagnosis of ovarian, fallopian tube or primary peritoneal cancers or women with a non-malignant ovarian mass (excluding low malignant potential tumors)
• no prior history of cancer
Exclusion Criteria:

• unable to tolerate normal breathing while wearing device mask
Conditions: Cancer
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015805
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-Cell Non-Hodgkin Lymphoma, B-NHL
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A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes

The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.

Principal Investigator: Antoinette Moran
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024994
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot study

The trial offers women with ductal cell carcinoma in situ (DCIS) 6 months of neoadjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.

Principal Investigator: Jane Hui
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022523
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of HR+ DCIS (at least 50% ER or PR (from biopsy at diagnosis) with or without microinvasion
• may have received endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• breast cancer is invasive
• unable to swallow tablets or capsules
• gastrointestinal conditions that would interfere with absorption of medication -- see link to clinical trials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer, DCIS
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MN CF Center Consent (PortCF) Cystic Fibrosis (CF) Center Program Accreditation and Funding

This retrospective, longitudinal project is to collect certain demographic and clinical health status information for entry into the CF Foundation Patient Registry (also known as PortCF). The registry has played an important role in CF research and will continue to do so. In addition, much of the same information is entered into the University of Minnesota Cystic Fibrosis Center Research Database. This patient database has been maintained since 1975.

Principal Investigator: Sarah Kiel
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 7405M00054
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• possible diagnosis of Cystic Fibrosis (CF) or CF-related complications
• receive care at the MN CF Center
Keywords: Clinics and Surgery Center (CSC), cystic fibrosis, CF, MNCF
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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Principal Investigator: Elliot Arsoniadis
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017257
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Sex: Male
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Conditions: Cancer, Prevention & Wellness
Keywords: Anal Cancer
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EX-VIVO TARGETED TREATMENT OF CANCEROUS EXTIRPATED PROSTATE TISSUE

This study focuses on testing new treatments on prostate tissue that has been removed during surgery. All testing is done in a lab setting to help develop and improve potential treatment options.

Principal Investigator: Christopher Warlick, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00010808
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• scheduled to undergo a radical prostatectomy
• able to understand and provide informed consent
Conditions: Cancer, Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Solar-Stage)

The purpose of this study is to test the safety and effectiveness of Copper Cu 64 PSMA I&T in detecting lesions during a PET scan. This study is open to men with newly diagnosed prostate cancer who plan to have a prostatectomy and lymph node removal. Copper Cu 64 PSMA I&T is an investigational PET imaging agent, given to you via IV injection, similar to the way other imaging agents are used in many other types of scans. Cu 64 specifically targets the prostate specific membrane antigen (PSMA) that is found on the surface of metastatic prostate cancer cells. Increased image contrast may make it easier for the doctor to see smaller lesions compared to other imaging agents.

Principal Investigator: Subodh Regmi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022112
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed with prostate adenocarcinoma with intermediate / high risk features
• planned prostatectomy with pelvic lymph node dissection
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received any therapy for prostate cancer before surgery
• not able to have a PET scan
• had a prostate-specific membrane antigen (PSMA) PET scan in the past 90 days
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000965
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
Exclusion Criteria:

• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML
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Evaluation of Microbiota Transplant Therapy in Patients with Alopecia Areata

The purpose of this study is to determine if microbiota transplant therapy (MTT) is an effective treatment for patients with alopecia areata, alopecia totalis, and alopecia universalis. We will be testing two different ways of doing the Microbiota transplant therapy (MTT): half the people who choose to be part of this study will take antibiotics before the transplant and half will take placebo antibiotics. We will collect 5 types of samples (2 or more times during the study): blood samples, skin samples, skin swabs, hair, and fecal samples.

Principal Investigator: Maria Hordinsky
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023721
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years of age
• moderate to severe alopecia areata with at least 30% scalp hair loss
• hair loss lasting for at least 3 months
• must be willing to stop using other types of medications to treat Alopecia Areata throughout the study
• evidence of active, ongoing regrowth of hair
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active medical conditions or cancer
• current gastrointestinal infection or use of antibiotics
• current treatment for gastrointestinal diagnosis or previous GI surgery (past 3 months)
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: alopecia, Hair loss
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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years& Less than 18 Years of Age with Alopecia Areata

We are conducting a research study for children ages 6-17 with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.

Principal Investigator: Maria Hordinsky
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001967
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• children 6 to 18 years old
• at or above the 5th percentile of weight for age
• diagnosis of Alopecia Areata (AA) for at least 1 year
• current AA episode of at least 6 months duration with hair loss encompassing 50% or more of the scalp
• history of trial and failure with at least 1 available treatment
• history of psychological counseling related to AA
Exclusion Criteria:

• primarily diffuse type of AA (characterized by diffuse hair shedding)
• currently experiencing other forms of alopecia including, but not limited to: trichotillomania, TE, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis)
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: AA, Alopecia Areata, hair loss
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COG AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients (≥1 year and < 22 years ) with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000160
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 1 to 21 years old
• must have B Acute Lymphoblastic Leukemia (B-ALL), or previously diagnosed B lymphoblastic lymphoma (B-LL)
• Patients with one of the following: Second or greater relapse; Primary refractory disease with at least 2 prior induction attempts; First relapse refractory to at least one prior re-induction attempt; OR Any relapse after HSCT (Cohort 1 ONLY)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• currently receiving another investigational drug
• currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
Conditions: Cancer
Keywords: B-LL, Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma. B-ALL
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MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)

CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001764
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CGD, Chronic Granulomatous Disease, Gene Therapy, GT, HCT, Hematopoietic Cell Transplant
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Principal Investigator: Douglas Yee, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00011111
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Conditions: Cancer
Keywords: Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2, Clinics and Surgery Center (CSC)

SMART Bottle Phase II

Feeding problems are common among preterm infants. Left untreated they can cause problems that impact an infant’s ability to breathe and get the necessary nutrition they need to grow. In this study, we will learn how healthy term infants without feeding impairments feed. The SMART bottle system is made up of a disposable pressure-sensing nipple that monitors suction pressures during a feed, a wireless module that collects the measurements and sends them over Bluetooth to a tablet receiver. This system is compatible with Dr. Brown’s bottle systems. This part of the study will include 50 preterm infants.

Principal Investigator: Katlyn McGrattan
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00022597
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• Infant born full term
• Infant <7 months old
• Infant receives nutrition at least partially via bottle
Exclusion Criteria:

• Feeding impairments
• Poor weight gain
• Conditions impacting feeding
Conditions: Breathing, Lung & Sleep Health, Children's Health, Digestive & Liver Health
Keywords: Bottle, Bottle feeding, Feeding, nutrition, suck, swallow
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PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001347
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
Conditions: Cancer
Keywords: recurrent cancer, refractory cancer, solid tumors
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PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001450
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
Conditions: Cancer, Cancer
Keywords: Brain Cancer, Glioma, Recurrent Lymphoma
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