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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.

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RO7790121 for Crohn's DiseaseLansdowne Town Center, Virginia

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).600 Participants Needed

RO7790121 for Ulcerative ColitisLansdowne Town Center, Virginia

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).350 Participants Needed

Dato-DXd + Rilvegostomig for Non-Small Cell Lung CancerLeesburg, Virginia

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.675 Participants Needed

Capivasertib + CDK4/6 Inhibitors + Fulvestrant for Breast CancerLeesburg, Virginia

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)895 Participants Needed

Adagrasib vs Docetaxel for Non-Small Cell Lung CancerLeesburg, Virginia

This trial is testing a new drug called adagrasib against an existing chemotherapy drug, docetaxel. It focuses on patients with advanced lung cancer who have a specific genetic mutation (KRAS G12C) and have already had treatment. The new drug aims to block this mutation in cancer cells to stop their growth.453 Participants Needed

Hypofractionated Radiation Therapy for Breast CancerLeesburg, Virginia

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.897 Participants Needed

Proton Therapy vs Photon Radiation for Esophageal CancerLeesburg, Virginia

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.300 Participants Needed

Adagrasib + Pembrolizumab for Lung CancerLeesburg, Virginia

This trial tests two drugs, MRTX849 and pembrolizumab, in patients with advanced lung cancer who have a specific genetic mutation. MRTX849 targets the mutation to stop cancer growth, while pembrolizumab boosts the immune system to fight the cancer. The study aims to see how well these treatments work alone and together.806 Participants Needed

Flu Vaccine for InfluenzaSterling, Virginia

This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.1380 Participants Needed

GS-1427 for Ulcerative ColitisLansdowne Town Center, Virginia

The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.228 Participants Needed

Tilpisertib for Ulcerative ColitisLansdowne Town Center, Virginia

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.176 Participants Needed

D-4517.2 for Age-Related Macular Degeneration and Diabetic Macular EdemaLeesburg, Virginia

This trial tests a new injectable drug, D-4517.2, in people with wet AMD or DME. The drug aims to block a protein that causes harmful blood vessel growth in the eye, potentially preventing further vision loss.50 Participants Needed

SAM + Diclofenac for Broken Bone PainLansdowne, Virginia

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.90 Participants Needed

TRK-950 Combinations for Ovarian CancerLeesburg, Virginia

This trial is testing a new drug, TRK-950, combined with other cancer treatments in patients with advanced cancers. The goal is to see if TRK-950 can help these treatments work better by boosting the body's ability to fight cancer or making cancer cells more vulnerable.138 Participants Needed

Exercise Coaching for Gynecologic CancersLeesburg, Virginia

Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.16 Participants Needed

SakuraBead Embolization for OsteoarthritisLeesburg, Virginia

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).89 Participants Needed

Psychosocial Education for Chronic PainAshburn, Virginia

Health inequalities in chronic pain exists in the US, with a greater burden of chronic pain and higher rate of misdiagnosis and undertreatment reported in minoritized groups compared to non-Hispanic Whites. Asian Americans (AA) are the fastest-growing racial/ethnic group in the US, yet despite the rapid growth in their numbers, AA remain under-represented in pain disparity research. Cultural norms of Asians may discourage reporting their pain to avoid burdening others or being seen as weak. Rather than seeking medical assistance, Asians have been reported to tend to accept the pain as natural or to suffer to maintain their independence. Very few evidence-based programs are available that can be implemented for this linguistically/socially isolated population in the US. This proposed study aims to fill critical knowledge gaps in pain disparity research by providing evidence of feasibility and acceptability of a culturally-tailored psychosocial pain education intervention for an underrepresented population using the KA community as an exemplar.45 Participants Needed

Monitoring Methods for Pancreatic CystLeesburg, Virginia

The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.4606 Participants Needed

CC-93538 for Eosinophilic EsophagitisLeesburg, Virginia

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms: Placebo for Induction and Maintenance CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance CC-93538 360 mg SC once weekly for Induction and Maintenance399 Participants Needed

Non-TNFi Biologics vs Targeted Synthetic DMARDs for Rheumatoid ArthritisReston, Virginia

This trial is testing advanced medications for RA patients who haven't responded to standard treatments. It compares biologic drugs that target immune proteins and synthetic drugs that block harmful molecules in immune cells. The goal is to see which treatment improves patients' quality of life and daily functioning better. Biologic therapies have notably improved the treatment of RA, making disease remission a realistic goal.924 Participants Needed

Perioperative Chemotherapy for Pancreatic CancerLeesburg, Virginia

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).352 Participants Needed

Ivonescimab + Pembrolizumab for Lung CancerReston, Virginia

This trial is testing two treatments for advanced lung cancer. One uses a new drug, Ivonescimab, and the other uses an existing drug, Pembrolizumab, both combined with chemotherapy. The goal is to see which treatment helps patients live longer and has fewer side effects.1080 Participants Needed

Camizestrant for Early Breast CancerReston, Virginia

This trial is testing camizestrant, a drug that blocks estrogen, in patients with ER+/HER2- early breast cancer at medium to high risk of recurrence. The goal is to see if it works better than standard hormone treatments by stopping cancer cells from growing.4300 Participants Needed

Milvexian for Acute Coronary SyndromeLeesburg, Virginia

This trial is testing a new medication called milvexian to see if it can better prevent serious heart problems like heart attacks and strokes in patients who are at high risk. The medication works by preventing blood clots, which helps keep blood flowing smoothly.16000 Participants Needed

Olpasiran for Cardiovascular DiseaseLeesburg, Virginia

This trial is testing olpasiran, a medication that may reduce heart risks, in patients with heart disease and high levels of a specific type of fat called Lipoprotein(a). By lowering this fat, olpasiran aims to prevent heart attacks and other serious heart problems. Inclisiran is another emerging drug targeting LDL cholesterol, similar to olpasiran's focus on reducing lipoprotein(a).7297 Participants Needed

Imlunestrant for Early Breast CancerReston, Virginia

This trial is testing a new medication called imlunestrant to see if it works better than standard hormone treatments for certain breast cancer patients. The study focuses on patients with early-stage breast cancer that is estrogen receptor positive and HER2 negative, who have already been on hormone therapy for a period of time and are at high risk of their cancer returning. Imlunestrant works by blocking estrogen from helping cancer cells grow.8000 Participants Needed

Elagolix + COC for EndometriosisReston, Virginia

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.800 Participants Needed

SAR408701 vs Docetaxel for Non-Small Cell Lung CancerLeesburg, Virginia

Primary Objectives: * Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\]) * Study success was defined either on PFS or OS * The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) * The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: * Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * Evaluated the safety of tusamitamab ravtansine compared to docetaxel * Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel389 Participants Needed

Mirikizumab for Ulcerative ColitisReston, Virginia

This trial is testing mirikizumab, a medication for people with severe ulcerative colitis. It aims to see if the drug can reduce gut inflammation by blocking a protein that causes it. The study will last several years. Mirikizumab has shown positive results in early tests for ulcerative colitis.1063 Participants Needed

Chemotherapy + Atezolizumab for Breast CancerLeesburg, Virginia

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.1550 Participants Needed

CM-AT for AutismHerndon, Virginia

This trial is testing a special enzyme powder called CM-AT to help children with autism digest protein better.405 Participants Needed

mRNA Vaccines Comparison for COVID-19 PreventionReston, Virginia

This trial is testing a new COVID-19 vaccine called mRNA-1283.222. It aims to see if this new vaccine is safe and effective. The vaccine works by using a small piece of genetic material to help the body recognize and fight the virus.14246 Participants Needed

REC-4881 for Solid TumorsGermantown, Maryland

This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.60 Participants Needed

Irinotecan + FOLFOX Chemotherapy for Rectal CancerLeesburg, Virginia

This trial is testing different treatments in patients with advanced rectal cancer to see which one is more effective at shrinking the tumor or stopping its growth, potentially avoiding surgery.312 Participants Needed

Zipalertinib for Non-Small Cell Lung CancerReston, Virginia

This Trial is testing zipalertinib, a new drug, in patients with advanced lung cancer that has specific genetic changes. The drug aims to stop cancer growth by blocking faulty proteins. The study involves patients with different backgrounds and genetic profiles.220 Participants Needed

PF-06835375 for Low Platelet CountGermantown, Maryland

This trial uses a new injectable medicine called PF-06835375. It targets adults with long-lasting or chronic low platelet counts due to primary immune thrombocytopenia (ITP). The medicine works by reducing specific immune cells to help increase platelet counts.61 Participants Needed

Valemetostat + Pembrolizumab for Lung CancerReston, Virginia

This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations137 Participants Needed

Adagrasib Combo Therapy for Lung CancerReston, Virginia

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation90 Participants Needed

Medtronic Device Follow-Up for Spinal ConditionsReston, Virginia

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.1000 Participants Needed

GAE with Embosphere Microspheres for Knee OsteoarthritisLeesburg, Virginia

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.264 Participants Needed

Synergy Disc vs. ACDF Surgery for Degenerative Disc DiseaseReston, Virginia

A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.200 Participants Needed

Synergy Disc vs ACDF Surgery for Degenerative Disc DiseaseReston, Virginia

A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.175 Participants Needed

INSPIRE Stewardship Bundle for Skin and Soft Tissue InfectionsReston, Virginia

This trial tests a computer system that helps doctors choose the right antibiotics for adults with skin infections by predicting if the infection will resist common treatments.102 Participants Needed

INSPIRE Stewardship Bundle for Abdominal InfectionsReston, Virginia

This trial tests a computer system that helps doctors choose the best antibiotics for non-critically ill adults with abdominal infections. The system shows how likely it is that an infection is resistant to common antibiotics. This aims to improve treatment decisions and outcomes for these patients.102 Participants Needed

Semaglutide + Low-Dose Insulin Glargine for Type 2 DiabetesReston, Virginia

This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.568 Participants Needed

MR-100A-01 for Birth ControlReston, Virginia

This trial is studying a birth control patch called MR-100A-01 in women. The patch contains hormones that prevent pregnancy by stopping ovulation and making it harder for sperm to reach eggs. The study will look at how well the patch works, how it affects menstrual cycles, and its safety and tolerability. The MR-100A-01 patch is similar to other transdermal contraceptive patches that have been studied for their effectiveness in preventing ovulation and controlling menstrual cycles.1321 Participants Needed

Donanemab for Alzheimer's DiseaseChantilly, Virginia

This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.2196 Participants Needed

RGX-202-01 Combination Therapy for Colorectal CancerGermantown, Maryland

This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. The single agent ompenaclid dose escalation stage and the ompenaclid in combination with FOLFIRI and bevacizumab dose escalation stage of the study has been completed; the expansion stage of ompenaclid in combination with FOLFIRI and bevacizumab is ongoing. In April-24 a protocol amendment added a new dose escalation and expansion stage which will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study.108 Participants Needed

Enhanced Cluster Detection Methods for Outbreak ControlReston, Virginia

Despite the critical importance of identifying hospital-associated outbreaks as early as possible in order to limit their spread, there are currently no standardized methods for cluster detection. The CLUSTER Trial (Cluster Linkage Using Statistics to Trigger and Evaluate Response) will assess whether a statistically-based automated cluster detection method coupled with a robust response protocol will enable rapid containment of hospital clusters as measured by a reduction in cluster size and duration as compared to routine hospital cluster detection methods coupled with the same response protocol. Note: that enrolled "subjects" represents 82 individual HCA Healthcare hospitals that have been randomized82 Participants Needed

Smart Prompt System vs Routine Care for Urinary Tract InfectionReston, Virginia

The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.59 Participants Needed

Smart Antibiotic Use Prompt for PneumoniaReston, Virginia

The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with PNA is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.59 Participants Needed

Serplulimab + Chemotherapy for Small Cell Lung CancerBethesda, Maryland

This trial is testing two different treatment combinations for patients with extensive-stage small cell lung cancer who have not received any prior treatment. One group will receive a new drug called Serplulimab along with standard chemotherapy, while the other group will receive an existing drug called Atezolizumab with the same chemotherapy. Both immunotherapy drugs aim to help the immune system fight cancer, and the chemotherapy drugs work by killing cancer cells. Atezolizumab has been shown to improve survival in small-cell lung cancer when combined with chemotherapy, changing the standard first-line therapy.200 Participants Needed

Serplulimab + Chemotherapy for Small Cell Lung CancerFairfax, Virginia

This trial tests if adding a new drug called Serplulimab to standard treatments (chemotherapy and radiotherapy) can help patients with a specific type of lung cancer. Serplulimab aims to boost the immune system to fight cancer more effectively. Serplulimab has shown benefits when combined with chemotherapy in previous trials.511 Participants Needed

Frexalimab for Multiple SclerosisVienna, Virginia

The study is evaluating the efficacy and safety of Frexalimab in patients with non-relapsing, secondary progressive MS. The primary objective is to determine whether Frexalimab can delay disability progression compared to placebo.858 Participants Needed

Frexalimab for Multiple SclerosisVienna, Virginia

The study is evaluating whether Frexalimab performs better than the existing MS medication, Teriflunomide, at reducing the number of relapses in patients with relapsing forms of multiple sclerosis.1400 Participants Needed

SEP-363856 for Major Depressive DisorderGaithersburg, Maryland

A Phase 2/3 Trial is designed to evaluate SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder900 Participants Needed

Osavampator as an Adjunctive Treatment for DepressionGaithersburg, Maryland

This trial evaluates whether adding the investigational drug Osavampator (also known as NBI-1065845) to existing oral antidepressant therapy can improve depressive symptoms in patients with depression who aren’t adequately responding to their current antidepressant medication(s).200 Participants Needed

ONC-392 vs Chemotherapy for Lung CancerFairfax, Virginia

This trial is testing gotistobart, a new drug that helps the immune system fight advanced lung cancer in patients who haven't responded to other treatments. It works by blocking a protein that allows cancer cells to hide from the immune system.600 Participants Needed

Trappsol Cyclo for Niemann-Pick DiseaseFairfax, Virginia

This trial is testing a medicine called Trappsol Cyclo, given through an IV, for patients with Niemann Pick disease type C1. The medicine helps remove harmful fat buildup in cells. The study will also look at safety in younger children. Trappsol Cyclo has shown promising results by mobilizing cholesterol, extending life, and reducing neurological damage in Niemann-Pick disease type C1.94 Participants Needed

Daraxonrasib for Non-Small Cell Lung CancerFairfax, Virginia

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.420 Participants Needed

Remibrutinib for Hidradenitis SuppurativaVienna, Virginia

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).555 Participants Needed

Investigational Vaccine for ChickenpoxVienna, Virginia

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.750 Participants Needed

Low Dose Tamoxifen for Breast CancerMcLean, Virginia

This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.1156 Participants Needed

EYP-1901 for Age-Related Macular DegenerationFairfax, Virginia

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.400 Participants Needed

RMC-6236 for Pancreatic CancerFairfax, Virginia

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.460 Participants Needed

Ambroxol for Sanfilippo SyndromeFairfax, Virginia

A dose escalation study to evaluate the safety, tolerability, and pharmacologic properties of Ambroxol in adult participants with Sanfilippo disease(s) (MPS3).10 Participants Needed

Optune + Temozolomide + Pembrolizumab for Brain CancerFairfax, Virginia

This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).741 Participants Needed

TAK-279 for PsoriasisRockville, Maryland

The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times.1300 Participants Needed

RSV Vaccine for Adults 60+Rockville, Maryland

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.15500 Participants Needed

Axitinib Implant for Age-Related Macular DegenerationFairfax, Virginia

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration825 Participants Needed

HyBryte Cream for Cutaneous T-Cell LymphomaFairfax, Virginia

To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).80 Participants Needed

Barzolvolimab for HivesRockville, Maryland

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.915 Participants Needed

BHV-7000 for EpilepsyMcLean, Virginia

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.390 Participants Needed

Psilocybin for DepressionRockville, Maryland

This trial is testing psilocybin, a substance from mushrooms, to see if it can help adults with depression who may not respond well to current treatments. Psilocybin works by affecting brain chemicals related to mood. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as a breakthrough therapy by the FDA in 2019.240 Participants Needed

ALZ-801 for Early Alzheimer's DiseaseFairfax, Virginia

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.163 Participants Needed

Dostarlimab for Head and Neck CancerFairfax, Virginia

The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)864 Participants Needed

Zongertinib for Lung CancerFairfax, Virginia

This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.416 Participants Needed

BHV-7000 for EpilepsyBethesda, Maryland

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.390 Participants Needed

Chemotherapy for Pancreatic CancerFairfax, Virginia

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.100 Participants Needed

Avutometinib + Defactinib for Ovarian CancerGainesville, Virginia

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.270 Participants Needed

Bria-IMT + CPI for Advanced Breast CancerBethesda, Maryland

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.404 Participants Needed

Nectero EAST System for Abdominal Aortic AneurysmFairfax, Virginia

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.400 Participants Needed

Alectinib Pharmacogenomics for Lung CancerRockville, Maryland

This trial investigates how genetic differences in patients with non-small cell lung cancer affect their response to ALECENSA treatment. By studying these genetic variations, researchers aim to improve the effectiveness and safety of the medication.600 Participants Needed

Disitamab Vedotin + Pembrolizumab vs Chemotherapy for Bladder CancerFairfax, Virginia

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease. Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced). In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.400 Participants Needed

Chemotherapy + Hormone Therapy for Breast CancerMcLean, Virginia

This trial is testing if adding additional cancer-fighting drugs to treatments that stop certain body functions is better than just using the treatments that stop those functions alone. It targets younger women with early-stage breast cancer who have a higher risk of dying from the disease. The treatment works by stopping certain body functions and using drugs to kill cancer cells.3960 Participants Needed

Luveltamab Tazevibulin for Ovarian CancerFairfax, Virginia

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.600 Participants Needed

Proton Therapy for Breast CancerFairfax, Virginia

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.276 Participants Needed

Dostarlimab for Colon CancerBethesda, Maryland

This trial is testing dostarlimab, a drug that helps the immune system fight cancer. It targets patients with a specific type of colon cancer that has certain genetic features and can be surgically removed. Dostarlimab works by helping the immune system recognize and destroy cancer cells.711 Participants Needed

Pembrolizumab for Triple-Negative Breast CancerMcLean, Virginia

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.1295 Participants Needed

Dexpramipexole for AsthmaVienna, Virginia

This trial is testing an oral medication called dexpramipexole in people with severe asthma that isn't well controlled by usual treatments. The medication aims to reduce certain cells in the blood that make asthma worse, helping to better manage symptoms.1395 Participants Needed

Chemotherapy + Immunotherapy for Esophageal and Gastric CancerFairfax, Virginia

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.382 Participants Needed

Ianalumab + Corticosteroids for Low Platelet CountBethesda, Maryland

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.225 Participants Needed

Psilocybin for Treatment-Resistant DepressionGaithersburg, Maryland

This trial is testing a new medication called COMP360 to help people with severe depression that hasn't improved with other treatments. The study involves adults aged 18 and older. Researchers want to see if a single dose of COMP360 can reduce depression symptoms when given with psychological support.255 Participants Needed

Furmonertinib for Non-Small Cell Lung CancerRockville, Maryland

This trial is testing furmonertinib at two different doses to treat a specific type of lung cancer. It targets patients with advanced or metastatic non-squamous NSCLC who have a particular genetic mutation. The medication works by blocking a protein that helps cancer cells grow, potentially slowing down or stopping the cancer.398 Participants Needed

CSL300 for Kidney FailureFairfax, Virginia

This trial is testing CSL300, a new treatment, to see if it helps people with heart disease or diabetes who are on dialysis. The study aims to find the right dose and check if it improves heart health by reducing inflammation.2310 Participants Needed

ECLIPSE PV / A22-203Bethesda, Maryland

This trial tests a medication called ropeginterferon alfa-2b-njft in adults with polycythemia vera, a type of blood cancer. The goal is to see how well it works and how safe it is. The medication helps the immune system control abnormal blood cells to prevent serious health issues. Ropeginterferon alfa-2b is a new form of treatment recently shown to be safe and effective in polycythemia vera.111 Participants Needed

Remternetug for Alzheimer's DiseaseFairfax, Virginia

This trial tests remternetug, a drug given by injection or IV, in people with early Alzheimer's disease. It aims to find out if the drug is safe and can help improve symptoms or slow down the disease.1667 Participants Needed

Surgery and Radiation vs. Radiation Alone for Brain CancerFairfax, Virginia

This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.236 Participants Needed

GBT021601 for Sickle Cell DiseaseFairfax, Virginia

This trial is testing an oral medication called osivelotor to see if it can safely help people with sickle cell disease feel better. It will also study how the medication works in the body.429 Participants Needed

Placebo +1 More for ConditionFairfax, Virginia

This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.750 Participants Needed

Venglustat vs Imiglucerase for Gaucher DiseaseFairfax, Virginia

This trial compares a pill to injections in patients aged 12-18 and adults with Gaucher disease Type 3. The pill aims to help with brain symptoms, while the injections maintain overall health. The pill has the potential to improve Gaucher disease by rebalancing certain substances in the body.43 Participants Needed

Venglustat for Fabry DiseaseFairfax, Virginia

This trial is testing a medication called venglustat to see if it can help reduce pain in people with Fabry disease. The medication works by targeting the root causes of nerve and abdominal pain.122 Participants Needed

Chemotherapy Tailored by ctDNA Status for Colon CancerMcLean, Virginia

This trial tests if a blood test for cancer DNA can help decide if colon cancer patients need more treatment after surgery. The test looks for cancer DNA in the blood to predict if the cancer might come back and to guide further treatment.1912 Participants Needed

Soticlestat for Dravet SyndromeBethesda, Maryland

This trial tests soticlestat to reduce seizures in children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome. Soticlestat helps by targeting brain pathways involved in seizure activity. The study will evaluate its safety, effectiveness, and tolerance over time.400 Participants Needed

Remibrutinib vs Teriflunomide for Multiple SclerosisVienna, Virginia

This trial compares remibrutinib and teriflunomide in patients with relapsing multiple sclerosis. It aims to find out which medication is more effective and safer. Both drugs work by controlling the immune system to reduce relapses. Teriflunomide is an approved treatment for adults with this condition.800 Participants Needed

Combination Immunotherapy for Lung CancerMcLean, Virginia

This trial is testing a new combination of treatments for patients with advanced lung cancer. The treatments aim to boost the immune system's ability to fight cancer and prevent it from growing. The goal is to see if this combination can help patients live longer compared to standard treatments.82 Participants Needed

Lomustine + Standard Therapy for GlioblastomaFairfax, Virginia

This phase III trial compares the effect of adding lomustine to standard chemotherapy with temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's DNA and may kill tumor cells. Radiation therapy uses high energy x-ray photons to kill tumor cells and shrink tumors. Adding lomustine to standard chemotherapy with temozolomide and radiation therapy may shrink or stabilize glioblastoma.306 Participants Needed

High-Dose vs Low-Dose Cisplatin with Radiation for Head and Neck CancerFairfax, Virginia

This phase II/III trial compares whether cisplatin given weekly with radiation therapy is better tolerated than cisplatin given every three weeks with radiation therapy for the treatment of head and neck cancer that has spread to other places in the body (advanced). The second part of this study will also help to find out if the cisplatin given weekly approach will extend patients' life by at least the same amount of time as the cisplatin given every three weeks approach. Cisplatin is in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Radiation with low-dose cisplatin given weekly may be effective in shrinking or stabilizing head and neck cancer or preventing its recurrence.1714 Participants Needed

Hormone Therapy + Radiation for Prostate CancerFairfax, Virginia

This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score. Patients with higher Decipher risk score will be assigned to the part of the study that compares the use of 6 months of the usual treatment (hormone therapy and radiation treatment) to the use of darolutamide plus the usual treatment (intensification). The purpose of this section of the study is to determine whether the additional drug can reduce the chance of cancer coming back and spreading in patients with higher Decipher score. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Alternatively, patients with low Decipher risk score will be assigned to the part of the study that compares the use of radiation treatment alone (de-intensification) to the usual approach (6 months of hormone therapy plus radiation). The purpose of this part of the study is to determine if radiation treatment alone is as effective compared to the usual treatment without affecting the chance of tumor coming back in patients with low Decipher score prostate cancer. Radiation therapy uses high energy to kill tumor cells and reduce the tumor size. Hormone therapy drugs such as darolutamide suppress or block the production or action of male hormones that play role in prostate cancer development. Effect of radiation treatment alone in patients with low Decipher score prostate cancer could be the same as the usual approach in stabilizing prostate cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy.2050 Participants Needed

Evorpacept Combo for Stomach CancerFairfax, Virginia

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.450 Participants Needed

Asciminib vs Other TKIs for Chronic Myeloid LeukemiaGainesville, Virginia

This trial is testing a new drug called asciminib against other existing treatments for adults newly diagnosed with a specific type of leukemia. The goal is to see if asciminib is more effective at blocking a protein that helps cancer cells grow. Asciminib has shown superior efficacy in patients with chronic myeloid leukemia (CML) previously treated with multiple other treatments.405 Participants Needed

Lanifibranor for Nonalcoholic Steatohepatitis (NASH)Fairfax, Virginia

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F31000 Participants Needed

Atropine Eye Drops for Near-SightednessRockville, Maryland

This trial is testing special eye drops with a tiny amount of atropine to see if they can slow down worsening nearsightedness in children. The drops work by relaxing eye muscles and slowing down changes in the eye. Lower doses of atropine have shown effectiveness with fewer side effects.678 Participants Needed

Atrasentan for IgA NephropathyFairfax, Virginia

This trial is testing a medication called atrasentan to help people with a kidney disease called IgA nephropathy. It aims to protect their kidneys by reducing protein in their urine. The study will compare atrasentan to another treatment over a few years. Atrasentan has been studied for its effects on reducing protein in urine and protecting kidney function in patients with diabetic nephropathy.404 Participants Needed

Combination Therapy for Multiple MyelomaFairfax, Virginia

This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, 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. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.1450 Participants Needed

Selinexor + Ruxolitinib for MyelofibrosisGainesville, Virginia

This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.350 Participants Needed

Pre- and Post-Surgery Chemotherapy for Gallbladder CancerFairfax, Virginia

This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine 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. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach.186 Participants Needed

Natural vs Programmed Frozen Embryo Transfer for PregnancyRockville, Maryland

NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).788 Participants Needed

Vagus Nerve Stimulation for Rheumatoid ArthritisFairfax, Virginia

The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.243 Participants Needed

Hormone + Radiation Therapy for Prostate CancerFairfax, Virginia

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.2753 Participants Needed

Chemotherapy + Retifanlimab for CancerFairfax, Virginia

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.308 Participants Needed

T-DM1 + Tucatinib for Breast CancerMcLean, Virginia

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.1031 Participants Needed

Radiation Therapy + Atezolizumab for Small Cell Lung CancerFairfax, Virginia

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.138 Participants Needed

Ipilimumab + Nivolumab + Radiation for GlioblastomaFairfax, Virginia

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, 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. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.159 Participants Needed

Immunotherapy + Chemotherapy for Non-Small Cell Lung CancerMcLean, Virginia

This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, 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. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.1210 Participants Needed

Atezolizumab + Radiation Therapy for Lung CancerFairfax, Virginia

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.480 Participants Needed

Duloxetine for Colorectal CancerFairfax, Virginia

This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.220 Participants Needed

Stereotactic Radiosurgery for Brain MetastasisFairfax, Virginia

This trial compares two radiation treatments for patients with brain cancer that has spread and been surgically removed. One treatment uses a single session of radiation, while the other uses several sessions. The goal is to see which method is more effective and has fewer side effects.242 Participants Needed

Tucatinib + T-DM1 for Breast CancerFairfax, Virginia

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.466 Participants Needed

De-intensified Radiation Therapy + Cisplatin/Nivolumab for Oropharyngeal CancerFairfax, Virginia

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.384 Participants Needed

Targeted Therapy Screening for Lung CancerMcLean, Virginia

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.10000 Participants Needed

Pembrolizumab for Skin CancerFairfax, Virginia

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.280 Participants Needed

Atezolizumab + Standard Therapy for HER2-Positive Breast CancerFairfax, Virginia

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, 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. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. \*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.190 Participants Needed

Chemotherapy + Immunotherapy for Recurrent Ovarian CancerMcLean, Virginia

This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.444 Participants Needed

Chemotherapy Combinations for Triple-Negative Breast CancerMcLean, Virginia

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.782 Participants Needed

Crizotinib for Non-Small Cell Lung CancerFairfax, Virginia

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.168 Participants Needed

Chemotherapy and Radiation Based on EBV DNA for Nasopharyngeal CancerFairfax, Virginia

This trial tests different combinations of chemotherapy drugs and radiation therapy for advanced nasopharyngeal cancer. It targets patients whose cancer has not spread beyond the local region. The treatment works by killing cancer cells or stopping their growth using powerful drugs and radiation. Previous studies have shown a survival benefit using a combination of these treatments for nasopharyngeal carcinoma.685 Participants Needed

Radiation vs. Radiation + Lymph Node Dissection for Breast CancerFairfax, Virginia

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.2012 Participants Needed

Radiation Therapy for Oropharyngeal CancerFairfax, Virginia

This randomized phase III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.440 Participants Needed

Eflornithine + Sulindac for Colorectal Cancer PreventionMcLean, Virginia

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.354 Participants Needed

Orforglipron for Type 2 Diabetes and ObesityRockville, Maryland

The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO. Participation in the study will last about 18 months.600 Participants Needed

VDPHL01 for Male Pattern BaldnessRockville, Maryland

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).480 Participants Needed

KarXT for Bipolar DisorderGaithersburg, Maryland

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.274 Participants Needed

KarXT for Bipolar DisorderGaithersburg, Maryland

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.300 Participants Needed

Tirzepatide for Type 1 Diabetes and ObesityRockville, Maryland

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.905 Participants Needed

Migalastat for Fabry DiseaseFairfax, Virginia

An open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric subjects 2 to \< 12 years of age with Fabry disease and with amenable GLA variants.8 Participants Needed

SEP-363856 for SchizophreniaGaithersburg, Maryland

This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia522 Participants Needed

Tezepelumab for COPDPotomac, Maryland

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)990 Participants Needed

4D-150 + EYLEA for Age-Related Macular DegenerationFairfax, Virginia

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration400 Participants Needed

AR882 for GoutRockville, Maryland

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months750 Participants Needed

Baxdrostat + Dapagliflozin for Chronic Kidney Disease and High Blood PressureFairfax, Virginia

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure5000 Participants Needed

Rilvegostomig + Pembrolizumab + Chemotherapy for Lung CancerFairfax, Virginia

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).880 Participants Needed

Baxdrostat + Dapagliflozin for Heart FailurePotomac, Maryland

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.11300 Participants Needed

Remternetug for Alzheimer's DiseaseFairfax, Virginia

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.1200 Participants Needed

High-Dose Vaccine for FluGaithersburg, Maryland

The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.1178 Participants Needed

Rilvegostomig + Pembrolizumab + Chemotherapy for Non-Small Cell Lung CancerFairfax, Virginia

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.878 Participants Needed

mRNA Vaccine for FluRockville, Maryland

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.56000 Participants Needed

Ixekizumab + Tirzepatide for PsoriasisRockville, Maryland

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.250 Participants Needed

AD109 for Obstructive Sleep ApneaVienna, Virginia

The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.1280 Participants Needed

Povetacicept for IgA NephropathyFairfax, Virginia

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.480 Participants Needed

Povorcitinib for Prurigo NodularisRockville, Maryland

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.330 Participants Needed

Elacestrant for Breast CancerFairfax, Virginia

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.4220 Participants Needed

Enlicitide Decanoate for High CholesterolRockville, Maryland

This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).3000 Participants Needed

Aflibercept for Age-Related Macular Degeneration and Diabetic Macular EdemaFairfax, Virginia

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications. The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.1118 Participants Needed

Upadacitinib vs Dupilumab for EczemaRockville, Maryland

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.675 Participants Needed

Sacituzumab Tirumotecan for Cervical CancerFairfax, Virginia

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion. The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.686 Participants Needed

Enlicitide Decanoate for High CholesterolRockville, Maryland

The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.301 Participants Needed

Zanidatamab vs Trastuzumab for Breast CancerFairfax, Virginia

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.550 Participants Needed

Venetoclax + Obinutuzumab/Acalabrutinib for Chronic Lymphocytic LeukemiaGainesville, Virginia

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.120 Participants Needed

Dato-DXd ± Osimertinib for Lung CancerFairfax, Virginia

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).630 Participants Needed

AK112 for Non-Small Cell Lung CancerFairfax, Virginia

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)420 Participants Needed

Sacituzumab Tirumotecan for Gastroesophageal CancerFairfax, Virginia

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).450 Participants Needed

Sacituzumab Tirumotecan + Pembrolizumab for Breast CancerFairfax, Virginia

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.1200 Participants Needed

V940 + Pembrolizumab for Skin CancerFairfax, Virginia

This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of intismeran autogene in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that intismeran autogene plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to intismeran autogene plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.1012 Participants Needed

Fianlimab + Cemiplimab for MelanomaFairfax, Virginia

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)560 Participants Needed

JNJ-77242113 for Plaque PsoriasisRockville, Maryland

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.731 Participants Needed

Epcoritamab + Rituximab + Lenalidomide for LymphomaFairfax, Virginia

This trial tests a new drug combination for adults with untreated follicular lymphoma, a type of blood cancer. The new treatment includes epcoritamab, lenalidomide, and rituximab, which work together to help the immune system attack cancer cells. The study will check how safe and effective this combination is. Lenalidomide combined with rituximab has shown high efficacy in both relapsed/refractory and untreated follicular lymphoma.1095 Participants Needed

Ritlecitinib for VitiligoRockville, Maryland

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: * if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) * Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study * Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: * have non-segmental vitiligo (either active or stable) and * received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.400 Participants Needed

Omadacycline vs Moxifloxacin for Community-acquired PneumoniaFairfax, Virginia

The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.100 Participants Needed

ABBV-383 for Multiple MyelomaFairfax, Virginia

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.380 Participants Needed

Opevesostat + Hormone Therapy for Prostate CancerFairfax, Virginia

This trial is testing a new drug called opevesostat for advanced prostate cancer patients who don't respond to usual care. The drug aims to stop the cancer from growing and spreading, potentially helping patients live longer.1500 Participants Needed

Nemtabrutinib for Chronic Lymphocytic LeukemiaFairfax, Virginia

The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.1200 Participants Needed

Volrustomig for Advanced Throat CancerFairfax, Virginia

This trial is testing volrustomig, a medication, in patients with a specific type of head and neck cancer that hasn't worsened after standard treatment. The goal is to see if volrustomig can help stop the cancer from growing.1145 Participants Needed

AZD5305 for Prostate CancerFairfax, Virginia

This trial is testing a new drug called Saruparib combined with hormone treatment in adults with prostate cancer that has spread but still responds to hormones. The drug aims to stop cancer cells from repairing themselves, potentially slowing down the disease.1800 Participants Needed

LY3537982 + Immunotherapy/Chemotherapy for Non-Small Cell Lung CancerFairfax, Virginia

This trial is testing a new drug, LY3537982, combined with standard treatments for patients with advanced lung cancer that have a specific genetic mutation. The goal is to see if this combination works better than the usual treatments alone.1016 Participants Needed

Ziltivekimab for Heart AttackFairfax, Virginia

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.10000 Participants Needed

Tarlatamab for Small Cell Lung CancerFairfax, Virginia

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).400 Participants Needed

Povorcitinib for VitiligoRockville, Maryland

This trial is testing a medication called povorcitinib to see if it can help people with nonsegmental vitiligo, a condition where skin loses its color in patches. The medication might work by stopping the immune system from attacking the cells that give skin its color. Researchers want to find out if it is effective and safe for these patients.450 Participants Needed

Dato-DXd + Durvalumab for Breast CancerFairfax, Virginia

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.1900 Participants Needed

TAK-279 for Plaque PsoriasisRockville, Maryland

This trial is testing a new drug called TAK-279 to see if it can help people with moderate to severe plaque psoriasis. The study will compare TAK-279 to an existing treatment called apremilast, which is approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis. The goal is to find out if TAK-279 can better reduce the skin problems associated with this condition.1108 Participants Needed

MEDI5752 + Chemotherapy for Pleural MesotheliomaFairfax, Virginia

This trial is testing a new drug called Volrustomig combined with two chemotherapy drugs, Carboplatin and Pemetrexed. It targets adult patients with advanced pleural mesothelioma that cannot be removed by surgery. The treatment aims to help the immune system fight the cancer while also killing cancer cells directly.825 Participants Needed

Toripalimab + Tifcemalimab for Small Cell Lung CancerBethesda, Maryland

The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.756 Participants Needed

V940 + Pembrolizumab for Lung CancerFairfax, Virginia

This trial is testing a new treatment combination of V940 and pembrolizumab in patients who have had surgery to remove Stage II, IIIA, or IIIB non-small cell lung cancer. The goal is to see if this new combination can help prevent the cancer from coming back. V940 and pembrolizumab work together to help the immune system find and destroy any leftover cancer cells.868 Participants Needed

Ritlecitinib for VitiligoRockville, Maryland

This trial is testing ritlecitinib, a medicine for treating vitiligo, in adults with nonsegmental vitiligo. The medicine works by protecting skin color cells from being destroyed by the immune system. The study will compare ritlecitinib to see if it is safe and effective. Ritlecitinib is being tested for its efficacy in treating alopecia areata and vitiligo.1201 Participants Needed

mRNA-1345 Vaccine for RSVRockville, Maryland

This trial tests the safety and immune response of the mRNA-1345 vaccine in high-risk adults and those with organ transplants. The vaccine uses genetic instructions to help the body recognize and fight the virus.1150 Participants Needed

Giredestrant vs. Fulvestrant for Advanced Breast CancerFairfax, Virginia

This trial is testing two drug combinations to treat a specific type of advanced breast cancer that no longer responds to standard hormone treatments. The goal is to see which combination works better by stopping the cancer cells from growing.1050 Participants Needed

Seladelpar for Primary Biliary CholangitisGermantown, Maryland

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.90 Participants Needed

Brigimadlin for LiposarcomaFairfax, Virginia

This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.138 Participants Needed

Fluticasone + Albuterol for AsthmaRockville, Maryland

This trial tests different doses of a combination of fluticasone and albuterol in an electronic inhaler for asthma patients. The goal is to reduce severe asthma attacks by decreasing lung inflammation and opening airways. Fluticasone is a potent anti-inflammatory medication, and albuterol helps to open airways.2196 Participants Needed

Seladelpar for Primary Biliary CholangitisFairfax, Virginia

This trial is testing Seladelpar, a medication that may help people with a specific liver disease called Primary Biliary Cholangitis (PBC) and early-stage cirrhosis. The drug aims to reduce liver inflammation and damage, potentially improving liver health. Seladelpar has shown promising results in previous studies for PBC, despite initial safety concerns.318 Participants Needed

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200 Clinical Trials Near You

Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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