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129 Clinical Paid Trials near Virginia
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 PowerCombination Immunotherapy for Human Papillomavirus Cancers
Bethesda, Maryland
Background:
More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help.
Objective:
To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers.
Eligibility:
People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; cyclin-dependent kinase inhibitor 2A (P16+) oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers
Design:
Participants will be screened with:
* medical history
* disease confirmation (or tumor biopsy)
* physical exam
* body scans (computed tomography (CT), magnetic resonance imaging (MRI), and/or nuclear)
* blood tests
* electrocardiogram (to measure the electrical activity of the heart)
* urine tests.
Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses.
Participants will get M7824 (MSB0011395C) by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period.
Participants will get NHS-IL12 injected under the skin every 4 weeks.
Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study.
About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life.
Patients with cervical cancer with prior pelvic radiation and boost brachytherapy will be enrolled in a separate cohort to evaluate safety and preliminary evidence of efficacy...
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Active Brain Metastasis, Autoimmune Disease, Pregnancy, Recent Major Surgery, Others
Must Not Be Taking:Corticosteroids, Immunosuppressives
51 Participants Needed
INBRX-106 + Pembrolizumab for Lung Cancer
Fairfax, Virginia
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Hematologic Malignancies, CNS Metastases, Autoimmune Disease, Others
Must Not Be Taking:OX40 Agonists, Immunosuppressants
333 Participants Needed
Gene Therapy for Huntington's Disease
Baltimore, Maryland
This trial tests AMT-130, a one-time gene therapy, in patients with early-stage Huntington's Disease. The treatment aims to lower a harmful brain protein to slow down the disease's progression. AMT-130 has shown promise in early research.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:25 - 65
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Experimental Agents, Brain Implants, Others
Must Be Taking:Immunosuppressants
37 Participants Needed
Gene Therapy for Fabry Disease
Fairfax, Virginia
This trial tests ST-920, a treatment using a virus to deliver a gene that helps produce an important enzyme in patients with Fabry disease. The goal is to help these patients by continuously making the enzyme to reduce harmful substances in their bodies. ST-920 is a gene therapy treatment for Fabry disease, which aims to deliver a gene to produce the enzyme alpha-galactosidase A, addressing the enzyme deficiency central to the disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Not Listed
34 Participants Needed
Zipalertinib for Non-Small Cell Lung Cancer
Fairfax, Virginia
This trial is testing CLN-081, a new drug, in patients with a specific type of lung cancer that has a genetic mutation. The drug aims to block a protein that helps cancer cells grow, to see if it can slow down or stop the cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:COVID-19 Pneumonitis, Brain Metastases, Cardiac Conditions, Others
Must Not Be Taking:CYP3A Inhibitors, P-gp Inducers
284 Participants Needed
Fibroblast Injection for Amputation Healing
Baltimore, Maryland
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Autoimmune Conditions, Metastatic Cancer, Infections, Others
Must Not Be Taking:Immunosuppressants, Topical Steroids, Sulfonamides, Others
50 Participants Needed
Immunotherapy + Radiation for Gastroesophageal Cancer
Baltimore, Maryland
This is a Phase 1B study assessing the safety of immune checkpoint inhibition after SBRT in patients with recurrent or metastatic gastroesophageal cancer (limited metastatic disease).
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Cardiovascular Disease, Brain Metastasis, Others
Must Not Be Taking:Systemic Steroids
21 Participants Needed
Adoptive Immunotherapy for Viral Infections
Washington, District of Columbia
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating.
The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnant, CNS Disease, Myelofibrosis, Others
36 Participants Needed
Cabotegravir + Rilpivirine for HIV Infection
Baltimore, Maryland
This trial tests new HIV medications in pill and injection forms for children and teens. The medications work by stopping the virus from growing.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Tuberculosis, Hepatitis, Others
Must Be Taking:Antiretrovirals
168 Participants Needed
Blinatumomab for Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Baltimore, Maryland
The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia \[ALL\], Non-Hodgkin's Lymphoma \[NHL\]).
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Active Infection, Severe GVHD, CNS Pathology, Others
Must Not Be Taking:Calcineurin Inhibitors, Immunosuppressants, TKIs, Others
44 Participants Needed
Brain Imaging + Ketamine for Suicide Risk
Bethesda, Maryland
Background:
There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.
Objective:
To understand what happens in the brain when someone has thought about or attempted suicide.
Eligibility:
Group 1: Adults ages 18 70 who have thought about or attempted suicide recently
Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past
Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide
Group 4: Healthy volunteers the same ages.
Design:
Participants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.
Phase 1: 1 week in hospital. Participants will have:
Physical exam.
Questions about thoughts and feelings.
Thinking and memory tests and simple tasks.
Blood and urine tests.
Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.
Sleep test. Disks and bands will be placed on the body to monitor it during sleep.
Magnetic detectors on their head while they perform tasks.
A wrist monitor for activity and sleep.
Lumbar puncture (optional). A needle will collect fluid from the back.
Shock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.
Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.
Phase 3: up to 4 more ketamine doses over 2 weeks.
Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic Features, Drug Dependence, Serious Medical Conditions, Others
Must Not Be Taking:Reversible MAOIs, Others
325 Participants Needed
Intensive Antiretroviral Therapy for HIV/AIDS in Infants
Baltimore, Maryland
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:< 48
Key Eligibility Criteria
Disqualifiers:Significant Diseases, Others
Must Be Taking:Antiretrovirals
1120 Participants Needed
BCG + N-803 for Bladder Cancer
Richmond, Virginia
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Muscle-invasive Cancer, HIV, CHF, Others
Must Be Taking:BCG Therapy
596 Participants Needed
ETX-636 for Cancer
Fairfax, Virginia
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Other Cancers, Brain Metastases, Diabetes, Others
233 Participants Needed
STC-15 + Toripalimab for Advanced Cancers
Fairfax, Virginia
This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in four different locally advanced unresectable or metastatic tumors such as indications: (1) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in locally advanced and unresectable or metastatic non-small cell lung cancer (NSCLC), (2) in combination with toripalimab in locally advanced unresectable or metastatic melanoma, (3) in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers, and (4) in combination with toripalimab in locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC).
This study comprises of 2 parts: a combination dose escalation part (Phase 1b) followed by an assessment of the combination treatment's antitumor activity (Phase 2). This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in combination with toripalimab.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Surgery, Pneumonitis, Others
Must Be Taking:Anti-PD-1/L1
188 Participants Needed
Lifestyle Intervention vs Metformin for Gestational Diabetes
Washington, District of Columbia
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is:
Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes?
Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes.
Participants will:
* Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
* Track diet, physical activity, and weight using the Fitbit and Looseit! apps.
* Attend weekly online group sessions for the first 4 weeks, then biweekly sessions.
* If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study.
* If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication.
* Continue with biweekly group sessions or have regular check-in calls.
* If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study.
* Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm.
* At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Malignancy, Others
Must Not Be Taking:Weight Loss Medications
60 Participants Needed
AGB101 for Dementia
Baltimore, Maryland
This randomized, crossover, placebo controlled clinical study will assess the efficacy and safety of a slow release form of levetiracetam (AGB101) in the treatment of cognitively normal adults by measuring change in several imaging measures over the course of a two week treatment period.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:50 - 80
Key Eligibility Criteria
Disqualifiers:Neurological Disease, Major Depression, Alcohol Abuse, Others
Must Not Be Taking:Anticonvulsants, Anticoagulants
60 Participants Needed
Mirdametinib + Sirolimus for Multiple Myeloma
Bethesda, Maryland
Background:
Multiple myeloma (MM) is a type of blood cancer that affects a person s immunity. MM returns after treatment (relapse) in almost all people; MM may also not respond to initial treatment (refractory). Many people with relapsed refractory MM (RRMM) also have changes in their KRAS and NRAS genes. Researchers want to try a new drug treatment that targets cancer with these changed genes.
Objective:
To test 2 drugs (mirdametinib and sirolimus) in people with RRMM.
Eligibility:
People aged 18 and older with RRMM who have changes in their KRAS or NRAS genes.
Design:
Participants will be screened. They will have blood tests and imaging scans. They will have an eye exam and a test of their heart function. They will need to provide proof of their disease status and of their KRAS or NRAS status. If neither is available, the tests will be repeated.
Participants will have a bone marrow biopsy: A needle will be inserted into a hipbone to draw out some soft tissue.
This study will be done in two parts. In the first part of this study, we will find a safe dose of mirdametinib combined with sirolimus. In the second part, we will learn more about how mirdametinib combined with sirolimus may work against RRMM.
Mirdametinib (capsules) and sirolimus (tablets) are taken by mouth. Participants will take both drugs at home on a 4-week cycle. They will take mirdametinib twice a day for the first 3 weeks of each cycle. They will take sirolimus once a day, every day, during each cycle.
Participants will have study visits once a week during the first cycle, and then on the first day of subsequent cycles. Blood, heart, imaging scans, and other tests will be repeated.
Treatment with the study drugs will go on for 1 year. Then participants will have follow-up visits every 3 months for 4 more years.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Plasma Cell Leukemia, Amyloidosis, Heart Failure, Others
Must Not Be Taking:CYP3A4 Inhibitors, BCRP Inhibitors
54 Participants Needed
Gene Therapy for Bubble Boy Disease
Bethesda, Maryland
Background:
X-linked severe combined immunodeficiency (XSCID) is a rare inherited disorder that affects the immune system. It is caused by a change in the IL2RG gene. Researchers are investigating a new type of gene therapy for people with XSCID. This technique, called base-edited stem cell transplants, involves collecting a person s own stem cells, editing the genes to repair IL2RG gene, and returning the edited cells to the person.
Objective:
To test base-edited stem cell transplants in people with XSCID.
Eligibility:
People aged 3 years and older with XSCID.
Design:
Participants will be screened. They will have a physical exam. They may give blood, urine, and stool samples. They may have tests of their heart and lung function. They may have fluid and cells drawn from their bone marrow.
Participants will undergo apheresis. Blood will be taken from the body through a needle inserted into 1 arm. The blood will pass through a machine that separates out the stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will undergo gene editing.
Participants will be admitted to the hospital 1 week before treatment. They will receive a central line: A flexible tube will be inserted into a large vein. This tube will be used to administer drugs and draw blood during their stay. They will receive drugs to prepare their bodies for the treatment.
The base-edited stem cells will be infused through the central line. Participants will remain in the hospital for at least 3 weeks while they recover.
Follow-up visits will continue for 15 years.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 1, 2
Age:3 - 99
Sex:Male
Key Eligibility Criteria
Disqualifiers:HLA-matched Sibling, Hypersensitivity To Busulfan, Childhood Malignancy, Others
Must Be Taking:Intravenous Gamma Globulin
18 Participants Needed
Adipose Tissue Allograft for Knee Arthritis
Oxon Hill, Maryland
The purpose of this study is to evaluate the safety profile of BRC-OA for pain treatment in patients with mild to severe OA of the knee, focusing particularly on two distinct doses. Alongside safety assessments, the study also aims to investigate the initial efficacy of BRC-OA in treating pain among these patients. The study product is a cryopreserved devitalized adipose tissue allograft (BRC-OA). BRC-OA is composed of a devitalized human adipose particulate that retains the inherent properties of adipose such as tissue architecture, extracellular matrix, and signaling molecules.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:BMI > 40, Knee Surgery, Others
Must Not Be Taking:Anticoagulants, Immunosuppressives, Marijuana, Others
42 Participants Needed
Why Other Patients Applied
"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 was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"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
"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
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
AV-1 for Dengue Fever
Baltimore, Maryland
The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Alcoholism, Drug Abuse, Hepatitis, Others
Must Not Be Taking:Antidepressants, Immunosuppressants, NSAIDs, Others
84 Participants Needed
PEP-TISSEEL for Radiation Ulcer
Bethesda, Maryland
The goal of this clinical trial is to learn if drug Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (PEP-TISSEEL) works to treat chronic radiation ulcer in adults and compare it with comparator TISSEEL. It will also learn about the safety of drug PEP-TISSEEL.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Infection, Vascular Compromise, Diabetes, Others
Must Not Be Taking:Investigational Drugs
184 Participants Needed
Glycerol Tributyrate for MELAS Syndrome and Optic Neuropathy
Washington, District of Columbia
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic neuropathy-Plus (LHON-Plus) participants will undergo simultaneous enrollment in two disease-based arms and receive daily oral doses of glycerol tributyrate to assess its safety and potential for efficacy using clinical, biochemical, and molecular evidence.
This study will utilize a two-month baseline lead-in phase to establish and document the clinical baseline for each participant in both arms in order to compare the molecular and clinical parameters. This is clinically relevant in light of the high clinical heterogeneity among subjects affected by the same mitochondrial disease (MELAS or LHON-Plus). For ethical concerns prompted by the lack of treatment for these two intractable and progressive mitochondrial diseases, there will not be a placebo control group. Thus, each participant will act as their own control and receive oral doses of glycerol tributyrate, eliminating the need for a placebo. Considering the high clinical heterogeneity among participants affected by MELAS or LHON-Plus and some clinical divergence between MELAS and LHON-Plus, this strategy is beneficial to every enrolled participants, as each will receive the investigational drug, glycerol tributyrate. In addition, this approach will determine the subject-specific maximal optimized dose in a personalized medicine-based approach.
After approval of the IRB protocol from the Institutional Review Board Data and signed consent form from all participants, this investigational basket clinical trial has three phases spanning over 20 months:
* A baseline lead-in phase (2 months) to collect participant-specific baseline for clinical, biochemical, molecular and metabolic biomarkers that will be monitored throughout the subsequent dose-escalation and clinical phases.
* A dose-escalation phase (6 months) to determine the participant-specific maximum tolerated dose (MTD) during which participant-specific clinical and biochemical biomarkers are collected every month.
* A clinical phase at a fixed subject-specific MTD dose (12 months) to collect participant-specific clinical, biochemical, molecular and metabolic biomarkers and to perform three scheduled skin biopsies: at the outset, mid-point, and the end of this clinucal phase. We have planned for a 12-month-long clinical phase at a fixed participant-specific MTD considering the absence of reliable predictors that makes idiosyncratic disease-specific symptoms for MELAS and LHON-Plus impossible to forecast among participant for assessing the potential efficacy of glycerol tributyrate by monitoring clinical symptoms specific for each disease. During the 12-month-long time-frame, disease-specific clinical symptoms will be collected as preliminary evidence of efficacy of glycerol tributyrate using disease-specific biomarkers.
Finally, discharge procedure during which the clinical investigator will record non-serious adverse events or serious adverse events for 7 or 30 days, respectively, after the last day of study participation.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Drug Abuse, Others
Must Not Be Taking:Investigational Agents
24 Participants Needed
GVAX vs mKRASvax for Pancreatic Cancer
Baltimore, Maryland
The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, HIV, Hepatitis, Others
Must Not Be Taking:Steroids, Immunosuppressants
38 Participants Needed
CVXGA Vaccine for Coronavirus
Washington, District of Columbia
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 10016 healthy participants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Acute Illness, Positive COVID-19, Autoimmune, Others
Must Not Be Taking:Intranasal Medications, Immunosuppressants
10016 Participants Needed
VAX-31 Vaccine for Pneumococcal Prevention
Charlottesville, Virginia
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 3 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:42 - 89
Key Eligibility Criteria
Disqualifiers:Pneumococcal Disease, Immunodeficiency, Bleeding Disorder, Others
Must Not Be Taking:Immunosuppressants
800 Participants Needed
Rifaximin for Dementia
Richmond, Virginia
Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:65+
Key Eligibility Criteria
Disqualifiers:Severe Psychopathology, Unstable Medical Conditions, Others
Must Not Be Taking:Antipsychotics, Antibiotics
20 Participants Needed
M9140 for Solid Tumors
Fairfax, Virginia
The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel.
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC);
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC);
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Recent Malignancy, Brain Metastases, Others
Must Not Be Taking:Irinotecan
250 Participants Needed
Azacytidine + Chemotherapy + Durvalumab for Non-Small Cell Lung Cancer
Bethesda, Maryland
Background:
Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \[AZA\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.
Objective:
To find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.
Eligibility:
Adults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.
Participants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.
AZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.
Participants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.
Participants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.
...
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Inoperable, T4 Tumors, Autoimmune, Others
Must Not Be Taking:Systemic Corticosteroids
60 Participants Needed
Ketone-IQ for Sleep Apnea
Baltimore, Maryland
Obstructive Sleep Apnea (OSA) is a common medical disorder that is associated with reduced quality of life and higher risk of cardiovascular disease. Treatments for OSA and limited and not well tolerated. The investigator's lab has shown that a low carbohydrate, high fat ketogenic diet (KD) can reduce OSA severity. Since it can be challenging to adhere to a ketogenic diet, the investigators propose that ingesting exogenous ketones can be an alternative method to improve OSA. Specifically the investigators will examine the effect of taking a commercially available product (Ketone-IQ) at bedtime on overnight ketones and sleep quality. The investigators will also examine the effect of Ketone-IQ on sleep apnea severity, compared to placebo.
This project will examine the the preliminary efficacy of ingesting exogenous ketones before sleep on sleep apnea.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Concomitant Sleep Disorder, Respiratory Impairment, Others
Must Not Be Taking:Opiates, Acetazolamide, SGLT2 Inhibitors
30 Participants Needed
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Frequently Asked Questions
How much do clinical trials in Virginia pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Virginia work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Virginia 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Virginia is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Virginia several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Virginia?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Virginia?
Most recently, we added LevoCept for Birth Control, Ketone-IQ for Sleep Apnea and Mirdametinib + Sirolimus for Multiple Myeloma to the Power online platform.
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