Search Results
PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA
The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.
• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
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.
• 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
• 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
MT2025-36: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
This study is about treatment of Melanoma (a kind of skin cancer) that has spread or cannot be surgically removed and has gotten worse after standard treatments. This study includes patients with melanoma from any part of the body except the eye. The main purpose of this study is to learn if the study medicine (tebentafusp), alone or a combination with pembrolizumab, helps patients with advanced melanoma live longer. The combination of pembrolizumab and tebentafusp used in this study is experimental.
• unresectable Stage III or Stage IV non-ocular melanoma
• may not be able to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• diagnosis of ocular or metastatic uveal melanoma
• history of a another type of cancer
• unable to be retreated with pembrolizumab because of a previous severe side effect
• significant pulmonary or cardiac disease or impaired lung or cardiac function
• known psychiatric or substance abuse disorders
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases
This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.
• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.
Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.
• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
PEPN2411; DT2216 (NSC#850950, IND# 170973) in combination with irinotecan for children, adolescents and young adults with relapsed or refractory solid tumors: A Phase 1 study with Phase 2 feasibility cohort for fibrolamellar carcinoma
Primary Aims 1. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DT2216 in combination with intravenous irinotecan in patients with recurrent/refractory solid tumors. 2. To define and describe the toxicities of DT2216 in combination with irinotecan administered on this schedule in patients with recurrent/refractory solid tumors and patients with fibrolamellar carcinoma (FLC). 3. To characterize the pharmacokinetics of DT2216 in combination with irinotecan in patients with recurrent/refractory solid tumors and patients with fibrolamellar carcinoma (FLC). 4. To preliminarily define antitumor activity of DT2216 in combination with irinotecan in patients with recurrent/refractory solid tumors (within the confines of a Phase 1 study) and in patients with recurrent/refractory FLC.
• Phase 1: Relapsed & refractory solid tumor. Age: Patients between ≥ 1 year and ≤ 21 years of age at the time of study. Diagnosis: Patients with recurrent/refractory solid tumors excluding primary central nervous system tumors. Disease Status: Patients must have either measurable or evaluable disease.
• Phase 2: Fibrolamelar carcinoma. Age: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment. Diagnosis: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a CLIA-certified laboratory. Disease Status: Patients must have measurable disease.
• Pregnant or breast-feeding women.
• Concommitant meds: Corticosteroids, Investigational Drugs, Anti-cancer Agents, Anti-GVHD agents post-transplant, CYP-450 Interactions.
• Patients with lymphoma.
• Patients who have an uncontrolled infection.
VX21-522-001: A Phase 1 Multiple Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
This is a clinical research study exploring the safety and tolerability of a single dose of VX-522 for people with cystic fibrosis (CF) who are not expected to benefit from CFTR modulators.
• 18 to 65 years old
• Stable cystic fibrosis disease
• FEV1 at least 40%
• Specific CFTR gene mutations
• Uncontrolled asthma in the last year
• Oxygen saturation without oxygen therapy is >94%
• Severe liver disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58) (EF-41)
The current study aims at testing the efficacy of concomitant temozolomide, Optune and pembrolizumab compared to concomitant temozolomide, Optune and placebo, following preclinical and clinical evidence demonstrating the potential augmentation of the immune response against glioblastoma under this regimen.
• new diagnosis of Glioblastoma (GBM)
• recovered from surgery (if done)
• completed standard adjuvant chemoradiotherapy or radiotherapy (RT) with TMZ chemotherapy
• may be to do physically strenuous activity but able to walk able to carry out work of a light or sedentary nature, e.g., light house work, office work
• on stable or decreasing dose of corticosteroids
• received prior therapy with an anti-Programmed Cell Death 1 (PD-1), anti- Programmed Cell Death-Ligand 1(PD-L1), or anti Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4), OX 40, CD137)
• diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• known additional malignancy that is progressing or has required active treatment within the past 3 years
A double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)
Nerandomilast is being developed to treat lung fibrosis. This study is to test a drug called nerandomilast in people with SARD-ILD who also take an immunosuppressant medicine. Participants are put into 2 groups randomly, which means by chance and will receive either nerandomilast or placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any study drug. Participants will be in the study for about 7.5 to 13 months depending on when they join the study.
• diagnosis of systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD)
• lung function has not improved with immunosuppressant (IS) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• active vasculitis
• suicidal behavior in the past 2 years
• see link to clinicaltrials.gov for complete Exclusion criteria
MOMENTOUS study (iMpact Of an ecg ai ModEl oN The diagnosis Of pUlmonary hypertenSion) (MOMENTOUS)
The purpose of this study is to understand if a new tool will help improve early detection of pulmonary hypertension (PH) in patients with interstitial lung disease. Pulmonary hypertension is high blood pressure in the pulmonary artery (which carries blood from your heart to the lungs). We are testing a tool that looks at an electrocardiogram (ECG) to find patients who are identified as being high risk for having PH that is not yet diagnosed. Participation in this study will last approximately six months.
• diagnosis of interstitial lung disease
• diagnosis of pulmonary hypertension
• LV ejection fraction ≤ 40% on most recent echo or cardiac MRI
ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
• 180 days to < 22 years (at time of study enrollment)
• patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• see link to clinicaltrials.gov for complete inclusion criteria
• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• history of solid organ or hematopoietic bone marrow transplantation
• female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• lactating females who plan to breastfeed their infants are ineligible
• see link to clinicaltrials.gov for complete exclusion criteria
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine in platinum-resistant ovarian cancer
This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.
• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)
This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly.
• patients must be >= 12 months and =< 21 years of age at the time of enrollment on Step 0
• patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG
• see link to clinicaltrials.gov for complete inclusion criteria
• female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities
• lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk
LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons with Colorectal Cancer
The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer and their caregiver. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services as part of this research. Participation in this study lasts for up to 3 months.
• Participant has a diagnosis advanced stage (Stage III or Stage IV) colorectal cancer in the past 3 months, starting or planning to start systemic cancer therapy, able to identify a caregiver for study participation, and able to understand, speak, read, and write in English
• Caregiver: identified as a caregiver by a person who has colorectal cancer and able to understand, speak, read, and write in English
• see link to clinicaltrials.gov for complete Inclusion criteria
• does not have the ability to provide informed consent
MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)
The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.
• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Closed Loop and Education for hypoglycemia Awareness Restoration (CLEAR) (CLEAR)
The purpose of this study is to learn how to improve hypoglycemia unawareness - a condition where people with Type 1 Diabetes may not be able to tell how low their blood sugar levels are. This study will use different types of education and devices to see if they can help people become more aware when the blood sugar is low.
• 18 to 75 years old
• diagnosis of type 1 diabetes
• sometimes struggle to feel symptoms of low blood sugar
• have had diabetes for at least 10 years
• A1c no more than 10.5%
• able to read and speak English (because non-English versions of the tests and the educational materials are not available)
• see link to clinicaltrials.gov for complete Inclusion criteria
• medical conditions that limit participation in study activities, as determined by the physician (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
• active alcohol or drug abuse
• seizure disorder unrelated to hypoglycemia, unless seizure-free for at 12 months and on stable therapy
• medical condition that requires intermittent or continuous use of glucocorticoids
• women who are pregnant, planning to become pregnant or are breastfeeding
• hospitalized for mental illness in last year
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027
Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.
• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
MT2024-19: Registry and Biological Specimen Repository for Inherited Disorders with High Risk for Squamous Cell Carcinoma Development
This study is for people who have Epidermolysis Bullosa (EB), Fanconi Anemia (FA) or a bone marrow failure disorder that puts them at a higher risk of developing a form of skin cancer called squamous cell carcinoma (SCC). To learn more about these disorders and their relationship to cancer, researchers are collecting skin and blood samples to study in the lab. Blood and skin donated to the will be used by researchers at the University of Minnesota in studying the causes, diagnosis, prevention, and treatment of these disorders. We expect that this study will take about two hours, or the amount of time it takes to check in for a clinic visit and collect the specimens.
• at least 2 years of age
• inherited disorders that have an increased risk for squamous cell carcinoma (SCC) development, including, but not limited to, epidermolysis bullosa (EB), Fanconi anemia (FA), and telomere biology disorders/dyskeratosis congenita (TBD/DC)
• women who are pregnant
• people who are a ward of the state
• a prisoner
• an employee, student or trainee of the researcher
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)
This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.
• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
Testing ACL Reconstruction Outcome PredicTions (TAROT)
The purpose of this study is to see how accurately orthopaedic surgeons predict outcomes for people who have an anterior cruciate ligament (ACL) reconstruction. Patients will be asked to complete post-surgery surveys about occurrence of side effects, return to activity, reoperation, and satisfaction with the surgery at 4 months, 2 years, and 5 years.
• patients undergoing primary ACLR (anterior cruciate ligament reconstruction) at the University of Minnesota, Tria and CentraCare.
A Phase 3, Open label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen in Children from 6 Years to less than 18 Years of Age with Active ANCA-associated Vasculitis (AAV)
Blood vessel inflammation can damage parts of the body. The medicines we use to treat AAV try to turn off the blood vessel inflammation to prevent damage to the body. The purpose of this study is to see how safe and how well a medicine called avacopan works when combined with a child’s regular medicine used to treat their AAV. This medicine is not approved in children, so will be called a “study drug.”
• 6 to 17 years old
• diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
• weigh at least 15 kg (33 lbs)
• any other known multisystem autoimmune disease
• any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids
CureGN: Cure Glomerulonephropathy Network Version 3.0
The purpose of CureGN3 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.
• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: diabetes mellitus (except gestational or diet controlled), diabetic glomerulosclerosis, systemic lupus erythematosus, HIV infection, active malignancy (except for non-melanoma skin cancer), active Hepatitis B or C infection, defined as positive viral load
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months
• 18 Years to 83 years old
• male or female of non-childbearing potential
• diagnosis of Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
• Chronic medication for heart failure or cardiovascular disease is at a stable dose
• see link to clinicaltrials.gov for complete Inclusion criteria
• started a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study
• history or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular disease liver disease, infectious disease, or malignancy
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy (BLOSSOM)
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the one’s own tissues. We are doing this study to see if the investigational medication called anifrolumab may have an effect in treating pediatric SLE, to see how well it is tolerated or how safe it is, to measure levels of anifrolumab in the blood and learn more about the disease and associated health problems.
• 5 years to less than 18 years old
• weight at lest 15 kg (33 pounds)
• diagnosis of Systemic Lupus Erythematosus (SLE)
• being treated with prednisone, or antimalarial drugs
• no active or chronic TB or contact with someone who has TB
• females and males must be willing to use birth control during the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months
• history of multiple infections requiring hospitalization and IV antibiotics over the past year
• history of cancer
• history of severe COVID-19 infection
• prior treatment with anifrolumab
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study (At-home ULTRA)
The research objective is to evaluate performance of ultrasound stimulation of the spleen for the treatment of rheumatoid arthritis (RA). In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics for up to 24 weeks of investigational ultrasound treatment.
• active moderate to severe seropositive rheumatoid arthritis (RA)
• have at least 6 total tender and/or swollen joints
• receiving stable background treatment with a csDMARD (e.g. methotrexate) for at least 8 weeks prior to start of the study. Participants must be willing to maintain their background medication regimen throughout the 28-week study period
• may receive up to 10 mg of daily prednisone as part of treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the study and be willing to maintain the stable dose until after the Week 24 of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or trying to get pregnant
• active bacterial or viral infection
• implanted device or other solid object on the spleen side of the torso
• recent abdominal surgery
• see link to clinicaltrials.gov for complete Exclusion criteria
COG AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to < 31 Years Old with First Relapse
The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.
• 1 to 30 years old
• must have first relapse of CD19+ B-ALL (relapse blasts must express CD19)
• must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• see link to clinicaltrials.gov for completed Inclusion criteria
• other types of blood disorders including: B-lymphoblastic lymphoma (B-LLy), Burkitt leukemia/lymphoma or mature B-cell leukemia, Philadelphia chromosome positive (Ph+) B-ALL, mixed phenotype acute leukemia (MPAL), known Charcot-Marie-Tooth disease, MYC translocation associated with mature (Burkitt) B-cell ALL
• active, uncontrolled infection
• significant central nervous system pathology including history of severe neurologic disorder or autoimmune disease with CNS involvement
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals with Co-Occurring Internalizing Disorders
This study is about a new mobile application program called “NEAT-O” which stands for Negative Emotions and Addiction Tools for Opioid Use Disorder. It is designed for people who are struggling with opioid use and also facing issues with anxiety or depression. We are testing the program to see if it's helpful and easy to use. We would also like to learn about your experiences and perspectives on coping strategies for managing symptoms related to opioid use disorder, anxiety, and depression.
• adults ages 22 to 65
• diagnosis of Opioid use disorder (OUD)
• diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, social anxiety disorder, or major depression
• in treatment for OUD using MOUD (medications for opioid use disorder)
• access to an internet-enabled smartphone for the duration of the study
• living in the United States
• diagnosis of psychosis
• current institutionalization (e.g., jail, hospital)
• women who are pregnant
• unable to speak English
AHOD2131, A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.
• 5 to 60 years old
• newly diagnosed untreated confirmed Hodgkin lymphoma
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• patients with nodular lymphocyte predominant Hodgkin lymphoma
• patients with a history of active interstitial pneumonitis or interstitial lung disease
• administration of prior chemotherapy, radiation, or antibody-based treatment for classic Hodgkin Lymphoma (cHL)
• prior solid organ transplant
• prior allogeneic stem cell transplantation
• women who are pregnant or breast feeding
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF SELINEXOR IN MAINTENANCE THERAPY AFTER SYSTEMIC THERAPY FOR PATIENTS WITH P53WILD-TYPE, ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA
The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.
• confirmed Endometrial cancer including: endometrioid, serous, undifferentiated, and carcinosarcoma
• Stage IV disease at diagnosis or first relapse
• may be unable to do physically strenuous activity but walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• gastrointestinal disease that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea)
• serious psychiatric or medical condition that could interfere with participation
• another cancer in the past 3 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria