Search Results
REFORM-HF. REducing Fluid Overload using Renal Independent systeM in Heart Failure Patients (REFORM-HF)
This research study is designed to evaluate a new treatment approach for patients with chronic heart failure. This study will assess the effectiveness and safety of a new medical device, the AquaPass system, in managing the accumulation of fluids in the body that persists despite standard medical treatment. The purpose of this study is to understand if the use of the AquaPass System with medication treatment results in increased fluid removal compared to only regular medication treatment.
• diagnosis of heart failure NYHA Class II, III who is congested and not responding to usual treatment such as 80mg of lasix (or another diuretic) per day
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• acute worsening of heart failure needing care in the ICU
• arrhythmia, infection, or other medical condition that is causing acute illness
• lower body skin problems (open wounds, ulcers, infections)
• severe peripheral artery disease
• women who are pregnant, breast feeding, or planning to get pregnant during the study period
A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)
The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.
• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function
There is evidence that a short daily resisted breathing exercise, called inspiratory muscle strength training, can lower blood pressure and improve cardiovascular health. However, the most effective inspiratory muscle strength training protocol has not been established. This study seeks to test different training protocols. Participants will perform inspiratory muscle strength training daily, for 6 weeks. Each day's training will take less than 15 minutes to complete. Cardiovascular function will be measured before and after the 6-week training period.
• Non-smoking (not smoking cigarettes or vaping over the past year)
• Resting systolic blood pressure at or greater than 120 mmHg
• Free from serious cardiovascular or metabolic diseases
• English-speaking with ability to comprehend study materials and instructions
• Willing to comply with pre-visit instructions (avoiding food and caffeine ≥ 3 hours, vigorous exercise, alcohol, and non-prescribed medications ≥ 24 hours) prior to each measurement visit
• History of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum)
• Recent abdominal surgery or presence of an abdominal hernia
• Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea
• Pregnant or planning to become pregnant during the study period
A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The purpose of this study is to look at the safety and efficacy of neoadjuvant ( before surgery) carboplatin and mirvetuximab soravtansine for women who have folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. All participants will receive an intravenous infusion of MIRV in combination with carboplatin for up to 6 - 9 Cycles
• 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
• confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer
• see link to clinicaltrials.gov for complete inclusion criteria
• have been treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
• previous clinical diagnosis of noninfectious interstitial lung disease
• eye conditions requiring ongoing treatment/monitoring
• history of another malignancy within past 3 years
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US). Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. Participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.
• 18 to 45 years old
• uncomplicated pregnancy at gestational week 30 or beyond, or birth of a child within the past 6 months
• history of ≥ 4 cigarettes per month during the six months prior to pregnancy
• motivation to become and/or stop smoking after delivery
• willing to use birth control for the 12 weeks of the study
• live in the continental US and have a device to connect to the internet for participation
• see link to clinicaltrials.gov for complete inclusion criteria
• current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• major depressive disorder
• current or within the past 3 months treatment for drug or alcohol use
• see link to clinicaltrials.gov for complete exclusion criteria
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
MT2024-16: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa (Regulate-HS)
This research study is for people who have Hidradenitis Suppurativa (HS) and it is moderate or severe in intensity and have been treated with at least one conventional therapy for HS. This study involves the investigational drug SBT777101, which is created by genetically modifying a patient’s own immune cells. The word “investigational” means that this drug has not been approved by the U.S. Food and Drug Administration (FDA) for marketing. SBT777101 is being developed to treat people with hidradenitis suppurativa (HS).
Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)
Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.
• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)
Levosimendan has not been approved by the FDA to treat people who have PH-HFpEF or approved to be taken by mouth (orally). In this study, we will measure the amount of levosimendan in blood at various times and evaluate the change in participants 6-Minute Walk Distance.
• 18 to 85 years old
• diagnosis of pulmonary arterial hypertension
• on stable doses of heart medication for at least 30 days
• there are specific requirements for birth control for women and men
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• ability to walk is limited by anything other than symptoms (shortness of breath and fatigue) related to pulmonary hypertension
• other diagnosis related to heart function such as valve disease, cardiomyopathy, etc.
• current lung disease
• study staff will review additional inclusion & exclusion criteria
Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments
This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.
• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
An open-label study to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice (NefXtend)
This study is about finding out if the study drug, TARPEYO®, can be taken for a longer time (2 years) than the current recommended 9 months, to better help people with primary IgA nephropathy (IgAN).
• diagnosed with biopsy-proven IgA nephropathy (IgAN)
• completed of 9 months of treatment of Tarpeyo 16mg twice a day (we start screening participants after 7 1/2 months of Tarpeyo treatment so we have enough time to complete all requirements before entering the study). Please contact the study team as early as possible.
• see link to clinicaltrials.gov for complete Inclusion criteria
• treated with systemic immunosuppressants including glucocorticosteroids other than Tarpeyo during treatment of Tarpeyo
• current or planned dialysis
• undergone kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Development of a RET-Specific Proteomic Assay from Circulating Tumor Cells in Lethal Prostate Cancer
The goal of this study is to find a special protein in the blood of individuals with serious prostate cancer. Special tests look for this protein in their blood while they are getting their regular cancer treatments.
• diagnosis of metastatic castration resistant prostate cancer receiving a standard-of-care systemic therapy (e.g. abiraterone acetate, enzalutamide, darolutamide, or chemotherapy).
• known HIV positivity and/or active Hepatitis B based on medical history
A PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF RO7790121 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
The purpose of this study is to learn about the efficacy and safety of RO7790121, which is a new medication being developed to treat people who have moderate to severe atopic dermatitis (AD). Participants will receive either the new medication or a placebo (doesn't contain any medicine) and the results will be compared. The total time of study treatment for an individual will be approximately 30 weeks.
• Diagnosis of Atopic Dermatitis
• Prior or current treatment with any approved or investigational biologics
CONQUER Protocol Number 001: COllaborative, National QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients (CONQUER)
The purpose of this study is to develop a cohort of patients with early scleroderma, and to collect data on clinical outcomes, radiological tests, laboratory tests and to obtain biological specimens for testing.We hope to explore medical care and the impact of SSc on patients' daily lives through various questionnaires that will be collected during study participation. By looking at all of the areas mentioned, we hope to find out information about SSc that will help treat future patients, develop new treatments, and work towards a cure.
• at least 18 years old
• have a diagnosis of systemic sclerosis
• less than 5 years from onset of first symptom attributed to systemic sclerosis
• cognitive impairment that interferes with ability to participate in the study
• unable to speak, read, and write English
MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.
• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
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
MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.
• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Prevalence of "funky" urine in lower urinary tract reconstruction utilizing bowel or catheter-based bladder management
This study is about improving our ability to characterize the prevalence of “funky” urine (i.e., urine with an abnormal odor, color, or appearance) in adults with either (1) a history of lower urinary tract reconstruction utilizing bowel and/or (2) catheter-based bladder management. We also aim to determine the frequency with which such patients receive antibiotic treatment for presumed urinary tract infections (UTIs). This may help us better understand how to help patients avoid unnecessary treatment with antibiotics.
• people who have catheter-based bladder management including an indwelling catheter (urethral or suprapubic, or a channel) or do intermittent clean catheterization OR
• have lower urinary tract reconstruction utilizing bowel including Ileal conduit, neobladder, bladder augmentation, or a catheter channel
• willing to share mobile phone number and use this for contact with the study team
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)
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.
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes. Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.
• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
PEPN2415; A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149, IND# 172675) when Combined with Focal Radiation in Pediatric Patients with High Grade Glioma
The primary purpose of this study is to define the recommended Phase 2 dose of AZD1390 when given in combination with radiation for pediatric supratentorial and infratentorial high-grade gliomas. The toxicities, safety profile and pharmacokinetic profile of AZD1390 in this setting will also be assessed.
• For the dose escalation phase, patients must be ≥ 12 months and < 18 years of age at the time of study enrollment.
• For the disease expansion phase, patients must be ≥ 12 months and < 22 years of age at the time of study enrollment.
• Patients with newly diagnosed primary High-Grade Glioma, Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma who are eligible to receive 54-59.4 Gy fractionated radiation at 1.8 Gy/day.
• Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG.
• Patients who are pregnant or breast-feeding.
• Patients who are currently receiving another investigational drug.
• Patients receiving prior therapy for any cancer diagnosis (including radiation) is not allowed with the exception of surgery and/or corticosteroids.
• Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids.
• Anti-GVHD agents post-transplant: Patients who are receiving anti-graft-versus-host disease post bone marrow transplant.
MTT for H.S. Investigate whether restoring normal gut microbiome composition with cMTT influences the relative overabundance of anaerobic bacteria and microbial diversity of the skin in patients with HS
This research is being done to gain a better understanding of Hidradenitis Suppurativa (HS) and treatment with oral capsule microbiota transplant therapy (MTT) and the effects. Participants will be randomized (by chance) into 1 of 2 groups, treatment or placebo (no active ingredients) group. This study will last for up to 6 months
• at least 18 years old
• diagnosis of Hidradenitis Suppurativa (HS)
• able to speak English
• women who are of child bearing age must use a highly effective form of birth control
• must be on a stable dose of medications for at least 30 days before starting the study
• see link to clinicaltrials.gov for complete inclusion criteria
• planning on moving within 6 months from start of study
• history of anaphylactic food allergies
• women who are pregnant, breastfeeding or planning to get pregnant during the time of the study
• history of inflammatory bowel disease or extensive bowel surgery
• see link to clinicaltrials.gov for complete exclusion criteria
Proteomics of Post-Operative Complications in Patients undergoing CABG
This study aims to identify independent blood-based risk factors for postoperative complications and near-term events among patients undergoing CABG surgery. In particular, this study will be using proteomics, the study of all proteins produced by the cells found in blood, as well as genetic analysis to identify potential predictive markers of postoperative complications. We will collect blood samples from before and after surgery. This study does not involve any medical treatment other than the one prescribed by your doctor, nor does it involve any additional medical procedures.
• Undergoing CABG procedure at MHealth Fairview hospital
• 45-80 years of age
• high risk patient as determined by the Society of Thoracic Surgeons (STS) Risk Assessment Score after designated number of patients have been included (study staff will review)
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.
• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
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
Perception of Affordances in Children with and without developmental coordination disorder
This study looks at perceptual abilities in healthy children and children with significant movement difficulties, a condition called developmental coordination disorder (DCD). The study involves a single session of using virtual reality (VR) to look at catching skills. This will help us to better understand movement difficulties in children so we can design programs to support them.
• children aged 11-17 years old with and without movement difficulties
• medical, behavioral, neurological or psychiatric conditions that prevent them from doing fine and gross motor activities
• children who are unable to communicate in English
PREVENT ALL ALS
Individuals who are carriers of ALS causative gene variants have an increased lifetime risk of developing ALS or a related disorder, Frontotemporal Dementia (FTD). We are doing this research to collect a wide range of biofluid samples, clinical information, and other health and wellbeing information to look for measurable differences that will help us understand how and when the body changes in response to ALS causative gene variants.
• first-degree relative of a known carrier of any Amyotrophic Lateral Sclerosis (ALS) causative gene1 (regardless of whether ALS or Frontotemporal Dementia FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
• access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
• evidence of neurological signs or symptoms concerning for ALS of FTD
• significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days (about 3 months)
• clinically significant, unstable medical condition