Search Results
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator s Choice in Participants with Chemotherapy-naïve Metastatic Castration resistant Prostate Cancer
This research study is being done to learn more about how safe and effective the investigational drug xaluritamig is when given in combination with abiraterone acetate compared to standard care (study doctor’s choice of abiraterone acetate, docetaxel, or cabazitaxel) in people with prostate cancer that has spread to other parts of the body but has not yet been treated with chemotherapy in the metastatic castration-resistant prostate cancer (mCRPC) setting.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide, darolutamide or apalutamide oral medications
• cancer is adenocarcinoma type
• prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT)
• no prior chemotherapy in the mCRPC setting (up to 6 cycles of docetaxel in the castration sensitive setting is allowed)
• unable to do physically strenuous activity but walking and able to 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
• history of central nervous system (CNS) metastases
• disease progression on or intolerance to abiraterone
• see link to clinicaltrials.gov for complete exclusion criteria
DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)
The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).
• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do strenuous activity but walking and able to 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
• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654) (INAVO123)
The purpose of this research is to test safety, efficacy and compare the effects of a combination therapy involving inavolisib plus a CDK4/6i (palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole on patients with HR+, HER2- advanced breast cancer (ABC). In this study, you will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole. A placebo looks like a drug but has no active ingredient.
• women or men with confirmed metastatic breast cancer
• ER-positive and/or progesterone receptor-positive and HER2-negative tumor and mutation in PI3K Gene
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Assessment of Patients’ Perspectives Regarding Primary Care Utilization within the Adult Cystic Fibrosis Population
The purpose of this project is to ask adults with cystic fibrosis (CF) about their opinions and experiences with working with a primary care provider (PCP). It is also to assess the utilization of primary care providers in a complex medical care patient population whose primary providers have historically had a medical home in the pulmonary subspecialty.
• adults who have cystic fibrosis (CF) and receive care at the MN CF Center
CVD in Women with CF: Assessing Cardiovascular Risk in Menopausal Women with Cystic Fibrosis
Women with cystic fibrosis (CF) during peri- and postmenopausal stages may be at increased risk for cardiovascular disease, partly mediated by accelerated cardiometabolic risks. This cross-sectional study aims to address critical gaps in understanding cardiovascular disease (CVD) risk in women with CF and will inform early interventions tailored to this growing population.
• women ages 45 years and older
• diagnosed with cystic fibrosis
• pregnant or suspect you may be pregnant
• cognitive or memory difficulties
• unable to read or speak English
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational drug called atumelnant for adults with classic Congenital Adrenal Hyperplasia (CAH) caused by 21-hydroxylase deficiency (21-OHD). Researchers want to learn how well atumelnant helps control CAH symptoms, how the body processes the drug (pharmacokinetics or PK), and whether it produces the expected effects in the body (pharmacodynamics or PD). The study will also evaluate whether participants may be able to reduce their steroid (glucocorticoid) dose while taking atumelnant.
• diagnosis of classical congenital adrenal hyperplasia (CAH)
• on a stable dose of your current steroid (glucocorticoid) treatment
• see link to clinicaltrials.gov for complete inclusion criteria
• diagnosis of any other form of CAH
• are pregnant, breastfeeding, or unable/unwilling to use effective birth control during the study
• see link to clinicaltrials.gov for complete exclusion criteria
MT2021-24: A Phase I Open Label Study to Evaluate the Safety and Tolerability of ISP-001 in Adult Patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie
The purpose of the study is to determine the safety and effectiveness of a new procedure to treat Mucopolysaccharidosis Type I Hurler-Scheie and Scheie (MPS I). This procedure involves collecting some white blood cells (termed “B cells”) and growing them outside of the body in a laboratory. While the cells are in the lab, the B cells will be changed to produce more of the IDUA that is missing. This process is called “genetic modification.” The newly modified B cells are then infused back into the participant.
• diagnosis of Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome
• creatinine clearance, calculated or measured directly, that is greater than 60ml/min/1.73m2
• ejection fraction at least 40% by echocardiogram
• must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion
• must commit to traveling to the study site for the necessary follow-up evaluations
• see link to clinicaltrials.gov for complete Inclusion criteria
• known family inherited cancer syndrome
• had a previous hematopoietic stem cell transplant (HSCT)
• any medical condition likely to interfere with assessment of safety or efficacy of the study treatment (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.
• 18 to 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial
This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.
• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
MT2025-31: A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
The purpose of this study is to test a new CAR T-cell therapy called AZD0120 in adults with multiple myeloma that has returned or has not responded to previous treatments. Researchers want to learn whether this therapy is safe, determine the best dose to use, and see how well it works against the cancer. The study will also look at how the treatment affects the immune system and participants’ quality of life.
• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including commonly used multiple myeloma therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• had serious side effects from prior CAR T-cell or similar immune-based therapies
• have another active cancer, significant medical condition (such as heart, neurological, mental health, autoimmune, or serious infection-related conditions), or plasma cell leukemia (some exceptions may apply)
• have had a recent stroke, seizure, bleeding in the brain, dementia, or major changes in mental status
• have multiple myeloma affecting the brain or central nervous system
• see link to clinicaltrials.gov for complete exclusion criteria
A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer
The purpose of this study is to learn more about ocular (relating to the eye) side-effects of tisotumab vedotin (brand name: TIVDAK™). A side effect is anything the drug does to your body besides treating your disease. It is approved for women with cervical cancer that has spread through the body or come back during or after chemotherapy. We are doing a study to understand whether there are any ocular side-effects of TIVDAK.
• cervical cancer that has returned (recurrent) or spread to other parts of the body (metastasized) during or after chemotherapy
• doctor has decided that Tivdak® is an option for treatment
• agree to use effective contraception
• active eye disease
• women who are breastfeeding, pregnant, or planning to become pregnant
MT2023-01:Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the safety of a new NK cell therapy for people with relapsed or treatment-resistant acute myeloid leukemia (AML). Participants will receive chemotherapy followed by an infusion of specially selected donor immune cells designed to help the body recognize and fight leukemia cells. Researchers will study the safety of this treatment, determine the most appropriate dose, and learn more about how the therapy works in the body.
• diagnosis of acute myeloid leukemia (AML)
• adequate heart, lung, liver, and kidney function
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breast feeding
• diagnosed with leukemia involving the brain or spinal fluid
• active HIV, Hepatitis B, Hepatitis C, other serious infection, recent heart attack, or another active cancer requiring recent chemotherapy
• see link to clinicaltrials.gov for complete exclusion criteria
A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors with Azirkitug as a Single Agent and in Combination(s) with Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
This trial will evaluate whether azirkitug (ABBV-514) as monotherapy and in combination with budigalimab (ABBV-181) or bevacizumab is safe and tolerable for people with locally advanced or metastatic solid tumors.
• 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
• advanced or metastatic cancer who have previously been treated
• see link to clinicaltrials.gov for complete Inclusion Criteria
• active autoimmune or immunodeficiency disease
• women who are pregnant
• significant heart disease
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)
The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.
• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2024-28: A Pilot Study to Investigate the Clinical Utility of Tremoflo Airway Oscillometry in the Pediatric and Adolescent Population with Pulmonary Pathology or at Risk of Lung Injury
The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.
• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
• unlikely to complete required study components
DAS181-3-01: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
This research study is for participants who have a weakened immune system (are immunocompromised), have a lower lung infection and are currently using a machine or device to help them breathe. The study will look at whether the study drug, DAS181, works and how safe it is compared with a placebo in adults who have a weakened immune system (immunocompromised) and a parainfluenza virus (PIV) infection of the lower respiratory tract. A placebo looks the same as the study drug but does not contain any active ingredients.
• needs supplemental oxygen ≥2 liters/minute due to low oxygen levels
• immunocompromised, as defined by one or more of the following: received a stem cell transplant, organ transplant, being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past, or has an immunodeficiency due to congenital abnormality
• men and women of childbearing potential must use effective birth control
• see link to clinical trials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• taking any other investigational drug used to treat pulmonary infection
• severe sepsis
• see link to clincialtrials.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
HM2025-16: Phase Ib/II Trial of Epcoritamab plus Ibrutinib in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma.
This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).
• diagnosis of B-cell non-Hodgkin lymphoma
• have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody
• treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days
• capable of all selfcare and able to walk but unable to carry out any work activities; up and about more than 50% of waking hours
• women of child-bearing potential and men must agree to use adequate contraception 2 weeks before starting treatment, for the duration of study participation and for 12 months after completing treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• active central nervous system (CNS) involvement
• active uncontrolled infection
• current uncontrolled or symptomatic cardiovascular conditions
• liver cirrhosis with moderate to severe liver impairment
• significant lung disease
• treatment with coumadin/warfarin
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
HEALEY ALS Platform Trial
The HEALEY ALS Platform Trial is a research trial that tests the safety and effectiveness of multiple treatments in ALS. A regimen is a specific course of treatment, each with a different study drug. We are doing this research to find out if different treatments have an effect on Amyotrophic Lateral Sclerosis (ALS). We also want to find out if these treatments are safe to take without causing too many side effects.
• 18 years or older
• diagnosed with sporadic or familial ALS
• weakness started no more than 36 months ago -able to to swallow pills and liquids
• unstable medical or mental health condition
• limitations on prior or current use of certain medications (study staff will review)
• women who are pregnant or breast feeding
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)
The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.
• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.
• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
A Phase Ib open label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
The goal of this study is to find out whether combining different study drugs makes tumors shrink in people with advanced head and neck cancer. This type of cancer is in the mouth, nose, throat, and sinuses. The study drugs are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 1 out of 3 groups, by chance (like drawing names from a hat), and which of the study treatments participants will receive.
• confirmed metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) of the primary tumor location of oral cavity, oropharynx, hypopharynx, and larynx
• have not received prior systemic treatment for metastatic or recurrent HNSCC
• do not have contraindications to pembrolizumab
• see link to clinicaltrials.gov for complete Inclusion criteria
• Nasopharyngeal cancer (NPC)
• progressive HNSCC within 6 months of completion of systemic therapy
• prior allogeneic stem cell or solid organ transplantation
• see link to clinicaltrials.gov for complete Exclusion critieria
Biorepository to Support ALS Research in Minnesota
The purpose of the study is to establish and maintain a biorepository of tissue and biospecimen samples relevant to Amyotrophic Lateral Sclerosis (ALS) research. We will obtain, store, and catalogue peripheral blood mononuclear cells (PBMCs), blood and blood components, skin punch biopsy samples, and cerebral spinal fluid (CSF) from people living with ALS, linked to clinical datasets, to advance ALS research.
• People living with ALS: people with a confirmed diagnosis of ALS
• Controls: people who have a neurological disorder other than ALS for which a comparison will assist in medical discovery Healthy controls: Individuals without ALS or other neurological disorders.
• age less than 18 or greater than 90
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM sleep Behavior Disorder
This research is being completed to examine the cells, brain imaging, and speech in individuals with REM Sleep Behavior Disorder who are taking serotonergic medications such as Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine and Sertraline. The purpose of examining these is to try and see if we can predict signs of Dementia with Lewy bodies (a progressive form of dementia with an increase in decline of thinking, reasoning, and other functions). This may benefit others by enabling us to diagnose Dementia with Lewy Bodies sooner rather than later.
• 18 to 75 years old
• diagnosis of polysomnogram-confirmed RBD (e.g. narcolepsy) with history of dream enactment or clear dream enactment visualized on video from polysomnogram
• dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication
• for Healthy Volunteers: on serotonergic medication for at least 6 months without history of dream enactment
• the following serotonergic medications are included for both groups: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
• Parkinsons disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimers disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
• untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
• unable to have a MRI scan
• women who are pregnant
• for Healthy Volunteers: same exclusion criteria as those with 5-HT RBD group, plus history of dream enactment, or increased REM motor tone
MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.
• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
Natural History Study for DNA Repair Disorders
This research is being done to help us better understand the different DNA repair disorders. We will collect data and samples that we will use to develop new therapies and medicine to help treat the disease. We expect that participants will be in this research study for 3 years. Visits will occur every six months and alternate between in-person and remote. Remote visits should be expected to last 1-2 hours, and in-person visits should be expected to last 3-4 hours.
• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
Minnesota Neurogenetics Repository
This research study is for participants who have an inherited neuromuscular disorder or neurogenetic disorder, or family members who are unaffected by such disorders
• individuals with DNA repair disorders including Cockayne syndrome, trichothiodystrophy, and xeroderma pigmentosum
• family members with a genetic neurological or muscle disease
• none
NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2 (NAPS2)
We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.
• male
• 54 to 75 years old
• Caucasian
• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder
A double-blind, randomized, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics and efficacy of BI 765423 administered intravenously on top of standard of care in patients with idiopathic pulmonary fibrosis
The purpose of this study is to find out if a study drug called BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis (IPF). This study compares BI 765423 with a placebo to see if there is a difference in lung function or blood test results related to lung health after 3 month. The placebo looks like BI 765423 but does not contain any active drug.
• at least 40 years old
• diagnosis of idiopathic pulmonary fibrosis (IPF)
• women can only be included if they are unable to become pregnant i.e. post hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, or post menopausal
• men who have woman of childbearing potential (WOCBP) sexual partners must use contraception
• see link to clinicaltrials.gov for complete Inclusion criteria
• acute exacerbation of IPF within at least 12 weeks prior
• significant cardiovascular disease such as severe hypertension, myocardial infarction, stroke, TIA
• significant pulmonary hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria