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412 Study Matches

Effectiveness of Screening and Decolonization of S. aureus to Prevent S. aureus Surgical Site Infections in Surgery Outpatients

The purpose of this study is to determine the most effective ways to get rid of Staph aureus on body surfaces before surgery. We will determine if the participants can effectively get rid of the bacteria with the simple application of various treatment methods assigned to them. We will study if these methods are useful and cost effective in preventing the infections after surgery.

Susan Kline, MD
18 years and over
This study is also accepting healthy volunteers
STUDY00019575
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Inclusion Criteria:

• at least 18 years old
• people who are scheduled for orthopedic, urology, neuro, otolaryngology, plastic and general surgery or OB/GYN surgery
• surgery is scheduled for at least 10 days following entry into the study
• have not taken antibiotics in the week before surgery
• will have a skin incision
Exclusion Criteria:

• surgery scheduled less than 10 days after the baseline cultures
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FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults with Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis (Aim 3)

The purpose of this study is to implement an intervention using a Follower, Action plan, and remote Monitoring (FAM) of glucose data to reduce severe hyperglycemia in adults with Type 1 Diabetes Mellitus at risk for diabetic ketoacidosis. You and your chosen “follower” (family member, caregiver, or friend) will be asked to attend 6 visits (in- person or remote) as a pair (“dyad”) with the study team that will last up to 30 minutes to 2 hours each across a span of 4 months.

Jacob Kohlenberg
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020104
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Inclusion Criteria:

• ages 18 to 65
• people with Type 1 Diabetes (T1DM) for at least 1 year
• HbA1C between 7.5% and 14.0%
• "Follower" (family member, friend, or caregiver who is at least 18 years old), willing to participate in the study and follow glucose data and has no self-reported cognitive impairment
Exclusion Criteria:

• active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
• active cancer with the exception of non-melanoma skin cancer
• receiving hospice care
Diabetes & Endocrine
T1DM, Type 1 Diabetes
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia

This is a long-term registry is designed to collect data on hypophosphatasia (HPP) to better understand the condition and learn more about the disease, how patients feel about living with HPP and effect of HPP on the patients wellbeing and health. The study will look at participant’s medical records and health questionnaires about the health status of patients. This study collects observational data from clinical care and does not involve any treatment for HPP or administration of medication for HPP.

Kyriakie Sarafoglou
Not specified
This study is NOT accepting healthy volunteers
STUDY00004936
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Inclusion Criteria:

• confirmed diagnosis of HPP.
• documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
• able to read and speak English
Exclusion Criteria:

• currently participating in an Alexion-sponsored clinical trial
Rare Diseases
HPP, Hypophosphatasia
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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.

Reza Talaie
18 years and over
This study is NOT accepting healthy volunteers
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
Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Clinics and Surgery Center (CSC), Osteoarthritis
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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.

Elliot Arsoniadis
18 years and over
This study is also accepting healthy volunteers
STUDY00017257
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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
Cancer, Prevention & Wellness
Clinics and Surgery Center (CSC), Anal Cancer
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MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Paul Orchard
Up to 55 years old
1406M51542
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Inclusion Criteria:
0 through 55 years of age Adequate graft available Adequate organ function Eligible Diseases: Mucopolysaccharidosis Disorders: MPS IH (Hurler syndrome) MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype MPS VI (Maroteaux-Lamy syndrome) MPS VII (Sly syndrome) Glycoprotein Metabolic Disorders: Alpha mannosidosis Fucosidosis Aspartylglucosaminuria Sphingolipidoses and Recessive Leukodystrophies: Globoid cell leukodystrophy Metachromatic leukodystrophy Niemann-Pick B patients (sphingomyelin deficiency) Niemann-Pick C subtype 2 Peroxisomal Disorders: Adrenoleukodystrophy with cerebral involvement Zellweger syndrome Neonatal Adrenoleukodystrophy Infantile Refsum disease Acyl-CoA-Oxidase Deficiency D-Bifunctional enzyme deficiency Multifunctional enzyme deficiency Alpha-methylacyl-CoA Racmase Deficiency (AMACRD) Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE) Severe Osteopetrosis (OP) Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation) Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others. Voluntary written consent
Exclusion Criteria:
Pregnancy - menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols) Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)
Clinics and Surgery Center (CSC)
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Neptunia A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants receiving Standard of Care

This research is studying enpatoran (M5049) as a possible treatment for dermatomyositis (DM) and polymyositis (PM). The study will last for approximately 31 weeks (upto 9 study visits) and an additional optional 24 weeks (upto 5 study visits) if you agree to participate in the extension period for a total of up to 14 months (55 weeks). It will include approximately up to 3 telephone calls from the study center. The main activities in the study include: providing consent to participate, performing tests to check your health throughout the study (such as physical exams, electrocardiogram (ECG) testing, collection of urine and blood draws for laboratory testing), study drug dosing and recording relevant information in the study diary, and performing tests, completing questionnaires and assess signs and symptoms of your condition. This is a Phase 2a study. and it is anticipated that approximately 40 people will participate in this study.

David Pearson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001761
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Inclusion Criteria:
Adults with primarily diagnosed with Dermatomyositis (DM) or Polymyositis (PM)
Exclusion Criteria:
Diagnosis of myositis within 3 years of cancer
Dermatology (Skin, Hair & Nails)
Dermatomyositis (DM), Polymyositis (PM)
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MT2022-30: A double-blind, randomized, placebo-controlled, interventional, multicenter, phase llI clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB)", allo-APZ2-EB-III

This is a study of an investigational drug (also known as the “study drug”) called allo-APZ2-OTS as a possible treatment for RDEB. The study drug contains allogeneic dermal ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs). These cells suppress inflammation and produce proteins that are important for wound healing. The study drug is expected to counteract local inflammation, improve wound healing and skin strength, and speed up wound closure.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
SITE00001758
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Inclusion Criteria:

• confirmed diagnosis of RDEB or JEB
• wound meeting the following criteria: 5-50 cm, present for at least 21 days and less than 9 months without signs of acute infection
• women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial
Exclusion Criteria:

• current cancer diagnosis including squamous cell carcinoma and basal cell carcinoma
• women who are pregnant or breast feeding
• clinically significant or unstable medical or mental health diagnosis (study staff will review)
Rare Diseases
EB, Epidermolysis Bullosa, RDEB
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MT2017-17:T Cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in patients with Inherited Bone Marrow Failure (BMF) Disorders

The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00003182
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Inclusion Criteria:

• up to 65 years of age
• have a diagnosis of Fanconi anemia
• have a suitable donor for peripheral blood cells
• women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• see link to clinicaltrials.gov for additional criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• cancer within previous 2 years
Blood Disorders, Rare Diseases
Clinics and Surgery Center (CSC), Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
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A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)

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

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

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

• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
Clinics and Surgery Center (CSC), Glomerulonephritis, IC-MPGN
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Arthritis & Rheumatic Diseases, Cancer
juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma Protocol Number: CA224069 (RELATIVITY-069)

CA224069 is an open-label, Phase 1/2 clinical trial of relatlimab + nivolumab in children, adolescents and young adults with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) and Non-Hodgkin Lymphoma (NHL). Part A will encompass safety and dose determination of relatlimab + nivolumab. Part B will be composed of an expansion cohort of cHL (Cohort 1) and an exploratory assessment in NHL (Cohort 2).

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00001545
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Inclusion Criteria:

• up to 30 years old
• pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL)
Exclusion Criteria:

• aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia
• prior autologous stem cell transplantation (HDCT/ASCT)
• see link to clinicaltrials.gov for additional exclusion criteria
Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
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A Phase III, multicentre, randomised, double-blind, placebo-controlled study to investigate the efficacy, safety, and tolerability of COMP360 in participants with treatment-resistant depression

COMP360 is a human-made form of the naturally occurring chemical compound, psilocybin which may help in treating depression. In this research study we are comparing COMP360 to placebo, when administered with psychological support from a trained study therapist. Placebo is a substance that has no active medical ingredients and is commonly used in research studies to see if the investigational drug works better or is as safe as not taking anything at all.

Ziad Nahas
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020807
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Inclusion Criteria:

• diagnosis of major depression without psychotic features
• if the current major depressive episode is the first episode of depression, the length of the current episode must be at least 3 months and no more than 2 years
• have not responded to an adequate dose and duration of two, three, or four different medications to treat the current episode
• agree to discontinue all prohibited medications (study staff will review)
Exclusion Criteria:

• any additional major mental health diagnosis
• required psychiatric inpatient care in the past 12 months
• treatment with electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
• transcranial magnetic stimulation within the past six months
• in a psychological therapy program that will not remain stable for the duration of the study
Mental Health & Addiction
TRD, Treatment Resistant Depression
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients (365 Days to 31 Years) with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000644
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Inclusion Criteria:

• Age: patients must be > 365 days and < 10 years of age (B-ALL patients without Down Syndrome-DS) OR no more than 31 years of age (B-ALL patients with DS) OR no more than 31 years of age (B-LLy patients with or without DS)
• Diagnosis: Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a BM aspirate; OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000 circulating leukemic cells;
• OR Patient has newly diagnosed B-cell LLy Murphy Stages I or II, with or without Down syndrome
• White Blood Cell Count (WBC) Criteria: B-ALL patients without DS must have an initial white blood cell count < 50,000
• B-ALL patients with DS are eligible regardless of the presenting WBC
Exclusion Criteria:

• Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
• Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731
• Patients requiring radiation at diagnosis
• Female patients who are pregnant or breastfeeding their infants
Cancer, Children's Health
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Down Syndrome
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Self-Weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot

This study will test whether adding in daily weighing (5-7 days per week) is helpful in weight loss. In adults, it has been found to be helpful to have individuals who are obese to be more successful with their weight loss efforts if they weigh themselves at home every day. We want to see if this could be helpful in children as well. This research will last for about 12 weeks (3 months).

Carolyn Bramante
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00012679
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Inclusion Criteria:

• aged 12 to <18 years
• BMI at the 95th percentile or greater
• weight loss or maintenance determined as the treatment goal by PWMC provider
Exclusion Criteria:

• any unhealthy weight control behaviors
• participation in other PWMC study
• developmental delay
• diagnosis that might cause weight fluctuations in weight
• severe anxiety or depression
Children's Health
children's health, obesity, weight, weight management
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MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) (MAYFLOWERS)

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

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

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

• none
Rare Diseases, Respiratory System
Clinics and Surgery Center (CSC), Cystic Fibrosis, Pregnancy
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PEPN2121 : A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that that has either come back (relapsed) or does not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, which is related to having more aggressive cancers that are harder to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001713
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Inclusion Criteria:

• patients must be >= 12 months of age at the time of study enrollment. For part A, patients must be <18 years old at enrollment. For part B, there is no upper age limit
• patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors verified through institutional immunohistochemistry (IHC) or molecular confirmation of a pathologic tumor bi-allelic SMARCB1 (INI1) or SMARCA4 loss or mutation from a Clinical Laboratory Improvement Act (CLIA) certified lab
• see link to clinicaltrials.gov for complete eligibility criteria
Exclusion Criteria:

• patients who have undergone allogeneic bone marrow or stem cell transplant are not eligible
• patients with known, untreated CNS metastases will be excluded
Cancer
Malignant Solid Neoplasm
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Uplifting Equitable Park Use and Promoting Physical Activity among African American Families in Minnesota: A Culturally-Responsive, Community-Engaged Approach

This is a study about a special park program built for kids and families who identify as African American or Black, live in the Twin Cities region, and participate in less physical activity than is recommended. This research study takes approximately 4 months, from June to September, with 1 additional visit in May. All activities will happen at French Regional Park, in Plymouth, MN.

Junia de Brito
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00021480
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Inclusion Criteria:

• African American parent and child aged 8-12 years old
• live in the Twin Cities metropolitan area
• participating in less than 60 minutes/day and 150 minutes/week of physical activity
• willing to attend weekly activities at French Regional Park in Plymouth, MN, for 12 to 16 weeks
• live with participating parent or caregiver at least half of the time
• able to read and speak English
Exclusion Criteria:

• currently doing 150 minutes or more physical activity per week for adults or more than 60 minutes per day for children
• unable to be physically active
• currently pregnant or planning to become pregnant or breastfeeding
Children's Health, Community Health, Prevention & Wellness
African American, children, nature, parents, park, physical activity, wellbeing
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Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to the potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its endogenous synthesis from nornicotine. The proposed study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also investigate the effect of the reduction of nornicotine content in smokeless tobacco on the extent of endogenous NNN formation. The knowledge gained in this study will lead to the development of recommendations for the regulation, or potentially elimination, of nornicotine in smokeless tobacco products in order to minimize exposure to NNN in the users of these products.

Irina Stepanov
18 years and over
This study is also accepting healthy volunteers
STUDY00002464
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Inclusion Criteria:

• ages 18 to 65
• smokeless tobacco user of at least 3 tins of product per week for 6 months
• used the same brand for greater than 80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks before starting the study
• not smoking or using any other nicotine or tobacco product in the past 2 weeks
• good physical health (no unstable medical condition) and good general oral health
• good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse)
Exclusion Criteria:

• regular smoking or tobacco use (e.g., greater than once a week)
• currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products
• women who are pregnant, planning to become pregnant, or breast feeding
• significant immune system disorders, respiratory diseases, kidney or liver diseases
Respiratory System
Smokeless Tobacco
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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.

Colleen Rivard
18 years and over
This study is NOT accepting healthy volunteers
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.
Cancer, Women's Health
Cervical Cancer
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Atherosclerosis Risk in Communities (ARIC) Study - Visits Component

The purpose of the Atherosclerosis Risk in Communities (ARIC) Study - ARIC Generation 2 research study is to evaluate the link between glucose and heart problems in adults with type 2 diabetes. Heart problems can be common in people with type 2 diabetes. We are interested in measuring your blood sugar (glucose) using a continuous glucose monitor and monitoring your heart rhythm at the same time.

Pamela Lutsey
18 years and over
This study is NOT accepting healthy volunteers
SITE00001721
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Inclusion Criteria:

• Have a diagnosis of Type II Diabetes
• Age 50-80 years old
• Be willing to wear a continuous glucose monitor and heart rhythm monitor for two weeks
• Fluent English speaker
Exclusion Criteria:

• Pacemaker
• Allergy to adhesive tape
• Planning to move away from the Minneapolis area in the next four years
• Live in nursing home/long-term care facility
• diagnosed with dementia or unable to consent for self
Diabetes & Endocrine, Heart & Vascular
aging, cognition, heart disease, Type 2 Diabetes, ARIC
Visit study website
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DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The purpose of this research is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy (at a lower dose) treatment versus using docetaxel alone (at the usual dose). The addition of radium-223 to docetaxel could be a better cancer treatment than just docetaxel alone, but it could also cause additional side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Gautam Jha
18 years and over
This study is NOT accepting healthy volunteers
SITE00001099
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Inclusion Criteria:

• at least 18 years old
• diagnosis of prostate cancer
• confirmed progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• two or more bone lesions
• serum testosterone less than 50 ng/dL
• able to walk, carry out light work, and care for self independently
Exclusion Criteria:

• received four or more systemic anticancer regimens for mCRPC (study staff will review) -received any prostate cancer chemotherapy for mCRPC
• any other serious illness or medical condition
Cancer
Clinics and Surgery Center (CSC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate Cancer, Prostate Cancer
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MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)

The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).

Patrick Nachman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019751
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
Exclusion Criteria:

• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
Immune Diseases
Clinics and Surgery Center (CSC), Lupus, Lupus Nephritis, SLE, Systemic Lupus Erythematosus
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Biomarkers of Exposure and Effect in SREC Users

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

Irina Stepanov
18 years and over
This study is also accepting healthy volunteers
STUDY00002033
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Inclusion Criteria:
Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine; Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product; Biochemically confirmed regular smoking status by a NicAlert test level of 6; Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group); No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures); Subjects are in good physical health (no unstable medical condition); Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse); Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes; Women who are not pregnant or nursing or planning to become pregnant; Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:
Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes; Currently using nicotine replacement or other tobacco cessation products; Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data; Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional); Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional); Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional; Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once; Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once; Pregnant or breastfeeding; Failure to agree to take adequate protection to avoid becoming pregnant during the study; Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once): Systolic BP greater than or equal to 160 mm/hg Diastolic BP greater than or equal to 100 mm/hg Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Heart rate greater than or equal to 105 bpm Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) Expired air carbon monoxide (CO) level greater than 80 ppm; Self-reported allergies to propylene glycol or vegetable glycerin; Adverse reactions when previously using electronic cigarettes; Household member enrolled in the study concurrently; Unable to read for comprehension or completion of study documents; Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Prevention & Wellness
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017906
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Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Boris Winterhoff
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014893
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Inclusion Criteria:

• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:

• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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Development of Tobacco Related Biomarkers

To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.

Stephen Hecht, PhD
18 years and over
This study is also accepting healthy volunteers
STUDY00021394
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Inclusion Criteria:
This study is recruiting people who fit one of the following:
• smokes cigarettes daily
• vapes daily
• uses smokeless tobacco
• smokes cigars
• uses nicotine gum, lozenges, patches, nasal spray, pouches, or inhaler
• formerly smoked cigarettes daily
Exclusion Criteria:

• younger than 21 years old
• smokes or vapes marijuana
Community Health, Prevention & Wellness
chewing, cigarettes, cigars, nicotine, smokeless tobacco, smoking, tobacco, vaping, gum, patches
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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.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001450
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Inclusion Criteria:

• 12 months to 30 years old
• 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
Cancer, Cancer
Brain Cancer, Glioma, Recurrent Lymphoma
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