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207 Clinical Trials near Newton, MA
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.
Learn More About PowerMirikizumab for Ulcerative Colitis
Waltham, Massachusetts
This trial is testing a medication called mirikizumab to see if it can help children with ulcerative colitis or Crohn's disease by reducing inflammation in their digestive tracts.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 19
Key Eligibility Criteria
Disqualifiers:Unstable Illness, Adenomatous Polyps, Others
150 Participants Needed
Sotatercept for Pulmonary Arterial Hypertension
Boston, Massachusetts
This trial is testing sotatercept, a medication for high blood pressure in the lungs, in adults with PAH who have completed earlier studies. It aims to see if the medication is safe and effective over a long period. Sotatercept helps lung blood vessels function better, reducing lung pressure. Sotatercept has shown promising results in earlier studies for reducing lung pressure and improving exercise tolerance in patients with pulmonary arterial hypertension (PAH).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Missed Doses, Others
Must Be Taking:PAH Therapy
815 Participants Needed
Systemic + Local Therapy for Prostate Cancer
Boston, Massachusetts
This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Castration-resistant Prostate Cancer, Brain Metastases, Others
Must Be Taking:SST Agents
464 Participants Needed
Vedolizumab for Ulcerative Colitis
Boston, Massachusetts
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Active Infections, TB, Others
Must Not Be Taking:Anti-integrins, Biologics
121 Participants Needed
Ketamine for Suicide Attempts
Boston, Massachusetts
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 60 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk \< 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:14 - 30
Key Eligibility Criteria
Disqualifiers:Autism, Schizophrenia, Substance Use, Others
Must Not Be Taking:Phencyclidine, Cocaine, Amphetamines
60 Participants Needed
Physical Therapy + Antidepressant for Chronic Lower Back Pain with Depression
Chestnut Hill, Massachusetts
This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Back Surgery, Worker’s Compensation, Pregnancy, Others
Must Be Taking:Opioids
330 Participants Needed
Rimegepant for Pediatric Migraine
Waltham, Massachusetts
This trial aims to test the safety of rimegepant, a medication for treating migraines. The study focuses on children and adolescents aged 6 to 17 years who experience moderate to severe migraines. Rimegepant works by blocking a protein that triggers migraine pain, helping to alleviate symptoms.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Cluster Headache, Hemiplegic Migraine, Others
Must Be Taking:Prophylactic Migraine
600 Participants Needed
Alpelisib + Olaparib for Ovarian Cancer
Boston, Massachusetts
This trial is testing whether a combination of two drugs, alpelisib and olaparib, is more effective than standard chemotherapy for women with a specific type of ovarian cancer that doesn't respond well to usual treatments. Alpelisib works by stopping cancer cells from growing, while olaparib makes it harder for them to repair themselves. Olaparib has shown effectiveness in treating ovarian cancer, particularly in patients with certain genetic backgrounds.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Bowel Obstruction, Liver Impairment, Others
Must Not Be Taking:PI3K, MTOR, AKT Inhibitors
358 Participants Needed
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis
Boston, Massachusetts
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Obstructive Airway, Cardiac Disease, Others
Must Be Taking:Pirfenidone, Nintedanib
576 Participants Needed
Ganciclovir for Acute Respiratory Failure
Boston, Massachusetts
This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Immunosuppression, Pregnancy, Cirrhosis, Others
Must Not Be Taking:Anti-CMV Drugs
500 Participants Needed
Fenofibrate for Diabetic Retinopathy
Boston, Massachusetts
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Decreased Renal Function, CI-DME, Others
Must Not Be Taking:Anti-VEGF, Corticosteroids
560 Participants Needed
Rimegepant for Pediatric Migraine
Waltham, Massachusetts
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Cluster Headache, Uncontrolled Psychiatric, Substance Abuse, Others
Must Be Taking:Prophylactic Migraine
2100 Participants Needed
Paclitaxel Coated Balloon for Stent Restenosis
Boston, Massachusetts
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Heart Failure, Substance Abuse, Others
Must Not Be Taking:Antiplatelets, Anticoagulants
600 Participants Needed
Natural vs Programmed Frozen Embryo Transfer for Pregnancy
Waltham, Massachusetts
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).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 41
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Hypertension, Others
Must Not Be Taking:Chronic Systemic Medications
788 Participants Needed
Patching Strategies for Lazy Eye
Boston, Massachusetts
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:3 - 13
Key Eligibility Criteria
Disqualifiers:Myopia > -6.00 D, Surgery, Allergies, Others
544 Participants Needed
Multiple Treatments for ALS
Boston, Massachusetts
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Unstable Medical Condition, Cancer, Others
Must Be Taking:Riluzole, Edaravone
1500 Participants Needed
TAK-788 vs Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer
Boston, Massachusetts
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.
Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Systemic Treatment, Other Malignancy, Uncontrolled Hypertension, Others
Must Not Be Taking:CYP3A Inhibitors, CYP3A Inducers
354 Participants Needed
Balanced Fluids for Pediatric Sepsis
Boston, Massachusetts
The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Brain Herniation, Hyperkalemia, Hypercalcemia, Others
8800 Participants Needed
IV Acetaminophen for Delirium After Cardiac Surgery
Boston, Massachusetts
Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Liver Dysfunction, Alcohol Abuse, Delirium, Others
900 Participants Needed
AT-001 for Diabetic Cardiomyopathy
Boston, Massachusetts
This trial is testing a new drug called AT-001 to see if it can help adults with a heart condition related to diabetes. The goal is to improve their heart function or prevent it from getting worse, especially for those at high risk of severe heart failure.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Heart Failure, Coronary Disease, Arrhythmia, Others
675 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
Anticoagulation + Antiplatelet Therapy for Post-Operative Atrial Fibrillation
Boston, Massachusetts
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Permanent AF, Cardiogenic Shock, Liver Cirrhosis, Others
Must Not Be Taking:Dual Antiplatelets
3200 Participants Needed
Mono vs Dual Therapy for Pediatric Pulmonary Hypertension
Boston, Massachusetts
The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:3 - 18
Key Eligibility Criteria
Disqualifiers:Syncope, RV Failure, Pregnancy, Others
Must Not Be Taking:Cyclosporine, Glyburide, CYP3A Inhibitors, Others
100 Participants Needed
ND0612 for Parkinson's Disease
Boston, Massachusetts
This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD.
Subjects can continue to an optional open-label extension period.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:30 - 80
Key Eligibility Criteria
Disqualifiers:Atypical Parkinsonism, Severe Dyskinesias, Others
Must Be Taking:Levodopa
381 Participants Needed
Multiple Therapies for Glioblastoma
Boston, Massachusetts
This trial is testing various treatments for patients with newly diagnosed or returning brain cancer. It adjusts treatments based on how well patients are doing to find the most effective options. The goal is to improve survival rates by matching the best treatments to specific patient types.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Leptomeningeal Disease, QTc Prolongation, Others
Must Not Be Taking:Carmustine, Lomustine, Bevacizumab, Others
1280 Participants Needed
Intensive Infant Rehabilitation for Perinatal Stroke
Boston, Massachusetts
This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:8 - 36
Key Eligibility Criteria
Disqualifiers:Uncontrolled Seizures, Fragile Health, Others
Must Not Be Taking:Botulinum Toxin
216 Participants Needed
Targeted Therapy Screening for Lung Cancer
Jamaica Plain, Massachusetts
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.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:EGFR Mutations, ALK Fusion, ROS1 Rearrangement, Others
Must Be Taking:Platinum-based Chemotherapy, Anti-PD-1/PD-L1
10000 Participants Needed
Targeted Therapy for Colorectal Cancer
Boston, Massachusetts
This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.
The names of the potential treatments involved in this study are:
* Active surveillance
* FOLFIRI treatment
* Nivolumab treatment
* Encorafenib/Binimetinib/Cetuximab treatment
* Trastuzumab + Pertuzumab
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Uncontrolled Illness, Others
Must Not Be Taking:Steroids, Immunosuppressants
400 Participants Needed
Inclisiran for Cardiovascular Disease
Boston, Massachusetts
This trial tests inclisiran, a new injection to lower cholesterol, in people who have had heart attacks, strokes, or surgeries for blocked arteries. It works by blocking a protein that produces bad cholesterol.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Chronic Liver Disease, Renal Dialysis, Cancer, Others
Must Not Be Taking:PCSK9 Inhibitors
16124 Participants Needed
Simvastatin for Liver Cirrhosis
Boston, Massachusetts
This trial tests if simvastatin can prevent serious liver problems in U.S. Veterans with early-stage liver damage. Simvastatin not only lowers cholesterol but also helps protect the liver from further damage and reduces the risk of severe liver issues. Statins, including simvastatin, have been increasingly recognized for their potential benefits in treating chronic liver diseases, including cirrhosis, by reducing portal pressure and protecting against liver damage.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Statin Use, Hepatocellular Carcinoma, ASCVD, Others
Must Not Be Taking:CYP34A4 Inhibitors
142 Participants Needed
Long-Acting Antiretroviral Therapy for HIV
Boston, Massachusetts
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Seizures, Liver Disease, Others
Must Be Taking:Antiretrovirals
456 Participants Needed
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