Search Results
MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Influence of functional hypothalamic amenorrhea on autonomic blood pressure regulation in female endurance athletes
This study is being done to learn more about how hormone changes related to menstrual cycle disruption and underfueling in highly trained endurance athletes may affect blood pressure regulation, blood vessel function, and cardiovascular health. Researchers will measure heart rate, blood pressure, blood vessel function, and nervous system activity in endurance athletes to better understand how these factors differ between athletes.
• females ages 18–35
• endurance athletes who regularly participate in sports such as running, cycling, swimming, skiing, rowing, or multisport activities
• current injury limiting training participation
• pregnant or breastfeeding
• use of depo provera, nexplanon implants, or progestin-only oral contraceptives
• diabetes or significant heart, lung, neurologic, metabolic, or endocrine conditions
• nicotine/tobacco use in the last six months
• current use of heart or blood pressure medications
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.
• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or 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 clinical trials.gov for complete Inclusion criteria
• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
Interpreting mmWave Radar Data for Decision-Making in Simulated
The purpose of this study is to learn how people interpret breathing information displayed during simulated overdose emergencies. Participants will review breathing data, answer questions, and share feedback to help researchers design clearer and more effective tools for emergency response.
• adults aged 18 years or older
• have overdose-response education or training
MT2023-05: GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)
The primary purpose of this study is to identify a safe dose of GTB-3650. The study also provides preliminary disease response information for larger future studies. GTB-3650 is designed to target CD33 on leukemia/MDS cells. Cancer cells must overexpress CD33 (also referred to as CD33+), a marker found in some blood/bone marrow cancers. Based on similar studies and lab studies, it is felt there is a chance of benefit from the study treatment but the duration of benefit is unknown.
• at least 18 years old
• diagnosis of refractory or relapsed myeloid cancer
• not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are usually given for treatment
• sexually active persons of childbearing potential or persons 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 the last dose of study drug
• for the Dose Finding Component Only: must agree to stay within a 60 minute drive of the Study Center through the last study visit after the first dose (29 days)
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• candidate for hematopoietic stem cell transplant (HSCT)
• known history of HIV
• active Hepatitis B or Hepatitis C
• known autoimmune disease requiring active treatment
I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)
The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.
• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
• other medical or mental health diagnosis that would limit compliance with study requirements
A Phase 3 Safety and Efficacy Trial of FLT201 Gene Therapy in Patients with Gaucher Disease Type 1 (GALILEO-3)
The purpose of this study is to evaluate the safety and effectiveness of FLT201, an investigational gene therapy for adults with Gaucher disease type 1. Participants will receive a one-time infusion of FLT201, continue their current treatment for a short time, and complete regular study visits and health assessments over a 5-year follow-up period. Researchers will study the safety of FLT201, how well it works, and how long its effects last.
• 18 years of age or older
• diagnosed with Gaucher disease type 1
• currently receiving enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years
• see the ClinicalTrials.gov listing for complete inclusion criteria
• diagnosis or suspected diagnosis of Gaucher disease type 2 or type 3
• previous gene therapy, cell therapy, or organ/bone marrow transplant
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT) (VICTORION-2P)
The purpose of this study is to learn whether the study treatment, inclisiran, taken in addition to standard cholesterol-lowering medication, can safely reduce the risk of heart attack, stroke, and other serious heart-related events in people with established cardiovascular disease.
• at least 40 years old
• fasting LDL-C at least 70 mg/dL
• stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen including a high-intensity statin therapy (atorvastatin or rosuvastatin)
• any of the following three conditions 1) heart attack (myocardial infarction), 2) stroke, or 3) symptomatic peripheral arterial disease (PAD)
• Heart attack, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease less than 4 weeks
• treatment with PCSK9 inhibitors (evolocumab or alirocumab) within past 90 days
• planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months starting the study
• cancer treated with surgery radiation therapy and/or systemic therapy during the past 3 years
• other significant medical conditions (study staff will review)
• women who are pregnant or breast feeding
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
A placebo-controlled, randomized clinical trial to assess the safety, feasibility, and pharmacokinetics of Microbiota transplant therapy with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension
There is evidence that the gut microbes interact with the body’s immune system, and people with pulmonary hypertension may have altered composition of gut microbes. We are studying whether transplanting gut microbes from healthy donors using a treatment called microbiota transplant therapy may have beneficial effects on pulmonary arterial hypertension.
• ages 18-75
• diagnosis of pulmonary arterial hypertension (PAH)
• on stable treatment for PAH for one month prior to enrollment
• able to swallow capsules
• able to provide blood sample and fecal sample
• active inflammatory bowel disease or celiac disease
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• on immunosuppressants (calcineurin inhibitors, prednisone at a dose of 20 mg/day or more, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
• history of solid organ or bone marrow transplant
• anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
• history of severe anaphylactic food allergy
• receiving cancer chemotherapy, immunotherapy, or radiation
A Phase 1b Study with IMGN151 Monotherapy and Combinations in Subjects with Gynecologic Cancers
This study is being done to test whether IMGN151, given alone or in combination with approved cancer treatments, is safe, well tolerated, and effective for treating ovarian, fallopian tube, or primary peritoneal cancer. Researchers will also study how the body responds to and processes IMGN151 when given at different doses.
• diagnosis of ovarian, fallopian tube, or primary peritoneal cancer
• completed previous cancer treatment before starting the study and have recovered from treatment-related side effects
• able to carry out normal daily activities with little or no assistance
• see link to ClinicalTrials.gov for complete inclusion criteria
• prior treatment with an FRα-targeted therapy
• see link to ClinicalTrials.gov for complete exclusion criteria
MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis (Regulate-RA)
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.
• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
This study tests whether the study drug, a T-cell engager therapy engineered to have fewer off-target effects by increasing its specificity to tumor cells, is safe and tolerable in subjects with metastatic castration-resistant prostate cancer (mCRPC) The study will also assess the potential Phase 2 dose regimens and determine a recommended Phase 2 dose.
• 18 years to 100 years old
• confirmed adenocarcinoma of the prostate
• Metastatic Castration-resistant Prostate Cancer (mCRPC) that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen
• see link to clinicaltrials.gov for complete inclusion criteria
• prior solid organ transplant
• treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
• significant cardiovascular disease
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects with Advanced Solid Tumors (BEHOLD-1)
This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.
• diagnosis of high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube or endometrial cancer that is metastatic or not able to have surgical treatment
• received or are intolerant to 1 but no more than 3 lines of prior systemic therapy
• 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 criteria
• pleural/abdominal effusion/ascites requiring clinical intervention or presence of pericardial effusion
• brain metastasis unless asymptomatic
• heart arrhythmias or ECG abnormalities
• Left ventricular ejection fraction (LVEF) < 50%
• see link to clinicaltrials.gov for complete exclusion criteria
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 non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)
The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.
• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
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
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
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous or Oral Lichen Planus or Lichen Planopilaris (ALPINE)
The purpose of this study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of lichen planopilaris (LPP). Brepocitinib (the “study drug”) is designed to decrease inflammation. The study will look at how safe and effective brepocitinib is and will monitor long-term safety when it is taken for up to 52 weeks. The study drug will be compared to a placebo which is a tablet that looks exactly like the study drug but does not contain any active ingredient.
• diagnosed with lichen planopilaris (LPP)
• have a history of certain blood or lymphatic system cancers, currently have cancer, or have been treated for most cancers within the past 5 years
• have a high risk of blood clots, heart disease, stroke, or shingles
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
Assessing Changes in Knowledge and Attitudes Toward Transcranial Magnetic Stimulation (TMS) After a Demonstration-Based Intervention
The purpose of this study is to learn whether watching a short educational video changes what people know and think about transcranial magnetic stimulation (TMS), a non-medication treatment for depression that uses magnetic pulses. Researchers will also compare different video styles to determine which is most effective at increasing knowledge and improving attitudes about TMS.
• ages 18+
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALTO-300 WITH AN OPEN-LABEL EXTENSION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
The purpose of this study is to evaluate the safety and effectiveness of ALTO-300, an investigational medication being studied for adults with Major Depressive Disorder (MDD). This study will compare ALTO-300 to a placebo to learn more about how the medication may improve symptoms of depression and to identify factors that may help predict who is most likely to benefit from treatment.
• ages 18-70 years old
• diagnosed with moderate to severe major depressive disorder (MDD)
• currently taking one approved antidepressant medication (SSRI, SNRI, or bupropion) for at least 6 weeks with no recent dose changes
• diagnosed with fibromyalgia
• pregnant or breastfeeding
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
Efficacy, safety, and pharmacokinetics of cargrilinitide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
This study will evaluate the efficacy, safety and pharmacokinetics of a combination drug called CagriSema, which is a combination of cagrilintide s.c. 2.4 mg and semaglutide s.c. 2.4 mg for the management of weight in children and adolescents with overweight or obesity. Participants in the study may receive study medication for up to 250 weeks.
• children who are 8 to <18 years old
• history of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counselling) for at least 3 months
• BMI requirements vary by age
• see link to clinicaltrials.gov for complete inclusion criteria
• treatment with any medication prescribed for obesity or weight management within 90 days before starting this study -Type 1 diabetes or monogenic diabetes
• HbA1c greater than or equal to 6.5% if diagnosis of Type 2 diabetes has not been made
• recurrent severe hypoglycaemic episodes within 1 year before starting the study
• see link to clinicaltrials.gov for complete exclusion criteria
HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.
• diagnosis of primary or secondary myelofibrosis
• may be restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria which are specified by diagnosis
• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms
Letermovir (MK-8228) is a medication that is used to prevent cytomegalovirus (CMV) infection and disease. This trial is testing letermovir in children and adolescents who weigh less than 40 kilograms and have had a kidney transplant. Letermovir is experimental in this trial. Everyone in this trial will get letermovir. The dose a child gets will depend on their weight at the start of the trial. The child, the trial doctor and the trial staff will know your child is getting letermovir and what dose they are getting.
• up to 17 years old
• recipient of a primary or secondary allograft kidney
• at least 4 weeks posttransplant and not more than 52 weeks posttransplant
• has stable kidney function since the transplant
• able to take letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube
• weighs ≥2.5 and <40 kg at enrollment (5.5 to 88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
• has CMV disease
• on dialysis or plasmapheresis
• multi-organ transplant recipient (e.g., kidney-pancreas)
• any uncontrolled infection
• see link to clinicaltrials.gov for complete Exclusion criteria
A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY
The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.
• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
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
NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.
• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants with Fragile X Syndrome
Researchers are studying an investigational medication called MRM-3379 for males with Fragile X syndrome (FXS), a genetic condition that can affect learning, memory, communication, and behavior. The goal of this study is to evaluate the safety and tolerability of MRM-3379 and explore whether it may help improve cognitive function by supporting brain cell communication. The study will also examine how the body processes the medication.
• male, ages 13-45
• diagnosed with Fragile X syndrome (FXS) confirmed through genetic testing
• able to complete study activities that assess language and thinking abilities
• have a consistent caregiver who is willing and able to provide regular support during the study
• able to swallow tablets or capsules
• see link to clinicaltrials.gov for complete inclusion criteria