Search Results
MT2022-49: Early identification of cognitive side-effects of immunotherapy
This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.
• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
• presence of speech or hearing problem
• diagnosis of cognitive impairment
A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies
This study is testing the study drug BDTX-4933 in people with locally advanced (unresectable) or metastatic solid tumors that are characterized by a KRAS, BRAF, or NRAS mutation/alteration(s). The primary objective of the study is to assess how well participants tolerate the drug and if it is effective.
• recurrent or advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations
• exhausted all available standard-of-care therapies
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• cancer that has a known MEK1/2 mutation
• ongoing anticancer or radiation therapy
• women who are pregnant or breastfeeding
COgnitive STrategies in Early Psychosis 1
This study is about decision making in psychosis spectrum disorders, like schizophrenia. We will study how a single dose of a study agent called modafinil changes how people complete computer tasks and changes how the brain functions. We hope to improve our understanding of psychosis to help people in the future.
• 18 to 35 years old
• speak English as primary language
• major medical diagnosis such as neurological disorder, kidney, heart, liver disease
• people who are pregnant, breastfeeding, or planning to become pregnant
• have a diagnosis or immediate family history of a psychotic, bipolar, or autism spectrum disorder
• study staff will review additional criteria
Solid Tumor Cancer Specimen Bank - Sarcoma Cohort
The purpose of this research is to collect, store and distribute specimens and information about people with solid tumors. Samples from many people are being collected and stored so they can be used for research now and in the future.
• diagnosis sarcoma
• planned visit at a University of Minnesota Cancer Clinic
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
A Pilot Study of Treatment of Bone Metastases in Spine: Radio Frequency Ablation/ Bone Augmentation plus Radiotherapy Vs. Radiotherapy
This clinical study is for adults whose cancer has spread to the bones of the middle or lower back (spine). Doctors are comparing two common treatments: (1) a needle procedure to treat the tumor and strengthen the bone, followed by radiation, and (2) radiation therapy alone. The goal is to see which option better relieves pain, protects the spine, and improves quality of life. The treatment you receive will be chosen at random (by chance), meaning you will be placed into a study group by chance.
• confirmed metastatic disease in the thoracic or lumbar region of the spine
• associated bone pain
• persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• prior radiation therapy to the same area of the spine
• spine stabilization surgery is being considered
• see link to clinicaltrials.gov for complete Exclusion criteria
Using MRI Scans to Inform Individualized Neuromodulation Interventions in Major Depressive Disorders with and without Comorbidities
This study collects MRI brain scans before, during, and after treatment in people with depression and other mental health conditions who are receiving neuromodulation therapies. The goal is to see whether differences in brain structure can help explain why some people respond to treatment better than others.
• age 18 or older
• seeking clinical or research neuromodulation interventions for depression (with or without comorbidities)
• able to read English
• cannot complete MRI
Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease (Le-Na)
This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.
• ages 18 to 80
• diagnosis of Gaucher Disease
• hematological cancer or other uncontrolled medical conditions
COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003) (OMAHA-003)
This trial is testing MK-5684 in men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with next-generation Hormonal Agent (NHA) and Taxane-based chemotherapy. This trial will compare MK-5684 to abiraterone acetate and enzalutamide. Abiraterone acetate and enzalutamide are standard treatments for mCRPC. The purpose of this trial is to test the safety of the trial drug, MK-5684, see how well the drug works, and see how the body handles the drug. We also want to see if participants who get MK-5684 live longer compared to those who get abiraterone acetate or enzalutamide.
• diagnosis of adenocarcinoma of the prostate
• cancer progression while on androgen deprivation therapy with metastasis to bone or other areas of the body
• received 1 but no more than 2 taxane-based chemotherapy regimens
• unable 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 and exclusion criteria
• unable to swallow capsules/tablets
• gastrointestinal disorder that might affect absorption
• poorly controlled diabetes mellitus
• history of clinically significant ventricular arrhythmias
• known additional cancer that is progressing or has required active treatment within the past 3 years
The effects of vagus nerve stimulation on intrinsic lower leg spinal motoneuron excitability in Parkinson's disease
This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson’s disease (PD) and test if stimulation of a nerve at the neck (vagus nerve) can improve muscle activation, walking and balance. People can participate in one of two experiments, or both. Both experiments will test the muscle activation patterns in the lower leg when producing low levels of force. We will also assess walking and balance. Experiment 2 will test muscle activation patterns, walking and balance before and after vagus nerve stimulation. We are also asking people who don’t have PD and are 21 to 76 years old and match in age and sex to participants to undergo the same study procedures.
• See link to clinicaltrials.gov for complete Inclusion criteria
• history of another significant neurological disorder including stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor
• severe orthopedic or other related musculoskeletal disease that significantly affects gait
• women who are pregnant
• history of substance abuse in the past two years
• unable to comprehend English
• see link to clinicaltrials.gov for complete Exclusion criteria
Neural underpinnings of understanding speech in different listening contexts
This study looks at how the brain processes speech in different listening situations, like when multiple people are talking at the same time or when there’s background noise.
• adults aged 18-29 years
• normal hearing
• proficient in spoken English
• neurological problems
• auditory neuropathy spectrum disorder (ANSD)
• wear a cochlear implant
MT2025-24: A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
This study is for people who have been diagnosed with advanced cancer that has not has not responded to standard treatment. FT836 is a type of cell product made up of “T cells” which are part of the immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells. We want to test the safety of FT836 at different doses, to understand how the body processes and responds to FT836, and to find out what effects FT836 may have on participants and the cancer. The study will also find out what effects FT836, when given alone and with or without chemotherapy treatment (paclitaxel) and/or a monoclonal antibody (cetuximab or trastuzumab.
• confirmed locally advanced or metastatic cancer including breast cancer, ovarian cancer, endometrial carcinoma, gastric/GEJ cancer, head & neck cancer, non small cell lung cancer, or colorectal cancer
• women & men of childbearing age must use highly effective birth control
• may not be able 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
• women who are pregnant or breastfeeding
• other cancer in the past two years
• significant cardiac (cardiac arrhythmias, myocardial infarction, unstable angina or congestive heart failure) or neurological disease (stroke, epilepsy, CNS vasculitis, or neurodegenerative disease)
• active central nervous system (CNS) involvement
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer
The main goal of this study is to see if it's safe for people to take xaluritamig together with either darolutamide or abiraterone.
• diagnosis of metastatic adenocarcinoma of the prostate
• started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (pre-enrollment treatment with enzalutamide, abiraterone, apalutamide, or darolutamide are allowed).
• first treatment with ADT should be no longer than 12 weeks before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of central nervous system (CNS) metastases
• autoimmune disease requiring systemic treatment in the past 2 years
• prior radiotherapy (to the prostate and/or to all visible metastatic lesions; palliative radiation within 2 weeks prior to first dose of study treatment is allowed
• see link to clinicaltrials.gov for complete Exclusion criteria
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: R33 Phase
This study will look at the effects of treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and Transcranial Magnetic Stimulation (TMS) for young people who have tic disorder. Participants must be 12- 21 years old and able to have an MRI. All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered to be the first treatment for tics. Participants will also be assigned randomly (by chance) to receive TMS or a sham (treatment not delivered) just before each CBIT session. The device for TMS delivers electromagnetic stimulation to a specific area of the brain with a small coil on the scalp. The effectiveness of the CBIT for the two groups, with and without the TMS, will be compared.
• between the ages of 12 – 21
• currently experiencing chronic motor and/or vocal tics
• able to undergo MRI
• study staff will review additional exclusion criteria
• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Investigating Vaped Phenanthrene Biomarkers in Former Smokers
Former smokers continue to be at higher risk for developing lung cancer than non-smokers,even years after quitting. This study will look at how a specific chemical, phenanthrene, is broken down in former smokers and non-smokers. If former smokers break down this chemical in a more harmful way, it might help explain their increased risk for lung cancer. Study participants will be asked to attend an in-person study visit to vape a small amount of phenanthrene. You'll then be given supplies to collect your urine for 24 hours afterwards.
• In good health
• 21 years or older
• Previously smoked cigarettes daily for at least 10 years
• Have been completely quit for at least 1 year
• Have tried vaping at least once
• Willing to vape a study compound (does not contain nicotine)
• Current smoker
A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled bySecond Generation H1-Antihistamines (RECLAIM)
The purpose of this study is to evaluate the efficacy of remibrutinib in comparison to dupilumab. We want to see which one works better for helping adults who have chronic spontaneous urticaria (CSU) and haven't had relief with use of second-generation antihistamines in treating adult participants who have CSU.
• diagnosis of Urticaria
• prior use of remibrutinib, dupilumab or other BTK inhibitors
An interventional Phase 3, open-label, two-cohort study to investigate the efficacy and safety of fosmanogepix in adult patients with invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds
The purpose of this study is to compare the effects of the study drug fosmanogepix with that of other currently approved treatments to find out if fosmanogepix is safe and effective in treating participants with invasive mold infections. Participants will be assigned to one of two groups depending on the study treatment already received for the current mold infection. Participation in this study will be for a maximum of 8 months.
• diagnosis of proven or probable Invasive mold infection
• see link to clinicaltrials.gov for complete Inclusion criteria
• need or anticipated need for hemodialysis, peritoneal dialysis, or hemofiltration
• moderate or severe liver disease
• known human immunodeficiency virus infection
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations.
This clinical research study is being conducted to gain knowledge about a new drug called BAY 2927088 for a type of cancer called advanced non-small cell lung cancer, which cannot be removed with surgery or has spread to other parts of the body, and has a mutation in the HER2 gene.
• locally advanced non small cell lung cancer (NSCLC) not suitable for definitive therapy or recurrent or metastatic NSCLC at screening
• treatment with at least one prior systemic therapy for advanced disease
• people who do not have standard of care access due to any reason, are intolerant to, or are not eligible for
• documented activating EGFR and/or HER2 mutation
• may be 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 primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery)
• history of congestive heart failure (CHF) Class >II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation)
• see link to clinicaltrials.gov for complete Exclusion criteria
A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)
This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.
• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
Continuous Glucose Monitor Derived Glucose Dynamic Index as a Diagnostic Marker for Progression to Type 1 Diabetes (Dx-T1D)
This study is being done to develop a way to use information from a continuous glucose monitor (CGM) to predict a person’s progression through the Stages of Type 1 Diabetes (T1D). A CGM is a wearable device that continuously measures and displays a person’s blood sugar levels throughout the day and night by sensing the glucose (blood sugar levels) in the fluid under the skin, providing real-time updates without the need for finger pricks.
• ≥2 years of age and older
• participants in Stage 1 or Stage 2 T1D monitored in the Pathway to Prevention (PTP) study at a TrialNet center
• willing to use a continuous glucose monitoring (CGM) system with a compatible smartphone for glucose data collection
• history of diabetes
• women who are pregnant
• allergy to adhesives
A Phase 1B/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7- H3 Antibody-Drug Conjugate (ADC), In combination with Atezolizumab with or Without Carboplatin as First Line Induction or Maintenance, In Subjects with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)
This study is being done to learn more about the safety and effectiveness of ifinatamab deruxtecan (I-DXd) against extensive stage small cell lung cancer.
• diagnosis of extensive small cell lung cancer
• have not received any prior treatment (first line therapy)
• may be unable to do physically strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• agree to use a contraceptive method that is highly effective
• see link to clincialtrials.gov for complete inclusion criteria
• any of the following within the past 6 months: cerebrovascular accident, (CVA) transient ischemic attack, (TIA) or another arterial thromboembolic event
• uncontrolled or significant cardiovascular disease
• history of another cancer in the past 5 years
• history of bone marrow, stem cell, or solid organ transplant
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
People planning to undergo a bone marrow transplant and are at risk for developing problems with the lungs related to this planned therapy. The types and seriousness of lung problems that may develop after transplant can be very different and currently, we don’t exactly know what risk factors influence who develops them or how they may respond to therapy. Also, we do not know what the best test is to monitor lung function after transplant, especially in children and young adults. The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what is the best method for diagnosing lung problems and following how well the lungs are working. In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.
• up to 24 years old
• undergoing allogeneic or autologous HSCT
A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
The goal of this study is to evaluate nemtabrutinib compared with either ibrutinib or acalabrutinib for treatment of people with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy.
• diagnosis of CLL/SLL and with active disease requires therapy
• able to swallow and retain oral medication
• at least capable of all selfcare but may unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
• active hepatitis B virus/ hepatitis C virus
• history of severe bleeding disorder
• clinically significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-42: Phase 1b Dose Expansion/2 Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis (NEXICART-2)
The purpose of this study is to find the best dose of NXC-201 to treat AL amyloidosis. The people in this study have AL amyloidosis that came back or does not get better with treatment. NXC-201 is a cellular therapy made from your own white blood cells called T cells. If you join this study, we will collect some of your T cells and modify (change) them in a lab. This modification will help your T cells find and kill abnormal plasma cells. These genetically changed T cells are called chimeric antigen receptor (CAR) T cells. NXC-201 is a CAR T cell therapy and is given intravenously (by vein). To prepare your body for NXC-201, you will also get fludarabine and cyclophosphamide, which are chemotherapy drugs. After you get NXC-201, you will be in the hospital for at least 10 days.
• walking and able to do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• proven diagnosis of systemic AL amyloidosis
• have symptoms of organ involvement (heart, kidney, liver/GI tract, peripheral nervous system)
• able to swallow pills
• see link to clinicaltrials.gov for complete Inclusion criteria
• prior treatment with CAR T therapy
• stroke or seizure within past 6 months
• significant heart disease
• women who is pregnant, or breastfeeding, or planning to become pregnant
• unwilling to practice effective birth control
• see link to clinical trials.gov for complete Exclusion criteria
A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.
• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)
We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.
• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
SUSTAINED RELEASE ORAL FORMULATION FOR TREATMENT OF PARKINSON'S DISEASE
Medications used to treat Parkinson's disease will be delivered using a sachet ; placed in the oral/buccal cavity (between cheek and gum of lower jaw). This study may be a good fit for you if you are healthy, between the ages of 18 and 65, and aren’t currently taking regular medications. We expect that you will be in this research study for one visit, approximately 7 hours total. Compensation and transportation expenses will be provided.
• Normal healthy
• 18-65 years of age
• Not currently taking medications regularly
• Able to fast 6 hours, only water allowed
Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Locally Advanced or Metastatic Solid Tumors
This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.
• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breastfeeding
Acoustic analysis of voice, speech, and breath sounds in subglottic stenosis
This study is about understanding how subglottic stenosis (narrowing within the airway) affects voice, speech, and breathing sounds. Changes in airflow from airway narrowing can alter how the voice sounds, how speech is timed, and how breaths are taken during speaking. By using advanced, noninvasive sound analysis, we hope to identify patterns that may help detect airway narrowing earlier and track improvement after treatment.
• at least 18 years of age
• diagnosis of subglottic stenosis by otolaryngologist and/or pulmonologist
• no known laryngeal or pulmonary comorbidities potentially contributing to voice or breathing problems (except asthma)
• able to read, write, and communicate in English
• Healthy Volunteers who will be matched by age & sex to study participants: at least 18 years of age, no known primary laryngeal or pulmonary comorbidities, no symptoms of shortness of breath and able to read, write, and communicate in English
• current voice/resonance, breathing, or swallowing disorder
• women who are pregnant
• current upper respiratory infection
• Healthy Volunteers: women who are pregnant or upper respiratory infection or obstruction